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

NCT0531xxxx/NCT05317793.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/NCT05317793</url> </required_header> <id_info> <org_study_id>R21149</org_study_id> <nct_id>NCT05317793</nct_id> </id_info> <brief_title>Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout</brief_title> <official_title>Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout</official_title> <sponsors> <lead_sponsor> <agency>Tampere University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Tampere University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Tampere University 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> The study investigates the associations of ambulatory electrodermal activity (EDA) measurements with mental well-being at work, especially job burnout. Appropriate statistical methods are applied to predict burnout with EDA measurements combined with self-report surveys on emotional valence. </textblock> </brief_summary> <detailed_description> <textblock> The aim of the study is to complement burnout research by considering ambulatory electrodermal activity (EDA) measurements as part of the identification and definition of the burnout phenomenon. Previous studies have shown that assessment methods for the physiological identification of burnout do not yet exist and that more information on the physiological markers of burnout is needed. The study also complements the understanding of how and in what cases ambulatory measurements of EDA can be justified, for example, as an occupational health care tool.  The study investigates the association between ambulatory EDA measurements and mental well-being, especially job burnout, and the potential of the measurements in supporting better mental health at work. According to research the EDA measurements alone do not always provide sufficient information and often context related information is needed to improve the interpretation of the measurement. Therefore, the EDA measurements are complemented with the self-reported emotional valence.  The state of mental well-being is defined using Peter Warr's model of affective well-being. The model proposes that two dimensions of emotion, arousal and emotional valence, together can provide information / be used to describe one's affective well-being at work. The model is further based on the circumplex model of affect.  Previous studies of EDA have shown that the measurement method has a potential role in assisting the diagnosis of some mental disorders, such as anxiety and depression. However, the measurements have been largely tied to laboratory settings and have not been able to be utilized in everyday life. The development of health and well-being technology has brought to the market methods for measuring the electrical conductivity of the skin, which are suitable for ambulatory measurements, but whose suitability must be critically assessed.  Within this study it is hypothesized that the average variation of the sympathetic nervous system activity measured with EDA and combined with a self-reported emotional valence is associated with mental well-being at work, as burnout measured with the Burnout Assessment Tool (BAT-12), anxiety measured with Generalized Anxiety Disorder (GAD-7) Scale, depression measured with Beck Depression Inventory (BDI-21), and job engagement measured with Utrecht Work Engagement Scale (UWES-9).  The study is longitudinal, consisting of four measurement periods at six-month interval. One measurement period of EDA and valence is two weeks. EDA and emotional valence are recorded with a commercially available Moodmetric smart ring and Moodmetric mobile app. EDA is measured with using the Moodmetric index which is calculated from the EDA raw signal produced by the Moodmetric smart ring. EDA and valence measurements are then compared with BAT-12, GAD-7, BDI-21, UWES-9 that measure burnout, anxiety, depression, and job engagement respectively. The survey data (BAT-12, GAD-7, BDI-21, and UWES-9) is gathered after every two-week measurement period is over. 150 voluntary knowledge workers from three Finnish companies are invited to participate in the study. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">March 28, 2022</start_date> <completion_date type="Anticipated">September 30, 2023</completion_date> <primary_completion_date type="Anticipated">September 30, 2023</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Association between electrodermal activity and valence measurements with burnout</measure> <time_frame>Two-weeks</time_frame> <description>Association between combined EDA and emotional valence measurements with burnout as measured with BAT-12. The cut-off scores for mild, moderate, and severe burnout are 1.00-2.58, 2.59-3.01 and 3.02-5.00 respectively.</description> </primary_outcome> <secondary_outcome> <measure>Association between electrodermal activity and valence measurements with anxiety</measure> <time_frame>Two-weeks</time_frame> <description>Association between combined EDA and emotional valence measurements with anxiety as measured with GAD-7. The cut-off scores for mild, moderate, and severe anxiety are 5-9, 10-14, 15-21 respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Association between electrodermal activity and valence measurements with depression</measure> <time_frame>Two-weeks</time_frame> <description>Association between combined EDA and emotional valence measurements with depression as measured with BDI-21. The cut-off scores for mild mood disturbance, borderline clinical depression, moderate depression, severe depression, and extreme depression are 11-16, 17-20, 21-30, 31-40, and over 40 respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Association between electrodermal activity and valence measurements with job engagement</measure> <time_frame>Two-weeks</time_frame> <description>Association between combined EDA and emotional valence measurements with job engagement as measured with UWES-9. Norm scores for very low, low, average, high, and very high are 1.77 or below, 1.78-2.88, 2.89-4.66, 4.67-5.50, and over 5.51 respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Association between electrodermal activity and valence measurements with burnout</measure> <time_frame>Throughout the study 1.5 years: baseline, 6 months, 12 months, and 18 months</time_frame> <description>Association between combined EDA and emotional valence measurements with burnout as measured with BAT-12. The cut-off values for mild, moderate, and severe burnout are 1.00-2.58, 2.59-3.01 and 3.02-5.00 respectively.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">150</enrollment> <condition>Burnout, Professional</condition> <condition>Mental Health Issue</condition> <condition>Anxiety</condition> <condition>Depression</condition> <arm_group> <arm_group_label>Professionals</arm_group_label> <description>150 knowledge workers from three Finnish companies.</description> </arm_group> <eligibility> <study_pop> <textblock> Knowledge workers from three Finnish companies. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Healthy volunteers, but they may have mental health issues  - Employed by one of the target organizations in the beginning of the study  - Informed consent in a written form by the study subject  Exclusion Criteria:  - Nickel sensitivity </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>Saija Mauno, Professor</last_name> <role>Study Director</role> <affiliation>Tampere University</affiliation> </overall_official> <location> <facility> <name>Heltti Oy</name> <address> <city>Helsinki</city> <country>Finland</country> </address> </facility> </location> <location> <facility> <name>Solita Oy</name> <address> <city>Helsinki</city> <country>Finland</country> </address> </facility> </location> <location> <facility> <name>Vincit Oyj</name> <address> <city>Tampere</city> <country>Finland</country> </address> </facility> </location> <location_countries> <country>Finland</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 14, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 14, 2023</last_update_submitted> <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 18, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Burnout, Professional</mesh_term> <mesh_term>Burnout, Psychological</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>The following physiological and survey data will be available to other researchers after the study is over, reported and the data irrevocably anonymized: Electrodermal activity measurements recorded with the Moodmetric smart ring Self-reported emotional valence recorded with the Moodmetric mobile app Burnout Assessment Tool (BAT) survey results Beck Depression Inventory (BD1-21) survey results Generalized Anxiety Disorder Scale (GAD-7) survey results Utrecht Work Engagement Scale (UWES-9) survey results Job satisfaction survey results The final IPD sharing plan will be made with the assistance of Finnish Social Science Data Archive.</ipd_description> <ipd_time_frame>To be determined.</ipd_time_frame> <ipd_access_criteria>To be determined.</ipd_access_criteria> </patient_data>  </clinical_study>

The study investigates the associations of ambulatory electrodermal activity (EDA) measurements with mental well-being at work, especially job burnout. Appropriate statistical methods are applied to predict burnout with EDA measurements combined with self-report surveys on emotional valence. The aim of the study is to complement burnout research by considering ambulatory electrodermal activity (EDA) measurements as part of the identification and definition of the burnout phenomenon. Previous studies have shown that assessment methods for the physiological identification of burnout do not yet exist and that more information on the physiological markers of burnout is needed. The study also complements the understanding of how and in what cases ambulatory measurements of EDA can be justified, for example, as an occupational health care tool. The study investigates the association between ambulatory EDA measurements and mental well-being, especially job burnout, and the potential of the measurements in supporting better mental health at work. According to research the EDA measurements alone do not always provide sufficient information and often context related information is needed to improve the interpretation of the measurement. Therefore, the EDA measurements are complemented with the self-reported emotional valence. The state of mental well-being is defined using Peter Warr's model of affective well-being. The model proposes that two dimensions of emotion, arousal and emotional valence, together can provide information / be used to describe one's affective well-being at work. The model is further based on the circumplex model of affect. Previous studies of EDA have shown that the measurement method has a potential role in assisting the diagnosis of some mental disorders, such as anxiety and depression. However, the measurements have been largely tied to laboratory settings and have not been able to be utilized in everyday life. The development of health and well-being technology has brought to the market methods for measuring the electrical conductivity of the skin, which are suitable for ambulatory measurements, but whose suitability must be critically assessed. Within this study it is hypothesized that the average variation of the sympathetic nervous system activity measured with EDA and combined with a self-reported emotional valence is associated with mental well-being at work, as burnout measured with the Burnout Assessment Tool (BAT-12), anxiety measured with Generalized Anxiety Disorder (GAD-7) Scale, depression measured with Beck Depression Inventory (BDI-21), and job engagement measured with Utrecht Work Engagement Scale (UWES-9). The study is longitudinal, consisting of four measurement periods at six-month interval. One measurement period of EDA and valence is two weeks. EDA and emotional valence are recorded with a commercially available Moodmetric smart ring and Moodmetric mobile app. EDA is measured with using the Moodmetric index which is calculated from the EDA raw signal produced by the Moodmetric smart ring. EDA and valence measurements are then compared with BAT-12, GAD-7, BDI-21, UWES-9 that measure burnout, anxiety, depression, and job engagement respectively. The survey data (BAT-12, GAD-7, BDI-21, and UWES-9) is gathered after every two-week measurement period is over. 150 voluntary knowledge workers from three Finnish companies are invited to participate in the study. Knowledge workers from three Finnish companies. Inclusion Criteria: - Healthy volunteers, but they may have mental health issues - Employed by one of the target organizations in the beginning of the study - Informed consent in a written form by the study subject Exclusion Criteria: - Nickel sensitivity

NCT0531xxxx/NCT05317806.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/NCT05317806</url> </required_header> <id_info> <org_study_id>R2O210069</org_study_id> <nct_id>NCT05317806</nct_id> </id_info> <brief_title>Metformin Use in Cardiac Fibrosis in PAI-1 Deficiency</brief_title> <official_title>Use of Metformin in Prevention and Treatment of Cardiac Fibrosis in PAI-1 Deficient Population</official_title> <sponsors> <lead_sponsor> <agency>Indiana Hemophilia &Thrombosis Center, Inc.</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Indiana Hemophilia &Thrombosis Center, Inc.</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 study will evaluate the efficacy and safety of metformin, in patients 18-65 years of age with homozygous plasminogen activator inhibitor-1 (PAI-1) deficiency, with or without cardiac fibrosis, for a period of 60 months. The starting dose of metformin will be 500 mg up to a maximum dose of 2000 mg for a period of 5 years with the aim to assess the safety and efficacy of metformin on prevention/stabilization or regression of cardiac fibrosis in a Treated population vs. a Comparison population. </textblock> </brief_summary> <detailed_description> <textblock> This study is a phase 4, prospective, open-label, US single center study to assess the efficacy and safety of metformin for prevention or stabilization or regression of cardiac fibrosis in individuals homozygous for PAI-1 deficiency. Approximately 15 patients 18-65 years of age are expected to be enrolled, due to the rarity of this blood disorder. The study will have one metformin Treatment group (daily metformin administered) and one Observation group (no study drug administered). Subjects will be consented and screened by Indiana Hemophilia and Thrombosis Center (IHTC) staff. Individuals will be eligible for study participation if they meet all inclusion criteria. Subjects will be excluded from the study if they meet any of the exclusion criteria. US-labeled oral metformin (extended release) will be administered using the FDA-approved dosing regimen for diabetes mellitus type II starting at a dose of 500 mg and escalating up to a maximum of 2000 mg. In the final assessment, subjects who receive metformin for at least 36 months (and up to a maximum of 60 months) will be considered part of the Treated population. Subjects who refuse treatment with metformin or complete <36 months of treatment on metformin either due to intolerance to the study drug or due to any other reason, will be considered part of the Comparison population and will be followed clinically. Females will be offered the option to temporarily discontinue metformin during pregnancy and/or lactation period; they will be considered part of the Treated population if they receive metformin for at least 36 months during the study (those 36 months need not be consecutive). If they receive metformin for 0 to <36 months, they will be considered part of the Comparison population. The study enrollment period will be 12 months. Every subject will be in the study for a period of 60 months from the point of enrollment. There is no minimum on-study period. The decision to continue metformin treatment beyond the study period in the metformin Treatment group, will be made based on drug efficacy, patient tolerability/preference, and provider discretion.  Basic laboratory parameters (serum chemistry and hematology), specific cardiac markers (NT-pro BNP, TGF-β1) cardiac imaging and electrocardiograms will be performed at baseline, at study close out/subject withdrawal, and as specified in the schedule of activities. Adverse events (AE) will be recorded on an ongoing basis as they occur during the study. During the study, annual cardiac consultation, New York Heart Association (NYHA) scale and as needed, the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be completed by patients.  The primary analysis will be performed when the last patient has completed 60 months in the study, is lost to follow up or has withdrawn from the study treatment, whichever occurs first.  An interim analysis will be performed at 30 months. All patients will be included in the interim analysis. This interim analysis will be performed for safety.  Definitions  • Complete PAI-1 deficiency defined as subjects with homozygous mutation in SERPINE 1.  During the clinical trial, subjects will be grouped according to whether they are currently receiving study drug or not. This will affect the schedule of study visits and assays/procedures performed.  - Metformin Treatment group: The group of individuals who are currently receiving metformin  - Observation group: The group of individuals who are NOT currently receiving metformin (this includes those who opted to never receive metformin) Patients will be allowed to switch between metformin treatment group and observation group.  Following the completion of the clinical trial, subjects will be grouped according to the total amount of time they received study drug. This grouping is for analytical/statistical purposes only.  - Treated population: Individuals who received at least 36 months of metformin treatment while on study  - Comparison population: Individuals who did not receive metformin treatment at any point during the study, or received metformin for a total less than 36 months of treatment while on study i.e. 0 to <36 months of treatment </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 10, 2022</start_date> <completion_date type="Anticipated">October 2027</completion_date> <primary_completion_date type="Anticipated">October 2027</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>The study will have one metformin Treatment group (daily metformin administered) and one Observation group (no study drug administered)</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Number of individuals homozygous for PAI-1 deficiency with stable or improved cardiac fibrosis</measure> <time_frame>through the study annually, up to 60 months</time_frame> <description>Measured using cardiac MRI to quantify the percentage cardiac fibrosis.</description> </primary_outcome> <primary_outcome> <measure>Number of individuals homozygous for PAI-1 deficiency with stable or improved Transforming growth factor (TGF-β1)</measure> <time_frame>through the study annually, up to 60 months</time_frame> <description>Measured by a blood draw as a surrogate marker for status of cardiac fibrosis stability or reduction.</description> </primary_outcome> <secondary_outcome> <measure>Number of individuals homozygous for PAI-1 deficiency with metformin related adverse events as assessed by grading of diarrhea (CTCAE v5.0)</measure> <time_frame>approximately monthly (±4 weeks) until maximum tolerated dose for metformin is achieved until 6 months (±4 weeks) and then every 3 months (±4 weeks) for the entire study period for the metformin group</time_frame> <description>Safety and tolerability of metformin when administered to individuals homozygous for PAI-1 deficiency as assessed by side effect profile (as measured by the type and number of adverse drug reactions and serious adverse drug reactions )</description> </secondary_outcome> <secondary_outcome> <measure>Number of individuals homozygous for PAI-1 deficiency with clinical symptoms of heart failure as measured by the New York Heart Association (NYHA) scale and as needed, the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)</measure> <time_frame>6 months after study enrollment, through the study annually, up to 60 months</time_frame> <description>Objective evaluation of cardiac symptoms by using a scale and questionnaire. New York Heart Association (NYHA) scale: lowest scale is Functional capacity I, Objective assessment A; Highest scale is Functional capacity IV, Objective assessment D. Higher scores worst outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Number of individuals homozygous for PAI-1 deficiency with additional signs of heart failure assessed by measuring N- terminal prohormone beta natriuretic peptide (NT-pro BNP)</measure> <time_frame>through the study annually, up to 60 months</time_frame> <description>Objective evaluation of heart failure using NT-proBNP value as stable, increasing or decreasing</description> </secondary_outcome> <secondary_outcome> <measure>Number of individuals homozygous for PAI-1 deficiency with stable or improved ejection fraction on echocardiogram</measure> <time_frame>through the study annually, up to 60 months</time_frame> <description>Evaluate changes in ejection fraction by standard transthoracic echocardiogram</description> </secondary_outcome> <secondary_outcome> <measure>Number of individuals homozygous for PAI-1 deficiency with clinical symptoms of heart failure impacting their health as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)</measure> <time_frame>6 months after study enrollment, through the study annually, up to 60 months</time_frame> <description>Objective evaluation of cardiac failure symptoms impact on health by using a questionnaire. Kansas City Cardiomyopathy Questionnaire (KCCQ-12): KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. Higher scores are better outcome</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">15</enrollment> <condition>Plasminogen Activator Inhibitor-1 Deficiency</condition> <condition>Cardiac Fibrosis</condition> <arm_group> <arm_group_label>Metformin Treatment Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects with PAI-1 deficiency with or without cardiac fibrosis, receiving daily treatment with metformin for a daily range of 500-2000mg</description> </arm_group> <arm_group> <arm_group_label>Observation Group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Subjects with PAI-1 deficiency with or without cardiac fibrosis, not receiving treatment with metformin Subjects are allowed to switch between the two groups</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Metformin Extended Release Oral Tablet</intervention_name> <description>daily metformin treatment vs. no treatment with metformin</description> <arm_group_label>Metformin Treatment Group</arm_group_label> <other_name>Glucophage XR</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Confirmed homozygosity for mutation in SERPINE-1 for PAI-1 deficiency  - Male or female  - Aged 18-65 years  - Willing and able to choose between being in a metformin Treatment group (daily metformin) or an Observation group (no study drug) at study entry  - Capable of understanding and willing to comply with the conditions of the study (in the opinion of the study investigator(s))  - Have read, understood and be able to provide written informed consent  Exclusion Criteria:  - Not homozygous for SERPINE-1 mutation for PAI-1 deficiency, based on genetic testing  - Ages <18 or >65 years  - Renal dysfunction (Cockcroft Gault CrCl < 30)  - History of hypersensitivity of metformin or any component in the extended release formulation  - Unwillingness to avoid alcohol  - Currently prescribed cimetidine, dolutegravir, patiromer, ranolazine, or tafenoquine and no alternate therapy is possible  - History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the study investigators' judgment  - Concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the study investigator(s), pose an additional unacceptable risk in administering study drug to the patient  - Receipt of any other investigational medicinal product currently being administered (or planned to be administered)  - Inability to comply with the study protocol (in the opinion of the study investigator(s))  - Inability to understand and provide written informed consent </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Sweta Gupta, MD</last_name> <role>Principal Investigator</role> <affiliation>Indiana Hemophilia and Thrombosis Center, Inc</affiliation> </overall_official> <overall_official> <last_name>Magdalena Lewandowska, MD</last_name> <role>Principal Investigator</role> <affiliation>Indiana Hemophilia and Thrombosis Center, Inc</affiliation> </overall_official> <overall_official> <last_name>Amy D Shapiro, MD</last_name> <role>Study Director</role> <affiliation>Indiana Hemophilia and Thrombosis Center, Inc</affiliation> </overall_official> <overall_contact> <last_name>Nicci Knipe</last_name> <phone>317-871-0011</phone> <phone_ext>281</phone_ext> <email>nknipe@ihtc.org</email> </overall_contact> <overall_contact_backup> <last_name>Meadow Heiman</last_name> <phone>317-871-0011</phone> <phone_ext>242</phone_ext> <email>mheiman@ihtc.org</email> </overall_contact_backup> <location> <facility> <name>Indiana Hemophilia and Thrombosis Center</name> <address> <city>Indianapolis</city> <state>Indiana</state> <zip>46260</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Nicci Knipe</last_name> <phone>317-871-0000</phone> <email>nknipe@IHTC.org</email> </contact> <contact_backup> <last_name>Tiffanie Skillman</last_name> <phone>3178710000</phone> <email>tskillman@ihtc.org</email> </contact_backup> <investigator> <last_name>Sweta Gupta, MD, MS</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Magdalena Lewandowska, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <link> <url>https://www.rarecoagulationdisorders.org/</url> <description>Gupta S, Sealls W, Shapiro A. Rare coagulation disorders resource room - plasminogen activator inbitor type 1 deficiency. Rare coagulation disorders resource room [cited August 8, 2019]</description> </link> <reference> <citation>Loskutoff DJ, Sawdey M, Mimuro J. Type 1 plasminogen activator inhibitor. Prog Hemost Thromb. 1989;9:87-115. No abstract available.</citation> <PMID>2492381</PMID> </reference> <reference> <citation>Chmielewska J, Ranby M, Wiman B. Evidence for a rapid inhibitor to tissue plasminogen activator in plasma. Thromb Res. 1983 Aug 1;31(3):427-36. doi: 10.1016/0049-3848(83)90407-3.</citation> <PMID>20217999</PMID> </reference> <reference> <citation>Chmielewska J, Ranby M, Wiman B. Kinetics of the inhibition of plasminogen activators by the plasminogen-activator inhibitor. Evidence for 'second-site' interactions. Biochem J. 1988 Apr 15;251(2):327-32. doi: 10.1042/bj2510327.</citation> <PMID>3135797</PMID> </reference> <reference> <citation>Mehta R, Shapiro AD. Plasminogen activator inhibitor type 1 deficiency. Haemophilia. 2008 Nov;14(6):1255-60. doi: 10.1111/j.1365-2516.2008.01834.x.</citation> <PMID>19141166</PMID> </reference> <reference> <citation>Fay WP, Parker AC, Condrey LR, Shapiro AD. Human plasminogen activator inhibitor-1 (PAI-1) deficiency: characterization of a large kindred with a null mutation in the PAI-1 gene. Blood. 1997 Jul 1;90(1):204-8.</citation> <PMID>9207454</PMID> </reference> <reference> <citation>Fay WP, Shapiro AD, Shih JL, Schleef RR, Ginsburg D. Brief report: complete deficiency of plasminogen-activator inhibitor type 1 due to a frame-shift mutation. N Engl J Med. 1992 Dec 10;327(24):1729-33. doi: 10.1056/NEJM199212103272406. No abstract available.</citation> <PMID>1435917</PMID> </reference> <reference> <citation>Iwaki T, Tanaka A, Miyawaki Y, Suzuki A, Kobayashi T, Takamatsu J, Matsushita T, Umemura K, Urano T, Kojima T, Terao T, Kanayama N. Life-threatening hemorrhage and prolonged wound healing are remarkable phenotypes manifested by complete plasminogen activator inhibitor-1 deficiency in humans. J Thromb Haemost. 2011 Jun;9(6):1200-6. doi: 10.1111/j.1538-7836.2011.04288.x.</citation> <PMID>21486382</PMID> </reference> <reference> <citation>Iwaki T, Nagahashi K, Kobayashi T, Umemura K, Terao T, Kanayama N. The first report of uncontrollable subchorionic and retroplacental haemorrhage inducing preterm labour in complete PAI-1 deficiency in a human. Thromb Res. 2012 Apr;129(4):e161-3. doi: 10.1016/j.thromres.2011.10.008. Epub 2011 Nov 17. No abstract available.</citation> <PMID>22099705</PMID> </reference> <reference> <citation>Iwaki T, Nagahashi K, Takano K, Suzuki-Inoue K, Kanayama N, Umemura K, Urano T. Mutation in a highly conserved glycine residue in strand 5B of plasminogen activator inhibitor 1 causes polymerisation. Thromb Haemost. 2017 May 3;117(5):860-869. doi: 10.1160/TH16-07-0572. 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J Cell Physiol. 2012 Feb;227(2):493-507. doi: 10.1002/jcp.22783.</citation> <PMID>21465481</PMID> </reference> <reference> <citation>Ghosh AK, Bradham WS, Gleaves LA, De Taeye B, Murphy SB, Covington JW, Vaughan DE. Genetic deficiency of plasminogen activator inhibitor-1 promotes cardiac fibrosis in aged mice: involvement of constitutive transforming growth factor-beta signaling and endothelial-to-mesenchymal transition. Circulation. 2010 Sep 21;122(12):1200-9. doi: 10.1161/CIRCULATIONAHA.110.955245. Epub 2010 Sep 7.</citation> <PMID>20823384</PMID> </reference> <reference> <citation>Xu Z, Castellino FJ, Ploplis VA. Plasminogen activator inhibitor-1 (PAI-1) is cardioprotective in mice by maintaining microvascular integrity and cardiac architecture. Blood. 2010 Mar 11;115(10):2038-47. doi: 10.1182/blood-2009-09-244962. 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Epub 2017 Jun 6.</citation> <PMID>28588076</PMID> </reference> <reference> <citation>Joshi N, Kopec AK, Towery K, Williams KJ, Luyendyk JP. The antifibrinolytic drug tranexamic acid reduces liver injury and fibrosis in a mouse model of chronic bile duct injury. J Pharmacol Exp Ther. 2014 Jun;349(3):383-92. doi: 10.1124/jpet.113.210880. Epub 2014 Mar 14.</citation> <PMID>24633426</PMID> </reference> <reference> <citation>King P, Peacock I, Donnelly R. The UK prospective diabetes study (UKPDS): clinical and therapeutic implications for type 2 diabetes. Br J Clin Pharmacol. 1999 Nov;48(5):643-8. doi: 10.1046/j.1365-2125.1999.00092.x. No abstract available.</citation> <PMID>10594464</PMID> </reference> <reference> <citation>Sasali A, Leahy JL. Is metformin cardioprotective? Diabetes Care. 2003 Jan;26(1):243-4. doi: 10.2337/diacare.26.1.243. No abstract available.</citation> <PMID>12502689</PMID> </reference> <reference> <citation>Choi SM, Jang AH, Kim H, Lee KH, Kim YW. Metformin Reduces Bleomycin-induced Pulmonary Fibrosis in Mice. J Korean Med Sci. 2016 Sep;31(9):1419-25. doi: 10.3346/jkms.2016.31.9.1419.</citation> <PMID>27510385</PMID> </reference> <reference> <citation>Kita Y, Takamura T, Misu H, Ota T, Kurita S, Takeshita Y, Uno M, Matsuzawa-Nagata N, Kato K, Ando H, Fujimura A, Hayashi K, Kimura T, Ni Y, Otoda T, Miyamoto K, Zen Y, Nakanuma Y, Kaneko S. Metformin prevents and reverses inflammation in a non-diabetic mouse model of nonalcoholic steatohepatitis. PLoS One. 2012;7(9):e43056. doi: 10.1371/journal.pone.0043056. Epub 2012 Sep 18.</citation> <PMID>23028442</PMID> </reference> <reference> <citation>Ursini F, Grembiale RD, D'Antona L, Gallo E, D'Angelo S, Citraro R, Visca P, Olivieri I, De Sarro G, Perrotti N, Russo E. Oral Metformin Ameliorates Bleomycin-Induced Skin Fibrosis. J Invest Dermatol. 2016 Sep;136(9):1892-1894. doi: 10.1016/j.jid.2016.05.097. Epub 2016 May 29. No abstract available.</citation> <PMID>27251791</PMID> </reference> <reference> <citation>Wang M, Weng X, Guo J, Chen Z, Jiang G, Liu X. Metformin alleviated EMT and fibrosis after renal ischemia-reperfusion injury in rats. Ren Fail. 2016;38(4):614-21. doi: 10.3109/0886022X.2016.1149770. Epub 2016 Feb 26.</citation> <PMID>26915376</PMID> </reference> <reference> <citation>Xiao H, Ma X, Feng W, Fu Y, Lu Z, Xu M, Shen Q, Zhu Y, Zhang Y. Metformin attenuates cardiac fibrosis by inhibiting the TGFbeta1-Smad3 signalling pathway. Cardiovasc Res. 2010 Aug 1;87(3):504-13. doi: 10.1093/cvr/cvq066. Epub 2010 Mar 3.</citation> <PMID>20200042</PMID> </reference> <reference> <citation>Xu S, Yang Z, Jin P, Yang X, Li X, Wei X, Wang Y, Long S, Zhang T, Chen G, Sun C, Ma D, Gao Q. Metformin Suppresses Tumor Progression by Inactivating Stromal Fibroblasts in Ovarian Cancer. Mol Cancer Ther. 2018 Jun;17(6):1291-1302. doi: 10.1158/1535-7163.MCT-17-0927. Epub 2018 Mar 15.</citation> <PMID>29545331</PMID> </reference> <reference> <citation>McCloskey CW, Cook DP, Kelly BS, Azzi F, Allen CH, Forsyth A, Upham J, Rayner KJ, Gray DA, Boyd RW, Murugkar S, Lo B, Trudel D, Senterman MK, Vanderhyden BC. Metformin Abrogates Age-Associated Ovarian Fibrosis. Clin Cancer Res. 2020 Feb 1;26(3):632-642. doi: 10.1158/1078-0432.CCR-19-0603. Epub 2019 Oct 9.</citation> <PMID>31597663</PMID> </reference> <reference> <citation>De Souza A, Khawaja KI, Masud F, Saif MW. Metformin and pancreatic cancer: Is there a role? Cancer Chemother Pharmacol. 2016 Feb;77(2):235-42. doi: 10.1007/s00280-015-2948-8. Epub 2016 Jan 6.</citation> <PMID>26740120</PMID> </reference> <reference> <citation>Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.</citation> <PMID>10758967</PMID> </reference> <reference> <citation>Liu Q, Li S, Quan H, Li J. Vitamin B12 status in metformin treated patients: systematic review. PLoS One. 2014 Jun 24;9(6):e100379. doi: 10.1371/journal.pone.0100379. eCollection 2014.</citation> <PMID>24959880</PMID> </reference> <reference> <citation>Carrizo E, Fernandez V, Connell L, Sandia I, Prieto D, Mogollon J, Valbuena D, Fernandez I, de Baptista EA, Baptista T. Extended release metformin for metabolic control assistance during prolonged clozapine administration: a 14 week, double-blind, parallel group, placebo-controlled study. Schizophr Res. 2009 Aug;113(1):19-26. doi: 10.1016/j.schres.2009.05.007. Epub 2009 Jun 9. Erratum In: Schizophr Res. 2009 Nov;115(1):96.</citation> <PMID>19515536</PMID> </reference> <reference> <citation>Rado J, von Ammon Cavanaugh S. A Naturalistic Randomized Placebo-Controlled Trial of Extended-Release Metformin to Prevent Weight Gain Associated With Olanzapine in a US Community-Dwelling Population. J Clin Psychopharmacol. 2016 Apr;36(2):163-8. doi: 10.1097/JCP.0000000000000469.</citation> <PMID>26872112</PMID> </reference> <reference> <citation>Lipska KJ, Bailey CJ, Inzucchi SE. Use of metformin in the setting of mild-to-moderate renal insufficiency. Diabetes Care. 2011 Jun;34(6):1431-7. doi: 10.2337/dc10-2361. No abstract available.</citation> <PMID>21617112</PMID> </reference> <reference> <citation>Inzucchi SE, Lipska KJ, Mayo H, Bailey CJ, McGuire DK. Metformin in patients with type 2 diabetes and kidney disease: a systematic review. JAMA. 2014 Dec 24-31;312(24):2668-75. doi: 10.1001/jama.2014.15298.</citation> <PMID>25536258</PMID> </reference> <reference> <citation>Kilo C. Metformin: a safe and effective treatment in the management of NIDDM. Mo Med. 1997 Mar;94(3):114-23.</citation> <PMID>9071866</PMID> </reference> <reference> <citation>Johnson NP. Metformin use in women with polycystic ovary syndrome. Ann Transl Med. 2014 Jun;2(6):56. doi: 10.3978/j.issn.2305-5839.2014.04.15.</citation> <PMID>25333031</PMID> </reference> <verification_date>February 2023</verification_date> <study_first_submitted>March 8, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>February 6, 2023</last_update_submitted> <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 8, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Indiana Hemophilia &Thrombosis Center, Inc.</investigator_affiliation> <investigator_full_name>Sweta Gupta</investigator_full_name> <investigator_title>Pediatric Hematologist</investigator_title> </responsible_party> <keyword>PAI-1 deficiency</keyword> <keyword>Amish</keyword> <keyword>cardiac fibrosis</keyword> <keyword>Metformin</keyword> <condition_browse>  <mesh_term>Fibrosis</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Metformin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>TBD based on analysis</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_time_frame>Post analysis</ipd_time_frame> </patient_data>  </clinical_study>

This study will evaluate the efficacy and safety of metformin, in patients 18-65 years of age with homozygous plasminogen activator inhibitor-1 (PAI-1) deficiency, with or without cardiac fibrosis, for a period of 60 months. The starting dose of metformin will be 500 mg up to a maximum dose of 2000 mg for a period of 5 years with the aim to assess the safety and efficacy of metformin on prevention/stabilization or regression of cardiac fibrosis in a Treated population vs. a Comparison population. This study is a phase 4, prospective, open-label, US single center study to assess the efficacy and safety of metformin for prevention or stabilization or regression of cardiac fibrosis in individuals homozygous for PAI-1 deficiency. Approximately 15 patients 18-65 years of age are expected to be enrolled, due to the rarity of this blood disorder. The study will have one metformin Treatment group (daily metformin administered) and one Observation group (no study drug administered). Subjects will be consented and screened by Indiana Hemophilia and Thrombosis Center (IHTC) staff. Individuals will be eligible for study participation if they meet all inclusion criteria. Subjects will be excluded from the study if they meet any of the exclusion criteria. US-labeled oral metformin (extended release) will be administered using the FDA-approved dosing regimen for diabetes mellitus type II starting at a dose of 500 mg and escalating up to a maximum of 2000 mg. In the final assessment, subjects who receive metformin for at least 36 months (and up to a maximum of 60 months) will be considered part of the Treated population. Subjects who refuse treatment with metformin or complete <36 months of treatment on metformin either due to intolerance to the study drug or due to any other reason, will be considered part of the Comparison population and will be followed clinically. Females will be offered the option to temporarily discontinue metformin during pregnancy and/or lactation period; they will be considered part of the Treated population if they receive metformin for at least 36 months during the study (those 36 months need not be consecutive). If they receive metformin for 0 to <36 months, they will be considered part of the Comparison population. The study enrollment period will be 12 months. Every subject will be in the study for a period of 60 months from the point of enrollment. There is no minimum on-study period. The decision to continue metformin treatment beyond the study period in the metformin Treatment group, will be made based on drug efficacy, patient tolerability/preference, and provider discretion. Basic laboratory parameters (serum chemistry and hematology), specific cardiac markers (NT-pro BNP, TGF-β1) cardiac imaging and electrocardiograms will be performed at baseline, at study close out/subject withdrawal, and as specified in the schedule of activities. Adverse events (AE) will be recorded on an ongoing basis as they occur during the study. During the study, annual cardiac consultation, New York Heart Association (NYHA) scale and as needed, the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be completed by patients. The primary analysis will be performed when the last patient has completed 60 months in the study, is lost to follow up or has withdrawn from the study treatment, whichever occurs first. An interim analysis will be performed at 30 months. All patients will be included in the interim analysis. This interim analysis will be performed for safety. Definitions • Complete PAI-1 deficiency defined as subjects with homozygous mutation in SERPINE 1. During the clinical trial, subjects will be grouped according to whether they are currently receiving study drug or not. This will affect the schedule of study visits and assays/procedures performed. - Metformin Treatment group: The group of individuals who are currently receiving metformin - Observation group: The group of individuals who are NOT currently receiving metformin (this includes those who opted to never receive metformin) Patients will be allowed to switch between metformin treatment group and observation group. Following the completion of the clinical trial, subjects will be grouped according to the total amount of time they received study drug. This grouping is for analytical/statistical purposes only. - Treated population: Individuals who received at least 36 months of metformin treatment while on study - Comparison population: Individuals who did not receive metformin treatment at any point during the study, or received metformin for a total less than 36 months of treatment while on study i.e. 0 to <36 months of treatment Inclusion Criteria: - Confirmed homozygosity for mutation in SERPINE-1 for PAI-1 deficiency - Male or female - Aged 18-65 years - Willing and able to choose between being in a metformin Treatment group (daily metformin) or an Observation group (no study drug) at study entry - Capable of understanding and willing to comply with the conditions of the study (in the opinion of the study investigator(s)) - Have read, understood and be able to provide written informed consent Exclusion Criteria: - Not homozygous for SERPINE-1 mutation for PAI-1 deficiency, based on genetic testing - Ages <18 or >65 years - Renal dysfunction (Cockcroft Gault CrCl < 30) - History of hypersensitivity of metformin or any component in the extended release formulation - Unwillingness to avoid alcohol - Currently prescribed cimetidine, dolutegravir, patiromer, ranolazine, or tafenoquine and no alternate therapy is possible - History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the study investigators' judgment - Concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the study investigator(s), pose an additional unacceptable risk in administering study drug to the patient - Receipt of any other investigational medicinal product currently being administered (or planned to be administered) - Inability to comply with the study protocol (in the opinion of the study investigator(s)) - Inability to understand and provide written informed consent

NCT0531xxxx/NCT05317819.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/NCT05317819</url> </required_header> <id_info> <org_study_id>POLARIS2021-001</org_study_id> <nct_id>NCT05317819</nct_id> </id_info> <brief_title>Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma</brief_title> <official_title>A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma</official_title> <sponsors> <lead_sponsor> <agency>Polaris Group</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Polaris Group</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> Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC </textblock> </brief_summary> <detailed_description> <textblock> Safety will be evaluated by laboratory tests, vital sign measurements, physical examinations and subject medical history which will be performed to detect new abnormalities and any deterioration in pre-existing conditions.  Efficacy will be determined by overall survival, progression free survival, pharmacodynamics (peripheral blood arginine and citrulline levels) and immunogenicity (antibodies to ADI-PEG 20). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 14, 2022</start_date> <completion_date type="Anticipated">October 2025</completion_date> <primary_completion_date type="Anticipated">September 2025</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>To evaluate efficacy and safety of ADI-PEG 20 or Placebo in patients with high-arginine-phenotypic and HCC</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Care Provider, Investigator)</masking> <masking_description>This is a randomized, double-blind trial.</masking_description> </study_design_info> <primary_outcome> <measure>Overall Survival (OS)</measure> <time_frame>Approximately 18 months</time_frame> <description>Time from study enrollment to death</description> </primary_outcome> <secondary_outcome> <measure>Progression free survival</measure> <time_frame>Approximately 18 months</time_frame> <description>Time from study enrollment to progressive disease or death</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">300</enrollment> <condition>Hepatocellular Carcinoma</condition> <condition>Advanced Hepatocellular Carcinoma</condition> <arm_group> <arm_group_label>Drug: ADI-PEG 20</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)</description> </arm_group> <arm_group> <arm_group_label>Drug: Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>ADI-PEG20</intervention_name> <description>Treatment for hepatocellular carcinoma</description> <arm_group_label>Drug: ADI-PEG 20</arm_group_label> <other_name>pegargiminase</other_name> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Treatment for hepatocellular carcinoma</description> <arm_group_label>Drug: Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Prior diagnosis of HCC confirmed by radiology, histology, or cytology.  2. Prior treatment with at least 1 systemic agent for Child-Pugh A subjects. However, Child-Pugh B7 subjects without prior systemic treatment may be enrolled, if they are not eligible for any approved systemic therapies.  3. Plasma arginine ≥ 84.2 μM at pre-screening visit.  4. Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapies are eligible, provided that they have either a target lesion which has not been treated with local therapy and/or the target lesion(s) within the field of the local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan.  5. Child-Pugh (cirrhosis status) score class A-B7 (Appendix C).  6. Barcelona Cancer of the Liver (BCLC) stage C (Appendix B)  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment (Appendix D).  8. Expected survival of at least 3 months.  9. Age >18 years.  10. Fully recovered from prior surgery, radiation, or chemotherapy, and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed.  11. Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study and for 35 days after last dose of ADI-PEG 20. Male partners of female subjects and female partners of male subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study if they are of childbearing potential. Females of childbearing potential must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this subject is deemed eligible. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual period for at least 12 months).  12. Informed consent must be obtained prior to study initiation.  13. No concurrent investigational studies are allowed.  14. Total bilirubin < 3.0 mg/dL and no evidence of bile obstruction.  15. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range.  16. Serum albumin level ≥ 3.0 g/dl.  17. Prothrombin time (PT)-international normalized ratio (INR): PT <3 seconds above control or INR <1.7.  18. Absolute neutrophil count (ANC) >1,500/µL.  19. Platelets >50,000/µL.  20. Serum uric acid ≤ 8 mg/dL (with or without medication control).  21. Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL/min.  22. Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon.  23. Encephalopathy - none or mild (grade 1 or 2, by Child-Pugh classification); lactulose of other supportive care allowed.  24. Ascites - absent or slight (by Child-Pugh classification); diuretic therapy allowed.  Exclusion Criteria:  1. Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs.  2. Prior allograft transplantation including liver transplantation.  3. Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia.  4. Serious infection requiring treatment with intravenous, systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.  5. Pregnancy or lactation.  6. Expected non-compliance.  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.  8. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.  9. Subjects who had been treated with ADI-PEG 20 previously.  10. History of uncontrolled seizure disorder not related to underlying cancer.  11. Allergy to pegylated compounds.  12. Allergy to E. coli drug products (such as GMCSF).  13. Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.  14. Uncontrolled ascites (defined as not easily controlled with diuretic treatment).  15. Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until week 1 visit.  16. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>99 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>John S Bomalaski</last_name> <role>Study Director</role> <affiliation>Polaris Group</affiliation> </overall_official> <overall_contact> <last_name>Fanny Chang</last_name> <phone>+886226562727</phone> <phone_ext>162</phone_ext> <email>fannychang@polarispharma.com</email> </overall_contact> <overall_contact_backup> <last_name>Stephanie V Rumund</last_name> <phone>858-452-6688</phone> <email>svanrumund@polarispharma.com</email> </overall_contact_backup> <location> <facility> <name>Changhua Christian Hospital (CCH)</name> <address> <city>Changhua</city> <zip>500</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yu-Chun Hsu</last_name> <phone>886-4-7238595</phone> <phone_ext>5507</phone_ext> <email>77149@cch.org.tw</email> </contact> </location> <location> <facility> <name>Ditmanson Medical Foundation Chiayi Christian Hospital (CYCH)</name> <address> <city>Chiayi City</city> <zip>600</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Chu-Kuang Chou</last_name> <phone>886-5-2765041</phone> <phone_ext>8636</phone_ext> <email>vacinu@gmail.com</email> </contact> </location> <location> <facility> <name>Chang Gung Medical Foundation-Chia-Yi (CGMF-CY)</name> <address> <city>Chiayi City</city> <zip>613</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Te-Sheng Chang</last_name> <phone>886-5-3621000</phone> <phone_ext>2242</phone_ext> <email>cgmh3621@cgmh.org.tw</email> </contact> </location> <location> <facility> <name>Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)</name> <address> <city>Kaohsiung</city> <zip>807</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ming-Lung Yu</last_name> <phone>886-7-3121101</phone> <phone_ext>.7475</phone_ext> <email>fish6069@gmail.com</email> </contact> </location> <location> <facility> <name>Chang Gung Medical Foundation-Kaohsiung(CGMF-KS)</name> <address> <city>Kaohsiung</city> <zip>833</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sheng-Nan Lu</last_name> <phone>886-7-7317123</phone> <phone_ext>8301</phone_ext> <email>juten@ms17.hinet.net</email> </contact> </location> <location> <facility> <name>Chi Mei Medical Center (CMMC-YK)</name> <address> <city>Tainan</city> <zip>710</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Hung-Chang Wu</last_name> <phone>886-6-2812811</phone> <phone_ext>53571</phone_ext> <email>hungchang.wu@gmail.com</email> </contact> </location> <location> <facility> <name>Chi Mei Hospital, Liouying (CMMC-LY)</name> <address> <city>Tainan</city> <zip>736</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Shang-Wen Chen</last_name> <phone>886-6-6226999</phone> <phone_ext>73132</phone_ext> <email>saintwin.chen@gmail.com</email> </contact> </location> <location> <facility> <name>Taipei Veterans General Hospital (TPVGH)</name> <address> <city>Taipei</city> <zip>112</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yi-Hsiang Huang</last_name> <phone>886-2-28757506</phone> <email>yhhuang@vghtpe.gov.tw</email> </contact> </location> <location> <facility> <name>Chang Gung Medical Foundation-Linkou (CGMF-LK)</name> <address> <city>Taoyuan</city> <zip>333</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Chau-Ting Yeh</last_name> <phone>886-3-3281200</phone> <phone_ext>8121</phone_ext> <email>chauting@cgmh.org.tw</email> </contact> </location> <location> <facility> <name>Bach Mai Hospital</name> <address> <city>Hanoi</city> <zip>100000</zip> <country>Vietnam</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Nguyen Quang Hung</last_name> <phone>(+84)909572686</phone> <email>nguyenquanghungbvbm2013@gmail.com</email> </contact> </location> <location> <facility> <name>Hue Central Hospital</name> <address> <city>Hue</city> <zip>49000</zip> <country>Vietnam</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Phan Hai Thanh</last_name> <phone>(+84)903591080</phone> <email>phanhaithanhvn@yahoo.com</email> </contact> </location> <location> <facility> <name>K Hospital</name> <address> <city>Hà Nội</city> <zip>100000</zip> <country>Vietnam</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Tran Thang</last_name> <phone>(+84)913064307</phone> <email>tranthangncc@gmail.com</email> </contact> <contact_backup> <last_name>Dao Van Tu</last_name> <phone>(+84)985696908</phone> <email>vantu.dao@nci.vn</email> </contact_backup> </location> <location_countries> <country>Taiwan</country> <country>Vietnam</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 26, 2023</last_update_submitted> <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 28, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Unresectable Hepatocellular Carcinoma</keyword> <keyword>Genotype</keyword> <keyword>Arginine</keyword> <keyword>Arginine Deiminase</keyword> <keyword>ADI-PEG 20</keyword> <keyword>pegargiminase</keyword> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Carcinoma, Hepatocellular</mesh_term> </condition_browse>  </clinical_study>

Evaluate efficacy and safety of ADI-PEG 20 in patients with high-argininephenotypic and HCC Safety will be evaluated by laboratory tests, vital sign measurements, physical examinations and subject medical history which will be performed to detect new abnormalities and any deterioration in pre-existing conditions. Efficacy will be determined by overall survival, progression free survival, pharmacodynamics (peripheral blood arginine and citrulline levels) and immunogenicity (antibodies to ADI-PEG 20). Inclusion Criteria: 1. Prior diagnosis of HCC confirmed by radiology, histology, or cytology. 2. Prior treatment with at least 1 systemic agent for Child-Pugh A subjects. However, Child-Pugh B7 subjects without prior systemic treatment may be enrolled, if they are not eligible for any approved systemic therapies. 3. Plasma arginine ≥ 84.2 μM at pre-screening visit. 4. Measurable disease using RECIST 1.1 (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapies are eligible, provided that they have either a target lesion which has not been treated with local therapy and/or the target lesion(s) within the field of the local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. 5. Child-Pugh (cirrhosis status) score class A-B7 (Appendix C). 6. Barcelona Cancer of the Liver (BCLC) stage C (Appendix B) 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment (Appendix D). 8. Expected survival of at least 3 months. 9. Age >18 years. 10. Fully recovered from prior surgery, radiation, or chemotherapy, and none within 2 weeks prior to week 1 visit. Liver biopsy for HCC confirmation is allowed. 11. Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study and for 35 days after last dose of ADI-PEG 20. Male partners of female subjects and female partners of male subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study if they are of childbearing potential. Females of childbearing potential must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this subject is deemed eligible. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual period for at least 12 months). 12. Informed consent must be obtained prior to study initiation. 13. No concurrent investigational studies are allowed. 14. Total bilirubin < 3.0 mg/dL and no evidence of bile obstruction. 15. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x upper limit of normal range. 16. Serum albumin level ≥ 3.0 g/dl. 17. Prothrombin time (PT)-international normalized ratio (INR): PT <3 seconds above control or INR <1.7. 18. Absolute neutrophil count (ANC) >1,500/µL. 19. Platelets >50,000/µL. 20. Serum uric acid ≤ 8 mg/dL (with or without medication control). 21. Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 40 mL/min. 22. Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon. 23. Encephalopathy - none or mild (grade 1 or 2, by Child-Pugh classification); lactulose of other supportive care allowed. 24. Ascites - absent or slight (by Child-Pugh classification); diuretic therapy allowed. Exclusion Criteria: 1. Candidate for potential curative therapies (i.e., resection or transplantation) or eligible for approved systemic therapies according to the labeling of such drugs. 2. Prior allograft transplantation including liver transplantation. 3. Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies, except for Grade 1 alopecia. 4. Serious infection requiring treatment with intravenous, systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment. 5. Pregnancy or lactation. 6. Expected non-compliance. 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements. 8. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome. 9. Subjects who had been treated with ADI-PEG 20 previously. 10. History of uncontrolled seizure disorder not related to underlying cancer. 11. Allergy to pegylated compounds. 12. Allergy to E. coli drug products (such as GMCSF). 13. Bleeding esophageal or gastric varices within the prior three months, except if banded or treated. 14. Uncontrolled ascites (defined as not easily controlled with diuretic treatment). 15. Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until week 1 visit. 16. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

NCT0531xxxx/NCT05317832.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/NCT05317832</url> </required_header> <id_info> <org_study_id>27338</org_study_id> <secondary_id>R01HD103904</secondary_id> <nct_id>NCT05317832</nct_id> </id_info> <brief_title>Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury</brief_title> <official_title>mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury</official_title> <sponsors> <lead_sponsor> <agency>Temple University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Northeastern University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Thomas Jefferson University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Magee Rehabilitation Hospital, Jefferson Health</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Albert Einstein Healthcare Network</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Alabama at Birmingham</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Michigan</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>Temple 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> The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI. </textblock> </brief_summary> <detailed_description> <textblock> The integration of the JITAI, which provides feedback and physical activity recommendations due to sensor-based assessments of physical activity, with a standard web-based physical activity intervention program will be tested via a clinical trial. Specifically, individuals with SCI will be randomized to web-based physical activity intervention program (WI) or web-based physical activity intervention program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.  Aim 1: Evaluate the efficacy of the WI + JITAI compared to the standard WI alone. We hypothesize that the integration of WI + JITAI will result in significantly higher physical activity levels compared to the standard WI alone.  Aim 2: Use a micro-randomized trial design to optimize the delivery of just-in-time physical activity feedback and recommendations in promoting physical activity.  Aim 3: Investigate moderators of the effect of WI + JITAI vs. standard WI alone. Moderators will include age, gender, race/ethnicity, level of injury, function, mobility, pain, and fatigue.  The proposed study will yield novel insights about JITAIs and JITAIs combined with more traditional, WI programs, which will help researchers design engaging physical activity interventions for individuals with disability in the community that may improve their health and quality of life. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 25, 2023</start_date> <completion_date type="Anticipated">June 30, 2026</completion_date> <primary_completion_date type="Anticipated">March 31, 2026</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> <intervention_model_description>The proposed study is a 24-week longitudinal study that will comprise of 2 weeks of baseline physical activity monitoring, 14 weeks of physical activity monitoring and intervention, and 8 weeks of physical activity monitoring to assess physical activity level sustainability. Individuals with SCI will be randomized to a web-based physical activity intervention (WI) program or a WI program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Single (Participant)</masking> <masking_description>All participants will be provided with the same WI program and mobile health technology. Furthermore, the participants in the WI + JITAI arm will receive randomized prompts of various types of tailored feedback and physical activity recommendations.</masking_description> </study_design_info> <primary_outcome> <measure>Change in moderate-intensity (or higher) physical activity</measure> <time_frame>Baseline (week 2) and WI Program (week 16)</time_frame> <description>The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and WI program.</description> </primary_outcome> <primary_outcome> <measure>Change in moderate-intensity (or higher) physical activity</measure> <time_frame>Baseline (week 2) and physical activity sustainability (week 24)</time_frame> <description>The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and physical activity sustainability.</description> </primary_outcome> <primary_outcome> <measure>Self-reported change in moderate-intensity (or higher) physical activity</measure> <time_frame>Baseline (week 2) and WI Program (week 16)</time_frame> <description>The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and WI program.</description> </primary_outcome> <primary_outcome> <measure>Self-reported change in moderate-intensity (or higher) physical activity</measure> <time_frame>Baseline (week 2) and physical activity sustainability (week 24)</time_frame> <description>The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and physical activity sustainability.</description> </primary_outcome> <primary_outcome> <measure>Self-reported change in moderate-intensity (or higher) leisure time physical activity</measure> <time_frame>Baseline (week 2) and WI program (week 16)</time_frame> <description>The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and WI program.</description> </primary_outcome> <primary_outcome> <measure>Self-reported change in moderate-intensity (or higher) leisure time physical activity</measure> <time_frame>Baseline (week 2) and physical activity sustainability (week 24)</time_frame> <description>The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and physical activity sustainability.</description> </primary_outcome> <primary_outcome> <measure>Change in proximal physical activity</measure> <time_frame>WI Program (week 2) and WI Program (week 16)</time_frame> <description>The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the WI program among those who are available at the previous randomization decision point.</description> </primary_outcome> <primary_outcome> <measure>Change in proximal physical activity</measure> <time_frame>Physical activity sustainability (week 17) and Physical activity sustainability (week 24)</time_frame> <description>The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the physical activity sustainability among those who are available at the previous randomization decision point.</description> </primary_outcome> <secondary_outcome> <measure>Pain level number</measure> <time_frame>Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)</time_frame> <description>The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the pain level (number) in the participants over the course of the study.</description> </secondary_outcome> <secondary_outcome> <measure>Pain level type</measure> <time_frame>Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)</time_frame> <description>The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the types of pain (nociceptive, neuropathic, and other) in the participants over the course of the study.</description> </secondary_outcome> <secondary_outcome> <measure>Fatigue level</measure> <time_frame>Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)</time_frame> <description>The Neuro-QOL Item Bank Version 1.0 Fatigue Short form will allow us to collect fatigue level.</description> </secondary_outcome> <other_outcome> <measure>Physical activity recommendations from JITAI</measure> <time_frame>WI Program (weeks 2-16)</time_frame> <description>The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the WI program. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application.</description> </other_outcome> <other_outcome> <measure>Physical activity recommendations from JITAI</measure> <time_frame>Physical activity sustainability (weeks 17-24)</time_frame> <description>The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the physical activity sustainability. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application.</description> </other_outcome> <other_outcome> <measure>Feedback about physical activity levels from JITAI</measure> <time_frame>WI Program (weeks 2-16)</time_frame> <description>The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the WI program. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch).</description> </other_outcome> <other_outcome> <measure>Feedback about physical activity levels from JITAI</measure> <time_frame>physical activity sustainability (weeks 17-24)</time_frame> <description>The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the physical activity sustainability. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch).</description> </other_outcome> <other_outcome> <measure>Age</measure> <time_frame>Baseline (week 0)</time_frame> <description>Age will be assessed as a moderator for Aim 3.</description> </other_outcome> <other_outcome> <measure>Sex</measure> <time_frame>Baseline (week 0)</time_frame> <description>Biological sex will be examined as a potential time-invariant moderator for Aim 3.</description> </other_outcome> <other_outcome> <measure>Race/ethnicity</measure> <time_frame>Baseline (week 0)</time_frame> <description>Race/ethnicity will be examined as a potential time-invariant moderator for Aim 3.</description> </other_outcome> <other_outcome> <measure>American Spinal Injury Association Impairment Scale (AIS)</measure> <time_frame>Baseline (week 0)</time_frame> <description>SCI impairment will be assessed using the American Spinal Injury Association Impairment scale (AIS) from the American Spinal Injury Association.</description> </other_outcome> <other_outcome> <measure>SCI and level of injury</measure> <time_frame>Baseline (week 0)</time_frame> <description>SCI and level of injury will be assessed using the SCI Spinal Column Injury Basic Data Set Form.</description> </other_outcome> <other_outcome> <measure>Non-traumatic SCI</measure> <time_frame>Baseline (week 0)</time_frame> <description>Non-traumatic SCI will be assessed using the Non-traumatic SCI Data set Version 1.0 Form.</description> </other_outcome> <other_outcome> <measure>Functional level of participants</measure> <time_frame>Baseline (week 0)</time_frame> <description>Spinal Cord Independence Measure version III (SCIM III) survey will be used to measure the functional levels of participants. The functional levels of participants is assessed through performance in activities of daily living and mobility.</description> </other_outcome> <other_outcome> <measure>Assistive or Mobility device use</measure> <time_frame>Baseline (week 0)</time_frame> <description>Descriptive information about participants using an assistive technology device or mobility device will be collected through an Assistive Mobility Devices and Orthoses Form (survey).</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">196</enrollment> <condition>Spinal Cord Injuries</condition> <arm_group> <arm_group_label>Web-based physical activity intervention (WI) program</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24).</description> </arm_group> <arm_group> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>WI program</intervention_name> <description>This 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features.</description> <arm_group_label>Web-based physical activity intervention (WI) program</arm_group_label> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>WI Program Reminder</intervention_name> <description>Participants will be provided with reminders to use the WI program</description> <arm_group_label>Web-based physical activity intervention (WI) program</arm_group_label> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>JITAI Goal Setting</intervention_name> <description>Participants will be provided with standard, tailored, or no goal for the day. The goal will focus on recommending minutes of moderate-intensity (or higher) physical activity and a reminder to perform strength exercises.</description> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>JITAI physical activity message</intervention_name> <description>Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.</description> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Notification EMA</intervention_name> <description>Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.</description> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>End of day EMA</intervention_name> <description>Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.</description> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Wake up time EMA</intervention_name> <description>Participants will be inquired, through an ecological momentary assessment (EMA), about the time they plan to wake up next day. This information will be used to provide a goal setting message for next day.</description> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Weekly PA Information</intervention_name> <description>Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.</description> <arm_group_label>Web-based physical activity intervention (WI) program</arm_group_label> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Daily PA Information</intervention_name> <description>Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.</description> <arm_group_label>Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria: Participants with SCI will be included if they are:  - 18-75 years of age  - have a traumatic or non-traumatic SCI (classification of neurological level of injury at cervical level 5 (C5) and below)  - are at least 6-months post-SCI  - use a manual or a power wheelchair as their primary means of mobility (>80% of time)  - can use their arms to exercise  - show readiness to physical activity as assessed by the Physical Activity Readiness Questionnaire  - have experience using a smartphone and smartwatch.  Exclusion Criteria: Participants will be excluded if they have:  - any secondary complications that medically restrict their activity in any way such as cardiovascular disease, pressure injuries, contractures, and infections  - are diagnosed with traumatic brain injury. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Shivayogi V Hiremath, PhD</last_name> <role>Principal Investigator</role> <affiliation>Temple University</affiliation> </overall_official> <overall_contact> <last_name>Shivayogi V Hiremath, PhD</last_name> <phone>2152040496</phone> <email>shiv.hiremath@temple.edu</email> </overall_contact> <location> <facility> <name>Temple University</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19121</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Shivayogi V Hiremath, PhD</last_name> <phone>215-204-0496</phone> <email>shiv.hiremath@temple.edu</email> </contact> <investigator> <last_name>Shivayogi V Hiremath, PhD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>February 28, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 3, 2023</last_update_submitted> <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 4, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>spinal cord injuries</keyword> <keyword>physical activity</keyword> <keyword>wearable sensors</keyword> <keyword>mobile health</keyword> <keyword>just-in-time adaptive intervention</keyword> <condition_browse>  <mesh_term>Spinal Cord Injuries</mesh_term> <mesh_term>Wounds and Injuries</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Sharing of data generated by the proposed research study will be carried out in several different ways. We will make our results available both to the consumers with SCI and scientific community. Conversely, we would welcome collaboration with others who could make use of the information gained in this project. Temple University and its collaborators will remain Health Insurance Portability and Accountability Act (HIPAA) compliant and all data will remain free of identifiers and variables that could lead to disclosure of participant identity. During the study, preliminary analyses will be conducted at periodic intervals. Our plan is to disseminate our findings in the form of interdisciplinary peer-reviewed manuscripts and presentations at national and international conferences.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_time_frame>The research team will work to make the data available in a reasonable amount of time after its collection and following the acceptance for publication of the main findings. Rules for maintaining and distributing data of Temple University and the NIH will be followed.</ipd_time_frame> <ipd_access_criteria>Requests for data from other scientists will be considered with provision of the following information: A brief description of the specific aims and/or hypotheses, data requirements, proposed analyses, how the data will be used, timeframe for use, and Institutional Review Board (IRB) approvals. Any identifying information in the data will be redacted before sharing. In an effort to provide further protection, parties requesting data will be asked to agree to use the data solely for research purposes, to refrain from identifying participants in any manner, to secure the data electronically through encryption and/or password protection, and to return or destroy the data upon completion of the analyses.</ipd_access_criteria> </patient_data>  </clinical_study>

The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI. The integration of the JITAI, which provides feedback and physical activity recommendations due to sensor-based assessments of physical activity, with a standard web-based physical activity intervention program will be tested via a clinical trial. Specifically, individuals with SCI will be randomized to web-based physical activity intervention program (WI) or web-based physical activity intervention program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations. Aim 1: Evaluate the efficacy of the WI + JITAI compared to the standard WI alone. We hypothesize that the integration of WI + JITAI will result in significantly higher physical activity levels compared to the standard WI alone. Aim 2: Use a micro-randomized trial design to optimize the delivery of just-in-time physical activity feedback and recommendations in promoting physical activity. Aim 3: Investigate moderators of the effect of WI + JITAI vs. standard WI alone. Moderators will include age, gender, race/ethnicity, level of injury, function, mobility, pain, and fatigue. The proposed study will yield novel insights about JITAIs and JITAIs combined with more traditional, WI programs, which will help researchers design engaging physical activity interventions for individuals with disability in the community that may improve their health and quality of life. Inclusion Criteria: Participants with SCI will be included if they are: - 18-75 years of age - have a traumatic or non-traumatic SCI (classification of neurological level of injury at cervical level 5 (C5) and below) - are at least 6-months post-SCI - use a manual or a power wheelchair as their primary means of mobility (>80% of time) - can use their arms to exercise - show readiness to physical activity as assessed by the Physical Activity Readiness Questionnaire - have experience using a smartphone and smartwatch. Exclusion Criteria: Participants will be excluded if they have: - any secondary complications that medically restrict their activity in any way such as cardiovascular disease, pressure injuries, contractures, and infections - are diagnosed with traumatic brain injury.

NCT0531xxxx/NCT05317845.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/NCT05317845</url> </required_header> <id_info> <org_study_id>DAS-007</org_study_id> <secondary_id>U1111-1266-5511</secondary_id> <nct_id>NCT05317845</nct_id> </id_info> <brief_title>An International Chart Review and Survey for the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes Across Countries in the Middle East and Africa</brief_title> <acronym>PACT-MEA</acronym> <official_title>A Multi-center, Cross-sectional Chart Review and Survey to Capture the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes Across Countries in the Middle East and Africa</official_title> <sponsors> <lead_sponsor> <agency>Novo Nordisk A/S</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Novo Nordisk A/S</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The study is intended to estimate the proportion and clinical management of people with type 2 diabetes having atherosclerotic cardiovascular diseases or who are at high risk to develop atherosclerotic cardiovascular diseases.  Participants will be asked to give information about their health. Partipants will continue normal way of life and will not get any medication other than those prescribed to them by the doctor.  The study will last for about 6 months. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">April 21, 2022</start_date> <completion_date type="Actual">August 31, 2022</completion_date> <primary_completion_date type="Actual">August 31, 2022</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>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope</measure> <time_frame>At the time of patient enrolment (Day 1)</time_frame> <description>Percentage patients</description> </primary_outcome> <secondary_outcome> <measure>Proportion of T2D patients with high risk of Atherosclerotic cardiovascular disease (ASCVD) and without eASCVD</measure> <time_frame>At the time of patient enrolment (Day 1)</time_frame> <description>Percentage patients</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">4089</enrollment> <condition>Diabetes Mellitus, Type 2</condition> <arm_group> <arm_group_label>Patients with Type 2 Diabetes (T2D)</arm_group_label> <description>Selected for inclusion in the study by their primary or secondary care physicians</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>No treatment given</intervention_name> <description>The clinical management and prescribed treatment of diabetes and eASCVD/ASCVD risk factors are independent of this study and are part of the routine clinical practice at the discretion of the treating physician.</description> <arm_group_label>Patients with Type 2 Diabetes (T2D)</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Type 2 Diabetes (T2D) patients seen in routine visits </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).  2. Male or female, age greater than or equal to 18 years at the time of signing informed consent.  3. Diagnosed with T2D grater than or equal to 180 days prior to the day of signing informed consent  Exclusion Criteria:  1. Previous participation in this study. Participation is defined as having given informed consent in this study.  2. Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation  3. Diagnosed with Type 1 Diabetes (T1D).  4. Patients with known congenital heart disease/malformation </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>Clinical Transparency (dept. 2834)</last_name> <role>Study Director</role> <affiliation>Novo Nordisk A/S</affiliation> </overall_official> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Manama</city> <country>Bahrain</country> </address> </facility> </location> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Alexandria</city> <country>Egypt</country> </address> </facility> </location> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Amman</city> <country>Jordan</country> </address> </facility> </location> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Salmiya</city> <country>Kuwait</country> </address> </facility> </location> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Doha</city> <country>Qatar</country> </address> </facility> </location> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Johannesburg</city> <country>South Africa</country> </address> </facility> </location> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Abu Dhabi</city> <country>United Arab Emirates</country> </address> </facility> </location> <location_countries> <country>Bahrain</country> <country>Egypt</country> <country>Jordan</country> <country>Kuwait</country> <country>Qatar</country> <country>South Africa</country> <country>United Arab Emirates</country> </location_countries> <reference> <citation>Verma S, Sabbour H, Alamuddin N, Alawadi F, Alkandari H, Almahmeed W, Assaad-Khalil SH, Haddad J, Lombard L, Malik RA, Mashaki Ceyhan E, Prasad P, Tombak G, Salek S. A cross-sectional study of the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across the Middle East and Africa (PACT-MEA): Study design and rationale. Diabetes Obes Metab. 2023 Jun;25(6):1444-1452. doi: 10.1111/dom.15011. Epub 2023 Mar 3.</citation> <PMID>36775980</PMID> </reference> <verification_date>March 2023</verification_date> <study_first_submitted>March 31, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 24, 2023</last_update_submitted> <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 28, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Cardiovascular Diseases</mesh_term> <mesh_term>Atherosclerosis</mesh_term> <mesh_term>Diabetes Mellitus</mesh_term> <mesh_term>Diabetes Mellitus, Type 2</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"</ipd_description> <ipd_url>http://novonordisk-trials.com</ipd_url> </patient_data>  </clinical_study>

The study is intended to estimate the proportion and clinical management of people with type 2 diabetes having atherosclerotic cardiovascular diseases or who are at high risk to develop atherosclerotic cardiovascular diseases. Participants will be asked to give information about their health. Partipants will continue normal way of life and will not get any medication other than those prescribed to them by the doctor. The study will last for about 6 months. Type 2 Diabetes (T2D) patients seen in routine visits Inclusion Criteria: 1. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. Male or female, age greater than or equal to 18 years at the time of signing informed consent. 3. Diagnosed with T2D grater than or equal to 180 days prior to the day of signing informed consent Exclusion Criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation 3. Diagnosed with Type 1 Diabetes (T1D). 4. Patients with known congenital heart disease/malformation

NCT0531xxxx/NCT05317858.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/NCT05317858</url> </required_header> <id_info> <org_study_id>BT012</org_study_id> <nct_id>NCT05317858</nct_id> </id_info> <brief_title>Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets</brief_title> <official_title>A Randomized Pivotal Study Assessing the Efficacy of Targeted Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin</official_title> <sponsors> <lead_sponsor> <agency>InSightec</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>InSightec</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy. </textblock> </brief_summary> <detailed_description> <textblock> This is a prospective, multi-center, randomized, two-arm, controlled, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned pembrolizumab monotherapy for their primary disease. The study will be conducted at up to 20 centers in the US. The immunotherapy regimen (every 3 weeks for 6 cycles) of pembrolizumab is per the FDA approved labeling for pembrolizumab (Keytruda®) and the subjects prescribed standard of care therapy for their primary NSCLC. The study aims to demonstrate superiority of Exablate BBBD targeted to their brain metastases over the standard of care without Exablate BBBD with respect to the percentage of subjects achieving Objective Response Rate (ORR) by 6 months follow-up. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 12, 2022</start_date> <completion_date type="Anticipated">December 1, 2024</completion_date> <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <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>Adverse events</measure> <time_frame>up to 6 months</time_frame> <description>Adverse events [ Time Frame: Through study completion, up to 6 months]. All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.</description> </primary_outcome> <primary_outcome> <measure>tumor lesion(s) on the MRI images</measure> <time_frame>up to 6 months</time_frame> <description>Efficacy will be determined by the response of the tumor lesion(s) compared to baseline. Tumor lesions on the MRI images (units: mm) will be measured every three weeks up to six months.</description> </primary_outcome> <secondary_outcome> <measure>evaluation of Neuro Oncology Brain Mets (RANO-BM) response</measure> <time_frame>up to 6 months</time_frame> <description>The evaluation of the percentages of subjects that achieved the stable disease (SD), partial response (PR) as the best objective response using the response assessment in Neuro Oncology Brain Mets (RANO-BM) response criteria measured at baseline and every 3 weeks during each treatment cycle to up to 6 months of therapy.</description> </secondary_outcome> <secondary_outcome> <measure>Time to response for brain metastases by treatment arm</measure> <time_frame>up to 6 months</time_frame> <description>The time to achieve a confirmed complete response or partial response for brain metastases by treatment arm as assessed using the RANO-BM criteria evaluated every 3 weeks up to 6 months during treatment cycles.</description> </secondary_outcome> <secondary_outcome> <measure>time to response for brain mets by treatment arm</measure> <time_frame>up to 6 months</time_frame> <description>The time to achieve a confirmed complete response or partial response for brain metastases by treatment arm as assessed using the RANO-BM criteria evaluated every 3 weeks up to 6 months during treatment cycles.</description> </secondary_outcome> <other_outcome> <measure>Patient reported quality of life measurement questionnaires</measure> <time_frame>up to 6 months</time_frame> <description>patient reported health and quality of life questionnaire completed every 3 weeks up to 6 months during treatment cycle.</description> </other_outcome> <other_outcome> <measure>Measurement of BBBD disruption</measure> <time_frame>up to 6 months</time_frame> <description>Measurement of blood brain barrier disruption (BBBD) assessment of post-sonication contrast-enhanced MR imaging evaluated every 3 weeks up to 6 months in comparison with pre-sonication imaging.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Brain Tumor</condition> <arm_group> <arm_group_label>Pembrolizumab with Exablate BBBD</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned pembrolizumab monotherapy.</description> </arm_group> <arm_group> <arm_group_label>Control Arm (Pembrolizumab only)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>subjects will undergo planned pembrolizumab monotherapy.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Blood Brain Barrier Disruption - Oncology</intervention_name> <description>BBB opening via Exablate Type 2 system with microbubble resonators on the day of pembrolizumab infusion to treat brain metastases</description> <arm_group_label>Pembrolizumab with Exablate BBBD</arm_group_label> <other_name>Exablate BBBD</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Pembrolizumab</intervention_name> <description>Pembrolizumab infusion</description> <arm_group_label>Control Arm (Pembrolizumab only)</arm_group_label> <arm_group_label>Pembrolizumab with Exablate BBBD</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Participant is ≥ 18 years of age  - The participant provides written informed consent for the trial  - Participant is willing to comply with all study procedures for the duration of the study  - Subject has tumor biomarkers that are EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) negative  - Participant is a NSCLC subject prescribed pembrolizumab monotherapy per standard of care  - Participant is diagnosed with at least 1 measurable brain metastasis ≥ 0.5 cm in longest diameter that is untreated, device-accessible and MR visible  - Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2  - Female subject is confirmed NOT PREGNANT each procedure day. Male and Female subjects are utilizing highly effective contraception during the study and through 120 days (4 months) after the study  - Screening/Baseline laboratory values  Exclusion Criteria  - Subject is pregnant or breastfeeding,  - Participant has evidence of acute intracranial hemorrhage or significant calcifications in the focused ultrasound sonication beam path  - Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology)  - Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation  - Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding  - History of bleeding disorder, coagulopathy or with a history of spontaneous brain tumor hemorrhage, anticoagulation or antiplatelet therapy or medication known to increase the risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment)  - Participant has a known chronic viral infection such as Hepatitis B, Hepatitis C or HIV or has a known history of/active TB (Bacillus tuberculosis)  - Subjects with evidence of cranial or systemic infection  - Participant has received a solid organ or hematopoietic stem cell transplant  - Participant has received a live vaccine within 28 days prior to the first dose of study agent Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid vaccine, and intranasal influenza vaccines (e.g., FluMist®)  - Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention  - Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products  - Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI  - Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2, creatinine >1.5 ULN and/or on dialysis  - Subjects with significant liver dysfunction, e.g., history of cirrhosis (hemochromatosis or severe alcohol abuse), or active hepatitis (autoimmune or infectious) with elevated AST, ALT INR or bilirubin (ALT: Male 21-72 units/L; Female 9-52 units/L; AST: Male 17-59 units/L, Female 14-36 units/L; INR >1.3; bilirubin >5 times lab normal)  - Subject is currently enrolled in another intervention based clinical trial  - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug  - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years  - Presence of leptomeningeal disease  - Contraindications to pembrolizumab or has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients  - Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis  - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator  - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>100 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Manmeet Ahluwalia, MD, MBA</last_name> <role>Principal Investigator</role> <affiliation>Miami Cancer Institute, Baptist Health South Florida</affiliation> </overall_official> <overall_contact> <last_name>Nadir Alikacem</last_name> <phone>+12146302000</phone> <email>nadira@insightec.com</email> </overall_contact> <location> <facility> <name>St. Joseph's Hospital and Medical Center</name> <address> <city>Phoenix</city> <state>Arizona</state> <zip>85013</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Phase O Navigator</last_name> <phone>602-406-8605</phone> <email>research@ivybraintumorcenter.org</email> </contact> <investigator> <last_name>Nader Sanai, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Miami Cancer Institute at Baptist Health</name> <address> <city>Miami</city> <state>Florida</state> <zip>33176</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Daylan L Santana, RN</last_name> <phone>786-527-8528</phone> <email>DaylenS@baptisthealth.net</email> </contact> <contact_backup> <last_name>Juliana Montoya</last_name> <phone>786-527-8864</phone> <email>Juliana.Montoya@BaptistHealth.ne</email> </contact_backup> <investigator> <last_name>Manmeet S Ahluwalia, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of Maryland</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21201</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kaitlyn Henry</last_name> <phone>410-328-0939</phone> <email>KHenry@som.umaryland.edu</email> </contact> <contact_backup> <last_name>Charlie Klontz</last_name> <phone>410-328-5332</phone> <email>CMKlontz@som.umaryland.edu</email> </contact_backup> <investigator> <last_name>Graeme Woodworth, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Howard Eisenberg, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Alexander Ksendzovsky, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>Johnston Willis Hospital</name> <address> <city>Richmond</city> <state>Virginia</state> <zip>23235</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kanwalcharan S Sahni, MD</last_name> <phone>804-330-4990</phone> <email>ksinghsahni@gmail.com</email> </contact> </location> <location> <facility> <name>Sunnybrook Research Institute</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M4N 3M5</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Meheleth Llinas</last_name> <phone>416-480-6100</phone> <phone_ext>2476</phone_ext> <email>maheleth.llinas@sunnybrook.ca</email> </contact> <investigator> <last_name>Nir Lipsman, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Seoul National University Hospital</name> <address> <city>Seoul</city> <zip>03080</zip> <country>Korea, Republic of</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Eun J Lee, MD</last_name> <phone>+82-10-4110-0121</phone> <email>eunjlee21@snu.ac.kr</email> </contact> </location> <location> <facility> <name>Samsung Medical Center</name> <address> <city>Seoul</city> <zip>06351</zip> <country>Korea, Republic of</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Jung-il Lee, MD</last_name> <phone>+82-2-3410-3494</phone> <email>jilee.lee@samsung.com</email> </contact> </location> <location_countries> <country>Canada</country> <country>Korea, Republic of</country> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 1, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>September 5, 2023</last_update_submitted> <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 7, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Brain Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Pembrolizumab</mesh_term> </intervention_browse>  </clinical_study>

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy. This is a prospective, multi-center, randomized, two-arm, controlled, pivotal clinical trial to evaluate the safety and efficacy of targeted blood brain barrier disruption using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned pembrolizumab monotherapy for their primary disease. The study will be conducted at up to 20 centers in the US. The immunotherapy regimen (every 3 weeks for 6 cycles) of pembrolizumab is per the FDA approved labeling for pembrolizumab (Keytruda®) and the subjects prescribed standard of care therapy for their primary NSCLC. The study aims to demonstrate superiority of Exablate BBBD targeted to their brain metastases over the standard of care without Exablate BBBD with respect to the percentage of subjects achieving Objective Response Rate (ORR) by 6 months follow-up. Inclusion Criteria: - Participant is ≥ 18 years of age - The participant provides written informed consent for the trial - Participant is willing to comply with all study procedures for the duration of the study - Subject has tumor biomarkers that are EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) negative - Participant is a NSCLC subject prescribed pembrolizumab monotherapy per standard of care - Participant is diagnosed with at least 1 measurable brain metastasis ≥ 0.5 cm in longest diameter that is untreated, device-accessible and MR visible - Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2 - Female subject is confirmed NOT PREGNANT each procedure day. Male and Female subjects are utilizing highly effective contraception during the study and through 120 days (4 months) after the study - Screening/Baseline laboratory values Exclusion Criteria - Subject is pregnant or breastfeeding, - Participant has evidence of acute intracranial hemorrhage or significant calcifications in the focused ultrasound sonication beam path - Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology) - Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation - Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding - History of bleeding disorder, coagulopathy or with a history of spontaneous brain tumor hemorrhage, anticoagulation or antiplatelet therapy or medication known to increase the risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment) - Participant has a known chronic viral infection such as Hepatitis B, Hepatitis C or HIV or has a known history of/active TB (Bacillus tuberculosis) - Subjects with evidence of cranial or systemic infection - Participant has received a solid organ or hematopoietic stem cell transplant - Participant has received a live vaccine within 28 days prior to the first dose of study agent Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid vaccine, and intranasal influenza vaccines (e.g., FluMist®) - Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention - Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products - Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI - Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2, creatinine >1.5 ULN and/or on dialysis - Subjects with significant liver dysfunction, e.g., history of cirrhosis (hemochromatosis or severe alcohol abuse), or active hepatitis (autoimmune or infectious) with elevated AST, ALT INR or bilirubin (ALT: Male 21-72 units/L; Female 9-52 units/L; AST: Male 17-59 units/L, Female 14-36 units/L; INR >1.3; bilirubin >5 times lab normal) - Subject is currently enrolled in another intervention based clinical trial - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years - Presence of leptomeningeal disease - Contraindications to pembrolizumab or has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients - Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

NCT0531xxxx/NCT05317871.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/NCT05317871</url> </required_header> <id_info> <org_study_id>21-0106</org_study_id> <nct_id>NCT05317871</nct_id> </id_info> <brief_title>Clearance Mechanisms in Atypical Neurodegenerative Diseases</brief_title> <acronym>PeptiClear</acronym> <official_title>Cerebral Clearance Mechanisms in Atypical Neurodegenerative Diseases: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function</official_title> <sponsors> <lead_sponsor> <agency>Ludwig-Maximilians - University of Munich</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Ludwig-Maximilians - University of Munich</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 project PeptiClear aims to investigate whether the blood-brain-barrier (BBB) and the glymphatic system are compromised in atypical neurodegenerative diseases, and whether Alzheimer´s disease (AD)-related copathology, vascular lesions or sleep disturbances modify the clinical picture or structural and/or functional features of the diseases. </textblock> </brief_summary> <detailed_description> <textblock> It is well established for the frequent sporadic (non-genetic) variant of Alzheimer´s disease (AD) that not the overproduction of a specific protein (Amyloid-beta - Aβ) is a major cause but rather the insufficient clearance of this protein from the central nervous system. On one hand, under physiological conditions, the interplay of the several cell types (cerebral endothelial cells, perivascular mural cells (pericytes), glial cells (astrocytes and microglia) and neurons) regulates the neuronal and glial cell environment and is crucial for cell function and survival. On the other hand, Aβ aggregates lead to BBB damage and activation of microglial cells. The BBB facilitates the clearance of proteins such as Aβ via the cerebrovascular system, but its association with other intracerebral Aβ drainage systems, such as the glympathic system, remains to be clarified. As the glymphatic system is mainly active during sleep, sleep disturbances could influence the clinical course. Concerning atypical neurodegenerative diseases, it is not clear whether tau or alpha-synuclein (alpha-syn) deposits also have a potential to damage the BBB. In AD Aβ aggregation and vascular changes give rise to insufficient protein clearance and thus contribute to AD pathogenesis in a synergistic fashion. However the role of copathology in atypical neurodegenerative diseases - which mainly consists of Alzheimer-related changes and vascular pathology - is elusive and remains to be clarified.  The prospective study cohort (N ~80) will include patients with Lewy Body spectrum disease, progressive supranuclear palsy, corticobasal syndrome and frontotemporal dementia. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. magnet resonance imaging (MRI), positron emission tomography (PET), cerebrospinal fluid (CSF), actigraphy). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Anticipated">April 2024</completion_date> <primary_completion_date type="Anticipated">April 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>Disruption of the brain-blood-barrier between the subgroups</measure> <time_frame>Baseline</time_frame> <description>Name of Measurement: Ktrans; Measurement Tool: dynamic contrast imaging(DCI) sequence (MRI); Unit: min -1</description> </primary_outcome> <primary_outcome> <measure>Clearance mechanisms and glymphatic or cerebral lymphatic system</measure> <time_frame>Baseline</time_frame> <description>Name of Measurement: Diffusion tensor imaging (DTI) Analysis along the perivascular space (ALPS); Measurement Tool: DTI MRI; Unit: mean (Dxpro, Dypro)/ mean (Dypro, Dzasc)</description> </primary_outcome> <primary_outcome> <measure>Changes in circadian rhythms</measure> <time_frame>Baseline</time_frame> <description>Sleep Efficiency, proportional integration mode (PIM) ;Measurement Tool: Actigraphy; Units: counts</description> </primary_outcome> <primary_outcome> <measure>Correlation between clinical symptoms, tau pathology and BBB disorder</measure> <time_frame>Baseline</time_frame> <description>Correlations between neuropsychological tests (e.g. Clinical Dementia Rating Sum of Boxes), CSF markers (pg/ml) and TAU PET, standardized uptake value ratio (SUVr) and Ktrans map</description> </primary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Anticipated">80</enrollment> <condition>Neurodegenerative Diseases</condition> <condition>Frontotemporal Degeneration</condition> <arm_group> <arm_group_label>Lewy Body Spectrum Diseases</arm_group_label> </arm_group> <arm_group> <arm_group_label>Progressive Supranuclear Palsy</arm_group_label> </arm_group> <arm_group> <arm_group_label>Corticobasal Syndrome</arm_group_label> </arm_group> <arm_group> <arm_group_label>Frontotemporal Degeneration</arm_group_label> </arm_group> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> APOE-genotyping </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Atypical neurodegerative diseases: Lewy-Body Spectrum Diseases, Progressive Supranuclear Palsy, Corticobasal Syndrome, Frontemporal Degeneration </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Diagnosis of Atypical Parkinsonian Disorders or Frontotemporal Dementia  - Able to provide written informed consent  - Unchanged pharmacotherapy within 4 days prior to the study specific assessments  - Fluent in German  Exclusion Criteria:  - Unable to give informed consent or has a legal guardian  - Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder  - Clinically relevant depression  - Acute suicidality  - Current alcohol, drug or medication abuse  - History of severe traumatic brain injury within 3 months prior to inclusion  - Structural lesions of the basal ganglia or brain stem  - Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus  - Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension  - Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication  - Renal failure > stage 3 (GFR < 30 mL/min)  - Pregnancy  - Unresolved malignancies within two years prior to inclusion  - Severe current infections or other chronic or systemic disorders  - Other circumstances which preclude participation based on the investigator's judgement </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>85 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Robert Perneczky, Prof. Dr.</last_name> <role>Principal Investigator</role> <affiliation>Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums</affiliation> </overall_official> <overall_contact> <last_name>Robert Perneczky, Prof. Dr.</last_name> <phone>+4989440055863</phone> <email>PSY.Alzheimerzentrum@med.uni-muenchen.de</email> </overall_contact> <overall_contact_backup> <last_name>Lena Burow, M.Sc.</last_name> <phone>+4989440055898</phone> <email>lena.burow@med.uni-muenchen.de</email> </overall_contact_backup> <location> <facility> <name>Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums</name> <address> <city>München</city> <state>Bayern</state> <zip>80336</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Robert Perneczky, Prof. Dr.</last_name> <phone>+49 89 4400 55863</phone> <email>psy.alzheimerzentrum@med.uni-muenchen.de</email> </contact> <contact_backup> <last_name>Lena Burow, M.Sc.</last_name> <phone>+49 89 4400 55898</phone> <email>lena.burow@med.uni-muenchen.de</email> </contact_backup> <investigator> <last_name>Carolin Kurz, Dr.med.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Boris-Stephan Rauchmann, Dr. med.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Selim Gürsel</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>November 2, 2021</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 8, 2023</last_update_submitted> <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation> <investigator_full_name>Robert Perneczky</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Neurodegenerative diseases</keyword> <keyword>Frontotemporal Degeneration</keyword> <keyword>Clearance</keyword> <keyword>Blood-brain-barrier</keyword> <keyword>Sleep</keyword> <keyword>Microglial activation</keyword> <keyword>Glymphatic system</keyword> <condition_browse>  <mesh_term>Neurodegenerative Diseases</mesh_term> </condition_browse>  </clinical_study>

The project PeptiClear aims to investigate whether the blood-brain-barrier (BBB) and the glymphatic system are compromised in atypical neurodegenerative diseases, and whether Alzheimer´s disease (AD)-related copathology, vascular lesions or sleep disturbances modify the clinical picture or structural and/or functional features of the diseases. It is well established for the frequent sporadic (non-genetic) variant of Alzheimer´s disease (AD) that not the overproduction of a specific protein (Amyloid-beta - Aβ) is a major cause but rather the insufficient clearance of this protein from the central nervous system. On one hand, under physiological conditions, the interplay of the several cell types (cerebral endothelial cells, perivascular mural cells (pericytes), glial cells (astrocytes and microglia) and neurons) regulates the neuronal and glial cell environment and is crucial for cell function and survival. On the other hand, Aβ aggregates lead to BBB damage and activation of microglial cells. The BBB facilitates the clearance of proteins such as Aβ via the cerebrovascular system, but its association with other intracerebral Aβ drainage systems, such as the glympathic system, remains to be clarified. As the glymphatic system is mainly active during sleep, sleep disturbances could influence the clinical course. Concerning atypical neurodegenerative diseases, it is not clear whether tau or alpha-synuclein (alpha-syn) deposits also have a potential to damage the BBB. In AD Aβ aggregation and vascular changes give rise to insufficient protein clearance and thus contribute to AD pathogenesis in a synergistic fashion. However the role of copathology in atypical neurodegenerative diseases - which mainly consists of Alzheimer-related changes and vascular pathology - is elusive and remains to be clarified. The prospective study cohort (N ~80) will include patients with Lewy Body spectrum disease, progressive supranuclear palsy, corticobasal syndrome and frontotemporal dementia. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. magnet resonance imaging (MRI), positron emission tomography (PET), cerebrospinal fluid (CSF), actigraphy). APOE-genotyping Atypical neurodegerative diseases: Lewy-Body Spectrum Diseases, Progressive Supranuclear Palsy, Corticobasal Syndrome, Frontemporal Degeneration Inclusion Criteria: - Diagnosis of Atypical Parkinsonian Disorders or Frontotemporal Dementia - Able to provide written informed consent - Unchanged pharmacotherapy within 4 days prior to the study specific assessments - Fluent in German Exclusion Criteria: - Unable to give informed consent or has a legal guardian - Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder - Clinically relevant depression - Acute suicidality - Current alcohol, drug or medication abuse - History of severe traumatic brain injury within 3 months prior to inclusion - Structural lesions of the basal ganglia or brain stem - Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus - Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension - Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication - Renal failure > stage 3 (GFR < 30 mL/min) - Pregnancy - Unresolved malignancies within two years prior to inclusion - Severe current infections or other chronic or systemic disorders - Other circumstances which preclude participation based on the investigator's judgement

NCT0531xxxx/NCT05317884.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/NCT05317884</url> </required_header> <id_info> <org_study_id>2021-0106</org_study_id> <nct_id>NCT05317884</nct_id> </id_info> <brief_title>Email-based Reminders Promoting Recommended Pediatric Preventative Visits</brief_title> <official_title>Evaluation of Email-based Reminders in Promoting Adherence to the Recommended Pediatric Preventative-visit Schedule Among Rural Patients</official_title> <sponsors> <lead_sponsor> <agency>Geisinger Clinic</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Geisinger Clinic</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 study is to assess, prospectively, the effect of email reminders for well-child check (WCC) visits on adherence to these visits among those who have not yet scheduled the visit. The investigators hypothesize that sending reminders will increase scheduling WCC visits, attending WCC visits, and being up to date for the child's required immunizations beyond what occurs in the absence of these reminders. </textblock> </brief_summary> <detailed_description> <textblock> Regular attendance at recommended WCC visits is associated with having up-to-date immunizations. Standard care involves scheduling a follow-up WCC visit at the end of the current visit. However, if the child's parents do not choose to schedule a follow-up visit at that time or miss a WCC visit, they may not be offered another easy opportunity to schedule one. That is, they would have to remember to schedule a visit and contact the clinic proactively.  In this study, 30 days before a child is due for their WCC visit, parents who have not yet scheduled a WCC visit for up to 30 days (for 5-month-olds) or 60 days (for all other ages) after their child is due for a visit will be randomly assigned to two groups with a random number generator. One group will receive an email reminder, while the other group will not receive any reminder.  The randomization of participants to different conditions will be in place until 800 participants have been identified and randomly assigned to one of the arms (estimated sample to detect at least a 10% absolute difference) or 180 days, whichever comes first. To account for delays in updating clinical databases, the final outcome data will be checked 90 days after the last eligible visit (for a maximum study period of 270 days). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 16, 2022</start_date> <completion_date type="Actual">September 13, 2022</completion_date> <primary_completion_date type="Actual">September 13, 2022</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>No reminder group vs. reminder group</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Double (Participant, Care Provider)</masking> <masking_description>The participants and providers will not know that email reminders were randomized. Participants who received an email (and their providers if they shared this email) will know that they have received an email, but it is not likely that they will know that other participants did not receive an email (and vice-versa).</masking_description> </study_design_info> <primary_outcome> <measure>WCC visit scheduled</measure> <time_frame>30-60 days from the email send date</time_frame> <description>Binary variable of scheduling a WCC visit as established by visit type, visit reasons, and billing codes (if available)</description> </primary_outcome> <secondary_outcome> <measure>WCC visit made</measure> <time_frame>30-60 days from the email send date</time_frame> <description>Binary variable of going to a WCC visit as established by billing codes</description> </secondary_outcome> <secondary_outcome> <measure>Immunization status</measure> <time_frame>60 days from the email send date</time_frame> <description>Binary variable indicating whether pediatric vaccinations are up to date, defined as having no current immunization care gaps</description> </secondary_outcome> <other_outcome> <measure>Emails opened</measure> <time_frame>60 days from the email send date</time_frame> <description>Binary variable of opening the email</description> </other_outcome> <other_outcome> <measure>Follow-up WCC visit scheduled</measure> <time_frame>61-150 days from the email send date</time_frame> <description>Binary variable of scheduling a WCC visit as established by visit type, visit reasons, and billing codes (if available)</description> </other_outcome> <other_outcome> <measure>Measles, Mumps, and Rubella immunization status</measure> <time_frame>60 days from the email send date</time_frame> <description>Binary variable indicating whether Measles, Mumps, and Rubella (MMR) vaccinations are up to date, defined as having no current immunization care gaps</description> </other_outcome> <other_outcome> <measure>Hepatitis A immunization status</measure> <time_frame>60 days from the email send date</time_frame> <description>Binary variable indicating whether Hepatitis A vaccinations are up to date, defined as having no current immunization care gaps</description> </other_outcome> <other_outcome> <measure>Hepatitis B immunization status</measure> <time_frame>60 days from the email send date</time_frame> <description>Binary variable indicating whether Hepatitis B vaccinations are up to date, defined as having no current immunization care gaps</description> </other_outcome> <other_outcome> <measure>Varicella immunization status</measure> <time_frame>60 days from the email send date</time_frame> <description>Binary variable indicating whether Varicella vaccinations are up to date, defined as having no current immunization care gaps</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">1186</enrollment> <condition>Immunization Programs</condition> <arm_group> <arm_group_label>No Contact</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>No reminder sent</description> </arm_group> <arm_group> <arm_group_label>Reminder</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Reminder email with contact information to set an appointment will be sent 12 weeks before the appointment.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Reminder</intervention_name> <description>Email</description> <arm_group_label>Reminder</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Parents (or contact on record) of children aged 5, 8, 11, 14, or 17 months  - No WCC visits scheduled 30 days after the child's monthly birthday (for 5 month-olds) or 60 days (for all other ages) ahead of their due date for a WCC (i.e., month 6, 9, 12, 15, or 18)  - Has an email address on record  - Child is currently seen in Pediatric clinics under the Geisinger umbrella (has at least one prior visit)  Exclusion Criteria:  - Did not opt out of emails </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>Amir Goren, PhD</last_name> <role>Principal Investigator</role> <affiliation>Program Director, Behavioral Insights Team</affiliation> </overall_official> <location> <facility> <name>Geisinger</name> <address> <city>Danville</city> <state>Pennsylvania</state> <zip>17822</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 21, 2022</last_update_submitted> <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 23, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Geisinger Clinic</investigator_affiliation> <investigator_full_name>Amir Goren</investigator_full_name> <investigator_title>Program Director, Behavioral Insights Team</investigator_title> </responsible_party> <keyword>Pediatrics</keyword> <keyword>Reminder Systems</keyword> <keyword>Preventive Medicine</keyword> <keyword>Child Health</keyword> <keyword>Appointments and Schedules</keyword> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Analytic Code</ipd_info_type> <ipd_time_frame>The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.</ipd_time_frame> <ipd_access_criteria>The data on the Open Science Framework will be open to anyone requesting that information.</ipd_access_criteria> <ipd_url>http://osf.io</ipd_url> </patient_data> <provided_document_section> <provided_document> <document_type>Study Protocol and Statistical Analysis Plan</document_type> <document_has_protocol>Yes</document_has_protocol> <document_has_icf>No</document_has_icf> <document_has_sap>Yes</document_has_sap> <document_date>April 8, 2022</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT05317884/Prot_SAP_000.pdf</document_url> </provided_document> </provided_document_section>  </clinical_study>

The purpose of this study is to assess, prospectively, the effect of email reminders for well-child check (WCC) visits on adherence to these visits among those who have not yet scheduled the visit. The investigators hypothesize that sending reminders will increase scheduling WCC visits, attending WCC visits, and being up to date for the child's required immunizations beyond what occurs in the absence of these reminders. Regular attendance at recommended WCC visits is associated with having up-to-date immunizations. Standard care involves scheduling a follow-up WCC visit at the end of the current visit. However, if the child's parents do not choose to schedule a follow-up visit at that time or miss a WCC visit, they may not be offered another easy opportunity to schedule one. That is, they would have to remember to schedule a visit and contact the clinic proactively. In this study, 30 days before a child is due for their WCC visit, parents who have not yet scheduled a WCC visit for up to 30 days (for 5-month-olds) or 60 days (for all other ages) after their child is due for a visit will be randomly assigned to two groups with a random number generator. One group will receive an email reminder, while the other group will not receive any reminder. The randomization of participants to different conditions will be in place until 800 participants have been identified and randomly assigned to one of the arms (estimated sample to detect at least a 10% absolute difference) or 180 days, whichever comes first. To account for delays in updating clinical databases, the final outcome data will be checked 90 days after the last eligible visit (for a maximum study period of 270 days). Inclusion Criteria: - Parents (or contact on record) of children aged 5, 8, 11, 14, or 17 months - No WCC visits scheduled 30 days after the child's monthly birthday (for 5 month-olds) or 60 days (for all other ages) ahead of their due date for a WCC (i.e., month 6, 9, 12, 15, or 18) - Has an email address on record - Child is currently seen in Pediatric clinics under the Geisinger umbrella (has at least one prior visit) Exclusion Criteria: - Did not opt out of emails

NCT0531xxxx/NCT05317897.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/NCT05317897</url> </required_header> <id_info> <org_study_id>MS-235-2017</org_study_id> <nct_id>NCT05317897</nct_id> </id_info> <brief_title>Utility of Lung Ultrasonography as a Predictor of Fast Track Extubation</brief_title> <official_title>Utility of Lung Ultrasonography as a Predictor of Fast Track Extubation in Pediatric Cardiac Surgeries An Observational Study</official_title> <sponsors> <lead_sponsor> <agency>Kasr El Aini Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Kasr El Aini Hospital</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation. </textblock> </brief_summary> <detailed_description> <textblock> background: Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation.  Methedology: in this prospective, observational study, 45 pediatric patients who will go elective repair of congenital acyanotic heart diseases were included and were examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined Demographic data: Patients' name, age, sex, diagnosis, relevant medical and surgical history. And Assessment data: Baseline arterial blood gases and lung ultrasound score assessment after induction of anesthesia and at the end of surgery.  Primary outcome will be the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation. and Secondary outcome will be correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">September 20, 2018</start_date> <completion_date type="Actual">August 1, 2022</completion_date> <primary_completion_date type="Actual">June 1, 2022</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>the sensitivity of lung ultrasound scores</measure> <time_frame>immediately at the end of pediatric cardiac operation</time_frame> <description>the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation</description> </primary_outcome> <secondary_outcome> <measure>correlation between lung ultrasound score and Po2/Fio2 ratio</measure> <time_frame>immediatly at the end of pediatric cardiac operation until 6 hours post operative until extubatiioon</time_frame> <description>correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation</description> </secondary_outcome> <enrollment type="Actual">45</enrollment> <condition>Exta Vascular Lung Water</condition> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Lung ultrasound examination</intervention_name> <description>45 pediatric patients who will go elective repair of congenital acyanotic heart diseases will be included and will be examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined.</description> <other_name>The lung ultrasound score</other_name> </intervention> <eligibility> <study_pop> <textblock> Patients suffering from Acyanotic congenital heart diseases. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - were Age 6 months to 7 years  - Patients suffering from Acyanotic congenital heart diseases.  Exclusion Criteria:  - Age is less than 6 months and more than 7 years,  - Preoperative mechanical ventilation,  - Preoperative inotropic support.,  - Trisomy 21,  - Patient with cyanotic heart diseases  - Coagulopathy INR >1.5 </textblock> </criteria> <gender>All</gender> <minimum_age>6 Months</minimum_age> <maximum_age>7 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Kasr Al Ainy Hospital</name> <address> <city>Cairo</city> <zip>11562</zip> <country>Egypt</country> </address> </facility> </location> <location> <facility> <name>Kasr Alainy hospital</name> <address> <city>Cairo</city> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>March 25, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 4, 2022</last_update_submitted> <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation> <investigator_full_name>Ahmed Mohamed Mohamed Elhaddad</investigator_full_name> <investigator_title>Lecturer of Anesthesia, ICU and Pain managment</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation. background: Fast-tracking in cardiac surgery refers to early extubation to reduce costs and perioperative morbidity. The use of lung ultrasound is recently accepted as a tool in the assessment of several lung conditions. The aim of this study was to assess the use of lung ultrasound score as a quantitative method to assist in the decision of early extubation. Methedology: in this prospective, observational study, 45 pediatric patients who will go elective repair of congenital acyanotic heart diseases were included and were examined with Lung ultrasound together with arterial blood gases preoperative and postoperative and given a score range from 0-3 according to number of B lines in each region and sensitivity of post-operative lung ultrasound score to extubation within 6 hours was examined Demographic data: Patients' name, age, sex, diagnosis, relevant medical and surgical history. And Assessment data: Baseline arterial blood gases and lung ultrasound score assessment after induction of anesthesia and at the end of surgery. Primary outcome will be the sensitivity of lung ultrasound scores immediately at the end of pediatric cardiac operation in prediction of extubation. and Secondary outcome will be correlation between lung ultrasound score and Po2/Fio2 ratio at the end of operation Patients suffering from Acyanotic congenital heart diseases. Inclusion Criteria: - were Age 6 months to 7 years - Patients suffering from Acyanotic congenital heart diseases. Exclusion Criteria: - Age is less than 6 months and more than 7 years, - Preoperative mechanical ventilation, - Preoperative inotropic support., - Trisomy 21, - Patient with cyanotic heart diseases - Coagulopathy INR >1.5

NCT0531xxxx/NCT05317910.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/NCT05317910</url> </required_header> <id_info> <org_study_id>AIDALZ</org_study_id> <nct_id>NCT05317910</nct_id> </id_info> <brief_title>Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients</brief_title> <official_title>Evaluation of Effect of Music Therapy on Anxiety of Carers of Alzheimer's Disease Patients</official_title> <sponsors> <lead_sponsor> <agency>Association de Musicothérapie Applications et Recherches Cliniques</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Association de Musicothérapie Applications et Recherches Cliniques</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 clinical trial evaluates the impact of music interventions on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day care hospital "Memory and Frailty" (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital. </textblock> </brief_summary> <detailed_description> <textblock> This clinical trial evaluates the impact of music on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day hospital "Memory and Frailty " (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital.  All participants will benefit from a first session of a relaxation-type musical technique in the Day care Hospital (HDJ), they will then follow the sessions in their own homes. During the first visit, all participants will complete self-assessments, including a questionnaire on musical preferences and a self-assessment anxiety scale.  The expected inclusion period is 30 days. Carers will be equipped with tablets, headphones, eye masks and workbooks/questionnaires to use every day for one month in their homes. A relaxation-type receptive musical technique is used. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to a state of relaxation using the new U technique. The effect works by reducing the musical rhythm, orchestral formation, frequencies and volume (the "U" descending phase). After a maximum relaxation phase (lower part of the "U"), a re-activating phase (ascending branch of the "U") follows. All the musical sequences, built with the U-shape editing method, were specially produced by the music publishing company Music Care©. During the first session in HDJ, the subjects will lie on a relaxation table with a raised headrest (extended or semi-seated listening position) in an enclosed space, calm, secure and comfortable, with minimum lighting, so that the participant feels comfortable. The music will be played on headphones.  The main objective is to reduce anxiety among carers who accompany patients with memory disorders, Alzheimer's disease and related dementia. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Actual">July 20, 2022</completion_date> <primary_completion_date type="Actual">July 20, 2022</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> </study_design_info> <primary_outcome> <measure>Change from baseline STAI score at 28 days</measure> <time_frame>Day 1 and Day 28</time_frame> <description>Long-term anxiety will be measured using the State Trait Anxiety Inventory (STAI) scale. The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety.</description> </primary_outcome> <secondary_outcome> <measure>Change on EVA score immediately after each session</measure> <time_frame>Before and immediately after each session (up to 28 days (one session every day))</time_frame> <description>Short-term anxiety will be evaluated by a Visual Analogue Scale (VAS) with a score from 0 to 10, which assesses caregiver anxiety, with higher scores correlating with greater anxiety.</description> </secondary_outcome> <secondary_outcome> <measure>Change from baseline STAI score at 15 days</measure> <time_frame>Day 1 and Day 15</time_frame> <description>Long-term anxiety will be measured using the State Trait Anxiety Inventory (STAI) scale. The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">26</enrollment> <condition>Alzheimer Disease</condition> <arm_group> <arm_group_label>Music intervention</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Music intervention (duration 20 minutes) every day for 30 days</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>MUSIC CARE</intervention_name> <description>Relaxation-type receptive musical intervention technique. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to relaxation using the new U-Mount technique [1, 2] (Figure 1). The effect works by reducing the musical rhythm, orchestral formation, frequencies and volume (the "U" descending phase). After a maximum relaxation phase (lower part of the "U"), a re-activating phase (ascending branch of the "U") is followed.</description> <arm_group_label>Music intervention</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Anxiety Self-Assessment Score (STAI) greater than 46 at Day 1  - Patient relationship (child, spouse, brother/sister)  Exclusion Criteria:  - Presence of a psychiatric disorder  - Intellectual disability  - Major hearing loss  - Professional musician </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>Sainte-Marie Hospital</name> <address> <city>Paris</city> <zip>75014</zip> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 13, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 26, 2022</last_update_submitted> <last_update_submitted_qc>July 26, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 27, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Music intervention</keyword> <keyword>Alzheimer</keyword> <keyword>Anxiety</keyword> <condition_browse>  <mesh_term>Alzheimer Disease</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

This clinical trial evaluates the impact of music interventions on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day care hospital "Memory and Frailty" (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital. This clinical trial evaluates the impact of music on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day hospital "Memory and Frailty " (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital. All participants will benefit from a first session of a relaxation-type musical technique in the Day care Hospital (HDJ), they will then follow the sessions in their own homes. During the first visit, all participants will complete self-assessments, including a questionnaire on musical preferences and a self-assessment anxiety scale. The expected inclusion period is 30 days. Carers will be equipped with tablets, headphones, eye masks and workbooks/questionnaires to use every day for one month in their homes. A relaxation-type receptive musical technique is used. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to a state of relaxation using the new U technique. The effect works by reducing the musical rhythm, orchestral formation, frequencies and volume (the "U" descending phase). After a maximum relaxation phase (lower part of the "U"), a re-activating phase (ascending branch of the "U") follows. All the musical sequences, built with the U-shape editing method, were specially produced by the music publishing company Music Care©. During the first session in HDJ, the subjects will lie on a relaxation table with a raised headrest (extended or semi-seated listening position) in an enclosed space, calm, secure and comfortable, with minimum lighting, so that the participant feels comfortable. The music will be played on headphones. The main objective is to reduce anxiety among carers who accompany patients with memory disorders, Alzheimer's disease and related dementia. Inclusion Criteria: - Anxiety Self-Assessment Score (STAI) greater than 46 at Day 1 - Patient relationship (child, spouse, brother/sister) Exclusion Criteria: - Presence of a psychiatric disorder - Intellectual disability - Major hearing loss - Professional musician

NCT0531xxxx/NCT05317923.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/NCT05317923</url> </required_header> <id_info> <org_study_id>2021/1958</org_study_id> <nct_id>NCT05317923</nct_id> </id_info> <brief_title>Airway Management During Unusual Tracheal Stenosis</brief_title> <official_title>Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial</official_title> <sponsors> <lead_sponsor> <agency>Istanbul University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Istanbul 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> Tracheal stenosis is a serious complication following prolonged intubation. There are important differences in the challenges of airway management. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation. </textblock> </brief_summary> <detailed_description> <textblock> Tracheal stenosis is a serious complication following prolonged intubation. Two types of tracheal stenosis; Glottic and subglottic stenoses have common features in that they are challenging in terms of ventilation, oxygenation and intubation. However, there are important differences in the challenges of airway managementA thinner tube may be sufficient to overcome the airway difficulty in glottic stenoses. However, in subglottic tracheal stenosis, a thinner tube may not be conveyed to the distal of the stenosis. As a result, adequate ventilation and oxygenation may not be provided with an intubation tube placed proximal to the trachea. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 14, 2022</start_date> <completion_date type="Actual">September 1, 2022</completion_date> <primary_completion_date type="Actual">June 30, 2022</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> </study_design_info> <primary_outcome> <measure>PCO2</measure> <time_frame>PCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion</time_frame> <description>blood partial pressure of carbondioxide</description> </primary_outcome> <primary_outcome> <measure>PO2</measure> <time_frame>PO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion</time_frame> <description>blood partial pressure of oxygen</description> </primary_outcome> <secondary_outcome> <measure>EtCO2</measure> <time_frame>EtCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion</time_frame> <description>end-tidal carbondioxide measurement</description> </secondary_outcome> <secondary_outcome> <measure>length of intubation due to Covid-19 Pnomonia</measure> <time_frame>postoperative period (up to 1 year)</time_frame> <description>time from intubation to extubation in ICU</description> </secondary_outcome> <secondary_outcome> <measure>sPO2</measure> <time_frame>SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion</time_frame> <description>peripheral oxygen saturation</description> </secondary_outcome> <secondary_outcome> <measure>Myers-Cotton grading scale (1/2/3)</measure> <time_frame>before the surgery</time_frame> <description>The grade of tracheal stenosis</description> </secondary_outcome> <secondary_outcome> <measure>VAS (Visual Analogue Scale) score (between 0 to 10 points)</measure> <time_frame>during surgery through surgery completion</time_frame> <description>surgeons' satisfaction(VAS 0=the worst view, 10= the best view)</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">24</enrollment> <condition>Tracheal Stenosis</condition> <arm_group> <arm_group_label>airway management and ventilation in patients with unusual placement of tracheal stenosis</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Flow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Flow Controlled Ventilation</intervention_name> <description>Anesthesia management in patients with subglottic tracheal stenosis with flow-controlled ventilation using an intubation tube with an inner diameter of less than 3 mm</description> <arm_group_label>airway management and ventilation in patients with unusual placement of tracheal stenosis</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - ASA 1-2-3 patients over the age of 18 who are scheduled for an elective laryngeal procedure due to subglottic stenosis will be included in our study.  Exclusion Criteria:  1. Patients who did not agree to participate in the study.  2. Congestive heart failure (ejection fraction ≤ 35 %)  3. Emergency laryngeal procedures.  4. Patients under 18 years old.  5. Patients with ASA > 3. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Istnabul University</last_name> <role>Principal Investigator</role> <affiliation>Istanbul University</affiliation> </overall_official> <location> <facility> <name>Istanbul University, Department of Anesthesiology</name> <address> <city>Istanbul</city> <zip>34093</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 14, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>September 15, 2022</last_update_submitted> <last_update_submitted_qc>September 15, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 16, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Istanbul University</investigator_affiliation> <investigator_full_name>Demet Altun</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <keyword>prolonged intubation,</keyword> <keyword>tracheal stenosis</keyword> <keyword>Covid-19</keyword> <condition_browse>  <mesh_term>Tracheal Stenosis</mesh_term> <mesh_term>Constriction, Pathologic</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Tracheal stenosis is a serious complication following prolonged intubation. There are important differences in the challenges of airway management. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation. Tracheal stenosis is a serious complication following prolonged intubation. Two types of tracheal stenosis; Glottic and subglottic stenoses have common features in that they are challenging in terms of ventilation, oxygenation and intubation. However, there are important differences in the challenges of airway managementA thinner tube may be sufficient to overcome the airway difficulty in glottic stenoses. However, in subglottic tracheal stenosis, a thinner tube may not be conveyed to the distal of the stenosis. As a result, adequate ventilation and oxygenation may not be provided with an intubation tube placed proximal to the trachea. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation. Inclusion Criteria: - ASA 1-2-3 patients over the age of 18 who are scheduled for an elective laryngeal procedure due to subglottic stenosis will be included in our study. Exclusion Criteria: 1. Patients who did not agree to participate in the study. 2. Congestive heart failure (ejection fraction ≤ 35 %) 3. Emergency laryngeal procedures. 4. Patients under 18 years old. 5. Patients with ASA > 3.

NCT0531xxxx/NCT05317936.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/NCT05317936</url> </required_header> <id_info> <org_study_id>2021-0953</org_study_id> <secondary_id>NCI-2022-02427</secondary_id> <nct_id>NCT05317936</nct_id> </id_info> <brief_title>Pirtobrutinib (LOXO-305) Consolidation for MRD Eradication in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) Treated With Venetoclax</brief_title> <official_title>Pirtobrutinib (LOXO-305) Consolidation for MRD Eradication in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) Treated With Venetoclax</official_title> <sponsors> <lead_sponsor> <agency>M.D. Anderson Cancer Center</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>M.D. Anderson Cancer Center</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> To learn if the combination of LOXO-305 (pirtobrutinib) and venetoclax can help to control previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). </textblock> </brief_summary> <detailed_description> <textblock> Primary Objective:  I. To estimate the therapeutic efficacy of pirtobrutinib consolidation in patients who have detectable CLL in peripheral blood after receiving venetoclax for at least 12 cycles. The primary endpoint will be the rate of undetectable MRD (U-MRD4) in the peripheral blood, assessed by NGS at a threshold of 0.01% sensitivity, after 24 cycles of combination therapy.  SECONDARY OBJECTIVES:  I. Determine the complete remission (CR)/complete remission with incomplete marrow recovery (CRi) rate after 6, 12 18 and 24 cycles of combination therapy, in patients who were not in CR/CRi at study initiation and estimate the time to best response with this combination.  II. Determine the cumulative rate of blood and bone marrow minimal residual disease undetectable minimal residual disease (MRD) by next generation sequencing (NGS) at thresholds of 0.01% sensitivity (MRD4), 0.001% sensitivity (MRD5) and 0.0001% sensitivity (MRD6).  III. Achievement of undetectable MRD at a sensitivity of 0.0001% (MRD6) in the bone marrow in patients who achieve undetectable (U)-MRD6 in peripheral blood.  IV. Determine the safety of combined pirtobrutinib and venetoclax. V. Determine the progression-free and overall survival.  OUTLINE:  Patients receive pirtobrutinib orally (PO) once daily (QD) and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After 24 cycles of combination therapy, patients who achieve U-MRD4 discontinue therapy. Patients who do not achieve U-MRD4 receive pirtobrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.  After completion of study treatment, patients are followed up at 4 weeks, and then every 24 weeks (6 months) for up to 5 years. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 16, 2022</start_date> <completion_date type="Anticipated">October 1, 2027</completion_date> <primary_completion_date type="Anticipated">October 1, 2027</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <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>Rate of undetectable (U) minimal residual disease (MRD) in the peripheral blood</measure> <time_frame>Up to completion of cycle 24 (each cycle is 28 days)</time_frame> <description>Assessed by next generation sequencing (NGS) at a threshold of 0.01% sensitivity. The rate of U-MRD will be reported separately for each cohort, along with the corresponding exact 95% confidence interval.</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">44</enrollment> <condition>Chronic Lymphocytic Leukemia</condition> <condition>Small Lymphocytic Lymphoma</condition> <arm_group> <arm_group_label>Pirtobrutinib+venetoclax</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Pirtobrutinib by mouth at the same time each day Venetoclax by mouth at the same time each day.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Pirtobrutinib</intervention_name> <description>Given by PO</description> <arm_group_label>Pirtobrutinib+venetoclax</arm_group_label> <other_name>LOXO-305</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Venetoclax</intervention_name> <description>GIven by PO</description> <arm_group_label>Pirtobrutinib+venetoclax</arm_group_label> <other_name>ABT-199</other_name> <other_name>GDC-0199</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Diagnosis of CLL per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria  - Received venetoclax for at least 12 cycles, with MRD > 0.01% detectable in peripheral blood, by Adaptive Biotechnologies NGS assay, within the month prior to study enrollment  - Age 18 years or older  - Eastern Cooperative Oncology Group (ECOG) performance status =< 2  - Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert's disease  - Serum creatinine clearance of >= 30 ml/min (calculated or measured)  - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN, unless clearly due to documented disease involvement, in which case ALT and AST =< 5.0 x ULN  - Platelet count of >= 50,000/ul, with no platelet transfusion in prior 2 weeks  - Absolute neutrophil count (ANC) >= 1000/ul in the absence of growth factor support  - Hemoglobin >= 8 mg/dL  - Activated partial thromboplastin time (aPTT) or partial thromboplastin time and prothrombin time (PT) or international normalized ratio (INR) not greater than 1.5 x ULN  - Ability to provide informed consent and adhere to the required follow-up  - Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 6 months after the last dose of study drug. Women of non-childbearing potential are those who are postmenopausal (defined as absence of menses for >= 1 year) or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use effective contraception, defined above, during the study and for 30 days following the last dose of study drug  Exclusion criteria Exclusion Criteria:  - Known or suspected Richter's transformation to diffuse large B cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin lymphoma at any time preceding enrollment  - Known or suspected history of central nervous system (CNS) involvement by CLL  - History of grade >= 3 arrhythmia on prior covalent Bruton's tyrosine kinase (BTK) inhibitor  - Patients who experienced a major bleeding event on a prior BTK inhibitor  * NOTE: Major bleeding is defined as bleeding having one or more of the following features: life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2 g/dL; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome)  - Active second malignancy. Patients with a treated second malignancy and with likelihood of requiring systemic therapy within the next 2 years of < 10%, as determined by an expert in the field, will be eligible. Examples include:  - Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease  - Adequately treated cervical carcinoma in situ without current evidence of disease  - Localized (e.g., lymph node negative) breast cancer treated with curative intent with no evidence of active disease present for more than 3 years and receiving adjuvant hormonal therapy  - Localized prostate cancer undergoing active surveillance  - History of treated and cured Hodgkin's disease or non-Hodgkin lymphoma (NHL) < 5 years from diagnosis  - Major surgery within 4 weeks of planned start of study therapy  - A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disorder, that, in the opinion of the Investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes  - History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor (CAR)-T therapy within the past 60 days or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing:  - Active graft versus host disease (GVHD)  - Need for anti-cytokine therapy for toxicity from CAR-T therapy  - Residual symptoms of neurotoxicity > grade 1 from CAR-T therapy  - Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])  - Significant cardiovascular disease, defined as any of the following:  - Unstable angina or acute coronary syndrome within the past 2 months  - History of myocardial infarction within 6 months prior to planned start of study treatment  - Documented left ventricular ejection fraction (LVEF) by any method of =< 45% in the 12 months prior to planned start of study treatment  - >= grade 3 New York Heart Association (NYHA) functional classification system of heart failure  - Uncontrolled or symptomatic arrhythmias  - Prolongation of the QT interval corrected (QTc) for heart rate using Fredericia's Formula (QTcF) > 470 msec on an electrocardiogram (EKG) during screening  - QTcF is calculated using Fredericia's Formula  - Correction of suspected drug-induced QTcF prolongation or prolongation due to electrolyte abnormalities can be attempted at the Investigator's discretion, and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation or electrolyte supplementation  - Correction of QTc for underlying bundle branch block (BBB) permissible  - Hepatitis B or hepatitis C testing indicating active/ongoing infection based on screening laboratory tests as defined as:  - Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Patients who are hepatitis B PCR positive will be excluded  - Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded  - Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal) or other clinically significant active disease process which in the opinion of the Principal Investigator may pose a risk for patient participation. Screening for chronic conditions is not required  - Known human immunodeficiency virus (HIV) infection, regardless of CD4 count. Patients with unknown or negative status are eligible  - Known active cytomegalovirus (CMV) infection. Patients with unknown or negative status are eligible  - Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the oral administered study treatments  - Investigational agent or anti-cancer therapy other than venetoclax, with the exception of hormonal therapy for breast or prostate cancer. Other agents must be discontinued for at least 4 weeks for monoclonal antibody therapy or 5 half lives for other agents  - Use of > 20 mg prednisone QD or equivalent dose of steroid per day at the time of cycle 1 day 1 (C1D1). Patients may not be on prednisone of any dose intended for anti-neoplastic use  - Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist  - Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inducers and/or strong P-glycoprotein (P-gp) inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study treatment start or planned use during study participation is prohibited:  - Grapefruit or products from grapefruit  - Seville oranges or products from Seville oranges  - Star fruit or products from star fruit  - Vaccination with a live vaccine within 28 days prior to study start  - Previous treatment with another non-covalent BTK inhibitor, such as nemtabrutinib  - Pregnancy, lactation or plan to breastfeed during the study or within 30 days of the last dose of study treatment  - Patients with known hypersensitivity to any component or excipient of LOXO-305 and venetoclax  - Any unresolved toxicity from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) grade 2 at the time of starting study treatment, except for alopecia </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>Alessandra Ferrajoli, MD</last_name> <role>Principal Investigator</role> <affiliation>M.D. Anderson Cancer Center</affiliation> </overall_official> <overall_contact> <last_name>Alessandra Ferrajoli, MD</last_name> <phone>(713) 792-2063</phone> <email>aferrajo@mdanderson.org</email> </overall_contact> <location> <facility> <name>M D Anderson Cancer Center</name> <address> <city>Houston</city> <state>Texas</state> <zip>77030</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Alessandra Ferrajoli, MD</last_name> <phone>713-792-2063</phone> <email>pathompson2@mdanderson.org</email> </contact> <investigator> <last_name>Alessandra Ferrajoli, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <link> <url>http://www.mdanderson.org</url> <description>M D Anderson Cancer Center</description> </link> <verification_date>February 2023</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>February 21, 2023</last_update_submitted> <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Lymphoma</mesh_term> <mesh_term>Leukemia</mesh_term> <mesh_term>Leukemia, Lymphoid</mesh_term> <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Venetoclax</mesh_term> <mesh_term>Pirtobrutinib</mesh_term> </intervention_browse>  </clinical_study>

To learn if the combination of LOXO-305 (pirtobrutinib) and venetoclax can help to control previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Primary Objective: I. To estimate the therapeutic efficacy of pirtobrutinib consolidation in patients who have detectable CLL in peripheral blood after receiving venetoclax for at least 12 cycles. The primary endpoint will be the rate of undetectable MRD (U-MRD4) in the peripheral blood, assessed by NGS at a threshold of 0.01% sensitivity, after 24 cycles of combination therapy. SECONDARY OBJECTIVES: I. Determine the complete remission (CR)/complete remission with incomplete marrow recovery (CRi) rate after 6, 12 18 and 24 cycles of combination therapy, in patients who were not in CR/CRi at study initiation and estimate the time to best response with this combination. II. Determine the cumulative rate of blood and bone marrow minimal residual disease undetectable minimal residual disease (MRD) by next generation sequencing (NGS) at thresholds of 0.01% sensitivity (MRD4), 0.001% sensitivity (MRD5) and 0.0001% sensitivity (MRD6). III. Achievement of undetectable MRD at a sensitivity of 0.0001% (MRD6) in the bone marrow in patients who achieve undetectable (U)-MRD6 in peripheral blood. IV. Determine the safety of combined pirtobrutinib and venetoclax. V. Determine the progression-free and overall survival. OUTLINE: Patients receive pirtobrutinib orally (PO) once daily (QD) and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After 24 cycles of combination therapy, patients who achieve U-MRD4 discontinue therapy. Patients who do not achieve U-MRD4 receive pirtobrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks, and then every 24 weeks (6 months) for up to 5 years. Inclusion Criteria: - Diagnosis of CLL per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria - Received venetoclax for at least 12 cycles, with MRD > 0.01% detectable in peripheral blood, by Adaptive Biotechnologies NGS assay, within the month prior to study enrollment - Age 18 years or older - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert's disease - Serum creatinine clearance of >= 30 ml/min (calculated or measured) - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN, unless clearly due to documented disease involvement, in which case ALT and AST =< 5.0 x ULN - Platelet count of >= 50,000/ul, with no platelet transfusion in prior 2 weeks - Absolute neutrophil count (ANC) >= 1000/ul in the absence of growth factor support - Hemoglobin >= 8 mg/dL - Activated partial thromboplastin time (aPTT) or partial thromboplastin time and prothrombin time (PT) or international normalized ratio (INR) not greater than 1.5 x ULN - Ability to provide informed consent and adhere to the required follow-up - Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 6 months after the last dose of study drug. Women of non-childbearing potential are those who are postmenopausal (defined as absence of menses for >= 1 year) or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use effective contraception, defined above, during the study and for 30 days following the last dose of study drug Exclusion criteria Exclusion Criteria: - Known or suspected Richter's transformation to diffuse large B cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin lymphoma at any time preceding enrollment - Known or suspected history of central nervous system (CNS) involvement by CLL - History of grade >= 3 arrhythmia on prior covalent Bruton's tyrosine kinase (BTK) inhibitor - Patients who experienced a major bleeding event on a prior BTK inhibitor * NOTE: Major bleeding is defined as bleeding having one or more of the following features: life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2 g/dL; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome) - Active second malignancy. Patients with a treated second malignancy and with likelihood of requiring systemic therapy within the next 2 years of < 10%, as determined by an expert in the field, will be eligible. Examples include: - Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease - Adequately treated cervical carcinoma in situ without current evidence of disease - Localized (e.g., lymph node negative) breast cancer treated with curative intent with no evidence of active disease present for more than 3 years and receiving adjuvant hormonal therapy - Localized prostate cancer undergoing active surveillance - History of treated and cured Hodgkin's disease or non-Hodgkin lymphoma (NHL) < 5 years from diagnosis - Major surgery within 4 weeks of planned start of study therapy - A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disorder, that, in the opinion of the Investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes - History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor (CAR)-T therapy within the past 60 days or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing: - Active graft versus host disease (GVHD) - Need for anti-cytokine therapy for toxicity from CAR-T therapy - Residual symptoms of neurotoxicity > grade 1 from CAR-T therapy - Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) - Significant cardiovascular disease, defined as any of the following: - Unstable angina or acute coronary syndrome within the past 2 months - History of myocardial infarction within 6 months prior to planned start of study treatment - Documented left ventricular ejection fraction (LVEF) by any method of =< 45% in the 12 months prior to planned start of study treatment - >= grade 3 New York Heart Association (NYHA) functional classification system of heart failure - Uncontrolled or symptomatic arrhythmias - Prolongation of the QT interval corrected (QTc) for heart rate using Fredericia's Formula (QTcF) > 470 msec on an electrocardiogram (EKG) during screening - QTcF is calculated using Fredericia's Formula - Correction of suspected drug-induced QTcF prolongation or prolongation due to electrolyte abnormalities can be attempted at the Investigator's discretion, and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation or electrolyte supplementation - Correction of QTc for underlying bundle branch block (BBB) permissible - Hepatitis B or hepatitis C testing indicating active/ongoing infection based on screening laboratory tests as defined as: - Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Patients who are hepatitis B PCR positive will be excluded - Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded - Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal) or other clinically significant active disease process which in the opinion of the Principal Investigator may pose a risk for patient participation. Screening for chronic conditions is not required - Known human immunodeficiency virus (HIV) infection, regardless of CD4 count. Patients with unknown or negative status are eligible - Known active cytomegalovirus (CMV) infection. Patients with unknown or negative status are eligible - Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the oral administered study treatments - Investigational agent or anti-cancer therapy other than venetoclax, with the exception of hormonal therapy for breast or prostate cancer. Other agents must be discontinued for at least 4 weeks for monoclonal antibody therapy or 5 half lives for other agents - Use of > 20 mg prednisone QD or equivalent dose of steroid per day at the time of cycle 1 day 1 (C1D1). Patients may not be on prednisone of any dose intended for anti-neoplastic use - Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist - Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inducers and/or strong P-glycoprotein (P-gp) inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study treatment start or planned use during study participation is prohibited: - Grapefruit or products from grapefruit - Seville oranges or products from Seville oranges - Star fruit or products from star fruit - Vaccination with a live vaccine within 28 days prior to study start - Previous treatment with another non-covalent BTK inhibitor, such as nemtabrutinib - Pregnancy, lactation or plan to breastfeed during the study or within 30 days of the last dose of study treatment - Patients with known hypersensitivity to any component or excipient of LOXO-305 and venetoclax - Any unresolved toxicity from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) grade 2 at the time of starting study treatment, except for alopecia

NCT0531xxxx/NCT05317949.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/NCT05317949</url> </required_header> <id_info> <org_study_id>REC/01254 Nadeem Afsar</org_study_id> <nct_id>NCT05317949</nct_id> </id_info> <brief_title>Effect of Integrated Neuromuscular Training on Medium Fast Bowler in Cricket</brief_title> <official_title>Effect of Integrated Neuromuscular Training on Explosive Strength, Speed and Endurance of Medium Fast Bowler in Cricket</official_title> <sponsors> <lead_sponsor> <agency>Riphah International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Riphah International 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> Effect of Integrated Neuromuscular Training on Explosive Strength, Speed and Endurance of Medium Fast Bowler in Cricket </textblock> </brief_summary> <detailed_description> <textblock> Integrated neuromuscular training (INT) is a combination of functional movement training and speciﬁc strength, balance, speed, sensitivity, and isometric training, which aims to evaluate and prevent sports injury and improve sports performance. Neuromuscular control defects are mainly manifested as decreases in muscle strength, explosive power, or abnormal activation patterns. INT is deﬁned as a conceptual training program that incorporates general (e.g., fundamental movements) and speciﬁc strength and conditioning tasks (e.g., resistance, balance, agility, plyometric) to improve injury resilience and to enhance sporting and motor skill performance. The majority of studies in youth examining neuromuscular training strategies to improve performance and injury prevention include multiple components (for example, balance, strength, plyometric, agility, speed, coordination. INT sessions are characterized by short bursts of physical activity interspersed with brief rest periods.  the purpose of this study is to find the effect of integrated neuromuscular training on explosive strength, speed and endurance of medium fast bowler in cricket </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Actual">January 1, 2023</completion_date> <primary_completion_date type="Actual">January 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> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Soft Ball Throw Test</measure> <time_frame>Eight weeks</time_frame> <description>the test involves throwing a soft for maximum distance this test measure explosive power, particularly of the upper body and evaluate throwing distance</description> </primary_outcome> <primary_outcome> <measure>50 Yard Dash</measure> <time_frame>Eight weeks</time_frame> <description>The aim of this test is to determine acceleration and speed procedure : The test involves running a single maximum sprint over 50 meters, with the time recorded.</description> </primary_outcome> <primary_outcome> <measure>1 Mile Run Test</measure> <time_frame>Eight weeks</time_frame> <description>The purpose of this test is to complete one mile in the fastest possible time. After the purpose of the test and instructions are given, the participants begin running on the count "Ready? Go!"</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">28</enrollment> <condition>Sports Physical Therapy</condition> <arm_group> <arm_group_label>Integrated neuromuscular training program group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Integrated neuromuscular training program group will perform exercise in three major domains</description> </arm_group> <arm_group> <arm_group_label>General fitness exercises program group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>General fitness exercises program group will perform general fitness exercises</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Integrated neuromuscular training program group</intervention_name> <description>Integrated neuromuscular training program group will do plyometric training, speed and sensitivity training, resistance training for 3 days in a week and total for eight weeks.</description> <arm_group_label>Integrated neuromuscular training program group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>General fitness exercises program group</intervention_name> <description>General fitness exercises program group will do general fitness exercise for 3 days in a week and total for eight weeks.</description> <arm_group_label>General fitness exercises program group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Medium fast bowlers  - Players playing cricket for > 1 year  - Players engaging in cricket ≥ 3 days in a week  Exclusion Criteria:  - History of any injury in past 6 months.  - Those players having musculoskeletal, neurological, cardiorespiratory problems  - Those players who have any medical condition </textblock> </criteria> <gender>All</gender> <minimum_age>15 Years</minimum_age> <maximum_age>35 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Aadil Omer, Ph.D*</last_name> <role>Principal Investigator</role> <affiliation>Riphah International University</affiliation> </overall_official> <location> <facility> <name>Sports Complex</name> <address> <city>Peshawar</city> <state>KPK</state> <zip>24840</zip> <country>Pakistan</country> </address> </facility> </location> <location_countries> <country>Pakistan</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>April 2, 2022</study_first_submitted> <study_first_submitted_qc>April 2, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>February 20, 2023</last_update_submitted> <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Sports Rehabilitation</keyword> <keyword>Integrated Neuromuscular Training</keyword> <keyword>Speed</keyword> <keyword>Endurance</keyword> <keyword>Explosive strength</keyword> <keyword>Fast bowler</keyword> <keyword>Cricket</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Effect of Integrated Neuromuscular Training on Explosive Strength, Speed and Endurance of Medium Fast Bowler in Cricket Integrated neuromuscular training (INT) is a combination of functional movement training and speciﬁc strength, balance, speed, sensitivity, and isometric training, which aims to evaluate and prevent sports injury and improve sports performance. Neuromuscular control defects are mainly manifested as decreases in muscle strength, explosive power, or abnormal activation patterns. INT is deﬁned as a conceptual training program that incorporates general (e.g., fundamental movements) and speciﬁc strength and conditioning tasks (e.g., resistance, balance, agility, plyometric) to improve injury resilience and to enhance sporting and motor skill performance. The majority of studies in youth examining neuromuscular training strategies to improve performance and injury prevention include multiple components (for example, balance, strength, plyometric, agility, speed, coordination. INT sessions are characterized by short bursts of physical activity interspersed with brief rest periods. the purpose of this study is to find the effect of integrated neuromuscular training on explosive strength, speed and endurance of medium fast bowler in cricket Inclusion Criteria: - Medium fast bowlers - Players playing cricket for > 1 year - Players engaging in cricket ≥ 3 days in a week Exclusion Criteria: - History of any injury in past 6 months. - Those players having musculoskeletal, neurological, cardiorespiratory problems - Those players who have any medical condition

NCT0531xxxx/NCT05317962.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/NCT05317962</url> </required_header> <id_info> <org_study_id>CRC/2020/002</org_study_id> <nct_id>NCT05317962</nct_id> </id_info> <brief_title>COVID-19 Echo Study</brief_title> <official_title>Cardiac Manifestations of COVID-19 in Patients Admitted to Hospital</official_title> <sponsors> <lead_sponsor> <agency>London North West Healthcare NHS Trust</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>London North West Healthcare NHS Trust</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> Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital </textblock> </brief_summary> <detailed_description> <textblock> The COVID-19 disease (caused by SARS-CoV-2) predominantly affects the lungs causing a pneumonia which can become severe and lead to death via a severe inflammatory response in the lungs for which patients require admission to intensive care units (ICU) and artificial ventilation of their lungs. However, early reports from China have documented an element of injury to the heart present in up to 20% of patients. They have also documented patients who have died on ICU from heart injury rather than lung injury in COVID-19 positive patients. There are increasing numbers of reports of patients with COVID-19 having significant inflammation of the heart. What is not known is the prevalence of significant inflammation of the heart secondary to the SARS-CoV-2 and also what the significance of the injury to the heart shown in 20% of patients through blood tests really represents. That is to say is the injury significant to the outcome of the patient?  In order to investigate this, it is proposed to conduct a heart scan in COVID-19 positive patients in hospital to determine what form of heart injury is caused by the disease as well as determining it's prevalence and whether a heart scan helps in risk stratifying the patient in terms of outcome. If it is found that there is a significant amount of heart injury done by the SARS-CoV-2 and it can be determined this at an early stage with a heart scan it may be possible to start a more aggressive strategy for the patient's management in hospital to reduce the chance of death. Alternatively, if it is found that the incidence of heart injury is low and a heart scan makes no difference to the management of the patient, medical teams can be advised of this. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 12, 2020</start_date> <completion_date type="Actual">October 31, 2021</completion_date> <primary_completion_date type="Actual">October 31, 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>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Prevalence of cardiac abnormalities and relationship to admission to ICU</measure> <time_frame>6 weeks from start of admission</time_frame> </primary_outcome> <secondary_outcome> <measure>Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation</measure> <time_frame>6 weeks from start of admission</time_frame> </secondary_outcome> <secondary_outcome> <measure>Prevalence of cardiac abnormalities and relationship to death or discharge</measure> <time_frame>6 weeks from start of admission</time_frame> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">251</enrollment> <condition>Covid-19</condition> <condition>Cardiac Disease</condition> <arm_group> <arm_group_label>COVID-19 positive patients admitted to hospital</arm_group_label> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Transthoracic echocardiogram</intervention_name> <description>Abbreviated transthoracic echocardiogram</description> <arm_group_label>COVID-19 positive patients admitted to hospital</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Patients referred to the cardiology department at Northwick Park Hospital to have a transthoracic echocardiogram who have also tested positive for COVID-19, </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Age > 18 years old  2. Positive swab or serology for COVID-19  3. Referred for echocardiographic evaluation for clinical reasons  4. Willing and able to give assent  Exclusion Criteria:  1. Known hypersensitivity to perflutren or known excipients in LUMINITY </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>Prof Roxy Senior, MD</last_name> <role>Principal Investigator</role> <affiliation>North West London University Healthcare NHS Trust</affiliation> </overall_official> <location> <facility> <name>London North West University Healthcare NHS Trust</name> <address> <city>Harrow</city> <zip>HA1 3UJ</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>April 2020</verification_date> <study_first_submitted>September 9, 2020</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Echocardiography</keyword> <condition_browse>  <mesh_term>COVID-19</mesh_term> <mesh_term>Heart Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital The COVID-19 disease (caused by SARS-CoV-2) predominantly affects the lungs causing a pneumonia which can become severe and lead to death via a severe inflammatory response in the lungs for which patients require admission to intensive care units (ICU) and artificial ventilation of their lungs. However, early reports from China have documented an element of injury to the heart present in up to 20% of patients. They have also documented patients who have died on ICU from heart injury rather than lung injury in COVID-19 positive patients. There are increasing numbers of reports of patients with COVID-19 having significant inflammation of the heart. What is not known is the prevalence of significant inflammation of the heart secondary to the SARS-CoV-2 and also what the significance of the injury to the heart shown in 20% of patients through blood tests really represents. That is to say is the injury significant to the outcome of the patient? In order to investigate this, it is proposed to conduct a heart scan in COVID-19 positive patients in hospital to determine what form of heart injury is caused by the disease as well as determining it's prevalence and whether a heart scan helps in risk stratifying the patient in terms of outcome. If it is found that there is a significant amount of heart injury done by the SARS-CoV-2 and it can be determined this at an early stage with a heart scan it may be possible to start a more aggressive strategy for the patient's management in hospital to reduce the chance of death. Alternatively, if it is found that the incidence of heart injury is low and a heart scan makes no difference to the management of the patient, medical teams can be advised of this. Patients referred to the cardiology department at Northwick Park Hospital to have a transthoracic echocardiogram who have also tested positive for COVID-19, Inclusion Criteria: 1. Age > 18 years old 2. Positive swab or serology for COVID-19 3. Referred for echocardiographic evaluation for clinical reasons 4. Willing and able to give assent Exclusion Criteria: 1. Known hypersensitivity to perflutren or known excipients in LUMINITY

NCT0531xxxx/NCT05317975.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/NCT05317975</url> </required_header> <id_info> <org_study_id>202106093RIND</org_study_id> <nct_id>NCT05317975</nct_id> </id_info> <brief_title>The Effect of Home-based Rehabilitation Program After COVID-19 Infection</brief_title> <official_title>The Cardiopulmonary Function Outcome and the Effect of Two Modules of Home-based Rehabilitation Programs in Patients After COVID-19 Infection - A Randomized and Controlled Trial.</official_title> <sponsors> <lead_sponsor> <agency>National Taiwan University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>National Taiwan University 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> To follow up the cardiopulmonary function after coronavirus disease 2019 (CoVID-19) infection and compare the effect of a 12-week home-based cardiopulmonary with or without add-on remote rehabilitation on the cardiopulmonary function, emotion and quality of outcome. </textblock> </brief_summary> <detailed_description> <textblock> The investigators will recruit the patients post-CoVID infection for a cardiopulmonary function evaluation and a home-based rehabilitation program. The investigators hypothesize that an add-on remote rehabilitation on a home-based rehabilitation has a better effect than a home-based rehabilitation alone on the compliance rate for the exercise, and also a better outcome in terms of cardiopulmonary function testing, 6-minute walking test, physical activities and quality of life, as well as less dyspnea, depression and anxiety. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 15, 2021</start_date> <completion_date type="Anticipated">July 2023</completion_date> <primary_completion_date type="Anticipated">July 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> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change of 6-minute walking test (6MWT) and exercise capacity</measure> <time_frame>The change in 6MWT and peak oxygen uptake will be measured at baseline, 12 weeks, 6 and 12 months after intervention.</time_frame> <description>The distance of a 6-minute walking test and peak oxygen uptake according to cardiopulmonary exercise test will be assessed before intervention (12-week rehabilitation course), 12 weeks, 6 months and 12 months after intervention.</description> </primary_outcome> <secondary_outcome> <measure>Dyspnea scale</measure> <time_frame>The change in mMRC will be measured at baseline, 12 weeks, 6 and 12 months after intervention.</time_frame> <description>The investigators will assess the change in the Modified Medical Research Council (mMRC) scale. The mMRC scale ranges from 0 to 4. Higher scores indicate worsen symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Fatigue</measure> <time_frame>The change in BFI will be measured at baseline, 12 weeks, 6 and 12 months after intervention.</time_frame> <description>The investigators will assess the change in the Brief Fatigue Inventory (BFI). The total score of BFI ranges from 0 to 10. Higher scores indicate greater level of fatigue.</description> </secondary_outcome> <secondary_outcome> <measure>Depression and anxiety</measure> <time_frame>The change in PHQ-9 and GAD-7 will be measured at baseline, 12 weeks, 6 and 12 months after intervention.</time_frame> <description>The investigators will assess the change in Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). The PHQ-9 score ranges from 0-27 and the GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Cognitive evaluation</measure> <time_frame>The change in MoCA will be measured at baseline, 12 weeks, 6 and 12 months after intervention.</time_frame> <description>The investigators will assess the change in Montreal Cognitive Assessment (MoCA). The total score of MoCA ranges from 0 to 30. Higher scores indicate better cognitive function.</description> </secondary_outcome> <secondary_outcome> <measure>Quality of life evaluation</measure> <time_frame>The change in EQ-5D will be measured at baseline, 12 weeks, 6 and 12 months after intervention.</time_frame> <description>The investigators will assess the change in EuroQol-5D.</description> </secondary_outcome> <secondary_outcome> <measure>Grip strength</measure> <time_frame>The change in grip strength will be measured at baseline, 12 weeks, 6 and 12 months after intervention.</time_frame> <description>The investigators will assess the grip strength using a grip goniometer with the participants seated and the elbow flexed at 90 degree.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">225</enrollment> <condition>COVID-19</condition> <arm_group> <arm_group_label>Add-on telerehabilitation combined with usual home-based rehabilitation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Add-on telerehabilitation combined with usual home-based rehabilitation</description> </arm_group> <arm_group> <arm_group_label>Stand-alone usual home-based rehabilitation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Stand-alone usual home-based rehabilitation</description> </arm_group> <arm_group> <arm_group_label>Usual care</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Usual care</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Add-on telerehabilitation and home-based rehabilitation</intervention_name> <description>12wk home-based rehabilitation including individualized exercise training and inspiratory muscle training with symptoms monitoring. Participants will be provided with a manual and routine telephone follow-up by a case manager. Add-on telerehabilitation for instruction and supervision of exercise training</description> <arm_group_label>Add-on telerehabilitation combined with usual home-based rehabilitation</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Home-based rehabilitation alone</intervention_name> <description>12wk home-based rehabilitation including individualized exercise training and inspiratory muscle training with symptoms monitoring. Participants will be provided with a manual and routine telephone follow-up by a case manager.</description> <arm_group_label>Stand-alone usual home-based rehabilitation</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria:  1. ≥ 20 years of age.  2. COVID-19 survivor after de-isolation at post-acute stage about to be discharged or already at outpatient follow-up who still have symptoms or exercise intolerance.  Exclusion criteria:  1. Unable to cooperate with rehabilitation or evaluation.  2. Dependent in basic activities of living before infection (Premorbid Barthel index <80).  3. End stage patient, with life expectancy less than 1 year.  4. Having contraindications for exercise according to the evaluation of a physician. </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Hung-Jui Chuang, MD</last_name> <role>Principal Investigator</role> <affiliation>Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital</affiliation> </overall_official> <overall_contact> <last_name>Huey-Wen Liang, MD-PHD</last_name> <phone>00886-2-23123456</phone> <phone_ext>66697</phone_ext> <email>lianghw@ntu.edu.tw</email> </overall_contact> <overall_contact_backup> <last_name>Hung-Jui Chuang, MD</last_name> <phone>00886-2-23123456</phone> <phone_ext>67034</phone_ext> <email>rexintwo@gmail.com</email> </overall_contact_backup> <location> <facility> <name>National Taiwan University Hospital</name> <address> <city>Taipei</city> <zip>100</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Hung-Jui Chuang, MD</last_name> <phone>00886-2-23123456</phone> <phone_ext>67034</phone_ext> <email>Rexintwo@gmail.com</email> </contact> </location> <location_countries> <country>Taiwan</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 31, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>COVID-19</keyword> <keyword>Rehabilitation</keyword> <keyword>Cardiopulmonary exercise testing</keyword> <condition_browse>  <mesh_term>COVID-19</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To follow up the cardiopulmonary function after coronavirus disease 2019 (CoVID-19) infection and compare the effect of a 12-week home-based cardiopulmonary with or without add-on remote rehabilitation on the cardiopulmonary function, emotion and quality of outcome. The investigators will recruit the patients post-CoVID infection for a cardiopulmonary function evaluation and a home-based rehabilitation program. The investigators hypothesize that an add-on remote rehabilitation on a home-based rehabilitation has a better effect than a home-based rehabilitation alone on the compliance rate for the exercise, and also a better outcome in terms of cardiopulmonary function testing, 6-minute walking test, physical activities and quality of life, as well as less dyspnea, depression and anxiety. Inclusion criteria: 1. ≥ 20 years of age. 2. COVID-19 survivor after de-isolation at post-acute stage about to be discharged or already at outpatient follow-up who still have symptoms or exercise intolerance. Exclusion criteria: 1. Unable to cooperate with rehabilitation or evaluation. 2. Dependent in basic activities of living before infection (Premorbid Barthel index <80). 3. End stage patient, with life expectancy less than 1 year. 4. Having contraindications for exercise according to the evaluation of a physician.

NCT0531xxxx/NCT05317988.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/NCT05317988</url> </required_header> <id_info> <org_study_id>TDGCOVID-EWC-06-2021</org_study_id> <nct_id>NCT05317988</nct_id> </id_info> <brief_title>Online Training for the Reconstitution of Fosun/BioNTech</brief_title> <official_title>Online Training for the Reconstitution of Fosun/BioNTech: a Learning Platform to Determine Readiness for Complex Medication Preparation Procedures</official_title> <sponsors> <lead_sponsor> <agency>The University of Hong Kong</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>The University of Hong Kong</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 COVID-19 vaccine by BioNTech requires specific, delicate storage and dilution procedures to be stringently followed for safety and effectiveness. Training should be completed prior to undertaking dilution procedures. Currently, the nursing and pharmacy curricula do not have content on specialized vaccine reconstitution techniques. E-learning has become an essential component of teaching and learning due to COVID. Yet, optimal online learning module development for clinical procedural skill acquisition and appropriate online formative assessment has not been adequately explored. To bridge this training gap for Hong Kong nurses and pharmacists, this project aims to develop a video-based online learning programme, coupled to a randomized controlled study to determine the effectiveness of online vaccine reconstitution training. The module, a supplement to the current teaching curriculum, will train students from both Nursing and Pharmacy disciplines. Outcome measures include formative assessment of student performance, which can be used to inform the design and content of experiential content in healthcare professional curriculums. If this learning platform is shown to be effective, the scope could be extended to other disciplines (not limited to healthcare) where learning complex procedural tasks are necessary for the absence of instructor-led teaching. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">March 28, 2022</start_date> <completion_date type="Actual">December 31, 2022</completion_date> <primary_completion_date type="Actual">December 31, 2022</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>Single Group Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Factual knowledge</measure> <time_frame>1 week</time_frame> <description>Students will complete a set of validated multiple-choice questions before and after the training.</description> </primary_outcome> <secondary_outcome> <measure>Procedural knowledge</measure> <time_frame>1 week</time_frame> <description>Students will complete an interactive psychomotor assessment, where they must sort out the correct sequence of reconstitution procedures using a drag-and-drop interface with instant formative feedback</description> </secondary_outcome> <secondary_outcome> <measure>Self-efficacy</measure> <time_frame>1 week</time_frame> <description>Students will rate their confidence on carrying out the reconstitution procedures in practice before and after the training based on a 10-point Likert scale</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">385</enrollment> <condition>COVID-19</condition> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Participants receive a generic video of similar duration on basic facts of COVID-19 (unrelated to reconstitution procedures) and text-based product information</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Intervention group</intervention_name> <description>Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information</description> <arm_group_label>Intervention group</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Control group</intervention_name> <description>Participants receive a generic video of similar duration on basic facts of COVID-19 (unrelated to reconstitution procedures) and text-based product information</description> <arm_group_label>Control group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Students currently enrolled in the Bachelor of Pharmacy and Bachelor of Nursing programmes (Years 1 to 4) at The University of Hong Kong  Exclusion Criteria:  - Students not from the aforementioned programmes and years of study </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Centre of Safe Medication Practice and Research</name> <address> <city>Hong Kong</city> <country>Hong Kong</country> </address> </facility> </location> <location_countries> <country>Hong Kong</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>April 6, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>May 9, 2023</last_update_submitted> <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>The University of Hong Kong</investigator_affiliation> <investigator_full_name>Dr. Esther Wai Yin Chan</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The COVID-19 vaccine by BioNTech requires specific, delicate storage and dilution procedures to be stringently followed for safety and effectiveness. Training should be completed prior to undertaking dilution procedures. Currently, the nursing and pharmacy curricula do not have content on specialized vaccine reconstitution techniques. E-learning has become an essential component of teaching and learning due to COVID. Yet, optimal online learning module development for clinical procedural skill acquisition and appropriate online formative assessment has not been adequately explored. To bridge this training gap for Hong Kong nurses and pharmacists, this project aims to develop a video-based online learning programme, coupled to a randomized controlled study to determine the effectiveness of online vaccine reconstitution training. The module, a supplement to the current teaching curriculum, will train students from both Nursing and Pharmacy disciplines. Outcome measures include formative assessment of student performance, which can be used to inform the design and content of experiential content in healthcare professional curriculums. If this learning platform is shown to be effective, the scope could be extended to other disciplines (not limited to healthcare) where learning complex procedural tasks are necessary for the absence of instructor-led teaching. Inclusion Criteria: - Students currently enrolled in the Bachelor of Pharmacy and Bachelor of Nursing programmes (Years 1 to 4) at The University of Hong Kong Exclusion Criteria: - Students not from the aforementioned programmes and years of study

NCT0531xxxx/NCT05318001.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/NCT05318001</url> </required_header> <id_info> <org_study_id>21</org_study_id> <nct_id>NCT05318001</nct_id> </id_info> <brief_title>Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women</brief_title> <official_title>Investigation of Normative Values of Trimester-Specific Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women</official_title> <sponsors> <lead_sponsor> <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</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 feet, which are support surfaces, are adapted to the physiological relaxation and biomechanical changes that occur during pregnancy. In this adaptation, it has not been objectively clarified how the plantar fascia, which plays a very important role in maintaining the height of the plantar arch, undergoes a change. Therefore, the aim of this study is to investigate the normative values of trimester-specific biomechanical and viscoelastic properties of the plantar fascia, which adapts to changes in foot structure during pregnancy. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2022</start_date> <completion_date type="Anticipated">October 25, 2023</completion_date> <primary_completion_date type="Anticipated">April 15, 2023</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>Evaluation of biomechanical properties of plantar fascia</measure> <time_frame>The measurement of the changes from baseline stiffness values of plantar fascia at 12., 22. and 34. weeks.</time_frame> <description>Measuring of the stiffness (N/m) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.</description> </primary_outcome> <primary_outcome> <measure>Evaluation of biomechanical properties of plantar fascia</measure> <time_frame>The measurement of the changes from baseline decrement values of plantar fascia at 12., 22. and 34. weeks.</time_frame> <description>Measuring of the biomechanical decrement of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.</description> </primary_outcome> <primary_outcome> <measure>Evaluation of biomechanical properties of plantar fascia</measure> <time_frame>The measurement of the changes from baseline tone values of plantar fascia at 12., 22. and 34. weeks.</time_frame> <description>Measuring of the tone (Hz) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.</description> </primary_outcome> <primary_outcome> <measure>Evaluation of viscoelastic properties of plantar fascia</measure> <time_frame>The measurement of the changes from baseline creep values of plantar fascia at 12., 22. and 34. weeks.</time_frame> <description>Measuring of the creep of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.</description> </primary_outcome> <primary_outcome> <measure>Evaluation of viscoelastic properties of plantar fascia</measure> <time_frame>The measurement of the changes from baseline relaxation time values of plantar fascia at 12., 22. and 34. weeks.</time_frame> <description>Measuring of the relaxation time (ms) of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.</description> </primary_outcome> <secondary_outcome> <measure>Evaluation of Body Weight</measure> <time_frame>The measurement of the changes from baseline body weight at 12., 22. and 34. weeks.</time_frame> <description>Body weight (kg) will be measured</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of Body Mass Index (BMI)</measure> <time_frame>The measurement of the changes from baseline BMI at 12., 22. and 34. weeks.</time_frame> <description>BMI will be calculated as person's weight in kilograms divided by the square of height in meters</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of Foot Morphological Characteristics</measure> <time_frame>The measurement of the changes from baseline foot width at 12., 22. and 34. weeks.</time_frame> <description>Foot width (cm) will be measured</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of Foot Morphological Characteristics</measure> <time_frame>The measurement of the changes from baseline foot length at 12., 22. and 34. weeks.</time_frame> <description>Foot length (cm) will be measured</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of foot mobility</measure> <time_frame>The measurement of the changes from baseline navicular drop values at 12., 22. and 34. weeks.</time_frame> <description>Navicular drop values will be measured</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of foot posture</measure> <time_frame>The measurement of the changes from baseline foot posture characteristics at 12., 22. and 34. weeks.</time_frame> <description>Foot posture will be evaluated according to foot posture index.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">163</enrollment> <condition>Pregnant Women</condition> <arm_group> <arm_group_label>Group: Pregnant women (first-timed pregnant)</arm_group_label> <description>This group will consist of women in first trimester of pregnancy</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Evaluation of biomechanics and viscoelastic properties of plantar fascia</intervention_name> <description>The biomechanical (Tone-Hz, Stiffness-N/m and decrement) and viscoelastic (creep and relaxation time-ms) properties of the plantar fascia will be measured in the side lying position. Measurements will be made with the ankle in neutral position.</description> <arm_group_label>Group: Pregnant women (first-timed pregnant)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Evaluation of Foot Morphological Characteristics</intervention_name> <description>Foot length and width will be measured.</description> <arm_group_label>Group: Pregnant women (first-timed pregnant)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Evaluation of navıcular mobility</intervention_name> <description>The amount of navicular drop of both feet will be measured.</description> <arm_group_label>Group: Pregnant women (first-timed pregnant)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Evaluation of Foot Posture</intervention_name> <description>Foot posture will be evaluated according to Foot Posture Index.</description> <arm_group_label>Group: Pregnant women (first-timed pregnant)</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Pregnant women (first-time pregnancy) </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - First-time pregnancy  - Being in the first trimester of pregnancy  - They are between the ages of 18-40  - Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2  Exclusion Criteria:  - Presence of any connective tissue disease that would affect the biomechanical or viscoelastic properties of the fascia  - Deterioration of skin integrity in measurement areas  - Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal in biomechanical alignment  - History of surgery or fracture in the lower extremity and foot-ankle region in the last 6 months  - Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Pregnant women</gender_description> <minimum_age>18 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Nilüfer KABLAN, PhD</last_name> <phone>05067638556</phone> <email>niluferkablan@yahoo.com</email> </overall_contact> <overall_contact_backup> <last_name>Merve CAN, Msc</last_name> <phone>05388397713</phone> <email>mervecaann@gmail.com</email> </overall_contact_backup> <location> <facility> <name>İstanbul Medeniyet University</name> <address> <city>İstanbul</city> <country>Turkey</country> </address> </facility> <contact> <last_name>Nilüfer KABLAN, PhD</last_name> <phone>05067638556</phone> <email>niluferkablan@yahoo.com</email> </contact> <investigator> <last_name>Merve CAN, Msc</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Turkey</country> </location_countries> <results_reference> <citation>Challis JR, Lockwood CJ, Myatt L, Norman JE, Strauss JF 3rd, Petraglia F. Inflammation and pregnancy. Reprod Sci. 2009 Feb;16(2):206-15. doi: 10.1177/1933719108329095.</citation> <PMID>19208789</PMID> </results_reference> <results_reference> <citation>Cherni Y, Desseauve D, Decatoire A, Veit-Rubinc N, Begon M, Pierre F, Fradet L. Evaluation of ligament laxity during pregnancy. J Gynecol Obstet Hum Reprod. 2019 May;48(5):351-357. doi: 10.1016/j.jogoh.2019.02.009. Epub 2019 Feb 20.</citation> <PMID>30794956</PMID> </results_reference> <results_reference> <citation>Segal NA, Boyer ER, Teran-Yengle P, Glass NA, Hillstrom HJ, Yack HJ. Pregnancy leads to lasting changes in foot structure. Am J Phys Med Rehabil. 2013 Mar;92(3):232-40. doi: 10.1097/PHM.0b013e31827443a9.</citation> <PMID>23117270</PMID> </results_reference> <results_reference> <citation>Huang J, Qin K, Tang C, Zhu Y, Klein CS, Zhang Z, Liu C. Assessment of Passive Stiffness of Medial and Lateral Heads of Gastrocnemius Muscle, Achilles Tendon, and Plantar Fascia at Different Ankle and Knee Positions Using the MyotonPRO. Med Sci Monit. 2018 Oct 23;24:7570-7576. doi: 10.12659/MSM.909550.</citation> <PMID>30352050</PMID> </results_reference> <results_reference> <citation>Sanjana F, Chaudhry H, Findley T. Effect of MELT method on thoracolumbar connective tissue: The full study. J Bodyw Mov Ther. 2017 Jan;21(1):179-185. doi: 10.1016/j.jbmt.2016.05.010. Epub 2016 Jun 3.</citation> <PMID>28167175</PMID> </results_reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 12, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 15, 2022</last_update_submitted> <last_update_submitted_qc>April 15, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 18, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>stiffness</keyword> <keyword>creep</keyword> <keyword>normative data</keyword> <keyword>plantar fascia</keyword> <keyword>pregnant women</keyword> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The feet, which are support surfaces, are adapted to the physiological relaxation and biomechanical changes that occur during pregnancy. In this adaptation, it has not been objectively clarified how the plantar fascia, which plays a very important role in maintaining the height of the plantar arch, undergoes a change. Therefore, the aim of this study is to investigate the normative values of trimester-specific biomechanical and viscoelastic properties of the plantar fascia, which adapts to changes in foot structure during pregnancy. Pregnant women (first-time pregnancy) Inclusion Criteria: - First-time pregnancy - Being in the first trimester of pregnancy - They are between the ages of 18-40 - Pre-pregnancy Body-Mass-Index (BMI) < 30 kg/m2 Exclusion Criteria: - Presence of any connective tissue disease that would affect the biomechanical or viscoelastic properties of the fascia - Deterioration of skin integrity in measurement areas - Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal in biomechanical alignment - History of surgery or fracture in the lower extremity and foot-ankle region in the last 6 months - Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia

NCT0531xxxx/NCT05318014.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/NCT05318014</url> </required_header> <id_info> <org_study_id>CF19237B</org_study_id> <nct_id>NCT05318014</nct_id> </id_info> <brief_title>Low-protein Formula Supplements in Chronic Kidney Disease</brief_title> <official_title>Effect of Low-protein Formula Nutritional Supplements on Renal Function Progression, Muscle Mass and Physical Activity With Chronic Kidney Disease</official_title> <sponsors> <lead_sponsor> <agency>Taichung Veterans General Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Taichung Veterans General 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> Prospective randomized contorl study.Comparing clinical outcome between chronic kidney disease who were prescribed 6% low-protein nutrition supplement along with dietatian regular nutrition education and those without oral nutrition supplement. </textblock> </brief_summary> <detailed_description> <textblock> Past studies have shown that supplementation with low-protein nutritional formulas helps to increase compliance with low-protein diet control, but few studies have explored low-protein nutritional formulas supplementing the calories chronic kidney disease patient need, and nutritional supplements rich in ω-3 fatty acids, vitamin D and essential amino acid having effect in chronic renal function and changes in muscle mass, strength, and mobility. The propose of this study that low protein supplement may help maintain renal function or delay deterioration of renal function, or may reduce the risk of malnutrition and further improve muscle strength and mobility or quality of life. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">September 25, 2019</start_date> <completion_date type="Actual">December 31, 2021</completion_date> <primary_completion_date type="Actual">October 31, 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>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change of muscle strength</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Hand grip strength</description> </primary_outcome> <primary_outcome> <measure>Change of Gait speed</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Gait speed measurement</description> </primary_outcome> <primary_outcome> <measure>Change of 5-meter distance walk</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>5-meter distance walk measurement</description> </primary_outcome> <primary_outcome> <measure>Change of nutrition status</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Mini Nutritional Assessment Short-Form score</description> </primary_outcome> <primary_outcome> <measure>Change of body composition</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)</description> </primary_outcome> <primary_outcome> <measure>Change of total energy intake</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>24-hour dietary record measurement</description> </primary_outcome> <primary_outcome> <measure>Change of protein intake</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>24-hour dietary record measurement</description> </primary_outcome> <primary_outcome> <measure>Change of carbohydrate intake</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>24-hour dietary record measurement</description> </primary_outcome> <primary_outcome> <measure>Change of fat intake</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>24-hour dietary record measurement</description> </primary_outcome> <primary_outcome> <measure>Change of micronutrients intake</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>24-hour dietary record measurement</description> </primary_outcome> <secondary_outcome> <measure>Change of serum creatinine</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>renal function monitoring</description> </secondary_outcome> <secondary_outcome> <measure>Change of blood urea nitrogen</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>renal function monitoring</description> </secondary_outcome> <secondary_outcome> <measure>Change of estimated glomerular filtration rate</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>renal function monitoring</description> </secondary_outcome> <secondary_outcome> <measure>Change of daily protein intake.</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>24-hour urine estimated protein intake with Maroni formula</description> </secondary_outcome> <secondary_outcome> <measure>Change of albumin</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Change of albumin in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of sodium</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>electrolyte measurement in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of potassium</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>electrolyte measurement in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of calcium</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>electrolyte measurement in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of phosphorus</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>electrolyte measurement in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of magnesium</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>electrolyte measurement in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of Hemoglobin A1c</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>monitoring and diagnosis diabetes</description> </secondary_outcome> <secondary_outcome> <measure>Change of blood sugar</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Blood sugar testing</description> </secondary_outcome> <secondary_outcome> <measure>Change of CRP</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Change of CRP in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of red blood cell</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Routine Blood Tests in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of White blood cell</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Routine Blood Tests in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of hemoglobin</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Routine Blood Tests in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of hematocrit</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Routine Blood Tests in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of liver function</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Change of ALT and AST in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of cholesterol</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Change in lipid analysis in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of triglyceride</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Change in lipid analysis in the blood</description> </secondary_outcome> <secondary_outcome> <measure>Change of LDL-cholesterol</measure> <time_frame>Baseline to 12 weeks and 24 weeks</time_frame> <description>Change in lipid analysis in the blood</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">95</enrollment> <condition>Chronic Kidney Disease</condition> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Regular nutrition education and supply one serving per day of 6% low protein formula.</description> </arm_group> <arm_group> <arm_group_label>Regular nutrition education</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Regular nutrition education</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Intervention group</intervention_name> <description>dietitian regular nutrition education which was following a low protein diet and supply one serving per day of 6 % low protein formula (200mL,2kcal/ml) for 24 weeks</description> <arm_group_label>Intervention group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Regular nutrition education</intervention_name> <description>dietitian regular nutrition educataion which was following a low protein diet</description> <arm_group_label>Regular nutrition education</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Subject is >65years of age.  2. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.  Exclusion Criteria:  1. The physician determines that the clinical condition is unstable.  2. Lower limb injury or severe edema.  3. food allergies to milk, or fish  4. There is a heart rhythm in the body and a prosthetic device.  5. Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician. </textblock> </criteria> <gender>All</gender> <minimum_age>65 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Cheng-Hsu Chen, MDPHD</last_name> <role>Principal Investigator</role> <affiliation>Division of Nephrology in Taichung Veterans General Hospital</affiliation> </overall_official> <location> <facility> <name>Taichung Verterans General Hospital Taichung</name> <address> <city>Taichung</city> <country>Taiwan</country> </address> </facility> </location> <location_countries> <country>Taiwan</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 31, 2022</last_update_submitted> <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Oral nutrition supplement</keyword> <keyword>Chronic kidney disease</keyword> <condition_browse>  <mesh_term>Kidney Diseases</mesh_term> <mesh_term>Renal Insufficiency, Chronic</mesh_term> </condition_browse>  </clinical_study>

Prospective randomized contorl study.Comparing clinical outcome between chronic kidney disease who were prescribed 6% low-protein nutrition supplement along with dietatian regular nutrition education and those without oral nutrition supplement. Past studies have shown that supplementation with low-protein nutritional formulas helps to increase compliance with low-protein diet control, but few studies have explored low-protein nutritional formulas supplementing the calories chronic kidney disease patient need, and nutritional supplements rich in ω-3 fatty acids, vitamin D and essential amino acid having effect in chronic renal function and changes in muscle mass, strength, and mobility. The propose of this study that low protein supplement may help maintain renal function or delay deterioration of renal function, or may reduce the risk of malnutrition and further improve muscle strength and mobility or quality of life. Inclusion Criteria: 1. Subject is >65years of age. 2. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5. Exclusion Criteria: 1. The physician determines that the clinical condition is unstable. 2. Lower limb injury or severe edema. 3. food allergies to milk, or fish 4. There is a heart rhythm in the body and a prosthetic device. 5. Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.

NCT0531xxxx/NCT05318027.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/NCT05318027</url> </required_header> <id_info> <org_study_id>UPCC 18921</org_study_id> <nct_id>NCT05318027</nct_id> </id_info> <brief_title>ChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy</brief_title> <official_title>Use of Natural Language Processing ChatBot and Automated Continuous Activity Monitoring Via Mobile Phones for Early Detection and Management of Symptoms in Patients Undergoing Cancer Treatment</official_title> <sponsors> <lead_sponsor> <agency>Abramson Cancer Center at Penn Medicine</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Abramson Cancer Center at Penn Medicine</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> Evaluate the feasibility of using a chatbot combined with continuous activity monitoring to proactively identify, appropriately triage and help manage patients' symptoms during cancer treatment Determine whether such an early outpatient clinic-based intervention can decrease rates of excess triage visits  Correlate changes in activity and early symptom management to emergency department visits, unplanned inpatient hospitalizations and treatment breaks </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 22, 2023</start_date> <completion_date type="Anticipated">May 2024</completion_date> <primary_completion_date type="Anticipated">February 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> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Number of triage visits</measure> <time_frame>13 weeks</time_frame> <description>Difference between Poisson event rates of triage visits between intervention and control arms</description> </primary_outcome> <secondary_outcome> <measure>Count of unplanned inpatient hospitalization</measure> <time_frame>13 weeks</time_frame> </secondary_outcome> <secondary_outcome> <measure>Count of treatment breaks</measure> <time_frame>13 weeks</time_frame> </secondary_outcome> <secondary_outcome> <measure>Count of emergency department visits</measure> <time_frame>13 weeks</time_frame> </secondary_outcome> <secondary_outcome> <measure>Quality of Life scores</measure> <time_frame>13 weeks</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">70</enrollment> <condition>Lung Cancer</condition> <condition>Gastrointestinal Cancer</condition> <condition>Head and Neck Cancer</condition> <arm_group> <arm_group_label>Activity Monitoring and ChatBot</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring and utilize a ChatBot</description> </arm_group> <arm_group> <arm_group_label>Activity Monitoring without ChatBot</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Patients will receive standard of care chemotherapy and radiation therapy regimens, activity monitoring alone</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>ChatBot</intervention_name> <description>The automated chatbot will check in with the patient on two pre-specified days between scheduled outpatient visits. The chatbot will follow pre-specified symptom algorithms and classify symptoms as requiring high, intermediate and low risk follow ups. High risk symptoms will trigger a same day nursing/physician visit or telemedicine call/video. Intermediate risk symptoms will trigger a nursing triage visit or telemedicine call/video on the next day or treatment day. Low risk symptoms will notify the treating physician to address the symptoms at the next scheduled on treatment visit (OTV). If adjustments are needed in the chat bot triage algorithms, they will be updated in real time to decrease risk for adverse patient events.</description> <arm_group_label>Activity Monitoring and ChatBot</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adults (age >18 years) with a diagnosis of a head and neck, lung, gastrointestinal cancer, that are receiving concurrent chemotherapy and radiation treatment.  - Possession of a mobile device that can receive SMS texts and can deliver FitBit data wirelessly  - Ability read and respond in English  - Ability to provide informed consent to participate in the study  Exclusion Criteria:  - Patients who are bed bound at baseline (ECOG 4)  - Patients who rely on a wheelchair for ambulation </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>Arun Goel, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Pennsylvania</affiliation> </overall_official> <overall_official> <last_name>Kristine Kim, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Pennsylvania</affiliation> </overall_official> <overall_official> <last_name>Nishant Shah, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Pennsylvania</affiliation> </overall_official> <overall_contact> <last_name>Michell Kim</last_name> <phone>215-760-2487</phone> <email>Michell.Kim@pennmedicine.upenn.edu</email> </overall_contact> <location> <facility> <name>Abramson Cancer Center of the University of Pennsylvania</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19104</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Arun Goel, MD</last_name> <phone>215-662-6059</phone> <email>Arun.Goel@pennmedicine.upenn.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Uyterlinde W. Overcoming toxicity-challenges in chemoradiation for non-small cell lung cancer. Transl Lung Cancer Res. 2016 Jun;5(3):239-43. doi: 10.21037/tlcr.2016.05.03.</citation> <PMID>27413701</PMID> </reference> <reference> <citation>Ghosh S, Rao PB, Kumar PR, Manam S. Concurrent Chemoradiation with Weekly Cisplatin for the Treatment of Head and Neck Cancers: an Institutional Study on Acute Toxicity and Response to Treatment. Asian Pac J Cancer Prev. 2015;16(16):7331-5. doi: 10.7314/apjcp.2015.16.16.7331.</citation> <PMID>26514533</PMID> </reference> <reference> <citation>Haj Mohammad N, Hulshof MC, Bergman JJ, Geijsen D, Wilmink JW, van Berge Henegouwen MI, van Laarhoven HW. Acute toxicity of definitive chemoradiation in patients with inoperable or irresectable esophageal carcinoma. BMC Cancer. 2014 Jan 31;14:56. doi: 10.1186/1471-2407-14-56.</citation> <PMID>24485047</PMID> </reference> <reference> <citation>Waddle MR, Chen RC, Arastu NH, Green RL, Jackson M, Qaqish BF, Camporeale J, Collichio FA, Marks LB. Unanticipated hospital admissions during or soon after radiation therapy: Incidence and predictive factors. Pract Radiat Oncol. 2015 May-Jun;5(3):e245-e253. doi: 10.1016/j.prro.2014.08.004. Epub 2014 Sep 17.</citation> <PMID>25413398</PMID> </reference> <reference> <citation>Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.</citation> <PMID>20351327</PMID> </reference> <reference> <citation>Lang K, Sussman M, Friedman M, Su J, Kan HJ, Mauro D, Tafesse E, Menzin J. Incidence and costs of treatment-related complications among patients with advanced squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 2009 Jun;135(6):582-8. doi: 10.1001/archoto.2009.46.</citation> <PMID>19528407</PMID> </reference> <reference> <citation>Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857.</citation> <PMID>28387544</PMID> </reference> <reference> <citation>McNeely ML, Campbell KL, Rowe BH, Klassen TP, Mackey JR, Courneya KS. Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. CMAJ. 2006 Jul 4;175(1):34-41. doi: 10.1503/cmaj.051073.</citation> <PMID>16818906</PMID> </reference> <verification_date>July 2023</verification_date> <study_first_submitted>December 6, 2021</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 19, 2023</last_update_submitted> <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 20, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Gastrointestinal Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Evaluate the feasibility of using a chatbot combined with continuous activity monitoring to proactively identify, appropriately triage and help manage patients' symptoms during cancer treatment Determine whether such an early outpatient clinic-based intervention can decrease rates of excess triage visits Correlate changes in activity and early symptom management to emergency department visits, unplanned inpatient hospitalizations and treatment breaks Inclusion Criteria: - Adults (age >18 years) with a diagnosis of a head and neck, lung, gastrointestinal cancer, that are receiving concurrent chemotherapy and radiation treatment. - Possession of a mobile device that can receive SMS texts and can deliver FitBit data wirelessly - Ability read and respond in English - Ability to provide informed consent to participate in the study Exclusion Criteria: - Patients who are bed bound at baseline (ECOG 4) - Patients who rely on a wheelchair for ambulation

NCT0531xxxx/NCT05318040.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/NCT05318040</url> </required_header> <id_info> <org_study_id>VG-CMS121-101</org_study_id> <secondary_id>R01AG074447</secondary_id> <nct_id>NCT05318040</nct_id> </id_info> <brief_title>Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects</brief_title> <acronym>CMS121</acronym> <official_title>Phase 1 Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of CMS121 and Food Effect in Healthy Volunteers</official_title> <sponsors> <lead_sponsor> <agency>Virogenics, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>National Institute on Aging (NIA)</agency> <agency_class>NIH</agency_class> </collaborator> <collaborator> <agency>Celerion</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Virogenics, Inc.</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 randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in a fed or fasted state to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days. </textblock> </brief_summary> <detailed_description> <textblock> This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of approximately 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of approximately 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for a total duration of approximately 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in fed and fasted states to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms (ECGs), blood and urine lab analyses and occurrence of adverse events (AEs). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Actual">December 17, 2022</completion_date> <primary_completion_date type="Actual">December 17, 2022</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> <intervention_model_description>This is a 4-Part study. Parts 1, 2, and 3 are randomized, double blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) in healthy young adult subjects and multiple doses in healthy elderly subjects (Part 3) of orally administered CMS121. Part 4 is an open label, 2 way crossover study to assess the effect of food on a single oral dose of CMS121 in healthy young adult subjects.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Care Provider, Investigator)</masking> <masking_description>Double Blinded</masking_description> </study_design_info> <primary_outcome> <measure>Safety: Treatment-emergent adverse events (TEAEs)</measure> <time_frame>From baseline through day 8 for SAD cohorts and through day 15 for MAD cohorts</time_frame> <description>Number of participants with TEAEs</description> </primary_outcome> <secondary_outcome> <measure>Pharmacokinetics (PK): Blood concentration levels of CMS121</measure> <time_frame>From baseline on day 1 through day 4 for SAD cohorts and through day 10 for MAD cohorts</time_frame> </secondary_outcome> <secondary_outcome> <measure>Pharmacokinetics (PK): Urine concentration levels of CMS121</measure> <time_frame>From baseline on day 1 through day 4 for SAD cohorts and through day 10 for MAD cohorts.</time_frame> </secondary_outcome> <secondary_outcome> <measure>Safety: Effect on electrocardiographic parameters</measure> <time_frame>From baseline on day 1 and for 24hr post day 1 dose for SAD cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for MAD cohorts.</time_frame> <description>CMS121 concentration and effect on interval change in QTc (dQTc) from baseline</description> </secondary_outcome> <number_of_arms>7</number_of_arms> <enrollment type="Actual">99</enrollment> <condition>Alzheimer Disease</condition> <arm_group> <arm_group_label>Single ascending dose - CMS121</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects will receive a single oral dose of CMS121 under fed conditions.</description> </arm_group> <arm_group> <arm_group_label>Single ascending dose - placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Subjects will receive a single oral dose of placebo under fed conditions.</description> </arm_group> <arm_group> <arm_group_label>Multiple ascending dose - CMS121</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions.</description> </arm_group> <arm_group> <arm_group_label>Multiple ascending dose - placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions.</description> </arm_group> <arm_group> <arm_group_label>Multiple ascending dose - Elderly cohort - CMS121</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions.</description> </arm_group> <arm_group> <arm_group_label>Multiple ascending dose - Elderly cohort - placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions.</description> </arm_group> <arm_group> <arm_group_label>Food Effect - CMS121</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>On Day 1 of each of 2 treatment periods, a single oral dose of CMS121 will be administered following either a standard high fat/high calorie meal (Treatment A) or an overnight fast (Treatment B), as per each subject's assigned randomization sequence (AB or BA). There will be a washout of at least 7 days between doses.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>CMS121</intervention_name> <description>CMS121 is a small molecule to be delivered orally in capsule form and is a therapeutic drug candidate for treatment of Alzheimer's Disease</description> <arm_group_label>Food Effect - CMS121</arm_group_label> <arm_group_label>Multiple ascending dose - CMS121</arm_group_label> <arm_group_label>Multiple ascending dose - Elderly cohort - CMS121</arm_group_label> <arm_group_label>Single ascending dose - CMS121</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo will be provided as visually matching placebo capsules.</description> <arm_group_label>Multiple ascending dose - Elderly cohort - placebo</arm_group_label> <arm_group_label>Multiple ascending dose - placebo</arm_group_label> <arm_group_label>Single ascending dose - placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  To qualify for enrollment, subjects must meet all of the following inclusion criteria:  All Subjects:  - Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the study schedule, requirements, and restrictions.  - Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing.  - Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.  - In good general health, free from clinically significant medical or psychiatric illness, based on medical/surgical history, physical examination, and clinical laboratory tests.  - All laboratory parameters (serum chemistry, hematology, coagulation, and urinalysis) are within the reference range or considered not clinically significant by the PI, at the screening visit.  - Negative results for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) tests (as outlined in protocol) at the screening visit.  - Female subjects must have negative results for pregnancy test at the screening visit and the first check-in and must not be lactating.  - Able to swallow multiple capsules.  - Adequate venous access in the left or right arm to allow collection of the required blood samples.  Parts 1 (SAD) and 2 (MAD):  - Healthy, adult, male or female, 19-60 years of age, inclusive, at the screening visit.  - Females of childbearing potential .  - Females of non-childbearing potential are defined as follows:  - Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:  - hysteroscopic sterilization;  - bilateral tubal ligation or bilateral salpingectomy;  - hysterectomy;  - bilateral oophorectomy. or  - Individuals who are postmenopausal (PMP) with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with PMP status.  - Females of childbearing potential and male subjects must follow protocol-specified contraception guidance.  - Vital signs must be within the protocol-specified ranges.  - No presence of a clinically significant ECG abnormality as judged by the PI or qualified designee and as per protocol-specified ranges.  Part 3 (Elderly):  - Healthy, adult, male or female, 65-85 years of age, inclusive, at the screening visit.  - Females of childbearing potential.  - Females of non-childbearing potential are defined as follows:  - Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:  - hysteroscopic sterilization;  - bilateral tubal ligation or bilateral salpingectomy;  - hysterectomy;  - bilateral oophorectomy. or  - Individuals who are postmenopausal (PMP) with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with PMP status.  or  - Individuals who are PMP with amenorrhea for at least 1 year prior to the first dosing and FSH serum levels consistent with PMP status.  - Females of childbearing potential and male subjects must follow protocol specified contraception guidance.  - Vital signs must be within the protocol-specified ranges.  - QTcF interval is ≤450 msec (males) or ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit and prior to the first dosing.  Part 4 (Food Effect):  - Healthy, adult, male or female, 19-60 years of age, inclusive, at the screening visit.  - Females of childbearing potential.  - Females of non-childbearing potential are defined as follows:  - Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:  - hysteroscopic sterilization;  - bilateral tubal ligation or bilateral salpingectomy;  - hysterectomy;  - bilateral oophorectomy. or  - Individuals who are PMP with amenorrhea for at least 1 year prior to the first dosing and FSH serum levels consistent with PMP status.  - Females of childbearing potential and male subjects must follow protocol specified contraception guidance.  - Vital signs must be within the protocol-specified ranges.  - QTcF interval is ≤450 msec (males) or ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit and prior to the first dosing.  - Able to completely consume a standardized high-fat/high-calorie breakfast as required by the study protocol.  Exclusion Criteria:  - Subjects who meet any of the following criteria must be excluded from the study:  All Subjects:  - Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.  - History or presence of malignancy within the past 2 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.  - History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study in the opinion of the PI or designee.  - Evidence of clinically relevant medical illness including cardiovascular, hematological, psychiatric, gastrointestinal, hepatic, renal, rheumatologic, autoimmune, endocrine, pulmonary, neurologic or dermatologic disorder in the opinion of the PI or designee.  - History of skin rash(es) associated with the use of any medication(s).  - Any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass) that could interfere with drug absorption, distribution, metabolism, or excretion.  - Clinically significant surgical procedure within 90 days prior to the screening visit.  - Clinically significant acute illness or infection within 14 days prior to the first dosing.  - History of significant drug allergies including a history of anaphylactic reaction.  - Family history of sudden death in an otherwise healthy individual.  - Positive urine cotinine at the screening visit or at first check-in.  - Excessive use of alcohol, defined as weekly intake in excess of 14 units of alcohol (1 unit = 12 fluid ounces of beer, 5 fluid ounces of wine, or 1.5 fluid ounces [1 shot] of distilled spirits or liquor), within 6 months prior to the screening visit.  - Positive test result for alcohol or drugs of abuse at the screening visit or first check-in, or history of alcohol and/or drug abuse within the past 2 years prior to the screening visit.  - Heavy caffeine drinker (defined as consumption of >5 servings of caffeinated beverages [e.g., coffee, tea, cola, energy drinks] per day).  - Refusal to refrain from strenuous physical activity from screening until first check-in.  - Unwillingness to avoid sun and/or phototherapy exposure for 72 hours after the last dose of study drug.  - Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing.  - Use of any investigational drug or device within 30 days or biologics for 90 days (or 5 half-lives of the drug, whichever is the longer) prior to the first dosing, or currently participating in another study of an investigational drug or biologics, or a medical device.  - Loss or donation of >500 mL blood within 56 days prior to study drug administration, or donation of plasma within 30 days prior to the first dosing.  - Employee or family member of the PI, study site personnel, or Sponsor.  - Any other reason that, in the opinion of the PI, would render the subject unsuitable for study enrollment.  Parts 1 (SAD):  - History or presence of:  - risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome or sudden unexpected cardiac death at a young age);  - sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities;  - ischemic heart disease, symptomatic arrhythmias, or poorly controlled hypertension.  - conditions predisposing to QT prolongation including pathological Q-wave.  - Unable to refrain from or anticipates the use of:  - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing;  - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/pharmacodynamic (PD) interaction with study drug;  - any drugs that prolong the QT/QTc interval within 14 days (or 5 half-lives, whichever is longer) prior to the first dosing.  - Allergy to band aids, adhesive dressing, or medical tape.  - Glomerular filtration rate (GFR) ≤ 80 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.  Part 2 (MAD):  - History or presence of:  - risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome or sudden unexpected cardiac death at a young age);  - sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities;  - ischemic heart disease, symptomatic arrhythmias, or poorly controlled hypertension.  - conditions predisposing to QT prolongation including pathological Q-wave.  - Unable to refrain from or anticipates the use of:  - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing;  - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug;  - any drugs that prolong the QT/QTc interval within 14 days (or 5 half-lives, whichever is longer) prior to the first dosing.  - Is at risk of suicide. Has attempted suicide in the past 12 months or Is at risk of suicide, as determined by the PI, psychiatric interview and/or the baseline C-SSRS.  - Allergy to band aids, adhesive dressing, or medical tape.  - GFR ≤ 80 mL/min/1.73 m2, as estimated by the CKD-EPI equation.  Part 3 (Elderly):  - Is at risk of suicide. Has attempted suicide in the past 12 months or Is at risk of suicide, as determined by the PI, psychiatric interview and/or the baseline C-SSRS.  - Unable to refrain from or anticipates the use of:  - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. Thyroid hormone replacement medication (refer to protocol) will be allowed;  - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug.  - GFR ≤ 70 mL/min/1.73 m2, as estimated by the CKD-EPI equation.  Part 4 (Food Effect):  - Is lactose intolerant.  - Unable to refrain from or anticipates the use of:  - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing;  - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug.  - GFR ≤ 80 mL/min/1.73 m2, as estimated by the CKD-EPI equation. </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>85 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Scott Rasmussen, MD</last_name> <role>Principal Investigator</role> <affiliation>Celerion</affiliation> </overall_official> <location> <facility> <name>Celerion</name> <address> <city>Lincoln</city> <state>Nebraska</state> <zip>68502-2040</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 31, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>February 14, 2023</last_update_submitted> <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 16, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Alzheimer's Disease</keyword> <condition_browse>  <mesh_term>Alzheimer Disease</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>February 18, 2022</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT05318040/ICF_000.pdf</document_url> </provided_document> </provided_document_section>  </clinical_study>

This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in a fed or fasted state to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days. This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of approximately 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of approximately 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for a total duration of approximately 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in fed and fasted states to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms (ECGs), blood and urine lab analyses and occurrence of adverse events (AEs). Inclusion Criteria: To qualify for enrollment, subjects must meet all of the following inclusion criteria: All Subjects: - Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the study schedule, requirements, and restrictions. - Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing. - Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit. - In good general health, free from clinically significant medical or psychiatric illness, based on medical/surgical history, physical examination, and clinical laboratory tests. - All laboratory parameters (serum chemistry, hematology, coagulation, and urinalysis) are within the reference range or considered not clinically significant by the PI, at the screening visit. - Negative results for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) tests (as outlined in protocol) at the screening visit. - Female subjects must have negative results for pregnancy test at the screening visit and the first check-in and must not be lactating. - Able to swallow multiple capsules. - Adequate venous access in the left or right arm to allow collection of the required blood samples. Parts 1 (SAD) and 2 (MAD): - Healthy, adult, male or female, 19-60 years of age, inclusive, at the screening visit. - Females of childbearing potential . - Females of non-childbearing potential are defined as follows: - Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: - hysteroscopic sterilization; - bilateral tubal ligation or bilateral salpingectomy; - hysterectomy; - bilateral oophorectomy. or - Individuals who are postmenopausal (PMP) with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with PMP status. - Females of childbearing potential and male subjects must follow protocol-specified contraception guidance. - Vital signs must be within the protocol-specified ranges. - No presence of a clinically significant ECG abnormality as judged by the PI or qualified designee and as per protocol-specified ranges. Part 3 (Elderly): - Healthy, adult, male or female, 65-85 years of age, inclusive, at the screening visit. - Females of childbearing potential. - Females of non-childbearing potential are defined as follows: - Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: - hysteroscopic sterilization; - bilateral tubal ligation or bilateral salpingectomy; - hysterectomy; - bilateral oophorectomy. or - Individuals who are postmenopausal (PMP) with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with PMP status. or - Individuals who are PMP with amenorrhea for at least 1 year prior to the first dosing and FSH serum levels consistent with PMP status. - Females of childbearing potential and male subjects must follow protocol specified contraception guidance. - Vital signs must be within the protocol-specified ranges. - QTcF interval is ≤450 msec (males) or ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit and prior to the first dosing. Part 4 (Food Effect): - Healthy, adult, male or female, 19-60 years of age, inclusive, at the screening visit. - Females of childbearing potential. - Females of non-childbearing potential are defined as follows: - Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: - hysteroscopic sterilization; - bilateral tubal ligation or bilateral salpingectomy; - hysterectomy; - bilateral oophorectomy. or - Individuals who are PMP with amenorrhea for at least 1 year prior to the first dosing and FSH serum levels consistent with PMP status. - Females of childbearing potential and male subjects must follow protocol specified contraception guidance. - Vital signs must be within the protocol-specified ranges. - QTcF interval is ≤450 msec (males) or ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit and prior to the first dosing. - Able to completely consume a standardized high-fat/high-calorie breakfast as required by the study protocol. Exclusion Criteria: - Subjects who meet any of the following criteria must be excluded from the study: All Subjects: - Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. - History or presence of malignancy within the past 2 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix. - History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study in the opinion of the PI or designee. - Evidence of clinically relevant medical illness including cardiovascular, hematological, psychiatric, gastrointestinal, hepatic, renal, rheumatologic, autoimmune, endocrine, pulmonary, neurologic or dermatologic disorder in the opinion of the PI or designee. - History of skin rash(es) associated with the use of any medication(s). - Any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass) that could interfere with drug absorption, distribution, metabolism, or excretion. - Clinically significant surgical procedure within 90 days prior to the screening visit. - Clinically significant acute illness or infection within 14 days prior to the first dosing. - History of significant drug allergies including a history of anaphylactic reaction. - Family history of sudden death in an otherwise healthy individual. - Positive urine cotinine at the screening visit or at first check-in. - Excessive use of alcohol, defined as weekly intake in excess of 14 units of alcohol (1 unit = 12 fluid ounces of beer, 5 fluid ounces of wine, or 1.5 fluid ounces [1 shot] of distilled spirits or liquor), within 6 months prior to the screening visit. - Positive test result for alcohol or drugs of abuse at the screening visit or first check-in, or history of alcohol and/or drug abuse within the past 2 years prior to the screening visit. - Heavy caffeine drinker (defined as consumption of >5 servings of caffeinated beverages [e.g., coffee, tea, cola, energy drinks] per day). - Refusal to refrain from strenuous physical activity from screening until first check-in. - Unwillingness to avoid sun and/or phototherapy exposure for 72 hours after the last dose of study drug. - Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing. - Use of any investigational drug or device within 30 days or biologics for 90 days (or 5 half-lives of the drug, whichever is the longer) prior to the first dosing, or currently participating in another study of an investigational drug or biologics, or a medical device. - Loss or donation of >500 mL blood within 56 days prior to study drug administration, or donation of plasma within 30 days prior to the first dosing. - Employee or family member of the PI, study site personnel, or Sponsor. - Any other reason that, in the opinion of the PI, would render the subject unsuitable for study enrollment. Parts 1 (SAD): - History or presence of: - risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome or sudden unexpected cardiac death at a young age); - sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities; - ischemic heart disease, symptomatic arrhythmias, or poorly controlled hypertension. - conditions predisposing to QT prolongation including pathological Q-wave. - Unable to refrain from or anticipates the use of: - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing; - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/pharmacodynamic (PD) interaction with study drug; - any drugs that prolong the QT/QTc interval within 14 days (or 5 half-lives, whichever is longer) prior to the first dosing. - Allergy to band aids, adhesive dressing, or medical tape. - Glomerular filtration rate (GFR) ≤ 80 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Part 2 (MAD): - History or presence of: - risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome or sudden unexpected cardiac death at a young age); - sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities; - ischemic heart disease, symptomatic arrhythmias, or poorly controlled hypertension. - conditions predisposing to QT prolongation including pathological Q-wave. - Unable to refrain from or anticipates the use of: - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing; - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug; - any drugs that prolong the QT/QTc interval within 14 days (or 5 half-lives, whichever is longer) prior to the first dosing. - Is at risk of suicide. Has attempted suicide in the past 12 months or Is at risk of suicide, as determined by the PI, psychiatric interview and/or the baseline C-SSRS. - Allergy to band aids, adhesive dressing, or medical tape. - GFR ≤ 80 mL/min/1.73 m2, as estimated by the CKD-EPI equation. Part 3 (Elderly): - Is at risk of suicide. Has attempted suicide in the past 12 months or Is at risk of suicide, as determined by the PI, psychiatric interview and/or the baseline C-SSRS. - Unable to refrain from or anticipates the use of: - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. Thyroid hormone replacement medication (refer to protocol) will be allowed; - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug. - GFR ≤ 70 mL/min/1.73 m2, as estimated by the CKD-EPI equation. Part 4 (Food Effect): - Is lactose intolerant. - Unable to refrain from or anticipates the use of: - any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing; - any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug. - GFR ≤ 80 mL/min/1.73 m2, as estimated by the CKD-EPI equation.

NCT0531xxxx/NCT05318053.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/NCT05318053</url> </required_header> <id_info> <org_study_id>T2021-01</org_study_id> <nct_id>NCT05318053</nct_id> </id_info> <brief_title>International Kink Health Study</brief_title> <acronym>IKHS</acronym> <official_title>International Kink Health Study</official_title> <sponsors> <lead_sponsor> <agency>The Alternative Sexualities Health Research Alliance</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>The Alternative Sexualities Health Research Alliance</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 study design is an observational, longitudinal study with data collected online via a computer-assisted survey. Subjects will be recruited through non-probability snowball sampling.  Objectives:  1. to document the prevalence of injuries and medical complications arising from kink activities  2. to document how healthcare is utilized by kink-involved people  3. to document the health outcomes particular to a large sample of kink-involved people  4. to test whether the centrality of kink identity and degree of community belongingness affect injuries, health outcomes, and healthcare utilization </textblock> </brief_summary> <detailed_description> <textblock> In 2016, TASHRA conducted the first ever health survey of the U.S. kink community, examining issues of injuries, risky behavior, health status, and healthcare access and utilization, and patient satisfaction. It included measures of kink identity centrality, coming out, and kink community involvement as predictive factors.  The findings provided a broad map of possible health disparities in a manner that was intended to direct future research. As such, several included measures did not ask any further questions to collect more detail of the context of health disparities or injuries, or their impact on the participant.  The 2016 Kink Health Survey was an anonymous online survey that collected data from kink-involved people, from April 2016 to October 2016 (six month window). 1,118 individuals completed the survey. The results indicated the following (Sprott, Randall, Smith & Woo, 2021):  - The percentage of people who reported past experiences of kink-related injury : 13.5%  - The percentage of people who reported delaying or avoiding healthcare because of perceived stigma: 19.0%.  - Past negative experiences with healthcare clinicians increased the odds of delaying or avoiding care significantly, with those participants four times more likely to avoid/delay care compared to participants who did not have negative experiences.  - A significant portion of participants had not disclosed their kink identity or behavior with their physical healthcare clinician (58.3%), nor with their therapist or mental healthcare clinician (49.6%).  The following health disparities were noted:  - 4.1% of the sample reported being HIV positive. This is approximately 10x the national average.  - 24% reported having attempted suicide at some point in their lives. This is approximately 5x the national average.  - 17.98% reported having PTSD. This is 2.6x the national average.  The current proposal, the International Kink Health Survey, proposes to follow up and expand on the previous 2016 survey in the following ways:  - to expand the collection of data beyond the United States, to other English-speaking populations  - to clarify the timing of health status measures and health disparities in relation to the initiation of kink activities  - to expand measures of stigma and discrimination, paying closer attention to questions of multiple minority status and intersectionality, and their relation to health status and health disparities  - to collect more in-depth information on kink community involvement, paying attention to online activities as part of community involvement in light of the COVID-19 pandemic  - to collect more fine-grained information about injuries or medical complications that arise from engagement in kink scenes/activities  - To collect more fine-grained information about suicidal behavior, mental health hospitalizations, and peoples' perceptions of the role of kink in relation to these mental health challenges  - to measure future intentions to disclose kink involvement to healthcare providers  The current proposed study will also address asexual people who engage in kink/BDSM behaviors (bondage, sadomasochism, and power exchange). The 2016 Kink Health Survey included this sexual orientation group, and we will continue to address this group.  The study design is an observational, longitudinal study with data collected online via a computer-assisted survey. Subjects will be recruited through non-probability snowball sampling. Interested individuals will initially be screened for inclusion criteria. All completed questionnaires will be reviewed to ascertain whether inclusion criteria are met or exclusion criteria are met. Those who meet the inclusion criteria will be sent a message asking them to read and sign the Informed Consent form if they wish to enroll in the study. Those who meet the exclusion criteria or who do not complete an Informed Consent form after 3 contacts will have their information on the screening questionnaire in Ripple de-identified. In order to characterize the prescreening sample for reporting purposes, the de-identified data will be retained and may be analyzed. If they provide their consent, prospective participants will be considered enrolled in the study and will be sent email invitations to fill out survey instrument 1, and then every week sent an email to fill out survey instrument 2, and so on, as appropriate.  IKHS Survey Instrument 1:  Demographics Kink Behaviors Kink Fantasies Kink/Sexual Desire  IKHS Survey Instrument 2:  Future Disclosure COVID  IKHS Survey Instrument 3:  Kink Injury  IKHS Survey Instrument 4:  Physical Health  IKHS Survey Instrument 5:  Mental Health  IKHS Survey Instrument 6:  Healthcare Utilization  IKHS Survey Instrument 7:  Sex Work Consent Violations Kink and Past Trauma Stigma Family Support Sexual Shame and Pride Scale  IKHS Survey Instrument 8:  Adverse Childhood Events / Sensation-Seeking Alcohol / Drug </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">July 31, 2028</completion_date> <primary_completion_date type="Anticipated">July 31, 2023</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>Kink Injury</measure> <time_frame>Year 1</time_frame> <description>self-report of injury or medical complication while engaged in kink activities; type of injury; frequency of injury</description> </primary_outcome> <primary_outcome> <measure>Healthcare Utilization</measure> <time_frame>Year 1</time_frame> <description>self-report of: types of care; frequency of care; patient satisfaction; experiences of discrimination in healthcare interactions</description> </primary_outcome> <primary_outcome> <measure>Health Disparities</measure> <time_frame>Year 1</time_frame> <description>self-report of: mental health issues; suicidality; obesity; sexually transmitted infections; blood-borne pathogens; alcohol/drug use</description> </primary_outcome> <secondary_outcome> <measure>Community Belongingness</measure> <time_frame>Year 1</time_frame> <description>self-report of sense of belonging to a kink community</description> </secondary_outcome> <secondary_outcome> <measure>Centrality of Kink Identity</measure> <time_frame>Year 1</time_frame> <description>self-report of felt centrality of kink identity to sense of self</description> </secondary_outcome> <secondary_outcome> <measure>Concealment / Disclosure of Kink Involvement</measure> <time_frame>Year 1</time_frame> <description>self-report of behavior on disclosure of kink identity or kink involvement</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">3164</enrollment> <condition>Wounds and Injuries</condition> <condition>Mental Health</condition> <arm_group> <arm_group_label>2022 Cohort</arm_group_label> <description>Successful completion of screening checklist to indicate one of the following conditions: recurring, long-standing fantasies that focus on kink, in areas such as: power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. By fetish, we mean a type of sexual desire in which gratification depends on or is significantly increased by particular objects, clothing items, parts of the body, or types of persons. OR currently engaging, or have engaged in the past, in consensual kink activities such as power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. Age of majority in the legal jurisdiction (geographic location) where the survey is taken (usually age 18) English-language proficiency sufficient to understand the study instruments Completion of an electronically signed and dated informed consent form</description> </arm_group> <eligibility> <study_pop> <textblock> People involved in kink activities: power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Successful completion of screening checklist to indicate one of the following conditions:  1. recurring, long-standing fantasies that focus on kink, in areas such as: power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. By fetish, we mean a type of sexual desire in which gratification depends on or is significantly increased by particular objects, clothing items, parts of the body, or types of persons.  2. OR currently engaging, or have engaged in the past, in consensual kink activities such as power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities.  2. Age of majority in the legal jurisdiction (geographic location) where the survey is taken (usually age 18)  3. English-language proficiency sufficient to understand the study instruments  4. Completion of an electronically signed and dated informed consent form  Exclusion Criteria:  People who respond "no" to the following question on the screening checklist  - I am familiar with the importance of consent and I endorse negotiation and safe words or safe signals in my sexual or kink play  - Clearly fraudulent use of the internet survey, such as: evidence of non-human data entry via an internet "bot", duplicative or prank data entry that entails contradictory or clearly fraudulent data.  - Any condition that, in the professional judgement of the Principal Investigator, should exclude an individual from participation in the study. </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>Richard A Sprott, PhD</last_name> <role>Principal Investigator</role> <affiliation>The Alternative Sexualities Health Research Alliance</affiliation> </overall_official> <overall_contact> <last_name>Richard A Sprott, PhD</last_name> <phone>510-919-4488</phone> <email>richard@tashra.org</email> </overall_contact> <overall_contact_backup> <last_name>Anna M Randall, LCSW</last_name> <phone>650-888-9640‬</phone> <email>anna@tashra.org</email> </overall_contact_backup> <location> <facility> <name>TASHRA</name> <address> <city>Rio Vista</city> <state>California</state> <zip>94571</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Richard A Sprott, PhD</last_name> <phone>510-919-4488</phone> <email>richard@tashra.org</email> </contact> <investigator> <last_name>Richard A Sprott, PhD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <link> <url>https://www.kinkhealth.org</url> <description>Study Website</description> </link> <reference> <citation>Sprott RA, Randall A, Smith K, Woo L. Rates of Injury and Healthcare Utilization for Kink-Identified Patients. J Sex Med. 2021 Oct;18(10):1721-1734. doi: 10.1016/j.jsxm.2021.08.001. Epub 2021 Sep 2.</citation> <PMID>34481743</PMID> </reference> <reference> <citation>Waldura JF, Arora I, Randall AM, Farala JP, Sprott RA. Fifty Shades of Stigma: Exploring the Health Care Experiences of Kink-Oriented Patients. J Sex Med. 2016 Dec;13(12):1918-1929. doi: 10.1016/j.jsxm.2016.09.019. Epub 2016 Oct 27.</citation> <PMID>28340946</PMID> </reference> <verification_date>October 2022</verification_date> <study_first_submitted>January 15, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>October 19, 2022</last_update_submitted> <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc> <last_update_posted type="Actual">October 21, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>BDSM</keyword> <keyword>Sexual Minority</keyword> <keyword>Kink</keyword> <condition_browse>  <mesh_term>Wounds and Injuries</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The study design is an observational, longitudinal study with data collected online via a computer-assisted survey. Subjects will be recruited through non-probability snowball sampling. Objectives: 1. to document the prevalence of injuries and medical complications arising from kink activities 2. to document how healthcare is utilized by kink-involved people 3. to document the health outcomes particular to a large sample of kink-involved people 4. to test whether the centrality of kink identity and degree of community belongingness affect injuries, health outcomes, and healthcare utilization In 2016, TASHRA conducted the first ever health survey of the U.S. kink community, examining issues of injuries, risky behavior, health status, and healthcare access and utilization, and patient satisfaction. It included measures of kink identity centrality, coming out, and kink community involvement as predictive factors. The findings provided a broad map of possible health disparities in a manner that was intended to direct future research. As such, several included measures did not ask any further questions to collect more detail of the context of health disparities or injuries, or their impact on the participant. The 2016 Kink Health Survey was an anonymous online survey that collected data from kink-involved people, from April 2016 to October 2016 (six month window). 1,118 individuals completed the survey. The results indicated the following (Sprott, Randall, Smith & Woo, 2021): - The percentage of people who reported past experiences of kink-related injury : 13.5% - The percentage of people who reported delaying or avoiding healthcare because of perceived stigma: 19.0%. - Past negative experiences with healthcare clinicians increased the odds of delaying or avoiding care significantly, with those participants four times more likely to avoid/delay care compared to participants who did not have negative experiences. - A significant portion of participants had not disclosed their kink identity or behavior with their physical healthcare clinician (58.3%), nor with their therapist or mental healthcare clinician (49.6%). The following health disparities were noted: - 4.1% of the sample reported being HIV positive. This is approximately 10x the national average. - 24% reported having attempted suicide at some point in their lives. This is approximately 5x the national average. - 17.98% reported having PTSD. This is 2.6x the national average. The current proposal, the International Kink Health Survey, proposes to follow up and expand on the previous 2016 survey in the following ways: - to expand the collection of data beyond the United States, to other English-speaking populations - to clarify the timing of health status measures and health disparities in relation to the initiation of kink activities - to expand measures of stigma and discrimination, paying closer attention to questions of multiple minority status and intersectionality, and their relation to health status and health disparities - to collect more in-depth information on kink community involvement, paying attention to online activities as part of community involvement in light of the COVID-19 pandemic - to collect more fine-grained information about injuries or medical complications that arise from engagement in kink scenes/activities - To collect more fine-grained information about suicidal behavior, mental health hospitalizations, and peoples' perceptions of the role of kink in relation to these mental health challenges - to measure future intentions to disclose kink involvement to healthcare providers The current proposed study will also address asexual people who engage in kink/BDSM behaviors (bondage, sadomasochism, and power exchange). The 2016 Kink Health Survey included this sexual orientation group, and we will continue to address this group. The study design is an observational, longitudinal study with data collected online via a computer-assisted survey. Subjects will be recruited through non-probability snowball sampling. Interested individuals will initially be screened for inclusion criteria. All completed questionnaires will be reviewed to ascertain whether inclusion criteria are met or exclusion criteria are met. Those who meet the inclusion criteria will be sent a message asking them to read and sign the Informed Consent form if they wish to enroll in the study. Those who meet the exclusion criteria or who do not complete an Informed Consent form after 3 contacts will have their information on the screening questionnaire in Ripple de-identified. In order to characterize the prescreening sample for reporting purposes, the de-identified data will be retained and may be analyzed. If they provide their consent, prospective participants will be considered enrolled in the study and will be sent email invitations to fill out survey instrument 1, and then every week sent an email to fill out survey instrument 2, and so on, as appropriate. IKHS Survey Instrument 1: Demographics Kink Behaviors Kink Fantasies Kink/Sexual Desire IKHS Survey Instrument 2: Future Disclosure COVID IKHS Survey Instrument 3: Kink Injury IKHS Survey Instrument 4: Physical Health IKHS Survey Instrument 5: Mental Health IKHS Survey Instrument 6: Healthcare Utilization IKHS Survey Instrument 7: Sex Work Consent Violations Kink and Past Trauma Stigma Family Support Sexual Shame and Pride Scale IKHS Survey Instrument 8: Adverse Childhood Events / Sensation-Seeking Alcohol / Drug People involved in kink activities: power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. Inclusion Criteria: 1. Successful completion of screening checklist to indicate one of the following conditions: 1. recurring, long-standing fantasies that focus on kink, in areas such as: power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. By fetish, we mean a type of sexual desire in which gratification depends on or is significantly increased by particular objects, clothing items, parts of the body, or types of persons. 2. OR currently engaging, or have engaged in the past, in consensual kink activities such as power exchange (Dominant/submissive roles), bondage, sadomasochism, or fetish activities. 2. Age of majority in the legal jurisdiction (geographic location) where the survey is taken (usually age 18) 3. English-language proficiency sufficient to understand the study instruments 4. Completion of an electronically signed and dated informed consent form Exclusion Criteria: People who respond "no" to the following question on the screening checklist - I am familiar with the importance of consent and I endorse negotiation and safe words or safe signals in my sexual or kink play - Clearly fraudulent use of the internet survey, such as: evidence of non-human data entry via an internet "bot", duplicative or prank data entry that entails contradictory or clearly fraudulent data. - Any condition that, in the professional judgement of the Principal Investigator, should exclude an individual from participation in the study.

NCT0531xxxx/NCT05318066.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/NCT05318066</url> </required_header> <id_info> <org_study_id>3957</org_study_id> <secondary_id>3957</secondary_id> <nct_id>NCT05318066</nct_id> </id_info> <brief_title>Effect of a FLUid Bolus or a Low Dose VAsopressor Infusion on Cardiovascular Collapse Among Critically Ill Adults Undergoing Tracheal Intubation.</brief_title> <acronym>FLUVA</acronym> <official_title>Effect of a FLUid Bolus or a Low Dose VAsopressor Infusion on Cardiovascular Collapse Among Critically Ill Adults Undergoing Tracheal Intubation: a Randomized Controlled Trial (FLUVA Study)</official_title> <sponsors> <lead_sponsor> <agency>Tata Memorial Centre</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Tata Memorial Centre</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> Tracheal intubation, which is one of the most commonly performed procedures in the care of critically ill patients in intensive care unit, is associated with a high incidence of complications. Approximately 30% of emergent tracheal intubations in the ICU are associated with complications like hypotension, hypoxia, failed tracheal intubation, esophageal intubation, airway trauma, aspiration, cardiac arrest, and death. An observational study of tracheal intubation practices in critically ill patients across twenty-nine countries found cardiovascular instability to be the commonest among these adverse peri-tracheal intubation event.  Tracheal intubation performed in a controlled, non-emergent setting, is associated with few complications. However in ICU, conditions like underlying shock, respiratory failure, metabolic acidosis, and other patho-physiological changes contribute to the increased peri-tracheal intubation complications. Post tracheal intubation hypotension frequently occurs within a few minutes following tracheal intubation. The additive effects of hypovolemia, the suppression of the endogenous activation of sympathetic response by the anesthetics drugs as well as the intrathoracic positive pressure due to mechanical ventilation are implicated in this cardiovascular collapse after tracheal intubation in critically ill patients.  Post-tracheal intubation hypotension has been shown to be associated with higher in-hospital mortality and longer ICU and hospital length of stay. Hence patient optimization prior to tracheal intubation may be important to ensure hemodynamic stability to minimize further deterioration during tracheal intubation.  Few techniques to optimize hemodynamics before tracheal intubation commonly involve the use of intravenous fluids and vasopressor medications; however, there are no standards of care guiding these practices. Jaber et al included pre tracheal intubation fluid loading (isotonic saline 500 ml or starch 250 ml) as a part of tracheal intubation care bundle management to show improved outcomes. However it was an observational study and also it was not possible to evaluate the contribution of the individual hemodynamic components of the bundle given the concurrent implementation of other interventions.  And a recent study by Janz et al showed that pre loading with a 500-mL bolus of crystalloids before tracheal intubation did not identify any benefit. However this trial was stopped early for futility and moreover the volume of intravenous fluids that patients received before enrolment was not recorded.  Few trials have used vasopressor bolus prior to tracheal intubation to avoid post tracheal intubation hypotension or use of prophylactic use of vasopressors in preventing post spinal hypotension. However currently, there are no randomized trials or evidence-based guidelines to support the choice between fluid loading or vasopressors for the tracheal intubation of critically ill adults. We would like to conduct a randomised controlled study comparing the effects of fluid bolus or low dose vasopressor given prior to tracheal intubation on post tracheal intubation hypotension among critically ill adults. </textblock> </brief_summary> <detailed_description> <textblock> OBJECTIVES:  Primary Objective:  Cardiovascular collapse - a composite endpoint defined as one or more of the following:  Decrease in systolic blood pressure (SBP) to less than 90 mm Hg or a decrease in mean arterial pressure to less than 65 mm Hg between induction and 5 min after tracheal intubation Cardiac arrest between induction and 1 hour after tracheal intubation; Death between induction and 1 hour after tracheal intubation  Secondary outcomes:  Clinical outcomes  - SBP <90 mm Hg or a MAP to less than 65 mm Hg within 5 min after tracheal intubation.  - Cardiac arrest between induction and 1 hour after tracheal intubation.  - Death between induction and 1 hour after tracheal intubation.  - Lowest SBP between induction and 5 min after tracheal intubation  - Ventilator-free days to 28 days  - ICU-free days to 28 days.  - Vasopressor free days at 28 days  - Need for Renal Replacement therapy post intubation in ICU  - ICU Mortality  - Hospital Mortality  - 28 Day Mortality  Safety outcomes  - Lowest arterial oxygen saturation between induction and 5 min after tracheal intubation.  - Incidence of hypoxaemia (oxygen saturation <90%) between induction and 5 min after tracheal intubation.  - Incidence of severe hypoxaemia (oxygen saturation <80%) between induction and 5 min after tracheal intubation.  - Incidence of hypertension (SBP >140) between induction and 5 min after tracheal intubation  - Oxygen saturation at 24 hours after tracheal intubation.  - Fraction of inspired oxygen at 24 hours after tracheal intubation.  - Pao2 /FiO2 ratio at 24 hours after tracheal intubation.  Process measures  - Initiation of an intravenous fluid bolus between induction and 5 min after tracheal intubation.  - Need for vasopressors in addition to study medication between induction and 5 min after tracheal intubation.  - Time from induction to successful tracheal intubation.  - Incidence of successful tracheal intubation on the first laryngoscopy attempt.  - Number of laryngoscopy attempts.  - Cormack-Lehane grade of glottic view on first attempt.  - Need for additional airway equipment or a second operator  Study design This is a pragmatic, single-centre, parallel group, randomised trial. comparing the impact of fluid loading vs low dose vasopressors on the incidence of cardiovascular collapse during tracheal intubation in critically ill adults.  STUDY SITES It will be conducted in 2ICUs (FICU and SICU) located at Tata Memorial Hospital, Mumbai.  Randomization and treatment allocation All patients in ICU will be screened at the time the clinical team decides that tracheal intubation is required. Consent will be obtained from the patient's surrogate once they meet the inclusion and have no exclusion criteria.Once consent is obtained, the patient will be randomized.  Study assignments will be placed in opaque randomization envelopes, and will be available to operators in the ICU. Study group assignment will remain concealed to study personnel and operators until after the decision has been made to enroll the patient in the study. The operator will open the next consecutively numbered envelope and follow the assignment of either fluid loading (FL arm) or low dose vasopressor (VP arm).  Blinding Preparation for tracheal intubation will be done as per the ICU protocol * The airway operator will be blinded to the intervention and thus sent out of the patient's cubicle. The study team will administer a fluid bolus over 10 minutes. in the FL arm. No fluid will be administered in the VP arm. The fluid bag will be brought into the cubicle in a concealed bag. After fluid administration or not the fluid bag will be taken out in the same bag. A vasopressin infusion or saline infusion will be started at as per the assigned arm at the same time as the fluid bolus. The airway operator will enter the room and proceed with tracheal intubation.  Study interventions Arm Fluids (FL)- 500 mL of ringer lactate over 10 minute prior to the administration of procedural medications.  Arm Vasopressor (VP)- Patients in this group would receive norepinephrine infusion at a dose of 0.08 μg/kg/min over 10 minutes prior and 5 minutes after tracheal intubation.  All medications that the patient is receiving for the critical illness will continue as usual during the study intervention period and be noted. Hypertension during study intervention period (defined as SBP greater than 140 mm Hg or more than 20 % of the baseline reading) will be managed by stopping the study drug infusion (norepinephrine or saline infusion). Treatment of hypertension will be left to the clinician's discretion. The study drug infusion will be resumed when blood pressure returns to its normal value up to 5 minutes after tracheal intubation. All study medications will continue for the patient as per the clinician's discretion. Hypotension during study intervention period (SBP, 90 mmHg or MAP <65) will be treated with a vasopressors or fluids as per the clinician's discretion.  Tracheal intubation Procedure Regardless of study group assignment, all airway operators will be encouraged to follow the institutional protocol for tracheal intubation. (Appendix 1) Monitors will be attached to the patient. Patient will be preoxygenation for 3 minutes, Rapid sequence tracheal intubation will be done using fentanyl, ketamine/ etomidate and rocuronium/Suxamethonium. Gentle bag mask is allowed if patient is at a risk for desaturation. Use of video laryngoscope and tracheal intubation aids will be encouraged. Tracheal intubation will be confirmed using capnography. Following confirmation of tube position and tube fixation the patient will be put on ventilator using protective lung ventilation.  Safety Intervention All complications that occur during the tracheal intubation procedure will be treated as per the clinician's discretion.  Data Collection:  All data collected are already a part of clinical data obtained in usual ICU care at the bedside or in the medical record. No additional data will be obtained beyond that which is obtained by bedside observation and from the electronic medical record. A trained, independent observer not involved in the performance of the procedure will collect data Demographic data  - Age  - Gender  - Height  - Weight  - BMI  - Acute Physiology and Chronic  - Health Evaluation (APACHE) II score  - Active medical problems at the time of tracheal intubation  - Active and chronic comorbidities complicating tracheal intubation  - Most recent pre-procedural Glasgow Coma Score  - Non-invasive ventilator and high flow nasal cannula use in the hour prior to starting pre-oxygenation.  - Pre intubation- PaO2, PCO2 and pH Tracheal intubation related data  - Indication for tracheal intubation  - Modality of pre-oxygenation  - Drugs used of induction with dose  - Drugs used for neuromuscular block with dose  - Use of ventilation between induction and laryngoscopy  - Laryngoscopy device used for first attempt  - Use of cricoid pressure,  - Cormack-Lehane grade of glottic view on the first attempt  - Use of a bougie or endotracheal tube with stylet on the first attempt  - Total number of attempts  Peri-procedural outcomes:  - Fluid volume received 4 hours prior to tracheal intubation  - Systolic blood pressure and oxygen saturation at the time of induction  - The lowest arterial oxygen saturation and systolic blood pressure from induction to 5 minutes after tracheal intubation  - The administration of a new fluid bolus between induction and 5 minutes after tracheal intubation  - The administration of a new dose of any vasopressor between induction and two minutes after tracheal intubation  - The total volume of new fluid bolus infused between induction and 5 minutes after tracheal intubation  - Post intubation PaO2, PCO2 and pH  - Any hypertension  - Any arrhythmia 0-1 hours:  - Cardiac arrest within 1 hour of tracheal intubation  - Death within 1 hour of tracheal intubation  - Systolic blood pressure, oxygen saturation, FiO2, and positive end expiratory pressure delivered every 5 minutes 1-24 hours:  - Systolic blood pressure, oxygen saturation, FiO2, and positive end expiratory pressure delivered every 1 hour  In-Hospital Outcomes:  - Total cumulative fluid administration in the ICU after randomization  - Date of extubation (ventilator-free days)  - Date of ICU discharge (ICU-free days)  - Date of death will be collected from the medical record.  STATISTICAL ANALYSIS Sample size estimation On the basis of previous research in our institute, the incidence of cardiovascular collapse in the fluid bolus group was found to be 40.5 %. Assuming this incidence rate and with the aim of reducing it by 50%, and to achieve a power of at least 80% with alpha error of 5% , 80 patients were needed in each group. Allowing for patients lost to follow up, 100 patients will be included in each group.  Analysis principles  - Primary analysis will be conducted on an intention-to-treat basis (patients with protocol violations are analyzed per the assigned treatment arm).  - All hypothesis tests will be two sided, with an α of 0.05 unless otherwise specified.  - All analyses will be unadjusted unless otherwise specified. SPSS Statistics (version 23.0) will be used for all analyses. Continuous variables will be reported as mean±SD or median and IQR; categorical variables will be reported as frequencies and proportions. All between-group comparisons with continuous variables will be performed using Mann-Whitney U tests and Fisher's exact test for categorical variables. Kaplan-Meier curves and log-rank tests will be used to analyze timeto-event comparisons between groups.  Primary analysis of the primary outcome The primary analysis will be an unadjusted, intention-to-treat comparison of patients randomised to the fluid bolus group versus patients randomised to the low dose vasopressor group with regard to the primary outcome of cardiovascular collapse. Between group differences will be tested using an unadjusted χ2 test. A p value <0.05 will be used to indicate statistical significance for the primary analysis.  Secondary analyses of the primary outcome To account for potential confounders, we will develop a logistic regression model with cardiovascular collapse (primary outcome) as the dependent variable and independent variables to include study group (fluid bolus group vs low dose vasopressors) and relevant confounders (age, Acute Physiology and Chronic Health Evaluation II (APACHE II) score at enrolment, presence of sepsis or septic shock and receipt of intravenous fluid infusion initiated prior to enrolment). We will also develop a logistic regression model accounting for the above variables plus any baseline characteristics that appear on visual review to be potentially imbalanced between the study groups.  Given the findings of the PrePARE trial subgroup analysis (ie, that the effect of fluid bolus administration on cardiovascular collapse may be related to the receipt of positive pressure ventilation during tracheal intubation), we will repeat the primary analysis excluding patients who did not receive positive pressure during l tracheal intubation.  Analysis of the secondary outcomes We will conduct unadjusted analyses examining the treatment effect of fluid loading on each of the pre-specified secondary and tertiary outcomes. Continuous outcomes will be compared with the Mann-Whitney U test and categorical variables with the Fischer exact test.  Handling of missing data Although we have allowed for loss to follow up in our power calculation, we do not anticipate that data for the primary outcome of cardiovascular collapse will be missing for any patients. Missing data will not be imputed for the primary or secondary outcome. In adjusted analyses, missing data for covariates may be imputed using a multiple imputation technique.  Ethics and dissemination Informed consent In current clinical practice, initiating an intravenous fluid bolus beginning prior to tracheal intubation and administering low dose vasopressors prior to tracheal intubation are both common management approaches, with significant variation between providers.15 . To be eligible for the trial, patients' treating clinicians must feel that initiation of a new fluid bolus for tracheal intubation is neither required nor contraindicated for the patient's optimal care. The protocol also states that vasopressor infusion will be stopped in case of hypertension. For these reasons, the trial is felt to pose minimal incremental risk compared with the clinical care patients would receive outside of the trial.  Tracheal intubation of critically ill adults is commonly an urgent or emergent procedure for which obtaining informed consent for the clinical procedure or informed consent for research is impracticable.  Information for patients and families A patient and family information sheet containing general study information and contact information for the research team provided to each patient and family at the time of admission to the study unit.  Adverse Events An adverse event is defined as any untoward medical occurrence in a clinical investigation where a participant is administered an intervention that does not necessarily have to have a causal relationship with the intervention. An adverse event therefore can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an intervention, whether or not the incident is considered related to the intervention  A serious adverse event (SAE) is defined as any unexpected and untoward medical occurrence that is probably or possibly related to the study and meets any of the following criteria:  1. Results in death  2. Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event and NOT an event that hypothetically might have caused death if it would have been more severe). Life-threatening cardiovascular complications, as defined as the primary endpoint of this trial, will be prospectively and systematically collected as the outcome. As such, these events will not be reported as SAEs. Similarly, life-threatening severe hypoxia will also be systematically collected as a secondary endpoint and will therefore not be reported as an SAE.  3. Requires inpatient hospitalization  4. Prolongs an existing hospitalization  5. Results in persistent or significant disability or incapacity  6. Results in a congenital anomaly or birth defect  7. Important medical event that requires an intervention to prevent any of a-f above.  The Principal Investigator will be responsible for overseeing the safety of this trial on a daily basis. He will be available at any time for questions from the clinical team or bedside nurses, who will also be monitoring the patients continuously for adverse events and serious adverse events. Serious and unexpected adverse events potentially associated with study interventions will be recorded. As endotracheal tracheal tracheal intubation in the critical care setting is known to be independently associated with numerous adverse events including hypoxemia, aspiration, esophageal tracheal tracheal intubation, airway trauma, failed attempts at tracheal intubation, pneumothorax, pneumomediastinum, hypotension, severe bradycardia, cardiac arrest, and death, these events will be recorded as study outcomes and monitored to determine if a preponderance of adverse events in one study group merits consideration of stoppage of the trial. However, in the absence of an imbalance of the above events between study groups, these events are expected in the routine performance of the airway management procedure and will not be individually reported to the as serious and unexpected adverse events, unless the investigators or clinical team believe the event was related to the study intervention. As an additional safety measure, the exclusion criteria specifically state that airway management events in which urgency precludes performance of study or the operator foresees a potential need for or contraindication to manual ventilation between induction and tracheal intubation will not be included in the trial so all airway management events studied will be those in which the treating clinical team felt equipoise between the interventions being examined.  Participant withdrawal and discontinuation criteria Withdrawal Criteria-  1. Withdrawal of consent  2. Following randomization, a clinician decides to limit therapy and hence not intubated the patient.  Discontinuation Criteria  1.Patient not tolerating the specific therapy. The reason and date of every withdrawal will be recorded in the patient study records. Follow up will be performed for all patients who discontinue due to an adverse event or any other safety parameter. Follow-up will also be performed for all patients who end participation in the protocol for another reason, but who also have an adverse event or other safety parameter that could have led to discontinuation. Follow-up will be conducted until the condition has resolved, until diagnosis of the adverse event or safety parameter is deemed chronic and stable, or as long as clinically appropriate. This follow-up will be documented in the patient study record as well.  Privacy/Confidentiality Issues At no time during the course of this study, its analysis, or its publication will patient identities be revealed in any manner. The minimum necessary data containing patient or provider identities will be collected. All patients will be assigned a unique study ID number for tracking. Data collected from the medical record will be entered into the secure online database.  Follow-up and Record Retention Patients will be followed after enrollment for 28 days or until hospital discharge, whichever occurs first. Data collected from the medical record will be entered into the secure online database. Hard copies of the data collection sheet completed at the time of the airway management event will be stored in a locked room until after the completion of enrollment and data cleaning. Once data are verified and the database is locked, all hard copies of data collection forms will be destroyed. All data will be maintained in the secure online database until the time of study publication.  ANNEXURE 1 Criteria for endotracheal intubation  These pre-determined criteria for endotracheal intubation and mechanical ventilation (MV) will be as follows to avoid delayed intubation:  A) If participant shows at least any of the 2 following signs of persisting or worsening respiratory failure then he/she will be intubated  1. a respiratory rate > 40 cycles/min  2. lack of improvement of signs of respiratory-muscle fatigue  3. development of copious tracheal secretions  4. acidosis with a pH <7.25  5. SpO2 < 90% for > 5min without technical dysfunction, or  6. intolerance to NIV B) Or if participant shows any one of the following sign he/she will be intubated and receive mechanical ventilation  1. hemodynamic instability defined by a SBP < 90 mmHg, MAP < 65 mmHg with requirement for vasopressor more than 0.25 mcg/kg/min  2. deterioration of neurologic status with a Glasgow coma scale < 12 points  ANNEXURE 2 PREPARATION OF TRACHEAL INTUBATION Preparation of equipment CO2-modul present and checked Patient equipped with pulse-oxymeter Box with regular intubation equipment present Box "difficult intubation" present Video laryngoscope Laryngoscope checked (light works) Reserve laryngoscope checked Bougie and stylet Magill forceps present Tube, cuff checked Reserve tube present Suction present and checked Facemask and bag present and checked Stethoscope present Material for tube-fixation present  Preparation of drugs-The following drugs should be immediately available at bedside:  Etomidate (2 mg/ml) Ketamine (2 mg/ml) Fentanyl (50 µg/ml) Midazolam (1 mg/ml) Succinylcholine (50 mg/ml) Rocuronium (10 mg/ml) Atropine (0.5 mg/ml) Ephedrine (5 mg/ml) Adrenaline (1 mg/ml and 0.1 mg/ml)  ANNEXURE 3 RAPID SEQUENCE INTUBATION INSTITUTIONAL PROTOCOL After attaching monitors like ecg, pulse oximeter and non invasive bp monitor,one wide bore peripheral iv would be secured. Preoxygenation for at least 3mins will be performed in the high-risk patients with the help of NIV with an inspiratory pressure of 5-15 cm H2O, PEEP of 5 cm H2O and tidal volume of 6-8 mL/kg in a head-up position or with the help of HFNO. Apnoeic oxygenation will be considered to prolong safe apnoea time during intubation. After which total of 2 μg/kg intravenous fentanyl will be administered. Thereafter, an intravenous induction agent will be administered: etomidate 0.3 mg/kg or ketamine 2 mg/kg. The neuromuscular blocking drug Succinylcholine(1.5 mg/kg) or rocuronium (2 mg/kg) will be injected as soon as the injection of the induction agent is completed. Gentle bag mask is allowed if patient is at a risk for desaturation and is not full stomach. Use of cricoid pressure will be left upto the discretion of the clinician. Video laryngoscopy will be done after 45-60 sec after the injection of the neuromuscular blocking drug. Intubations will be performed using a rigid stylet loaded appropriate sized tracheal tube. Tracheal intubation will be confirmed by 6 continuous waveforms on capnography. Following confirmation of tube position and tube fixation the patient will be put on ventilator using protective lung ventilation </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 15, 2022</start_date> <completion_date type="Anticipated">August 2023</completion_date> <primary_completion_date type="Anticipated">June 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>Randomization and treatment allocation All patients in ICU will be screened at the time the clinical team decides that tracheal intubation is required. Consent will be obtained from the patient's surrogate once they meet the inclusion and have no exclusion criteria. Once consent is obtained, the patient will be randomized. Study assignments will be placed in opaque randomization envelopes, and will be available to operators in the ICU. Study group assignment will remain concealed to study personnel and operators until after the decision has been made to enroll the patient in the study. The operator will open the next consecutively numbered envelope and follow the assignment of either fluid loading (FL arm) or low dose vasopressor (VP arm).</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> <masking_description>Blinding Preparation for tracheal intubation will be done as per the ICU protocol * The airway operator will be blinded to the intervention and thus sent out of the patient's cubicle. The study team will administer a fluid bolus over 10 minutes. in the FL arm. No fluid will be administered in the VP arm. The fluid bag will be brought into the cubicle in a concealed bag. After fluid administration or not the fluid bag will be taken out in the same bag. A vasopressin infusion or saline infusion will be started at as per the assigned arm at the same time as the fluid bolus. The airway operator will enter the room and proceed with tracheal intubation.</masking_description> </study_design_info> <primary_outcome> <measure>Cardiovascular collapse (composite outcome)</measure> <time_frame>1 hour</time_frame> <description>Cardiovascular collapse - a composite endpoint defined as one or more of the following: Decrease in systolic blood pressure (SBP) to less than 90 mm Hg or a decrease in mean arterial pressure to less than 65 mm Hg between induction and 5 min after tracheal intubation. Cardiac arrest between induction and 1 hour after tracheal intubation. Death between induction and 1 hour after tracheal intubation.</description> </primary_outcome> <secondary_outcome> <measure>Hypotension</measure> <time_frame>28 days</time_frame> <description>Systolic BP <90 mm Hg or a Mean Arterial Pressure to less than 65 mm Hg within 5 min after tracheal intubation.</description> </secondary_outcome> <secondary_outcome> <measure>Cardiac arrest</measure> <time_frame>1 hour</time_frame> <description>Cardiac arrest between induction and 1 hour after tracheal intubation.</description> </secondary_outcome> <secondary_outcome> <measure>Death</measure> <time_frame>1 hour</time_frame> <description>Death between induction and 1 hour after tracheal intubation.</description> </secondary_outcome> <secondary_outcome> <measure>Lowest Systolic Blood Pressure</measure> <time_frame>5 min</time_frame> <description>Lowest SBP between induction and 5 min after tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>Ventilator-free days to 28 days</measure> <time_frame>28 days</time_frame> <description>Ventilator-free days to 28 days</description> </secondary_outcome> <secondary_outcome> <measure>ICU-free days to 28 days</measure> <time_frame>28 days</time_frame> <description>ICU-free days to 28 days</description> </secondary_outcome> <secondary_outcome> <measure>Vasopressor free days at 28 days</measure> <time_frame>28 days</time_frame> <description>Vasopressor free days at 28 days</description> </secondary_outcome> <secondary_outcome> <measure>Need for Renal Replacement therapy post intubation in ICU</measure> <time_frame>28 days</time_frame> <description>Need for Renal Replacement therapy post intubation in ICU</description> </secondary_outcome> <secondary_outcome> <measure>ICU Mortality</measure> <time_frame>No of days stayed in the ICU</time_frame> <description>ICU Mortality</description> </secondary_outcome> <secondary_outcome> <measure>Hospital Mortality</measure> <time_frame>No of days stayed in the Hospital</time_frame> <description>Death during hospital stay</description> </secondary_outcome> <secondary_outcome> <measure>28 days Mortality</measure> <time_frame>28 days</time_frame> <description>28 days Mortality</description> </secondary_outcome> <secondary_outcome> <measure>Lowest arterial oxygen saturation</measure> <time_frame>5 min</time_frame> <description>Lowest arterial oxygen saturation between induction and 5 min after tracheal intubation.</description> </secondary_outcome> <secondary_outcome> <measure>Hypoxemia</measure> <time_frame>5 min</time_frame> <description>Incidence of hypoxemia (oxygen saturation <90%) between induction and 5 min after tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>Severe Hypoxemia</measure> <time_frame>5 min</time_frame> <description>Incidence of severe hypoxemia (oxygen saturation <80%) between induction and 5 min after tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of hypertension</measure> <time_frame>5 min</time_frame> <description>Incidence of hypertension (SBP >140) between induction and 5 min after tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>Oxygen Saturation at 24 hours</measure> <time_frame>24 hours</time_frame> <description>Oxygen saturation at 24 hours after tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>FiO2 at 24 hours</measure> <time_frame>24 hours</time_frame> <description>Fraction of inspired oxygen at 24 hours after tracheal intubation.</description> </secondary_outcome> <secondary_outcome> <measure>Pao2 /FiO2 ratio at 24 hours</measure> <time_frame>24 hours</time_frame> <description>Pao2 /FiO2 ratio at 24 hours after tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>Initiation of an intravenous fluid bolus</measure> <time_frame>5 min</time_frame> <description>Initiation of an intravenous fluid bolus between induction and 5 min after tracheal intubation.</description> </secondary_outcome> <secondary_outcome> <measure>Need for vasopressors</measure> <time_frame>5 min</time_frame> <description>Need for vasopressors in addition to study medication between induction and 5 min after tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>Time from induction to successful tracheal intubation</measure> <time_frame>5 min</time_frame> <description>Time from induction to successful tracheal intubation</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of successful tracheal intubation on the first laryngoscopy attempt</measure> <time_frame>5 min</time_frame> <description>Incidence of successful tracheal intubation on the first laryngoscopy attempt</description> </secondary_outcome> <secondary_outcome> <measure>Number of laryngoscopy attempts</measure> <time_frame>5 min</time_frame> <description>Number of laryngoscopy attempts</description> </secondary_outcome> <secondary_outcome> <measure>Cormack-Lehane grade of glottic view on first attempt</measure> <time_frame>5 min</time_frame> <description>Cormack-Lehane grade of glottic view on first attempt</description> </secondary_outcome> <secondary_outcome> <measure>Need for additional airway equipment or a second operator</measure> <time_frame>5 min</time_frame> <description>Need for additional airway equipment or a second operator</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">200</enrollment> <condition>Critically Ill Adults in the ICU, Requiring Endotracheal Intubation</condition> <arm_group> <arm_group_label>Arm Fluids (FL)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>500 mL of ringer lactate over 10 minute prior to the administration of procedural medications.</description> </arm_group> <arm_group> <arm_group_label>Arm Vasopressor (VP)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients in this group would receive norepinephrine infusion at a dose of 0.08 μg/kg/min over 10 minutes prior and 5 minutes after tracheal intubation.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ringer Lactate and Norepinephrine infusion</intervention_name> <description>Arm Fluids (FL)- 500 mL of ringer lactate over 10 minute prior to the administration of procedural medications. Arm Vasopressor (VP)- Patients in this group would receive norepinephrine infusion at a dose of 0.08 μg/kg/min over 10 minutes prior and 5 minutes after tracheal intubation.</description> <arm_group_label>Arm Fluids (FL)</arm_group_label> <arm_group_label>Arm Vasopressor (VP)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adult patients (≥ 18 years old)  - Critically ill patients needing emergent tracheal intubation in ICU  Exclusion Criteria:  - Tracheal intubation performed in the out-of-ICU/hospital setting  - Tracheal intubation during cardiac arrest.  - Patients with age <18 years  - Elective tracheal intubation(for e.g for diagnostic/surgical procedures)  - Patients on vasoactive medications at the time of screening  - Hypotension (SBP <90) at screening  - Hypertension(SBP >140)at screening  - Urgency of tracheal intubation precludes performance of study procedures  - Operator feels administration of a fluid bolus vasopressor is strongly indicated or contraindicated  - Inability to obtain consent from the surrogate </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>99 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Sheila Myatra</last_name> <phone>02224177000</phone> <phone_ext>7050</phone_ext> <email>sheila150@hotmail.com</email> </overall_contact> <location> <facility> <name>Tata Memorial Hospital</name> <address> <city>Mumbai</city> <state>Maharashtra</state> <zip>400012</zip> <country>India</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sheila Myatra, MD</last_name> <phone>9820156070</phone> <email>sheila150@hotmail.com</email> </contact> </location> <location_countries> <country>India</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 22, 2022</last_update_submitted> <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 27, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Critical Illness</mesh_term> <mesh_term>Shock</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Norepinephrine</mesh_term> </intervention_browse>  </clinical_study>

Tracheal intubation, which is one of the most commonly performed procedures in the care of critically ill patients in intensive care unit, is associated with a high incidence of complications. Approximately 30% of emergent tracheal intubations in the ICU are associated with complications like hypotension, hypoxia, failed tracheal intubation, esophageal intubation, airway trauma, aspiration, cardiac arrest, and death. An observational study of tracheal intubation practices in critically ill patients across twenty-nine countries found cardiovascular instability to be the commonest among these adverse peri-tracheal intubation event. Tracheal intubation performed in a controlled, non-emergent setting, is associated with few complications. However in ICU, conditions like underlying shock, respiratory failure, metabolic acidosis, and other patho-physiological changes contribute to the increased peri-tracheal intubation complications. Post tracheal intubation hypotension frequently occurs within a few minutes following tracheal intubation. The additive effects of hypovolemia, the suppression of the endogenous activation of sympathetic response by the anesthetics drugs as well as the intrathoracic positive pressure due to mechanical ventilation are implicated in this cardiovascular collapse after tracheal intubation in critically ill patients. Post-tracheal intubation hypotension has been shown to be associated with higher in-hospital mortality and longer ICU and hospital length of stay. Hence patient optimization prior to tracheal intubation may be important to ensure hemodynamic stability to minimize further deterioration during tracheal intubation. Few techniques to optimize hemodynamics before tracheal intubation commonly involve the use of intravenous fluids and vasopressor medications; however, there are no standards of care guiding these practices. Jaber et al included pre tracheal intubation fluid loading (isotonic saline 500 ml or starch 250 ml) as a part of tracheal intubation care bundle management to show improved outcomes. However it was an observational study and also it was not possible to evaluate the contribution of the individual hemodynamic components of the bundle given the concurrent implementation of other interventions. And a recent study by Janz et al showed that pre loading with a 500-mL bolus of crystalloids before tracheal intubation did not identify any benefit. However this trial was stopped early for futility and moreover the volume of intravenous fluids that patients received before enrolment was not recorded. Few trials have used vasopressor bolus prior to tracheal intubation to avoid post tracheal intubation hypotension or use of prophylactic use of vasopressors in preventing post spinal hypotension. However currently, there are no randomized trials or evidence-based guidelines to support the choice between fluid loading or vasopressors for the tracheal intubation of critically ill adults. We would like to conduct a randomised controlled study comparing the effects of fluid bolus or low dose vasopressor given prior to tracheal intubation on post tracheal intubation hypotension among critically ill adults. OBJECTIVES: Primary Objective: Cardiovascular collapse - a composite endpoint defined as one or more of the following: Decrease in systolic blood pressure (SBP) to less than 90 mm Hg or a decrease in mean arterial pressure to less than 65 mm Hg between induction and 5 min after tracheal intubation Cardiac arrest between induction and 1 hour after tracheal intubation; Death between induction and 1 hour after tracheal intubation Secondary outcomes: Clinical outcomes - SBP <90 mm Hg or a MAP to less than 65 mm Hg within 5 min after tracheal intubation. - Cardiac arrest between induction and 1 hour after tracheal intubation. - Death between induction and 1 hour after tracheal intubation. - Lowest SBP between induction and 5 min after tracheal intubation - Ventilator-free days to 28 days - ICU-free days to 28 days. - Vasopressor free days at 28 days - Need for Renal Replacement therapy post intubation in ICU - ICU Mortality - Hospital Mortality - 28 Day Mortality Safety outcomes - Lowest arterial oxygen saturation between induction and 5 min after tracheal intubation. - Incidence of hypoxaemia (oxygen saturation <90%) between induction and 5 min after tracheal intubation. - Incidence of severe hypoxaemia (oxygen saturation <80%) between induction and 5 min after tracheal intubation. - Incidence of hypertension (SBP >140) between induction and 5 min after tracheal intubation - Oxygen saturation at 24 hours after tracheal intubation. - Fraction of inspired oxygen at 24 hours after tracheal intubation. - Pao2 /FiO2 ratio at 24 hours after tracheal intubation. Process measures - Initiation of an intravenous fluid bolus between induction and 5 min after tracheal intubation. - Need for vasopressors in addition to study medication between induction and 5 min after tracheal intubation. - Time from induction to successful tracheal intubation. - Incidence of successful tracheal intubation on the first laryngoscopy attempt. - Number of laryngoscopy attempts. - Cormack-Lehane grade of glottic view on first attempt. - Need for additional airway equipment or a second operator Study design This is a pragmatic, single-centre, parallel group, randomised trial. comparing the impact of fluid loading vs low dose vasopressors on the incidence of cardiovascular collapse during tracheal intubation in critically ill adults. STUDY SITES It will be conducted in 2ICUs (FICU and SICU) located at Tata Memorial Hospital, Mumbai. Randomization and treatment allocation All patients in ICU will be screened at the time the clinical team decides that tracheal intubation is required. Consent will be obtained from the patient's surrogate once they meet the inclusion and have no exclusion criteria.Once consent is obtained, the patient will be randomized. Study assignments will be placed in opaque randomization envelopes, and will be available to operators in the ICU. Study group assignment will remain concealed to study personnel and operators until after the decision has been made to enroll the patient in the study. The operator will open the next consecutively numbered envelope and follow the assignment of either fluid loading (FL arm) or low dose vasopressor (VP arm). Blinding Preparation for tracheal intubation will be done as per the ICU protocol * The airway operator will be blinded to the intervention and thus sent out of the patient's cubicle. The study team will administer a fluid bolus over 10 minutes. in the FL arm. No fluid will be administered in the VP arm. The fluid bag will be brought into the cubicle in a concealed bag. After fluid administration or not the fluid bag will be taken out in the same bag. A vasopressin infusion or saline infusion will be started at as per the assigned arm at the same time as the fluid bolus. The airway operator will enter the room and proceed with tracheal intubation. Study interventions Arm Fluids (FL)- 500 mL of ringer lactate over 10 minute prior to the administration of procedural medications. Arm Vasopressor (VP)- Patients in this group would receive norepinephrine infusion at a dose of 0.08 μg/kg/min over 10 minutes prior and 5 minutes after tracheal intubation. All medications that the patient is receiving for the critical illness will continue as usual during the study intervention period and be noted. Hypertension during study intervention period (defined as SBP greater than 140 mm Hg or more than 20 % of the baseline reading) will be managed by stopping the study drug infusion (norepinephrine or saline infusion). Treatment of hypertension will be left to the clinician's discretion. The study drug infusion will be resumed when blood pressure returns to its normal value up to 5 minutes after tracheal intubation. All study medications will continue for the patient as per the clinician's discretion. Hypotension during study intervention period (SBP, 90 mmHg or MAP <65) will be treated with a vasopressors or fluids as per the clinician's discretion. Tracheal intubation Procedure Regardless of study group assignment, all airway operators will be encouraged to follow the institutional protocol for tracheal intubation. (Appendix 1) Monitors will be attached to the patient. Patient will be preoxygenation for 3 minutes, Rapid sequence tracheal intubation will be done using fentanyl, ketamine/ etomidate and rocuronium/Suxamethonium. Gentle bag mask is allowed if patient is at a risk for desaturation. Use of video laryngoscope and tracheal intubation aids will be encouraged. Tracheal intubation will be confirmed using capnography. Following confirmation of tube position and tube fixation the patient will be put on ventilator using protective lung ventilation. Safety Intervention All complications that occur during the tracheal intubation procedure will be treated as per the clinician's discretion. Data Collection: All data collected are already a part of clinical data obtained in usual ICU care at the bedside or in the medical record. No additional data will be obtained beyond that which is obtained by bedside observation and from the electronic medical record. A trained, independent observer not involved in the performance of the procedure will collect data Demographic data - Age - Gender - Height - Weight - BMI - Acute Physiology and Chronic - Health Evaluation (APACHE) II score - Active medical problems at the time of tracheal intubation - Active and chronic comorbidities complicating tracheal intubation - Most recent pre-procedural Glasgow Coma Score - Non-invasive ventilator and high flow nasal cannula use in the hour prior to starting pre-oxygenation. - Pre intubation- PaO2, PCO2 and pH Tracheal intubation related data - Indication for tracheal intubation - Modality of pre-oxygenation - Drugs used of induction with dose - Drugs used for neuromuscular block with dose - Use of ventilation between induction and laryngoscopy - Laryngoscopy device used for first attempt - Use of cricoid pressure, - Cormack-Lehane grade of glottic view on the first attempt - Use of a bougie or endotracheal tube with stylet on the first attempt - Total number of attempts Peri-procedural outcomes: - Fluid volume received 4 hours prior to tracheal intubation - Systolic blood pressure and oxygen saturation at the time of induction - The lowest arterial oxygen saturation and systolic blood pressure from induction to 5 minutes after tracheal intubation - The administration of a new fluid bolus between induction and 5 minutes after tracheal intubation - The administration of a new dose of any vasopressor between induction and two minutes after tracheal intubation - The total volume of new fluid bolus infused between induction and 5 minutes after tracheal intubation - Post intubation PaO2, PCO2 and pH - Any hypertension - Any arrhythmia 0-1 hours: - Cardiac arrest within 1 hour of tracheal intubation - Death within 1 hour of tracheal intubation - Systolic blood pressure, oxygen saturation, FiO2, and positive end expiratory pressure delivered every 5 minutes 1-24 hours: - Systolic blood pressure, oxygen saturation, FiO2, and positive end expiratory pressure delivered every 1 hour In-Hospital Outcomes: - Total cumulative fluid administration in the ICU after randomization - Date of extubation (ventilator-free days) - Date of ICU discharge (ICU-free days) - Date of death will be collected from the medical record. STATISTICAL ANALYSIS Sample size estimation On the basis of previous research in our institute, the incidence of cardiovascular collapse in the fluid bolus group was found to be 40.5 %. Assuming this incidence rate and with the aim of reducing it by 50%, and to achieve a power of at least 80% with alpha error of 5% , 80 patients were needed in each group. Allowing for patients lost to follow up, 100 patients will be included in each group. Analysis principles - Primary analysis will be conducted on an intention-to-treat basis (patients with protocol violations are analyzed per the assigned treatment arm). - All hypothesis tests will be two sided, with an α of 0.05 unless otherwise specified. - All analyses will be unadjusted unless otherwise specified. SPSS Statistics (version 23.0) will be used for all analyses. Continuous variables will be reported as mean±SD or median and IQR; categorical variables will be reported as frequencies and proportions. All between-group comparisons with continuous variables will be performed using Mann-Whitney U tests and Fisher's exact test for categorical variables. Kaplan-Meier curves and log-rank tests will be used to analyze timeto-event comparisons between groups. Primary analysis of the primary outcome The primary analysis will be an unadjusted, intention-to-treat comparison of patients randomised to the fluid bolus group versus patients randomised to the low dose vasopressor group with regard to the primary outcome of cardiovascular collapse. Between group differences will be tested using an unadjusted χ2 test. A p value <0.05 will be used to indicate statistical significance for the primary analysis. Secondary analyses of the primary outcome To account for potential confounders, we will develop a logistic regression model with cardiovascular collapse (primary outcome) as the dependent variable and independent variables to include study group (fluid bolus group vs low dose vasopressors) and relevant confounders (age, Acute Physiology and Chronic Health Evaluation II (APACHE II) score at enrolment, presence of sepsis or septic shock and receipt of intravenous fluid infusion initiated prior to enrolment). We will also develop a logistic regression model accounting for the above variables plus any baseline characteristics that appear on visual review to be potentially imbalanced between the study groups. Given the findings of the PrePARE trial subgroup analysis (ie, that the effect of fluid bolus administration on cardiovascular collapse may be related to the receipt of positive pressure ventilation during tracheal intubation), we will repeat the primary analysis excluding patients who did not receive positive pressure during l tracheal intubation. Analysis of the secondary outcomes We will conduct unadjusted analyses examining the treatment effect of fluid loading on each of the pre-specified secondary and tertiary outcomes. Continuous outcomes will be compared with the Mann-Whitney U test and categorical variables with the Fischer exact test. Handling of missing data Although we have allowed for loss to follow up in our power calculation, we do not anticipate that data for the primary outcome of cardiovascular collapse will be missing for any patients. Missing data will not be imputed for the primary or secondary outcome. In adjusted analyses, missing data for covariates may be imputed using a multiple imputation technique. Ethics and dissemination Informed consent In current clinical practice, initiating an intravenous fluid bolus beginning prior to tracheal intubation and administering low dose vasopressors prior to tracheal intubation are both common management approaches, with significant variation between providers.15 . To be eligible for the trial, patients' treating clinicians must feel that initiation of a new fluid bolus for tracheal intubation is neither required nor contraindicated for the patient's optimal care. The protocol also states that vasopressor infusion will be stopped in case of hypertension. For these reasons, the trial is felt to pose minimal incremental risk compared with the clinical care patients would receive outside of the trial. Tracheal intubation of critically ill adults is commonly an urgent or emergent procedure for which obtaining informed consent for the clinical procedure or informed consent for research is impracticable. Information for patients and families A patient and family information sheet containing general study information and contact information for the research team provided to each patient and family at the time of admission to the study unit. Adverse Events An adverse event is defined as any untoward medical occurrence in a clinical investigation where a participant is administered an intervention that does not necessarily have to have a causal relationship with the intervention. An adverse event therefore can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an intervention, whether or not the incident is considered related to the intervention A serious adverse event (SAE) is defined as any unexpected and untoward medical occurrence that is probably or possibly related to the study and meets any of the following criteria: 1. Results in death 2. Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event and NOT an event that hypothetically might have caused death if it would have been more severe). Life-threatening cardiovascular complications, as defined as the primary endpoint of this trial, will be prospectively and systematically collected as the outcome. As such, these events will not be reported as SAEs. Similarly, life-threatening severe hypoxia will also be systematically collected as a secondary endpoint and will therefore not be reported as an SAE. 3. Requires inpatient hospitalization 4. Prolongs an existing hospitalization 5. Results in persistent or significant disability or incapacity 6. Results in a congenital anomaly or birth defect 7. Important medical event that requires an intervention to prevent any of a-f above. The Principal Investigator will be responsible for overseeing the safety of this trial on a daily basis. He will be available at any time for questions from the clinical team or bedside nurses, who will also be monitoring the patients continuously for adverse events and serious adverse events. Serious and unexpected adverse events potentially associated with study interventions will be recorded. As endotracheal tracheal tracheal intubation in the critical care setting is known to be independently associated with numerous adverse events including hypoxemia, aspiration, esophageal tracheal tracheal intubation, airway trauma, failed attempts at tracheal intubation, pneumothorax, pneumomediastinum, hypotension, severe bradycardia, cardiac arrest, and death, these events will be recorded as study outcomes and monitored to determine if a preponderance of adverse events in one study group merits consideration of stoppage of the trial. However, in the absence of an imbalance of the above events between study groups, these events are expected in the routine performance of the airway management procedure and will not be individually reported to the as serious and unexpected adverse events, unless the investigators or clinical team believe the event was related to the study intervention. As an additional safety measure, the exclusion criteria specifically state that airway management events in which urgency precludes performance of study or the operator foresees a potential need for or contraindication to manual ventilation between induction and tracheal intubation will not be included in the trial so all airway management events studied will be those in which the treating clinical team felt equipoise between the interventions being examined. Participant withdrawal and discontinuation criteria Withdrawal Criteria- 1. Withdrawal of consent 2. Following randomization, a clinician decides to limit therapy and hence not intubated the patient. Discontinuation Criteria 1.Patient not tolerating the specific therapy. The reason and date of every withdrawal will be recorded in the patient study records. Follow up will be performed for all patients who discontinue due to an adverse event or any other safety parameter. Follow-up will also be performed for all patients who end participation in the protocol for another reason, but who also have an adverse event or other safety parameter that could have led to discontinuation. Follow-up will be conducted until the condition has resolved, until diagnosis of the adverse event or safety parameter is deemed chronic and stable, or as long as clinically appropriate. This follow-up will be documented in the patient study record as well. Privacy/Confidentiality Issues At no time during the course of this study, its analysis, or its publication will patient identities be revealed in any manner. The minimum necessary data containing patient or provider identities will be collected. All patients will be assigned a unique study ID number for tracking. Data collected from the medical record will be entered into the secure online database. Follow-up and Record Retention Patients will be followed after enrollment for 28 days or until hospital discharge, whichever occurs first. Data collected from the medical record will be entered into the secure online database. Hard copies of the data collection sheet completed at the time of the airway management event will be stored in a locked room until after the completion of enrollment and data cleaning. Once data are verified and the database is locked, all hard copies of data collection forms will be destroyed. All data will be maintained in the secure online database until the time of study publication. ANNEXURE 1 Criteria for endotracheal intubation These pre-determined criteria for endotracheal intubation and mechanical ventilation (MV) will be as follows to avoid delayed intubation: A) If participant shows at least any of the 2 following signs of persisting or worsening respiratory failure then he/she will be intubated 1. a respiratory rate > 40 cycles/min 2. lack of improvement of signs of respiratory-muscle fatigue 3. development of copious tracheal secretions 4. acidosis with a pH <7.25 5. SpO2 < 90% for > 5min without technical dysfunction, or 6. intolerance to NIV B) Or if participant shows any one of the following sign he/she will be intubated and receive mechanical ventilation 1. hemodynamic instability defined by a SBP < 90 mmHg, MAP < 65 mmHg with requirement for vasopressor more than 0.25 mcg/kg/min 2. deterioration of neurologic status with a Glasgow coma scale < 12 points ANNEXURE 2 PREPARATION OF TRACHEAL INTUBATION Preparation of equipment CO2-modul present and checked Patient equipped with pulse-oxymeter Box with regular intubation equipment present Box "difficult intubation" present Video laryngoscope Laryngoscope checked (light works) Reserve laryngoscope checked Bougie and stylet Magill forceps present Tube, cuff checked Reserve tube present Suction present and checked Facemask and bag present and checked Stethoscope present Material for tube-fixation present Preparation of drugs-The following drugs should be immediately available at bedside: Etomidate (2 mg/ml) Ketamine (2 mg/ml) Fentanyl (50 µg/ml) Midazolam (1 mg/ml) Succinylcholine (50 mg/ml) Rocuronium (10 mg/ml) Atropine (0.5 mg/ml) Ephedrine (5 mg/ml) Adrenaline (1 mg/ml and 0.1 mg/ml) ANNEXURE 3 RAPID SEQUENCE INTUBATION INSTITUTIONAL PROTOCOL After attaching monitors like ecg, pulse oximeter and non invasive bp monitor,one wide bore peripheral iv would be secured. Preoxygenation for at least 3mins will be performed in the high-risk patients with the help of NIV with an inspiratory pressure of 5-15 cm H2O, PEEP of 5 cm H2O and tidal volume of 6-8 mL/kg in a head-up position or with the help of HFNO. Apnoeic oxygenation will be considered to prolong safe apnoea time during intubation. After which total of 2 μg/kg intravenous fentanyl will be administered. Thereafter, an intravenous induction agent will be administered: etomidate 0.3 mg/kg or ketamine 2 mg/kg. The neuromuscular blocking drug Succinylcholine(1.5 mg/kg) or rocuronium (2 mg/kg) will be injected as soon as the injection of the induction agent is completed. Gentle bag mask is allowed if patient is at a risk for desaturation and is not full stomach. Use of cricoid pressure will be left upto the discretion of the clinician. Video laryngoscopy will be done after 45-60 sec after the injection of the neuromuscular blocking drug. Intubations will be performed using a rigid stylet loaded appropriate sized tracheal tube. Tracheal intubation will be confirmed by 6 continuous waveforms on capnography. Following confirmation of tube position and tube fixation the patient will be put on ventilator using protective lung ventilation Inclusion Criteria: - Adult patients (≥ 18 years old) - Critically ill patients needing emergent tracheal intubation in ICU Exclusion Criteria: - Tracheal intubation performed in the out-of-ICU/hospital setting - Tracheal intubation during cardiac arrest. - Patients with age <18 years - Elective tracheal intubation(for e.g for diagnostic/surgical procedures) - Patients on vasoactive medications at the time of screening - Hypotension (SBP <90) at screening - Hypertension(SBP >140)at screening - Urgency of tracheal intubation precludes performance of study procedures - Operator feels administration of a fluid bolus vasopressor is strongly indicated or contraindicated - Inability to obtain consent from the surrogate

NCT0531xxxx/NCT05318079.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/NCT05318079</url> </required_header> <id_info> <org_study_id>IRB-300008605</org_study_id> <nct_id>NCT05318079</nct_id> </id_info> <brief_title>Telehealth Virtual Reality Exergaming for Spinal Cord Injury</brief_title> <official_title>Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury</official_title> <sponsors> <lead_sponsor> <agency>University of Alabama at Birmingham</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Alabama at Birmingham</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 pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. A second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health. </textblock> </brief_summary> <detailed_description> <textblock> There are three purposes to this study.  The first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. These variables will be compared against a priori criteria for acceptability. These variables will help determine whether modifications to the intervention protocol are necessary.  The second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. This information will be used to explain how to improve implementation issues identified in Aim 1.  The third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test. </textblock> </detailed_description> <overall_status>Withdrawn</overall_status> <why_stopped> The study was not selected for funding. </why_stopped> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Actual">April 13, 2022</completion_date> <primary_completion_date type="Actual">April 12, 2022</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 (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Total play time</measure> <time_frame>Intervention Week 1 - Week 8</time_frame> <description>Percentage of the 300 minutes of prescribed play per week across the intervention.</description> </primary_outcome> <primary_outcome> <measure>Total exercise time</measure> <time_frame>Intervention Week 1 - Week 8</time_frame> <description>Moderate exercise minutes where prescription was met (percent of prescription achieved: weeks where the ≥90 minutes of moderate intensity exercise per week was achieved across the intervention, divided by total weeks).</description> </primary_outcome> <primary_outcome> <measure>Playtime with others</measure> <time_frame>Intervention Week 1 - Week 8</time_frame> <description>Measured by the number of play sessions with other players (online multiplayer and/or peer-gaming). This number will be totaled across the 8-week intervention and divided by 16 (the exercise prescription of 2 x per week of multiplayer gaming).</description> </primary_outcome> <primary_outcome> <measure>Compliance to baseline data collection</measure> <time_frame>Week 0</time_frame> <description>Number of pre data collections completed, converted into a percentage dividing by the total possible.</description> </primary_outcome> <primary_outcome> <measure>Compliance to post data collections</measure> <time_frame>Week 9</time_frame> <description>Number of pre data collections completed, converted into a percentage dividing by the total possible.</description> </primary_outcome> <secondary_outcome> <measure>Hospital Anxiety and Depression Scale</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>The Hospital Anxiety and Depression Scale is a 14-item self-report measure that provides separate scores for anxiety and depression. Hospital Anxiety and Depression Scale is a common clinical measure that has strong psychometric properties. Scores range from 0 to 42, where a higher score represents a worse level of depression.</description> </secondary_outcome> <secondary_outcome> <measure>World Health Organization Quality of Life</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>The World Health Organization Quality of Life is a self-report questionnaire with 26 items that cover 5 dimensions: physical health (7 items); psychological health (6 items); social relationships (3 items); environment (8 items); and overall quality of life (2 items). Raw scores are calculated for each domain on a lilkert scale of 1-5 (low domain score of 3, max domain raw score of 40. Raw scores are then multiplied by 4 to transform the raw score into a scaled score. Higher scores represent higher perceived ratings of quality of life.</description> </secondary_outcome> <secondary_outcome> <measure>Functional Grip Strength</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Grip strength will be measured as an indicator of global muscular strength, using a low-cost hand-held dynamometer.</description> </secondary_outcome> <secondary_outcome> <measure>Critical factors that affected adherence</measure> <time_frame>Intervention Week 9</time_frame> <description>Participants will undergo one-on-one, semi-structured interviews after the intervention to identify critical factors that affected their participation to the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in blood pressure</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in resting home-blood pressure (systolic and diastolic ) measured via blood pressure cuff across the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in high sensitivity C-reactive protein (hsCRP)</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in high sensitivity C-reactive protein measured via blood spot test across the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in hemoglobin A1c</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in hemoglobin A1c measured via blood spot test across the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in fasting insulin</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in fasting insulin levels measured via blood spot test across the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in fasting triglycerides</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in fasting triglycerides levels measured via blood spot test across the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in total cholesterol</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in total cholesterol measured via blood spot test across the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in low-density lipoprotein (LDL)</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in low-density lipoprotein via blood spot test across the intervention.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in high-density lipoprotein (LDL)</measure> <time_frame>Week 0, Week 5, Week 9</time_frame> <description>Changes in high-density lipoprotein via blood spot test across the intervention.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">0</enrollment> <condition>Spinal Cord Injuries</condition> <arm_group> <arm_group_label>Group virtual reality gaming</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The intervention will include home-based exercise using the Oculus Quest 2. Participants will be prescribed two gaming goals to achieve across the 8-week intervention. The first goal will be to play with the Quest for at least ≥60 minutes, 5 days per week (Monday - Friday) across the 8-week intervention: a total of 300 minutes. Participants can achieve these goals through either single- or multiplayer gaming but will be prescribed to engage in online multiplayer or peer-to-peer gaming at least 2 days per week.</description> </arm_group> <arm_group> <arm_group_label>Wait-list Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>People who are randomized to the waitlist group will undergo 4-weeks of wait (habitual daily activities), followed by 8-weeks of VR intervention. People in the wait-group will be in the study for a total of 12 weeks.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Virtual Reality Gaming</intervention_name> <description>Peer-to-peer gaming.</description> <arm_group_label>Group virtual reality gaming</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease [ICD] codes)  - a caregiver to support the participant if the participant is a child (<18 years of age)  - access to a Wi-Fi Internet connection in the home  Exclusion Criteria:  - physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)  - cannot use the arms for exercise or operate the controller buttons using their fingers  - complete blindness or deafness  - recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension [BP >/= 180/110 mmHg]  - prone to seizures </textblock> </criteria> <gender>All</gender> <minimum_age>15 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <verification_date>April 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 13, 2022</last_update_submitted> <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 21, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation> <investigator_full_name>Byron Lai</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Spinal Cord Injuries</mesh_term> <mesh_term>Wounds and Injuries</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. A second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health. There are three purposes to this study. The first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. These variables will be compared against a priori criteria for acceptability. These variables will help determine whether modifications to the intervention protocol are necessary. The second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. This information will be used to explain how to improve implementation issues identified in Aim 1. The third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test. Inclusion Criteria: - medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease [ICD] codes) - a caregiver to support the participant if the participant is a child (<18 years of age) - access to a Wi-Fi Internet connection in the home Exclusion Criteria: - physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week) - cannot use the arms for exercise or operate the controller buttons using their fingers - complete blindness or deafness - recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension [BP >/= 180/110 mmHg] - prone to seizures

NCT0531xxxx/NCT05318092.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/NCT05318092</url> </required_header> <id_info> <org_study_id>2021-EVT-01</org_study_id> <nct_id>NCT05318092</nct_id> </id_info> <brief_title>Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism</brief_title> <acronym>APEX-AV</acronym> <official_title>Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism</official_title> <sponsors> <lead_sponsor> <agency>Angiodynamics, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Angiodynamics, Inc.</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> </oversight_info> <brief_summary> <textblock> To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 19, 2022</start_date> <completion_date type="Anticipated">November 1, 2023</completion_date> <primary_completion_date type="Anticipated">November 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>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>Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.</measure> <time_frame>At 48 hours post-procedure</time_frame> <description>Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.</description> </primary_outcome> <primary_outcome> <measure>Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure.</measure> <time_frame>At 48 hours post-procedure</time_frame> <description>Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding Device-related SAEs which includes: Clinical Deterioration Pulmonary Vascular Injury Cardiac Injury</description> </primary_outcome> <secondary_outcome> <measure>Use of thrombolytics within 48 hours of the procedure.</measure> <time_frame>Within 48 hours of the procedure</time_frame> <description>Use of thrombolytics within 48 hours of the procedure.</description> </secondary_outcome> <secondary_outcome> <measure>Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.</measure> <time_frame>Within 30 days of the procedure</time_frame> <description>Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.</measure> <time_frame>At 48 hours post-procedure</time_frame> <description>Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA.</description> </secondary_outcome> <secondary_outcome> <measure>Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.</measure> <time_frame>Within 48 hours of the procedure</time_frame> <description>Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure.</description> </secondary_outcome> <secondary_outcome> <measure>Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.</measure> <time_frame>Within 30 days of the procedure</time_frame> <description>Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure.</description> </secondary_outcome> <secondary_outcome> <measure>Symptomatic PE recurrence within 30 days.</measure> <time_frame>Within 30 days of the procedure</time_frame> <description>Symptomatic PE recurrence within 30 days.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">122</enrollment> <condition>Pulmonary Embolism</condition> <condition>Acute Pulmonary Embolism</condition> <arm_group> <arm_group_label>AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for the treatment of acute pulmonary embolism</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE</intervention_name> <description>The AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE has five main components, a flexible cannula (F1885), sheath, tapered obturator, aspirator handle, and waste bag.</description> <arm_group_label>AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Signed and dated informed consent form.  - 18 years of age and older.  - Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.  - Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).  - RV/LV ratio of 0.9 or higher.  - Systolic blood pressure (SBP) of 90mmHg or higher  - Heart rate of 130 beats per minute (BPM) or less prior to the procedure.  - Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.  Exclusion Criteria:  Excluded from the study if he/she meets any of the following exclusion criteria  - May be pregnant as determined by a positive pregnancy test or who are breastfeeding.  - Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.  - Has used thrombolytics (tPA) in the past 30 days of baseline CTA.  - Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg.  - FiO2 requirement >40% or >6 LPM to keep oxygen saturations >90%  - Hematocrit <28% within 6 hours of the index procedure.  - Platelets count < 100,000/µL.  - Serum creatinine >1.8 mg/dL.  - International Normalized Ratio (INR) > 3  - Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15.  - Presence of cancer requiring active chemotherapy.  - Known bleeding diathesis or coagulation disorder.  - Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.  - History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%.  - Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.  - Requires Vasopressor after fluids to keep pressure ≥ 90mmHg.  - With left bundle branch block.  - Has intracardiac lead in the right ventricle or atrium.  - Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.  - Has life expectancy < 90 days.  - Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).  - Participation in another investigational study </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>Elizabeth Manning</last_name> <phone>339-237-2765</phone> <email>liz.manning@angiodynamics.com</email> </overall_contact> <location> <facility> <name>HonorHealth</name> <address> <city>Scottsdale</city> <state>Arizona</state> <zip>85258</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Alexandra Gaughan</last_name> <phone>480-323-1046</phone> <email>agaughan@honorhealth.com</email> </contact> <investigator> <last_name>Taral Patel, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>UCLA Health</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90404</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Victoria Rueda</last_name> <phone>310-562-9694</phone> <email>vrueda@mednet.ucla.edu</email> </contact> <investigator> <last_name>Mona Ranade, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Yale University</name> <address> <city>New Haven</city> <state>Connecticut</state> <zip>06519</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Patricia Fugal</last_name> <phone>203-785-4855</phone> <email>patricia.fugal@yale.edu</email> </contact> <investigator> <last_name>Jeffrey Pollak, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Delray Medical Center/ Prima Vascular Institute/ Tenet Florida Physician Services</name> <address> <city>Delray Beach</city> <state>Florida</state> <zip>33484</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Christopher Minnerly</last_name> <phone>561-303-0013</phone> <email>christopher.minnerly@tenethealth.com</email> </contact> <investigator> <last_name>Joseph Ricotta, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>HCA Memorial Hospital Jacksonville</name> <address> <city>Jacksonville</city> <state>Florida</state> <zip>32216</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Elizabeth Breting</last_name> <email>elizabeth.breting@hcahealthcare.com</email> </contact> <investigator> <last_name>Mohannad Bisharat, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Emory University at Grady Memorial Hospital</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30303</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Katherin Bachman</last_name> <phone>404-251-8916</phone> <email>katherine.bachman@emory.edu</email> </contact> <investigator> <last_name>Christopher Ramos, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Piedmont Heart Institute</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30309</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Suzanne Corley</last_name> <email>suzanne.corley@piedmont.org</email> </contact> <investigator> <last_name>Andrew Klein, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>OSF Healthcare</name> <address> <city>Peoria</city> <state>Illinois</state> <zip>61611</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kimberly Hartwig</last_name> <phone>309-655-4229</phone> <email>kimberly.hartwig@osfhealthcare.org</email> </contact> <investigator> <last_name>Daniel Gans, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Indiana University</name> <address> <city>Indianapolis</city> <state>Indiana</state> <zip>47405</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Eric Grubbs</last_name> <email>eegrubbs@iu.edu</email> </contact> <investigator> <last_name>Sabah Butty, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Community Hospital</name> <address> <city>Munster</city> <state>Indiana</state> <zip>46321</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Tera Gagne</last_name> <phone>219-703-1152</phone> <email>tera.m.gagne@comhs.org</email> </contact> <investigator> <last_name>Dean Ferrera, DO</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Oshner Medical Center</name> <address> <city>Jefferson</city> <state>Louisiana</state> <zip>70121</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Michael Harrison</last_name> <email>michael.harrison@ochsner.org</email> </contact> <investigator> <last_name>James Jenkins, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Washington University School of Medicine</name> <address> <city>Saint Louis</city> <state>Missouri</state> <zip>63110</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ashley Cosentino</last_name> <phone>314-362-6257</phone> <email>ashley.cosentino@wustl.edu</email> </contact> <investigator> <last_name>Vipul Khetarpaul, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Virtua Health</name> <address> <city>Mount Laurel</city> <state>New Jersey</state> <zip>08054</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kristin Broderick</last_name> <phone>856-355-1225</phone> <email>KBroderick@virtua.org</email> </contact> <investigator> <last_name>Ibrahim Moussa, DO</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Rutgers University</name> <address> <city>Newark</city> <state>New Jersey</state> <zip>07103</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yanille Taveras</last_name> <email>taveraya@njms.rutgers.edu</email> </contact> <investigator> <last_name>Pratik Shukla, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Jacobi Medical Center</name> <address> <city>Bronx</city> <state>New York</state> <zip>10461</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Cidney Schultz</last_name> <email>cidney.schultz@nychhc.org</email> </contact> <investigator> <last_name>Seth Sokol, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of Buffalo</name> <address> <city>Buffalo</city> <state>New York</state> <zip>14203</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Courtney Bishop</last_name> <phone>716-888-4839</phone> <email>cabishop@buffalo.edu</email> </contact> <investigator> <last_name>David Zlotnick, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Mount Sinai Ichan School of Medicine</name> <address> <city>New York</city> <state>New York</state> <zip>10029</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Aaron Greenberg</last_name> <phone>212-636-8705</phone> <email>aaron.greenberg@mountsinai.org</email> </contact> <investigator> <last_name>Robert Lookstein, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Columbia University Medical Center/NYPH</name> <address> <city>New York</city> <state>New York</state> <zip>10032</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kartik Kodali</last_name> <email>kk3544@cumc.columbia.edu</email> </contact> <investigator> <last_name>Sanjum Sethi, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Ohio State University Wexner Medical Center</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43221</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Evan Prather</last_name> <email>Evan.Prather@osumc.edu</email> </contact> <investigator> <last_name>Sitaramesh Emani, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Kettering Health</name> <address> <city>Miamisburg</city> <state>Ohio</state> <zip>45342</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Chris Seger</last_name> <email>chris.seger@ketteringhealth.org</email> </contact> <investigator> <last_name>Ammar Safar, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>UPMC Hamot</name> <address> <city>Erie</city> <state>Pennsylvania</state> <zip>16550</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Shawna Chylinski</last_name> <email>chylinskisj@upmc.edu</email> </contact> <investigator> <last_name>Robert Maholic, DO</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Einstein Medical Center</name> <address> <city>Montgomery</city> <state>Pennsylvania</state> <zip>19403</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Meera Kasireddy</last_name> <phone>215-456-6370</phone> <email>meera.kasireddy@jefferson.edu</email> </contact> <investigator> <last_name>Kenneth Cho, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Paul Brady, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>Tennova Healthcare -Turkey Creek Medical Center</name> <address> <city>Knoxville</city> <state>Tennessee</state> <zip>37934</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Beth Polk</last_name> <phone>865-392-3400</phone> <email>beth.polk@tennova.com</email> </contact> <investigator> <last_name>Malcolm Foster, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Memorial Hermann (University of Texas at Houston)</name> <address> <city>Houston</city> <state>Texas</state> <zip>77030</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Brody Judice</last_name> <phone>713-704-4300</phone> <email>brody.judice@uth.tmc.edu</email> </contact> <investigator> <last_name>Sukhdeep Basra, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Danny Ramzy, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Methodist Hospital</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78229</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Maurene Cantu</last_name> <phone>210-575-7863</phone> <email>maurene.cantu@hcahealthcare.com</email> </contact> <investigator> <last_name>Chandra Kunavarapu, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Aurora Health Care</name> <address> <city>Milwaukee</city> <state>Wisconsin</state> <zip>53215</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sara Anderson</last_name> <email>sara.klein@aah.org</email> </contact> <investigator> <last_name>Ramagopal Tumuluri, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 18, 2023</last_update_submitted> <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 19, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Pulmonary Embolism</mesh_term> <mesh_term>Embolism</mesh_term> </condition_browse>  </clinical_study>

To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). Inclusion Criteria: - Signed and dated informed consent form. - 18 years of age and older. - Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days. - Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA). - RV/LV ratio of 0.9 or higher. - Systolic blood pressure (SBP) of 90mmHg or higher - Heart rate of 130 beats per minute (BPM) or less prior to the procedure. - Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment. Exclusion Criteria: Excluded from the study if he/she meets any of the following exclusion criteria - May be pregnant as determined by a positive pregnancy test or who are breastfeeding. - Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants. - Has used thrombolytics (tPA) in the past 30 days of baseline CTA. - Has pulmonary hypertension with peak pulmonary artery pressure (PAP) > 70 mmHg. - FiO2 requirement >40% or >6 LPM to keep oxygen saturations >90% - Hematocrit <28% within 6 hours of the index procedure. - Platelets count < 100,000/µL. - Serum creatinine >1.8 mg/dL. - International Normalized Ratio (INR) > 3 - Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) > 15. - Presence of cancer requiring active chemotherapy. - Known bleeding diathesis or coagulation disorder. - Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure. - History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%. - Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated. - Requires Vasopressor after fluids to keep pressure ≥ 90mmHg. - With left bundle branch block. - Has intracardiac lead in the right ventricle or atrium. - Evidence such as imaging or other that suggests the subject is not appropriate for this procedure. - Has life expectancy < 90 days. - Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO). - Participation in another investigational study

NCT0531xxxx/NCT05318105.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/NCT05318105</url> </required_header> <id_info> <org_study_id>CLIN07687</org_study_id> <nct_id>NCT05318105</nct_id> </id_info> <brief_title>Ultrafiltration Versus IV Diuretics in Worsening Heart Failure</brief_title> <acronym>REVERSE-HF</acronym> <official_title>A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload</official_title> <sponsors> <lead_sponsor> <agency>Nuwellis, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Nuwellis, Inc.</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_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 28, 2022</start_date> <completion_date type="Anticipated">December 30, 2024</completion_date> <primary_completion_date type="Anticipated">September 30, 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> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>All-cause mortality</measure> <time_frame>within 90 days</time_frame> </primary_outcome> <primary_outcome> <measure>Heart failure (HF) events</measure> <time_frame>within 30 days</time_frame> <description>HF rehospitalization or unplanned use of Aquadex ultrafiltration therapy, IV loop diuretics, or vasoactive medications</description> </primary_outcome> <primary_outcome> <measure>Time to first Heart Failure (HF) event</measure> <time_frame>within 90 days</time_frame> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">372</enrollment> <condition>Heart Failure (for Example, Fluid Overload)</condition> <arm_group> <arm_group_label>Aquadex ultrafiltration therapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>IV loop diuretics</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Aquadex Smartflow® System</intervention_name> <description>ultrafiltration</description> <arm_group_label>Aquadex ultrafiltration therapy</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>IV Loop Diuretics</intervention_name> <description>diuretics</description> <arm_group_label>IV loop diuretics</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 18 years or older  - Man, or non-pregnant woman  - Admitted to the hospital with a primary diagnosis of acute decompensated heart failure  - On regularly prescribed oral loop diuretics prior to admission  - Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)  - Provide written informed consent  Exclusion Criteria:  - New diagnosis of heart failure  - Acute coronary syndromes  - Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment  - Contraindications to systemic anticoagulation  - Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days  - Sepsis or ongoing systemic infection  - Active myocarditis  - Constrictive pericarditis or restrictive cardiomyopathy  - Severe aortic stenosis  - Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival </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>Sean Pinney, MD</last_name> <role>Principal Investigator</role> <affiliation>Mount Sinai Morningside</affiliation> </overall_official> <overall_official> <last_name>Maria DeVita, MD, FASN</last_name> <role>Principal Investigator</role> <affiliation>Lenox Hill Hospital</affiliation> </overall_official> <overall_contact> <last_name>Megan Cease</last_name> <phone>952-345-4217</phone> <email>megan.cease@nuwellis.com</email> </overall_contact> <location> <facility> <name>Banner Health</name> <address> <city>Tucson</city> <state>Arizona</state> <zip>85721</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dalise Dai</last_name> <phone>312-237-5891</phone> <email>daliseshatz@arizona.edu</email> </contact> <investigator> <last_name>Radha Gopalan, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Sharp Memorial Hospital, San Diego Cardiac Center</name> <address> <city>San Diego</city> <state>California</state> <zip>92123</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Emma Burkhalter, RN, MSN</last_name> <phone>858-244-6889</phone> <email>eburkhalter@sdcardiac.com</email> </contact> <contact_backup> <last_name>Diana Nguyen</last_name> <email>dnguyen@sdcardiac.com</email> </contact_backup> <investigator> <last_name>Brian Jaski, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of California San Francisco</name> <address> <city>San Francisco</city> <state>California</state> <zip>94143</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Cassie Nguyen</last_name> <phone>415-353-9124</phone> <email>cassie.nguyen@ucsf.edu</email> </contact> <investigator> <last_name>Liviu Klein, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>BayCare Medical Group, Morton Plant</name> <address> <city>Clearwater</city> <state>Florida</state> <zip>33756</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sherry McLean</last_name> <phone>727-723-6527</phone> <email>Sherry.McLean@baycare.org</email> </contact> <investigator> <last_name>Leslie Miller, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>St. Joseph's Hospital</name> <address> <city>Tampa</city> <state>Florida</state> <zip>33614</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Karen Herring, RN</last_name> <phone>813-875-9000</phone> <email>Karen.Herring@baycare.org</email> </contact> <investigator> <last_name>Daniel Dries, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of Kentucky</name> <address> <city>Lexington</city> <state>Kentucky</state> <zip>40536</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jennifer Isaacs</last_name> <phone>859-323-4738</phone> <email>jennifer.isaacs@uky.edu</email> </contact> <investigator> <last_name>Andrew Kolodziej, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>The Mount Sinai Hospital</name> <address> <city>New York</city> <state>New York</state> <zip>10029</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kathryn Bass</last_name> <phone>212-241-3149</phone> <email>Kathryn.Bass@mountsinai.org</email> </contact> <contact_backup> <last_name>Samantha Ortiz Muriel</last_name> <phone>212-241-4580</phone> <email>Samantha.OrtizMuriel@mountsinai.org</email> </contact_backup> <investigator> <last_name>Umesh Gidwani, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Northwell Health</name> <address> <city>New York</city> <state>New York</state> <zip>10075</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Alana Gulliver</last_name> <phone>212-434-3802</phone> <email>agulliver@northwell.edu</email> </contact> <investigator> <last_name>Sirish Vullaganti, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>The Ohio State University</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43215</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>maeve McLoughlin, MPH</last_name> <phone>614-292-4084</phone> <email>Maeve.McLoughlin@osumc.edu</email> </contact> <investigator> <last_name>Sitaramesh Emani, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Abington Jefferson Health</name> <address> <city>Abington</city> <state>Pennsylvania</state> <zip>19001</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Amanda Merrill, RN</last_name> <phone>215-481-4661</phone> <email>amanda.merrill@jefferson.edu</email> </contact> <contact_backup> <last_name>Colleen Marchand, RN</last_name> <phone>215-481-4661</phone> <email>colleen.marchand@jefferson.edu</email> </contact_backup> <investigator> <last_name>Donald Haas, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Jackson Madison County General Hospital</name> <address> <city>Jackson</city> <state>Tennessee</state> <zip>38301</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Mary Harris, RN</last_name> <phone>731-541-6910</phone> <email>mary.harris@wth.org</email> </contact> <investigator> <last_name>Shree Mulay, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Baylor Scott & White Research Institute</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75207</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Amy Watts</last_name> <phone>254-724-1392</phone> <email>Amy.Watts@BSWHealth.org</email> </contact> <investigator> <last_name>Jamie Hernandez Montfort, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 10, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 10, 2023</last_update_submitted> <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Heart failure</keyword> <keyword>Fluid overload</keyword> <condition_browse>  <mesh_term>Heart Failure</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Diuretics</mesh_term> <mesh_term>Sodium Potassium Chloride Symporter Inhibitors</mesh_term> </intervention_browse>  </clinical_study>

The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload. Inclusion Criteria: - 18 years or older - Man, or non-pregnant woman - Admitted to the hospital with a primary diagnosis of acute decompensated heart failure - On regularly prescribed oral loop diuretics prior to admission - Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.) - Provide written informed consent Exclusion Criteria: - New diagnosis of heart failure - Acute coronary syndromes - Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment - Contraindications to systemic anticoagulation - Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days - Sepsis or ongoing systemic infection - Active myocarditis - Constrictive pericarditis or restrictive cardiomyopathy - Severe aortic stenosis - Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival

NCT0531xxxx/NCT05318118.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/NCT05318118</url> </required_header> <id_info> <org_study_id>KB-98/2021</org_study_id> <nct_id>NCT05318118</nct_id> </id_info> <brief_title>Comparison of the Results of Arthroscopic Suturing of the Medial Meniscus Using the Fast Fix and FiberStitch Systems</brief_title> <official_title>Comparative of Clinical and Evaluation Results of Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix and FiberStitch Systems</official_title> <sponsors> <lead_sponsor> <agency>eMKa MED Medical Center</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Wroclaw Medical University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>eMKa MED Medical Center</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> Clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of the medial meniscus of the knee joint using the Fast Fix and FiberStitch systems. </textblock> </brief_summary> <detailed_description> <textblock> The main goal of the project is to evaluate the results of medial meniscus traumatic injury suturing. Further (detailed) objectives are: to compare the results obtained in the study groups of suturing the medial meniscus with the use of two systems: Fast Fix (smith & nephew) and Fiber Stitch (arthrex). The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 8, 2021</start_date> <completion_date type="Anticipated">September 1, 2022</completion_date> <primary_completion_date type="Anticipated">September 1, 2022</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>The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Tegner Activity Level Scale (TAS);</measure> <time_frame>1 day</time_frame> <description>The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description> </primary_outcome> <primary_outcome> <measure>Tegner Activity Level Scale (TAS);</measure> <time_frame>3 months after procedure</time_frame> <description>The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description> </primary_outcome> <primary_outcome> <measure>Tegner Activity Level Scale (TAS);</measure> <time_frame>6 months after procedure</time_frame> <description>The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description> </primary_outcome> <primary_outcome> <measure>Tegner Activity Level Scale (TAS);</measure> <time_frame>12 months after procedure</time_frame> <description>The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description> </primary_outcome> <primary_outcome> <measure>Visual Analogue Score (VAS)</measure> <time_frame>1 day</time_frame> <description>Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; 75 to 100 mm, severe pain.</description> </primary_outcome> <primary_outcome> <measure>Visual Analogue Score (VAS)</measure> <time_frame>3 months after procedure</time_frame> <description>Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; 75 to 100 mm, severe pain.</description> </primary_outcome> <primary_outcome> <measure>Visual Analogue Score (VAS)</measure> <time_frame>6 months after procedure</time_frame> <description>Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; 75 to 100 mm, severe pain.</description> </primary_outcome> <primary_outcome> <measure>Visual Analogue Score (VAS)</measure> <time_frame>12 months after procedure</time_frame> <description>Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; 75 to 100 mm, severe pain.</description> </primary_outcome> <primary_outcome> <measure>IKDC SUBJECTIVE KNEE EVALUATION FORM</measure> <time_frame>1 day</time_frame> <description>Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.</description> </primary_outcome> <primary_outcome> <measure>IKDC SUBJECTIVE KNEE EVALUATION FORM</measure> <time_frame>3 months after procedure</time_frame> <description>Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.</description> </primary_outcome> <primary_outcome> <measure>IKDC SUBJECTIVE KNEE EVALUATION FORM</measure> <time_frame>6 months after procedure</time_frame> <description>Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.</description> </primary_outcome> <primary_outcome> <measure>IKDC SUBJECTIVE KNEE EVALUATION FORM</measure> <time_frame>12 months after procedure</time_frame> <description>Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.</description> </primary_outcome> <primary_outcome> <measure>Knee Society Score (KSS);</measure> <time_frame>1 day</time_frame> <description>The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.</description> </primary_outcome> <primary_outcome> <measure>Knee Society Score (KSS);</measure> <time_frame>3 months after procedure</time_frame> <description>The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.</description> </primary_outcome> <primary_outcome> <measure>Knee Society Score (KSS);</measure> <time_frame>6 months after procedure</time_frame> <description>The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.</description> </primary_outcome> <primary_outcome> <measure>Knee Society Score (KSS);</measure> <time_frame>12 months after procedure</time_frame> <description>The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.</description> </primary_outcome> <primary_outcome> <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS);</measure> <time_frame>1 day</time_frame> <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.</description> </primary_outcome> <primary_outcome> <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS);</measure> <time_frame>3 months after procedure</time_frame> <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.</description> </primary_outcome> <primary_outcome> <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS);</measure> <time_frame>6 months after procedure</time_frame> <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.</description> </primary_outcome> <primary_outcome> <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS);</measure> <time_frame>12 months after procedure</time_frame> <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.</description> </primary_outcome> <primary_outcome> <measure>Tegner Lysholm Knee Scoring Scale;</measure> <time_frame>1 day</time_frame> <description>The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: <65 - poor; 65-83 - fair; 84-90 - good; >90 - excellent.</description> </primary_outcome> <primary_outcome> <measure>Tegner Lysholm Knee Scoring Scale;</measure> <time_frame>3 months after procedure</time_frame> <description>The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: <65 - poor; 65-83 - fair; 84-90 - good; >90 - excellent.</description> </primary_outcome> <primary_outcome> <measure>Tegner Lysholm Knee Scoring Scale;</measure> <time_frame>6 months after procedure</time_frame> <description>The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: <65 - poor; 65-83 - fair; 84-90 - good; >90 - excellent.</description> </primary_outcome> <primary_outcome> <measure>Tegner Lysholm Knee Scoring Scale;</measure> <time_frame>12 months after procedure</time_frame> <description>The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: <65 - poor; 65-83 - fair; 84-90 - good; >90 - excellent.</description> </primary_outcome> <primary_outcome> <measure>Body Mass Index (BMI)</measure> <time_frame>1 day</time_frame> <description>BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.</description> </primary_outcome> <primary_outcome> <measure>Body Mass Index (BMI)</measure> <time_frame>3 months after procedure</time_frame> <description>BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.</description> </primary_outcome> <primary_outcome> <measure>Body Mass Index (BMI)</measure> <time_frame>6 months after procedure</time_frame> <description>BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.</description> </primary_outcome> <primary_outcome> <measure>Body Mass Index (BMI)</measure> <time_frame>12 months after procedure</time_frame> <description>BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.</description> </primary_outcome> <primary_outcome> <measure>Biomechanical examination</measure> <time_frame>9 months after procedure</time_frame> <description>On the Biodex 3 System measuring device</description> </primary_outcome> <primary_outcome> <measure>Biomechanical examination</measure> <time_frame>12 months after procedure</time_frame> <description>On the Biodex 3 System measuring device</description> </primary_outcome> <primary_outcome> <measure>Ultrasound examination (USG)</measure> <time_frame>6 months after procedure</time_frame> <description>Ultrasound examination on the apparatus with the option of elastometry</description> </primary_outcome> <primary_outcome> <measure>Ultrasound examination (USG)</measure> <time_frame>12 months after procedure</time_frame> <description>Ultrasound examination on the apparatus with the option of elastometry</description> </primary_outcome> <primary_outcome> <measure>Magnetic resonance imaging (MRI)</measure> <time_frame>6 months after procedure</time_frame> <description>1,5 Tesli</description> </primary_outcome> <primary_outcome> <measure>Magnetic resonance imaging (MRI)</measure> <time_frame>12 months after procedure</time_frame> <description>1,5 Tesli</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Meniscus; Detachment, Current Injury</condition> <condition>Detachment</condition> <condition>Medial Mensical Tear</condition> <condition>Medial Meniscus Knee Injury</condition> <arm_group> <arm_group_label>Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <arm_group> <arm_group_label>Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix</intervention_name> <description>Arthroscopic reconstruction of damaged Medial Meniscus using Fast-Fix (Smith & Nephew) implant.</description> <arm_group_label>Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch</intervention_name> <description>Arthroscopic reconstruction of damaged Medial Meniscus using Fiber-Stitch (Arthrex) implant</description> <arm_group_label>Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Isolated MM damage.  - Operation performed only in arthroscopy technique.  - No any knee intervention earlier.  - No other pathology in the anatomical area.  - Patient informed consent to participate in research  Exclusion Criteria:  - Age under 18 years old or above 35 years old.  - Any knee intervention performed earlier.  - Any other pathology in the anatomical area identified during preoperative diagnostics.  - Any damage in the area of the second knee joint.  - Failure complying the same treatment protocol rigor. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>35 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Maciej Kentel, MD PhD</last_name> <phone>+48518744908</phone> <email>emkamed.cm@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Kacper Kentel, master's degree</last_name> <phone>+48695263711</phone> <email>kacper.kentel@emkamed.com.pl</email> </overall_contact_backup> <location> <facility> <name>eMKa MED Medical Center</name> <address> <city>Wrocław</city> <state>Dolnośląsk</state> <zip>53-110</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Maciej Kentel, MD</last_name> <phone>+48518744908</phone> <email>emkamed.cm@gmail.com</email> </contact> <contact_backup> <last_name>Kacper Kentel, master's degree</last_name> <phone>+48695263711</phone> <email>kacper.kentel@emkamed.com.pl</email> </contact_backup> </location> <location_countries> <country>Poland</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 22, 2021</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>meniscus;</keyword> <keyword>medial;</keyword> <keyword>injury;</keyword> <keyword>suture;</keyword> <keyword>techniques;</keyword> <condition_browse>  <mesh_term>Wounds and Injuries</mesh_term> <mesh_term>Knee Injuries</mesh_term> <mesh_term>Dissociative Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of the medial meniscus of the knee joint using the Fast Fix and FiberStitch systems. The main goal of the project is to evaluate the results of medial meniscus traumatic injury suturing. Further (detailed) objectives are: to compare the results obtained in the study groups of suturing the medial meniscus with the use of two systems: Fast Fix (smith & nephew) and Fiber Stitch (arthrex). The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs. Inclusion Criteria: - Isolated MM damage. - Operation performed only in arthroscopy technique. - No any knee intervention earlier. - No other pathology in the anatomical area. - Patient informed consent to participate in research Exclusion Criteria: - Age under 18 years old or above 35 years old. - Any knee intervention performed earlier. - Any other pathology in the anatomical area identified during preoperative diagnostics. - Any damage in the area of the second knee joint. - Failure complying the same treatment protocol rigor.

NCT0531xxxx/NCT05318131.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/NCT05318131</url> </required_header> <id_info> <org_study_id>20-00078</org_study_id> <nct_id>NCT05318131</nct_id> </id_info> <brief_title>Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer</brief_title> <official_title>Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer</official_title> <sponsors> <lead_sponsor> <agency>NYU Langone Health</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>New York State Department of Health</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>NYU Langone Health</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 primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer. </textblock> </brief_summary> <detailed_description> <textblock> The primary objective of this study is to determine whether exposure to a website with recommendations about sleep and lifestyle for patients with prostate cancer and caregivers leads to an improvement in sleep and healthy lifestyle. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">August 30, 2022</start_date> <completion_date type="Anticipated">October 31, 2023</completion_date> <primary_completion_date type="Anticipated">October 31, 2023</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>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in Sleep Efficiency</measure> <time_frame>Baseline, 3 months</time_frame> <description>The study team will use ActiGraph software to calculate device-based measures of sleep efficiency. Sleep efficiency is the ratio of total sleep time (total time spent asleep) to time in bed and is reported as a percentage (total sleep time / time in bed x 100).</description> </primary_outcome> <primary_outcome> <measure>Change in Number of Awakenings After Sleep Onset</measure> <time_frame>Baseline, 3 months</time_frame> <description>The study team will use ActiGraph software to calculate device-based measure number of awakenings (when a participant wakes up) after sleep onset (the transition from wakefulness into sleep).</description> </primary_outcome> <primary_outcome> <measure>Change in Sleep Duration</measure> <time_frame>Baseline, 3 months</time_frame> <description>The study team will use ActiGraph software to calculate device-based measures of sleep duration</description> </primary_outcome> <primary_outcome> <measure>Change in Sleep Hygiene Index (SHI) Score</measure> <time_frame>Baseline, 3 months</time_frame> <description>SHI is a 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.</description> </primary_outcome> <primary_outcome> <measure>Change in Pittsburgh Sleep Quality Index (PSQI) Score</measure> <time_frame>Baseline, 3 months</time_frame> <description>PSQI contains 19 self-reported questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score "0" indicates no difficulty, while "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points; the higher the score, the more severe the difficulties in all areas.</description> </primary_outcome> <primary_outcome> <measure>Change in Insomnia Severity Index Score</measure> <time_frame>Baseline, 3 months</time_frame> <description>The Insomnia Severity Index has 7 questions, each rated on a 5-point Likert scale (0-4). The total score range is 0-28; the higher the score, the more severe the insomnia. 0-7 = no clinical significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinical insomnia (moderate severity), and 22-28 = clinical insomnia (severe)</description> </primary_outcome> <secondary_outcome> <measure>Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day</measure> <time_frame>Baseline, 3 months</time_frame> <description>The study team will use ActiGraph's GT3X tri-axial accelerometer and ActiLife software to calculate device-based measures of physical activity. Daily MVPA will be based on least 4 days of at least 10 hours of device wear time. A higher number of minutes of MVPA indicates more physical activity. Among U.S. adults aged 60 years or older, mean number of minutes per day of MVPA ranges from 10.8 to 106.8.</description> </secondary_outcome> <secondary_outcome> <measure>Change in device-based step counts per day</measure> <time_frame>Baseline, 3 months</time_frame> <description>The study team will use ActiLife software to calculate step counts per day. Daily steps will be based on at least 4 days of at least 10 hours of device wear time. A higher step count indicates more physical activity. Based on U.S. population samples, normative daily step count ranges are 41 to 12,780 steps for men aged 60 years or older and 55 to 9,735 for women aged 60 years or older.</description> </secondary_outcome> <secondary_outcome> <measure>Change in self-reported total physical activity MET-minutes per day</measure> <time_frame>Baseline, 3 months</time_frame> <description>The study team will use the International Physical Activity Questionnaire short form (IPAQ-SF). It will be used to assess time spent in 3 specific types of activity over the previous 7 days: vigorous-intensity activities, moderate-intensity activities, and walking. Time spent in these 3 activity types will be combined to calculate total physical activity minutes per day, a continuous variable with a plausible range of 0 to 960. Then, the study team will apply metabolic equivalents by intensity to calculate total physical activity MET-minutes per day.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Dietary Consumption</measure> <time_frame>Baseline, 3 months</time_frame> <description>The study team will use a food frequency questionnaire to measure servings per week of foods. Each food category is measured in never (lowest), once per month, 2-3 times last month, 1 time per week, 2 times per week, 3-4 times per week, 5-6 per week, 1 time per day, 2-3 times per day, 4-5 times per day, and 6+ times per day (highest).</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">50</enrollment> <condition>Prostate Cancer</condition> <arm_group> <arm_group_label>Single Arm Prospective Study</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Sleep and Lifestyle Advice Website</intervention_name> <description>Participants will be asked to view a website at least once a week for 3 months (remotely). The website includes information about exercise, nutrition and sleep. Participants will also have a check-in call with a health coach at 6 weeks, and will be sent email newsletters at approximately 1 and 2 months with additional information about sleep, nutrition, and exercise.</description> <arm_group_label>Single Arm Prospective Study</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Surveys and Sleep Monitors</intervention_name> <description>At baseline and at 3 months, participants will be asked to complete online surveys and to wear an ActiGraph sleep monitor for one week. ActiGraph sleep monitors are wristbands that measure continuous sleep/wake activity information. The recorded ActiGraph data is deidentified and no individual personally identifiable information is collected. A unique serial number identifies each wrist monitor. At the end of the study, participants will also have a telephone exit interview with the study team to provide feedback on their progress during the study and about the website.</description> <arm_group_label>Single Arm Prospective Study</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Adult U.S. male age >18 with prostate cancer OR  2. Adult U.S. male or female >18 who is a family member/partner/caregiver of a prostate cancer patient AND  3. Telephone and internet access AND  4. Able to read, comprehend, and sign informed consent in English AND  5. Perceived deficits in sleep, nutrition, and/or physical activity  Exclusion Criteria:  1. Age <18 years  2. Not English proficient  3. No or irregular access to the same telephone number and/or mailing address  4. No or less than weekly access to the internet  5. Patients who do not have a diagnosis of prostate cancer  6. Caregivers/family members for a condition other than prostate cancer  7. Mental or cognitive impairment that interferes with ability to provide informed consent  8. Surgery within the past 6 weeks or planned within the next 3 months (must wait until cleared to participate)  9. Other restrictions or upcoming events that affect sleep, physical activity or nutrition (e.g. doctor's orders) </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>Stacy Loeb, MD MSc</last_name> <role>Principal Investigator</role> <affiliation>NYU Langone Health</affiliation> </overall_official> <location> <facility> <name>NYU Langone Health</name> <address> <city>New York</city> <state>New York</state> <zip>10016</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>June 13, 2023</last_update_submitted> <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 15, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Prostatic Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame> <ipd_access_criteria>The investigator who proposed to use the data will have access to the data upon reasonable request for the purposes of an IRB approved scientific research project. Requests should be directed to stacy.loeb@nyulangone.org. To gain access, data requestors will need an IRB approved protocol and to sign a data access agreement.</ipd_access_criteria> </patient_data>  </clinical_study>

The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer. The primary objective of this study is to determine whether exposure to a website with recommendations about sleep and lifestyle for patients with prostate cancer and caregivers leads to an improvement in sleep and healthy lifestyle. Inclusion Criteria: 1. Adult U.S. male age >18 with prostate cancer OR 2. Adult U.S. male or female >18 who is a family member/partner/caregiver of a prostate cancer patient AND 3. Telephone and internet access AND 4. Able to read, comprehend, and sign informed consent in English AND 5. Perceived deficits in sleep, nutrition, and/or physical activity Exclusion Criteria: 1. Age <18 years 2. Not English proficient 3. No or irregular access to the same telephone number and/or mailing address 4. No or less than weekly access to the internet 5. Patients who do not have a diagnosis of prostate cancer 6. Caregivers/family members for a condition other than prostate cancer 7. Mental or cognitive impairment that interferes with ability to provide informed consent 8. Surgery within the past 6 weeks or planned within the next 3 months (must wait until cleared to participate) 9. Other restrictions or upcoming events that affect sleep, physical activity or nutrition (e.g. doctor's orders)

NCT0531xxxx/NCT05318144.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/NCT05318144</url> </required_header> <id_info> <org_study_id>COVID-19 and pregnancy</org_study_id> <nct_id>NCT05318144</nct_id> </id_info> <brief_title>Melatonin Levels on COVID-19 Positive Pregnant Women</brief_title> <official_title>Prognostic Value of Serum Melatonin as a Biomarker for the Determination of Severe COVID-19 Infection in Pregnant Women</official_title> <sponsors> <lead_sponsor> <agency>Nazan Yurtcu MD</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cumhuriyet 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 aimed to investigate the prognostic value of serum melatonin as a biomarker for the determination of severe COVID-19 infection in pregnant women.  Four study groups were formed, including pregnant women with a positive COVID-19 PCR test, severe symptoms, and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints, but had a PCR test due to the surveillance program and negative test results were included in the control group.  Methods and Main Outcome measure: Laboratory values of the cases at the time of diagnosis parameters were collected.  Melatonin levels decrease in pregnant women with COVID-19 symptoms, the severity of symptoms increases. In addition, patients with low melatonin levels have an increase in infection parameters and an increase in the hospital stay. </textblock> </brief_summary> <detailed_description> <textblock> A total of 228 pregnant women included in this prospective controlled study between June 20021 and June 2022 at Gynecology and Obstetrics Department of Health Sciences University Samsun Training and Research Hospital. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 1, 2021</start_date> <completion_date type="Actual">February 1, 2022</completion_date> <primary_completion_date type="Actual">December 1, 2021</primary_completion_date> <study_type>Observational [Patient Registry]</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <target_duration>6 Months</target_duration> <primary_outcome> <measure>Melatonin level</measure> <time_frame>6 year</time_frame> <description>Melatonin level of pregnant women with COVID-19</description> </primary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Actual">228</enrollment> <condition>COVID-19 Acute Respiratory Distress Syndrome</condition> <condition>Pregnancy Related</condition> <condition>Pregnancy Complications</condition> <arm_group> <arm_group_label>PCR (-) symptomatic</arm_group_label> <description>control group, pregnant women with negative COVID-19 Polymerase Chain Reaction (PCR) test</description> </arm_group> <arm_group> <arm_group_label>PCR (+) asymptomatic</arm_group_label> <description>Pregnant women who have a positive COVID-19 PCR test and have had the infection without symptoms</description> </arm_group> <arm_group> <arm_group_label>PCR (+) mild-moderate</arm_group_label> <description>Pregnant women with positive COVID-19 PCR test and mild to moderate symptoms and inpatient treatment</description> </arm_group> <arm_group> <arm_group_label>PCR (+) severe COVID-19</arm_group_label> <description>Pregnant women with positive COVID-19 PCR test and severe symptoms</description> </arm_group> <eligibility> <study_pop> <textblock> Pregnant women with COVID-19 and control groups </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - pregnant women with a positive COVID-19 PCR test and severe symptoms and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints but had a PCR test due to the surveillance program and negative test results were included in the control group. Pregnant women who had contact with people with COVID-19 infection and had a PCR test due to the surveillance program and had positive results, but no complaints were included in the other study group. The PCR test of pregnant women who had complaints and needed inpatient treatment during the COVID-19 infection was confirmed, and the COVID-19 infection was graded according to WHO's criteria. Pregnant women with viral infection with symptoms compatible with infection and virus isolation in any culture samples collected at admission were included in the patient group with PCR positive mild-moderate and severe COVID-19 infection. </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Serkan Oral</last_name> <role>Study Chair</role> <affiliation>Halic University Faculty of Medicine, Department of Obstetrics and Gynecology</affiliation> </overall_official> <location> <facility> <name>Samsun Training and Research Hospital</name> <address> <city>Samsun</city> <zip>58153</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <reference> <citation>Di Mascio D, Buca D, Berghella V, Khalil A, Rizzo G, Odibo A, Saccone G, Galindo A, Liberati M, D'Antonio F. Counseling in maternal-fetal medicine: SARS-CoV-2 infection in pregnancy. Ultrasound Obstet Gynecol. 2021 May;57(5):687-697. doi: 10.1002/uog.23628.</citation> <PMID>33724545</PMID> </reference> <reference> <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation> <PMID>32171076</PMID> </reference> <reference> <citation>Huntley BJF, Huntley ES, Di Mascio D, Chen T, Berghella V, Chauhan SP. Rates of Maternal and Perinatal Mortality and Vertical Transmission in Pregnancies Complicated by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2) Infection: A Systematic Review. Obstet Gynecol. 2020 Aug;136(2):303-312. doi: 10.1097/AOG.0000000000004010.</citation> <PMID>32516273</PMID> </reference> <results_reference> <citation>Yurtcu N, Caliskan C, Celik S. Serum Melatonin as a Biomarker for Assessment of Late-term and Postterm Pregnancies in Women without Spontaneous Onset of Labor. Z Geburtshilfe Neonatol. 2021 Dec;225(6):499-505. doi: 10.1055/a-1479-3220. Epub 2021 May 31.</citation> <PMID>34058776</PMID> </results_reference> <results_reference> <citation>Zauche LH, Wallace B, Smoots AN, Olson CK, Oduyebo T, Kim SY, Peterson EE, Ju J, Beauregard J, Wilcox AJ, Rose CE, Meaney-Delman D, Ellington SR. Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21. Res Sq. 2021 Aug 9:rs.3.rs-798175. doi: 10.21203/rs.3.rs-798175/v1. Preprint.</citation> <PMID>34401872</PMID> </results_reference> <results_reference> <citation>Wastnedge EAN, Reynolds RM, van Boeckel SR, Stock SJ, Denison FC, Maybin JA, Critchley HOD. Pregnancy and COVID-19. Physiol Rev. 2021 Jan 1;101(1):303-318. doi: 10.1152/physrev.00024.2020. Epub 2020 Sep 24.</citation> <PMID>32969772</PMID> </results_reference> <results_reference> <citation>Wong SF, Chow KM, Leung TN, Ng WF, Ng TK, Shek CC, Ng PC, Lam PW, Ho LC, To WW, Lai ST, Yan WW, Tan PY. Pregnancy and perinatal outcomes of women with severe acute respiratory syndrome. Am J Obstet Gynecol. 2004 Jul;191(1):292-7. doi: 10.1016/j.ajog.2003.11.019.</citation> <PMID>15295381</PMID> </results_reference> <results_reference> <citation>Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25.</citation> <PMID>32292902</PMID> </results_reference> <results_reference> <citation>Voiculescu SE, Zygouropoulos N, Zahiu CD, Zagrean AM. Role of melatonin in embryo fetal development. J Med Life. 2014 Oct-Dec;7(4):488-92.</citation> <PMID>25713608</PMID> </results_reference> <results_reference> <citation>Uzun M, Gencer M, Turkon H, Oztopuz RO, Demir U, Ovali MA. Effects of Melatonin on Blood Pressure, Oxidative Stress and Placental Expressions of TNFalpha, IL-6, VEGF and sFlt-1 in RUPP Rat Model of Preeclampsia. Arch Med Res. 2017 Oct;48(7):592-598. doi: 10.1016/j.arcmed.2017.08.007. Epub 2018 Feb 1. No abstract available.</citation> <PMID>29397206</PMID> </results_reference> <results_reference> <citation>Anderson G, Maes M, Markus RP, Rodriguez M. Ebola virus: melatonin as a readily available treatment option. J Med Virol. 2015 Apr;87(4):537-43. doi: 10.1002/jmv.24130. Epub 2015 Jan 21.</citation> <PMID>25611054</PMID> </results_reference> <results_reference> <citation>Anderson G, Reiter RJ. Melatonin: Roles in influenza, Covid-19, and other viral infections. Rev Med Virol. 2020 May;30(3):e2109. doi: 10.1002/rmv.2109. Epub 2020 Apr 21.</citation> <PMID>32314850</PMID> </results_reference> <results_reference> <citation>Nehme PA, Amaral FG, Middleton B, Lowden A, Marqueze E, Franca-Junior I, Antunes JLF, Cipolla-Neto J, Skene DJ, Moreno CRC. Melatonin profiles during the third trimester of pregnancy and health status in the offspring among day and night workers: A case series. Neurobiol Sleep Circadian Rhythms. 2019 Apr 13;6:70-76. doi: 10.1016/j.nbscr.2019.04.001. eCollection 2019 Jan.</citation> <PMID>31236522</PMID> </results_reference> <results_reference> <citation>Farnoosh G, Akbariqomi M, Badri T, Bagheri M, Izadi M, Saeedi-Boroujeni A, Rezaie E, Ghaleh HEG, Aghamollaei H, Fasihi-Ramandi M, Hassanpour K, Alishiri G. Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial. Arch Med Res. 2022 Jan;53(1):79-85. doi: 10.1016/j.arcmed.2021.06.006. Epub 2021 Jun 23.</citation> <PMID>34229896</PMID> </results_reference> <results_reference> <citation>Salles C. Correspondence COVID-19: Melatonin as a potential adjuvant treatment. Life Sci. 2020 Jul 15;253:117716. doi: 10.1016/j.lfs.2020.117716. Epub 2020 Apr 22. No abstract available.</citation> <PMID>32334009</PMID> </results_reference> <results_reference> <citation>Liset R, Gronli J, Henriksen RE, Henriksen TEG, Nilsen RM, Pallesen S. A randomized controlled trial on the effect of blue-blocking glasses compared to partial blue-blockers on melatonin profile among nulliparous women in third trimester of the pregnancy. Neurobiol Sleep Circadian Rhythms. 2021 Dec 29;12:100074. doi: 10.1016/j.nbscr.2021.100074. eCollection 2022 May.</citation> <PMID>35024497</PMID> </results_reference> <verification_date>April 2022</verification_date> <study_first_submitted>April 6, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 6, 2022</last_update_submitted> <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Cumhuriyet University</investigator_affiliation> <investigator_full_name>Nazan Yurtcu MD</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <keyword>COVID-19</keyword> <keyword>SARS-CoV-2</keyword> <keyword>Melatonine</keyword> <keyword>pregnancy</keyword> <keyword>pregnancy outcomes</keyword> <condition_browse>  <mesh_term>COVID-19</mesh_term> <mesh_term>Respiratory Distress Syndrome</mesh_term> <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term> <mesh_term>Acute Lung Injury</mesh_term> <mesh_term>Pregnancy Complications</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>June 2021- December 2021</ipd_description> </patient_data>  </clinical_study>

This study aimed to investigate the prognostic value of serum melatonin as a biomarker for the determination of severe COVID-19 infection in pregnant women. Four study groups were formed, including pregnant women with a positive COVID-19 PCR test, severe symptoms, and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints, but had a PCR test due to the surveillance program and negative test results were included in the control group. Methods and Main Outcome measure: Laboratory values of the cases at the time of diagnosis parameters were collected. Melatonin levels decrease in pregnant women with COVID-19 symptoms, the severity of symptoms increases. In addition, patients with low melatonin levels have an increase in infection parameters and an increase in the hospital stay. A total of 228 pregnant women included in this prospective controlled study between June 20021 and June 2022 at Gynecology and Obstetrics Department of Health Sciences University Samsun Training and Research Hospital. Pregnant women with COVID-19 and control groups Inclusion Criteria: - pregnant women with a positive COVID-19 PCR test and severe symptoms and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints but had a PCR test due to the surveillance program and negative test results were included in the control group. Pregnant women who had contact with people with COVID-19 infection and had a PCR test due to the surveillance program and had positive results, but no complaints were included in the other study group. The PCR test of pregnant women who had complaints and needed inpatient treatment during the COVID-19 infection was confirmed, and the COVID-19 infection was graded according to WHO's criteria. Pregnant women with viral infection with symptoms compatible with infection and virus isolation in any culture samples collected at admission were included in the patient group with PCR positive mild-moderate and severe COVID-19 infection.

NCT0531xxxx/NCT05318157.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/NCT05318157</url> </required_header> <id_info> <org_study_id>TR-SAR-AIT</org_study_id> <nct_id>NCT05318157</nct_id> </id_info> <brief_title>Efficacy of Artemisia Pollen Specific Allergen Immunotherapy</brief_title> <official_title>Long Term Efficacy of Artemisia Pollen Specific Allergen Immunotherapy in Patients With Seasonal Allergic Rhinitis</official_title> <sponsors> <lead_sponsor> <agency>Beijing Tongren Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Beijing Shijitan Hospital, Capital Medical University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Peking University People's Hospital</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Beijing Tongren Hospital</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> Allergic rhinitis (AR) is a noninfectious inflammatory disease of the nasal mucosa mediated by immunoglobulin E (IgE) after exposure to allergens. Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.  The trial is a randomized, Open label, multicentred trial. A total of 150 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and conversation drugs group. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 31, 2022</start_date> <completion_date type="Anticipated">November 30, 2024</completion_date> <primary_completion_date type="Anticipated">October 15, 2024</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change from baseline symptom scores</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>Symptom change before and after treatment was estimated by Visual analogue scale(VAS) symptom score. The VAS symptom scores ranged from 0 (asymptomatic) to 10 (very severe). Four nasal symptoms (itching, sneezing, rhinorrhoea and nasal obstruction) and two ocular symptoms (ocular itch and watery eyes) were included.</description> </primary_outcome> <primary_outcome> <measure>the change of rhinoconjunctivitis quality of life questionnaire (RQLQ)</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>RQLQ score includes 7 aspects and 28 items: nasal symptoms, eye symptoms, non nasal and eye symptoms, behavior problems, sleep, daily activities and emotional reactions. It adopts a 0-6 point design. Among the emotional reactions, 0 point: none at any time; 1 point, not at any time; 2 points, occasionally; 3 points, sometimes; 4 points, often; 5 points, most of the time; 6 points, all the time; In other items: 0 point, not troubled; 1 point, hardly disturbed; 2 points, occasionally troubled; 3 points, moderate distress; 4 points, quite troubled; 5 points, very troubled; 6 points, extremely troubled.</description> </primary_outcome> <secondary_outcome> <measure>daily medication score</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>medication score in each day during the peak pollen season (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines.</description> </secondary_outcome> <secondary_outcome> <measure>combined symptom and medication score, CSMS</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score.</description> </secondary_outcome> <secondary_outcome> <measure>Health economics evaluation</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>Record the treatment cost of patients with allergy related diseases in the period.</description> </secondary_outcome> <secondary_outcome> <measure>adverse events</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>Any adverse event following acupuncture was assessed by physicians and patients. Patients were instructed to record any unexpected signs, symptoms, and feelings during the entire trial period.</description> </secondary_outcome> <secondary_outcome> <measure>The change of biomarkers</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>The levels of neuropeptides; including substance P, vasoactive intestinal peptide (VIP) , neuropeptide Y (NPY)) will be analysed using ELISA. The unit of all these parameters is ng/ml.</description> </secondary_outcome> <secondary_outcome> <measure>The change of cytokine expression</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>Quantitative real-time reverse transcription PCR (qRT-PCR) was used to analyze the mRNA expression levels of the cytokines interleukin-4, interleukin-5, interleukin-13, leukotriene C4, RANTES, tumor necrosis factor-α, thymic stromal lymphopoietin, and EOTAXIN in the nasal mucosa before and after treatment. The qRT-PCR data were processed using the 2-△△CT method.</description> </secondary_outcome> <secondary_outcome> <measure>nasal patency</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>Eccovision acoustic rhinometry was used to measure the nasal cavity volume (NCV) according to standardized recommendations. Measurements of nasal volume were made from the first 2 cm (V2), the first 4 cm (V4), from the first 6 cm (V6), from the segment between 0 and 5 cm (V0-5), and the segment between 0 and 7 cm (V0-7) of the nose. All measurements were performed three times by the same operator, and nasal volumes were calculated as the sum of both nostrils24. In the current study, the change in the nasal cavity volume was measured at 2-5 cm, as this seems to be an important variable for mucosal changes.24 Nasal airway resistance (NAR) was measured by anterior active rhinomanometry in a quiet room at temperature of 25°C and humidity of 70%. NAR was measured at 75 Pa point (R75T).</description> </secondary_outcome> <secondary_outcome> <measure>The change of IgE level</measure> <time_frame>Visit 0: at baseline; Visit 1: at the first year of the high pollen stage; Visit 2: at the second year of the high pollen stage; Visit 3: at ending of 2 years treatment; Visit 4: at the third year of the high pollen stage.</time_frame> <description>The levels of sIgE and sIgG will be analysed using Unicap250. The unit of all these parameters is kU/ml.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">150</enrollment> <condition>Allergic Rhinitis</condition> <arm_group> <arm_group_label>Sublingual Immunotherapy group</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Drugs treatment group</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>AIT drops</intervention_name> <description>Once a day</description> <arm_group_label>Sublingual Immunotherapy group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Clarityne, Rhinocort and Emedastine Difumarate Eye Drops</intervention_name> <description>The following drugs were permitted as allergy symptoms-relieving medications according to the actual needs in groups: Clarityne, Rhinocort and Emedastine Difumarate Eye Drops, Once a day</description> <arm_group_label>Drugs treatment group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - presence of seasonal rhinitis symptoms.  - the TNSS was higher than 6 scores in last autumn pollen season.  - artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) at least class 3, and higher than both of ragweed and Humulus IgE levels.  - patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.  - patients who are able to understand the information given and the consent and complete the daily record card.  Exclusion Criteria:  - ulcers, inflammation or trauma in the sublingual part;  - oral diseases / oral allergies;  - had surgery within four weeks before screening evaluation;  - Continuous use of systemic glucocorticoids within four weeks before screening evaluation;  - Any history of severe systemic allergic reaction and eosinophilic esophagitis before screening evaluation;  - Suffering from perennial allergic rhinitis;  - Complicated with chronic rhinitis or sinusitis, nasal polyps;  - In the recent pollen season, rhinitis can be relieved without symptomatic treatment;  - Within 2 years before enrollment, diagnosed with a history of moderate and severe asthma or FEV1 less than 70% of the estimated value;  - Applying β Treatment with receptor blockers (including systemic and local drugs) or angiotensin converting enzyme (ACE) inhibitors;  - Participated in clinical trials of other drugs within one month; Receiving other pollen allergen specific immunotherapy;  - Pregnant and lactating women or those who have pregnancy planning within the past year;  - history of immunosuppressive disease (such as HIV infection history), history of malignancy, history of autoimmune diseases, history of pulmonary tuberculosis, cardiovascular dysfunction, or other serious diseases of other organ systems judged by researchers.  - received pollen allergen specific immunotherapy or are receiving allergen specific immunotherapy within three years. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Chengshuo Wang</last_name> <phone>58265806</phone> <email>wangcs@126.com</email> </overall_contact> <overall_contact_backup> <last_name>Yuan Zhang</last_name> </overall_contact_backup> <location> <facility> <name>Beijing Shijitan Hospital</name> <address> <city>Beijing</city> <country>China</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Xueyan Wang</last_name> </contact> </location> <location> <facility> <name>Beijing TongRen hospitial</name> <address> <city>Beijing</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yuan Zhang</last_name> </contact> </location> <location> <facility> <name>Peking University People's hospital</name> <address> <city>Beijing</city> <country>China</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Xing Zhimin</last_name> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>May 21, 2022</last_update_submitted> <last_update_submitted_qc>May 21, 2022</last_update_submitted_qc> <last_update_posted type="Actual">May 26, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Rhinitis</mesh_term> <mesh_term>Rhinitis, Allergic</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Emedastine</mesh_term> <mesh_term>Budesonide</mesh_term> <mesh_term>Ophthalmic Solutions</mesh_term> </intervention_browse>  </clinical_study>

Allergic rhinitis (AR) is a noninfectious inflammatory disease of the nasal mucosa mediated by immunoglobulin E (IgE) after exposure to allergens. Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. The trial is a randomized, Open label, multicentred trial. A total of 150 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and conversation drugs group. Inclusion Criteria: - presence of seasonal rhinitis symptoms. - the TNSS was higher than 6 scores in last autumn pollen season. - artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) at least class 3, and higher than both of ragweed and Humulus IgE levels. - patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol. - patients who are able to understand the information given and the consent and complete the daily record card. Exclusion Criteria: - ulcers, inflammation or trauma in the sublingual part; - oral diseases / oral allergies; - had surgery within four weeks before screening evaluation; - Continuous use of systemic glucocorticoids within four weeks before screening evaluation; - Any history of severe systemic allergic reaction and eosinophilic esophagitis before screening evaluation; - Suffering from perennial allergic rhinitis; - Complicated with chronic rhinitis or sinusitis, nasal polyps; - In the recent pollen season, rhinitis can be relieved without symptomatic treatment; - Within 2 years before enrollment, diagnosed with a history of moderate and severe asthma or FEV1 less than 70% of the estimated value; - Applying β Treatment with receptor blockers (including systemic and local drugs) or angiotensin converting enzyme (ACE) inhibitors; - Participated in clinical trials of other drugs within one month; Receiving other pollen allergen specific immunotherapy; - Pregnant and lactating women or those who have pregnancy planning within the past year; - history of immunosuppressive disease (such as HIV infection history), history of malignancy, history of autoimmune diseases, history of pulmonary tuberculosis, cardiovascular dysfunction, or other serious diseases of other organ systems judged by researchers. - received pollen allergen specific immunotherapy or are receiving allergen specific immunotherapy within three years.

NCT0531xxxx/NCT05318170.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/NCT05318170</url> </required_header> <id_info> <org_study_id>Yasargil-1</org_study_id> <nct_id>NCT05318170</nct_id> </id_info> <brief_title>Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)</brief_title> <official_title>Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies</official_title> <sponsors> <lead_sponsor> <agency>University of Palermo</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Fondazione Policlinico Universitario A. Gemelli, IRCCS</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Universita di Verona</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Palermo</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> Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable.  To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Actual">April 11, 2022</completion_date> <primary_completion_date type="Actual">April 8, 2022</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>Complications</measure> <time_frame>During the surgery and within 30 days after the surgery</time_frame> <description>Any complication occurred</description> </primary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">43</enrollment> <condition>Gynecologic Cancer</condition> <arm_group> <arm_group_label>Women affected by gynecological cancer</arm_group_label> <description>Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Laparoscopic ultra-radical lymph node debulking</intervention_name> <description>Laparoscopic ultra-radical lymph node debulking using Yasargil clamps</description> <arm_group_label>Women affected by gynecological cancer</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Women affected by gynecological cancer. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - At least one bulky lymph node with size ≥ 25 mm  - Age > 18 years  - Body mass index (BMI) < 40 kg/m²  - Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation  Exclusion Criteria:  - Disease-free interval < 6 months and/or  - Performance status > 2 according to Eastern Cooperative Oncology Group (ECOG) criteria </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> </eligibility> <overall_official> <last_name>Antonio Simone Laganà, M.D., Ph.D.</last_name> <role>Study Chair</role> <affiliation>University of Palermo</affiliation> </overall_official> <overall_official> <last_name>Vito Chiantera</last_name> <role>Study Director</role> <affiliation>University of Palermo</affiliation> </overall_official> <overall_official> <last_name>Mariano Catello Di Donna</last_name> <role>Principal Investigator</role> <affiliation>University of Palermo</affiliation> </overall_official> <location> <facility> <name>University of Palermo</name> <address> <city>Palermo</city> <state>Sicily</state> <zip>90133</zip> <country>Italy</country> </address> </facility> </location> <location_countries> <country>Italy</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>April 4, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 13, 2022</last_update_submitted> <last_update_submitted_qc>July 13, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 18, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Palermo</investigator_affiliation> <investigator_full_name>Antonio Simone Laganà</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Gynecological oncology</keyword> <keyword>Gynecological cancers</keyword> <keyword>Bulky lymph nodes</keyword> <keyword>Laparoscopic ultra-radical lymph node debulking</keyword> <keyword>Yasargil clamps</keyword> <keyword>Complications</keyword> <keyword>Surgical outcomes</keyword> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable. To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases. Women affected by gynecological cancer. Inclusion Criteria: - At least one bulky lymph node with size ≥ 25 mm - Age > 18 years - Body mass index (BMI) < 40 kg/m² - Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation Exclusion Criteria: - Disease-free interval < 6 months and/or - Performance status > 2 according to Eastern Cooperative Oncology Group (ECOG) criteria

NCT0531xxxx/NCT05318183.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/NCT05318183</url> </required_header> <id_info> <org_study_id>2021H0347</org_study_id> <nct_id>NCT05318183</nct_id> </id_info> <brief_title>Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components</brief_title> <official_title>Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components</official_title> <sponsors> <lead_sponsor> <agency>Ohio State University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>USDA Beltsville Human Nutrition Research Center</agency> <agency_class>U.S. Fed</agency_class> </collaborator> </sponsors> <source>Ohio State 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> This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum). </textblock> </brief_summary> <detailed_description> <textblock> Accumulating clinical evidence suggests positive effects of whole grain on cardiometabolic risk. However, outcomes of controlled trials indicate that substantial interpersonal variation occurs in these studies with regard to glucose homeostasis, with some persons being unaffected and others experiencing glucose-lowering effects due to whole wheat bread consumption. Whole grain (whole wheat) contains bioactive phytochemicals in addition to its well-recognized fiber content, and these constituents have not received adequate study to inform dietary recommendations. The objective of this study is to investigate the glucose-lowering effects of whole wheat bread in persons with prediabetes using multi-omics platforms that can provide an understanding of the complex interactions among the gut microbiome, gut metabolome, host metabolome, and gut barrier function. The hypothesis is that gut microbial metabolism of whole wheat and its major bioactive components is a determining factor of human health benefits. This will be tested by conducting a randomized, controlled crossover trial in persons with pre-diabetes who follow a controlled diet containing whole wheat bread or white bread for 2-weeks. Outcomes are expected to significantly advance an understanding of personalized, gut microbiome-mediated approaches in individuals with pre-diabetes to help guide dietary recommendations of whole wheat intake. In addition, novel evidence that maps out the differential functions of diverse genus/species of microbiota to biotransform whole wheat nutrients into more bioactive metabolites are expected. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 27, 2022</start_date> <completion_date type="Anticipated">February 2025</completion_date> <primary_completion_date type="Anticipated">June 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>Participants will be randomized to receive 4 servings per day of whole wheat bread (WWB) or white bread (WB) for 2 weeks. During each study arm, participants will be provided eucaloric standardized diets that are devoid of whole wheat products, probiotic-containing foods, and fermented foods. Before and after each study arm, a fasting blood sample and fecal sample will be obtained for metabolomic and clinical measures. Anthropometric measurements and blood pressure will be assessed at days 0, 7, and 14 of each study arm. On day 14, participants will complete an oral glucose tolerance test (OGTT) with collection of blood samples every 30 minutes for 3 hours and a simultaneous gut permeability test that entails ingesting non-digestible sugar probes and subsequent 24-h collection of urine. Upon completion of these procedures, participants will undergo a ~1 month washout before repeating the study identically, with the crossover to the alternate bread diet.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in fasting plasma glucose</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fasting plasma glucose concentrations (mg/dL) will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </primary_outcome> <secondary_outcome> <measure>Change in plasma insulin</measure> <time_frame>Day 0, Day 14</time_frame> <description>Plasma concentration (μIU/mL) of insulin will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Change in insulin sensitivity</measure> <time_frame>Day 14</time_frame> <description>Evaluated through an oral glucose tolerance test and quantified using the area under the curve (AUC) of the temporal changes in blood glucose and insulin conducted at the end of each intervention arm to assess between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Small gastrointestinal permeability</measure> <time_frame>Day 14</time_frame> <description>Lactulose/mannitol ratio will be measured in urine collected 0-5 h following the digestion of non-digestible sugar probes to assess small intestinal permeability. Excretion ratios will be measured at the end of each intervention arm to assess between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Colonic gastrointestinal permeability</measure> <time_frame>Day 14</time_frame> <description>Sucralose/erythritol ratio will be measured in urine collected 6-24 h following digestion of non-digestible sugar probes to access colonic permeability. Excretion ratios will be measured at the end of each intervention arm to assess between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Metabolic Endotoxemia</measure> <time_frame>Day 0, Day 14</time_frame> <description>Serum endotoxin concentration (EU/mL) will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Serum myeloperoxidase</measure> <time_frame>Day 0, Day 14</time_frame> <description>Serum concentration (ng/mL) of myeloperoxidase will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of toll-like receptor 4 gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory toll-like receptor 4 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of myeloid differentiation factor 88 gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory myeloid differentiation factor 88 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of tumor necrosis factor alpha gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory tumor necrosis factor alpha gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of p65 subunit of nuclear factor kappa B gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory p65 subunit of nuclear factor kappa B gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of interleukin-6 gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory interleukin-6 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of interleukin-8 gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory interleukin-8 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of myeloperoxidase gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory myeloperoxidase gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Level of monocyte chemoattractant protein-1 gene expression</measure> <time_frame>Day 0, Day 14</time_frame> <description>Expression of pro-inflammatory monocyte chemoattractant protein-1 gene from peripheral blood mononuclear cells will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Fecal calprotectin</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentration (μg/g) of calprotectin will be measured in samples collected and the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Fecal myeloperoxidase</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentration (ng/g) of myeloperoxidase will be measured in samples collected at the beginning and end of each study arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Fecal short-chain fatty acid: butyrate</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations (mmol/kg) of butyrate will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Fecal short-chain fatty acid: acetate</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations (mmol/kg) of acetate will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Fecal short-chain fatty acid: propionate</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations (mmol/kg) of propionate will be measured individually in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Fecal short-chain fatty acid: isobutyric acid</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations (mmol/kg) of isobutyric acid will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Fecal short-chain fatty acid: isovaleric acid</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations (mmol/kg) of isovaleric acid will be measured in samples collected at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Serum whole wheat bread phytochemical: alkylersorcinols</measure> <time_frame>Day 0, Day 14</time_frame> <description>Serum concentrations of (nmol/L) alkylresorcinol and alkylresorcinol derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Serum whole wheat bread phytochemical: benoxazinods</measure> <time_frame>Day 0, Day 14</time_frame> <description>Serum concentrations of (nmol/L) benoxazinoids and benoxazinoids derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Serum whole wheat bread phytochemical: phenolic compounds</measure> <time_frame>Day 0, Day 14</time_frame> <description>Serum concentrations of (nmol/L) phenolic compounds and phenolic derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Intestinal whole wheat phytochemical: alkylresorcinols</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations of (μmol/L) alkylresorcinols and alkylresorcinol derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Intestinal whole wheat phytochemical: benoxazinoids</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations of (μmol/L) benoxazinoids and benoxazinoids derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </secondary_outcome> <secondary_outcome> <measure>Intestinal whole wheat phytochemical: phenolic compounds</measure> <time_frame>Day 0, Day 14</time_frame> <description>Fecal concentrations of (μmol/L) phenolic compounds and phenolic derivatives will be measured at the beginning and end of each intervention arm to assess within-treatment and between treatment effects.</description> </secondary_outcome> <other_outcome> <measure>Plasma triglyceride levels</measure> <time_frame>Day 0, Day 14</time_frame> <description>Plasma triglyceride concentrations (mg/dL) will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </other_outcome> <other_outcome> <measure>Plasma cholesterol levels</measure> <time_frame>Day 0, Day 14</time_frame> <description>Plasma cholesterol concentrations (mg/dL) will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </other_outcome> <other_outcome> <measure>Plasma HDL-cholesterol levels</measure> <time_frame>Day 0, Day 14</time_frame> <description>Plasma HDL-cholesterol concentrations (mg/dL) will be measured at the beginning and end of each intervention arm to assess within-treatment and between-treatment effects.</description> </other_outcome> <other_outcome> <measure>Serum alanine transaminase</measure> <time_frame>Day 0, Day 14</time_frame> <description>Serum concentrations (U/L) of alanine transaminase will be measured at the beginning and end of each intervention arm to assess within-treatment and between treatment effects.</description> </other_outcome> <other_outcome> <measure>Serum inflammatory biomarker: C-reactive protein</measure> <time_frame>Day 14</time_frame> <description>Serum concentration (mg/L) of C-reactive protein will be measured at the end of each intervention arm to assess between-treatment effects.</description> </other_outcome> <other_outcome> <measure>Serum inflammatory biomarker: interleukin-6</measure> <time_frame>Day 14</time_frame> <description>Serum interleukin-6 concentrations (pg/mL) of interleukin-6 will be measured at the end of each intervention arm to assess between-treatment effects.</description> </other_outcome> <other_outcome> <measure>Serum inflammatory biomarker: interleukin-8</measure> <time_frame>Day 14</time_frame> <description>Serum interleukin-8 concentrations (pg/mL) will be measured at the end of each intervention arm to assess between-treatment effects.</description> </other_outcome> <other_outcome> <measure>Serum inflammatory biomarker: tumor necrosis factor alpha</measure> <time_frame>Day 14</time_frame> <description>Serum tumor necrosis factor alpha concentrations (pg/mL) will be measured at the end of each intervention arm to assess between-treatment effects.</description> </other_outcome> <other_outcome> <measure>Gut microbiota alpha-diversity indices</measure> <time_frame>Day 0, Day 14</time_frame> <description>Within-treatment and between-treatment effects regarding alpha-diversity will be determined based on the Shannon-Wiener diversity index. Fecal samples collected at the beginning and end of each intervention period will be used to perform microbiota assessments and the subsequent determinations of alpha-diversity.</description> </other_outcome> <other_outcome> <measure>Gut microbiota beta-diversity indices</measure> <time_frame>Day 0, Day 14</time_frame> <description>Within-treatment and between-treatment effects regarding beta-diversity will be determined based on the Bray-Curtis diversity index. Fecal samples collected at the beginning and end of each intervention period will be used to perform microbiota assessments and the subsequent determinations of beta-diversity.</description> </other_outcome> <other_outcome> <measure>Gut microbiota relative abundance</measure> <time_frame>Day 0, Day 14</time_frame> <description>Gut microbiota relative abundance (percent order, genus, and species level) will be measured in fecal samples collected at the beginning and end of each intervention arm to assess within-treatment and between treatment effects.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>PreDiabetes</condition> <condition>Dysbiosis</condition> <condition>Endotoxemia</condition> <condition>Inflammation</condition> <arm_group> <arm_group_label>Whole Wheat Bread</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants consuming 128 g of whole wheat bread (4 slices of bread) daily for two weeks</description> </arm_group> <arm_group> <arm_group_label>White Bread (control)</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Participants consuming 128 g of white bread (4 slices of bread) daily for two weeks</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Whole Wheat Bread</intervention_name> <description>Standardized whole wheat bread (128 g daily)</description> <arm_group_label>Whole Wheat Bread</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>White Bread (control)</intervention_name> <description>Standardized white bread (128 g daily)</description> <arm_group_label>White Bread (control)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Fasting blood glucose between 100-125 mg/dL  - BMI of 30-35 kg/m2  Exclusion Criteria:  - History of liver disease, cardiovascular disease, overt diabetes, or cancer  - Prescribed medications for hyperglycemia or dyslipidemia  - Use of dietary supplements, prebiotics, or probiotics  - Usage of antibiotics or anti-fungals within 3 months prior to enrollment  - Smoker  - Alcohol consumption greater than 2 drinks per day  - Aerobic exercise greater than 5 hours per week  - Pregnancy or fertility treatments  - History of chronically active inflammatory or neoplastic disease in 3 years prior to enrollment  - History of chronic gastrointestinal disorder including diarrhea, inflammatory bowel disease, celiac disease; coagulation disorders, chronic immunosuppressive medication usage  - History of myocardial infarction or cerebrovascular accident within 6 months prior to participation </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Richard Bruno, PhD, RD</last_name> <role>Principal Investigator</role> <affiliation>Ohio State University</affiliation> </overall_official> <overall_contact> <last_name>Richard Bruno, PhD, RD</last_name> <phone>6142925522</phone> <email>bruno.27@osu.edu</email> </overall_contact> <location> <facility> <name>The Ohio State University</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43210</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>December 16, 2022</last_update_submitted> <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 19, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Ohio State University</investigator_affiliation> <investigator_full_name>Richard Bruno</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Gut microbiota</keyword> <keyword>Microbiome</keyword> <keyword>Metabolomics</keyword> <keyword>Prediabetes</keyword> <keyword>Glycemic response</keyword> <keyword>Intestinal permeability</keyword> <keyword>Gut dysbiosis</keyword> <keyword>Microbiome metabolism</keyword> <keyword>Whole Wheat</keyword> <keyword>Phytochemicals</keyword> <condition_browse>  <mesh_term>Endotoxemia</mesh_term> <mesh_term>Prediabetic State</mesh_term> <mesh_term>Glucose Intolerance</mesh_term> <mesh_term>Inflammation</mesh_term> <mesh_term>Dysbiosis</mesh_term> </condition_browse>  </clinical_study>

This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum). Accumulating clinical evidence suggests positive effects of whole grain on cardiometabolic risk. However, outcomes of controlled trials indicate that substantial interpersonal variation occurs in these studies with regard to glucose homeostasis, with some persons being unaffected and others experiencing glucose-lowering effects due to whole wheat bread consumption. Whole grain (whole wheat) contains bioactive phytochemicals in addition to its well-recognized fiber content, and these constituents have not received adequate study to inform dietary recommendations. The objective of this study is to investigate the glucose-lowering effects of whole wheat bread in persons with prediabetes using multi-omics platforms that can provide an understanding of the complex interactions among the gut microbiome, gut metabolome, host metabolome, and gut barrier function. The hypothesis is that gut microbial metabolism of whole wheat and its major bioactive components is a determining factor of human health benefits. This will be tested by conducting a randomized, controlled crossover trial in persons with pre-diabetes who follow a controlled diet containing whole wheat bread or white bread for 2-weeks. Outcomes are expected to significantly advance an understanding of personalized, gut microbiome-mediated approaches in individuals with pre-diabetes to help guide dietary recommendations of whole wheat intake. In addition, novel evidence that maps out the differential functions of diverse genus/species of microbiota to biotransform whole wheat nutrients into more bioactive metabolites are expected. Inclusion Criteria: - Fasting blood glucose between 100-125 mg/dL - BMI of 30-35 kg/m2 Exclusion Criteria: - History of liver disease, cardiovascular disease, overt diabetes, or cancer - Prescribed medications for hyperglycemia or dyslipidemia - Use of dietary supplements, prebiotics, or probiotics - Usage of antibiotics or anti-fungals within 3 months prior to enrollment - Smoker - Alcohol consumption greater than 2 drinks per day - Aerobic exercise greater than 5 hours per week - Pregnancy or fertility treatments - History of chronically active inflammatory or neoplastic disease in 3 years prior to enrollment - History of chronic gastrointestinal disorder including diarrhea, inflammatory bowel disease, celiac disease; coagulation disorders, chronic immunosuppressive medication usage - History of myocardial infarction or cerebrovascular accident within 6 months prior to participation

NCT0531xxxx/NCT05318196.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/NCT05318196</url> </required_header> <id_info> <org_study_id>RC31/21/0154</org_study_id> <nct_id>NCT05318196</nct_id> </id_info> <brief_title>Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases</brief_title> <acronym>NEPHROGENE2</acronym> <official_title>Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Toulouse</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University Hospital, Toulouse</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> Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases. </textblock> </brief_summary> <detailed_description> <textblock> Acute renal failure (ARF) and chronic kidney disease (CKD) are frequent pathologies (850 million people are affected worldwide). Renal failure is associated with an increased morbidity and mortality, including an increased risk of infections, drug toxicity and cardiovascular death. The causes of renal failure are numerous: metabolic (diabetes, hypertension), immunological (autoimmune diseases, monoclonal gammopathies), toxic (environment, drugs), genetic, infectious, ischemic, paraneoplastic... Any episode of ARF is also accompanied by a risk of secondary CKD (relative risk multiplied by 9).  The mechanisms leading to renal failure are multiple and combine predisposing genetic factors, inadequate intra-renal or systemic immune response, endothelial and epithelial dysfunctions, and potentially inappropriate regenerative capacity. In addition, renal failure or its treatment itself may be accompanied by additional renal lesions (e.g. nephrotoxicity of calcineurin inhibitors used as anti-rejection treatment in transplantation, hemodynamic intolerance with secondary ARF during hemodialysis sessions, iatrogenic ARF when using diuretics or inhibitors of the renin angiotensin system) or extra-renal complications (e.g. immunosuppression and infections induced by immunomodulatory therapies during autoimmune diseases or for prevention of transplant rejection; vascular diseases secondary to phosphocalcic disorders).  Patients included in the NEPHROGENE 2.0 cohort will be followed during 10 years and clinical data and biological samples will be collected at the inclusion in the cohort, at each monitoring programmed in their usual care and and at each event (infection, acute kidney injury, cancer…). Samples will be collected according to the symptoms of the patients. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 5, 2022</start_date> <completion_date type="Anticipated">September 1, 2032</completion_date> <primary_completion_date type="Anticipated">September 1, 2027</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>Identification of the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases.</measure> <time_frame>yearly and up to 10 years after inclusion in the study</time_frame> <description>To identify the molecular mechanisms underlying kidney, immune and solid organ transplantation-related diseases. An unbiased multi-omic approach (including peptidomics, metabolomics, genome sequencing, and flow cytometry and transcriptomic of circulating immune cells) will be performed at the inclusion in the study and correlated to specific end-points (acute kidney injury, kidney failure progression, end-stage kidney disease, infection, cancer according to the underlying condition). Multiple measurements will be studied individually to identify genes variations, gene expression changes, urinary or plasma peptides abundance, immune cells relative abundance in the blood that correlate with the end-point. In a second step, an attempt to combine them in a single predictive signature using artificial intelligence approach.</description> </primary_outcome> <secondary_outcome> <measure>Identification of the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases</measure> <time_frame>up to 10 years after inclusion in the study</time_frame> <description>To identify the predictive factors (immunological, metabolic, genetic…) for the development or progression of renal diseases: end-points will be end-stage kidney disease, or a decrease of the estimated glomerular filtration rate (eGFR) > 50%</description> </secondary_outcome> <secondary_outcome> <measure>Identification of the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases</measure> <time_frame>up to 10 years after inclusion in the study</time_frame> <description>To identify the molecular mechanisms (immunological, genetic…) driving complications of kidney, immune and SOT-related diseases: end-points will the development of bacterial, viral (CytoMégaloVirus, Herpes simplex virus, varicella-zoster virus, BK virus…) or fungal (candidiasis, aspergillosis…) infections, as well as cardiovascular events or other complications</description> </secondary_outcome> <secondary_outcome> <measure>To specify the individual risk of complications secondary to SOT or its treatment</measure> <time_frame>up to 10 years after inclusion in the study</time_frame> <description>To specify the individual risk of renal and immunological complications secondary to cancer or hematological malignancies, or their treatments: end points will be the development of acute kidney injury, end-stage kidney disease or >50% reduction of the eGFR</description> </secondary_outcome> <enrollment type="Anticipated">5000</enrollment> <condition>Acute Kidney Injury</condition> <condition>Chronic Kidney Diseases</condition> <condition>Solid-organ Transplantation</condition> <condition>Cancer</condition> <condition>Metabolic Disease</condition> <condition>Immune Diseases</condition> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Biological samples collection</intervention_name> <description>SOT patients: samples will be collected at the time of the protocol follow-up visit (registration on the transplant list, on the day of the transplantation, and then at day 15, month 1-3-6-9-12 and then annually, as well as if complications or therapeutic modifications). Dialysis patients: at the start of the dialysis and then at M3, M12, and if complications or modification of the dialysis protocol. Non-dialysis or cancer patients: the sampling frequency will be individualized according to the pathology studied (acute or chronic) and the purpose of the sampling (diagnostic, mechanistic, prediction, evaluation of the therapeutic response). Samples for diagnostic and mechanistic purposes will be taken only once. Samples for prognostic purposes will be taken at regular intervals, adapted to the natural history of the disease while respecting the maximum volume of blood samples defined by the French law. Samples will be collected during a sampling performed as part of routine care.</description> </intervention> <eligibility> <study_pop> <textblock> Patients who develop or have progression of kidney, immune or transplantation-related diseases, as well as specific complications of these conditions </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patients (> 18 year of age) with kidney disease or at risk to develop a kidney disease,  - Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France)  Exclusion Criteria:  - consent deny  - inability of the patient or its family to give consent. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>99 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Stanislas Faguer, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>University Hospital, Toulouse</affiliation> </overall_official> <overall_contact> <last_name>Stanislas Faguer, MD, PhD</last_name> <phone>561322475</phone> <phone_ext>0033</phone_ext> <email>faguer.s@chu-toulouse.fr</email> </overall_contact> <location> <facility> <name>Rangueil University Hospital</name> <address> <city>Toulouse</city> <zip>31059</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Stanislas Faguer, MD, PhD</last_name> <phone>561322475</phone> <phone_ext>0033</phone_ext> <email>faguer.s@chu-toulouse.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>December 6, 2022</last_update_submitted> <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>risk stratification</keyword> <keyword>solid-organ transplantation</keyword> <keyword>cancer</keyword> <keyword>Chronic kidney disease</keyword> <keyword>Acute kidney injury</keyword> <condition_browse>  <mesh_term>Kidney Diseases</mesh_term> <mesh_term>Renal Insufficiency, Chronic</mesh_term> <mesh_term>Acute Kidney Injury</mesh_term> <mesh_term>Metabolic Diseases</mesh_term> <mesh_term>Immune System Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases. Acute renal failure (ARF) and chronic kidney disease (CKD) are frequent pathologies (850 million people are affected worldwide). Renal failure is associated with an increased morbidity and mortality, including an increased risk of infections, drug toxicity and cardiovascular death. The causes of renal failure are numerous: metabolic (diabetes, hypertension), immunological (autoimmune diseases, monoclonal gammopathies), toxic (environment, drugs), genetic, infectious, ischemic, paraneoplastic... Any episode of ARF is also accompanied by a risk of secondary CKD (relative risk multiplied by 9). The mechanisms leading to renal failure are multiple and combine predisposing genetic factors, inadequate intra-renal or systemic immune response, endothelial and epithelial dysfunctions, and potentially inappropriate regenerative capacity. In addition, renal failure or its treatment itself may be accompanied by additional renal lesions (e.g. nephrotoxicity of calcineurin inhibitors used as anti-rejection treatment in transplantation, hemodynamic intolerance with secondary ARF during hemodialysis sessions, iatrogenic ARF when using diuretics or inhibitors of the renin angiotensin system) or extra-renal complications (e.g. immunosuppression and infections induced by immunomodulatory therapies during autoimmune diseases or for prevention of transplant rejection; vascular diseases secondary to phosphocalcic disorders). Patients included in the NEPHROGENE 2.0 cohort will be followed during 10 years and clinical data and biological samples will be collected at the inclusion in the cohort, at each monitoring programmed in their usual care and and at each event (infection, acute kidney injury, cancer…). Samples will be collected according to the symptoms of the patients. Patients who develop or have progression of kidney, immune or transplantation-related diseases, as well as specific complications of these conditions Inclusion Criteria: - Patients (> 18 year of age) with kidney disease or at risk to develop a kidney disease, - Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France) Exclusion Criteria: - consent deny - inability of the patient or its family to give consent.

NCT0531xxxx/NCT05318209.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/NCT05318209</url> </required_header> <id_info> <org_study_id>P.T.REC/012/003377</org_study_id> <nct_id>NCT05318209</nct_id> </id_info> <brief_title>Effect of Closed-chain Shoulder Girdle Scapular Depression Exercise on Shoulder Impingement Syndrome</brief_title> <official_title>Comparison Between Closed-chain Shoulder Girdle Scapular Depression Exercise and Shoulder Girdle Depression Against Manual Resistance on Patients With Shoulder Impingement Syndrome</official_title> <sponsors> <lead_sponsor> <agency>Nasr Awad Abdelkader Othman</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Atef Abdulalim Nadier, Pharos University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Ehab Ai Abdalah,Lecurer, Horus University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Cairo 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> forty patients will be assigned randomly into 2 equal groups Study group (n=23) will receive "closed-chain shoulder girdle scapular depression exercise" in addition to Stretching for posterior capsule & pectoralis minor, Eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound Control group B (n=23) will receive "shoulder girdle depression against manual resistance exercise" in addition to stretching for posterior capsule & pectoralis minor, eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound .  The exercise program will consist of 3 sessions / week for 5 weeks </textblock> </brief_summary> <detailed_description> <textblock> BACKGROUND:  Patients with shoulder impingment syndrome report disability, especially during overhead movements, which may hinder activities of daily living .  Muscular strengthening training influences the resting position and scapular movement pattern of subjects with shoulder impingement syndrome and improve function of the affected shoulder.  Therefore, the focus of treatment for the syndrome is on performing exercises, including stretching, strengthening, and neuromuscular control exercises.  Although multiple types of exercise, such as scapular stability exercises, strengthening of the rotator cuff through range, and flexibility exercises for the anterior and posterior shoulder exercise is effective in the management of patients with shoulder impingement syndrome, there is not enough evidence to say whether one mode of exercise is superior to another.  RESEARCH QUESTION:  Are there any difference between closed-chain shoulder girdle scapular depression exercise and shoulder girdle depression against manual resistance exercise on patients with shoulder impingement syndrome  METHODS:  forty patients will be assigned randomly into 2 equal groups Study group (n=23) will receive "closed-chain shoulder girdle scapular depression exercise" in addition to Stretching for posterior capsule & pectoralis minor, Eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound Control group B (n=23) will receive "shoulder girdle depression against manual resistance exercise" in addition to stretching for posterior capsule & pectoralis minor, eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound .  The exercise program will consist of 3 sessions / week for 5 weeks </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Anticipated">December 1, 2022</start_date> <completion_date type="Anticipated">August 1, 2023</completion_date> <primary_completion_date type="Anticipated">March 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> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Pain will be measured by visual analogue scale</measure> <time_frame>10 minutes</time_frame> <description>10cm visual analogue scale (0= no pain, and 10= maximum pain) will be used to determine overall shoulder pain</description> </primary_outcome> <secondary_outcome> <measure>Range of motion (flexion and abduction) will be measured by Electronic goniometer</measure> <time_frame>20 minutes</time_frame> <description>Electronic Goniometer will be used to measure shoulder range of motion (Flexion and abduction)</description> </secondary_outcome> <secondary_outcome> <measure>Function</measure> <time_frame>30 minutes</time_frame> <description>shoulder function will be measured by western Ontario Rotator Cuff Questionnaire (WORC).</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">46</enrollment> <condition>Shoulder Impingement Syndrome</condition> <arm_group> <arm_group_label>Study grou[p</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Closed-chain shoulder girdle scapular depression exercise</description> </arm_group> <arm_group> <arm_group_label>control group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Shoulder girdle depression against manual resistance exercise</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Exercise</intervention_name> <description>Closed-chain Shoulder Girdle Scapular Depression Exercise</description> <arm_group_label>Study grou[p</arm_group_label> <arm_group_label>control group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients aged from 25 to 45 years old.  - Patients with shoulder impingement stage I &II as judged by criteria of neer classification.  - Patients diagnosed by orthopedic surgeon with shoulder impingement, the diagnosis will be confirmed by positive Neer and Hawkins tests.  Exclusion Criteria:  - History of cardiac diseases or dyspnea on exertion  - Patients with cervical radiculopathy.  - Patients with shoulder instability.  - Patients with frozen shoulder.  - Acute shoulder trauma. </textblock> </criteria> <gender>All</gender> <minimum_age>25 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Nasr A. Abdelkader, PhD</last_name> <phone>00201025771117</phone> <email>dr.nasrawad@cu.edu.eg</email> </overall_contact> <location> <facility> <name>Kafr Elshiekh Hospital</name> <address> <city>Kafr Ash Shaykh</city> <country>Egypt</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Atef A. Nadier, PhD</last_name> <phone>00201003867064</phone> <email>atef.neder@pua.edu.eg</email> </contact> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 20, 2022</last_update_submitted> <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 21, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Nasr Awad Abdelkader Othman</investigator_full_name> <investigator_title>Assistant Professor,Department of Physical Therapy for Musculoskeletal Disorders</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Shoulder Impingement Syndrome</mesh_term> <mesh_term>Syndrome</mesh_term> <mesh_term>Rotator Cuff Injuries</mesh_term> <mesh_term>Depression</mesh_term> </condition_browse>  </clinical_study>

forty patients will be assigned randomly into 2 equal groups Study group (n=23) will receive "closed-chain shoulder girdle scapular depression exercise" in addition to Stretching for posterior capsule & pectoralis minor, Eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound Control group B (n=23) will receive "shoulder girdle depression against manual resistance exercise" in addition to stretching for posterior capsule & pectoralis minor, eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound . The exercise program will consist of 3 sessions / week for 5 weeks BACKGROUND: Patients with shoulder impingment syndrome report disability, especially during overhead movements, which may hinder activities of daily living . Muscular strengthening training influences the resting position and scapular movement pattern of subjects with shoulder impingement syndrome and improve function of the affected shoulder. Therefore, the focus of treatment for the syndrome is on performing exercises, including stretching, strengthening, and neuromuscular control exercises. Although multiple types of exercise, such as scapular stability exercises, strengthening of the rotator cuff through range, and flexibility exercises for the anterior and posterior shoulder exercise is effective in the management of patients with shoulder impingement syndrome, there is not enough evidence to say whether one mode of exercise is superior to another. RESEARCH QUESTION: Are there any difference between closed-chain shoulder girdle scapular depression exercise and shoulder girdle depression against manual resistance exercise on patients with shoulder impingement syndrome METHODS: forty patients will be assigned randomly into 2 equal groups Study group (n=23) will receive "closed-chain shoulder girdle scapular depression exercise" in addition to Stretching for posterior capsule & pectoralis minor, Eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound Control group B (n=23) will receive "shoulder girdle depression against manual resistance exercise" in addition to stretching for posterior capsule & pectoralis minor, eccentric exercise for external rotators and Strength exercises for serrates anterior and low intensity ultrasound . The exercise program will consist of 3 sessions / week for 5 weeks Inclusion Criteria: - Patients aged from 25 to 45 years old. - Patients with shoulder impingement stage I &II as judged by criteria of neer classification. - Patients diagnosed by orthopedic surgeon with shoulder impingement, the diagnosis will be confirmed by positive Neer and Hawkins tests. Exclusion Criteria: - History of cardiac diseases or dyspnea on exertion - Patients with cervical radiculopathy. - Patients with shoulder instability. - Patients with frozen shoulder. - Acute shoulder trauma.

NCT0531xxxx/NCT05318222.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/NCT05318222</url> </required_header> <id_info> <org_study_id>H-50430</org_study_id> <nct_id>NCT05318222</nct_id> </id_info> <brief_title>Genetic Inclusion by Virtual Evaluation</brief_title> <acronym>GIVE</acronym> <official_title>Virtual Platforms for Genetics Evaluation in the Medically Underserved</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 transform the current clinical practice paradigm by leveraging an internally designed web-based model of delivery of care called Consultagene to provide remote evaluation and genomic sequencing for improving genetic health of less resourced children with rare disorders living along the Texas-Mexico border. </textblock> </brief_summary> <detailed_description> <textblock> Inadequate access to genetics evaluation and genomic testing in the Hispanic minorities living along the Texas-Mexico has marginalized the most vulnerable pediatric group. In this study, we will (1) implement a virtual web-based service, called Consultagene for simplifying patient pathways and deliver virtual genetics evaluation in Rio Grande Valley (RGV) (2) provide rapid genetic diagnoses through whole genome sequencing and interpretation of diagnostic studies for medical decision-making and improving health outcomes for the minorities, and (3) build genomic competency of front-line healthcare providers through education and machine learning to expedite referral of pediatric patients with suspected rare diseases for shortening diagnostic odyssey. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">January 31, 2024</completion_date> <primary_completion_date type="Anticipated">January 31, 2024</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>Diagnostic</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Time to diagnosis</measure> <time_frame>12 months</time_frame> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Birth Defects</condition> <condition>Multiple Congenital Anomaly</condition> <condition>Neurodevelopmental Disorders</condition> <arm_group> <arm_group_label>WGS arm</arm_group_label> <arm_group_type>Other</arm_group_type> <description>All 100 patients recruited will undergo WGS</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Whole genome sequencing (WGS)</intervention_name> <description>WGS will identify copy number variations (CNVs), single nucleotide variants (SNVs), as well as triplet repeat disorders in children with rare diseases</description> <arm_group_label>WGS arm</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley in Texas  Exclusion Criteria:  Children with known genetic diseases </textblock> </criteria> <gender>All</gender> <minimum_age>1 Day</minimum_age> <maximum_age>18 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Seema Lalani</last_name> <role>Principal Investigator</role> <affiliation>Baylor College of Medicine</affiliation> </overall_official> <overall_contact> <last_name>Seema Lalani, MD</last_name> <phone>832-822-4280</phone> <email>seemal@bcm.edu</email> </overall_contact> <overall_contact_backup> <last_name>Brendan Lee, MD; PhD</last_name> <phone>832-822-4280</phone> <email>blee@bcm.edu</email> </overall_contact_backup> <location> <facility> <name>University of Texas Rio Grande Valley</name> <address> <city>Edinburg</city> <state>Texas</state> <zip>78539</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kent Carter, MD</last_name> <email>kent.carter@utrgv.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 31, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 17, 2023</last_update_submitted> <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 20, 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>Seema Lalani</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Congenital Abnormalities</mesh_term> <mesh_term>Abnormalities, Multiple</mesh_term> <mesh_term>Neurodevelopmental Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study aims to transform the current clinical practice paradigm by leveraging an internally designed web-based model of delivery of care called Consultagene to provide remote evaluation and genomic sequencing for improving genetic health of less resourced children with rare disorders living along the Texas-Mexico border. Inadequate access to genetics evaluation and genomic testing in the Hispanic minorities living along the Texas-Mexico has marginalized the most vulnerable pediatric group. In this study, we will (1) implement a virtual web-based service, called Consultagene for simplifying patient pathways and deliver virtual genetics evaluation in Rio Grande Valley (RGV) (2) provide rapid genetic diagnoses through whole genome sequencing and interpretation of diagnostic studies for medical decision-making and improving health outcomes for the minorities, and (3) build genomic competency of front-line healthcare providers through education and machine learning to expedite referral of pediatric patients with suspected rare diseases for shortening diagnostic odyssey. Inclusion Criteria: Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley in Texas Exclusion Criteria: Children with known genetic diseases

NCT0531xxxx/NCT05318235.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/NCT05318235</url> </required_header> <id_info> <org_study_id>NL78424.041.21</org_study_id> <nct_id>NCT05318235</nct_id> </id_info> <brief_title>Virus Interactions in the Respiratory Tract; a Cohort Study With Children</brief_title> <acronym>VIOOL</acronym> <official_title>Virus Interactions in the Respiratory Tract; a Cohort Study With Children</official_title> <sponsors> <lead_sponsor> <agency>UMC Utrecht</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>UMC Utrecht</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> Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children.  Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children.  Study design: This is a prospective observational cohort study.  Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands.  Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis.  Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">September 15, 2021</start_date> <completion_date type="Anticipated">April 2024</completion_date> <primary_completion_date type="Anticipated">April 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>Strength of viral interactions</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> <description>To quantify the strength of interactions between common respiratory virus infections in young children.</description> </primary_outcome> <primary_outcome> <measure>Direction of viral interactions</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> <description>To quantify the direction of interactions between common respiratory virus</description> </primary_outcome> <secondary_outcome> <measure>To quantify relative change in disease severity due to viral interactions.</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> <description>This will be measured as changes in disease severity scores of one virus infection upon recent exposure to another virus infection</description> </secondary_outcome> <secondary_outcome> <measure>To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </secondary_outcome> <secondary_outcome> <measure>To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this.</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </secondary_outcome> <secondary_outcome> <measure>To quantify the changes in viral exposure in the pandemic-to-post-pandemic transition period and study effects of these changes on viral interaction patterns</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </secondary_outcome> <other_outcome> <measure>To explore local inflammatory responses that could mediate observed virus interaction patterns and effects on disease severity</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </other_outcome> <other_outcome> <measure>To explore the nasal microbiological community in young children</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </other_outcome> <other_outcome> <measure>To examine immunity against respiratory viruses in saliva</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </other_outcome> <other_outcome> <measure>To explore viral-bacterial interactions in young children</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </other_outcome> <other_outcome> <measure>To study the effect of pandemic exposure on respiratory infections and local inflammatory responses</measure> <time_frame>Samples and data collected during 16 weeks of follow-up</time_frame> </other_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">225</enrollment> <condition>Respiratory Tract Infections</condition> <condition>Coinfection</condition> <arm_group> <arm_group_label>Children</arm_group_label> <description>Children between 6 weeks and 4 years of age who have a older sibling or attend day care</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>No intervention</intervention_name> <description>No intervention</description> <arm_group_label>Children</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Community sample of children living within the region of Utrecht. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Age between 6 weeks and 4 years AND  - 1) have older siblings or 2) attend daycare. AND  - Live within 30 minutes drive from UMCU (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored  Exclusion Criteria:  - recurrent respiratory tract infections and are treated with antibiotic prophylaxis OR  - known immunodeficiency OR  - chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) OR  - congenital anomalies of the airways  - Parents/guardians have insufficient comprehension of Dutch language (all study communication and questionnaires are in Dutch language) </textblock> </criteria> <gender>All</gender> <minimum_age>6 Weeks</minimum_age> <maximum_age>4 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Patricia Bruijning, MD PhD</last_name> <role>Principal Investigator</role> <affiliation>UMC Utrecht</affiliation> </overall_official> <location> <facility> <name>UMC Utrecht</name> <address> <city>Utrecht</city> <zip>3584 CX</zip> <country>Netherlands</country> </address> </facility> </location> <location_countries> <country>Netherlands</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 17, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</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 25, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>UMC Utrecht</investigator_affiliation> <investigator_full_name>Patricia Bruijning-Verhagen</investigator_full_name> <investigator_title>Principal investigator</investigator_title> </responsible_party> <keyword>Child</keyword> <keyword>Viral interference</keyword> <condition_browse>  <mesh_term>Respiratory Tract Infections</mesh_term> <mesh_term>Coinfection</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children. Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children. Study design: This is a prospective observational cohort study. Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands. Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis. Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling. Community sample of children living within the region of Utrecht. Inclusion Criteria: - Age between 6 weeks and 4 years AND - 1) have older siblings or 2) attend daycare. AND - Live within 30 minutes drive from UMCU (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored Exclusion Criteria: - recurrent respiratory tract infections and are treated with antibiotic prophylaxis OR - known immunodeficiency OR - chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) OR - congenital anomalies of the airways - Parents/guardians have insufficient comprehension of Dutch language (all study communication and questionnaires are in Dutch language)

NCT0531xxxx/NCT05318248.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/NCT05318248</url> </required_header> <id_info> <org_study_id>WI 3396-11</org_study_id> <nct_id>NCT05318248</nct_id> </id_info> <brief_title>The Role of Stress Neuromodulators in Decision Making Under Risk (Part II)</brief_title> <acronym>SID2</acronym> <official_title>The Role of Stress Neuromodulators in Decision Making Under Risk</official_title> <sponsors> <lead_sponsor> <agency>Charite University, Berlin, Germany</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Charite University, Berlin, Germany</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 aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory. </textblock> </brief_summary> <detailed_description> <textblock> Affective states like acute stress can influence cognition, i.e., memory processes. Physiologically, acute stress elicits an array of autonomic and endocrine responses, including a fast release of norepinephrine from the locus coeruleus noradrenergic (LC NA) system. Compelling evidence shows that in healthy humans, stimulation of the noradrenergic system increases memory performance whereas noradrenergic blockade reduces memory performance. Functional magnetic resonance imaging (fMRI) studies have shown that manipulations of the noradrenergic system affects responsiveness and connectivity within networks that are important for autonomic-neuroendocrine control and temporal and spatial attention orientation. So far, no study investigated the neural underpinnings of memory processes after a pharmacologically induced noradrenergic blockade. The aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of distinct memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on two distinct memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory. Participants are randomly assigned to one of two groups: (A) clonidine, or (B) placebo. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 1, 2022</start_date> <completion_date type="Actual">March 31, 2023</completion_date> <primary_completion_date type="Actual">March 31, 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> <primary_purpose>Basic Science</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Working Memory (n-back task)</measure> <time_frame>11 minutes</time_frame> <description>Behavioral outcome of emotional two-back task = number of correct answers / button presses</description> </primary_outcome> <primary_outcome> <measure>Recognition Memory (word list learning)</measure> <time_frame>25 minutes</time_frame> <description>Behavioral outcome of word recognition task = number of correctly recognized words</description> </primary_outcome> <primary_outcome> <measure>Blood-oxygen-level-dependent (BOLD) response</measure> <time_frame>46 minutes</time_frame> <description>fMRI data</description> </primary_outcome> <secondary_outcome> <measure>blood pressure</measure> <time_frame>2.5 hours</time_frame> <description>Treatment check</description> </secondary_outcome> <secondary_outcome> <measure>Heart rate</measure> <time_frame>2.5 hours</time_frame> <description>Treatment check</description> </secondary_outcome> <secondary_outcome> <measure>salivary cortisol</measure> <time_frame>2.5 hours</time_frame> <description>Treatment check</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">82</enrollment> <condition>Stress</condition> <arm_group> <arm_group_label>Clonidin</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>pill 0,15 mg clonidin</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>placebo pill</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Clonidin</intervention_name> <description>0,15mg Clonidin orally versus placebo pill</description> <arm_group_label>Clonidin</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>placebo pill</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - right handed, high-school diploma  Exclusion Criteria:  - former & present DSM-5 axis I disorders, medication, </textblock> </criteria> <gender>Male</gender> <gender_based>Yes</gender_based> <minimum_age>18 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Charite University</name> <address> <city>Berlin</city> <country>Germany</country> </address> </facility> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 31, 2023</last_update_submitted> <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 3, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation> <investigator_full_name>Katja Wingenfeld</investigator_full_name> <investigator_title>Prof. Dr.</investigator_title> </responsible_party> <intervention_browse>  <mesh_term>Clonidine</mesh_term> </intervention_browse>  </clinical_study>

The aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory. Affective states like acute stress can influence cognition, i.e., memory processes. Physiologically, acute stress elicits an array of autonomic and endocrine responses, including a fast release of norepinephrine from the locus coeruleus noradrenergic (LC NA) system. Compelling evidence shows that in healthy humans, stimulation of the noradrenergic system increases memory performance whereas noradrenergic blockade reduces memory performance. Functional magnetic resonance imaging (fMRI) studies have shown that manipulations of the noradrenergic system affects responsiveness and connectivity within networks that are important for autonomic-neuroendocrine control and temporal and spatial attention orientation. So far, no study investigated the neural underpinnings of memory processes after a pharmacologically induced noradrenergic blockade. The aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of distinct memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on two distinct memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory. Participants are randomly assigned to one of two groups: (A) clonidine, or (B) placebo. Inclusion Criteria: - right handed, high-school diploma Exclusion Criteria: - former & present DSM-5 axis I disorders, medication,

NCT0531xxxx/NCT05318261.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/NCT05318261</url> </required_header> <id_info> <org_study_id>2017-A00392-51</org_study_id> <nct_id>NCT05318261</nct_id> </id_info> <brief_title>Incidence and Risk Factors of Weaning-induced Cardiac Dysfunction: Results From a Multicenter, Observational Study</brief_title> <acronym>WIPO</acronym> <official_title>Incidence of Weaning-induced Pulmonary Oedema (The WIPO Study)</official_title> <sponsors> <lead_sponsor> <agency>Bicetre Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Bicetre Hospital</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> During weaning from mechanical ventilation, the shift from positive to negative pressure ventilation may be responsible for a cardiac dysfunction that can lead to the development of pulmonary oedema (weaning-induced pulmonary oedema, WIPO) and to the failure of spontaneous breathing trials. However, the incidence and risk factors for WIPO development are not well defined and have been investigated only by a few studies. </textblock> </brief_summary> <detailed_description> <textblock> During weaning from mechanical ventilation, the shift from positive to negative pressure ventilation may be responsible for a cardiac dysfunction that can lead to the development of pulmonary oedema (weaning-induced pulmonary oedema, WIPO) and to the failure of spontaneous breathing trials. The mechanisms leading to WIPO have been described in many studies. The fact that the intrathoracic pressure becomes negative increases right ventricle preload and afterload, reduces right ventricle compliance and increases left ventricle afterload. Arterial hypertension, which results from adrenergic stress and possibly from hypercapnia, usually worsens this latter mechanism. Myocardial ischemia, resulting from the imbalance between the reduction of oxygen delivery (hypoxemia) and increased oxygen demand (unfavourable loading conditions, increase of inotropic and heart rate) may participate in this phenomenon, even though its incidence seems to be low. The means for detecting WIPO in a patient performing a spontaneous breathing trial (SBT) have been widely investigated. To avoid the insertion of a pulmonary artery catheter, which clinicians nowadays tend to avoid when the patient is ready to be extubated, many alternatives methods have been proposed. The increase of left ventricular filling pressure during an SBT was detected with echocardiography, the increase during the test either of B-type natriuretic peptide levels or of extravascular lung water measured by transpulmonary thermodilution can be used. The investigators have also demonstrated that the detection of haemoconcentration during a weaning test, which is related to the filtration of a significant amount of plasma through the alveolar-capillary barrier, allows the detection of WIPO.  Unresolved questions:  The incidence of WIPO is not well defined. In the studies where it has been reported, it ranged between 44% and 87% of SBT failures. However, these studies included a small number of patients and/or included a specific population of patients that had already failed one or more weaning tests. In a monocentric study, the investigators recently reported that WIPO occurred in 59% of cases of SBT failures.  The risk factors for WIPO development are not well defined and have been investigated only by a few studies. In the above-mentioned one, the investigators have identified the presence of pre-existing cardiopathy, pre-existing chronic respiratory failure and obesity as independent risk factors for developing WIPO. However, these results were obtained only from a monocentric cohort. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">July 1, 2019</start_date> <completion_date type="Actual">June 3, 2022</completion_date> <primary_completion_date type="Actual">February 28, 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>The incidence of WIPO</measure> <time_frame>30-120 mins during the Spontaneous Breathing Trial</time_frame> <description>The diagnosis of WIPO will be done a posteriori by a group of experts. They will establish the diagnosis of WIPO, based on the following elements: Failure or success of SBT Clinical examination at the end of SBT Variation during SBT of arterial blood gas variables, plasmatic protein and blood haemoglobin concentration, extravascular lung water (optional), B-type natriuretic peptide (optional), echocardiographic estimation of left ventricular preload (E and A waves of mitral flow, e' wave of the mitral valve annulus), pulmonary arterial occlusion pressure (optional).</description> </primary_outcome> <secondary_outcome> <measure>Risk factors for developing WIPO</measure> <time_frame>The risk factors for WIPO will be done a posteriori by multivaraite analysis</time_frame> </secondary_outcome> <enrollment type="Actual">500</enrollment> <condition>Weaning Failure</condition> <condition>Weaning-induced Pulmonary Edema</condition> <condition>Spontaneous Breathing Trial</condition> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Spontaneous breathing trial</intervention_name> <description>A spontaneous breathing trial (SBT) is used to identify patients who are likely to fail liberation from mechanical ventilation. The test can be done according to the usual modalities of the participating centre, following the international recommendations, meaning either by disconnecting the endotracheal tube from the ventilator and connecting it to a source of oxygen through the T-tube or by setting pressure support with low positive end-expiratory pressure (PEEP). The choice of the method will not be determined according to the participation in this study but will be done according to the habits of the participating centre.</description> </intervention> <eligibility> <study_pop> <textblock> All the intubated patients who need to do a Spontaneous Breathing Trial </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Age ≥ 18 years.  2. Social coverage from health insurance (in France).  3. Decision of the attending physicians to perform an SBT.  Exclusion Criteria:  1. Presence of tracheostomy (in this case at the end of the test the patient could be connected to the ventilator, even in case of positivity of the weaning test. Thus, it is not possible to test the absence of reintubation at 48 hours, which is one of the criteria defining the success of weaning).  2. Refusal of the patient or, if the case, one of the relatives to participate to the study. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Medical Intensive Care Unit</name> <address> <city>Le Kremlin-Bicêtre</city> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <results_reference> <citation>Dres M, Teboul JL, Monnet X. Weaning the cardiac patient from mechanical ventilation. Curr Opin Crit Care. 2014 Oct;20(5):493-8. doi: 10.1097/MCC.0000000000000131.</citation> <PMID>25159477</PMID> </results_reference> <results_reference> <citation>Teboul JL. Weaning-induced cardiac dysfunction: where are we today? Intensive Care Med. 2014 Aug;40(8):1069-79. doi: 10.1007/s00134-014-3334-4. Epub 2014 May 27.</citation> <PMID>24861350</PMID> </results_reference> <results_reference> <citation>Lemaire F, Teboul JL, Cinotti L, Giotto G, Abrouk F, Steg G, Macquin-Mavier I, Zapol WM. Acute left ventricular dysfunction during unsuccessful weaning from mechanical ventilation. Anesthesiology. 1988 Aug;69(2):171-9. doi: 10.1097/00000542-198808000-00004.</citation> <PMID>3044189</PMID> </results_reference> <results_reference> <citation>Liu J, Shen F, Teboul JL, Anguel N, Beurton A, Bezaz N, Richard C, Monnet X. Cardiac dysfunction induced by weaning from mechanical ventilation: incidence, risk factors, and effects of fluid removal. Crit Care. 2016 Nov 12;20(1):369. doi: 10.1186/s13054-016-1533-9. Erratum In: Crit Care. 2017 Mar 8;21(1):50.</citation> <PMID>27836002</PMID> </results_reference> <results_reference> <citation>Lamia B, Maizel J, Ochagavia A, Chemla D, Osman D, Richard C, Teboul JL. Echocardiographic diagnosis of pulmonary artery occlusion pressure elevation during weaning from mechanical ventilation. Crit Care Med. 2009 May;37(5):1696-701. doi: 10.1097/CCM.0b013e31819f13d0. Erratum In: Crit Care Med. 2009 Jul;37(7):2331.</citation> <PMID>19325473</PMID> </results_reference> <results_reference> <citation>Grasso S, Leone A, De Michele M, Anaclerio R, Cafarelli A, Ancona G, Stripoli T, Bruno F, Pugliese P, Dambrosio M, Dalfino L, Di Serio F, Fiore T. Use of N-terminal pro-brain natriuretic peptide to detect acute cardiac dysfunction during weaning failure in difficult-to-wean patients with chronic obstructive pulmonary disease. Crit Care Med. 2007 Jan;35(1):96-105. doi: 10.1097/01.CCM.0000250391.89780.64.</citation> <PMID>17095948</PMID> </results_reference> <results_reference> <citation>Dres M, Teboul JL, Anguel N, Guerin L, Richard C, Monnet X. Extravascular lung water, B-type natriuretic peptide, and blood volume contraction enable diagnosis of weaning-induced pulmonary edema. Crit Care Med. 2014 Aug;42(8):1882-9. doi: 10.1097/CCM.0000000000000295.</citation> <PMID>24717458</PMID> </results_reference> <results_reference> <citation>Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.</citation> <PMID>12185425</PMID> </results_reference> <results_reference> <citation>Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.</citation> <PMID>17470624</PMID> </results_reference> <results_reference> <citation>Cabello B, Thille AW, Roche-Campo F, Brochard L, Gomez FJ, Mancebo J. Physiological comparison of three spontaneous breathing trials in difficult-to-wean patients. Intensive Care Med. 2010 Jul;36(7):1171-9. doi: 10.1007/s00134-010-1870-0. Epub 2010 Mar 30.</citation> <PMID>20352189</PMID> </results_reference> <results_reference> <citation>Dres M, Teboul JL, Anguel N, Guerin L, Richard C, Monnet X. Passive leg raising performed before a spontaneous breathing trial predicts weaning-induced cardiac dysfunction. Intensive Care Med. 2015 Mar;41(3):487-94. doi: 10.1007/s00134-015-3653-0. Epub 2015 Jan 24.</citation> <PMID>25617264</PMID> </results_reference> <results_reference> <citation>Caille V, Amiel JB, Charron C, Belliard G, Vieillard-Baron A, Vignon P. Echocardiography: a help in the weaning process. Crit Care. 2010;14(3):R120. doi: 10.1186/cc9076. Epub 2010 Jun 22.</citation> <PMID>20569504</PMID> </results_reference> <verification_date>November 2022</verification_date> <study_first_submitted>March 31, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 15, 2022</last_update_submitted> <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 16, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Bicetre Hospital</investigator_affiliation> <investigator_full_name>Xavier Monnet</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Pulmonary Edema</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

During weaning from mechanical ventilation, the shift from positive to negative pressure ventilation may be responsible for a cardiac dysfunction that can lead to the development of pulmonary oedema (weaning-induced pulmonary oedema, WIPO) and to the failure of spontaneous breathing trials. However, the incidence and risk factors for WIPO development are not well defined and have been investigated only by a few studies. During weaning from mechanical ventilation, the shift from positive to negative pressure ventilation may be responsible for a cardiac dysfunction that can lead to the development of pulmonary oedema (weaning-induced pulmonary oedema, WIPO) and to the failure of spontaneous breathing trials. The mechanisms leading to WIPO have been described in many studies. The fact that the intrathoracic pressure becomes negative increases right ventricle preload and afterload, reduces right ventricle compliance and increases left ventricle afterload. Arterial hypertension, which results from adrenergic stress and possibly from hypercapnia, usually worsens this latter mechanism. Myocardial ischemia, resulting from the imbalance between the reduction of oxygen delivery (hypoxemia) and increased oxygen demand (unfavourable loading conditions, increase of inotropic and heart rate) may participate in this phenomenon, even though its incidence seems to be low. The means for detecting WIPO in a patient performing a spontaneous breathing trial (SBT) have been widely investigated. To avoid the insertion of a pulmonary artery catheter, which clinicians nowadays tend to avoid when the patient is ready to be extubated, many alternatives methods have been proposed. The increase of left ventricular filling pressure during an SBT was detected with echocardiography, the increase during the test either of B-type natriuretic peptide levels or of extravascular lung water measured by transpulmonary thermodilution can be used. The investigators have also demonstrated that the detection of haemoconcentration during a weaning test, which is related to the filtration of a significant amount of plasma through the alveolar-capillary barrier, allows the detection of WIPO. Unresolved questions: The incidence of WIPO is not well defined. In the studies where it has been reported, it ranged between 44% and 87% of SBT failures. However, these studies included a small number of patients and/or included a specific population of patients that had already failed one or more weaning tests. In a monocentric study, the investigators recently reported that WIPO occurred in 59% of cases of SBT failures. The risk factors for WIPO development are not well defined and have been investigated only by a few studies. In the above-mentioned one, the investigators have identified the presence of pre-existing cardiopathy, pre-existing chronic respiratory failure and obesity as independent risk factors for developing WIPO. However, these results were obtained only from a monocentric cohort. All the intubated patients who need to do a Spontaneous Breathing Trial Inclusion Criteria: 1. Age ≥ 18 years. 2. Social coverage from health insurance (in France). 3. Decision of the attending physicians to perform an SBT. Exclusion Criteria: 1. Presence of tracheostomy (in this case at the end of the test the patient could be connected to the ventilator, even in case of positivity of the weaning test. Thus, it is not possible to test the absence of reintubation at 48 hours, which is one of the criteria defining the success of weaning). 2. Refusal of the patient or, if the case, one of the relatives to participate to the study.

NCT0531xxxx/NCT05318274.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/NCT05318274</url> </required_header> <id_info> <org_study_id>R-2021-3203-005</org_study_id> <nct_id>NCT05318274</nct_id> </id_info> <brief_title>Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.</brief_title> <official_title>Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.</official_title> <sponsors> <lead_sponsor> <agency>Coordinación de Investigación en Salud, Mexico</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Coordinación de Investigación en Salud, Mexico</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> An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment. </textblock> </brief_summary> <detailed_description> <textblock> PRIMARY OBJECTIVE:  I. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery.  SECONDARY OBJECTIVES:  I. Identify the histological lineage of the tumor.  II. Identify the degree of differentiation of tumor cells.  III. Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry.  IV. Measure the frequency of progression or recurrence.  V. Identify the site of progression or recurrence.  VI. Measure the frequency of toxicity in both groups.  VII. Classify toxicity according to its severity.  VIII. Classify toxicity according to chronological presentation, acute, subacute, or chronic.  IX. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale, Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).  X. Measure quality of life in both groups according to the Eastern Collaborative Oncology Group (ECOG) performance scale.  XI. Measure 5-year survival.  OUTLINE: Patients are randomized to 1 of 2 arms.  ARM I: will receive radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.  ARM II: will receive radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients.  After completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 26, 2021</start_date> <completion_date type="Anticipated">June 30, 2026</completion_date> <primary_completion_date type="Anticipated">March 30, 2026</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Identify the progression timing.</measure> <time_frame>5 years</time_frame> <description>Quantify the time to progression through follow up in both groups</description> </primary_outcome> <primary_outcome> <measure>Identify the recurrence timing.</measure> <time_frame>5 years</time_frame> <description>Quantify the time to recurrence through follow up in both groups</description> </primary_outcome> <secondary_outcome> <measure>Identify the histological lineage of the tumor</measure> <time_frame>14 Months</time_frame> <description>Carcinoma InSitu or Invasive Carcinoma; - Adenocarcinoma - Other</description> </secondary_outcome> <secondary_outcome> <measure>Identify the degree of differentiation of tumor cells</measure> <time_frame>14 months</time_frame> <description>Histologic grade identification using Scarff-Bloom-Richardson (SBR) scale Grade 1: 3-5 points Grade 2: 6-7 points Grade 3: 8-9 points</description> </secondary_outcome> <secondary_outcome> <measure>Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry</measure> <time_frame>14 months</time_frame> <description>Number of participants with presence of Luminal A, B, HER-2NEU enriched or triple negative immunohistochemistry subtype. Luminal A: RE (+), RP >20%, Ki67 <20% y HER 2 NEU (-) Luminal B: RE (+), RP <20%, Ki67 >20% y HER 2 NEU (+/-) HER-2 Enriched: RE (-), RP (-),Ki67 any, HER 2 NEU (+) Triple Negative: RE (-), RP (-), Ki67 any, HER-2 (-)</description> </secondary_outcome> <secondary_outcome> <measure>Measure the frequency of toxicity in both groups.</measure> <time_frame>5 years</time_frame> <description>Quantify the presence of toxicity categorized by CTCAE version 5 system. Grade 1: characterized by the presence of a mild adverse event that does not require treatment Grade 2: considers a moderate adverse event that may require medical treatment on an outpatient basis Grade 3: is a serious adverse event that should receive medical treatment, and even hospital treatment. Grade 4: is an adverse event with risk of death or disability that requires specialized medical management and hospitalization. Grade 5: considers the presence of death associated with an adverse event.</description> </secondary_outcome> <secondary_outcome> <measure>Classify toxicity according to its severity.</measure> <time_frame>5 years</time_frame> <description>Quantify toxicity according to its severity categorized by CTCAE version 5 system. Dry skin: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture - Grade 1 to 3 Eczema: A disorder characterized by skin which becomes itchy, red, inflamed, crusty, thick, scaly, and/or forms blisters. - Grade 1 to 3 Skin hyperpigmentation: A disorder characterized by darkening of the skin due to excessive melanin deposition. - Grade 1 to 2 Dysphagia: A disorder characterized by difficulty in swallowing. - Grade 1 to 4 Cough: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound. - Grade 1 to 3 Pneumonitis: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma. Grade 1 to 5</description> </secondary_outcome> <other_outcome> <measure>Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).</measure> <time_frame>5 Years</time_frame> <description>Quantify quality of life with QLQ-BR23 questionnaire created by the European Organization for Research and Treatment of Cancer Group</description> </other_outcome> <other_outcome> <measure>Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale (ECOG)</measure> <time_frame>5 Years</time_frame> <description>Quantify quality of life with Eastern Cooperative Oncology Group (ECOG) Performance Status Scale</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">72</enrollment> <condition>Ductal Breast Carcinoma in Situ</condition> <condition>Invasive Breast Cancer</condition> <condition>Early-stage Breast Cancer</condition> <condition>Stage 0 Breast Cancer</condition> <condition>Stage I Breast Cancer</condition> <condition>Stage IA Breast Cancer</condition> <condition>Stage IB Breast Cancer</condition> <arm_group> <arm_group_label>ARM I</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast.</description> </arm_group> <arm_group> <arm_group_label>ARM II</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients.</description> </arm_group> <intervention> <intervention_type>Radiation</intervention_type> <intervention_name>Hypofractionated radiotherapy</intervention_name> <description>Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.</description> <arm_group_label>ARM I</arm_group_label> <arm_group_label>ARM II</arm_group_label> <other_name>Adjuvant Radiation Therapy</other_name> <other_name>External Beam Radiotherapy</other_name> <other_name>3D Conformal Radiation Therapy</other_name> <other_name>Intensity Modulated Radiation Therapy</other_name> <other_name>IMRT Fixed Gantry Radiation Therapy</other_name> <other_name>Hypofractionated Whole Breast Irradiation</other_name> <other_name>Quality of Life Questionnaire: EORTC QLQ-BR23</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma.  - Treated with breast-conserving surgery and stage pT1-2 pN0 M0.  - Over 18 years.  - Patients who sign informed consent for research study.  Exclusion Criteria:  - Positive nodes.  - Clinical or pathological stage T3-T4.  - History of previous irradiation.  - Postoperative positive margin. </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Female with ductal carcinoma in situ or early breast cancer.</gender_description> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Fernando H Castillo-Lopez, Phy.</last_name> <role>Principal Investigator</role> <affiliation>Instituto Mexicano del Seguro Social</affiliation> </overall_official> <overall_contact> <last_name>Patricia B Bolado-García, MD.</last_name> <phone>9994695696</phone> <email>investigacion.umae.imss@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Jose L Reyes-Leon, Phy.</last_name> <phone>9992977873</phone> <email>drreyescozumel@gmail.com</email> </overall_contact_backup> <location> <facility> <name>Unidad Medica de Alta Especialidad</name> <address> <city>Mérida</city> <state>Yucatán</state> <zip>97150</zip> <country>Mexico</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Patricia B Bolado-García, MD.</last_name> <phone>9994695696</phone> <email>investigacion.umae.imss@gmail.com</email> </contact> <contact_backup> <last_name>Jose L Reyes-Leon, Phy.</last_name> <phone>9992977873</phone> <email>drreyescozumel@gmail.com</email> </contact_backup> <investigator> <last_name>Fernando H Castillo-Lopez, Phy.</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Jose L Reyes-Leon, Phy.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Emma M Melgoza-Alcorta, Phy.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Patricia B Bolado-Garcia, MD.</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Juan M Pech-Leon, Phy</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Mexico</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>February 23, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 7, 2022</last_update_submitted> <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 9, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Coordinación de Investigación en Salud, Mexico</investigator_affiliation> <investigator_full_name>Patricia Berenice Bolado Garcia</investigator_full_name> <investigator_title>MD.</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Breast Neoplasms</mesh_term> <mesh_term>Carcinoma in Situ</mesh_term> <mesh_term>Carcinoma, Ductal, Breast</mesh_term> <mesh_term>Breast Carcinoma In Situ</mesh_term> <mesh_term>Carcinoma, Intraductal, Noninfiltrating</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment. PRIMARY OBJECTIVE: I. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery. SECONDARY OBJECTIVES: I. Identify the histological lineage of the tumor. II. Identify the degree of differentiation of tumor cells. III. Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry. IV. Measure the frequency of progression or recurrence. V. Identify the site of progression or recurrence. VI. Measure the frequency of toxicity in both groups. VII. Classify toxicity according to its severity. VIII. Classify toxicity according to chronological presentation, acute, subacute, or chronic. IX. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale, Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23). X. Measure quality of life in both groups according to the Eastern Collaborative Oncology Group (ECOG) performance scale. XI. Measure 5-year survival. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: will receive radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast. ARM II: will receive radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients. After completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years Inclusion Criteria: - Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma. - Treated with breast-conserving surgery and stage pT1-2 pN0 M0. - Over 18 years. - Patients who sign informed consent for research study. Exclusion Criteria: - Positive nodes. - Clinical or pathological stage T3-T4. - History of previous irradiation. - Postoperative positive margin.

NCT0531xxxx/NCT05318287.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/NCT05318287</url> </required_header> <id_info> <org_study_id>MH126788</org_study_id> <nct_id>NCT05318287</nct_id> </id_info> <brief_title>Walk With Me for Perinatal Grief</brief_title> <acronym>PeriGrief</acronym> <official_title>Walk With Me (WWM) for Perinatal Grief</official_title> <sponsors> <lead_sponsor> <agency>Oregon Research Behavioral Intervention Strategies, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Oregon Research Behavioral Intervention Strategies, Inc.</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 research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to support the grieving process. </textblock> </brief_summary> <detailed_description> <textblock> The investigators will develop grief processing and healing activities for bereaved parents, via an iterative formative development process with stakeholder input. The investigators will embed the core intervention components in administrative, provider, and client interfaces which will comprise the prototype Walk with Me (WWM) intervention.  The investigators will evaluate its feasibility and initial efficacy of WWM in a within-subjects pre-post design study. The investigators will provide the mobile-based provider component for use by HCPs who work in the partner hospital. HCPs will have access to training videos and bereaved parent content. After training, the HCPs will recruit 52 bereaved parents.  HCPs will obtain consent from bereaved parents who express interest in the study to share their contact information with the research team. Parents who wish to participate will provide consent for their own participation in the study. After consent, parents will complete the baseline survey via the Qualtrics online assessment form and then be provided download access to the WWM prototype. At 4 and 8 weeks, parents will be administered post-treatment surveys. This design will allow the investigators to evaluate baseline to follow-up change in the proposed study outcomes and acceptability of the prototype WWM program.  Baseline and post-treatment surveys will measure bereaved parents traumatic stress, grief intensity, grief, grief management self-efficacy, and care experiences. The post-survey questionnaire will contain measures of usability, as well as any difficulties experienced or problems made worse. Demographics will be collected at the baseline assessment. Project staff will follow-up with parents as needed to encourage survey completion in a timely manner. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 17, 2023</start_date> <completion_date type="Anticipated">August 31, 2023</completion_date> <primary_completion_date type="Anticipated">August 31, 2023</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>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Traumatic stress will be analyzed as change over time</measure> <time_frame>Baseline (immediately following loss), 4 weeks and 8 weeks post loss</time_frame> <description>Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Higher scores indicate greater distress/trauma. Participants will be instructed to relate the IES-R items specifically to the loss of their child. The investigators will examine scores as a continuous variable and presence/absence of diagnosis using a cutoff score of 35 or more.</description> </primary_outcome> <primary_outcome> <measure>Grief intensity will be analyzed as change over time</measure> <time_frame>Baseline (immediately following loss), 4 weeks and 8 weeks post loss</time_frame> <description>The Perinatal Grief Intensity Scale is 14 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale (1 to 4) and is averaged across three scales with a total possible score of 4. Higher overall scores indicating higher intensity of grief.</description> </primary_outcome> <primary_outcome> <measure>Grief</measure> <time_frame>Baseline (immediately following loss)</time_frame> <description>The Perinatal Bereavement Scale is a 15-item scale designed as a measure of grief and yearning for the lost pregnancy and the lost baby. Respondents indicate how often the statement has been true in the past week, using a 4-point Likert-type scale ranging from rarely or none of the time, less than 1 day (scored 1) to most or all of the time, 5 to 7 days (scored 4). Responses are summed to yield a total score (possible range, 15-60)</description> </primary_outcome> <primary_outcome> <measure>Grief management self-efficacy will be analyzed as a change over time</measure> <time_frame>4 weeks and 8 weeks post loss</time_frame> <description>Three items that rate the bereaved parents' confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a four-point scale (1 to 4) with a total available score of 12. Higher scores indicate greater self-efficacy.</description> </primary_outcome> <primary_outcome> <measure>Care experiences will be analyzed as a change over time</measure> <time_frame>Baseline (immediately following loss), 4 weeks and 8 weeks post loss</time_frame> <description>11 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale (1 to 4) to indicate level of agreement with a total available score of 44. Higher scores indicating better experiences.</description> </primary_outcome> <primary_outcome> <measure>Usability</measure> <time_frame>Post-Treatment (8 weeks post loss)</time_frame> <description>The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable.</description> </primary_outcome> <primary_outcome> <measure>Acceptability</measure> <time_frame>Post-Treatment (8 weeks post loss)</time_frame> <description>Developed as part of the current study. Items developed to measure the degree, on a 7-point Likert-type scale, to which parents found the program helpful, acceptable, and suited to their needs. Higher scores will indicate greater acceptability.</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">92</enrollment> <condition>Grief</condition> <condition>Traumatic Stress</condition> <condition>Usability</condition> <arm_group> <arm_group_label>PeriGrief</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Walk with Me</intervention_name> <description>Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving.</description> <arm_group_label>PeriGrief</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusions Criteria  Focus Groups and Usability Testing (Bereaved Parents)  - Experienced a perinatal loss  - Have had at least 6 months pass since experiencing the most recent loss  - Age 15 and older  Efficacy Study (Bereaved Parents)  - Bereaved parent who has experienced a perinatal loss within the last two weeks * Age 15 and older  - Have access to technology to view WWM content  Exclusion Criteria  * Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established. </textblock> </criteria> <gender>All</gender> <minimum_age>15 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Camille C Cioffi, PhD</last_name> <role>Principal Investigator</role> <affiliation>Oregon Research Behavioral Intervention Strategies, Inc.</affiliation> </overall_official> <overall_contact> <last_name>Camille C Cioffi, PhD</last_name> <phone>541-484-2123</phone> <email>camille.cioffi@influentsin.com</email> </overall_contact> <overall_contact_backup> <last_name>David R Smith, PhD</last_name> <phone>541-484-2123</phone> <email>David.Smith@influentsin.com</email> </overall_contact_backup> <location> <facility> <name>Oregon Research Behavioral Intervention Strategies, Inc.</name> <address> <city>Springfield</city> <state>Oregon</state> <zip>97477</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>David R. Smith, PhD</last_name> <phone>541-484-2123</phone> <email>david.smith@or-bis.com</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>February 1, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>May 15, 2023</last_update_submitted> <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 17, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party>  </clinical_study>

This research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to support the grieving process. The investigators will develop grief processing and healing activities for bereaved parents, via an iterative formative development process with stakeholder input. The investigators will embed the core intervention components in administrative, provider, and client interfaces which will comprise the prototype Walk with Me (WWM) intervention. The investigators will evaluate its feasibility and initial efficacy of WWM in a within-subjects pre-post design study. The investigators will provide the mobile-based provider component for use by HCPs who work in the partner hospital. HCPs will have access to training videos and bereaved parent content. After training, the HCPs will recruit 52 bereaved parents. HCPs will obtain consent from bereaved parents who express interest in the study to share their contact information with the research team. Parents who wish to participate will provide consent for their own participation in the study. After consent, parents will complete the baseline survey via the Qualtrics online assessment form and then be provided download access to the WWM prototype. At 4 and 8 weeks, parents will be administered post-treatment surveys. This design will allow the investigators to evaluate baseline to follow-up change in the proposed study outcomes and acceptability of the prototype WWM program. Baseline and post-treatment surveys will measure bereaved parents traumatic stress, grief intensity, grief, grief management self-efficacy, and care experiences. The post-survey questionnaire will contain measures of usability, as well as any difficulties experienced or problems made worse. Demographics will be collected at the baseline assessment. Project staff will follow-up with parents as needed to encourage survey completion in a timely manner. Inclusions Criteria Focus Groups and Usability Testing (Bereaved Parents) - Experienced a perinatal loss - Have had at least 6 months pass since experiencing the most recent loss - Age 15 and older Efficacy Study (Bereaved Parents) - Bereaved parent who has experienced a perinatal loss within the last two weeks * Age 15 and older - Have access to technology to view WWM content Exclusion Criteria * Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established.

NCT0531xxxx/NCT05318300.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/NCT05318300</url> </required_header> <id_info> <org_study_id>UP2018-EFITOP</org_study_id> <nct_id>NCT05318300</nct_id> </id_info> <brief_title>Evaluation of an Adapted Formula on Atopic Dermatitis.</brief_title> <official_title>Assessment of the Effect of Cow's Milk Protein-based Formulas for Infants in the Management of Moderate to Severe aTOPic Dermatitis in Infants Aged Less Than 18 Months</official_title> <sponsors> <lead_sponsor> <agency>United Pharmaceuticals</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>United Pharmaceuticals</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 aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis. </textblock> </brief_summary> <detailed_description> <textblock> The study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. During this period of time, all infant include in the study will be fed with the study formula. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 24, 2022</start_date> <completion_date type="Anticipated">December 2023</completion_date> <primary_completion_date type="Anticipated">October 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> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>EASI (Eczema Area Severity Index) score after 90 days.</measure> <time_frame>90 days</time_frame> <description>evolution of the EASI score between day 0 to day 90. The score range is between 0 (no eczema) and 72 (highest score of eczema)</description> </primary_outcome> <secondary_outcome> <measure>EASI (Eczema Area Severity Index) score after 30 days.</measure> <time_frame>30 days</time_frame> <description>evolution of the EASI score between day 0 to day 30. The score range is between 0 (no eczema) and 72 (highest score of eczema)</description> </secondary_outcome> <secondary_outcome> <measure>EASI (Eczema Area Severity Index) score after 60 days.</measure> <time_frame>60 days</time_frame> <description>evolution of the EASI score between day 0 to day 60. The score range is between 0 (no eczema) and 72 (highest score of eczema)</description> </secondary_outcome> <secondary_outcome> <measure>EASI (Eczema Area Severity Index) score after 180 days.</measure> <time_frame>180 days</time_frame> <description>evolution of the EASI score between day 0 to day 180. The score range is between 0 (no eczema) and 72 (highest score of eczema)</description> </secondary_outcome> <secondary_outcome> <measure>PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution</measure> <time_frame>30 days</time_frame> <description>Area under the curve of PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution</measure> <time_frame>60 days</time_frame> <description>Area under the curve of PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution</measure> <time_frame>90 days</time_frame> <description>Area under the curve of PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution</measure> <time_frame>180 days</time_frame> <description>Area under the curve of PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>Skin dryness</measure> <time_frame>30 days</time_frame> <description>Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>Skin dryness</measure> <time_frame>60 days</time_frame> <description>Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>Skin dryness</measure> <time_frame>90 days</time_frame> <description>Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>Skin dryness</measure> <time_frame>180 days</time_frame> <description>Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD</description> </secondary_outcome> <secondary_outcome> <measure>Itching</measure> <time_frame>30 days</time_frame> <description>Evolution of itching evaluated by the investigator using an analogic visual scale</description> </secondary_outcome> <secondary_outcome> <measure>Itching</measure> <time_frame>60 days</time_frame> <description>Evolution of itching evaluated by the investigator using an analogic visual scale</description> </secondary_outcome> <secondary_outcome> <measure>Itching</measure> <time_frame>90 days</time_frame> <description>Evolution of itching evaluated by the investigator using an analogic visual scale</description> </secondary_outcome> <secondary_outcome> <measure>Itching</measure> <time_frame>180 days</time_frame> <description>Evolution of itching evaluated by the investigator using an analogic visual scale</description> </secondary_outcome> <secondary_outcome> <measure>Quality of sleep (assessed by VAS)</measure> <time_frame>30 days</time_frame> <description>Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)</description> </secondary_outcome> <secondary_outcome> <measure>Quality of sleep (assessed by VAS)</measure> <time_frame>60 days</time_frame> <description>Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)</description> </secondary_outcome> <secondary_outcome> <measure>Quality of sleep (assessed by VAS)</measure> <time_frame>90 days</time_frame> <description>Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)</description> </secondary_outcome> <secondary_outcome> <measure>Quality of sleep (assessed by VAS)</measure> <time_frame>180 days</time_frame> <description>Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles)</description> </secondary_outcome> <secondary_outcome> <measure>Sleep time</measure> <time_frame>30 days</time_frame> <description>Evaluation of the duration of sleep by parents</description> </secondary_outcome> <secondary_outcome> <measure>Sleep time</measure> <time_frame>60 days</time_frame> <description>Evaluation of the duration of sleep by parents</description> </secondary_outcome> <secondary_outcome> <measure>Sleep time</measure> <time_frame>90 days</time_frame> <description>Evaluation of the duration of sleep by parents</description> </secondary_outcome> <secondary_outcome> <measure>Sleep time</measure> <time_frame>180 days</time_frame> <description>Evaluation of the duration of sleep by parents</description> </secondary_outcome> <secondary_outcome> <measure>IDQoL (Infant's Dermatitis Quality of Life)</measure> <time_frame>90 days</time_frame> <description>Evaluation of the infant's quality of life through the IDQoL (Infant's Dermatitis Quality of Life)</description> </secondary_outcome> <secondary_outcome> <measure>Use of topical dermocorticoids</measure> <time_frame>30 days</time_frame> <description>The quantity and class of dermocorticoids used will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Use of topical dermocorticoids</measure> <time_frame>60 days</time_frame> <description>The quantity and class of dermocorticoids used will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Use of topical dermocorticoids</measure> <time_frame>90 days</time_frame> <description>The quantity and class of dermocorticoids used will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Use of topical dermocorticoids</measure> <time_frame>180 days</time_frame> <description>The quantity and class of dermocorticoids used will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Atopic dermatitis flare</measure> <time_frame>30 days</time_frame> <description>The number of flare will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Atopic dermatitis flare</measure> <time_frame>60 days</time_frame> <description>The number of flare will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Atopic dermatitis flare</measure> <time_frame>90 days</time_frame> <description>The number of flare will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Atopic dermatitis flare</measure> <time_frame>180 days</time_frame> <description>The number of flare will be evaluated</description> </secondary_outcome> <secondary_outcome> <measure>Weight</measure> <time_frame>30 days</time_frame> <description>Weight evolution</description> </secondary_outcome> <secondary_outcome> <measure>Weight</measure> <time_frame>60 days</time_frame> <description>Weight evolution</description> </secondary_outcome> <secondary_outcome> <measure>Weight</measure> <time_frame>90 days</time_frame> <description>Weight evolution</description> </secondary_outcome> <secondary_outcome> <measure>Weight</measure> <time_frame>180 days</time_frame> <description>Weight evolution</description> </secondary_outcome> <secondary_outcome> <measure>Length/Height</measure> <time_frame>30 days</time_frame> <description>Length/Height evolution</description> </secondary_outcome> <secondary_outcome> <measure>Length/Height</measure> <time_frame>60 days</time_frame> <description>Length/Height evolution</description> </secondary_outcome> <secondary_outcome> <measure>Length/Height</measure> <time_frame>90 days</time_frame> <description>Length/Height evolution</description> </secondary_outcome> <secondary_outcome> <measure>Length/Height</measure> <time_frame>180 days</time_frame> <description>Length/Height evolution</description> </secondary_outcome> <secondary_outcome> <measure>Regurgitations</measure> <time_frame>Day 30</time_frame> <description>Evolution of the daily number of regurgitations</description> </secondary_outcome> <secondary_outcome> <measure>Regurgitations</measure> <time_frame>Day 60</time_frame> <description>Evolution of the daily number of regurgitations</description> </secondary_outcome> <secondary_outcome> <measure>Regurgitations</measure> <time_frame>Day 90</time_frame> <description>Evolution of the daily number of regurgitations</description> </secondary_outcome> <secondary_outcome> <measure>Regurgitations</measure> <time_frame>Day 180</time_frame> <description>Evolution of the daily number of regurgitations</description> </secondary_outcome> <secondary_outcome> <measure>Stool's frequency</measure> <time_frame>Day 30</time_frame> <description>Evolution of the number of stools per day through a qualitative scale</description> </secondary_outcome> <secondary_outcome> <measure>Stool's frequency</measure> <time_frame>Day 60</time_frame> <description>Evolution of the number of stools per day through a qualitative scale</description> </secondary_outcome> <secondary_outcome> <measure>Stool's frequency</measure> <time_frame>Day 90</time_frame> <description>Evolution of the number of stools per day through a qualitative scale</description> </secondary_outcome> <secondary_outcome> <measure>Stool's frequency</measure> <time_frame>Day 180</time_frame> <description>Evolution of the number of stools per day through a qualitative scale</description> </secondary_outcome> <secondary_outcome> <measure>Stool's consistency</measure> <time_frame>Day 30</time_frame> <description>Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale</description> </secondary_outcome> <secondary_outcome> <measure>Stool's consistency</measure> <time_frame>Day 60</time_frame> <description>Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale</description> </secondary_outcome> <secondary_outcome> <measure>Stool's consistency</measure> <time_frame>Day 90</time_frame> <description>Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale</description> </secondary_outcome> <secondary_outcome> <measure>Stool's consistency</measure> <time_frame>Day 180</time_frame> <description>Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale</description> </secondary_outcome> <secondary_outcome> <measure>Gas, bloating</measure> <time_frame>Day 30</time_frame> <description>Evolution of presence/absence of gas, bloating</description> </secondary_outcome> <secondary_outcome> <measure>Gas, bloating</measure> <time_frame>Day 60</time_frame> <description>Evolution of presence/absence of gas, bloating</description> </secondary_outcome> <secondary_outcome> <measure>Gas, bloating</measure> <time_frame>Day 90</time_frame> <description>Evolution of presence/absence of gas, bloating</description> </secondary_outcome> <secondary_outcome> <measure>Gas, bloating</measure> <time_frame>Day 180</time_frame> <description>Evolution of presence/absence of gas, bloating</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the parents</measure> <time_frame>Day 30</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the parents</measure> <time_frame>Day 60</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the parents</measure> <time_frame>Day 90</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the parents</measure> <time_frame>Day 180</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the investigator</measure> <time_frame>Day 30</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the investigator</measure> <time_frame>Day 60</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the investigator</measure> <time_frame>Day 90</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <secondary_outcome> <measure>Satisfaction of the investigator</measure> <time_frame>Day 180</time_frame> <description>Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">126</enrollment> <condition>Atopic Dermatitis</condition> <arm_group> <arm_group_label>Tested formula LP-2018</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>infant formula containing fibers</description> </arm_group> <arm_group> <arm_group_label>Placebo formula CT-2018</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>infant formula without fibers</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>tested formula with fiber</intervention_name> <description>formula containing fibers</description> <arm_group_label>Tested formula LP-2018</arm_group_label> </intervention> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Control</intervention_name> <description>formula without fiber</description> <arm_group_label>Placebo formula CT-2018</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Aged below 18 month  - Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0  - Whose parents gave their informed consent  Exclusion Criteria:  - systemic corticotherapy  - antihistamine  - use of dermocorticoide and/or antibiotics within 15 days  - symptoms of cutaneous infection  - Past anaphylactic shock  - cow's milk, soya or fish allergy  - Exclusive or predominant breast feediing (more than one feeding/day)  - Consumption of less than 500 ml per day  - Participation to another trial. </textblock> </criteria> <gender>All</gender> <minimum_age>1 Month</minimum_age> <maximum_age>18 Months</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Fabienne Cahn-Sellem</last_name> <role>Principal Investigator</role> <affiliation>Private Practice</affiliation> </overall_official> <overall_official> <last_name>Sebastien Barbarot</last_name> <role>Study Chair</role> <affiliation>Hotel Dieu Hospital, Nantes, France</affiliation> </overall_official> <overall_official> <last_name>Elena Bradatan</last_name> <role>Principal Investigator</role> <affiliation>Private Practice</affiliation> </overall_official> <overall_contact> <last_name>Anne-Sophie GARREAU</last_name> <phone>003315572222</phone> <email>as.garreau@novalac.com</email> </overall_contact> <location> <facility> <name>Center_05</name> <address> <city>Nice</city> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>MD</last_name> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 18, 2022</last_update_submitted> <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 21, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Dermatitis, Atopic</mesh_term> <mesh_term>Dermatitis</mesh_term> <mesh_term>Eczema</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis. The study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. During this period of time, all infant include in the study will be fed with the study formula. Inclusion Criteria: - Aged below 18 month - Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0 - Whose parents gave their informed consent Exclusion Criteria: - systemic corticotherapy - antihistamine - use of dermocorticoide and/or antibiotics within 15 days - symptoms of cutaneous infection - Past anaphylactic shock - cow's milk, soya or fish allergy - Exclusive or predominant breast feediing (more than one feeding/day) - Consumption of less than 500 ml per day - Participation to another trial.

NCT0531xxxx/NCT05318313.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/NCT05318313</url> </required_header> <id_info> <org_study_id>DENT-2022-30141</org_study_id> <nct_id>NCT05318313</nct_id> </id_info> <brief_title>Telerehabilitation for TMD</brief_title> <official_title>Telerehabilitation Effectiveness for Individuals With Temporomandibular Disorders (TMD): A Non-Inferiority Study</official_title> <sponsors> <lead_sponsor> <agency>University of Minnesota</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Minnesota</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> This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via telerehabilitation is as good as standard in-person care for these individuals. Long term outcomes including patient satisfaction, cost-effectiveness analysis, and functional status will describe the feasibility of telerehabilitation as a management intervention for this population. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 15, 2022</start_date> <completion_date type="Anticipated">June 1, 2024</completion_date> <primary_completion_date type="Anticipated">December 1, 2023</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>Specialist diagnosis</measure> <time_frame>Measured directly after the PT evaluation (Day 1)</time_frame> <description>Diagnosis will be determined by putting clinical assessment results into the Brief Diagnostic Criteria for TMD (Brief DC/TMD) algorithm and getting one or more of 7 possible diagnoses: TMJ arthralgia (joint), Masticatory myofascial pain (muscle), TMJ disc displacement with reduction (joint), TMJ disc displacement without reduction (joint), TMJ arthritis (joint), TMD headache (muscle), other (neither). The diagnosis will be measured as one of four options: 1. joint; 2. muscle; 3. both; or 4. neither.</description> </primary_outcome> <primary_outcome> <measure>Diagnostic agreement</measure> <time_frame>Measured directly after the PT evaluation (Day 1)</time_frame> <description>Agreement data for each subject will be collected comparing two specialist diagnoses: dentist and physical therapist. Agreement about the diagnostic category will be recorded as a binary "yes/no" measure.</description> </primary_outcome> <primary_outcome> <measure>The Oral Health Impact Profile for TMD summary score</measure> <time_frame>6 weeks after intervention onset</time_frame> <description>The OHIP-TMD is a condition-specific quality-of-life scale with 22 items and a 0-4 scoring option for each item. A higher score means lower quality-of life. The summary score after 6 weeks will be compared to the baseline summary score, and a score decrease ≥6.9 units will be considered evidence of therapy success. The proportion of therapy success in each group will be used for non-inferiority comparison.</description> </primary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Anticipated">189</enrollment> <condition>Temporomandibular Disorder</condition> <condition>TMJ Disc Displacement With Reduction</condition> <condition>TMJ Disc Displacement Without Reduction</condition> <condition>Masticatory Myofascial Pain</condition> <condition>TMJ Arthralgia</condition> <condition>TMD Headache</condition> <arm_group> <arm_group_label>Telerehabilitation only</arm_group_label> <description>Participants choose to have all of their physical therapy provided virtually throughout the length of the study</description> </arm_group> <arm_group> <arm_group_label>In-person only</arm_group_label> <description>Participants choose to have all of their physical therapy provided in-person throughout the length of the study</description> </arm_group> <arm_group> <arm_group_label>Hybrid 1</arm_group_label> <description>The TR PT evaluation and follow-up visits in the initial 6 weeks will be performed via Zoom software and subsequent follow-up visits will switch to in person after 6 weeks</description> </arm_group> <arm_group> <arm_group_label>Hybrid 2</arm_group_label> <description>The PT evaluation and follow-up visits in the initial 6 weeks will be performed in person and will switch to TR via Zoom software after 6 weeks</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Telerehabilitation</intervention_name> <description>The TR PT evaluation and follow-up visits will be performed via Zoom software</description> <arm_group_label>Hybrid 1</arm_group_label> <arm_group_label>Hybrid 2</arm_group_label> <arm_group_label>Telerehabilitation only</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Individuals diagnosed with at least one subtype of temporomandibular disorders by a TMD specialist at the University of Minnesota TMD, Orofacial Pain and Dental Sleep Medicine Clinic and referred for physical therapy at the same clinic. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - 18-70 years old  - Referred to PT with ≥1 TMD subtype diagnosis  - PI has no previous knowledge of the participant's diagnosis  - Email access  - Possession of any device that can be positioned for hands-free TR visits (TR group only)  - Willingness and ability to comply with all study requirements and PT program  - Able to provide informed consent  Exclusion Criteria:  - Non-English speakers  - Permanent residence outside of the state of Minnesota (TR group only)  - Women in the last trimester of pregnancy  - Referred for post-surgical rehabilitation  - Severe chronic pain as identified by level 4 classification on the GCPS  - Current diagnosis or existence of the following conditions that can limit response to PT and participation in study activities:  1. Neuropathic pain  2. Fibromyalgia and/or generalized widespread pain on both sides of the body in ≥3 areas above and below the waist  3. Rheumatoid arthritis or juvenile idiopathic arthritis  4. Dystonia or other movement disorder  5. Fractures and/or recent jaw or facial trauma  6. Malignancies  7. Current substance abuse </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Emily Kahnert</last_name> <role>Principal Investigator</role> <affiliation>University of Minnesota</affiliation> </overall_official> <overall_contact> <last_name>Tom Keeler</last_name> <phone>218-208-7045</phone> <email>keele075@umn.edu</email> </overall_contact> <location> <facility> <name>University of Minnesota</name> <address> <city>Minneapolis</city> <state>Minnesota</state> <zip>55455</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Tom Keeler</last_name> <phone>218-208-7045</phone> <email>keele075@umn.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 3, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 11, 2023</last_update_submitted> <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Temporomandibular Disorders</keyword> <keyword>TMD</keyword> <keyword>telerehabilitation</keyword> <keyword>telehealth</keyword> <keyword>physical therapy</keyword> <keyword>PT</keyword> <condition_browse>  <mesh_term>Temporomandibular Joint Disorders</mesh_term> <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term> <mesh_term>Arthralgia</mesh_term> <mesh_term>Headache</mesh_term> </condition_browse>  </clinical_study>

This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via telerehabilitation is as good as standard in-person care for these individuals. Long term outcomes including patient satisfaction, cost-effectiveness analysis, and functional status will describe the feasibility of telerehabilitation as a management intervention for this population. Individuals diagnosed with at least one subtype of temporomandibular disorders by a TMD specialist at the University of Minnesota TMD, Orofacial Pain and Dental Sleep Medicine Clinic and referred for physical therapy at the same clinic. Inclusion Criteria: - 18-70 years old - Referred to PT with ≥1 TMD subtype diagnosis - PI has no previous knowledge of the participant's diagnosis - Email access - Possession of any device that can be positioned for hands-free TR visits (TR group only) - Willingness and ability to comply with all study requirements and PT program - Able to provide informed consent Exclusion Criteria: - Non-English speakers - Permanent residence outside of the state of Minnesota (TR group only) - Women in the last trimester of pregnancy - Referred for post-surgical rehabilitation - Severe chronic pain as identified by level 4 classification on the GCPS - Current diagnosis or existence of the following conditions that can limit response to PT and participation in study activities: 1. Neuropathic pain 2. Fibromyalgia and/or generalized widespread pain on both sides of the body in ≥3 areas above and below the waist 3. Rheumatoid arthritis or juvenile idiopathic arthritis 4. Dystonia or other movement disorder 5. Fractures and/or recent jaw or facial trauma 6. Malignancies 7. Current substance abuse

NCT0531xxxx/NCT05318326.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/NCT05318326</url> </required_header> <id_info> <org_study_id>ChengduEastonBiopharma</org_study_id> <nct_id>NCT05318326</nct_id> </id_info> <brief_title>A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Clinical Efficacy and Safety of Yogliptin Tablets</brief_title> <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Clinical Efficacy and Safety of Yogliptin Tablets in Chinese Patients With Type 2 Diabetes Mellitus and Poor Diet and Exercise Control</official_title> <sponsors> <lead_sponsor> <agency>Chengdu Easton Biopharmaceuticals Co,Ltd</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Chengdu Easton Biopharmaceuticals Co,Ltd</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 purpose of this study is to assess the efficacy of Yogliptin (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of Yogliptin in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise. </textblock> </brief_summary> <detailed_description> <textblock> The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 200 mg or 400 mg dose of Yogliptin and matching placebo, or placebo only. During the open-label period, all participants will receive 400 mg dose of Yogliptin. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 1, 2022</start_date> <completion_date type="Anticipated">December 31, 2024</completion_date> <primary_completion_date type="Anticipated">December 31, 2024</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> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>HbA1c change from baseline at week 24</measure> <time_frame>Baseline and week 24</time_frame> <description>Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24</description> </primary_outcome> <secondary_outcome> <measure>FPG Change From Baseline at Week 24 and Week 52</measure> <time_frame>Baseline, week 24 and week 52</time_frame> </secondary_outcome> <secondary_outcome> <measure>2h-PPG Change From Baseline at Week 24 and Week 44 and Week 52</measure> <time_frame>Baseline, week 24 and Week 44 and Week 52</time_frame> </secondary_outcome> <secondary_outcome> <measure>Percentage of Patients With HbA1c <6.5%</measure> <time_frame>Time Frame: Baseline, week 24 and week 52</time_frame> </secondary_outcome> <secondary_outcome> <measure>Percentage of Patients With HbA1c <7.0%</measure> <time_frame>Baseline, week 24 and week 52</time_frame> </secondary_outcome> <secondary_outcome> <measure>blood pressure Change From Baseline at Week 24 and Week 52</measure> <time_frame>Baseline, week 24 and week 52</time_frame> </secondary_outcome> <secondary_outcome> <measure>Weight Change From Baseline at Week 24 and Week 52</measure> <time_frame>Baseline, week 24 and week 52</time_frame> </secondary_outcome> <secondary_outcome> <measure>Fasting lipids From Baseline at Week 24 and Week 52</measure> <time_frame>Baseline, week 24 and week 52</time_frame> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">450</enrollment> <condition>Type 2 Diabetes</condition> <arm_group> <arm_group_label>Placebo control group</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Placebo control group</description> </arm_group> <arm_group> <arm_group_label>Yogliptin 200mg group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Yogliptin 200mg group</description> </arm_group> <arm_group> <arm_group_label>Yogliptin 400mg group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Yogliptin 400mg group</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>placebo group</intervention_name> <description>placebo 400mg (4 tablet) , Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52.</description> <arm_group_label>Placebo control group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Yogliptin 400mg group</intervention_name> <description>Yogliptin 400mg (4 tablet) , Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52.</description> <arm_group_label>Yogliptin 200mg group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Yogliptin 200mg group</intervention_name> <description>Yogliptin 200mg (2 tablet) and placebo 200 mg (2 tablet), Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52.</description> <arm_group_label>Yogliptin 400mg group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 1.Men or women aged 18 to 75 years old at the day of signing the informed consent;  - 2.Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued byChinese Guidelines for the Prevention and Treatment of Type 2 Diabetesin 2020;  - 3.Receive at least 8 weeks of diet and exercise treatment before screening;Not treated with any antidiabetic drugs within 8 weeks before screening;  - 4.Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 11% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.5% (central laboratory test) Measurement);  5.fasting blood glucose(FPG): Screening period: FPG≤15.0mmol/L (tested by the research center), when randomly enrolled: FPG≤15.0mmol/L (central laboratory test) Measurement);  - 6.Screening period Body mass index(BMI) 19.0kg/m2 to 35.0kg/m2 ;  - 7.Agree to maintain the same diet and exercise habits throughout the trial and be willing and able to accurately use a home blood glucose meter for self-monitoring and recording of blood glucose  - 8.Can understand the procedures and methods of this study, willing to strictly abide by the clinical trial protocol to complete this trial, and voluntarily sign an informed consent.  Exclusion Criteria:  - 1.Non-type 2 diabetes: such as type 1 diabetes, secondary diabetes or other special types of diabetes ；  - 2.History or condition of any of the following at screening or run-in:Those who have a history of diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening;  - 3.History or condition of any of the following at screening or run-in:Unstable condition or severe diabetic complications such as proliferative retinopathy or maculopathy, severe diabetic neuropathy, intermittent claudication, diabetic foot in the past 6 months；  - 4.History or condition of any of the following at screening or run-in:Three or more episodes of grade 3 hypoglycemia in the past 6 months (according to the diagnostic criteria for hypoglycemia in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)) ;  - 5.History or condition of any of the following at screening or run-in:Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of);  - 6.History or condition of any of the following at screening or run-in:Hemorrhagic stroke or ischemic stroke within the past 6 months, and is not suitable for this clinical trial judged by the investigator ;  - 7. History or condition of any of the following at screening or run-in:Previous history of other serious endocrine diseases affecting glucose metabolism, such as multiple endocrine neoplasia, limb hypertrophy syndrome, Cushing's syndrome, etc., which are not suitable for this clinical trial judged by the ;  - 8. History or condition of any of the following at screening or run-in:Patients with previous severe digestive system diseases, nutritional metabolic diseases and rheumatic diseases, who are not suitable to participate in this clinical trial as judged by the investigator；  - 9. any of the following medical history or conditions at screening or run-in: current thyroid dysfunction not controlled with stable drug dose, and clinically significant abnormalities in thyroid function test results at screening  - 10 Any of the following medical history or conditions at screening or run-in: History or presence of malignancy (except for malignancies that have not recurred in the last 5 years)  - 11 History or condition of any of the following at screening or run-in: Presence of significant psychiatric disorder or speech disorder Unwilling or unable to fully understand and collaborate Contacts and Locations  - 12 Any of the following medical history or conditions at screening or run-in: significant infection or major surgery within 6 months prior to screening, which, in the judgment of the investigator, would make the patient inappropriate for this clinical trial ;  - 13 History or conditions of any of the following at screening or run-in: those with a history or clinical evidence of acute or chronic pancreatitis；  - 14 History or condition of any of the following at screening or run-in: poorly controlled blood pressure, ie, systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg ;  - 15 Use of any of the following medications or therapies prior to Screening or Run-in: Dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists prior to Screening or within 3 months prior to Run-in ;  - 16 Use of any of the following drugs or therapies before screening or run-in: Use of other drugs that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc., before screening or within 3 months before run-in;  - 17 Use of any of the following drugs or therapies before screening or run-in: those with cumulative use of insulin and its analogues for more than 28 days in the previous year (except for gestational diabetes treated with insulin and its analogues)  - 18. When screening, any one of the laboratory inspection indicators meets the following standards: ALT/AST> 2.5ULN; Total bilirubin> 2.0ULN; Subjects with current severe renal disease, or eGFR (CKD-EPI2012Scr-CysC) ≤ 60 mL/min/1.73 m2;TG）>5.6mmol/L;Blood amylase>>1.5ULN;HGB<10.0g/dL（100g/L）;  - 19 Any positive HCV antibody, HIV antibody or Treponema pallidum antibody at screening; positive hepatitis B HBsAg, additionally test hepatitis B virus load (HBV-DNA), positive HBsAg and HBV-DNA higher than the lower limit of detection in the local laboratory;  - 20 .The patient may have any contraindications, allergies or hypersensitivity to Test drug (including study drug and placebo) or its excipients, DPP4 drugs  - 21.Patients with a history of joint pain after taking DPP-4 inhibitors ;  - 22.Patients who have received 3 or more times of clinical trial drugs within the past year, or patients who have received 1 time of clinical trial drugs within 1 month before screening ;  - 23 Female subjects who are pregnant, lactating, or planning pregnancy during the study ;  - 24 Male and female subjects of childbearing potential who do not agree to practice contraception during the study. Females of childbearing potential (including those less than 2 years postmenopausal) must agree to practice a reliable method of contraception (e.g., transdermal contraceptive patch, implantable long-acting solution for injection, contraceptive ring, subdermal implant, intrauterine device, or double barrier method (diaphragm+condom) throughout the entire study period) ;  - 25 One or more grade 3 hypoglycemic events without obvious cause during the run-in period ；  - 26 Medication compliance with the lozenge was < 75% or > 125% during the run-in period ；  - 27 The subject has any other factors that the investigator considers inappropriate for the trial 。 </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Lixin Guo</last_name> <role>Study Director</role> <affiliation>Beijing Hospital</affiliation> </overall_official> <overall_contact> <last_name>yunju Yi</last_name> <phone>+8613518115493</phone> <email>yiyunju@eastonpharma.cn</email> </overall_contact> <location> <facility> <name>Beijing Hospital</name> <address> <city>Beijing</city> <state>Beijing</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Lixin Guo</last_name> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 31, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 19, 2022</last_update_submitted> <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 20, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Diabetes Mellitus, Type 2</mesh_term> </condition_browse>  </clinical_study>

The purpose of this study is to assess the efficacy of Yogliptin (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of Yogliptin in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise. The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 200 mg or 400 mg dose of Yogliptin and matching placebo, or placebo only. During the open-label period, all participants will receive 400 mg dose of Yogliptin. Inclusion Criteria: - 1.Men or women aged 18 to 75 years old at the day of signing the informed consent; - 2.Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued byChinese Guidelines for the Prevention and Treatment of Type 2 Diabetesin 2020; - 3.Receive at least 8 weeks of diet and exercise treatment before screening;Not treated with any antidiabetic drugs within 8 weeks before screening; - 4.Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 11% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.5% (central laboratory test) Measurement); 5.fasting blood glucose(FPG): Screening period: FPG≤15.0mmol/L (tested by the research center), when randomly enrolled: FPG≤15.0mmol/L (central laboratory test) Measurement); - 6.Screening period Body mass index(BMI) 19.0kg/m2 to 35.0kg/m2 ; - 7.Agree to maintain the same diet and exercise habits throughout the trial and be willing and able to accurately use a home blood glucose meter for self-monitoring and recording of blood glucose - 8.Can understand the procedures and methods of this study, willing to strictly abide by the clinical trial protocol to complete this trial, and voluntarily sign an informed consent. Exclusion Criteria: - 1.Non-type 2 diabetes: such as type 1 diabetes, secondary diabetes or other special types of diabetes ； - 2.History or condition of any of the following at screening or run-in:Those who have a history of diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening; - 3.History or condition of any of the following at screening or run-in:Unstable condition or severe diabetic complications such as proliferative retinopathy or maculopathy, severe diabetic neuropathy, intermittent claudication, diabetic foot in the past 6 months； - 4.History or condition of any of the following at screening or run-in:Three or more episodes of grade 3 hypoglycemia in the past 6 months (according to the diagnostic criteria for hypoglycemia in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)) ; - 5.History or condition of any of the following at screening or run-in:Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of); - 6.History or condition of any of the following at screening or run-in:Hemorrhagic stroke or ischemic stroke within the past 6 months, and is not suitable for this clinical trial judged by the investigator ; - 7. History or condition of any of the following at screening or run-in:Previous history of other serious endocrine diseases affecting glucose metabolism, such as multiple endocrine neoplasia, limb hypertrophy syndrome, Cushing's syndrome, etc., which are not suitable for this clinical trial judged by the ; - 8. History or condition of any of the following at screening or run-in:Patients with previous severe digestive system diseases, nutritional metabolic diseases and rheumatic diseases, who are not suitable to participate in this clinical trial as judged by the investigator； - 9. any of the following medical history or conditions at screening or run-in: current thyroid dysfunction not controlled with stable drug dose, and clinically significant abnormalities in thyroid function test results at screening - 10 Any of the following medical history or conditions at screening or run-in: History or presence of malignancy (except for malignancies that have not recurred in the last 5 years) - 11 History or condition of any of the following at screening or run-in: Presence of significant psychiatric disorder or speech disorder Unwilling or unable to fully understand and collaborate Contacts and Locations - 12 Any of the following medical history or conditions at screening or run-in: significant infection or major surgery within 6 months prior to screening, which, in the judgment of the investigator, would make the patient inappropriate for this clinical trial ; - 13 History or conditions of any of the following at screening or run-in: those with a history or clinical evidence of acute or chronic pancreatitis； - 14 History or condition of any of the following at screening or run-in: poorly controlled blood pressure, ie, systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg ; - 15 Use of any of the following medications or therapies prior to Screening or Run-in: Dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists prior to Screening or within 3 months prior to Run-in ; - 16 Use of any of the following drugs or therapies before screening or run-in: Use of other drugs that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc., before screening or within 3 months before run-in; - 17 Use of any of the following drugs or therapies before screening or run-in: those with cumulative use of insulin and its analogues for more than 28 days in the previous year (except for gestational diabetes treated with insulin and its analogues) - 18. When screening, any one of the laboratory inspection indicators meets the following standards: ALT/AST> 2.5ULN; Total bilirubin> 2.0ULN; Subjects with current severe renal disease, or eGFR (CKD-EPI2012Scr-CysC) ≤ 60 mL/min/1.73 m2;TG）>5.6mmol/L;Blood amylase>>1.5ULN;HGB<10.0g/dL（100g/L）; - 19 Any positive HCV antibody, HIV antibody or Treponema pallidum antibody at screening; positive hepatitis B HBsAg, additionally test hepatitis B virus load (HBV-DNA), positive HBsAg and HBV-DNA higher than the lower limit of detection in the local laboratory; - 20 .The patient may have any contraindications, allergies or hypersensitivity to Test drug (including study drug and placebo) or its excipients, DPP4 drugs - 21.Patients with a history of joint pain after taking DPP-4 inhibitors ; - 22.Patients who have received 3 or more times of clinical trial drugs within the past year, or patients who have received 1 time of clinical trial drugs within 1 month before screening ; - 23 Female subjects who are pregnant, lactating, or planning pregnancy during the study ; - 24 Male and female subjects of childbearing potential who do not agree to practice contraception during the study. Females of childbearing potential (including those less than 2 years postmenopausal) must agree to practice a reliable method of contraception (e.g., transdermal contraceptive patch, implantable long-acting solution for injection, contraceptive ring, subdermal implant, intrauterine device, or double barrier method (diaphragm+condom) throughout the entire study period) ; - 25 One or more grade 3 hypoglycemic events without obvious cause during the run-in period ； - 26 Medication compliance with the lozenge was < 75% or > 125% during the run-in period ； - 27 The subject has any other factors that the investigator considers inappropriate for the trial 。

NCT0531xxxx/NCT05318339.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/NCT05318339</url> </required_header> <id_info> <org_study_id>NCC3398</org_study_id> <nct_id>NCT05318339</nct_id> </id_info> <brief_title>A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma</brief_title> <official_title>Open-label, Single-arm Phase II Study of Trastuzumab and Pyrotinib Combination Regimen in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma Refractory to Standard Therapies</official_title> <sponsors> <lead_sponsor> <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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> A open-label, single-arm, phase II trial to study was designed to evaluate the effectiveness and safety of trastuzumab and pyrotinib in treating HER2 positive patients who have previously treated, locally advanced, or metastatic urothelial carcinoma. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 10, 2022</start_date> <completion_date type="Anticipated">December 10, 2024</completion_date> <primary_completion_date type="Anticipated">March 10, 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>ORR</measure> <time_frame>1 year</time_frame> <description>Objective response rate as assessed by RECIST criteria</description> </primary_outcome> <secondary_outcome> <measure>OS</measure> <time_frame>From date of initiation of treatment to date of death due to any cause, assessed up to 2 years</time_frame> <description>Overall survival</description> </secondary_outcome> <secondary_outcome> <measure>PFS</measure> <time_frame>From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years</time_frame> <description>Progression free survival</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Carcinoma, Transitional Cell</condition> <condition>HER-2 Gene Amplification</condition> <arm_group> <arm_group_label>Trastuzumab + Pyrotinib</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients receive a loading dose of trastuzumab IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes every three weeks. Meanwhile, patients also receive pyrotinib 400mg PO daily. Treatment may continue till unacceptable toxicity or disease progression occurs.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Trastuzumab</intervention_name> <description>A loading dose of trastuzumab 8mg/kg IV over 90 minutes will be administrated on day 1 of week 1. For all subsequent doses, trastuzumab 6mg/kg IV over 30 minutes will be administrated every three weeks. Pyrotinib 400mg PO daily will be administrated at the same time.</description> <arm_group_label>Trastuzumab + Pyrotinib</arm_group_label> <other_name>Pyrotinib</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Sign the informed consent form  - Locally advanced or metastatic histologically confirmed transitional cell carcinoma of the urothelium, including the bladder, urethra, ureter, or renal pelvis  - 18 years and older  - HER2 expression (3+ or 2+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization  - Relapsed from or failed at least one prior standard systemic chemotherapy regimen, including immunotherapy, HER2 ADC durgs, and chemothearpy containing cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine  - At least 1 measurable lesion could be evaluated by RECIST v1.1  - Performance status: ECOG 0-1  - Life expectancy more than 12 weeks  - Ejection fraction at least 50% (or lower limit of normal) by echocardiogram  - Good organ function:  Blood routine: hemoglobin ≥80g/L, neutrophil ≥1.5×10^9/L, platelet ≥75×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis  Exclusion Criteria:  - Have received trastuzumab or pyrotinib treatment in the past  - Known to have allergic reactions to any ingredients or excipients of experimental drugs  - Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy)  - Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment  - Clinically significant ascites  - Brain metastasis or meningeal metastasis with neurological symptoms  - Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure > 140 / 90 mmHg after antihypertensive drug  - Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months  - Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C  - Pregnant or nursing  - May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results  - There are other serious diseases that the researchers believe patients cannot be included in the study </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name> <address> <city>Beijing</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Aiping Zhou, MD</last_name> <phone>+86 13691161998</phone> <email>zhouap1825@126.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 31, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 31, 2022</last_update_submitted> <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation> <investigator_full_name>Aiping Zhou</investigator_full_name> <investigator_title>Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Carcinoma, Transitional Cell</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Trastuzumab</mesh_term> </intervention_browse>  </clinical_study>

A open-label, single-arm, phase II trial to study was designed to evaluate the effectiveness and safety of trastuzumab and pyrotinib in treating HER2 positive patients who have previously treated, locally advanced, or metastatic urothelial carcinoma. Inclusion Criteria: - Sign the informed consent form - Locally advanced or metastatic histologically confirmed transitional cell carcinoma of the urothelium, including the bladder, urethra, ureter, or renal pelvis - 18 years and older - HER2 expression (3+ or 2+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization - Relapsed from or failed at least one prior standard systemic chemotherapy regimen, including immunotherapy, HER2 ADC durgs, and chemothearpy containing cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine - At least 1 measurable lesion could be evaluated by RECIST v1.1 - Performance status: ECOG 0-1 - Life expectancy more than 12 weeks - Ejection fraction at least 50% (or lower limit of normal) by echocardiogram - Good organ function: Blood routine: hemoglobin ≥80g/L, neutrophil ≥1.5×10^9/L, platelet ≥75×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis Exclusion Criteria: - Have received trastuzumab or pyrotinib treatment in the past - Known to have allergic reactions to any ingredients or excipients of experimental drugs - Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy) - Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment - Clinically significant ascites - Brain metastasis or meningeal metastasis with neurological symptoms - Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure > 140 / 90 mmHg after antihypertensive drug - Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months - Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C - Pregnant or nursing - May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results - There are other serious diseases that the researchers believe patients cannot be included in the study

NCT0531xxxx/NCT05318352.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/NCT05318352</url> </required_header> <id_info> <org_study_id>80-2021</org_study_id> <nct_id>NCT05318352</nct_id> </id_info> <brief_title>tDCS in Improving Quality of Sleep in Athletes</brief_title> <acronym>tDCS</acronym> <official_title>The Effect of Using Transcranial Direct Current Stimulation in Improving Quality of Sleep in Athletes: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>University of Jordan</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Jordan</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> Sleep disturbances in athletes was found prevalent and affect their cognitive and physical abilities and increase the risk of injury. Moreover, studies showed also that a better sleep produces a better athletic performance. Therefore, it is important to find out management strategies that improve quality of sleep in this population.  Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that modulates cortical activity. tDCS has been conducted to improve wide range of neurological impairments including sleep. tDCS was used in improving the quality of sleep in older adults and in athletes. Both studies found improvement in some sleep indices. </textblock> </brief_summary> <detailed_description> <textblock> Research ethics:  1. Institutional Review Board approval was sought out from University of Jordan before the beginning of the study.  2. Informed consent will be obtained from athletes guaranteed their approval to participate in the study.  3. To insure the privacy of participants, every athlete will be assigned a study identification number.  4. All results will be stored in a locked cabinet/computer.  Study design and participants:  This is double -blinded randomized placebo-controlled parallel trial. The study will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological treatment (Boutron et al., 2008). Data will be collected prospectively from athletes from different sports in Jordan.  Sample Size calculation:  The sample size was calculated using G*Power software, according to the study of Acler et al,. 2013. The study found Cohen d=0.7012 effect size of transcranial direct current stimulation on PSQI. Based on 0.7012 effect size, bidirectional alpha of 0.05, and 80% test power, a minimum of 70 participants were needed to the study. The sample will be increased by 20 % to compensate possible dropouts, overall sample of 84 participants will be included in this study.  Procedures:  1. Eligible athletes will be approached via the Jordanian Olympic Committee to participate in this study.  2. A researcher will explain the whole procedures of the research study including the randomization.  3. Athletes will go through baseline assessment.  4. A randomization will be conducted using a computerized program.  5. Participants will be invited to start the intervention sessions.  6. At the end of the treatment, athletes will go through post-treatment assessment.  The demographic data will be collected from eligible participants by a blinded assessor at baseline period. The included participants will be randomly allocated to tDCS groups or control group by a website (www.randomization.com) in a balanced allocation ratio. Outcome measures will be conducted by an assessor blinded to group randomization at baseline, after tDCS interventions, and at 1-month follow up. Allocation will be concealed from the assessor until the end of the study. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">December 31, 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> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Severity of sleep impairment (using Insomnia Severity Index)</measure> <time_frame>Baseline.</time_frame> <description>The total score ranges between 0 and 28 with a higher score indicates more sever insomnia (worse).</description> </primary_outcome> <primary_outcome> <measure>Severity of sleep impairment (using Insomnia Severity Index)</measure> <time_frame>After 4 weeks.</time_frame> <description>The effect of the intervention on insomnia severity. The total score ranges between 0 and 28 with a higher score indicates more sever insomnia (worse).</description> </primary_outcome> <primary_outcome> <measure>Quality of Sleep (using Actigraph activity monitor)</measure> <time_frame>Baseline.</time_frame> <description>The wGT3X-BT is ActiGraph's flagship activity monitor, used to capture and record continuous, high resolution physical activity and sleep/wake information.</description> </primary_outcome> <primary_outcome> <measure>Quality of Sleep (using Actigraph activity monitor)</measure> <time_frame>After 3 weeks.</time_frame> <description>The effect of the intervention on quality of sleep. The wGT3X-BT is ActiGraph's flagship activity monitor, used to capture and record continuous, high resolution physical activity and sleep/wake information.</description> </primary_outcome> <primary_outcome> <measure>Daytime sleepiness (using Epworth Sleepiness Scale)</measure> <time_frame>Baseline.</time_frame> <description>It consists of 8 items where the subject uses a 4-point Likert scale to rate how likely they would be to fall asleep in 8 different scenarios of daily activities. The total score ranges between 0-24 with a higher score indicates worse daytime sleepiness.</description> </primary_outcome> <primary_outcome> <measure>Daytime sleepiness (using Epworth Sleepiness Scale)</measure> <time_frame>After 4 weeks.</time_frame> <description>The effect of the intervention on daytime sleepiness. It consists of 8 items where the subject uses a 4-point Likert scale to rate how likely they would be to fall asleep in 8 different scenarios of daily activities. The total score ranges between 0-24 with a higher score indicates worse daytime sleepiness.</description> </primary_outcome> <primary_outcome> <measure>The Quality of sleep (Using Pittsburgh Sleep Quality Index)</measure> <time_frame>Screening for eligibility.</time_frame> <description>The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse). A cut-off score of >5 indicates poor sleep quality.</description> </primary_outcome> <primary_outcome> <measure>The Quality of sleep (Using Pittsburgh Sleep Quality Index)</measure> <time_frame>After 4 weeks.</time_frame> <description>The effect of the intervention on the Quality of sleep. The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse). A cut-off score of >5 indicates poor sleep quality.</description> </primary_outcome> <primary_outcome> <measure>The Quality of sleep (Using Pittsburgh Sleep Quality Index)</measure> <time_frame>After 2 Months from baseline.</time_frame> <description>The effect of the intervention on the Quality of sleep. The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse). A cut-off score of >5 indicates poor sleep quality.</description> </primary_outcome> <secondary_outcome> <measure>The Quality of Life (using Medical Outcomes Study Short Form 12)</measure> <time_frame>Baseline.</time_frame> <description>The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better).</description> </secondary_outcome> <secondary_outcome> <measure>The Quality of Life (using Medical Outcomes Study Short Form 12)</measure> <time_frame>After 4 weeks.</time_frame> <description>The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better).</description> </secondary_outcome> <secondary_outcome> <measure>The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)</measure> <time_frame>Baseline.</time_frame> <description>The effect of the intervention on anxiety, depression, and stress. The total score ranges from 0 to 63 with higher score indicates more severe anxiety, depression, and stress (worse).</description> </secondary_outcome> <secondary_outcome> <measure>The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)</measure> <time_frame>After 4 weeks.</time_frame> <description>The effect of the intervention on anxiety, depression, and stress. The total score ranges from 0 to 63 with higher score indicates more severe anxiety, depression, and stress (worse).</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">90</enrollment> <condition>Sleep Disorder</condition> <arm_group> <arm_group_label>Transcranial Direct Current Stimulation (tDCS)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Athletes with poor sleep quality will receive tDCS over the right and left prefrontal cortex (F3 and F4 areas) with a constant current of 1.5 mA intensity that lasts for 20 minutes, 3 times a week for 2 weeks in daytime.</description> </arm_group> <arm_group> <arm_group_label>Sham transcranial Direct Current Stimulation (tDCS)</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>Athletes with poor sleep quality will receive sham tDCS over the right and left prefrontal cortex.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Transcranial Direct Current Stimulation</intervention_name> <description>Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that modulates cortical activity. tDCS has been conducted to improve wide range of neurological impairments including sleep.</description> <arm_group_label>Sham transcranial Direct Current Stimulation (tDCS)</arm_group_label> <arm_group_label>Transcranial Direct Current Stimulation (tDCS)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Athletes who are 12 years of age and older.  - Athletes who have a complaint of sleep impairment determined by >5 total score on Pittsburg Sleep Quality Index (PSQI).  Exclusion Criteria:  - Athletes who is using sleep medications or treatment.  - Athletes who have more than 1 concussion in the past year.  - Wearing a pacemaker.  - Pregnant athletes.  - Athletes who have repetitive migraine  - Athletes who are wearing a metal implant.  - Athletes who have epilepsy. </textblock> </criteria> <gender>All</gender> <minimum_age>12 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Alia Alghwiri, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of Jordan</affiliation> </overall_official> <overall_contact> <last_name>Alia Alghwiri, PhD</last_name> <phone>+96265355000</phone> <phone_ext>23200</phone_ext> <email>alia.alghwiri@gmail.com</email> </overall_contact> <location> <facility> <name>University of Jordan</name> <address> <city>Amman</city> <zip>11942</zip> <country>Jordan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Alia A. Alghwiri</last_name> <phone>0798525162</phone> <email>ALIA.ALGHWIRI@GMAIL.COM</email> </contact> </location> <location_countries> <country>Jordan</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 4, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</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>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Jordan</investigator_affiliation> <investigator_full_name>Alia A. Alghwiri</investigator_full_name> <investigator_title>Professor of Physiotherapy</investigator_title> </responsible_party> <keyword>tDCS, Sleep, Athletes</keyword> <condition_browse>  <mesh_term>Sleep Wake Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Sleep disturbances in athletes was found prevalent and affect their cognitive and physical abilities and increase the risk of injury. Moreover, studies showed also that a better sleep produces a better athletic performance. Therefore, it is important to find out management strategies that improve quality of sleep in this population. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that modulates cortical activity. tDCS has been conducted to improve wide range of neurological impairments including sleep. tDCS was used in improving the quality of sleep in older adults and in athletes. Both studies found improvement in some sleep indices. Research ethics: 1. Institutional Review Board approval was sought out from University of Jordan before the beginning of the study. 2. Informed consent will be obtained from athletes guaranteed their approval to participate in the study. 3. To insure the privacy of participants, every athlete will be assigned a study identification number. 4. All results will be stored in a locked cabinet/computer. Study design and participants: This is double -blinded randomized placebo-controlled parallel trial. The study will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological treatment (Boutron et al., 2008). Data will be collected prospectively from athletes from different sports in Jordan. Sample Size calculation: The sample size was calculated using G*Power software, according to the study of Acler et al,. 2013. The study found Cohen d=0.7012 effect size of transcranial direct current stimulation on PSQI. Based on 0.7012 effect size, bidirectional alpha of 0.05, and 80% test power, a minimum of 70 participants were needed to the study. The sample will be increased by 20 % to compensate possible dropouts, overall sample of 84 participants will be included in this study. Procedures: 1. Eligible athletes will be approached via the Jordanian Olympic Committee to participate in this study. 2. A researcher will explain the whole procedures of the research study including the randomization. 3. Athletes will go through baseline assessment. 4. A randomization will be conducted using a computerized program. 5. Participants will be invited to start the intervention sessions. 6. At the end of the treatment, athletes will go through post-treatment assessment. The demographic data will be collected from eligible participants by a blinded assessor at baseline period. The included participants will be randomly allocated to tDCS groups or control group by a website (www.randomization.com) in a balanced allocation ratio. Outcome measures will be conducted by an assessor blinded to group randomization at baseline, after tDCS interventions, and at 1-month follow up. Allocation will be concealed from the assessor until the end of the study. Inclusion Criteria: - Athletes who are 12 years of age and older. - Athletes who have a complaint of sleep impairment determined by >5 total score on Pittsburg Sleep Quality Index (PSQI). Exclusion Criteria: - Athletes who is using sleep medications or treatment. - Athletes who have more than 1 concussion in the past year. - Wearing a pacemaker. - Pregnant athletes. - Athletes who have repetitive migraine - Athletes who are wearing a metal implant. - Athletes who have epilepsy.

NCT0531xxxx/NCT05318365.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/NCT05318365</url> </required_header> <id_info> <org_study_id>BBD_Children</org_study_id> <nct_id>NCT05318365</nct_id> </id_info> <brief_title>Bladder and Bowel Dysfunction in Children</brief_title> <official_title>Bladder and Bowel Dysfunction in Children</official_title> <sponsors> <lead_sponsor> <agency>University of Aarhus</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Aarhus</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> Background:  Bladder and bowel dysfunction (BBD) is characterized by lower urinary tract symptoms accompanied by bowel complaints. BBD is a common condition in childhood. The present treatment strategy for BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. This is, however, based on clinical experience and few retrospective, non-randomized studies and high-level evidence of the succession of the elements in treatment of BBD children is missing.  Our microbiome, and its role in health and disease, has gained increased focus during the past years. Studies suggest the urine and gut microbiome to be critical for maintenance of a well-functioning bladder- and bowel system. The microbiome in children is only sparsely investigated and its role in BBD is to the investigator's knowledge still unexplored.  Study 1:  Aim: To investigate if combination therapy is more effective in treating urinary incontinence in BBD children.  Materials and methods: A prospective randomized multicentre study on children with BBD (n=100) between 5-14 years and 9 months old. They are randomized to: 1) Medical treatment of bowel symptoms (n=50) or 2) Medical treatment of bowel symptoms combined with standard urotherapy.  The effect of treatment will be evaluated after 3 months. Primary endpoint: Resolution of incontinence after treatment. Secondary endpoint: Improved quality of life after successful treatment of urinary incontinence.  Study 2:  Aim: To investigate the urofecal microbiome in children with BBD  Materials and methods:  1. A cohort study to investigate, whether the urofecal microbiome can predict response to treatment and whether it changes during treatment period  2. A case control study to investigate whether the urofecal microbiome is different in children with BBD and recurrent UTI 's and children with BBD without recurrent UTI 's.  The study population consists of children with BBD included in study 1. A urine-, stool sample and a perineum swab will be collected from all participants before and after treatment. Bacterial DNA will be extracted and the microbiome will be determined.  Perspectives:  BBD is a common condition in childhood. It is associated with a considerable psychological burden and a risk of more severe physical complications.  The studies will provide basic knowledge about characteristics of the BBD patients and contribute new information about the optimal treatment of BBD children. </textblock> </brief_summary> <detailed_description> <textblock> Background Bladder and bowel dysfunction (BBD) is characterised by lower urinary tract symptoms (LUTS) accompanied by bowel complaints, primarily functional constipation and/or faecal incontinence. To standardise the terminology used for BBD, LUTS symptoms related to the disease have been defined by International Children's Continence Society (ICCS).  The prevalence of BBD is probably underestimated but studies suggest BBD to be present in up to 20 % of school children and to represent up to 40% of paediatric urology consults.  Embryological, anatomical and functional interactions between the rectum and urinary bladder are well known. Bladder and bowel are anatomically closely related and share innervation from the parasympathetic S2-S4 and sympathetic L1-L3 nerve roots.  Research on successful treatment of BBD is sparse, with only few retrospective, non-randomized studies, documenting that treatment of defecation problems in children with BBD enhances successful management of lower urinary tract disturbances such as daytime urinary incontinence (DUI), enuresis and urinary tract infections (UTI's). Based on this knowledge and clinical experience, the present treatment strategy for children with BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. Standard urotherapy encompasses information and demystification of the disorder along with behavioural modification such as timed voiding, proper voiding posture, avoidance of holding manoeuvers and balanced fluid intake. Standard urotherapy is well-established as first-line treatment for children with LUTS. However, high-level evidence of the succession of the elements in treatment of BBD children is missing.  BBD is commonly associated with vesicoureteral reflux (VUR) and recurrent UTI's, which may lead to renal scarring , kidney failure and hypertension. It is a potential cause of significant physical and psychosocial burden for children and families. Therefore, optimization of treatment is critical to avoid secondary comorbidities.  Our microbiome, and its role in health and disease, has gained increased focus during the past few years.  Studies suggest the urine and gut microbiome to be critical for maintenance of a well-functioning bladder- and bowel system.  Dysbiosis is defined by the presence of unbalanced and disease-promoting composition of the microbiome. It is well-established that dysbiosis is associated with constipation in children and the condition is suspected to be involved in urological disorders such as overactive bladder, urge, incontinence and recurrent UTI's in adults. However, the composition of the urine microbiome in children is only sparsely investigated and its role in BBD and childhood UTI's is to the investigator's knowledge still unexplored.  Study 1: Does successful treatment of bowel symptoms resolve urinary incontinence in children with BBD? Aim and hypothesis Aim: To investigate if effective treatment of bowel problems resolves urinary incontinence in BBD children.  The hypothesis of the investigators is:  1. Treatment of bowel symptoms resolves urinary incontinence in BBD children.  2. It is more effective to initiate urotherapy from the beginning in combination with treatment of bowel symptoms instead of the present regime where bowel symptoms are managed before urotherapy is started.  3. Succesful treatment of urinary incontinence in children with BBD improves their quality of life.  1.2 Materials and methods A prospective multicentre randomised study on children with BBD referred to the Pediatric Incontinence and Gastroenterology outpatient clinics at the Department of Pediatrics, Aarhus University Hospital, Aalborg University Hospital and Regional Hospital Goedstrup.  Children (n=100) between 5-14 years and 9 months diagnosed with BBD at their first visit to the outpatient clinic will be included if they meet in- and exclusion criteria.  The included children will be randomised to one of the following treatments:  1. Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) (n=50)  2. Medical treatment of bowel symptoms in accordance with the ESPGHAN guidelines combined with standard urotherapy (n=50)  At first visit to the outpatient clinic, enrolled children will undergo physical examination including neurological examination. Data on medical history will be collected including number of and time for UTI's. Participants will be asked to fill in a 48-hour flow-volume chart and in case of enuresis nocturna the chart will also include registration for 7 nights. Participants will also fill in "Toerfisk" which is a validated tool to monitor severity of urinary incontinence. Routine uroflowmetry will be performed for further evaluation of lower urinary symptoms. A urine sample will be collected for diagnosing on-going UTI and for microbiome analysis in study 3. The children will be screened for constipation in accordance with the ROME IV criteria. Rectal examination will be performed or transrectal diameter will be evaluated with point-of-care ultrasound. Stool sample and perineum swab will be collected for microbiome analysis.  The psychological burden from the children´s BBD condition will be evaluated by PinQ, a validated questionnaire used for assessment of quality of life according to the incontinence issue of the patients.  All participants will be informed about bladder and bowel function in order to demystify the disorder. Daily defecation will be induced by reconditioning to normal bowel habits through timed toilet sitting and daily administration of laxatives (e.g. PEG3350) in relevant dosage according to the ESPGHAN guidelines.  Participants randomized to combined medical treatment for bowel symptoms and urotherapy will be instructed in urotherapy in accordance with earlier description.  After 1 month of treatment the participants will be contacted by telephone to ensure compliance and for adjustment of laxative dose depending on the bowel symptoms.  The second visit in the outpatient clinic will be after 3 months of treatment. Before the consultation, the participants will be asked to fill in a second flow-volume chart as well as "Toerfisk" and PinQ questionnaires. Uroflowmetry will be repeated and a second urine sample will be collected for stix, culturing and microbiome analysis. Bowel symptoms will be evaluated using ROME IV, rectal examination and transrectal diameter and a second stool sample and perineum swab will be collected for microbiome analysis for study 3.  Data storage Data will be entered into RedCap, which is a secure web platform for building and managing online databases.  Power estimation The sample size (n=100) was calculated for each group to achieve a power of 80% for detecting a difference in proportions of 0.30 between the two groups (test - reference group) at a two sided p-value of 0.05.  Study 2: Urine, perineal and gut microbiome in children with BBD before and after treatment Aim and hypothesis To investigate the urine, perineal and gut microbiome in children with BBD before and after treatment.  The hypothesis of the investigators is that  1. Response to treatment can be predicted by the composition of the urine, perineal and gut microbiome in children with BBD.  2. The composition of the urine, perineal and gut microbiome is different in BBD children with recurrent UTI's compared to BBD children without recurrent UTI's.  3. The urine, perineal and gut microbiome in children with BBD will change when bladder and bowel symptoms successfully treated.  Materials and methods  The study is a multicentre study consisting of two elements:  1. a cohort study to investigate, whether the urine, perineal and gut microbiome can predict response to treatment and whether it changes during treatment period  2. a case control study to investigate whether the urine, perineal and gut microbiome is different in children with BBD and recurrent UTI 's and children with BBD without recurrent UTI 's.  The study population consists of children with BBD included in study 1.  Collection and analysis of samples A urine-, stool sample and a perineum swab will be collected from all participants before initiation of treatment and after 3 months of treatment as described in study 1. Bacterial DNA will be extracted and the microbiome will be determined.  Data storage Biological material will be pseudonymised and stored in a -80 degree fridge until analysis is performed.  Statistical analysis for all 3 studies Distribution and variance will be analysed by QQ plot, Shapiro-Wilks test and Bartletts test. Microbiota alpha-diversity will be addressed by ASV richness, Faith's phylogenetic diversity, Shannon diversity index, and Pielou's evenness index. Beta-diversity analysis will include principal coordinate analysis (PCoA) using Bray-Curtis dissimilarity, weighted and unweighted UniFrac. Parametric data will be compared using Student's t-test or one-way ANOVA and Tukey´s post hoc test, while non-parametric data will be compared with Kruskal-Wallis test or Mann-Whitney U-test. Chi Squared test will be used for proportions. Level of significance will be as following *: p <0.05, **: p<0.01 and ***: p<0.001.  Ethics The studies will be conducted in accordance with the Declaration of Helsinki. All side effects will be handled in accordance with the actual legislation. No risk or unknown side effects are expected to urotherapy or medical treatment of bowel symptoms. No risk, side effects or discomfort is expected from collection of urine, stool and perineum samples or from uroflowmetry or transabdominal ultrasound.  Perspectives BBD is a common condition in childhood. It is associated with a considerable psychological burden and a risk of more severe physical complications.  The term BBD is recently defined and therefore only sparsely investigated. The studies will provide basic knowledge about characteristics of the BBD patients and contribute new information about the optimal treatment of BBD children. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 1, 2022</start_date> <completion_date type="Anticipated">December 1, 2023</completion_date> <primary_completion_date type="Anticipated">December 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> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Number of participants with reduction in weekly episodes of urinary incontinence</measure> <time_frame>Evaluation after 3 months of treatment</time_frame> <description>No-response: <50% reduction, Partial response: 50 to 99% reduction, Complete response: 100% reduction.</description> </primary_outcome> <secondary_outcome> <measure>Number of participants with a change in quality of life after succesful treatment of urinary incontinence</measure> <time_frame>Evaluation after 3 months of treatment</time_frame> <description>Tool: PinQ Questionnaire</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Bladder and Bowel Dysfunction</condition> <arm_group> <arm_group_label>Treatment of constipation and/or faecal incontinence</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition</description> </arm_group> <arm_group> <arm_group_label>Treatment of constipation and/or faecal incontinence combined with urotherapy</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition combined with standard urotherapy in accordance with International Children's Continence Society (ICCS)</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Polyethylene Glycol 3350</intervention_name> <description>PEG3350, klysma, laxoberal and magnesia will be administered in accordance with actual guidelines for treatment of constipation in children</description> <arm_group_label>Treatment of constipation and/or faecal incontinence</arm_group_label> <arm_group_label>Treatment of constipation and/or faecal incontinence combined with urotherapy</arm_group_label> <other_name>Magnesia</other_name> <other_name>Laxoberal</other_name> <other_name>Glyoktylklysma</other_name> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Urotherapy</intervention_name> <description>Information and demystification of the disorder along with behavioural modification such as timed voiding, proper voiding posture, avoidance of holding manoeuvers and balanced fluid intake</description> <arm_group_label>Treatment of constipation and/or faecal incontinence combined with urotherapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age 5-14 years and 9 months at time of inclusion  - Diagnosed with urinary incontinence and/or enuresis nocturna defined by the ICCS criteria  - Diagnosed with constipation and/or faecal incontinence defined by the ROME IV criteria  - Normal clinical examination  - Parents/guardian can understand the written and spoken information  - Informed assent to participation from both parents/guardian  Exclusion Criteria:  - Neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal canal  - Earlier surgical intervention of the urinary tract (except circumcision)  - Neurological illness or earlier cerebral surgical intervention  - On-going urinary tract infection  - On-going treatment with anticholinergics and/or β3-adenoceptoragonist  - On-going treatment with laxatives in correct dosage (PEG3350 1-2 g/kg/day)  - Inflammatory bowel disease  - Other disorder affection bladder or bowel function  - For Study 2 (microbiome): Systemic antibiotics within the past 3 months </textblock> </criteria> <gender>All</gender> <minimum_age>5 Years</minimum_age> <maximum_age>15 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Sofie Axelgaard, MD</last_name> <role>Study Chair</role> <affiliation>Department of Childhood and Adolescent Medicine, Regional Hospital Goedstrup</affiliation> </overall_official> <overall_official> <last_name>Soeren Hagstroem, Professor, MD</last_name> <role>Principal Investigator</role> <affiliation>Department of Childhood and Adolescent Medicine, Aalborg University Hospital</affiliation> </overall_official> <overall_official> <last_name>Luise Borch, MD, PhD</last_name> <role>Study Director</role> <affiliation>Department of Childhood and Adolescent Medicine, Regional Hospital Goedstrup</affiliation> </overall_official> <overall_official> <last_name>Konstantinos Kamperis, MD, PhD</last_name> <role>Study Director</role> <affiliation>Department of Childhood and Adolescent Medicine, Aarhus University Hospital</affiliation> </overall_official> <overall_contact> <last_name>Sofie Axelgaard, MD</last_name> <phone>+45 61460024</phone> <email>sofiaxel@rm.dk</email> </overall_contact> <overall_contact_backup> <last_name>Luise Borch, MD, PhD</last_name> <phone>+45 78433654</phone> <email>luise.borch@rm.dk</email> </overall_contact_backup> <location> <facility> <name>Aalborg University Hospital</name> <address> <city>Aalborg</city> <zip>9000</zip> <country>Denmark</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Søren Hagstrøm, M.D., professor</last_name> <email>soha@rn.dk</email> </contact> </location> <location> <facility> <name>Aarhus University Hospital</name> <address> <city>Aarhus</city> <zip>8000</zip> <country>Denmark</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Konstantinos Kamperis, M.D.</last_name> <email>kostas.kamperis@clin.au.dk</email> </contact> </location> <location> <facility> <name>Goedstrup Regional Hospital</name> <address> <city>Herning</city> <zip>7400</zip> <country>Denmark</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sofie Axelgaard, M.D.</last_name> <phone>+45 61460024</phone> <email>sofiaxel@rm.dk</email> </contact> <contact_backup> <last_name>Luise Borch, M.D.</last_name> <email>luise.borch@rm.dk</email> </contact_backup> </location> <location_countries> <country>Denmark</country> </location_countries> <reference> <citation>Conway PH, Cnaan A, Zaoutis T, Henry BV, Grundmeier RW, Keren R. 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J Wound Ostomy Continence Nurs. 2008 Nov-Dec;35(6):617-21. doi: 10.1097/01.WON.0000341476.71685.78.</citation> <PMID>19018203</PMID> </reference> <reference> <citation>Equit M, Hill J, Hubner A, von Gontard A. Health-related quality of life and treatment effects on children with functional incontinence, and their parents. J Pediatr Urol. 2014 Oct;10(5):922-8. doi: 10.1016/j.jpurol.2014.03.002. Epub 2014 Mar 26.</citation> <PMID>24726201</PMID> </reference> <reference> <citation>Whiteside SA, Razvi H, Dave S, Reid G, Burton JP. The microbiome of the urinary tract--a role beyond infection. Nat Rev Urol. 2015 Feb;12(2):81-90. doi: 10.1038/nrurol.2014.361. Epub 2015 Jan 20.</citation> <PMID>25600098</PMID> </reference> <reference> <citation>Nishida A, Inoue R, Inatomi O, Bamba S, Naito Y, Andoh A. Gut microbiota in the pathogenesis of inflammatory bowel disease. Clin J Gastroenterol. 2018 Feb;11(1):1-10. doi: 10.1007/s12328-017-0813-5. Epub 2017 Dec 29.</citation> <PMID>29285689</PMID> </reference> <reference> <citation>de Moraes JG, Motta ME, Beltrao MF, Salviano TL, da Silva GA. Fecal Microbiota and Diet of Children with Chronic Constipation. Int J Pediatr. 2016;2016:6787269. doi: 10.1155/2016/6787269. Epub 2016 Jun 23.</citation> <PMID>27418934</PMID> </reference> <reference> <citation>Petersen C, Round JL. Defining dysbiosis and its influence on host immunity and disease. Cell Microbiol. 2014 Jul;16(7):1024-33. doi: 10.1111/cmi.12308. Epub 2014 Jun 2.</citation> <PMID>24798552</PMID> </reference> <reference> <citation>Pearce MM, Hilt EE, Rosenfeld AB, Zilliox MJ, Thomas-White K, Fok C, Kliethermes S, Schreckenberger PC, Brubaker L, Gai X, Wolfe AJ. The female urinary microbiome: a comparison of women with and without urgency urinary incontinence. mBio. 2014 Jul 8;5(4):e01283-14. doi: 10.1128/mBio.01283-14.</citation> <PMID>25006228</PMID> </reference> <reference> <citation>Jung C, Brubaker L. The etiology and management of recurrent urinary tract infections in postmenopausal women. Climacteric. 2019 Jun;22(3):242-249. doi: 10.1080/13697137.2018.1551871. Epub 2019 Jan 9.</citation> <PMID>30624087</PMID> </reference> <reference> <citation>Kinneman L, Zhu W, Wong WSW, Clemency N, Provenzano M, Vilboux T, Jane't K, Seo-Mayer P, Levorson R, Kou M, Ascher D, Niederhuber JE, Hourigan SK. Assessment of the Urinary Microbiome in Children Younger Than 48 Months. Pediatr Infect Dis J. 2020 Jul;39(7):565-570. doi: 10.1097/INF.0000000000002622.</citation> <PMID>32091499</PMID> </reference> <reference> <citation>Kassiri B, Shrestha E, Kasprenski M, Antonescu C, Florea LD, Sfanos KS, Wang MH. A Prospective Study of the Urinary and Gastrointestinal Microbiome in Prepubertal Males. Urology. 2019 Sep;131:204-210. doi: 10.1016/j.urology.2019.05.031. Epub 2019 Jun 10.</citation> <PMID>31195012</PMID> </reference> <reference> <citation>Levy EI, Lemmens R, Vandenplas Y, Devreker T. Functional constipation in children: challenges and solutions. Pediatric Health Med Ther. 2017 Mar 9;8:19-27. doi: 10.2147/PHMT.S110940. eCollection 2017.</citation> <PMID>29388621</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 1, 2022</last_update_submitted> <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 2, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Dysfunctional Elimination Syndrome</keyword> <keyword>Urinary Incontinence in Children</keyword> <keyword>Functional constipation in Children</keyword> <keyword>Gut Microbiome</keyword> <keyword>Urine Microbiome</keyword> <condition_browse>  <mesh_term>Intestinal Diseases</mesh_term> <mesh_term>Gastrointestinal Diseases</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Polyethylene glycol 3350</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Background: Bladder and bowel dysfunction (BBD) is characterized by lower urinary tract symptoms accompanied by bowel complaints. BBD is a common condition in childhood. The present treatment strategy for BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. This is, however, based on clinical experience and few retrospective, non-randomized studies and high-level evidence of the succession of the elements in treatment of BBD children is missing. Our microbiome, and its role in health and disease, has gained increased focus during the past years. Studies suggest the urine and gut microbiome to be critical for maintenance of a well-functioning bladder- and bowel system. The microbiome in children is only sparsely investigated and its role in BBD is to the investigator's knowledge still unexplored. Study 1: Aim: To investigate if combination therapy is more effective in treating urinary incontinence in BBD children. Materials and methods: A prospective randomized multicentre study on children with BBD (n=100) between 5-14 years and 9 months old. They are randomized to: 1) Medical treatment of bowel symptoms (n=50) or 2) Medical treatment of bowel symptoms combined with standard urotherapy. The effect of treatment will be evaluated after 3 months. Primary endpoint: Resolution of incontinence after treatment. Secondary endpoint: Improved quality of life after successful treatment of urinary incontinence. Study 2: Aim: To investigate the urofecal microbiome in children with BBD Materials and methods: 1. A cohort study to investigate, whether the urofecal microbiome can predict response to treatment and whether it changes during treatment period 2. A case control study to investigate whether the urofecal microbiome is different in children with BBD and recurrent UTI 's and children with BBD without recurrent UTI 's. The study population consists of children with BBD included in study 1. A urine-, stool sample and a perineum swab will be collected from all participants before and after treatment. Bacterial DNA will be extracted and the microbiome will be determined. Perspectives: BBD is a common condition in childhood. It is associated with a considerable psychological burden and a risk of more severe physical complications. The studies will provide basic knowledge about characteristics of the BBD patients and contribute new information about the optimal treatment of BBD children. Background Bladder and bowel dysfunction (BBD) is characterised by lower urinary tract symptoms (LUTS) accompanied by bowel complaints, primarily functional constipation and/or faecal incontinence. To standardise the terminology used for BBD, LUTS symptoms related to the disease have been defined by International Children's Continence Society (ICCS). The prevalence of BBD is probably underestimated but studies suggest BBD to be present in up to 20 % of school children and to represent up to 40% of paediatric urology consults. Embryological, anatomical and functional interactions between the rectum and urinary bladder are well known. Bladder and bowel are anatomically closely related and share innervation from the parasympathetic S2-S4 and sympathetic L1-L3 nerve roots. Research on successful treatment of BBD is sparse, with only few retrospective, non-randomized studies, documenting that treatment of defecation problems in children with BBD enhances successful management of lower urinary tract disturbances such as daytime urinary incontinence (DUI), enuresis and urinary tract infections (UTI's). Based on this knowledge and clinical experience, the present treatment strategy for children with BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. Standard urotherapy encompasses information and demystification of the disorder along with behavioural modification such as timed voiding, proper voiding posture, avoidance of holding manoeuvers and balanced fluid intake. Standard urotherapy is well-established as first-line treatment for children with LUTS. However, high-level evidence of the succession of the elements in treatment of BBD children is missing. BBD is commonly associated with vesicoureteral reflux (VUR) and recurrent UTI's, which may lead to renal scarring , kidney failure and hypertension. It is a potential cause of significant physical and psychosocial burden for children and families. Therefore, optimization of treatment is critical to avoid secondary comorbidities. Our microbiome, and its role in health and disease, has gained increased focus during the past few years. Studies suggest the urine and gut microbiome to be critical for maintenance of a well-functioning bladder- and bowel system. Dysbiosis is defined by the presence of unbalanced and disease-promoting composition of the microbiome. It is well-established that dysbiosis is associated with constipation in children and the condition is suspected to be involved in urological disorders such as overactive bladder, urge, incontinence and recurrent UTI's in adults. However, the composition of the urine microbiome in children is only sparsely investigated and its role in BBD and childhood UTI's is to the investigator's knowledge still unexplored. Study 1: Does successful treatment of bowel symptoms resolve urinary incontinence in children with BBD? Aim and hypothesis Aim: To investigate if effective treatment of bowel problems resolves urinary incontinence in BBD children. The hypothesis of the investigators is: 1. Treatment of bowel symptoms resolves urinary incontinence in BBD children. 2. It is more effective to initiate urotherapy from the beginning in combination with treatment of bowel symptoms instead of the present regime where bowel symptoms are managed before urotherapy is started. 3. Succesful treatment of urinary incontinence in children with BBD improves their quality of life. 1.2 Materials and methods A prospective multicentre randomised study on children with BBD referred to the Pediatric Incontinence and Gastroenterology outpatient clinics at the Department of Pediatrics, Aarhus University Hospital, Aalborg University Hospital and Regional Hospital Goedstrup. Children (n=100) between 5-14 years and 9 months diagnosed with BBD at their first visit to the outpatient clinic will be included if they meet in- and exclusion criteria. The included children will be randomised to one of the following treatments: 1. Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) (n=50) 2. Medical treatment of bowel symptoms in accordance with the ESPGHAN guidelines combined with standard urotherapy (n=50) At first visit to the outpatient clinic, enrolled children will undergo physical examination including neurological examination. Data on medical history will be collected including number of and time for UTI's. Participants will be asked to fill in a 48-hour flow-volume chart and in case of enuresis nocturna the chart will also include registration for 7 nights. Participants will also fill in "Toerfisk" which is a validated tool to monitor severity of urinary incontinence. Routine uroflowmetry will be performed for further evaluation of lower urinary symptoms. A urine sample will be collected for diagnosing on-going UTI and for microbiome analysis in study 3. The children will be screened for constipation in accordance with the ROME IV criteria. Rectal examination will be performed or transrectal diameter will be evaluated with point-of-care ultrasound. Stool sample and perineum swab will be collected for microbiome analysis. The psychological burden from the children´s BBD condition will be evaluated by PinQ, a validated questionnaire used for assessment of quality of life according to the incontinence issue of the patients. All participants will be informed about bladder and bowel function in order to demystify the disorder. Daily defecation will be induced by reconditioning to normal bowel habits through timed toilet sitting and daily administration of laxatives (e.g. PEG3350) in relevant dosage according to the ESPGHAN guidelines. Participants randomized to combined medical treatment for bowel symptoms and urotherapy will be instructed in urotherapy in accordance with earlier description. After 1 month of treatment the participants will be contacted by telephone to ensure compliance and for adjustment of laxative dose depending on the bowel symptoms. The second visit in the outpatient clinic will be after 3 months of treatment. Before the consultation, the participants will be asked to fill in a second flow-volume chart as well as "Toerfisk" and PinQ questionnaires. Uroflowmetry will be repeated and a second urine sample will be collected for stix, culturing and microbiome analysis. Bowel symptoms will be evaluated using ROME IV, rectal examination and transrectal diameter and a second stool sample and perineum swab will be collected for microbiome analysis for study 3. Data storage Data will be entered into RedCap, which is a secure web platform for building and managing online databases. Power estimation The sample size (n=100) was calculated for each group to achieve a power of 80% for detecting a difference in proportions of 0.30 between the two groups (test - reference group) at a two sided p-value of 0.05. Study 2: Urine, perineal and gut microbiome in children with BBD before and after treatment Aim and hypothesis To investigate the urine, perineal and gut microbiome in children with BBD before and after treatment. The hypothesis of the investigators is that 1. Response to treatment can be predicted by the composition of the urine, perineal and gut microbiome in children with BBD. 2. The composition of the urine, perineal and gut microbiome is different in BBD children with recurrent UTI's compared to BBD children without recurrent UTI's. 3. The urine, perineal and gut microbiome in children with BBD will change when bladder and bowel symptoms successfully treated. Materials and methods The study is a multicentre study consisting of two elements: 1. a cohort study to investigate, whether the urine, perineal and gut microbiome can predict response to treatment and whether it changes during treatment period 2. a case control study to investigate whether the urine, perineal and gut microbiome is different in children with BBD and recurrent UTI 's and children with BBD without recurrent UTI 's. The study population consists of children with BBD included in study 1. Collection and analysis of samples A urine-, stool sample and a perineum swab will be collected from all participants before initiation of treatment and after 3 months of treatment as described in study 1. Bacterial DNA will be extracted and the microbiome will be determined. Data storage Biological material will be pseudonymised and stored in a -80 degree fridge until analysis is performed. Statistical analysis for all 3 studies Distribution and variance will be analysed by QQ plot, Shapiro-Wilks test and Bartletts test. Microbiota alpha-diversity will be addressed by ASV richness, Faith's phylogenetic diversity, Shannon diversity index, and Pielou's evenness index. Beta-diversity analysis will include principal coordinate analysis (PCoA) using Bray-Curtis dissimilarity, weighted and unweighted UniFrac. Parametric data will be compared using Student's t-test or one-way ANOVA and Tukey´s post hoc test, while non-parametric data will be compared with Kruskal-Wallis test or Mann-Whitney U-test. Chi Squared test will be used for proportions. Level of significance will be as following *: p <0.05, **: p<0.01 and ***: p<0.001. Ethics The studies will be conducted in accordance with the Declaration of Helsinki. All side effects will be handled in accordance with the actual legislation. No risk or unknown side effects are expected to urotherapy or medical treatment of bowel symptoms. No risk, side effects or discomfort is expected from collection of urine, stool and perineum samples or from uroflowmetry or transabdominal ultrasound. Perspectives BBD is a common condition in childhood. It is associated with a considerable psychological burden and a risk of more severe physical complications. The term BBD is recently defined and therefore only sparsely investigated. The studies will provide basic knowledge about characteristics of the BBD patients and contribute new information about the optimal treatment of BBD children. Inclusion Criteria: - Age 5-14 years and 9 months at time of inclusion - Diagnosed with urinary incontinence and/or enuresis nocturna defined by the ICCS criteria - Diagnosed with constipation and/or faecal incontinence defined by the ROME IV criteria - Normal clinical examination - Parents/guardian can understand the written and spoken information - Informed assent to participation from both parents/guardian Exclusion Criteria: - Neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal canal - Earlier surgical intervention of the urinary tract (except circumcision) - Neurological illness or earlier cerebral surgical intervention - On-going urinary tract infection - On-going treatment with anticholinergics and/or β3-adenoceptoragonist - On-going treatment with laxatives in correct dosage (PEG3350 1-2 g/kg/day) - Inflammatory bowel disease - Other disorder affection bladder or bowel function - For Study 2 (microbiome): Systemic antibiotics within the past 3 months

NCT0531xxxx/NCT05318378.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/NCT05318378</url> </required_header> <id_info> <org_study_id>BIXAM</org_study_id> <nct_id>NCT05318378</nct_id> </id_info> <brief_title>Inverting Grayscale Improves Detection of Proximal Femur Fracture</brief_title> <official_title>Inverting Grayscale in Conventional Orthopedics X-rays Improves Detection of Proximal Femur Fracture Among Undergraduate Medical Students</official_title> <sponsors> <lead_sponsor> <agency>Centre de l'arthrose, Paris</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Centre de l'arthrose, Paris</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> Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. The study aims to determine if using inverted grayscale radiography results in better diagnoses of PFF among medical students.  Material and Methods. The investigators evaluated the detection of PFF by fifth-year medical students on a series of 30 pelvis X-rays. The series was composed of 20 X-rays with PFF and 10 X-rays without fracture. A first reading session was set up where X-rays were presented separately in conventional and inverted grayscale. A second session one month later showed both grayscale visualizations together (BIcontrast X-rays Analysis Method - BIXAM). X-rays' order of appearance was randomized. The investigators performed the same evaluation on senior orthopedic surgeons as a control. Finally, sensitivity, specificity, and accuracy were assessed for each method (conventional, inverted, and BIXAM) with the McNemar test. Subgroup analyses were performed on the fracture localization (femoral neck, trochanteric). </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 31, 2022</start_date> <completion_date type="Anticipated">April 30, 2022</completion_date> <primary_completion_date type="Actual">March 31, 2022</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>Diagnostic</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> <masking_description>We built two series of images. Series one was composed of separated conventional and inverted images. Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together (Figure). An independent assessor randomly duplicated four and two images for series one and two, respectively, to evaluate the intra-observer agreement. The same assessor randomized the images' order of appearance for the two series with a free online available list randomizer (www.randomizer.org). The principal investigator was blinded to the randomization during the sessions.</masking_description> </study_design_info> <primary_outcome> <measure>accuracy</measure> <time_frame>one month</time_frame> <description>accuracy was compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test</description> </primary_outcome> <primary_outcome> <measure>Sensibility, specificity,</measure> <time_frame>one month</time_frame> <description>Sensibility, specificity were compared between conventional and inverted grayscales or both images shown together (BIXAM series) with non-parametric McNemar test</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Diagnoses Disease</condition> <arm_group> <arm_group_label>student</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Twenty fifth-year medical students were asked to participate in the study</description> </arm_group> <arm_group> <arm_group_label>senior surgeon</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>As controls, we asked 3 independent board-certified orthopedic surgeons to participate in the study following the same conditions as described previously.</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>BIXAM</intervention_name> <description>Series two consisted of inverted and conventional X-rays of the same subject (BIXAM) shown together</description> <arm_group_label>senior surgeon</arm_group_label> <arm_group_label>student</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - fifth-year medical students  Exclusion Criteria:  - other medical students </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>cedric maillot</last_name> <role>Study Director</role> <affiliation>APHP</affiliation> </overall_official> <overall_contact> <last_name>cedric maillot, msc</last_name> <phone>0611789158</phone> <email>cedric.maillot@aphp.fr</email> </overall_contact> <location> <facility> <name>Aphp</name> <address> <city>Paris</city> <zip>75018</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>maillot cedric, msc</last_name> <phone>0611789158</phone> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Femoral Fractures</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Proximal femur fractures (PFF) are a worldwide public health concern. A delay in the diagnosis and treatment worsens the prognosis. Inversion of grayscale is a tool available on most X-rays visualization software, and its use has been suggested to improve radiological diagnosis. The study aims to determine if using inverted grayscale radiography results in better diagnoses of PFF among medical students. Material and Methods. The investigators evaluated the detection of PFF by fifth-year medical students on a series of 30 pelvis X-rays. The series was composed of 20 X-rays with PFF and 10 X-rays without fracture. A first reading session was set up where X-rays were presented separately in conventional and inverted grayscale. A second session one month later showed both grayscale visualizations together (BIcontrast X-rays Analysis Method - BIXAM). X-rays' order of appearance was randomized. The investigators performed the same evaluation on senior orthopedic surgeons as a control. Finally, sensitivity, specificity, and accuracy were assessed for each method (conventional, inverted, and BIXAM) with the McNemar test. Subgroup analyses were performed on the fracture localization (femoral neck, trochanteric). Inclusion Criteria: - fifth-year medical students Exclusion Criteria: - other medical students

NCT0531xxxx/NCT05318391.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/NCT05318391</url> </required_header> <id_info> <org_study_id>SHZS-DLBCL001</org_study_id> <nct_id>NCT05318391</nct_id> </id_info> <brief_title>Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma</brief_title> <official_title>Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma</official_title> <sponsors> <lead_sponsor> <agency>Shanghai Zhongshan Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Wuxi People's Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Shanghai Minhang Central Hospital</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Shanghai Zhongshan 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> The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars. </textblock> </brief_summary> <detailed_description> <textblock> This is a multi-center, observational, retrospective study that examines approximately 200 R/R DLBCL patients treated with BTK inhibitors or lenalidomide and its biosimilars. For patients meet the inclusion criteria, gene expression analysis is performed on formalin fixed paraffin-embedded tissue by using Canhelp-COO Assay, and determine the COO subtype for each specimen. The proportion of COO subtypes in R/R DLBCL and the correlation between COO subtypes and clinicopathological information are further analyzed. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 14, 2021</start_date> <completion_date type="Actual">March 30, 2022</completion_date> <primary_completion_date type="Actual">January 30, 2022</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>proportion of the cell of origin subtypes in the study population</measure> <time_frame>up to 24 weeks</time_frame> <description>Investigate the proportion of the cell of origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.</description> </primary_outcome> <secondary_outcome> <measure>correlation between COO subtypes and the ORR of the treatment of R/R DLBCL.</measure> <time_frame>up to 24 weeks</time_frame> <description>Based on the objective response rate (ORR) measured by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL.</description> </secondary_outcome> <secondary_outcome> <measure>correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL.</measure> <time_frame>up to 24 weeks</time_frame> <description>Based on the progression-free survival (PFS) and overall survival (OS) measuredd by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL .</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">324</enrollment> <condition>Lymphoma, Large B-Cell, Diffuse</condition> <condition>Gene Expression Profiling</condition> <arm_group> <arm_group_label>Group/Cohort</arm_group_label> <description>Retrospective Cohort： Participants who diagnosed with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) patients and treated with BTK inhibitor or lenalidomide and its biosimilars.</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Gene expression profile</intervention_name> <description>Diagnostic Test: The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)</description> <arm_group_label>Group/Cohort</arm_group_label> </intervention> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Formalin-Fixed and Parrffin-Embedded </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Relapsed/refractory DLBCL patients who had received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment.Patients with comprehensive history information and follow-up data and are able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma.  2. Meet the definition of relapsed/refractory DLBCL.  3. Patients received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment. The efficacy was evaluated by the investigators. Cohort plans to enroll one hundred patients with BTK inhibitors treatment (excluding the combination with lenalidomide), one hundred patients with lenalidomide treatment (excluding the combination with BTK inhibitors) and any number of the cases with BTK inhibitors and lenalidomide combination.  a) BTK inhibitors include ibrutinib, zanubrutinib and acalabrutinib  4. Patients with comprehensive history information and follow-up data.  5. Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.  Exclusion Criteria:  1. The archived tumor tissue is too little to test.  2. Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma.  3. R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle. </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>Peng Liu, MD,PhD</last_name> <role>Principal Investigator</role> <affiliation>Fudan University</affiliation> </overall_official> <location> <facility> <name>Yian Zhang</name> <address> <city>Shanghai</city> <state>Shanghai</state> <zip>200032</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <reference> <citation>Yan WH, Jiang XN, Wang WG, Sun YF, Wo YX, Luo ZZ, Xu QH, Zhou XY, Cao JN, Hong XN, Li XQ. Cell-of-Origin Subtyping of Diffuse Large B-Cell Lymphoma by Using a qPCR-based Gene Expression Assay on Formalin-Fixed Paraffin-Embedded Tissues. Front Oncol. 2020 Jun 5;10:803. doi: 10.3389/fonc.2020.00803. eCollection 2020.</citation> <PMID>32582543</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>May 8, 2021</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 31, 2022</last_update_submitted> <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation> <investigator_full_name>Peng Liu</investigator_full_name> <investigator_title>Chief of hematology department</investigator_title> </responsible_party> <keyword>Canhelp-COO Assay</keyword> <condition_browse>  <mesh_term>Lymphoma</mesh_term> <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars. This is a multi-center, observational, retrospective study that examines approximately 200 R/R DLBCL patients treated with BTK inhibitors or lenalidomide and its biosimilars. For patients meet the inclusion criteria, gene expression analysis is performed on formalin fixed paraffin-embedded tissue by using Canhelp-COO Assay, and determine the COO subtype for each specimen. The proportion of COO subtypes in R/R DLBCL and the correlation between COO subtypes and clinicopathological information are further analyzed. Formalin-Fixed and Parrffin-Embedded Relapsed/refractory DLBCL patients who had received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment.Patients with comprehensive history information and follow-up data and are able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research. Inclusion Criteria: 1. Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma. 2. Meet the definition of relapsed/refractory DLBCL. 3. Patients received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment. The efficacy was evaluated by the investigators. Cohort plans to enroll one hundred patients with BTK inhibitors treatment (excluding the combination with lenalidomide), one hundred patients with lenalidomide treatment (excluding the combination with BTK inhibitors) and any number of the cases with BTK inhibitors and lenalidomide combination. a) BTK inhibitors include ibrutinib, zanubrutinib and acalabrutinib 4. Patients with comprehensive history information and follow-up data. 5. Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research. Exclusion Criteria: 1. The archived tumor tissue is too little to test. 2. Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma. 3. R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle.

NCT0531xxxx/NCT05318404.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/NCT05318404</url> </required_header> <id_info> <org_study_id>2020-1756</org_study_id> <nct_id>NCT05318404</nct_id> </id_info> <brief_title>Conventional Oral Intake vs Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy (JNS Study)</brief_title> <acronym>JNS</acronym> <official_title>Comparison of Clinical Outcomes and Nutritional Status Between Conventional Oral Intake and Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy: An Open Labeled Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Seoul National University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Seoul National University Hospital</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> Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer </textblock> </brief_summary> <detailed_description> <textblock> Esophageal cancer is a highly aggressive malignancy that metastasizes to the lymph nodes and is associated with a poor prognosis. The 5-year overall survival rate is 40.0 % and the 30-day mortality rate is 1.7 %. Surgical resection is the most effective treatment for localized esophageal cancer; however, esophagectomy is extremely invasive and is associated with high morbidity and mortality rates.  Nutrition is one of the most important factors to consider after esophagectomy in order to reduce surgical mortality. The European Society for Parenteral and Enteral Nutrition guidelines recommend early tube feeding after major gastrointestinal surgery for cancer. Several studies have shown that enteral nutrition is more effective than parenteral nutrition in reducing postoperative complications in postesophagectomy patients. It has been reported that 5 to 7 days are required for anastomosis site healing. Therefore, many centers start oral feeding after esophagectomy on postoperative 7 days after anastomosis site evaluation, and enteral feeding via jejunostomy are maintained for nutritional support. However, the optimal timing for oral feeding after esophagectomy is still under debate.  In our center, the investigators routinely place jejunostomy tube for sufficient enteral feeding after esophagectomy. Before 2014, the investigators started oral feeding 5 to 7 days after esophagectomy and patients were discharged with soft blended diet. After 2014, the investigators changed our postoperative management protocols: 1) the investigators started only liquid diet 5 to 7 days after esophagectomy and maintained this feeding regimen until the first postoperative clinic visit with supplement of enteral feeding by jejunostomy tube. However, no studies have been conducted showing the optimal timing for oral feeding for esophagectomy patients for nutritional support and postoperative care.  The investigators hypothesized that delayed oral feeding after esophagectomy with jejunostomy feeding is superior to conventional oral feeding for nutritional support and early clinical outcome. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">December 8, 2020</start_date> <completion_date type="Actual">November 8, 2022</completion_date> <primary_completion_date type="Actual">November 8, 2022</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>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Percentage of body weight loss</measure> <time_frame>at postoperative 1st visit (postoperative 4-5 weeks)</time_frame> <description>Percentage of body weight loss from preoperative body weight</description> </primary_outcome> <secondary_outcome> <measure>Postoperative complication rate</measure> <time_frame>From date of randomization until the date of discharge after operation, assessed up to 2 months</time_frame> <description>Postoperative complication rate</description> </secondary_outcome> <secondary_outcome> <measure>Complication related to jejunostomy feeding</measure> <time_frame>From date of randomization until the date of discharge after operation, assessed up to 2 months</time_frame> <description>Complication related to jejunostomy feeding</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative Nutritional index</measure> <time_frame>at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months</time_frame> <description>GLIM criteria for malnutrition, handgrip strength, serum albumin, serum prealbumin</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative daily total calorie intake</measure> <time_frame>at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months</time_frame> <description>Postoperative daily total calorie intake (kcal/day)</description> </secondary_outcome> <secondary_outcome> <measure>Postoperative daily protein intake</measure> <time_frame>at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months</time_frame> <description>Postoperative daily protein intake (g/day)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">58</enrollment> <condition>Esophageal Cancer</condition> <condition>Surgery</condition> <condition>Jejunostomy; Complications</condition> <condition>Nutrition Related Cancer</condition> <arm_group> <arm_group_label>Conventinal feeding group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Start oral feeding 5-7 days after esophagectomy and discharge with soft blended diet as major energy source</description> </arm_group> <arm_group> <arm_group_label>Delayed feeding group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Start clear liquid fluid diet 5-7 days after esophagectomy and discharge with jejunostomy feeding as the major energy source. Start oral feeding at postoperative 1st visit</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Jejunostomy feeding</intervention_name> <description>Maintain jejunostomy feeding till postoperative 1st visit after esophagectomy in delayed feeding group</description> <arm_group_label>Delayed feeding group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose  - Patients who can understand the purpose and protocol of the clinical trial  Exclusion Criteria:  - BMI < 18kg/m2 or BMI > 25kg/m2  - Patients who needs colon of jejunum for esophageal reconstruction  - Patients who needed enteral feeding before esophagectomy  - Preoperative major organ failure (ex. renal failure requiring renal replacement, hepatic failure)  - Severe metabolic disorder (ex. uncontrolled diabetes mellitus, uncontrolled thyroid disease)  - Other patients who are not suitable for clinical trial </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Seoul National University Hospital</name> <address> <city>Seoul</city> <zip>03080</zip> <country>Korea, Republic of</country> </address> </facility> </location> <location_countries> <country>Korea, Republic of</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 8, 2022</last_update_submitted> <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 9, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>esophagectomy</keyword> <keyword>esophageal cancer</keyword> <keyword>nutritional support</keyword> <keyword>jejunostomy</keyword> <condition_browse>  <mesh_term>Esophageal Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer Esophageal cancer is a highly aggressive malignancy that metastasizes to the lymph nodes and is associated with a poor prognosis. The 5-year overall survival rate is 40.0 % and the 30-day mortality rate is 1.7 %. Surgical resection is the most effective treatment for localized esophageal cancer; however, esophagectomy is extremely invasive and is associated with high morbidity and mortality rates. Nutrition is one of the most important factors to consider after esophagectomy in order to reduce surgical mortality. The European Society for Parenteral and Enteral Nutrition guidelines recommend early tube feeding after major gastrointestinal surgery for cancer. Several studies have shown that enteral nutrition is more effective than parenteral nutrition in reducing postoperative complications in postesophagectomy patients. It has been reported that 5 to 7 days are required for anastomosis site healing. Therefore, many centers start oral feeding after esophagectomy on postoperative 7 days after anastomosis site evaluation, and enteral feeding via jejunostomy are maintained for nutritional support. However, the optimal timing for oral feeding after esophagectomy is still under debate. In our center, the investigators routinely place jejunostomy tube for sufficient enteral feeding after esophagectomy. Before 2014, the investigators started oral feeding 5 to 7 days after esophagectomy and patients were discharged with soft blended diet. After 2014, the investigators changed our postoperative management protocols: 1) the investigators started only liquid diet 5 to 7 days after esophagectomy and maintained this feeding regimen until the first postoperative clinic visit with supplement of enteral feeding by jejunostomy tube. However, no studies have been conducted showing the optimal timing for oral feeding for esophagectomy patients for nutritional support and postoperative care. The investigators hypothesized that delayed oral feeding after esophagectomy with jejunostomy feeding is superior to conventional oral feeding for nutritional support and early clinical outcome. Inclusion Criteria: - Patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose - Patients who can understand the purpose and protocol of the clinical trial Exclusion Criteria: - BMI < 18kg/m2 or BMI > 25kg/m2 - Patients who needs colon of jejunum for esophageal reconstruction - Patients who needed enteral feeding before esophagectomy - Preoperative major organ failure (ex. renal failure requiring renal replacement, hepatic failure) - Severe metabolic disorder (ex. uncontrolled diabetes mellitus, uncontrolled thyroid disease) - Other patients who are not suitable for clinical trial

NCT0531xxxx/NCT05318417.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/NCT05318417</url> </required_header> <id_info> <org_study_id>CAM5816</org_study_id> <nct_id>NCT05318417</nct_id> </id_info> <brief_title>Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness</brief_title> <acronym>PAS-SSD</acronym> <official_title>A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness</official_title> <sponsors> <lead_sponsor> <agency>Cochlear</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>NAMSA</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Cochlear</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_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 19, 2022</start_date> <completion_date type="Anticipated">June 2027</completion_date> <primary_completion_date type="Anticipated">May 2027</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> </study_design_info> <primary_outcome> <measure>Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.</measure> <time_frame>pre-implantation, 12 months post-activation</time_frame> <description>Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear.</description> </primary_outcome> <primary_outcome> <measure>Number of procedure and device related adverse events classified by type, frequency and severity.</measure> <time_frame>36 months post-activation</time_frame> </primary_outcome> <secondary_outcome> <measure>Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.</measure> <time_frame>pre-implantation, 12 months post-activation</time_frame> <description>Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities.</description> </secondary_outcome> <secondary_outcome> <measure>Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.</measure> <time_frame>pre-implantation, 12 months post-activation</time_frame> <description>Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">60</enrollment> <condition>Hearing Loss, Unilateral</condition> <condition>Deafness, Unilateral</condition> <arm_group> <arm_group_label>Children and adults with unilateral hearing loss/single-sided deafness</arm_group_label> <arm_group_type>Other</arm_group_type> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>The Cochlear™ Nucleus® Cochlear Implant (CI) System</intervention_name> <description>The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.</description> <arm_group_label>Children and adults with unilateral hearing loss/single-sided deafness</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  • Individuals 18 years or older (Group A)  Ear to be Implanted:  Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and  Normal Hearing Ear:  Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL  • Children 5 years to 17 years, 11 months (Group B)  Ear to be Implanted:  Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and  Normal Hearing Ear:  Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL  - Previous experience with a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required  - English spoken as a primary language  - Willing and able to provide written informed consent  Exclusion Criteria:  - Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array  - Previous cochlear implantation  - Hearing loss of neural or central origin, including auditory neuropathy  - Duration of profound sensorineural HL >10 years per self-report  - Active / chronic middle-ear infection; conductive HL in either ear  - Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator  - Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator  - Evidence of and/or suspected cognitive or developmental concern  - Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator  - Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling  - Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation  - Pregnant or breastfeeding women  - Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device. </textblock> </criteria> <gender>All</gender> <minimum_age>5 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Jillian Crosson</last_name> <role>Study Director</role> <affiliation>Cochlear</affiliation> </overall_official> <overall_contact> <last_name>Kathryn Henion</last_name> <phone>210-238-8094</phone> <email>khenion@cochlear.com</email> </overall_contact> <overall_contact_backup> <last_name>Jillian Crosson</last_name> <phone>601-209-8781</phone> <email>jcrosson@cochlear.com</email> </overall_contact_backup> <location> <facility> <name>Stanford University</name> <address> <city>Palo Alto</city> <state>California</state> <zip>94304</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <investigator> <last_name>Jennifer C Alyono, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Rocky Mountain Ear Center</name> <address> <city>Englewood</city> <state>Colorado</state> <zip>80113</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Allison Biever, AuD</last_name> <phone>303-806-6293</phone> <email>allisonb@rockymountainearcenter.com</email> </contact> </location> <location> <facility> <name>University of Iowa</name> <address> <city>Iowa City</city> <state>Iowa</state> <zip>52242</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Camille Dunn, PhD</last_name> <phone>319-353-8776</phone> <email>Camille_dunn@uiowa.edu</email> </contact> </location> <location> <facility> <name>New York Eye and Ear Infirmary</name> <address> <city>New York</city> <state>New York</state> <zip>10003</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Namrata Marjit</last_name> <phone>929-489-9611</phone> <email>Namrata.Marjit@mountsinai.org</email> </contact> </location> <location> <facility> <name>University of North Carolina</name> <address> <city>Chapel Hill</city> <state>North Carolina</state> <zip>27517</zip> <country>United States</country> </address> </facility> <status>Not yet recruiting</status> <contact> <phone>919-966-5251</phone> <email>ciresearch@unc.edu</email> </contact> </location> <location> <facility> <name>Nationwide Children's Hospital</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43205</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75390</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Virginia Mason Medical Center</name> <address> <city>Seattle</city> <state>Washington</state> <zip>98101</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Leslie Stevens</last_name> <phone>206-287-6267</phone> <email>Leslie.stevens@virginiamason.org</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 17, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 14, 2023</last_update_submitted> <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 18, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Hearing Loss</mesh_term> <mesh_term>Deafness</mesh_term> <mesh_term>Hearing Loss, Unilateral</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.</ipd_description> </patient_data>  </clinical_study>

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use. Inclusion Criteria: • Individuals 18 years or older (Group A) Ear to be Implanted: Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL • Children 5 years to 17 years, 11 months (Group B) Ear to be Implanted: Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and Normal Hearing Ear: Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL - Previous experience with a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required - English spoken as a primary language - Willing and able to provide written informed consent Exclusion Criteria: - Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array - Previous cochlear implantation - Hearing loss of neural or central origin, including auditory neuropathy - Duration of profound sensorineural HL >10 years per self-report - Active / chronic middle-ear infection; conductive HL in either ear - Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator - Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator - Evidence of and/or suspected cognitive or developmental concern - Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator - Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling - Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation - Pregnant or breastfeeding women - Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

NCT0531xxxx/NCT05318430.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/NCT05318430</url> </required_header> <id_info> <org_study_id>BFH-SCD</org_study_id> <nct_id>NCT05318430</nct_id> </id_info> <brief_title>Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study</brief_title> <official_title>Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study</official_title> <sponsors> <lead_sponsor> <agency>Beijing Friendship Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Beijing Friendship Hospital</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> This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 1, 2021</start_date> <completion_date type="Anticipated">December 31, 2022</completion_date> <primary_completion_date type="Anticipated">December 31, 2022</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>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Rate of poor healing of incisions</measure> <time_frame>Within 30 days after surgery</time_frame> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">228</enrollment> <condition>All Diseases That Require Gastrointestinal Open Surgery</condition> <arm_group> <arm_group_label>Experimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>the closed-suction drainage device will be placed subcutaneously when closing the incision</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>the closed-suction drainage device will not be placed subcutaneously when closing the incision</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Subcutaneous closed-suction drainage device</intervention_name> <description>This subcutaneous closed-suction drainage device was designed to be placed subcutaneously when surgeons have completed all intra-abdominal operations and are about to suture subcutaneous layer and skin</description> <arm_group_label>Experimental group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - aged 18-85 years old, male or female  - all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal  - open surgery (instead of laparoscopic) required  - willing participated in clinical verification and signed informed consent.  Exclusion Criteria:  - laparoscopic surgery  - upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas)  - simple appendectomy / total appendectomy  - hernia surgery and intestinal obstruction surgery without intestinal resection  - infection of incision site before operation  - pregnant women  - expected death within 1 month after operation. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>85 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Jun Li, M.D.</last_name> <phone>+86 13811379656</phone> <email>lijunsy2002@ccmu.edu.cn</email> </overall_contact> <location> <facility> <name>Beijing Friendship Hospital, Capital Medical University</name> <address> <city>Beijing</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jun Li, M.D.</last_name> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation> <investigator_full_name>Zhongtao Zhang</investigator_full_name> <investigator_title>Director</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Surgical Wound</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Export of individual patient data is not permitted by Chinese laws</ipd_description> </patient_data>  </clinical_study>

This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed. Inclusion Criteria: - aged 18-85 years old, male or female - all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal - open surgery (instead of laparoscopic) required - willing participated in clinical verification and signed informed consent. Exclusion Criteria: - laparoscopic surgery - upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas) - simple appendectomy / total appendectomy - hernia surgery and intestinal obstruction surgery without intestinal resection - infection of incision site before operation - pregnant women - expected death within 1 month after operation.

NCT0531xxxx/NCT05318443.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/NCT05318443</url> </required_header> <id_info> <org_study_id>SIBP04-02</org_study_id> <nct_id>NCT05318443</nct_id> </id_info> <brief_title>A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer</brief_title> <official_title>A Randomized, Double-blind, Parallel-controlled Study Comparing the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (SIBP04) and Bevacizumab Injection (Avastin) in Combination With Paclitaxel and Carboplatin Respectively in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.</official_title> <sponsors> <lead_sponsor> <agency>Shanghai Institute Of Biological Products</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Shanghai Institute Of Biological Products</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 trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer. </textblock> </brief_summary> <detailed_description> <textblock> This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. The study was divided into three stages: screening stage, treatment stage (combined chemotherapy stage, single drug maintenance treatment stage, visit after treatment) and follow-up stage (survival follow-up after disease progression). To evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer. </textblock> </detailed_description> <overall_status>Unknown status</overall_status> <last_known_status>Recruiting</last_known_status> <start_date type="Actual">April 17, 2020</start_date> <completion_date type="Anticipated">September 30, 2022</completion_date> <primary_completion_date type="Anticipated">September 30, 2022</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>This is a randomized, double-blind, parallel-controlled, multicenter Phase III clinical study.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Objective response rate (ORR)</measure> <time_frame>up to 18th week.</time_frame> <description>ORR is defined as the best ORR from the first medication to the 18th week, initially evaluated by the investigator, and finally evaluated by a third-party independent blinded imaging, including cases of complete response (CR) and partial response (PR).</description> </primary_outcome> <secondary_outcome> <measure>Progression-free survival(PFS)</measure> <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 weeks.</time_frame> <description>PFS is defined as the time between randomization and disease progression or death(The date when event happened first).</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival (OS)</measure> <time_frame>From date of randomization until the date of event-occurring or last visit, assessed up to 30 weeks.</time_frame> <description>OS is defined as the time between randomization and patient death from all causes, with the date of last contact as the cut-off date if the patient is lost to follow-up.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of response (DOR)</measure> <time_frame>From date of the first evaluation of a tumor as CR or PR until the date of the first evaluation of a patient's state as disease progression or death, assessed up to 30 weeks.</time_frame> <description>DOR is defined as the time from the first evaluation of a tumor as CR or PR to the first evaluation of disease progression or death.</description> </secondary_outcome> <secondary_outcome> <measure>Disease control rate (DCR)</measure> <time_frame>up to 18th week.</time_frame> <description>DCR was defined as the percentage of the total evaluable cases with remission or disease stabilization after treatment (That is, cases of CR, PR and stable disease(SD)).</description> </secondary_outcome> <other_outcome> <measure>The number of adverse events (AE)</measure> <time_frame>The last 1 day of 18th weeks after randomization.</time_frame> <description>Total number of any spontaneously reported and all directly observed adverse events.</description> </other_outcome> <other_outcome> <measure>The number of serious adverse events (SAE)</measure> <time_frame>The last 1 day of 30th weeks after randomization.</time_frame> <description>That is serious adverse events, any serious adverse events that occurred to the subject during the study period.</description> </other_outcome> <other_outcome> <measure>The incidence of anti-drug antibodies(ADAs)</measure> <time_frame>The last 1 day of 18th weeks after randomization.</time_frame> <description>Evaluate the immunogenicity of the SIBP04 group and the bevacizumab group.</description> </other_outcome> <other_outcome> <measure>The titer of ADAs</measure> <time_frame>The last 1 day of 18th weeks after randomization.</time_frame> <description>Evaluate the immunogenicity of the SIBP04 group and the bevacizumab group.</description> </other_outcome> <other_outcome> <measure>The incidence of neutralizing antibodies (NAbs)</measure> <time_frame>The last 1 day of 18th weeks after randomization.</time_frame> <description>Evaluate the immunogenicity of the SIBP04 group and the bevacizumab group.</description> </other_outcome> <other_outcome> <measure>The trough concentration</measure> <time_frame>The last 1 day of 18th weeks after randomization.</time_frame> <description>The trough concentration is a pharmacokinetic evaluation index.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">512</enrollment> <condition>Non-squamous Non-small-cell Lung Cancer</condition> <arm_group> <arm_group_label>Experimental</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>SIBP04 & Paclitaxel & Carboplatin</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Avastin & Paclitaxel & Carboplatin</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>SIBP04</intervention_name> <description>SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.</description> <arm_group_label>Experimental</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Avastin</intervention_name> <description>Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.</description> <arm_group_label>Control group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Paclitaxel</intervention_name> <description>Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.</description> <arm_group_label>Control group</arm_group_label> <arm_group_label>Experimental</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Carboplatin</intervention_name> <description>Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.</description> <arm_group_label>Control group</arm_group_label> <arm_group_label>Experimental</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - The subjects voluntarily joined the trial and signed the informed consent form;  - Age≥18 years old and≤75 years old (subject to the date of signing the informed consent form), male or female;  - Non-squamous non-small cell lung cancer confirmed by histology or cytology (excluding sputum cytology), and according to the International Association for the Study of Lung Cancer (IASLC) eighth edition staging criteria, evaluated as stage IIIB-IV inoperable treatment or locally advanced, recurrent or metastatic subjects who cannot receive radical radiotherapy or refuse radical radiotherapy; if there are multiple tumor components, they should be classified according to their main cell types;  - EGFR, ALK, ROS-1 positive patients can be enrolled voluntarily, and the subjects need to provide the test results report of the above genes (If the subject fails to provide the EGFR, ALK, ROS-1 gene test report, he or she must provide tissue sections or tumor specimens for testing in this research center or a tertiary hospital. When the driver gene is unknown, the investigator and the subject jointly decide whether to join the group);  - At least one evaluable target lesion confirmed by imaging (evaluated according to RECIST 1.1 criteria);  - ECOG PS score is 0-1;  - Expected survival time ≥ 6 months;  - No systematic anti-tumor treatment for locally advanced or metastatic non-squamous non-small cell lung cancer [Subjects can be enrolled if they receive adjuvant therapy after completing curative treatment for early-stage non-small cell lung cancer, but have disease recurrence. In this case, the end time of adjuvant therapy is required to be more than 6 months after the first administration of this study, and the various toxic reactions caused by adjuvant therapy have recovered (judged by CTCAE 5.0 standard ≤ grade 1, except for alopecia ) or a new lesion appeared 6 months after the end of radical radiotherapy in stage IIIB patients]  - Laboratory results at screening:  Blood routine: white blood cell count≥3.5×109/L, absolute value of neutrophil ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥100g/L; Liver function: total bilirubin ≤1.5× upper limit of normal (ULN); subjects without liver metastases had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; liver Metastatic subjects with ALT and AST ≤ 5×ULN; Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥ 55mL/min, and urine routine test results show urine protein <2+, for subjects whose urine routine test shows urine protein ≥2+ at baseline, 24 hours urine collection should be performed and protein content in urine <1.0g within 24 hours; Coagulation function: International Normalized Ratio (INR) ≤1.5, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;  - Female subjects of childbearing age, male subjects and male subjects' partners agree to use reliable contraceptive measures from the time of signing the informed consent to 6 months after the end of the last trial drug infusion (such as abstinence, or physical contraception, or hormonal contraception, etc.);  - Subjects need to communicate well with the investigator, and be able to follow the visit, treatment, laboratory examination and other relevant regulations.  Exclusion Criteria:  - Subjects with non-small cell lung cancer of other pathological histological types [including squamous cell carcinoma, mixed non-small cell and small cell lung cancer, and lung adenosquamous carcinoma with squamous cell carcinoma predominant];  - Malignant tumors other than lung cancer within 5 years, excluding cured cervical carcinoma in situ, skin basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and breast ductal carcinoma in situ after radical resection, etc. ;  - Left ventricular ejection fraction (LVEF) < 50% by color Doppler echocardiography;  - Imaging examination at the screening stage show that the tumor approaches, surrounds, or invades the lumen of a large vessel (eg, the pulmonary artery or superior vena cava);  - Subjects with high suspicion of idiopathic pulmonary fibrosis, organizing pneumonia, drug-related pneumonia, idiopathic pneumonia, active pneumonia or active pulmonary tuberculosis by chest imaging examination during the screening stage;  - Previous history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension (systolic blood pressure>150mmHg, and/or diastolic blood pressure>100mmHg);  - Any unstable systemic disease within 6 months prior to randomization: Including but not limited to cerebrovascular accident or transient ischemic attack, unstable angina pectoris, myocardial infarction, congestive heart failure [New York Heart Association (NYHA) grade ≥ grade II], severe arrhythmia requiring drug treatment, etc.;  - There are serious unhealed wounds or fractures, or major surgery (including thoracotomy, or major surgery is expected during the study period) within 28 days before randomization; For major surgery, refer to the 3rd and 4th grade surgery stipulated in the "Administrative Measures for the Classification of Surgery in Medical Institutions (Trial)";  - Subjects who have undergone minor surgery within 48 hours before randomization, and who are judged by the investigator to have a bleeding tendency;  - Subjects who have a history of chest radiotherapy within 28 days before randomization, or those who have received palliative radiotherapy for bone metastases within 14 days before randomization;  - History of the following within 6 months before randomization: peptic ulcer, gastrointestinal perforation, erosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, or intra-abdominal abscess;  - Definite diagnosis of tracheoesophageal fistula;  - Bleeding tendency, high bleeding risk, or coagulation disorder, including history of hemoptysis within 3 months before screening (single hemoptysis ≥ 2.5 ml bright red blood),or recently (≤10 days from first dose of study drug) full-dose oral or parenteral anticoagulants or thrombolytics or aspirin (>325 mg/day) or other non-steroidal anti-inflammatory drugs that inhibit platelet function; or have undergone surgery before, and the investigator judges that they have bleeding tendency;  - Subjects with known central nervous system metastases (except for the subjects with asymptomatic brain metastases and whose symptoms were controlled after treatment and stable within 1 month before randomization);  - Serious infection (including but not limited to infection requiring hospitalization, bacteremia, severe pneumonia, etc.) occurred within 28 days before randomization;  - A history of vascular disease requiring surgical repair within 6 months prior to randomization, such as aortic aneurysm or arterial thrombosis;  - Known to be allergic to SIBP04, Avastin®, Paclitaxel, Carboplatin injection or their excipients;  - Known history of autoimmune disease, allergic disease or allergic constitution (allergic to two or more foods and drugs);  - Received any other experimental drug treatment or participated in another interventional clinical trial within 3 months before screening;  - In the screening stage, Hepatitis B surface antigen was positive, and the level of hepatitis B virus DNA (HBV-DNA) in peripheral blood was higher than the reference value or lower limit of detection method; Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody test was positive;  - Pregnant or lactating women or women preparing to be pregnant or lactating during the study period, or with a positive pregnancy test result at screening stage or baseline;  - Uncontrollable pericardial effusion, abdominal cavity, pleural effusion and other third space effusion within 14 days before randomization, and the investigator judges that they are not suitable for this study;  - Other circumstances determined by the investigator as unsuitable for participation in this study. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Yuankai Shi, Doctor</last_name> <role>Principal Investigator</role> <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation> </overall_official> <overall_official> <last_name>Aidong Qu, Master</last_name> <role>Study Director</role> <affiliation>Co., Ltd Shanghai Institute Of Biological Products</affiliation> </overall_official> <overall_contact> <last_name>Dandan Chen, Master</last_name> <phone>86-021-62800991</phone> <email>ddchen.sh@sinopharm.com</email> </overall_contact> <overall_contact_backup> <last_name>Aidong Qu, Master</last_name> <phone>86-021-62750096</phone> <email>quaidong1@sinopharm.com</email> </overall_contact_backup> <location> <facility> <name>Cancer Hospital Chinese Academy of Medical Sciences</name> <address> <city>Beijing</city> <state>Beijing</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yuankai Shi, Doctor</last_name> <phone>010-87788293</phone> <email>syuankaipumc@126.com</email> </contact> <contact_backup> <last_name>Sheng Yang, Doctor</last_name> <phone>86-13683260156</phone> <email>medart@126.com</email> </contact_backup> </location> <location_countries> <country>China</country> </location_countries> <verification_date>August 2021</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Non-squamous Non-small-cell Lung Cancer</keyword> <keyword>Efficacy</keyword> <keyword>Safety</keyword> <keyword>Tolerability</keyword> <keyword>Pharmacokinetics</keyword> <condition_browse>  <mesh_term>Lung Neoplasms</mesh_term> <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Paclitaxel</mesh_term> <mesh_term>Carboplatin</mesh_term> <mesh_term>Bevacizumab</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer. This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. The study was divided into three stages: screening stage, treatment stage (combined chemotherapy stage, single drug maintenance treatment stage, visit after treatment) and follow-up stage (survival follow-up after disease progression). To evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer. Inclusion Criteria: - The subjects voluntarily joined the trial and signed the informed consent form; - Age≥18 years old and≤75 years old (subject to the date of signing the informed consent form), male or female; - Non-squamous non-small cell lung cancer confirmed by histology or cytology (excluding sputum cytology), and according to the International Association for the Study of Lung Cancer (IASLC) eighth edition staging criteria, evaluated as stage IIIB-IV inoperable treatment or locally advanced, recurrent or metastatic subjects who cannot receive radical radiotherapy or refuse radical radiotherapy; if there are multiple tumor components, they should be classified according to their main cell types; - EGFR, ALK, ROS-1 positive patients can be enrolled voluntarily, and the subjects need to provide the test results report of the above genes (If the subject fails to provide the EGFR, ALK, ROS-1 gene test report, he or she must provide tissue sections or tumor specimens for testing in this research center or a tertiary hospital. When the driver gene is unknown, the investigator and the subject jointly decide whether to join the group); - At least one evaluable target lesion confirmed by imaging (evaluated according to RECIST 1.1 criteria); - ECOG PS score is 0-1; - Expected survival time ≥ 6 months; - No systematic anti-tumor treatment for locally advanced or metastatic non-squamous non-small cell lung cancer [Subjects can be enrolled if they receive adjuvant therapy after completing curative treatment for early-stage non-small cell lung cancer, but have disease recurrence. In this case, the end time of adjuvant therapy is required to be more than 6 months after the first administration of this study, and the various toxic reactions caused by adjuvant therapy have recovered (judged by CTCAE 5.0 standard ≤ grade 1, except for alopecia ) or a new lesion appeared 6 months after the end of radical radiotherapy in stage IIIB patients] - Laboratory results at screening: Blood routine: white blood cell count≥3.5×109/L, absolute value of neutrophil ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥100g/L; Liver function: total bilirubin ≤1.5× upper limit of normal (ULN); subjects without liver metastases had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; liver Metastatic subjects with ALT and AST ≤ 5×ULN; Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥ 55mL/min, and urine routine test results show urine protein <2+, for subjects whose urine routine test shows urine protein ≥2+ at baseline, 24 hours urine collection should be performed and protein content in urine <1.0g within 24 hours; Coagulation function: International Normalized Ratio (INR) ≤1.5, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; - Female subjects of childbearing age, male subjects and male subjects' partners agree to use reliable contraceptive measures from the time of signing the informed consent to 6 months after the end of the last trial drug infusion (such as abstinence, or physical contraception, or hormonal contraception, etc.); - Subjects need to communicate well with the investigator, and be able to follow the visit, treatment, laboratory examination and other relevant regulations. Exclusion Criteria: - Subjects with non-small cell lung cancer of other pathological histological types [including squamous cell carcinoma, mixed non-small cell and small cell lung cancer, and lung adenosquamous carcinoma with squamous cell carcinoma predominant]; - Malignant tumors other than lung cancer within 5 years, excluding cured cervical carcinoma in situ, skin basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and breast ductal carcinoma in situ after radical resection, etc. ; - Left ventricular ejection fraction (LVEF) < 50% by color Doppler echocardiography; - Imaging examination at the screening stage show that the tumor approaches, surrounds, or invades the lumen of a large vessel (eg, the pulmonary artery or superior vena cava); - Subjects with high suspicion of idiopathic pulmonary fibrosis, organizing pneumonia, drug-related pneumonia, idiopathic pneumonia, active pneumonia or active pulmonary tuberculosis by chest imaging examination during the screening stage; - Previous history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension (systolic blood pressure>150mmHg, and/or diastolic blood pressure>100mmHg); - Any unstable systemic disease within 6 months prior to randomization: Including but not limited to cerebrovascular accident or transient ischemic attack, unstable angina pectoris, myocardial infarction, congestive heart failure [New York Heart Association (NYHA) grade ≥ grade II], severe arrhythmia requiring drug treatment, etc.; - There are serious unhealed wounds or fractures, or major surgery (including thoracotomy, or major surgery is expected during the study period) within 28 days before randomization; For major surgery, refer to the 3rd and 4th grade surgery stipulated in the "Administrative Measures for the Classification of Surgery in Medical Institutions (Trial)"; - Subjects who have undergone minor surgery within 48 hours before randomization, and who are judged by the investigator to have a bleeding tendency; - Subjects who have a history of chest radiotherapy within 28 days before randomization, or those who have received palliative radiotherapy for bone metastases within 14 days before randomization; - History of the following within 6 months before randomization: peptic ulcer, gastrointestinal perforation, erosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, or intra-abdominal abscess; - Definite diagnosis of tracheoesophageal fistula; - Bleeding tendency, high bleeding risk, or coagulation disorder, including history of hemoptysis within 3 months before screening (single hemoptysis ≥ 2.5 ml bright red blood),or recently (≤10 days from first dose of study drug) full-dose oral or parenteral anticoagulants or thrombolytics or aspirin (>325 mg/day) or other non-steroidal anti-inflammatory drugs that inhibit platelet function; or have undergone surgery before, and the investigator judges that they have bleeding tendency; - Subjects with known central nervous system metastases (except for the subjects with asymptomatic brain metastases and whose symptoms were controlled after treatment and stable within 1 month before randomization); - Serious infection (including but not limited to infection requiring hospitalization, bacteremia, severe pneumonia, etc.) occurred within 28 days before randomization; - A history of vascular disease requiring surgical repair within 6 months prior to randomization, such as aortic aneurysm or arterial thrombosis; - Known to be allergic to SIBP04, Avastin®, Paclitaxel, Carboplatin injection or their excipients; - Known history of autoimmune disease, allergic disease or allergic constitution (allergic to two or more foods and drugs); - Received any other experimental drug treatment or participated in another interventional clinical trial within 3 months before screening; - In the screening stage, Hepatitis B surface antigen was positive, and the level of hepatitis B virus DNA (HBV-DNA) in peripheral blood was higher than the reference value or lower limit of detection method; Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody test was positive; - Pregnant or lactating women or women preparing to be pregnant or lactating during the study period, or with a positive pregnancy test result at screening stage or baseline; - Uncontrollable pericardial effusion, abdominal cavity, pleural effusion and other third space effusion within 14 days before randomization, and the investigator judges that they are not suitable for this study; - Other circumstances determined by the investigator as unsuitable for participation in this study.

NCT0531xxxx/NCT05318456.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/NCT05318456</url> </required_header> <id_info> <org_study_id>21CNCFT01</org_study_id> <nct_id>NCT05318456</nct_id> </id_info> <brief_title>The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention</brief_title> <official_title>A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention</official_title> <sponsors> <lead_sponsor> <agency>Chenland Nutritionals Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>KGK Science Inc.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Chenland Nutritionals Inc.</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 objective of this study is to investigate the efficacy and safety of MoodElite T-4003-1 on improving mood in a healthy adult population with mild to moderate depressive symptoms not eligible for therapeutic intervention. </textblock> </brief_summary> <detailed_description> <textblock> The objective of this study is to investigate the safety and efficacy of 42-day supplementation of MoodElite T-4003-1 on improving mood in healthy adults. The efficacy of MoodElite T-4003-1 on mood will be assessed by the Beck Depression Inventory (BDI-II) and Profile of Mood States (POMS) Questionnaire. POMS is a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Self-reported sleep efficiency, perceived sleep debt, and sleep difficulty will be assessed by a Sleep Quality Questionnaire and supported by sleep scoring from actigraphy readings. As vitality is related to both mood and sleep, the Vitality and Quality of Life questionnaire will be used to measure changes in energy levels and quality of life over the 42-day study period. The effects of MoodElite T-4003-1 will be compared to a placebo and comparator product, EasyMind T-4008-1. EasyMind T-4008-1 contains extracts from Paeonia lactiflora, Gardenia jasminoides, Albizia julibrissin, Paeonia suffruticosa and has been shown to reduce anxiety-like behaviour in a rodent model using chronic restraint stress through reduction of corticosterone (cortisol) (unpublished results).  For the study population, the eligibility criteria limits the presence of confounding variables that could influence study outcomes. Participants will be healthy men and women between 18 and 65 years of age. Individuals will be recruited based on having mild to moderate depressive symptoms, as assessed by the BDI-II. The BDI-II contains 21 items and evaluates both psychological and physical symptoms related to depression. Participants with diagnosed chronic or major depression or psychiatric disorders will be excluded to ensure only those with mild, non-pathological depressive symptoms are enrolled. Any participants taking prescribed or over the counter mood altering medications will be excluded, as not to interfere with the evaluation of the effects of MoodElite T-4003-1 on mood. Participants taking supplements for mood support at a stable dose for at least three months will be evaluated by the QI to determine eligibility. Shift workers or individuals who have recently travelled across one or more time zones will be excluded to limit any confounding effects on outcomes. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 24, 2022</start_date> <completion_date type="Actual">March 20, 2023</completion_date> <primary_completion_date type="Actual">January 19, 2023</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>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by BDI-ll</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Beck Depression Inventory-II (BDI-II). The BDI-II contains 21 items on a 4-point scale from 0 'Symptom Absent' to 3 'Severe Symptom'. Scoring is achieved by adding the highest ratings for all 21 items with a minimum score of 0 and maximum score of 63. A higher total BDI-II score indicates greater symptom severity.</description> </primary_outcome> <primary_outcome> <measure>Change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS Questionnaire</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.</description> </primary_outcome> <secondary_outcome> <measure>Change in tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in POMS subscale of tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in POMS subscale of depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in POMS subscale of anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in POMS subscale of vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in POMS subscale of fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS</measure> <time_frame>Days 0, 42 and day 56 (follow-up)</time_frame> <description>The change in POMS subscale of confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire</measure> <time_frame>Days 0 and 42</time_frame> <description>The change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire</measure> <time_frame>Days 0 and 42</time_frame> <description>The change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire.</measure> <time_frame>Days 0 and 42</time_frame> <description>The change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.</description> </secondary_outcome> <secondary_outcome> <measure>Change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by actigraphy readings</measure> <time_frame>Days 0 and 42</time_frame> <description>The change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using actigraphy readings. The actigraphy device is an objective measure of sleep during the study period. Each subject will wear the actigraphy device on their non-dominant arm for seven consecutive days prior to each study visit, allowing for charging and periods when the device is may not be worn (i.e. showering). The actigraphy device will be used to collect sleep outcome variables including but not limited to sleep start and end, average length and number of awakenings, sleep efficiency, sleep latency, time asleep, wake episodes, and fragmentation index.</description> </secondary_outcome> <secondary_outcome> <measure>Change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by Vitality and Quality of Life Questionnaire</measure> <time_frame>Days 0 and 42</time_frame> <description>The change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Vitality and Quality of Life Questionnaire. The Vitality and QoL Questionnaire will be used to assess the energy levels and quality of life of the participants. The 31-item questionnaire consists of a 7-point Likert scale, with answers ranging from 1 to 7. The higher the summative score the more vitality that was subjectively perceived by the participants.</description> </secondary_outcome> <secondary_outcome> <measure>Change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation</measure> <time_frame>Days 0 and 42</time_frame> <description>The change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured.</description> </secondary_outcome> <secondary_outcome> <measure>Change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation</measure> <time_frame>Days 0 and 42</time_frame> <description>The change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured.</description> </secondary_outcome> <other_outcome> <measure>Incidence of pre-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Incidence of pre-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Incidence of post-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Incidence of post-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in Aspartate Aminotransferase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in Aspartate Aminotransferase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in alanine aminotransferase levels from baseline to baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in alanine aminotransferase levels from baseline to baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in urinalysis levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in urinalysis levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in alkaline phosphatase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in alkaline phosphatase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in total bilirubin levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in total bilirubin levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in creatinine levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in creatinine levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in potassium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in potassium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in sodium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in sodium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in chloride levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in chloride levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in glucose levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in glucose levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in estimated glomerular filtration rate (eGFR) from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in estimated glomerular filtration rate (eGFR) from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in white blood cell count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in white blood cell count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of neutrophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of neutrophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of lymphocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of lymphocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of monocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of monocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of eosinophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of eosinophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of basophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of basophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of hematocrit from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of hematocrit from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in Red Blood Cell Count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in Red Blood Cell Count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in platelet count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in platelet count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of immature granulocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of immature granulocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in levels of nucleated red blood cells from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in levels of nucleated red blood cells from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in mean corpuscular volume from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in mean corpuscular volume from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in mean corpuscular hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in mean corpuscular hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in mean corpuscular hemoglobin concentration from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in mean corpuscular hemoglobin concentration from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <other_outcome> <measure>Change in red cell distribution width from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo</measure> <time_frame>Days 0 and 42</time_frame> <description>Change in red cell distribution width from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.</description> </other_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">44</enrollment> <condition>Mood</condition> <arm_group> <arm_group_label>MoodElite T-4003-1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.</description> </arm_group> <arm_group> <arm_group_label>Comparator</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>MoodElite T-4003-1</intervention_name> <description>Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food for 42 days.</description> <arm_group_label>MoodElite T-4003-1</arm_group_label> </intervention> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Comparator</intervention_name> <description>Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food for 42 days.</description> <arm_group_label>Comparator</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food for 42 days.</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Individuals 18-65 years of age, inclusive  2. Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening  Or,  Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:  - Injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)  - Double-barrier method  - Intrauterine devices  - Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)  - Vasectomy of partner at least 6 months prior to screening  3. Individuals with mild to mild-moderate depressive symptoms, as determined by a score of 14-24 on the BDI-II at screening, and as assessed by the Qualified Investigator (QI)  4. Education level no less than that of primary school  5. Individuals who can read and write in English and can understand the BDI-II  6. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period  7. Provided voluntary, written, informed consent to participate in the study  8. Healthy as determined by medical history and laboratory results as assessed by QI  Exclusion Criteria:  1. Women who are pregnant, breast feeding, or planning to become pregnant during the study  2. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients  3. History of diagnosed chronic or major depression as assessed by the QI  4. Participants undergoing behavioural therapy for depression. Participants who have completed at least 8 sessions of behavioural therapy with no improvement will be considered by the QI  5. Suicidal ideation as assessed by the BDI-II  6. History of psychiatric disorders such as organic brain disorders, bipolar affective disorder, personality disorder, as assessed by the QI  7. Diagnosed insomnia or other sleep disorders as assessed by the QI  8. Current employment that calls for shift work or have worked shift work in the last 3 weeks  9. Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel  10. Current use of prescribed medications, over-the-counter (OTC) medications, or supplements taken for treatment of depression or used to help sleep  11. Current use of prescribed medications that interact with Hypericum perforatum  12. Unstable metabolic disease or chronic diseases as assessed by the QI  13. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI  14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI  15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable  16. Individuals with an autoimmune disease or are immune compromised as assessed by the QI  17. Use of medical cannabinoid products  18. Current chronic use of cannabinoid products (>8 times/month) and is unwilling to stop for the duration of the study beginning 1 week prior to baseline. History of chronic and occasional use and the purpose of use to be assessed by QI on a case-by-case basis  19. Alcohol intake >2 standard drinks per day as assessed by the QI  20. Alcohol or drug abuse within the last 12 months  21. Clinically significant abnormal laboratory results at screening as assessed by the QI  22. Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI  23. Individuals who are unable to give informed consent  24. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>David Crowley, MD</last_name> <role>Principal Investigator</role> <affiliation>KGK Science Inc.</affiliation> </overall_official> <location> <facility> <name>KGK Science Inc.</name> <address> <city>London</city> <state>Ontario</state> <zip>N6A5R8</zip> <country>Canada</country> </address> </facility> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 21, 2023</last_update_submitted> <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 22, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Mild to moderate depression</keyword> <keyword>Mild to moderate depressive symptoms not eligible for therapeutic intervention</keyword> <keyword>MoodElite T-4003-1</keyword> <condition_browse>  <mesh_term>Depression</mesh_term> </condition_browse>  </clinical_study>

The objective of this study is to investigate the efficacy and safety of MoodElite T-4003-1 on improving mood in a healthy adult population with mild to moderate depressive symptoms not eligible for therapeutic intervention. The objective of this study is to investigate the safety and efficacy of 42-day supplementation of MoodElite T-4003-1 on improving mood in healthy adults. The efficacy of MoodElite T-4003-1 on mood will be assessed by the Beck Depression Inventory (BDI-II) and Profile of Mood States (POMS) Questionnaire. POMS is a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Self-reported sleep efficiency, perceived sleep debt, and sleep difficulty will be assessed by a Sleep Quality Questionnaire and supported by sleep scoring from actigraphy readings. As vitality is related to both mood and sleep, the Vitality and Quality of Life questionnaire will be used to measure changes in energy levels and quality of life over the 42-day study period. The effects of MoodElite T-4003-1 will be compared to a placebo and comparator product, EasyMind T-4008-1. EasyMind T-4008-1 contains extracts from Paeonia lactiflora, Gardenia jasminoides, Albizia julibrissin, Paeonia suffruticosa and has been shown to reduce anxiety-like behaviour in a rodent model using chronic restraint stress through reduction of corticosterone (cortisol) (unpublished results). For the study population, the eligibility criteria limits the presence of confounding variables that could influence study outcomes. Participants will be healthy men and women between 18 and 65 years of age. Individuals will be recruited based on having mild to moderate depressive symptoms, as assessed by the BDI-II. The BDI-II contains 21 items and evaluates both psychological and physical symptoms related to depression. Participants with diagnosed chronic or major depression or psychiatric disorders will be excluded to ensure only those with mild, non-pathological depressive symptoms are enrolled. Any participants taking prescribed or over the counter mood altering medications will be excluded, as not to interfere with the evaluation of the effects of MoodElite T-4003-1 on mood. Participants taking supplements for mood support at a stable dose for at least three months will be evaluated by the QI to determine eligibility. Shift workers or individuals who have recently travelled across one or more time zones will be excluded to limit any confounding effects on outcomes. Inclusion Criteria: 1. Individuals 18-65 years of age, inclusive 2. Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: - Injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) - Double-barrier method - Intrauterine devices - Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) - Vasectomy of partner at least 6 months prior to screening 3. Individuals with mild to mild-moderate depressive symptoms, as determined by a score of 14-24 on the BDI-II at screening, and as assessed by the Qualified Investigator (QI) 4. Education level no less than that of primary school 5. Individuals who can read and write in English and can understand the BDI-II 6. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period 7. Provided voluntary, written, informed consent to participate in the study 8. Healthy as determined by medical history and laboratory results as assessed by QI Exclusion Criteria: 1. Women who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients 3. History of diagnosed chronic or major depression as assessed by the QI 4. Participants undergoing behavioural therapy for depression. Participants who have completed at least 8 sessions of behavioural therapy with no improvement will be considered by the QI 5. Suicidal ideation as assessed by the BDI-II 6. History of psychiatric disorders such as organic brain disorders, bipolar affective disorder, personality disorder, as assessed by the QI 7. Diagnosed insomnia or other sleep disorders as assessed by the QI 8. Current employment that calls for shift work or have worked shift work in the last 3 weeks 9. Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel 10. Current use of prescribed medications, over-the-counter (OTC) medications, or supplements taken for treatment of depression or used to help sleep 11. Current use of prescribed medications that interact with Hypericum perforatum 12. Unstable metabolic disease or chronic diseases as assessed by the QI 13. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI 15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable 16. Individuals with an autoimmune disease or are immune compromised as assessed by the QI 17. Use of medical cannabinoid products 18. Current chronic use of cannabinoid products (>8 times/month) and is unwilling to stop for the duration of the study beginning 1 week prior to baseline. History of chronic and occasional use and the purpose of use to be assessed by QI on a case-by-case basis 19. Alcohol intake >2 standard drinks per day as assessed by the QI 20. Alcohol or drug abuse within the last 12 months 21. Clinically significant abnormal laboratory results at screening as assessed by the QI 22. Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI 23. Individuals who are unable to give informed consent 24. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

NCT0531xxxx/NCT05318469.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/NCT05318469</url> </required_header> <id_info> <org_study_id>IIT2022-07-YUAN-IB-TNBC</org_study_id> <nct_id>NCT05318469</nct_id> </id_info> <brief_title>Ivermectin and Balstilimab for the Treatment of Metastatic Triple Negative Breast Cancer</brief_title> <official_title>A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Balstilimab in Patients With Metastatic Triple Negative Breast Cancer With Expansion Cohort in PD-L1 Negative TNBC</official_title> <sponsors> <lead_sponsor> <agency>Yuan Yuan</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Agenus Inc.</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Gateway for Cancer Research</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Cedars-Sinai Medical Center</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 phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab may increase the effect of balstilimab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). </textblock> </brief_summary> <detailed_description> <textblock> Patients receive ivermectin orally (PO) once daily (QD) on days 1-3, 8-10, and 15-17. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive balstilimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.  After completion of study treatment, patients are followed up for 90 days and then periodically thereafter. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 2023</start_date> <completion_date type="Anticipated">October 2026</completion_date> <primary_completion_date type="Anticipated">October 2026</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>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Incidence of adverse events</measure> <time_frame>From start of study treatment until 90 days after treatment completion</time_frame> <description>Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.</description> </primary_outcome> <primary_outcome> <measure>Objective response rate</measure> <time_frame>From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 2 years.</time_frame> <description>Proportion of participants that are programmed cell death ligand 1 (PD-L1) negative with confirmed complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.</description> </primary_outcome> <secondary_outcome> <measure>Objective response rate</measure> <time_frame>From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 2 years.</time_frame> <description>Proportion of participants with confirmed complete response (CR) or partial response (PR) as measured by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1.</description> </secondary_outcome> <secondary_outcome> <measure>Progression free survival</measure> <time_frame>From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 6 years.</time_frame> <description>From start of therapy until first documentation of disease progression per RECIST 1.1 or death due to any cause.</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival</measure> <time_frame>From start of study treatment to death or last contact. Assessed up to 6 years</time_frame> <description>From start of study treatment to date of death due to any cause. Patient's last known to be alive are censored at date of last contact.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of response</measure> <time_frame>From the date of first objective response recorded until disease progression, death or last contact. Assessed up to 6 years</time_frame> <description>Measured from the date of first objective response recorded (CR or PR) until progression per RECIST 1.1, death or last contact (censored). Patient's last known to be alive are censored at date of last contact.</description> </secondary_outcome> <secondary_outcome> <measure>Clinical benefit rate</measure> <time_frame>From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 6 years.</time_frame> <description>Defined as progression-free for at least 6 months or CR or PR per RECIST 1.1.</description> </secondary_outcome> <secondary_outcome> <measure>Patients' quality of life</measure> <time_frame>On day 1 of each 3 week cycle and at end of treatment visit. Assessed up to 2 years.</time_frame> <description>Evaluated by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 per standardized EORTC scoring guidelines.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">41</enrollment> <condition>Anatomic Stage IV Breast Cancer AJCC v8</condition> <condition>Metastatic Triple-Negative Breast Carcinoma</condition> <arm_group> <arm_group_label>Treatment (ivermectin, balstilimab)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients receive ivermectin PO QD on days 1-3, 8-10, and 15-17. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive balstilimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ivermectin</intervention_name> <description>Ivermectin at the assigned dose administered PO on Days 1-3, 8-10, 15-17 of each 21 day cycle (Days1-3 of each week).</description> <arm_group_label>Treatment (ivermectin, balstilimab)</arm_group_label> <other_name>Sklice</other_name> <other_name>Stromectol</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Balstilmab</intervention_name> <description>Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.</description> <arm_group_label>Treatment (ivermectin, balstilimab)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age: ≥ 18 years  - Eastern Cooperative Oncology Group (ECOG) ≤ 1  - Life expectancy > 3 months  - Histologically confirmed metastatic triple negative breast cancer. Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10% and HER2 negative (by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]), per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines  - Patients must have progressed on 1-2 prior lines of systemic therapy (chemotherapy and/or drug-antibody conjugate) in the metastatic setting  - Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions  - Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 2 from prior anti-cancer therapy  - For Phase 2 expansion only, must be PD-L1 negative. Note: For Phase 1 safety cohort, any PD-L1 status will be allowed to enroll.  - Patients must have adequate organ function as defined in the following:  - Absolute neutrophil count (ANC) ≥ 1,500/mm^3  - Platelets ≥ 100,000/mm^3  - Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks  - Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN  - Aspartate aminotransferase (AST) ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases  - Alanine aminotransferase (ALT) ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases  - Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 x institutional ULN  - International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants  - Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram  - Women of childbearing potential (WOCBP): negative urine or serum pregnancy test  - If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required  - A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period  - A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:  - Not a woman of childbearing potential (WOCBP) OR  - Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose  - Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.  Exclusion Criteria:  - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug  - Prohibited Treatments and/or Therapies:  - Chemotherapy, radiation therapy, biological therapy, immunotherapy within 28 days prior to day 1 of protocol therapy  - Prior immune checkpoint inhibitor therapy in metastatic setting (Note: Prior use of immune checkpoint inhibitor in neoadjuvant or adjuvant setting only permitted if last dose is at least 1 year from start of study intervention)  - Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease  - Any live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed  - Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed  - Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention  - Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting during screening)  - Women who are or are planning to become pregnant or breastfeed  - Known allergy to any of the components within the study agents and/or their excipients  - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years  - Participants must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention  - History of (non-infectious) pneumonitis that required steroids or has current pneumonitis  - Active infection requiring systemic therapy  - Known history of Human Immunodeficiency Virus (HIV) infection  - Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority  - Known history of active TB (Mycobacterium tuberculosis)  - Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection).  - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator  - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial  - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment  - Has had an allogenic tissue/solid organ transplant  - Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening  - Subjects having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is < 1 g/24 hours  - Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed  - Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures </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>Yuan Yuan, MD</last_name> <role>Principal Investigator</role> <affiliation>Cedars-Sinai Medical Center</affiliation> </overall_official> <overall_contact> <last_name>Clinical Trial Navigator</last_name> <phone>3104232133</phone> <email>cancer.trial.info@cshs.org</email> </overall_contact> <location> <facility> <name>Cedars-Sinai Medical Center</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90048</zip> <country>United States</country> </address> </facility> <contact> <last_name>Clinical Trial Recruitment Navigator</last_name> <phone>310-423-2133</phone> <email>cancer.trial.info@cshs.org</email> </contact> <investigator> <last_name>Yuan Yuan, MD, PhD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Monica Mita, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Stephen Shiao, MD, PhD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 30, 2023</last_update_submitted> <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 3, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation> <investigator_full_name>Yuan Yuan</investigator_full_name> <investigator_title>Medical Director, Breast Oncology DRG</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Breast Neoplasms</mesh_term> <mesh_term>Triple Negative Breast Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Ivermectin</mesh_term> </intervention_browse>  </clinical_study>

This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab may increase the effect of balstilimab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). Patients receive ivermectin orally (PO) once daily (QD) on days 1-3, 8-10, and 15-17. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive balstilimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 90 days and then periodically thereafter. Inclusion Criteria: - Age: ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) ≤ 1 - Life expectancy > 3 months - Histologically confirmed metastatic triple negative breast cancer. Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10% and HER2 negative (by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]), per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines - Patients must have progressed on 1-2 prior lines of systemic therapy (chemotherapy and/or drug-antibody conjugate) in the metastatic setting - Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions - Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 2 from prior anti-cancer therapy - For Phase 2 expansion only, must be PD-L1 negative. Note: For Phase 1 safety cohort, any PD-L1 status will be allowed to enroll. - Patients must have adequate organ function as defined in the following: - Absolute neutrophil count (ANC) ≥ 1,500/mm^3 - Platelets ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks - Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN - Aspartate aminotransferase (AST) ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases - Alanine aminotransferase (ALT) ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases - Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 x institutional ULN - International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants - Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram - Women of childbearing potential (WOCBP): negative urine or serum pregnancy test - If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required - A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period - A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: - Not a woman of childbearing potential (WOCBP) OR - Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose - Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug - Prohibited Treatments and/or Therapies: - Chemotherapy, radiation therapy, biological therapy, immunotherapy within 28 days prior to day 1 of protocol therapy - Prior immune checkpoint inhibitor therapy in metastatic setting (Note: Prior use of immune checkpoint inhibitor in neoadjuvant or adjuvant setting only permitted if last dose is at least 1 year from start of study intervention) - Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease - Any live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed - Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed - Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention - Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting during screening) - Women who are or are planning to become pregnant or breastfeed - Known allergy to any of the components within the study agents and/or their excipients - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years - Participants must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention - History of (non-infectious) pneumonitis that required steroids or has current pneumonitis - Active infection requiring systemic therapy - Known history of Human Immunodeficiency Virus (HIV) infection - Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority - Known history of active TB (Mycobacterium tuberculosis) - Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection). - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment - Has had an allogenic tissue/solid organ transplant - Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening - Subjects having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is < 1 g/24 hours - Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed - Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

NCT0531xxxx/NCT05318482.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/NCT05318482</url> </required_header> <id_info> <org_study_id>CE 2608</org_study_id> <nct_id>NCT05318482</nct_id> </id_info> <brief_title>Motivational Program on Physical Activity in Cardio-respiratory Patients: an RCT Study</brief_title> <official_title>Effects of Physical Activity of an In-hospital Motivational Program in Cardio-respiratory Patients: a Randomized Control Trial</official_title> <sponsors> <lead_sponsor> <agency>Istituti Clinici Scientifici Maugeri SpA</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Istituti Clinici Scientifici Maugeri SpA</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> According to actual scientific evidence, the interventions on the general population aiming at regular physical activity are one of the most efficient strategies for health improvement. Regardless of this evidence, there is a large part of the elderly population does not adhere to the recommendations of the international guidelines on daily physical activity.  This is even more evident in patients with chronic respiratory and cardiological disease because exercise exacerbates existing symptoms of breathlessness.  This study aims to evaluate the impact of an in-hospital motivational program dedicated to increasing physical activity. With the data of an electronic wristwatch that keeps records of movement, the health professionals incentive an increase in physical activity leading to long term behavioural changes (evaluated by the number of steps per day) in hospitalized patients with COPD and HF, which already perform a standard rehabilitation program (14 sessions). </textblock> </brief_summary> <detailed_description> <textblock> There are studies in the literature that have reported, in comparison with healthy subjects, a lower level of physical activity in COPD patients; other studies associate less physical activity with increased risk of hospitalization and mortality, which is even more evident considering patients with chronic respiratory diseases. In the same way, patients with Heart Failure (HF) reduce their activity and exercise capacity increasing hospitalization and mortality.  With more fatigue and dyspnoea, a vicious circle is created, with a consequent further reduction of levels of physical activity and worsening of symptoms.  Therefore, it is necessary to provide augmented physical activity in rehabilitation hospital environments.  Rehabilitation is a way to encourage and support patients to achieve their best physical condition. At present, COPD and HF patients admitted in rehabilitative cardio-respiratory wards dedicate a limited amount of time to physical activity, when referred to the entire day of hospitalization, whereas the rest of their time is spent in a sedentary condition. Thus, it is difficult to imagine that an actual change in the patients' lifestyle can be obtained by such a cardio-respiratory rehabilitation. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 23, 2022</start_date> <completion_date type="Anticipated">March 15, 2024</completion_date> <primary_completion_date type="Anticipated">March 15, 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>Cardio-respiratory patients (COPD and CHF), with similar comorbidity, needing rehabilitation, will be consecutively enrolled at Istituti Clinici Scientifici Maugeri.</intervention_model_description> <primary_purpose>Health Services Research</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Delta change in number of steps per day</measure> <time_frame>Day 0 and day 17</time_frame> <description>To evaluate the impact of a motivational program, by an electronic wristwatch for health tracking dedicated to improving physical activity, on behavioural changes (number of steps per day) in hospitalized patients with COPD and HF, which already have performed a standard rehabilitation program.</description> </primary_outcome> <secondary_outcome> <measure>Delta change in PASE Questionnaire</measure> <time_frame>Day 0 and day 17</time_frame> <description>The Physical Activity Scale for the Elderly (PASE) is an easily administered and scored instrument that measures the level of physical activity in individuals aged 65 years and older. It is divided into two main sections, one for the activities performed in the spare time, and one for household activities. The total score is obtained by multiplying the time amount spent on each free-time activity (hours/day/week) or household activity (yes/no) by certain values derived empirically for each of them; the sum of all activities correlates with the physical activity level.</description> </secondary_outcome> <secondary_outcome> <measure>Delta change in 6 MWT</measure> <time_frame>Day 0 and day 17</time_frame> <description>The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. This assessment will include also the Borg Scale for Dyspnoea and Fatigue. They both have a minimum score, 0, and a maximum score, 10. Higher scores indicate greater symptom severity (either for dyspnoea or for fatigue).</description> </secondary_outcome> <secondary_outcome> <measure>Delta change in SPPB Scale</measure> <time_frame>Day 0 and day 17</time_frame> <description>The SPPB Scale evaluates the level of safety in motor ability. It is divided into three items, each ranging from 0 to 4. The first item is balance (the score is assigned according to the difficulty level in keeping balance), the second is walking (the score reflects the amount of time taken to walk a distance of 4 meters), and the third is the 1-Minute-Sit-To-Stand-Test (the score is determined by the number of lifts from sitting to standing, performed within the first 5 seconds in one minute. The sum of the scores for each item may vary from 0, which indicates the complete motor inability, to a maximum of 12, which indicates a total motor autonomy.</description> </secondary_outcome> <secondary_outcome> <measure>Delta change in EMI-2 questionnaire</measure> <time_frame>Day 0 and day 17</time_frame> <description>The EMI (Markland and Hardy, 1993) was developed as a means of assessing participation motives in order to examine such issues as the influence of motives on exercise participation, how such motives might influence the choice of activities undertaken, how affective responses to exercise may be influenced by reasons for exercising and how involvement in physical activity might have a reciprocal influence on participation motives. In particular, the authors developed the instrument to examine questions concerning the functional significance of exercise motives from the perspective of Deci and Ryan's (1985) self-determination theory. It is presented as a list of 51 motivational sentences, each of them is assigned a score from 0 (totally false) to 5 (totally true). The sum of each score is the final result, ranging from a minimum of 0 (absence of motivation to do exercise) to a maximum of 255 (highest motivation to do exercise).</description> </secondary_outcome> <secondary_outcome> <measure>Delta change in SF-12 questionnaire</measure> <time_frame>Day 0 and day 17</time_frame> <description>The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 uses the same eight domains as the SF-36: Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The PCS includes 6 questions concerning different issues. Two questions are about physical activit</description> </secondary_outcome> <secondary_outcome> <measure>Delta change in BDI questionnaire</measure> <time_frame>Day 0 and day 17</time_frame> <description>The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations. Twenty-one items were consolidated from those observations and ranked 0-3 for severity. The questionnaire is administered by health professionals. The minimum score is 0 and the maximum score is 63. Higher scores indicate greater symptom severity.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">50</enrollment> <condition>Cardiorespiratory Failure</condition> <arm_group> <arm_group_label>Motivational group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The patients of this group will be equipped with an electronic wristwatch and will be monitored every day by the physiotherapist (PT) through an application on their mobiles. The PT will follow these patients with a daily motivational session (15 minutes, modality 1 patient: 1 PT) and with an educational program about the definition, importance and benefits of physical activity.</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>The patients of this group will have an electronic wristwatch and will be advised by the PT only with generic recommendations of daily exercise during the hospitalization, besides the usual activities of the rehabilitation program.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Motivational group</intervention_name> <description>In addition to the activities of the usual rehabilitation program, the PT will perform a daily motivational session of 15 minutes in a 1 patient: 1 physiotherapist modality. On that occasion, the patient will report the number of steps performed the previous day; the physiotherapist will check and promote the increase of 10% in the number of steps for the next day. If the patient fails to achieve the goal, the PT will analyze the reasons with the patient, in order to facilitate the achievement of the goal. The PT will advise on the time and place to perform physical activity and the patients will receive a diary to record his/her progress (number of steps and heart rate, Borg Fatigue and Borg Dyspnea before and after an exercise task). The PT will record all these evaluations on an excel database.</description> <arm_group_label>Motivational group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Control group</intervention_name> <description>Besides the activities of the usual rehabilitation program, the patients of this group will be provided by the PT only with the generic recommendations of daily exercise during the in-hospital stay</description> <arm_group_label>Control</arm_group_label> <other_name>Generic recommendations</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - >18 years, both of genders;  - Scheduled time of hospitalization of at least 14-16 days;  - Ability to walk by themselves, with safety (SPPB >10);  - Hospital admission with a diagnosis of COPD (GOLD III-IV, B-D), with or without respiratory failure, or HF (NYHA II-III), sufficiently stabilized with a specific pharmacological therapy  - Possession of a smartphone and ability to use the app for health tracking.  Exclusion Criteria:  - Significant symptoms of the primary disorder, not properly stabilized;  - Hemodynamic and clinic instability;  - Musculoskeletal issues or other types (neurological, orthopedical…), which involve an important limitation in physical exercise performance;  - Medical comorbidities with a life expectancy shorter than one year;  - Clinical signs of cognitive impairment (MMSE < 25). </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>Michele Vitacca, MD</last_name> <role>Principal Investigator</role> <affiliation>Istituti Clinici Scientifici Maugeri</affiliation> </overall_official> <overall_contact> <last_name>Mara Paneroni, MSc</last_name> <phone>0039+030+8253</phone> <phone_ext>122</phone_ext> <email>mara.paneroni@icsmaugeri.it</email> </overall_contact> <overall_contact_backup> <last_name>Paola Baiardi, PhD Math</last_name> <phone>0039+0382+592</phone> <phone_ext>599</phone_ext> <email>paola.baiardi@icsmaugeri.it</email> </overall_contact_backup> <location> <facility> <name>Istituti Clinici Scientifici Maugeri IRCCS</name> <address> <city>Lumezzane</city> <state>Brescia</state> <zip>25065</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Mara Paneroni, PT, MSc</last_name> <phone>0039+030+8253</phone> <phone_ext>122</phone_ext> <email>mara.paneroni@icsmaugeri.it</email> </contact> <contact_backup> <last_name>Michele Vitacca, MD</last_name> <phone>0039+030+825</phone> <phone_ext>182</phone_ext> <email>michele.vitacca@icsmaugeri.it</email> </contact_backup> </location> <location_countries> <country>Italy</country> </location_countries> <reference> <citation>Demeyer H, Louvaris Z, Frei A, Rabinovich RA, de Jong C, Gimeno-Santos E, Loeckx M, Buttery SC, Rubio N, Van der Molen T, Hopkinson NS, Vogiatzis I, Puhan MA, Garcia-Aymerich J, Polkey MI, Troosters T; Mr Papp PROactive study group and the PROactive consortium. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017 May;72(5):415-423. doi: 10.1136/thoraxjnl-2016-209026. Epub 2017 Jan 30.</citation> <PMID>28137918</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Rehabilitation</keyword> <keyword>behaviour</keyword> <keyword>COPD</keyword> <keyword>heart failure</keyword> <keyword>tracing</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Protocol submitted to technical and Scientific Committee and Ethical Committee</ipd_description> </patient_data>  </clinical_study>

According to actual scientific evidence, the interventions on the general population aiming at regular physical activity are one of the most efficient strategies for health improvement. Regardless of this evidence, there is a large part of the elderly population does not adhere to the recommendations of the international guidelines on daily physical activity. This is even more evident in patients with chronic respiratory and cardiological disease because exercise exacerbates existing symptoms of breathlessness. This study aims to evaluate the impact of an in-hospital motivational program dedicated to increasing physical activity. With the data of an electronic wristwatch that keeps records of movement, the health professionals incentive an increase in physical activity leading to long term behavioural changes (evaluated by the number of steps per day) in hospitalized patients with COPD and HF, which already perform a standard rehabilitation program (14 sessions). There are studies in the literature that have reported, in comparison with healthy subjects, a lower level of physical activity in COPD patients; other studies associate less physical activity with increased risk of hospitalization and mortality, which is even more evident considering patients with chronic respiratory diseases. In the same way, patients with Heart Failure (HF) reduce their activity and exercise capacity increasing hospitalization and mortality. With more fatigue and dyspnoea, a vicious circle is created, with a consequent further reduction of levels of physical activity and worsening of symptoms. Therefore, it is necessary to provide augmented physical activity in rehabilitation hospital environments. Rehabilitation is a way to encourage and support patients to achieve their best physical condition. At present, COPD and HF patients admitted in rehabilitative cardio-respiratory wards dedicate a limited amount of time to physical activity, when referred to the entire day of hospitalization, whereas the rest of their time is spent in a sedentary condition. Thus, it is difficult to imagine that an actual change in the patients' lifestyle can be obtained by such a cardio-respiratory rehabilitation. Inclusion Criteria: - >18 years, both of genders; - Scheduled time of hospitalization of at least 14-16 days; - Ability to walk by themselves, with safety (SPPB >10); - Hospital admission with a diagnosis of COPD (GOLD III-IV, B-D), with or without respiratory failure, or HF (NYHA II-III), sufficiently stabilized with a specific pharmacological therapy - Possession of a smartphone and ability to use the app for health tracking. Exclusion Criteria: - Significant symptoms of the primary disorder, not properly stabilized; - Hemodynamic and clinic instability; - Musculoskeletal issues or other types (neurological, orthopedical…), which involve an important limitation in physical exercise performance; - Medical comorbidities with a life expectancy shorter than one year; - Clinical signs of cognitive impairment (MMSE < 25).

NCT0531xxxx/NCT05318495.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/NCT05318495</url> </required_header> <id_info> <org_study_id>Dual Tandem</org_study_id> <nct_id>NCT05318495</nct_id> </id_info> <brief_title>A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE</brief_title> <official_title>A Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of SC to That of Artificial Intelligence (CAD-EYE) Aided Colonoscopy and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy.</official_title> <sponsors> <lead_sponsor> <agency>Dr. Horst Schmidt Klinik GmbH</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Dr. Horst Schmidt Klinik GmbH</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> Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:  1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).  2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.  3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning. </textblock> </brief_summary> <detailed_description> <textblock> Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:  1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).  2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.  3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.  Total of up to 372 patients will be randomized,186 to each of the two tandems </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 1, 2022</start_date> <completion_date type="Anticipated">December 2022</completion_date> <primary_completion_date type="Anticipated">December 2022</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>Screening</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Additional adenoma detection yield</measure> <time_frame>6 weeks</time_frame> <description>additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard coloscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy</description> </primary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">372</enrollment> <condition>Adenoma</condition> <condition>Colo-rectal Cancer</condition> <arm_group> <arm_group_label>Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).</description> </arm_group> <arm_group> <arm_group_label>Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).</description> </arm_group> <arm_group> <arm_group_label>Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.</description> </arm_group> <arm_group> <arm_group_label>Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Standard Colonoscopy</intervention_name> <description>The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).</description> <arm_group_label>Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE</arm_group_label> <arm_group_label>Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE</arm_group_label> <arm_group_label>Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy</arm_group_label> <arm_group_label>Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>CAD-EYE</intervention_name> <description>CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.</description> <arm_group_label>Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE</arm_group_label> <arm_group_label>Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE</arm_group_label> <arm_group_label>Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy</arm_group_label> <arm_group_label>Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>G-EYE</intervention_name> <description>The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.</description> <arm_group_label>Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE</arm_group_label> <arm_group_label>Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Screening and surveillance population for Adenoma and CRC.  2. The patient must understand and sign a written informed consent for the procedure.  Exclusion Criteria:  1. Subjects with inflammatory bowel disease;  2. Subjects with a personal history of hereditary polyposis syndrome;  3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;  4. Subjects with diverticulitis or toxic megacolon;  5. Subjects with prior colonic surgery (exclusion appendectomy)  6. Subjects with a history of radiation therapy to abdomen or pelvis;  7. Pregnant or lactating female subjects;  8. Subjects who are currently enrolled in another clinical investigation.  9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.  10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)  11. Any patient condition deemed too risky for the study by the investigator </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ralf Kiesslich, Prof.</last_name> <role>Principal Investigator</role> <affiliation>Helios Dr. Horst Schmidt Kliniken Wiesbaden</affiliation> </overall_official> <overall_contact> <last_name>Ralf Kiesslich, Prof.</last_name> <phone>49-611432421</phone> <email>Ralf.Kiesslich@helios-gesundheit.de</email> </overall_contact> <location> <facility> <name>Helios Dr. Horst Schmidt Kliniken</name> <address> <city>Wiesbaden</city> <zip>65199</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ralf Kiesslich, Prof.</last_name> <phone>49-611432421</phone> <email>ralf.kiesslich@helios-gesundheit.de</email> </contact> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Dr. Horst Schmidt Klinik GmbH</investigator_affiliation> <investigator_full_name>Prof. Dr. Ralf Kiesslich</investigator_full_name> <investigator_title>Prof.</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Adenoma</mesh_term> </condition_browse>  </clinical_study>

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. 3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning. Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. 3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning. Total of up to 372 patients will be randomized,186 to each of the two tandems Inclusion Criteria: 1. Screening and surveillance population for Adenoma and CRC. 2. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of hereditary polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with prior colonic surgery (exclusion appendectomy) 6. Subjects with a history of radiation therapy to abdomen or pelvis; 7. Pregnant or lactating female subjects; 8. Subjects who are currently enrolled in another clinical investigation. 9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 11. Any patient condition deemed too risky for the study by the investigator

NCT0531xxxx/NCT05318508.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/NCT05318508</url> </required_header> <id_info> <org_study_id>E2/AMPUTATION/2021</org_study_id> <nct_id>NCT05318508</nct_id> </id_info> <brief_title>Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation</brief_title> <official_title>Sagittal Spinopelvic Parameters in Patients With Lower Extremity Amputation</official_title> <sponsors> <lead_sponsor> <agency>Hitit University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Hitit 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> The aim of this study is to investigate the relationship between sagittal spinopelvic parameters and low back pain and quality of life in individuals with lower extremity amputation. </textblock> </brief_summary> <detailed_description> <textblock> Low back pain is one of the secondary health problems that negatively affect functionality, independence and quality of life in individuals with lower extremity amputation. The prevalence of low back pain was reported to be higher in individuals with lower extremity amputation (52-89%) than in the non-amputee population (12-45%). Although the etiology of low back pain is multifactorial, changing anatomy and biomechanics after lower extremity amputation and maintaining daily activities are often associated with the development of low back pain. Postural imbalance, which is one of the musculoskeletal disorders of the spine that contributes to low back pain, is considered to cause additional load on the spinal structures. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 10, 2022</start_date> <completion_date type="Anticipated">March 2023</completion_date> <primary_completion_date type="Anticipated">March 2023</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Thoracic kyphosis</measure> <time_frame>baseline</time_frame> <description>The angle between the line drawn perpendicular to the line through the T4 upper end plate and the lines drawn perpendicular to the line through the T12 lower end plate.</description> </primary_outcome> <secondary_outcome> <measure>Cervical lordosis</measure> <time_frame>baseline</time_frame> </secondary_outcome> <secondary_outcome> <measure>Lumbar lordosis</measure> <time_frame>baseline</time_frame> </secondary_outcome> <secondary_outcome> <measure>Pelvic tilt</measure> <time_frame>baseline</time_frame> </secondary_outcome> <secondary_outcome> <measure>Pelvic incidence</measure> <time_frame>baseline</time_frame> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">30</enrollment> <condition>Amputation, Traumatic</condition> <condition>Low Back Pain</condition> <arm_group> <arm_group_label>patients with low back pain</arm_group_label> </arm_group> <arm_group> <arm_group_label>patients without low back pain</arm_group_label> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Measurements of sagittal spinopelvic parameters</intervention_name> <description>Sagittal spinopelvic parameters will be measured from lateral cervicothoracolumbar radiographs of patients with lower extremity amputation.</description> <arm_group_label>patients with low back pain</arm_group_label> <arm_group_label>patients without low back pain</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Lower extremity amputation </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patients aged ≥ 18 and ≤ 65 years  - Patients followed for at least 12 months with lower extremity amputation  - Patients who have been using prosthesis for at least 3 months  - Patients with stable medical and psychological status  - Patients willing to participate in the study  Exclusion Criteria:  - Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking  - Patients with severe vision, hearing and language problems </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Gaziler Physical Therapy and Rehabilitation Education and Research Hospital</name> <address> <city>Ankara</city> <country>Turkey</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Tuğba Atan</last_name> <phone>+90312 291 10 00</phone> <email>tubaatan@gmail.com</email> </contact> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>January 27, 2023</last_update_submitted> <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 30, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Hitit University</investigator_affiliation> <investigator_full_name>Tuğba Atan, MD</investigator_full_name> <investigator_title>Assoc. Prof</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Low Back Pain</mesh_term> <mesh_term>Amputation, Traumatic</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The aim of this study is to investigate the relationship between sagittal spinopelvic parameters and low back pain and quality of life in individuals with lower extremity amputation. Low back pain is one of the secondary health problems that negatively affect functionality, independence and quality of life in individuals with lower extremity amputation. The prevalence of low back pain was reported to be higher in individuals with lower extremity amputation (52-89%) than in the non-amputee population (12-45%). Although the etiology of low back pain is multifactorial, changing anatomy and biomechanics after lower extremity amputation and maintaining daily activities are often associated with the development of low back pain. Postural imbalance, which is one of the musculoskeletal disorders of the spine that contributes to low back pain, is considered to cause additional load on the spinal structures. Lower extremity amputation Inclusion Criteria: - Patients aged ≥ 18 and ≤ 65 years - Patients followed for at least 12 months with lower extremity amputation - Patients who have been using prosthesis for at least 3 months - Patients with stable medical and psychological status - Patients willing to participate in the study Exclusion Criteria: - Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking - Patients with severe vision, hearing and language problems

NCT0531xxxx/NCT05318521.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/NCT05318521</url> </required_header> <id_info> <org_study_id>OVEIBUA20201225</org_study_id> <nct_id>NCT05318521</nct_id> </id_info> <brief_title>RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee</brief_title> <official_title>A Randomized, Double-Blind, Parallel-Arm Study Comparing the Efficacy of Investigational Product "Ibuprofen Modified-Release Tablets 800 mg" and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee</official_title> <sponsors> <lead_sponsor> <agency>Overseas Pharmaceuticals, Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Virginia Contract Research Organization Co., Ltd.</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Overseas Pharmaceuticals, Ltd.</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> It is a Phase III efficacy study as the title 'A randomized, double-blind, parallel-arm study comparing the efficacy of investigational product "Ibuprofen Modified-Release Tablets 800 mg" and placebo in patients with chronic pain related to osteoarthritis of the knee.' The primary objective is to determine the analgesic efficacy of orally administered IBUMR in patients with osteoarthritis (OA) of the knee.  The Secondary objectives are to compare the treatment effect on patient pain, function and stiffness between IBUMR- and placebo-treated patients as measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC), to compare the treatment effect on Patient Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the treatment effect on Investigator's Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the use of analgesic rescue medicine between IBUMR- and placebo-treated patients, to determine the safety profile of IBUMR. </textblock> </brief_summary> <detailed_description> <textblock> The study is a randomized, double-blinded, placebo-controlled, parallel group-study. The duration will be approximately 127 days (4 weeks screening; 12 weeks treatment; 2 weeks follow-up. Currently, Approximately 9 sites in Taiwan and 6 sites in the United States have been selected. Approximately 500 evaluable patients will be enrolled and randomly assigned to receive IBUMR or placebo at a fixed ratio of 1:1. The treatment regimen will be dosing twice a day (BID) for a total of 12 weeks.. The randomized, IP-treated subject with baseline value for primary analysis will be considered evaluable. Considering an estimated randomization failure rate of 10%, approximately 556 eligible patients will be recruited.  For Primary Endpoint, WOMAC Pain will be measured using visual analogue scale (VAS) ranging from 0 mm (no pain) to 100 mm (extreme pain) at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85).  For secondary endpoint, WOMAC Physical function will be measured using VAS ranging from 0 mm (no difficulty) to 100 mm (extreme difficulty) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC stiffness will be measured using VAS ranging from 0 mm (no stiffness) to 100 mm (maximum stiffness) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC Total Index will be calculated at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions.  For other secondary endpoints, Patients will perform a PGADS via a 0-100 mm VAS, ranging from 0 mm (best ever) to 100 mm (worst ever) with respect to "Considering all the ways your arthritis conditionhas affected you, how do you feel your arthritis is today? " PGADS will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. The degree of the patient's disease status, based on the Investigator's judgment, in terms of pain intensity, joint swelling and tenderness, functional capacity and ability to flex the knee will be assessed by an established IGADS (0-4 point Likert scale), ranging from 0 (very well) to 4 (very poor). IGADS scores will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85.  Safety will also be monitored and evaluated by changes occurring at the baseline and during treatment periods.  Subjects may withdraw from this study due to reasons. A withdrawal occurs when an enrolled patient ceases to participate in the study, regardless of the circumstances, prior to completion of the protocol. The investigators should try their best to complete the evaluation items for the final evaluation visit upon a patient's withdrawal. The reason for a patient withdrawn from the study will be recorded in the case report form (CRF) and in the patient's medical record.  The sample size of this study was based on results from a previous study (Puopolo et al., 2007(2)) which suggested that the least-square mean (95% CI) change in WOMAC pain scores (WOMAC-PS) from baseline is -24.10 (-27.20, -20.99) for treatment group (2400 mg/day; 800 mg TID) and -16.47 (-20.55, -12.40) for placebo group, respectively.  Considering the regimen of our study product (1600 mg; 800 mg BID) and the primary estimand which imputes efficacy data with baseline values for subjects with intercurrent events, we adjusted the treatment effect to -6.005 which is conditional under a 20% reduction in the treatment effect from the study by Puopolo et al. in 2007 (i.e., -7.63 = -24.10 - (-16.47)) and the effect of data imputation, which the proportions of missing data are assumed to be 15% in treatment group and 20% in control group.  A sample size of 250 in each group will have ≥ 85% power to detect a difference in means of -6.005 between treatment and control groups, assuming that the standard deviation for treatment group (t) is 22.879 and the standard deviation for placebo group (p) is 21.463, using a two group Satterthwaite t-test with a 0.050 two-sided significance level.  Analyses on efficacy endpoints will utilize mITT population. A sensitivity analysis using PP population to analyze efficacy endpoints will be conducted if more than 20% of patients are excluded from PP population. Safety evaluation will be performed on mITT population. The conclusion of efficacy (i.e., primary endpoint analysis) of the study will be made according to the results of mITT analysis. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 10, 2021</start_date> <completion_date type="Anticipated">October 19, 2022</completion_date> <primary_completion_date type="Anticipated">August 2022</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>Approximately 500 evaluable patients will be enrolled. The randomized, IP-treated subject with baseline value for primary analysis will be considered evaluable. Considering an estimated randomization failure rate of 10%, approximately 556 eligible patients will be recruited. Eligible patients will be randomly assigned to receive IBUMR or placebo at a fixed ratio of 1:1. The treatment regimen will be dosing twice a day (BID) for a total of 12 weeks.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> <masking_description>Double-blinded.</masking_description> </study_design_info> <primary_outcome> <measure>Change from baseline in the WOMAC visual analogue 3.1 Pain intensity subscale, over 12 weeks of treatment. [Time frame: Baseline week up to Week 12]</measure> <time_frame>at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85).</time_frame> <description>WOMAC Pain will be measured using visual analogue scale (VAS) ranging from 0 mm (no pain) to 100 mm (extreme pain)</description> </primary_outcome> <secondary_outcome> <measure>1. Change from baseline in WOMAC Physical function subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]</measure> <time_frame>at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85</time_frame> <description>WOMAC Physical function will be measured using VAS ranging from 0 mm (no difficulty) to 100 mm (extreme difficulty)</description> </secondary_outcome> <secondary_outcome> <measure>2. Change from baseline in WOMAC Joint stiffness subscale of the knee over 12 weeks of treatment. [Time frame: Baseline up to Week 12]</measure> <time_frame>at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85</time_frame> <description>WOMAC stiffness will be measured using VAS ranging from 0 mm (no stiffness) to 100 mm (maximum stiffness)</description> </secondary_outcome> <secondary_outcome> <measure>3. Change from baseline in WOMAC Total Index over 12 weeks of treatment. [Time frame: Baseline up to Week 12]</measure> <time_frame>at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions.</time_frame> <description>WOMAC Total Index will be calculated</description> </secondary_outcome> <other_outcome> <measure>The ≥ 30% and ≥ 50% responder rate of percent improvement</measure> <time_frame>from baseline to Week 12</time_frame> <description>use the WOMAC Pain intensity subscale</description> </other_outcome> <other_outcome> <measure>Mean change from baseline</measure> <time_frame>over 12 weeks of treatment. [Time frame: Baseline up to Week 12]</time_frame> <description>use Patient Global Assessment of Disease Status (PGADS) .a PGADS via a 0-100 mm VAS, ranging from 0 mm (best ever) to 100 mm (worst ever)</description> </other_outcome> <other_outcome> <measure>Mean change from baseline in IGADS</measure> <time_frame>at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85.</time_frame> <description>The degree of the patient's disease status, based on the Investigator's judgment, in terms of pain intensity, joint swelling and tenderness, functional capacity and ability to flex the knee will be assessed by an established IGADS (0-4 point Likert scale), ranging from 0 (very well) to 4 (very poor). IGADS scores will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85.</description> </other_outcome> <other_outcome> <measure>Mean use of rescue medication (daily average number of tablets)</measure> <time_frame>[Time frame: Baseline up to Week 12]</time_frame> <description>record and statistically analyse the mean use of rescue medication (daily average number of tablets) for each arm</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">500</enrollment> <condition>Degenerative Arthritis</condition> <arm_group> <arm_group_label>Ibuprofen Modified-Release Tablets 800 mg (IBUMR)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Ibuprofen Modified-Release Tablets 800 mg (IBUMR), twice daily with 12h interval, for 12-week treatment period.</description> </arm_group> <arm_group> <arm_group_label>placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>placebo 800mg, twice daily with 12h interval, for 12-week treatment period.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>The 800mg ibuprofen sustained-release tablet is the same as the next generation of ibuprofen sustained-release tablets developed by foreign pharmaceutical companies, but does not contain a placebo that the active ingredient of ibuprofen</description> <arm_group_label>placebo</arm_group_label> <other_name>IBUMR</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ibuprofen modified release tablet 800 mg</intervention_name> <description>Medication: ibuprofen modified sustained release tablets 800 mg Ibuprofen sustained Release Tablet 800mg is a new generation of ibuprofen developed by overseas pharmaceutical companies. It works fast and lasts for up to 12 hours. The dosing regimen was twice daily, 12 hours apart. Ibuprofen :2-[4-(2-methylpropyl) phenyl] propionic acid, nonselective nonsteroidal anti-inflammatory drug (NSAID).</description> <arm_group_label>Ibuprofen Modified-Release Tablets 800 mg (IBUMR)</arm_group_label> <other_name>IBUMR</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Male and female patients ≥18 years of age at the screening visit.  2. Patients diagnosed with symptomatic OA of the knee based on the American College of Rheumatology (ACR) clinical criteria and have an American Rheumatology Association (ARA) functional class rating of I, II, or III (1), for ≥ 3 months prior to date of screening; with recent (≤ 6 months) radiographic evidence of tibiofemoral OA: ≥ Grade 2 on the Kellgren & Lawrence scale. (In cases where both knees are affected, the most painful knee joint is selected as the target knee for study evaluation).  3. Patients had been prescribed NSAIDs or acetaminophen to treat their OA-related pain for at least 3 months prior to the screening visit.  4. Following discontinuation of analgesic medication (a washout period of at least 5 times the half-life (prior to Day -7), plus a subsequent additional 7 days prior to Baseline visit (Day -7 to Day-1), patients must have a reported pain score of at least 40 mm for WOMAC Pain intensity question: 'walking on a flat surface' at Baseline Visit.  5. Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form or legal representative if he/she is under the statutory age of consent as per the local authority.  Exclusion Criteria:  1. Patients with a history of gastroduodenal perforations and/or obstructions; gastric and/or duodenal surgery; recent (≤ 6 months) active gastrointestinal (GI) ulceration; inflammatory bowel disease; GI bleeding in the past year.  2. Patients with a history of congestive heart failure, coronary artery disease, renal artery stenosis or recent (within 1 year) myocardial infarction, angina, stroke, or transient ischemic attack and/or with uncontrolled hypertension.  3. Patients with moderate to severe hepatic impairment (alanine aminotransferase [ALT] or aspartate transaminase [AST] concentrations > 2.5 times the upper limit of normal).  4. Patients with a medical condition (e.g., a cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine [adrenal hyperplasia], immunologic, dermatologic, neurologic, oncologic, or psychiatric) or a significant laboratory abnormality that, in the Investigator's opinion, would jeopardize the safety of the patient or is likely to confound the study measurements.  5. Patients receiving ongoing opioid therapy for their OA-related pain; or requiring ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments known to interfere with pain perception. (Note: 'stabilized' is defined as being used for at least 3 months).  6. Patients who have received intra-articular injection of corticosteroids, hyaluronic acid or platelet-rich plasma in the target knee within 6 months prior to the screening visit (within 1 year for long-acting formulations); or have received opioid medication within 14 days prior to the screening visit.  7. Patients who are unable to be prescribed NSAIDs or are known or suspected to have hypersensitivity to study medication or their excipients.  8. Patients who have participated in investigational drug trials and took any investigational therapy within 90 days or a time of 5 half-lives prior to the study dosing.  9. Patients currently pregnant, lactating, or planning to pregnant during the trial period. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods mentioned below, during dosing and for at least 4 weeks after stopping study treatment.  - Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.  - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.  - Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.  - Combination of any two of the following listed methods: (a+b or a+c, or b+c):  1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.  2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).  3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.  10. Subjects with underlying medical, mental, psychological, or other inappropriate conditions that would impair treatment compliance, or in the opinion of the Investigator would not permit to participate in the study. </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>Pamela Kane</last_name> <role>Principal Investigator</role> <affiliation>Palm Beach Research Center</affiliation> </overall_official> <overall_contact> <last_name>huaihan Cai</last_name> <phone>+86 183 5261 6957</phone> <email>caihuaihan@overseaspharm.com</email> </overall_contact> <location> <facility> <name>Palm Beach Research Center</name> <address> <city>West Palm Beach</city> <state>Florida</state> <zip>33409</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Nora Norcross</last_name> <phone>561-689-0606</phone> <phone_ext>304</phone_ext> <email>Nora@PalmBeachResearch.com</email> </contact> <investigator> <last_name>Pamela Kane, M.D.</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>December 2021</verification_date> <study_first_submitted>December 20, 2021</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 13, 2022</last_update_submitted> <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Ibuprofen Modified-Release Tablets</keyword> <keyword>chronic pain related to osteoarthritis of the knee</keyword> <keyword>general pain</keyword> <keyword>fast onset and longer effectiveness</keyword> <condition_browse>  <mesh_term>Osteoarthritis</mesh_term> <mesh_term>Osteoarthritis, Knee</mesh_term> <mesh_term>Chronic Pain</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Ibuprofen</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

It is a Phase III efficacy study as the title 'A randomized, double-blind, parallel-arm study comparing the efficacy of investigational product "Ibuprofen Modified-Release Tablets 800 mg" and placebo in patients with chronic pain related to osteoarthritis of the knee.' The primary objective is to determine the analgesic efficacy of orally administered IBUMR in patients with osteoarthritis (OA) of the knee. The Secondary objectives are to compare the treatment effect on patient pain, function and stiffness between IBUMR- and placebo-treated patients as measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC), to compare the treatment effect on Patient Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the treatment effect on Investigator's Global Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the use of analgesic rescue medicine between IBUMR- and placebo-treated patients, to determine the safety profile of IBUMR. The study is a randomized, double-blinded, placebo-controlled, parallel group-study. The duration will be approximately 127 days (4 weeks screening; 12 weeks treatment; 2 weeks follow-up. Currently, Approximately 9 sites in Taiwan and 6 sites in the United States have been selected. Approximately 500 evaluable patients will be enrolled and randomly assigned to receive IBUMR or placebo at a fixed ratio of 1:1. The treatment regimen will be dosing twice a day (BID) for a total of 12 weeks.. The randomized, IP-treated subject with baseline value for primary analysis will be considered evaluable. Considering an estimated randomization failure rate of 10%, approximately 556 eligible patients will be recruited. For Primary Endpoint, WOMAC Pain will be measured using visual analogue scale (VAS) ranging from 0 mm (no pain) to 100 mm (extreme pain) at baseline week (Day -6 to Day 1) and at Day 8, 15, 22, 29, 43, 57 and Week 12 (Day 79 to Day 85). For secondary endpoint, WOMAC Physical function will be measured using VAS ranging from 0 mm (no difficulty) to 100 mm (extreme difficulty) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC stiffness will be measured using VAS ranging from 0 mm (no stiffness) to 100 mm (maximum stiffness) at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. WOMAC Total Index will be calculated at baseline (Day 1) and Day 8, 15, 22, 29, 43, 57 and 85 as sum of scores of all 24 WOMAC questions. For other secondary endpoints, Patients will perform a PGADS via a 0-100 mm VAS, ranging from 0 mm (best ever) to 100 mm (worst ever) with respect to "Considering all the ways your arthritis conditionhas affected you, how do you feel your arthritis is today? " PGADS will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. The degree of the patient's disease status, based on the Investigator's judgment, in terms of pain intensity, joint swelling and tenderness, functional capacity and ability to flex the knee will be assessed by an established IGADS (0-4 point Likert scale), ranging from 0 (very well) to 4 (very poor). IGADS scores will be calculated periodically, at baseline (Day 1) and at Day 8, 15, 22, 29, 43, 57 and 85. Safety will also be monitored and evaluated by changes occurring at the baseline and during treatment periods. Subjects may withdraw from this study due to reasons. A withdrawal occurs when an enrolled patient ceases to participate in the study, regardless of the circumstances, prior to completion of the protocol. The investigators should try their best to complete the evaluation items for the final evaluation visit upon a patient's withdrawal. The reason for a patient withdrawn from the study will be recorded in the case report form (CRF) and in the patient's medical record. The sample size of this study was based on results from a previous study (Puopolo et al., 2007(2)) which suggested that the least-square mean (95% CI) change in WOMAC pain scores (WOMAC-PS) from baseline is -24.10 (-27.20, -20.99) for treatment group (2400 mg/day; 800 mg TID) and -16.47 (-20.55, -12.40) for placebo group, respectively. Considering the regimen of our study product (1600 mg; 800 mg BID) and the primary estimand which imputes efficacy data with baseline values for subjects with intercurrent events, we adjusted the treatment effect to -6.005 which is conditional under a 20% reduction in the treatment effect from the study by Puopolo et al. in 2007 (i.e., -7.63 = -24.10 - (-16.47)) and the effect of data imputation, which the proportions of missing data are assumed to be 15% in treatment group and 20% in control group. A sample size of 250 in each group will have ≥ 85% power to detect a difference in means of -6.005 between treatment and control groups, assuming that the standard deviation for treatment group (t) is 22.879 and the standard deviation for placebo group (p) is 21.463, using a two group Satterthwaite t-test with a 0.050 two-sided significance level. Analyses on efficacy endpoints will utilize mITT population. A sensitivity analysis using PP population to analyze efficacy endpoints will be conducted if more than 20% of patients are excluded from PP population. Safety evaluation will be performed on mITT population. The conclusion of efficacy (i.e., primary endpoint analysis) of the study will be made according to the results of mITT analysis. Inclusion Criteria: 1. Male and female patients ≥18 years of age at the screening visit. 2. Patients diagnosed with symptomatic OA of the knee based on the American College of Rheumatology (ACR) clinical criteria and have an American Rheumatology Association (ARA) functional class rating of I, II, or III (1), for ≥ 3 months prior to date of screening; with recent (≤ 6 months) radiographic evidence of tibiofemoral OA: ≥ Grade 2 on the Kellgren & Lawrence scale. (In cases where both knees are affected, the most painful knee joint is selected as the target knee for study evaluation). 3. Patients had been prescribed NSAIDs or acetaminophen to treat their OA-related pain for at least 3 months prior to the screening visit. 4. Following discontinuation of analgesic medication (a washout period of at least 5 times the half-life (prior to Day -7), plus a subsequent additional 7 days prior to Baseline visit (Day -7 to Day-1), patients must have a reported pain score of at least 40 mm for WOMAC Pain intensity question: 'walking on a flat surface' at Baseline Visit. 5. Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form or legal representative if he/she is under the statutory age of consent as per the local authority. Exclusion Criteria: 1. Patients with a history of gastroduodenal perforations and/or obstructions; gastric and/or duodenal surgery; recent (≤ 6 months) active gastrointestinal (GI) ulceration; inflammatory bowel disease; GI bleeding in the past year. 2. Patients with a history of congestive heart failure, coronary artery disease, renal artery stenosis or recent (within 1 year) myocardial infarction, angina, stroke, or transient ischemic attack and/or with uncontrolled hypertension. 3. Patients with moderate to severe hepatic impairment (alanine aminotransferase [ALT] or aspartate transaminase [AST] concentrations > 2.5 times the upper limit of normal). 4. Patients with a medical condition (e.g., a cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine [adrenal hyperplasia], immunologic, dermatologic, neurologic, oncologic, or psychiatric) or a significant laboratory abnormality that, in the Investigator's opinion, would jeopardize the safety of the patient or is likely to confound the study measurements. 5. Patients receiving ongoing opioid therapy for their OA-related pain; or requiring ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments known to interfere with pain perception. (Note: 'stabilized' is defined as being used for at least 3 months). 6. Patients who have received intra-articular injection of corticosteroids, hyaluronic acid or platelet-rich plasma in the target knee within 6 months prior to the screening visit (within 1 year for long-acting formulations); or have received opioid medication within 14 days prior to the screening visit. 7. Patients who are unable to be prescribed NSAIDs or are known or suspected to have hypersensitivity to study medication or their excipients. 8. Patients who have participated in investigational drug trials and took any investigational therapy within 90 days or a time of 5 half-lives prior to the study dosing. 9. Patients currently pregnant, lactating, or planning to pregnant during the trial period. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods mentioned below, during dosing and for at least 4 weeks after stopping study treatment. - Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. - Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject. - Combination of any two of the following listed methods: (a+b or a+c, or b+c): 1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. 10. Subjects with underlying medical, mental, psychological, or other inappropriate conditions that would impair treatment compliance, or in the opinion of the Investigator would not permit to participate in the study.

NCT0531xxxx/NCT05318534.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/NCT05318534</url> </required_header> <id_info> <org_study_id>GL0719-01</org_study_id> <secondary_id>2021-004925-57</secondary_id> <nct_id>NCT05318534</nct_id> </id_info> <brief_title>Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects</brief_title> <official_title>GL-0719 - A Phase 1, Double-blind, Placebo-controlled, Single Ascending Intravenous and Subcutaneous Injection Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects</official_title> <sponsors> <lead_sponsor> <agency>Gliknik Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Gliknik Inc.</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 first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in healthy adult male and female subjects. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 8, 2022</start_date> <completion_date type="Anticipated">October 2023</completion_date> <primary_completion_date type="Anticipated">October 2023</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> </study_design_info> <primary_outcome> <measure>Incidence and severity of adverse events (AEs)</measure> <time_frame>Day 1 to Follow-up (Day 31±2)</time_frame> </primary_outcome> <primary_outcome> <measure>Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results</measure> <time_frame>Screening (Days -42 to -15) to Follow-up (Day 31±2)</time_frame> </primary_outcome> <primary_outcome> <measure>Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, physical examination and measurement of cytokines</measure> <time_frame>Screening (Days -42 to -15) to Follow-up (Day 31±2)</time_frame> </primary_outcome> <secondary_outcome> <measure>Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)</measure> <time_frame>Day 1 to Follow-up (Day 31±2)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Area Under the Concentration time Curve from Time 0 to the Time of the Last (AUC0-tlast)</measure> <time_frame>Day 1 to Follow-up (Day 31±2)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Maximum Observed Concentration (Cmax)</measure> <time_frame>Day 1 to Follow-up (Day 31±2)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time of the maximum observed concentration (tmax)</measure> <time_frame>Day 1 to Follow-up (Day 31±2)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Apparent terminal elimination half-life (t1/2)</measure> <time_frame>Day 1 to Follow-up (Day 31±2)</time_frame> </secondary_outcome> <secondary_outcome> <measure>The degree of complement classical pathway inhibition in study subjects over time as evaluated by the MicroVue CH50 Eq EIA assay</measure> <time_frame>Day 1 to Follow-up (Day 31±2)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Incidence of anti-drug antibodies</measure> <time_frame>Day -1, Day 15±1 and Follow-up (Day 31±2)</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">52</enrollment> <condition>First in Man Study to Evaluate Initial Safety</condition> <arm_group> <arm_group_label>GL-0719</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Dose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively. The study will comprise a single-dose, sequential-group design. Single Ascending IV Dose Cohorts Cohort 1: 4 subjects Cohort 2: 8 subjects Cohort 3: 8 subjects Cohort 4: 8 subjects Cohort 5: 8 subjects Subcutaneous Injection Cohort Cohort 6: 8 subjects Cohort 7: 8 subjects</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Dose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively. The study will comprise a single-dose, sequential-group design. Single Ascending IV Dose Cohorts Cohort 1: 4 subjects Cohort 2: 8 subjects Cohort 3: 8 subjects Cohort 4: 8 subjects Cohort 5: 8 subjects Subcutaneous Injection Cohort Cohort 6: 8 subjects Cohort 7: 8 subjects</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>GL-0719</intervention_name> <description>Administration route: intravenous infusion and subcutaneous injection</description> <arm_group_label>GL-0719</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Administration route: intravenous infusion and subcutaneous injection</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Healthy female or male subjects who, at the time of screening, are between the ages of 18 and 65 years, inclusive.  2. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.  3. Body mass index of 18.0 to 32.0 kg/m^2, inclusive; and a total body weight > 50 kg up to a maximum of 110 kg.  4. Study subjects must have received a quadrivalent meningococcal conjugate vaccine (meningococcal serogroups A, C, W, and Y) within the past 5 years or vaccination a minimum of 14 days prior to initial study drug administration.  5. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.  6. The subject must be willing to return to the study center for study treatment and study-related follow-up procedures as required by the protocol.  Exclusion Criteria:  1. History of any clinically significant (as determined by the investigator) cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or other major disease.  2. Evidence of clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.  3. Signs and symptoms of, or diagnosis consistent with a chronic autoimmune disorder and/or positive antinuclear antibodies (ANA) test by indirect immunofluorescence confirmed by ANA titer ≥ 1:160.  4. Documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.  5. Any underlying medical condition that, in the opinion of the investigator, renders the subject a poor candidate for this study or could confound the results of the study or put the subject at undue risk.  6. Concurrent medical condition requiring the chronic concurrent use of systemic steroids or immunosuppressants.  7. Subjects with ANY of the following abnormalities in clinical laboratory tests at screening or on admission, as assessed by the study-specific laboratory and confirmed by a single repeat tests, if deemed necessary:  - Aspartate aminotransferase or alanine aminotransferase level >1.25 × upper limit of normal (ULN).  - Total bilirubin level > ULN; subjects with a history of Gilberts syndrome will not be eligible for the study.  - Serum creatinine levels > ULN.  - Estimated glomerular filtration rate of < 80 mL/min/1.73m^2 (screening only) calculated using the Modification of Diet in Renal Disease (MDRD) equation.  8. Any history of thromboembolic events or coagulopathy.  9. Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the subject has been disease-free for ≥ 5 years.  10. Active infection or other immunocompromising condition requiring IV treatment within 28 days of study treatment on Day 1.  11. Prior splenectomy or organ allograft.  Other protocol defined inclusion/exclusion criteria may apply. </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>Jim Bush, MBChB, PhD</last_name> <role>Principal Investigator</role> <affiliation>Fortrea Clinical Research Unit Ltd.</affiliation> </overall_official> <overall_contact> <last_name>Gliknik Clinical Trials Group</last_name> <phone>410-665-0662</phone> <email>gliknikclinicaltrialinquiries@gliknik.com</email> </overall_contact> <location> <facility> <name>Fortrea Clinical Research Unit Ltd</name> <address> <city>Leeds</city> <zip>LS2 9LH</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jim Bush, MBChB, PhD</last_name> <phone>01133013500</phone> </contact> <investigator> <last_name>Jim Bush, MBChB, PhD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 26, 2023</last_update_submitted> <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 28, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>complement-mediated diseases</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in healthy adult male and female subjects. Inclusion Criteria: 1. Healthy female or male subjects who, at the time of screening, are between the ages of 18 and 65 years, inclusive. 2. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. 3. Body mass index of 18.0 to 32.0 kg/m^2, inclusive; and a total body weight > 50 kg up to a maximum of 110 kg. 4. Study subjects must have received a quadrivalent meningococcal conjugate vaccine (meningococcal serogroups A, C, W, and Y) within the past 5 years or vaccination a minimum of 14 days prior to initial study drug administration. 5. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent. 6. The subject must be willing to return to the study center for study treatment and study-related follow-up procedures as required by the protocol. Exclusion Criteria: 1. History of any clinically significant (as determined by the investigator) cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or other major disease. 2. Evidence of clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study. 3. Signs and symptoms of, or diagnosis consistent with a chronic autoimmune disorder and/or positive antinuclear antibodies (ANA) test by indirect immunofluorescence confirmed by ANA titer ≥ 1:160. 4. Documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy. 5. Any underlying medical condition that, in the opinion of the investigator, renders the subject a poor candidate for this study or could confound the results of the study or put the subject at undue risk. 6. Concurrent medical condition requiring the chronic concurrent use of systemic steroids or immunosuppressants. 7. Subjects with ANY of the following abnormalities in clinical laboratory tests at screening or on admission, as assessed by the study-specific laboratory and confirmed by a single repeat tests, if deemed necessary: - Aspartate aminotransferase or alanine aminotransferase level >1.25 × upper limit of normal (ULN). - Total bilirubin level > ULN; subjects with a history of Gilberts syndrome will not be eligible for the study. - Serum creatinine levels > ULN. - Estimated glomerular filtration rate of < 80 mL/min/1.73m^2 (screening only) calculated using the Modification of Diet in Renal Disease (MDRD) equation. 8. Any history of thromboembolic events or coagulopathy. 9. Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the subject has been disease-free for ≥ 5 years. 10. Active infection or other immunocompromising condition requiring IV treatment within 28 days of study treatment on Day 1. 11. Prior splenectomy or organ allograft. Other protocol defined inclusion/exclusion criteria may apply.

NCT0531xxxx/NCT05318547.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/NCT05318547</url> </required_header> <id_info> <org_study_id>PREFER-PP</org_study_id> <nct_id>NCT05318547</nct_id> </id_info> <brief_title>Assessing Women's Preferences for Postpartum Thromboprophylaxis: the PREFER-PostPartum</brief_title> <acronym>PREFER-PP</acronym> <official_title>Assessing Women's Preferences for Postpartum Thromboprophylaxis: the PREFER-PostPartum</official_title> <sponsors> <lead_sponsor> <agency>Fondation Hôpital Saint-Joseph</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fondation Hôpital Saint-Joseph</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 risk of venous thromboembolism (VTE), which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE), increases during pregnancy and most strikingly in the postpartum period (6 weeks after delivery). Extensive research efforts have led to the identification of many risk factors for VTE events. Examples of such factors include maternal characteristics (personal history of VTE, thrombophilia, obesity, race) and obstetrical characteristics (methods of delivery, pre-term delivery, growth retardation). These allow care providers to risk stratify women at the time of delivery into low, moderate and high-risk women, based on experts' opinion. Further, a risk score, which was recently developed and validated on English and Swedish populations, estimates the risk of postpartum VTE in individuals.  Thromboprophylaxis (TPX) focuses on the use of short-term low-molecular-weight heparin (LMWH). LMWH is believed to reduce the risk of VTE by 50-70%, but the evidence is indirect, with a lack of large-scale randomized trial in the setting of the postpartum period. Further, LMWH is both inconvenient (subcutaneous injections) and possibly associated with haemorrhagic side effects. Alternative drugs do not exist, because direct oral anticoagulants (DOAC) and aspirin are not studied in this setting and because DOAC are contra-indicated in pregnancy and breastfeeding.  Given the unclear balance of benefits and risks, current guidelines vary greatly in the proportion of women with recommended TPX. Gassmann et al. have recently demonstrated, among a cohort of parturients at the Geneva University Hospitals: a recommendation of postpartum TPX in 40.1% of women, with an estimated mean risk of postpartum VTE of 0.12%, according to the 2015 UK guidelines (RCOG), and a recommendation of postpartum TPX in 8.7% of women, with an estimated mean risk of postpartum VTE of 0.20%, according to the 2018 US guidance (ACOG).These low risks of VTE to trigger a recommendation of TPX use contrast with that of experts' opinions, which advocate for a threshold of VTE risk of 1-3% to recommend the use of TPX. Currently, all women delivering by C-section in Geneva receive TPX regardless of their VTE risk.  This dramatic discrepancy of TPX guidance between guidelines, and between guidelines and individual experts, highlights the uncertainty in this setting. Womens' preferences would be critically important here, to guide a rationale and desired use of TPX. Quite surprisingly, such preferences have never been elicited, in spite of the very large number of births every year (5 and 4 million in Europe and the US, respectively).  To inform prescription patterns of postpartum TPX, investigators propose to conduct this prospective study to elicit values and preferences of pregnant and postpartum women. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 13, 2022</start_date> <completion_date type="Anticipated">December 31, 2024</completion_date> <primary_completion_date type="Anticipated">January 12, 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> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Definition of the Threshold of Risk for Postpartum Venous Thromboembolism</measure> <time_frame>Day 1</time_frame> <description>This outcome corresponds to the threshold of risk of postpartum Venous thromboembolism at which women prefer the use of short-term postpartum TPX with LMWH over no treatment.</description> </primary_outcome> <secondary_outcome> <measure>Correlation of the time of interview (antenatal vs. postnatal) with the risk threshold</measure> <time_frame>Day 1</time_frame> <description>This outcome corresponds to the determinants of this threshold within the time of interview (antenatal vs. postnatal).</description> </secondary_outcome> <secondary_outcome> <measure>Correlation of demographic factors with the risk threshold</measure> <time_frame>Day 1</time_frame> <description>This outcome corresponds tof this threshold within the time of interview (antenatal vs. postnatal), demographic factors.</description> </secondary_outcome> <secondary_outcome> <measure>Correlation of medical factors with the risk threshold</measure> <time_frame>Day 1</time_frame> <description>This outcome corresponds to tDeterminants of this threshold within the time of interview (antenatal vs. postnatal) medical factors.</description> </secondary_outcome> <secondary_outcome> <measure>Correlation of obstetric factors with the risk threshold</measure> <time_frame>Day 1</time_frame> <description>This outcome corresponds to the Determinants of this threshold within the time of interview (antenatal vs. postnatal), obstetrical factors.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">52</enrollment> <condition>Pregnancy</condition> <arm_group> <arm_group_label>standard-gamble technique</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will be asked to imagine a scenario in which they are experiencing one of the 4 described conditions in the long-term. They will declare their preference between (a) keeping this long-term condition as is, or using a painless hypothetical cure that is associated with some risk of death, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision whether to take the treatment or not. The utility will be calculated as 1 - the obtained risk of death of the point of equipoise. Health states will be evaluted in different orders across participants. The elicitation of health state utilites by the standard-gamble technique is further clarified.</description> </arm_group> <arm_group> <arm_group_label>time trade-off technique</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will be asked to declare their preference between 50 years of life with the symptoms of 1 of the conditions, or 50-X years without these symptoms, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision on the preference of the 2 choices. The utility will be calculated as the 50-x/50 obtained at this point of equipoise. Health states will be evaluted in different orders across participants.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>standard-gamble technique</intervention_name> <description>Participants will be asked to imagine a scenario in which they are experiencing one of the 4 described conditions in the long-term. They will declare their preference between (a) keeping this long-term condition as is, or using a painless hypothetical cure that is associated with some risk of death, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision whether to take the treatment or not. The utility will be calculated as 1 - the obtained risk of death of the point of equipoise. Health states will be evaluted in different orders across participants. The elicitation of health state utilites by the standard-gamble technique is further clarified.</description> <arm_group_label>standard-gamble technique</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>time trade-off technique</intervention_name> <description>Participants will be asked to declare their preference between 50 years of life with the symptoms of 1 of the conditions, or 50-X years without these symptoms, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision on the preference of the 2 choices. The utility will be calculated as the 50-x/50 obtained at this point of equipoise. Health states will be evaluted in different orders across participants.</description> <arm_group_label>time trade-off technique</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Women aged ≥18 years  - Ongoing pregnancy or in the early postpartum period (within 7 days of delivery)  - Participants may be with or without prior VTE or major bleeding, and with or without previous/current use of postpartum TPX.  - Fluency in French  - Women are able and willing to give free, informed and written consent  Exclusion Criteria:  - Fetal or neonatal death, in order not to bother women during their mourning.  - Women under tutorship or curatorship  - Women deprived of liberty  - Women under court protection There will be no further exclusion criteria, to maximize the external validity of the study. </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Justine P Hugon Rodin, MD</last_name> <role>Principal Investigator</role> <affiliation>Fondation Hôpital Saint-Joseph</affiliation> </overall_official> <overall_contact> <last_name>Justine Hugon Rodin, MD</last_name> <phone>144123934</phone> <phone_ext>+33</phone_ext> <email>jhugon@ghpsj.fr</email> </overall_contact> <overall_contact_backup> <last_name>Helene BEAUSSIER, PharmD, PhD</last_name> <phone>0144127883</phone> <phone_ext>+33</phone_ext> <email>crc@ghpsj.fr</email> </overall_contact_backup> <location> <facility> <name>Groupe Hospitalier Paris Saint-Joseph</name> <address> <city>Paris</city> <zip>75014</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Justine P Hugon-Rodin, MD</last_name> <phone>0144123934</phone> <phone_ext>+33</phone_ext> <email>jhugon@ghpsj.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <link> <url>https://www.practiceupdate.com/content/risks-of-venous-thromboembolism-after-cesarean-section/40288</url> <description>Risks of Venous Thromboembolism After Cesarean Section</description> </link> <link> <url>https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf</url> <description>Reducing the Risk of Venous Thromboembolism during Pregnancy and the Puerperium</description> </link> <reference> <citation>Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31.</citation> <PMID>18248600</PMID> </reference> <reference> <citation>Blondon M, Quon BS, Harrington LB, Bounameaux H, Smith NL. Association between newborn birth weight and the risk of postpartum maternal venous thromboembolism: a population-based case-control study. Circulation. 2015 Apr 28;131(17):1471-6; discussion 1476. doi: 10.1161/CIRCULATIONAHA.114.012749. Epub 2015 Mar 5.</citation> <PMID>25745022</PMID> </reference> <reference> <citation>Blondon M, Harrington LB, Boehlen F, Robert-Ebadi H, Righini M, Smith NL. Pre-pregnancy BMI, delivery BMI, gestational weight gain and the risk of postpartum venous thrombosis. Thromb Res. 2016 Sep;145:151-6. doi: 10.1016/j.thromres.2016.06.026. Epub 2016 Jun 24.</citation> <PMID>27421192</PMID> </reference> <reference> <citation>Sultan AA, West J, Grainge MJ, Riley RD, Tata LJ, Stephansson O, Fleming KM, Nelson-Piercy C, Ludvigsson JF. Development and validation of risk prediction model for venous thromboembolism in postpartum women: multinational cohort study. BMJ. 2016 Dec 5;355:i6253. doi: 10.1136/bmj.i6253.</citation> <PMID>27919934</PMID> </reference> <reference> <citation>Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.</citation> <PMID>11442521</PMID> </reference> <reference> <citation>Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.</citation> <PMID>25884460</PMID> </reference> <reference> <citation>Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.</citation> <PMID>30482767</PMID> </reference> <verification_date>August 2023</verification_date> <study_first_submitted>December 30, 2021</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 8, 2023</last_update_submitted> <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party>  </clinical_study>

The risk of venous thromboembolism (VTE), which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE), increases during pregnancy and most strikingly in the postpartum period (6 weeks after delivery). Extensive research efforts have led to the identification of many risk factors for VTE events. Examples of such factors include maternal characteristics (personal history of VTE, thrombophilia, obesity, race) and obstetrical characteristics (methods of delivery, pre-term delivery, growth retardation). These allow care providers to risk stratify women at the time of delivery into low, moderate and high-risk women, based on experts' opinion. Further, a risk score, which was recently developed and validated on English and Swedish populations, estimates the risk of postpartum VTE in individuals. Thromboprophylaxis (TPX) focuses on the use of short-term low-molecular-weight heparin (LMWH). LMWH is believed to reduce the risk of VTE by 50-70%, but the evidence is indirect, with a lack of large-scale randomized trial in the setting of the postpartum period. Further, LMWH is both inconvenient (subcutaneous injections) and possibly associated with haemorrhagic side effects. Alternative drugs do not exist, because direct oral anticoagulants (DOAC) and aspirin are not studied in this setting and because DOAC are contra-indicated in pregnancy and breastfeeding. Given the unclear balance of benefits and risks, current guidelines vary greatly in the proportion of women with recommended TPX. Gassmann et al. have recently demonstrated, among a cohort of parturients at the Geneva University Hospitals: a recommendation of postpartum TPX in 40.1% of women, with an estimated mean risk of postpartum VTE of 0.12%, according to the 2015 UK guidelines (RCOG), and a recommendation of postpartum TPX in 8.7% of women, with an estimated mean risk of postpartum VTE of 0.20%, according to the 2018 US guidance (ACOG).These low risks of VTE to trigger a recommendation of TPX use contrast with that of experts' opinions, which advocate for a threshold of VTE risk of 1-3% to recommend the use of TPX. Currently, all women delivering by C-section in Geneva receive TPX regardless of their VTE risk. This dramatic discrepancy of TPX guidance between guidelines, and between guidelines and individual experts, highlights the uncertainty in this setting. Womens' preferences would be critically important here, to guide a rationale and desired use of TPX. Quite surprisingly, such preferences have never been elicited, in spite of the very large number of births every year (5 and 4 million in Europe and the US, respectively). To inform prescription patterns of postpartum TPX, investigators propose to conduct this prospective study to elicit values and preferences of pregnant and postpartum women. Inclusion Criteria: - Women aged ≥18 years - Ongoing pregnancy or in the early postpartum period (within 7 days of delivery) - Participants may be with or without prior VTE or major bleeding, and with or without previous/current use of postpartum TPX. - Fluency in French - Women are able and willing to give free, informed and written consent Exclusion Criteria: - Fetal or neonatal death, in order not to bother women during their mourning. - Women under tutorship or curatorship - Women deprived of liberty - Women under court protection There will be no further exclusion criteria, to maximize the external validity of the study.

NCT0531xxxx/NCT05318560.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/NCT05318560</url> </required_header> <id_info> <org_study_id>PamukkaleU-Simsek-003</org_study_id> <nct_id>NCT05318560</nct_id> </id_info> <brief_title>Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome</brief_title> <official_title>Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome</official_title> <sponsors> <lead_sponsor> <agency>Pamukkale University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Pamukkale 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> In this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome. </textblock> </brief_summary> <detailed_description> <textblock> The investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (MAS) (according to Travell-Simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic.  Age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. Patients will be randomly divided into three groups. A total of 3 consecutive weeks of treatment were planned. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">June 30, 2022</start_date> <completion_date type="Anticipated">December 10, 2022</completion_date> <primary_completion_date type="Anticipated">September 10, 2022</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 (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Visual Analogue Scale (VAS)</measure> <time_frame>Change from baseline VAS at the 1st week after the treatment.</time_frame> <description>The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.</description> </primary_outcome> <secondary_outcome> <measure>Neck Disability Index (NDI)</measure> <time_frame>Change from baseline VAS at the 1st week after the treatment.</time_frame> <description>NDI was assessed by the neck pain questionnaire that included 10 questions regarding the severity of neck pain, its impact on sleeping, driving, etc. Each question was scored from 0 to 5 and the total score was measured from 50 and was finally reported in percent (%). A higher percentage of NDI was an indicator of more disability and pain.</description> </secondary_outcome> <secondary_outcome> <measure>Range of motion (ROM)</measure> <time_frame>Change from baseline VAS at the 1st week after the treatment.</time_frame> <description>Range of motion (ROM) in neck lateral flexion movement measured according to the maximum angle that the patient could laterally bend his or her neck to the right and left side, using three consecutive times of goniometry and recording maximum value of them. Mean of the highest values of both directions was recorded as the final amount.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">72</enrollment> <condition>Myofascial Pain Syndrome</condition> <condition>Ozone</condition> <arm_group> <arm_group_label>Local anesthetic injection</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients will be injected with lidocaine and given upper trapezius muscle stretching exercises. Lidocaine injection 2cc 2% will be administered to all patients using a 26 gauge, 0.45x13 mm disposable sterile needle to the affected trigger point.</description> </arm_group> <arm_group> <arm_group_label>Ozone injection</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Ozone injection will be performed on patients and upper trapezius muscle stretching exercises will be given. 8 cc of oxygen/ozone gas at a concentration of 15 µg/mL will be injected into the trigger point.</description> </arm_group> <arm_group> <arm_group_label>Stretching exercise</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients will be given a home program that includes upper trapezius muscle stretching exercises. Upper trapezius stretching exercises will be performed twice a day for at least 15 seconds, ten sets each time, for three weeks, with one hand on the patient's back and the other hand holding the side of the head and tilting it to the side until a slight tension is felt. The exercises will be explained in the text, visual and verbal forms with the exercise form.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Lidocaine 2% Injectable Solution</intervention_name> <description>for MPS</description> <arm_group_label>Local anesthetic injection</arm_group_label> <other_name>jetokain simplex</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ozone</intervention_name> <description>for MPS</description> <arm_group_label>Ozone injection</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>stretching exercise</intervention_name> <description>for MPS</description> <arm_group_label>Local anesthetic injection</arm_group_label> <arm_group_label>Ozone injection</arm_group_label> <arm_group_label>Stretching exercise</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS  Exclusion Criteria:  - Presence of any cervical radiculopathy or a history of degenerative conditions  - Presence of any cervical surgery or trauma in the past year,  - History of injection for the treatment of MAS in the last 6 months,  - Cognitive disorder,  - Rheumatological disease, fibromyalgia,  - History of metabolic diseases such as hypothyroidism and diabetes mellitus </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Hakan Alkan, Prof.</last_name> <role>Study Director</role> <affiliation>Pamukkale University</affiliation> </overall_official> <overall_contact> <last_name>Ayse Simsek, m.d.</last_name> <phone>+905319698492</phone> <email>draysesimsek2@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Hakan Alkan, Prof.</last_name> </overall_contact_backup> <verification_date>June 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>June 22, 2022</last_update_submitted> <last_update_submitted_qc>June 22, 2022</last_update_submitted_qc> <last_update_posted type="Actual">June 23, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Pamukkale University</investigator_affiliation> <investigator_full_name>Hakan Alkan</investigator_full_name> <investigator_title>Clinical Professor</investigator_title> </responsible_party> <keyword>Ozone</keyword> <keyword>Pain</keyword> <condition_browse>  <mesh_term>Myofascial Pain Syndromes</mesh_term> <mesh_term>Fibromyalgia</mesh_term> <mesh_term>Syndrome</mesh_term> <mesh_term>Somatoform Disorders</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Lidocaine</mesh_term> </intervention_browse>  </clinical_study>

In this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome. The investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (MAS) (according to Travell-Simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic. Age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. Patients will be randomly divided into three groups. A total of 3 consecutive weeks of treatment were planned. Inclusion Criteria: - With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS Exclusion Criteria: - Presence of any cervical radiculopathy or a history of degenerative conditions - Presence of any cervical surgery or trauma in the past year, - History of injection for the treatment of MAS in the last 6 months, - Cognitive disorder, - Rheumatological disease, fibromyalgia, - History of metabolic diseases such as hypothyroidism and diabetes mellitus

NCT0531xxxx/NCT05318573.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/NCT05318573</url> </required_header> <id_info> <org_study_id>FF10832-PEM-201/KEYNOTE-B57</org_study_id> <nct_id>NCT05318573</nct_id> </id_info> <brief_title>A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors</brief_title> <official_title>A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors</official_title> <sponsors> <lead_sponsor> <agency>Fujifilm Pharmaceuticals U.S.A., Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Merck Sharp & Dohme LLC</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Fujifilm Pharmaceuticals U.S.A., 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> To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced solid tumors. </textblock> </brief_summary> <detailed_description> <textblock> This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg). The dose of FF-10832 may be reduced to 30 mg/m2 and tested in 10 patients after review of safety data by a safety review committee (SRC). Lower or intermediate doses of FF-10832 may be explored if necessary After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer [UC] and non-small cell lung cancer [NSCLC]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC.  The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">November 2029</completion_date> <primary_completion_date type="Anticipated">May 2029</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> <intervention_model_description>FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Determine the incidence of Treament Emergent Adverse Events (TEAE)</measure> <time_frame>7 years</time_frame> <description>Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs) and to confirm dose (RP2D) of FF-10832 given intravenously Day 1 of a 21 day cycle, in combination with 200 mg pembrolizumab, given intravenously Day 1 of the same 21-day cycle, for treatment of advanced solid tumors.</description> </primary_outcome> <primary_outcome> <measure>Duration of Stable Disease in Monotherapy</measure> <time_frame>7 years</time_frame> <description>To obtain a preliminary estimate of efficacy of FF-10832 monotherapy in expansion cohorts of patients with urothelial cancer (UC) and non-small cell lung cancer (NSCLC). Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression are met</description> </primary_outcome> <primary_outcome> <measure>Duration of Stable Disease in Combination Therapy</measure> <time_frame>7 years</time_frame> <description>To obtain a preliminary estimate of efficacy of the combination in expansion cohorts of patients with UC and NSCLC. Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression</description> </primary_outcome> <secondary_outcome> <measure>Determine Safety Profile of Monotherapy</measure> <time_frame>7 years</time_frame> <description>To describe the safety profile of FF-10832 monotherapy 40 mg/m2 given intravenously Day 1 of a 21-day cycle, including treatment-emergent AEs. Safety assessed by adverse events (AEs) and serious adverse events (SAEs)</description> </secondary_outcome> <secondary_outcome> <measure>Determine Safety Profile of Combination Therapy</measure> <time_frame>7 years</time_frame> <description>Describe the safety profile of the combination, including dose limiting toxicities, immune related toxicities, and other treatment emergent AEs. Safety assessed by adverse events (AEs) and serious adverse events (SAEs)</description> </secondary_outcome> <secondary_outcome> <measure>Overall Response Rate (ORR)</measure> <time_frame>7 years</time_frame> <description>Overall Response Rate is determined by classification of solid tumors via RECIST v.1.1</description> </secondary_outcome> <secondary_outcome> <measure>Duration of Response (DOR)</measure> <time_frame>7 years</time_frame> <description>Duration of Response is calculated from the date of first response to the date of progression or death</description> </secondary_outcome> <secondary_outcome> <measure>Progression-free survival (PFS)</measure> <time_frame>7 years</time_frame> <description>Progression-free survival will be calculated from the date of first treatment to the date of progression or death</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival (OS)</measure> <time_frame>7 years</time_frame> <description>Overall survival will be calculated from the date of first treatment to the date of death from any cause</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">10</enrollment> <condition>Advanced Solid Tumor</condition> <arm_group> <arm_group_label>Safety Run-in Phase</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Pembrolizumab</intervention_name> <description>Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832</description> <arm_group_label>Safety Run-in Phase</arm_group_label> <other_name>Keytruda</other_name> <other_name>MK-3475</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>FF-10832</intervention_name> <description>Following administration of pembrolizumab, FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle</description> <arm_group_label>Safety Run-in Phase</arm_group_label> <other_name>Gemcitabine Liposome Injection</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Written informed consent is provided by patient or legally acceptable representative;  2. Age ≥ 18 years;  3. Patient populations:  a. In the Safety Run-in, patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with standard therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment or refuse standard treatment will be enrolled in this study  4. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology  5. Eastern Cooperative Oncology Group performance status of 0 to 1  6. Life expectancy of ≥ 3 months  Exclusion Criteria:  1. Positive urine pregnancy test within 72 hours prior to treatment. I  2. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment;  3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), AND was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event;  4. Has received prior radiotherapy within 2 weeks of start of study treatment.  5. For patients with NSCLC:  1. Patients who have received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment are excluded;  2. Patients with mutations (e.g., EGFR mutations or ALK gene rearrangements) will be excluded unless they have been previously treated with all specific targeted therapies.  6. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.  7. Has had an allogeneic tissue /solid organ transplant. </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>FPHU Study Coordinator</last_name> <email>fphucontact@fujifilm.com</email> </overall_contact> <location> <facility> <name>Atlantic Health System / Morristown Medical Center</name> <address> <city>Morristown</city> <state>New Jersey</state> <zip>07960</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Icahn School of Medicine at Mount Sinai</name> <address> <city>New York</city> <state>New York</state> <zip>10029</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Providence Cancer Institute Franz Clinic</name> <address> <city>Portland</city> <state>Oregon</state> <zip>97213</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital of the Univ of Pennsylvania Perlman Center</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19104</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Sarah Cannon Research Institute</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37203</zip> <country>United States</country> </address> </facility> <status>Completed</status> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>May 25, 2023</last_update_submitted> <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 26, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Gemcitabine</mesh_term> <mesh_term>Pembrolizumab</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> <ipd_description>undecided</ipd_description> </patient_data>  </clinical_study>

To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced solid tumors. This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg). The dose of FF-10832 may be reduced to 30 mg/m2 and tested in 10 patients after review of safety data by a safety review committee (SRC). Lower or intermediate doses of FF-10832 may be explored if necessary After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer [UC] and non-small cell lung cancer [NSCLC]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC. The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab. Inclusion Criteria: 1. Written informed consent is provided by patient or legally acceptable representative; 2. Age ≥ 18 years; 3. Patient populations: a. In the Safety Run-in, patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with standard therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment or refuse standard treatment will be enrolled in this study 4. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology 5. Eastern Cooperative Oncology Group performance status of 0 to 1 6. Life expectancy of ≥ 3 months Exclusion Criteria: 1. Positive urine pregnancy test within 72 hours prior to treatment. I 2. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment; 3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), AND was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event; 4. Has received prior radiotherapy within 2 weeks of start of study treatment. 5. For patients with NSCLC: 1. Patients who have received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment are excluded; 2. Patients with mutations (e.g., EGFR mutations or ALK gene rearrangements) will be excluded unless they have been previously treated with all specific targeted therapies. 6. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. 7. Has had an allogeneic tissue /solid organ transplant.

NCT0531xxxx/NCT05318586.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/NCT05318586</url> </required_header> <id_info> <org_study_id>2022JQ-982</org_study_id> <nct_id>NCT05318586</nct_id> </id_info> <brief_title>Individualized rTMS Based on fNIRS to Spasticity</brief_title> <official_title>Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke</official_title> <sponsors> <lead_sponsor> <agency>First Affiliated Hospital Xi'an Jiaotong University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>First Affiliated Hospital Xi'an Jiaotong 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> Stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. However, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been widely used to promote brain network remodeling after stroke. The investigators attempted to evaluate the motor brain network characteristics of spastic patients by fNIRS, and used the most active brain regions as rTMS stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 10, 2022</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">September 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> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>modified Ashworth scale</measure> <time_frame>1 month</time_frame> <description>The range is 0-Ⅳ level, the higher the level, the higher the spasticity.</description> </primary_outcome> <secondary_outcome> <measure>Fugl-Meyer Assessment of upper limb motor function</measure> <time_frame>1 month</time_frame> <description>The score range is 0-66 points, the higher the score, the better the motor function of upper limb.</description> </secondary_outcome> <secondary_outcome> <measure>Barthel index</measure> <time_frame>1 month</time_frame> <description>The score range is 0-100 points, the higher the score, the better the activities of daily living.</description> </secondary_outcome> <secondary_outcome> <measure>average weighted clustering coefficient</measure> <time_frame>1 month</time_frame> <description>This is a brain network indicator based on graph theory. It is a measure of the local separation of the graph. The higher the average weighted clustering coefficient, the higher the degree of segregation of the brain network.</description> </secondary_outcome> <secondary_outcome> <measure>global efficiency</measure> <time_frame>1 month</time_frame> <description>This is a brain network indicator based on graph theory. It is a measure of the local integration of the graph. The higher the global efficiency, the stronger the ability of the network to transmit information.</description> </secondary_outcome> <secondary_outcome> <measure>inter-density</measure> <time_frame>1 month</time_frame> <description>It is a brain network indicator based on graph theory and is defined as the ratio of the actual number of connections among all possible connections between bilateral hemispheres.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Stroke</condition> <condition>Spasticity, Muscle</condition> <condition>Rehabilitation</condition> <arm_group> <arm_group_label>Individualized rTMS based on fNIRS</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.</description> </arm_group> <arm_group> <arm_group_label>Traditional rTMS strategy</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The control group will always be given low-frequency rTMS to contralesional M1</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>individual rTMS based on fNIRS</intervention_name> <description>The rTMS parameters will be set according to fNIRS results.</description> <arm_group_label>Individualized rTMS based on fNIRS</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Traditional rTMS strategy</intervention_name> <description>The low-frequency rTMS to contralesional M1 will always be used.</description> <arm_group_label>Traditional rTMS strategy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Aged 40-79 years;  - Patients with first-onset stroke within 1 to 3 months after onset;  - Consciousness, sitting balance level 1 or above, can cooperate with fNIRS assessment;  - The patient or its authorized agent signs the informed consent form.  Exclusion Criteria:  - Previous seizures;  - Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;  - Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS. </textblock> </criteria> <gender>All</gender> <minimum_age>40 Years</minimum_age> <maximum_age>79 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Ziwen Yuan, MD</last_name> <phone>+8617502991129</phone> <email>yuanziwen@xjtufh.edu.cn</email> </overall_contact> <location> <facility> <name>First Affiliated Hospital of Xi'an Jiaotong University</name> <address> <city>Xi'an</city> <state>Shaanxi</state> <zip>710000</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ziwen Yuan, MD.</last_name> <phone>+86 17502991129</phone> <email>yuanziwen@xjtufh.edu.cn</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 18, 2022</last_update_submitted> <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 20, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Stroke</keyword> <keyword>Spasticity, Muscle</keyword> <keyword>Rehabilitation</keyword> <keyword>fNIRS</keyword> <keyword>rTMS</keyword> <keyword>Activation</keyword> <keyword>Brain network</keyword> <condition_browse>  <mesh_term>Muscle Spasticity</mesh_term> <mesh_term>Stroke</mesh_term> </condition_browse>  </clinical_study>

Stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. However, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been widely used to promote brain network remodeling after stroke. The investigators attempted to evaluate the motor brain network characteristics of spastic patients by fNIRS, and used the most active brain regions as rTMS stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity. Inclusion Criteria: - Aged 40-79 years; - Patients with first-onset stroke within 1 to 3 months after onset; - Consciousness, sitting balance level 1 or above, can cooperate with fNIRS assessment; - The patient or its authorized agent signs the informed consent form. Exclusion Criteria: - Previous seizures; - Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset; - Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.

NCT0531xxxx/NCT05318599.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/NCT05318599</url> </required_header> <id_info> <org_study_id>IPFoscope</org_study_id> <nct_id>NCT05318599</nct_id> </id_info> <brief_title>Deep Learning Diagnostic and Risk-stratification for IPF and COPD</brief_title> <acronym>DeepBreath</acronym> <official_title>Deep Learning Diagnostic and Risk-stratification for Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease in Digital Lung Auscultations</official_title> <sponsors> <lead_sponsor> <agency>Pediatric Clinical Research Platform</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University Hospital, Geneva</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Swiss Federal Institute of Technology</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Hôpital du Valais</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Pediatric Clinical Research Platform</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> Idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonia (NSIP), and chronic obstructive pulmonary disease (COPD) are severe, progressive, irreversibly incapacitating pulmonary disorders with modest response to therapeutic interventions and poor prognosis. Prompt and accurate diagnosis is important to enable patients to receive appropriate care at the earliest possible stage to delay disease progression and prolong survival.  Artificial intelligence (AI)-assisted digital lung auscultation could constitute an alternative to conventional subjective operator-related auscultation to accurately and earlier diagnose these diseases. Moreover, lung ultrasound (LUS), a relevant gold standard for lung pathology, could also benefit from automation by deep learning. </textblock> </brief_summary> <detailed_description> <textblock> Aim: To develop and determine the predictive power of an AI (deep learning) algorithm in identifying the acoustic and LUS signatures of IPF, NSIP and COPD in an adult population and discriminating them from age-matched, never smoker, control subjects with normal lung function.  Methodology: A single-center, prospective, population-based case-control study that will be carried out in subjects with IPF, NSIP and COPD. A total of 120 consecutive patients aged ≥ 18 years and meeting IPF, NSIP or COPD international criteria, and 40 age-matched controls, will be recruited in a Swiss pulmonology outpatient clinic with a total of approximately 7000 specialized consultations per year, starting from August 2022.  At inclusion, demographic and clinical data will be collected. Additionally, lung auscultation will be recorded with a digital stethoscope and LUS performed. A deep learning algorithm (DeepBreath) using various deep learning networks with aggregation strategies will be trained on these audio recordings and lung images to derive an automated prediction of diagnostic (i.e., positive vs negative) and risk stratification categories (mild to severe).  Secondary outcomes will be to measures the association of analysed lung sounds with clinical, functional and radiological characteristics of IPF, NSIP and COPD diagnosis. Patients' quality of life will be measured with the standardized dedicated King's Brief Interstitial Lung Disease (K-BILD) and the COPD assessment test (CAT) questionnaires.  Expected results: This study seeks to explore the synergistic value of several point-of-care-tests for the detection and differential diagnosis of ILD and COPD as well as estimate severity to better guide care management in adults </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">September 2, 2022</start_date> <completion_date type="Anticipated">January 30, 2023</completion_date> <primary_completion_date type="Anticipated">December 31, 2022</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>To differentiate ILD from control subjects based on digital lung sounds recordings and LUS.</measure> <time_frame>During lung auscultation (10 minutes). Each patient will provide 10 recordings of 30 seconds. LUS images and 5 second video clips of each anatomic region (10 regions represented).</time_frame> <description>To determine the predictive performance of the AI algorithm-evaluated lung auscultation and LUS in the identification and risk stratification of ILD signatures from control subjects described in terms of descriptive statistics, area under the receiver operating characteristic curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratios (95% confidence intervals). Digital lung sounds will be transformed to Mel Frequency Cepstrum Coefficients. Several data augmentation techniques will be explored. The effect of each pre-processing method will be tested. The best performing approach according to sensitivity and specificity will be reported. This dataset will then be fed into a various deep learning networks with aggregation strategies for binary classification into positive vs negative for diagnostic results for: ILD or control subjects ILD or COPD (If ILD+) IPF or NSIP The same prediction will also be made using LUS images.</description> </primary_outcome> <primary_outcome> <measure>Predictive performance of the DeepBreath algorithm to stratify ILD severity based on human digital lung sounds recordings and LUS (i.e. physiological parameters) compared to grading scales.</measure> <time_frame>During lung auscultation (10 minutes). Each patient will provide 10 recordings of 30 seconds. LUS images and 5 second video clips of each anatomic region (10 regions represented).</time_frame> <description>To determine the ILD clinical severity predictive performance of the DeepBreath algorithm based on human digital lung sounds recordings and LUS, risk stratification will use multiclass or regression according to grading scales obtained from: K-BILD and CAT impact of life questionnaire. Lung function tests (Forced Expiratory Volume in 1 sec, Forced vital capacity, Forced Expiratory Volume in 1 sec/Forced vital capacity, Total lung capacity, functional respiratory capacity, Transfer capacity for carbon monoxide, Alveolar Volume). High-Resolution Computed Tomography (severity markers that will be used are: traction bronchiectasis, presence of honeycombing, ground glass opacities, reticulation, emphysema. Chest CT-scans will be reviewed independently by two radiologists blinded to each other).</description> </primary_outcome> <primary_outcome> <measure>Performance of the DeepBreath algorithm to subcategorize ILD by discriminating digital lung sounds recordings and LUS (i.e. physiological parameters).</measure> <time_frame>During lung auscultation (10 minutes). Each patient will provide 10 recordings of 30 seconds. LUS images and 5 second video clips of each anatomic region (10 regions represented).</time_frame> <description>The performance of the DeepBreath algorithm to determine the subcategories of ILD such as IPF and NSIP based on digital lungs sounds and LUS according to gold standard diagnosis: IPF follows the Fleischner Society Consensus criteria. NSIP diagnosis follows the American Thoracic Society classification.</description> </primary_outcome> <secondary_outcome> <measure>Performance of human expert-identified acoustic signatures.</measure> <time_frame>During the data analysis period (i.e., after the 60-minute study intervention period).</time_frame> <description>Comparison of the predictive performance of human expert-identified acoustic signatures in the predictive tasks described above in the primary outcomes (Kappa coefficient).</description> </secondary_outcome> <secondary_outcome> <measure>Agreement of human labels with objectively clustered pathological sounds by machine learning.</measure> <time_frame>During the data analysis period (i.e., after the 60-minute study intervention period).</time_frame> <description>To quantify the agreement of human labels with objectively clustered pathological sounds by machine learning (ie, the DeepBreath AI algorithm).</description> </secondary_outcome> <secondary_outcome> <measure>Diagnostic performance of DeepBreath to detect crackles in IPF patients.</measure> <time_frame>During the data analysis period (i.e., after the 60-minute study intervention period).</time_frame> <description>Diagnostic performance of the AI algorithm (DeepBreath) trained to detect crackles in IPF patients.</description> </secondary_outcome> <secondary_outcome> <measure>To test whether performance of DeepBreath could be improved using clinical features (i.e., signs, respiratory symptoms, demographics, medical history and basic paraclinical tests).</measure> <time_frame>During the data analysis period (i.e., after the 60-minute study intervention period)</time_frame> <description>To explore the utility of adding clinical data collected at enrolment including demographic information (age and sex), several binary clinical symptoms (respiratory symptoms), medical history and basic paraclinical tests to improve the accuracy of the DeepBreath algorithm in detecting IPF from control subjects or COPD. Clinical data will be explored for their predictive capacity in the above tasks and added to the breath sound analysis either as an Support vector machine or in conditional feature extraction upstream of the neural network.</description> </secondary_outcome> <secondary_outcome> <measure>K-BILD</measure> <time_frame>Baseline</time_frame> <description>King's brief Interstitial Lung Disease Health Status: the K-BILD health status questionnaire is a 15 item validated, self-completed heath status questionnaire. It has three domains: breathlessness and activities, psychological and chest symptoms. The K-BILD domain and total score ranges are 0-100, with the higher scores corresponding with better health-related quality of life. This questionnaire will be used to assess the Impact of ILD on subjects' health-related quality of life. It will take about 3 minutes to complete this questionnaire.</description> </secondary_outcome> <secondary_outcome> <measure>CAT</measure> <time_frame>Baseline</time_frame> <description>COPD assessment test: the CAT health status questionnaire is a 8 item validated, self-completed heath status questionnaire. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. This questionnaire will be used to assess the Impact of COPD on subjects' health-related quality of life. It will take about 3 minutes to complete this questionnaire.</description> </secondary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Anticipated">160</enrollment> <condition>Lung; Disease, Interstitial, With Fibrosis</condition> <condition>Pulmonary Disease, Chronic Obstructive</condition> <condition>Artificial Intelligence</condition> <arm_group> <arm_group_label>IPF patients (group 1)</arm_group_label> <description>Consenting adult patients >18 years old with with already-diagnosed IPF</description> </arm_group> <arm_group> <arm_group_label>NSIP patients (group 2)</arm_group_label> <description>Consenting adult patients >18 years old with with already-diagnosed non-specific interstitial pneumonia (NSIP)</description> </arm_group> <arm_group> <arm_group_label>COPD patients (group 3)</arm_group_label> <description>Consenting adult patients >18 years old with with already-diagnosed chronic obstructive pulmonary disease (COPD)</description> </arm_group> <arm_group> <arm_group_label>Control subjects (group 4)</arm_group_label> <description>Consenting age-matched (+/- 2.5 years) never smokers patients with normal lung function (spirometry, lung volume and Transfer Factor for Carbon Monoxide (TLCO)) followed in the pulmonology outpatient clinic with similar quality of electronic medical records but for diseases other than the outcome of interest, namely: patients with obstructive sleep apnea. patients followed-up for occupational lung diseases (miners, chemical workers, etc.). patients followed-up for pulmonary nodules (considered benign after 2 years).</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Lung auscultation</intervention_name> <description>Digital lung auscultation with the Eko core digital stethoscope (Eko Devices, Inc., CA, USA).</description> <arm_group_label>COPD patients (group 3)</arm_group_label> <arm_group_label>Control subjects (group 4)</arm_group_label> <arm_group_label>IPF patients (group 1)</arm_group_label> <arm_group_label>NSIP patients (group 2)</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Lung ultrasound</intervention_name> <description>Lung ultrasonography</description> <arm_group_label>COPD patients (group 3)</arm_group_label> <arm_group_label>Control subjects (group 4)</arm_group_label> <arm_group_label>IPF patients (group 1)</arm_group_label> <arm_group_label>NSIP patients (group 2)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Quality of Life's questionnaires</intervention_name> <description>Impact of the diseases on subjects' health-related quality of life measured with standardized questionnaires (K-BILD, CAT)</description> <arm_group_label>COPD patients (group 3)</arm_group_label> <arm_group_label>Control subjects (group 4)</arm_group_label> <arm_group_label>IPF patients (group 1)</arm_group_label> <arm_group_label>NSIP patients (group 2)</arm_group_label> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Pulmonary functional tests</intervention_name> <description>Spirometry, body-plethysmographic parameters and lung diffusion capacity for carbon monoxide will be measured.</description> <arm_group_label>COPD patients (group 3)</arm_group_label> <arm_group_label>Control subjects (group 4)</arm_group_label> <arm_group_label>IPF patients (group 1)</arm_group_label> <arm_group_label>NSIP patients (group 2)</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Cases: 120 patients (80 ILD [40 IPF, 40 NSIP], 40 COPD) will be recruited from an outpatient pulmonology clinic in Switzerland in daily clinical practice on the day of intervention.  Probable and definitive IPF diagnosis will be made according to the Fleischner Society Consensus, NSIP diagnosis with the American Thoracic Society classification, and COPD with the Global Initiative for Chronic Obstructive Lung Disease criteria.  Controls: 40 age-matched (+/- 2.5 years) never smokers with normal lung function (spirometry, lung volume and transfer factor for carbon monoxide) followed in the pulmonology outpatient clinic with similar quality of electronic medical records but for diseases other than the outcome of interest (see eligibility criteria) will serve as the 1:1 control group. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Written informed consent  - age > 18 years old.  - patients with already-diagnosed IPF (group 1) prior to the consultation (index) date.  - patients with already-diagnosed NSIP (group 2) prior to the consultation (index) date.  - patients with already-diagnosed COPD (group 3) prior to the consultation (index) date.  - Control subjects must be followed-up at the pulmonology outpatient clinic for:  1. obstructive sleep apnoea.  2. occupational lung diseases (miners, chemical workers, etc.).  3. pulmonary nodules (considered benign after 2 years).  Exclusion Criteria:  - patients who cannot be mobilized for posterior auscultation.  - patients known for severe cardiovascular disease with pulmonary repercussion.  - patients known for a concurrent, acute, infectious pulmonary disease (e.g., pneumonia, bronchitis).  - patients known for asthma.  - patients known or suspected of immunodeficiency, alpha-1-antitrypsin deficit, and or under immunotherapy.  - patients with physical inability to follow procedures.  - patients with inability to give informed consent. </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>Pierre-Olivier Bridevaux, Prof.</last_name> <role>Principal Investigator</role> <affiliation>Hôpital du Valais, Switzerland</affiliation> </overall_official> <overall_official> <last_name>Johan N. Siebert, MD</last_name> <role>Study Director</role> <affiliation>Geneva University Hospitals, Switzerland</affiliation> </overall_official> <overall_contact> <last_name>Johan N. Siebert, MD</last_name> <phone>+41795534072</phone> <email>Johan.Siebert@hcuge.ch</email> </overall_contact> <overall_contact_backup> <last_name>Pierre-Olivier Bridevaux, Prof.</last_name> <phone>+41276034678</phone> <email>pierre-olivier.bridevaux@hopitalvs.ch</email> </overall_contact_backup> <location> <facility> <name>Centre Hospitalier du Valais Romand</name> <address> <city>Sion</city> <state>Wallis</state> <zip>1951</zip> <country>Switzerland</country> </address> </facility> <contact> <last_name>Pierre-Olivier Bridevaux, Prof</last_name> <phone>+41276034678</phone> <email>pierre-olivier.bridevaux@hopitalvs.ch</email> </contact> <contact_backup> <last_name>Johan N. Siebert, MD</last_name> <phone>+41795534072</phone> <email>Johan.Siebert@hcuge.ch</email> </contact_backup> <investigator> <last_name>Pierre-Olivier Bridevaux, Prof.</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Mary-Anne Hartley, MD, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Delphine S. Courvoisier, Prof.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Constance Barazzone-Argiroffo, Prof.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Marlène Salamin, RN</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Alain Gervaix, Prof.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Johan N. Siebert, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Switzerland</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>September 1, 2022</last_update_submitted> <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Lung; Disease, Interstitial, with Fibrosis</keyword> <keyword>Idiopathic Pulmonary Fibrosis</keyword> <keyword>Idiopathic Interstitial Pneumonias</keyword> <keyword>Pulmonary Disease, Chronic Obstructive</keyword> <keyword>Artificial Intelligence</keyword> <keyword>Deep Learning</keyword> <keyword>Respiratory Sounds; Auscultation</keyword> <keyword>Ultrasonography</keyword> <keyword>Diagnostic imaging</keyword> <condition_browse>  <mesh_term>Lung Diseases</mesh_term> <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term> <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term> <mesh_term>Lung Diseases, Interstitial</mesh_term> <mesh_term>Fibrosis</mesh_term> <mesh_term>Chronic Disease</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>All pertinent data generated or analysed during this study will be included in the published articles (and supplementary information files). An anonymous copy of the final (anonymized) datasets (but not digitized lung sounds) used and/or analyzed during the current study will be available from the corresponding author (see access criteria).</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>Data will be available beginning 6 months and ending 5 years following article publication.</ipd_time_frame> <ipd_access_criteria>De-identified data will be available from the corresponding author on reasonable request upon approval of a proposal and with a signed data access agreement. Data will be made available for a specified research purpose to qualified external researchers whose proposed use of the data has been approved by their institutional review board. The request proposal must include a statistician. There are no plans to share the digitized lung sounds collected during the study procedure.</ipd_access_criteria> </patient_data>  </clinical_study>

Idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonia (NSIP), and chronic obstructive pulmonary disease (COPD) are severe, progressive, irreversibly incapacitating pulmonary disorders with modest response to therapeutic interventions and poor prognosis. Prompt and accurate diagnosis is important to enable patients to receive appropriate care at the earliest possible stage to delay disease progression and prolong survival. Artificial intelligence (AI)-assisted digital lung auscultation could constitute an alternative to conventional subjective operator-related auscultation to accurately and earlier diagnose these diseases. Moreover, lung ultrasound (LUS), a relevant gold standard for lung pathology, could also benefit from automation by deep learning. Aim: To develop and determine the predictive power of an AI (deep learning) algorithm in identifying the acoustic and LUS signatures of IPF, NSIP and COPD in an adult population and discriminating them from age-matched, never smoker, control subjects with normal lung function. Methodology: A single-center, prospective, population-based case-control study that will be carried out in subjects with IPF, NSIP and COPD. A total of 120 consecutive patients aged ≥ 18 years and meeting IPF, NSIP or COPD international criteria, and 40 age-matched controls, will be recruited in a Swiss pulmonology outpatient clinic with a total of approximately 7000 specialized consultations per year, starting from August 2022. At inclusion, demographic and clinical data will be collected. Additionally, lung auscultation will be recorded with a digital stethoscope and LUS performed. A deep learning algorithm (DeepBreath) using various deep learning networks with aggregation strategies will be trained on these audio recordings and lung images to derive an automated prediction of diagnostic (i.e., positive vs negative) and risk stratification categories (mild to severe). Secondary outcomes will be to measures the association of analysed lung sounds with clinical, functional and radiological characteristics of IPF, NSIP and COPD diagnosis. Patients' quality of life will be measured with the standardized dedicated King's Brief Interstitial Lung Disease (K-BILD) and the COPD assessment test (CAT) questionnaires. Expected results: This study seeks to explore the synergistic value of several point-of-care-tests for the detection and differential diagnosis of ILD and COPD as well as estimate severity to better guide care management in adults Cases: 120 patients (80 ILD [40 IPF, 40 NSIP], 40 COPD) will be recruited from an outpatient pulmonology clinic in Switzerland in daily clinical practice on the day of intervention. Probable and definitive IPF diagnosis will be made according to the Fleischner Society Consensus, NSIP diagnosis with the American Thoracic Society classification, and COPD with the Global Initiative for Chronic Obstructive Lung Disease criteria. Controls: 40 age-matched (+/- 2.5 years) never smokers with normal lung function (spirometry, lung volume and transfer factor for carbon monoxide) followed in the pulmonology outpatient clinic with similar quality of electronic medical records but for diseases other than the outcome of interest (see eligibility criteria) will serve as the 1:1 control group. Inclusion Criteria: - Written informed consent - age > 18 years old. - patients with already-diagnosed IPF (group 1) prior to the consultation (index) date. - patients with already-diagnosed NSIP (group 2) prior to the consultation (index) date. - patients with already-diagnosed COPD (group 3) prior to the consultation (index) date. - Control subjects must be followed-up at the pulmonology outpatient clinic for: 1. obstructive sleep apnoea. 2. occupational lung diseases (miners, chemical workers, etc.). 3. pulmonary nodules (considered benign after 2 years). Exclusion Criteria: - patients who cannot be mobilized for posterior auscultation. - patients known for severe cardiovascular disease with pulmonary repercussion. - patients known for a concurrent, acute, infectious pulmonary disease (e.g., pneumonia, bronchitis). - patients known for asthma. - patients known or suspected of immunodeficiency, alpha-1-antitrypsin deficit, and or under immunotherapy. - patients with physical inability to follow procedures. - patients with inability to give informed consent.

NCT0531xxxx/NCT05318612.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/NCT05318612</url> </required_header> <id_info> <org_study_id>NL79202.091.21</org_study_id> <nct_id>NCT05318612</nct_id> </id_info> <brief_title>Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)</brief_title> <acronym>EMITT</acronym> <official_title>(Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)</official_title> <sponsors> <lead_sponsor> <agency>Radboud University Medical Center</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Dutch National Health Care Institute</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>UMC Utrecht</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Radboud University Medical Center</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> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59 years), responsible for up to 7% of total life years lost from cancer before the age of 70.  The current treatment of glioblastoma consists of maximal safe surgery combined with adjuvant chemoradiation therapy (CRT). However, despite this aggressive treatment, these patients still face a poor prognosis (median overall survival 14.5 - 18.5 months). In addition to that, around 30% of the patients diagnosed with a glioblastoma are not suitable for surgery. These patients miss the benefit of a resection and face an even worse prognosis (median overall survival 5.1 months).  The primary aim of this project is to investigate whether laser therapy combined with CRT improves overall survival, without compromising quality of life, in comparison with CRT alone in patients with primary irresectable glioblastoma. </textblock> </brief_summary> <detailed_description> <textblock> RATIONALE: Glioblastoma (GBM) is the most common primary brain tumor with about 1000 new patients facing this diagnosis each year in the Netherlands alone. It is also one of the most devastating malignancies and due to relatively young age at presentation (median 59 years), GBMs are responsible for up to 7% of total life years lost from cancer before the age of 70. Despite many efforts, patients with glioblastoma face a poor prognosis, with 2-year survival less than 20%. Current standard of care includes maximal safe surgical resection followed by adjuvant chemoradiation therapy (CRT). Subtotal and gross total resection have been associated with significantly longer survival (median OS: 14.5-18.5 months; RR: 0.71-0.84) 6,7, but in 30% of patients surgery is not feasible. These patients miss the benefit of surgical resection and with CRT alone have a profoundly worse survival (median 5.1 months). Laser interstitial thermal therapy (LITT) is recently growing as a minimally invasive alternative to treat brain tumors. Multiple studies have shown the application of LITT in newly diagnosed and recurrent glioblastoma, in radiotherapy and chemotherapy resistant metastases or in tumors in difficult accessible locations, with promising initial results. A recent systematic review of current phase I/II studies in patients with newly diagnosed irresectable glioblastoma who received LITT yields a mean survival of 10.2 months, i.e. twice as long as with CRT alone (5.1 months). However, there is currently no high-quality prospective evidence directly comparing LITT with standard of care, precluding any conclusions on (cost-)effectiveness. After conducting a pilot study at Radboud University Medical Center to locally confirm safety and feasibility of LITT in patients with irresectable glioblastoma, we propose a prospective multicenter randomized controlled study to evaluate (cost-)effectiveness of this technique.  OBJECTIVE: The primary objective is to prove an improvement in survival without substantially compromising quality-of-life (QoL) in patients with primary irresectable glioblastoma (GBM) treated with LITT plus chemoradiation therapy (CRT) vs. CRT alone.  STUDY DESIGN: Prospective multicenter randomized controlled trial. Study population: Adult (>18 years old) patients with a radiologically suspected diagnosis of primary glioblastoma not amenable for surgical resection.  INTERVENTION: Patients will be randomized to receive either (i) biopsy and LITT, followed by standard CRT or (ii) biopsy alone, followed by standard CRT.  MAIN STUDY PARAMETERS/ENDPOINTS: The primary endpoints are overall survival (OS) and quality-of-life (QoL) using QLQ-C30+BN20 questionnaire 5 months after randomization.  Secondary endpoints are disease-specific and progression-free survival (PFS), generic QoL using EQ5D-5L and QLQ-C30+BN20, complication rates, tumor volume response, effects on adjuvant treatment and costs.  NATURE AND EXTENT OF THE BURDER AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS: We hypothesize that the addition of LITT provides patients with an irresectable glioblastoma a relevant survival benefit without compromising their quality of life as compared to current standard treatment. LITT has been shown to carry limited risk of post-operative complications, mostly reversible, and has been associated with fast recovery post-treatment. The main risks associated to the procedure are bleeding, brain edema, neurological deterioration, operation site infection, epilepsy. The results of our near-finished pilot study are showing that the procedure seems to be safe and feasible. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 8, 2022</start_date> <completion_date type="Anticipated">October 31, 2027</completion_date> <primary_completion_date type="Anticipated">October 31, 2025</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>Prospective, multicenter, open-label randomized controlled trial</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Overall survival</measure> <time_frame>Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).</time_frame> <description>Percentage of patients still alive for a given period of time after randomization.</description> </primary_outcome> <primary_outcome> <measure>Health Related Quality of Life (HR-QoL)</measure> <time_frame>At 5 months after randomization</time_frame> <description>QoL measured with the QLQ-C30BN20 at 5 months after randomization.</description> </primary_outcome> <secondary_outcome> <measure>Costs</measure> <time_frame>At 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.</time_frame> <description>Use of care and health-related costs measured using costs questionnaires.</description> </secondary_outcome> <secondary_outcome> <measure>Ablation rate</measure> <time_frame>Using the MRI made right after LITT procedure</time_frame> <description>Measuring the expected ablation rate.</description> </secondary_outcome> <secondary_outcome> <measure>Progression Free Survival (PFS)</measure> <time_frame>During the entire study period, estimated 18 months for each patient</time_frame> <description>The length of time during and after the treatment of the disease that a patient lives with the disease but it does not get worse.</description> </secondary_outcome> <secondary_outcome> <measure>Disease Specific Survival (DSS)</measure> <time_frame>During the entire study period, estimated 18 months for each patient</time_frame> <description>The percentage of patients who have not died from glioblastoma.</description> </secondary_outcome> <secondary_outcome> <measure>Complication rate</measure> <time_frame>During the entire study period, estimated 18 months for each patient</time_frame> <description>Registration of complications in both study groups.</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival since intervention</measure> <time_frame>During the entire study period, estimated 18 months for each patient</time_frame> <description>Percentage of patients still alive for a given period of time after surgery.</description> </secondary_outcome> <secondary_outcome> <measure>Tumor volume response</measure> <time_frame>Using the MRI made right after LITT procedure</time_frame> <description>Response of tumor tissue to LITT.</description> </secondary_outcome> <secondary_outcome> <measure>Effects of LITT on adjuvant treatment</measure> <time_frame>During the entire study period, estimated 18 months for each patient</time_frame> <description>Effects of LITT on the effect of adjuvant treatment assessed by tumor response to chemotherapy and radiotherapy on follow-up MRI.</description> </secondary_outcome> <secondary_outcome> <measure>General Quality of Life</measure> <time_frame>At randomization, 72 hours after surgery, 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.</time_frame> <description>QoL measured with the QoL questionnaires.</description> </secondary_outcome> <secondary_outcome> <measure>Longitudinal effects</measure> <time_frame>During the entire study period, estimated 18 months for each patient.</time_frame> <description>Changes attributable to aging during the study period. Longitudinal effects will be assessed using mixed model analysis.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">238</enrollment> <condition>Primary Glioblastoma</condition> <arm_group> <arm_group_label>Control group (biopsy group)</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Standard of care: biopsy + adjuvant treatment</description> </arm_group> <arm_group> <arm_group_label>Intervention group (LITT group)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Biopsy + LITT + adjuvant treatment</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Laser Interstitial Thermal Therapy (LITT)</intervention_name> <description>LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.</description> <arm_group_label>Intervention group (LITT group)</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Biopsy</intervention_name> <description>A sample of tissue from the tumor is obtained to confirm the diagnosis.</description> <arm_group_label>Control group (biopsy group)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Informed consent, age >18 years  - Suspected glioblastoma  - Supratentorial localization  - Patient is not amendable for surgical resection as decided by the tumor board  - Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures  - Karnofsky Performance Status (KPS) >=70  Exclusion Criteria:  - Contra-indication for general anesthesia or MRI  - Non-glioblastoma diagnosis on pathology analysis  - No final pathology available  - Pregnancy  - Insufficient command of the Dutch language by the patient or a family member, making it impossible to fill in the questionnaires </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>Mark ter Laan, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Radboud University Medical Center</affiliation> </overall_official> <overall_contact> <last_name>Céline Neutel, MD</last_name> <phone>(024) 361 66 04</phone> <email>celine.neutel@radboudumc.nl</email> </overall_contact> <location> <facility> <name>Amsterdam Medical Center</name> <address> <city>Amsterdam</city> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Philip de Witt Hamer, MD, PhD</last_name> </contact> </location> <location> <facility> <name>University Medical Center Groningen</name> <address> <city>Groningen</city> <country>Netherlands</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Michiel Wagemakers, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Maastricht University Medical Center</name> <address> <city>Maastricht</city> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Koos Hovinga, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Radboud University Medical Center</name> <address> <city>Nijmegen</city> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Céline Neutel, MD</last_name> <email>celine.neutel@radboudumc.nl</email> </contact> </location> <location> <facility> <name>Erasmus Medical Center</name> <address> <city>Rotterdam</city> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rutger Balvers, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Elisabeth Tweesteden Ziekenhuis</name> <address> <city>Tilburg</city> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Hilko Ardon, MD, PhD</last_name> </contact> </location> <location> <facility> <name>University Medical Center Utrecht</name> <address> <city>Utrecht</city> <country>Netherlands</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Pieter van Eijsden, MD, PhD</last_name> </contact> </location> <location_countries> <country>Netherlands</country> </location_countries> <reference> <citation>Incidentie Hersentumoren. 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J Magn Reson Imaging. 2008 Feb;27(2):376-90. doi: 10.1002/jmri.21265.</citation> <PMID>18219673</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 1, 2022</last_update_submitted> <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 2, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Glioblastoma</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Data will be shared with other researchers. All data will be made findable and shared for reuse and/or verification. Restrictions on data sharing only apply to MRI images due to privacy. Metadata will be published in a data repository (Radboud Data Repository). This way the data is findable. When desired, external researchers can request our data.</ipd_description> </patient_data>  </clinical_study>

The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59 years), responsible for up to 7% of total life years lost from cancer before the age of 70. The current treatment of glioblastoma consists of maximal safe surgery combined with adjuvant chemoradiation therapy (CRT). However, despite this aggressive treatment, these patients still face a poor prognosis (median overall survival 14.5 - 18.5 months). In addition to that, around 30% of the patients diagnosed with a glioblastoma are not suitable for surgery. These patients miss the benefit of a resection and face an even worse prognosis (median overall survival 5.1 months). The primary aim of this project is to investigate whether laser therapy combined with CRT improves overall survival, without compromising quality of life, in comparison with CRT alone in patients with primary irresectable glioblastoma. RATIONALE: Glioblastoma (GBM) is the most common primary brain tumor with about 1000 new patients facing this diagnosis each year in the Netherlands alone. It is also one of the most devastating malignancies and due to relatively young age at presentation (median 59 years), GBMs are responsible for up to 7% of total life years lost from cancer before the age of 70. Despite many efforts, patients with glioblastoma face a poor prognosis, with 2-year survival less than 20%. Current standard of care includes maximal safe surgical resection followed by adjuvant chemoradiation therapy (CRT). Subtotal and gross total resection have been associated with significantly longer survival (median OS: 14.5-18.5 months; RR: 0.71-0.84) 6,7, but in 30% of patients surgery is not feasible. These patients miss the benefit of surgical resection and with CRT alone have a profoundly worse survival (median 5.1 months). Laser interstitial thermal therapy (LITT) is recently growing as a minimally invasive alternative to treat brain tumors. Multiple studies have shown the application of LITT in newly diagnosed and recurrent glioblastoma, in radiotherapy and chemotherapy resistant metastases or in tumors in difficult accessible locations, with promising initial results. A recent systematic review of current phase I/II studies in patients with newly diagnosed irresectable glioblastoma who received LITT yields a mean survival of 10.2 months, i.e. twice as long as with CRT alone (5.1 months). However, there is currently no high-quality prospective evidence directly comparing LITT with standard of care, precluding any conclusions on (cost-)effectiveness. After conducting a pilot study at Radboud University Medical Center to locally confirm safety and feasibility of LITT in patients with irresectable glioblastoma, we propose a prospective multicenter randomized controlled study to evaluate (cost-)effectiveness of this technique. OBJECTIVE: The primary objective is to prove an improvement in survival without substantially compromising quality-of-life (QoL) in patients with primary irresectable glioblastoma (GBM) treated with LITT plus chemoradiation therapy (CRT) vs. CRT alone. STUDY DESIGN: Prospective multicenter randomized controlled trial. Study population: Adult (>18 years old) patients with a radiologically suspected diagnosis of primary glioblastoma not amenable for surgical resection. INTERVENTION: Patients will be randomized to receive either (i) biopsy and LITT, followed by standard CRT or (ii) biopsy alone, followed by standard CRT. MAIN STUDY PARAMETERS/ENDPOINTS: The primary endpoints are overall survival (OS) and quality-of-life (QoL) using QLQ-C30+BN20 questionnaire 5 months after randomization. Secondary endpoints are disease-specific and progression-free survival (PFS), generic QoL using EQ5D-5L and QLQ-C30+BN20, complication rates, tumor volume response, effects on adjuvant treatment and costs. NATURE AND EXTENT OF THE BURDER AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS: We hypothesize that the addition of LITT provides patients with an irresectable glioblastoma a relevant survival benefit without compromising their quality of life as compared to current standard treatment. LITT has been shown to carry limited risk of post-operative complications, mostly reversible, and has been associated with fast recovery post-treatment. The main risks associated to the procedure are bleeding, brain edema, neurological deterioration, operation site infection, epilepsy. The results of our near-finished pilot study are showing that the procedure seems to be safe and feasible. Inclusion Criteria: - Informed consent, age >18 years - Suspected glioblastoma - Supratentorial localization - Patient is not amendable for surgical resection as decided by the tumor board - Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures - Karnofsky Performance Status (KPS) >=70 Exclusion Criteria: - Contra-indication for general anesthesia or MRI - Non-glioblastoma diagnosis on pathology analysis - No final pathology available - Pregnancy - Insufficient command of the Dutch language by the patient or a family member, making it impossible to fill in the questionnaires

NCT0531xxxx/NCT05318625.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/NCT05318625</url> </required_header> <id_info> <org_study_id>PRHK02_TD8072</org_study_id> <nct_id>NCT05318625</nct_id> </id_info> <brief_title>A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.</brief_title> <official_title>A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.</official_title> <sponsors> <lead_sponsor> <agency>Precision Robotics (Hong Kong) Limited</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Gleneagles Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Queen Mary Hospital, Hong Kong</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Precision Robotics (Hong Kong) Limited</source> <oversight_info> <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> Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.  A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.  The study is a single-arm prospective study to evaluate the Performance and Safety of the SIRIUS Endoscope System. </textblock> </brief_summary> <detailed_description> <textblock> Minimally invasive surgery (MIS) is well established in gynecological surgery. Compared to laparotomy, MIS is associated with reduced morbidity and quicker recovery. With advancement in laparoscopic technology and techniques, MIS in gynecology has progressed from multi-port to single incision laparoscopic surgery (SILS) and vaginal natural orifice transluminal endoscopic surgery (vNOTEs), thus further reducing morbidity and enhancing recovery.  One of the challenges of MIS is the restriction of the range of surgical movement. To overcome these technical challenges, articulated instruments are increasingly being used. The SIRIUS Endoscope System is a new, fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. The articulated tip has three degrees of freedom, enabling C and S-shaped bending, and providing a wider field of view compared to conventional laparoscopes. This wider field of view is of advantage for SILS and vNOTEs. Presently available commercial systems do not have the same field of view or degrees of freedom.  A first in-human, proof of concept, and early development study of the SIRIUS Endoscope System was done at GHK in 2021 (HKU-GHK IRB 2021-01, ClinicalTrials.gov NCT05048407). The successful completion of 11 of 13 (85%) planned procedures in this sequentially reported, prospective case series, shows that the SIRIUS Endoscope System can be used with indications of safety, and efficacy for intermediate and major MIS laparoscopic procedures in gynecology. The findings have been submitted for consideration for publication.  Based on the outcome of this study, further improvements to the SIRIUS Endoscope System have been made to enhance safety, reliability, and usability. This proposed prospective study is a confirmatory study to evaluate the performance and safety of the SIRIUS Endoscope System in preparation for regulatory approval. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">January 10, 2023</start_date> <completion_date type="Anticipated">July 2024</completion_date> <primary_completion_date type="Anticipated">July 2024</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> </study_design_info> <primary_outcome> <measure>General Assessment of SIRIUS Endoscope System.</measure> <time_frame>Through study completion, Up to 1 year from the first to the last patients</time_frame> <description>General Assessment of SIRIUS Endoscope System, using Questionnaire- Clinical Study General Assessment of SIRIUS Endoscope System)</description> </primary_outcome> <primary_outcome> <measure>SIRIUS Endoscope Articulated tip assessment.</measure> <time_frame>Through study completion, Up to 1 year from the first to the last patients</time_frame> <description>SIRIUS Endoscope Articulated tip assessment, using the Questionnaire -Clinical Study Assessment of SIRIUS Endoscope System Articulated Tip</description> </primary_outcome> <secondary_outcome> <measure>The time of straight and bending positions of SIRIUS Endoscope System articulated tip</measure> <time_frame>Through study completion, Up to 1 year from the first to the last patients</time_frame> </secondary_outcome> <secondary_outcome> <measure>Events of device deficiency and/or malfunctions of SIRIUS Endoscope System</measure> <time_frame>Through study completion, Up to 1 year from the first to the last patients</time_frame> </secondary_outcome> <secondary_outcome> <measure>Intraoperative adverse events related to the SIRIUS Endoscope System</measure> <time_frame>Through study completion, Up to 1 year from the first to the last patients</time_frame> </secondary_outcome> <secondary_outcome> <measure>Postoperative complications related to the SIRIUS Endoscope System</measure> <time_frame>Through study completion, Up to 1 year from the first to the last patients</time_frame> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Ovarian Cancer</condition> <condition>Cervical Cancer</condition> <condition>Gynecologic Cancer</condition> <arm_group> <arm_group_label>Gynaecological laparoscopic surgery</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Eligible women aged 18 - 70 years, regardless of parity, who need laparoscopic gynaecological surgery and who provide informed consent prior to surgery</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Gynaecological laparoscopic surgery (Sirius System)</intervention_name> <description>The laparoscopic procedures were done in the usual manner. The only difference was for the study participants, the Sirius System was used in place of the usual conventional laparoscope. All other procedures and instruments including the number of ports remained the same. For every procedure using the Sirius System, a conventional laparoscope was on immediate standby to replace the Sirius System should there be an unanticipated equipment failure so that the procedure could be completed without delay.</description> <arm_group_label>Gynaecological laparoscopic surgery</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients who are planned for Laparoscopic Gynecological Surgery (LGS)  - Patient is 18 years of age or older  - Signed written informed consent.  Exclusion Criteria:  - Patient is pregnant, or planning on becoming pregnant  - Obese patients (BMI >35)  - Patient with known contraindication(s) to Laparoscopic Gynecological Surgery  - Patient with operations planned for longer than 4 hours  - Subjects are considered ineligible for the study as judged by the investigator. </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Women-only</gender_description> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Tong Yow Ng, MD</last_name> <role>Principal Investigator</role> <affiliation>Gleneagles Hospital</affiliation> </overall_official> <location> <facility> <name>Gleneagles Hospital Hong Kong</name> <address> <city>Wong Chuk Hang</city> <country>Hong Kong</country> </address> </facility> </location> <location_countries> <country>Hong Kong</country> </location_countries> <link> <url>https://sit.bmj.com/content/bmjsit/4/1/e000117.full.pdf</url> <description>First in-human trial and prospective case series of an articulated laparoscopic camera system in minimally invasive surgery in gynecology: an IDEAL stage 1 and 2a study</description> </link> <verification_date>August 2023</verification_date> <study_first_submitted>March 25, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 2, 2023</last_update_submitted> <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 3, 2023</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>

Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery. The study is a single-arm prospective study to evaluate the Performance and Safety of the SIRIUS Endoscope System. Minimally invasive surgery (MIS) is well established in gynecological surgery. Compared to laparotomy, MIS is associated with reduced morbidity and quicker recovery. With advancement in laparoscopic technology and techniques, MIS in gynecology has progressed from multi-port to single incision laparoscopic surgery (SILS) and vaginal natural orifice transluminal endoscopic surgery (vNOTEs), thus further reducing morbidity and enhancing recovery. One of the challenges of MIS is the restriction of the range of surgical movement. To overcome these technical challenges, articulated instruments are increasingly being used. The SIRIUS Endoscope System is a new, fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. The articulated tip has three degrees of freedom, enabling C and S-shaped bending, and providing a wider field of view compared to conventional laparoscopes. This wider field of view is of advantage for SILS and vNOTEs. Presently available commercial systems do not have the same field of view or degrees of freedom. A first in-human, proof of concept, and early development study of the SIRIUS Endoscope System was done at GHK in 2021 (HKU-GHK IRB 2021-01, ClinicalTrials.gov NCT05048407). The successful completion of 11 of 13 (85%) planned procedures in this sequentially reported, prospective case series, shows that the SIRIUS Endoscope System can be used with indications of safety, and efficacy for intermediate and major MIS laparoscopic procedures in gynecology. The findings have been submitted for consideration for publication. Based on the outcome of this study, further improvements to the SIRIUS Endoscope System have been made to enhance safety, reliability, and usability. This proposed prospective study is a confirmatory study to evaluate the performance and safety of the SIRIUS Endoscope System in preparation for regulatory approval. Inclusion Criteria: - Patients who are planned for Laparoscopic Gynecological Surgery (LGS) - Patient is 18 years of age or older - Signed written informed consent. Exclusion Criteria: - Patient is pregnant, or planning on becoming pregnant - Obese patients (BMI >35) - Patient with known contraindication(s) to Laparoscopic Gynecological Surgery - Patient with operations planned for longer than 4 hours - Subjects are considered ineligible for the study as judged by the investigator.

NCT0531xxxx/NCT05318638.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/NCT05318638</url> </required_header> <id_info> <org_study_id>80144</org_study_id> <nct_id>NCT05318638</nct_id> </id_info> <brief_title>Soft-robotic Glove Support of High-demand Tasks</brief_title> <official_title>Changes in Movement Profile Related to Use of a Soft-robotic Glove During High-demand Tasks</official_title> <sponsors> <lead_sponsor> <agency>Roessingh Research and Development</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Roessingh Research and Development</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 hand is important to perform activities of daily living (ADL). However, many people experience a loss of hand function as result of a traumatic brain injury, spinal cord injury, stroke or orthopedic problems, or due to ageing. To improve hand function, or reduce its decline, one can benefit from exercise therapy or use of assistive aids to improve ADL independence. A promising innovative approach combining both is a wearable soft-robotic glove that supports hand grip. With this glove, performance of functional activities can be supported directly, while also facilitating repeated use of the affected arm and hand during functional daily activities. One of our previous studies showed that besides a direct support effect, a therapeutic effect on performance was found after several weeks of using the soft-robotic glove as support during ADL. However, several participants reported complaints of increased pain and/or overload, mainly at the beginning of the trial. Clinicians suspect that a (too) high intensity of hand use compared to normal is contributing to this observation. This might be related to more fatigue experienced when using the glove in high-demand tasks, due to a larger movement capacity (faster, further, more repetitions) and can be associated with decreased blood perfusion/lower saturation levels at muscular level and altered muscle activation and movement coordination.  Therefore, the primary objective is to examine the effect of use of the assistive soft-robotic glove during strenuous ADL tasks on the kinematic movement profile, compared to not using the soft-robotic glove. Secondary objectives are to examine whether pain or discomfort is experienced in strenuous activities with the soft-robotic glove as well as the characteristics and locations of such pain/discomfort, and to examine whether use of the glove is associated with increased handgrip strength, larger number of ADL task repetitions, diminished blood perfusion / reduced tissue saturation at the muscle and/or changes in muscle activity. </textblock> </brief_summary> <detailed_description> <textblock> A promising innovative approach to improve hand function is to integrate exercise therapy with support of activities of daily life using an assistive device. This is possible using a wearable soft-robotic glove that supports hand grip. With this glove, performance of functional activities can be supported directly, while also facilitating repeated use of the affected arm and hand during functional daily activities. One of our previous studies showed that besides a direct support effect, a therapeutic effect on performance was found after several weeks of using the soft-robotic glove as support during ADL. However, several participants reported complaints of increased pain and/or overload, mainly at the beginning of the trial. Clinicians suspect that a (too) high intensity of hand use compared to normal is contributing to this observation. This might be related to more fatigue experienced when using the glove in high-demand tasks, due to a larger movement capacity (faster, further, more repetitions) and can be associated with decreased blood perfusion/lower saturation levels at muscular level and altered muscle activation and movement coordination.  The primary objective is to examine the effect of use of the assistive soft-robotic glove during strenuous ADL tasks on the kinematic movement profile, compared to not using the soft-robotic glove. Secondary objectives are to examine whether pain or discomfort is experienced in strenuous activities with the soft-robotic glove as well as the characteristics and locations of such pain/discomfort, and to examine whether use of the glove is associated with increased handgrip strength, larger number of ADL task repetitions, diminished blood perfusion / reduced tissue saturation at the muscle and/or changes in muscle activity.  The study is set-up as a cross-sectional intervention study with one measurement session, where participants will perform maximum handgrip strength tests and high-demand ADL-tasks with and without the soft-robotic glove. The aim is to include 20 participants in total, 10 of which will be frail elderly and the other 10 will be neuromuscular patients, all suffering from reduced hand function.  All participants will perform each movement task with and without the soft-robotic glove. The soft-robotic glove used in the study is the Carbonhand system (Bioservo Technologies, Sweden). It is a CE-marked medical device and it consists of a glove that supports finger flexion via sewn-in tendons and a control unit housing the actuators that pull on the tendons and the batteries. The grip support is activated by applying very light pressure on sensors in the fingertips of the glove, and de-activated by releasing the pressure on the sensors. After execution of all tasks with and without glove, differences in outcome measures will be compared between glove conditions. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 17, 2022</start_date> <completion_date type="Anticipated">December 2024</completion_date> <primary_completion_date type="Anticipated">December 2024</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> <intervention_model_description>The study is a cross-sectional intervention study with one measurement session, where participants will perform maximum handgrip strength tests and high-demand ADL-tasks with and without the soft-robotic glove (glove condition in randomized order).</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Kinematic movement profile during performance of strenuous ADL task</measure> <time_frame>1-2 hours during the measurement session</time_frame> <description>The kinematic movement profile during performance of strenuous ADL task, characterized by the following parameters as assessed using 3D marker-based motion capture: • Total movement duration Duration of movement phases Movement smoothness Trunk displacement Peak hand velocity Time to peak velocity of reach phase Hand opening Joint excursion of the elbow Joint excursion of the wrist Endpoint straightness Endpoint error</description> </primary_outcome> <secondary_outcome> <measure>Experienced pain/discomfort rating + description</measure> <time_frame>Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.</time_frame> <description>Discomfort and pain in the hand experienced by the participants will be assessed using a report form, indicating the amount of experienced pain and/or discomfort (using Visual Analogue Scales), and in case of discomfort or pain, a map of the hands to localize the pain/discomfort and a description of its sensation as well as an assumed cause. This will be done separately for each area in which discomfort and/or pain is reported.</description> </secondary_outcome> <secondary_outcome> <measure>Perceived exertion and confidence in grip rating</measure> <time_frame>Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.</time_frame> <description>Perceived exertion/fatigue after the strenuous ADL tasks will be assessed using the Borg Rating Scale of Perceived Exertion. An additional question assesses the participants' confidence in their grip on the object as experienced during the ADL task performance.</description> </secondary_outcome> <secondary_outcome> <measure>Maximal handgrip strength</measure> <time_frame>1-2 hours during the measurement session</time_frame> <description>The maximal handgrip strength will be measured with a custom-made cylindrical dynamometer, recording the maximum force a person can exert on the dynamometer by forcefully gripping the cylinder. This will be done three times, if the last attempt is done with higher force than the second-to-last attempt, another attempt will be added, until the last value is lower than the second-to-last value.</description> </secondary_outcome> <secondary_outcome> <measure>Handgrip endurance</measure> <time_frame>1-2 hours during the measurement session</time_frame> <description>Handgrip endurance will also be measured with a custom-made cylindrical dynamometer. It will be measured in a static situation, by prolonged max contraction of hand grip during 30 seconds.</description> </secondary_outcome> <secondary_outcome> <measure>Number of repetitions achieved during ADL task</measure> <time_frame>1-2 hours during the measurement session</time_frame> <description>The number of repetitions achieved during execution of the ADL task (i.e., number of times the task was completed succesfully) in the four different conditions (no glove and unsupported max weight, no glove and supported max weight, glove and unsupported max weight, glove and supported max weight) will be recorded.</description> </secondary_outcome> <secondary_outcome> <measure>Muscle tissue oxygen saturation</measure> <time_frame>1-2 hours during the measurement session</time_frame> <description>The muscle oxygen saturation in the forearm is measured during the ADL task execution and handgrip strength and endurance tests using a NIRS sensor placed over the M. flexor radialis and ulnaris and the M. flexor digitorum superficialis, secured with Velcro straps around the forearm.</description> </secondary_outcome> <secondary_outcome> <measure>Amplitude, on/off times and median frequency of muscle activity</measure> <time_frame>1-2 hours during the measurement session</time_frame> <description>Muscle activity parameters will be calculated from surface EMG recordings of Abductor pollicis brevis, Extensor digitorum, Extensor carpi radialis, Extensor carpi ulnaris, Extensor pollicis brevis/longus, Flexor carpi ulnaris, Flexor carpi radialis</description> </secondary_outcome> <other_outcome> <measure>Subject characteristics</measure> <time_frame>At the start of the measurement session, taking about 5 minutes</time_frame> <description>Age Sex Most-affected side Dominant side Impairment/ disorder and date of diagnosis</description> </other_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Neuromuscular Diseases</condition> <condition>Sarcopenia</condition> <arm_group> <arm_group_label>Study group</arm_group_label> <arm_group_type>Other</arm_group_type> <description>All participants in the study will perform arm/hand movement tasks in both of two conditions (with and without soft-robotic glove), so they constitute 1 study arm, but all receiving both intervention conditions (experimental - with glove and control - without glove).</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Soft robotic glove</intervention_name> <description>The soft-robotic glove used in the study is the Carbonhand system (Bioservo Technologies, Sweden). It is a CE-marked medical device and it consists of a glove that supports finger flexion via sewn-in tendons and a control unit housing the actuators that pull on the tendons and the batteries. The grip support is activated by applying very light pressure on sensors in the fingertips of the glove, and de-activated by releasing the pressure on the sensors.</description> <arm_group_label>Study group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Frail elderly with reduced hand function:  - Age between 65 and 90 years  - Experience difficulties in performing ADL due to a decline in hand function  - Able to make a pinch grip between thumb and middle or ring finger  - Sufficient cognitive status to understand two-step instructions  - Having (corrected to) normal vision  - Able to provide written informed consent  - Neuromuscular patients:  - Age between 18 and 80 years  - Experience difficulties in performing ADL due to a decline in hand function that can be attributed to a diagnosed neuromuscular disease  - Being in a chronic and stable phase of disease  - Able to make a pinch grip between thumb and middle or ring finger  - Sufficient cognitive status to understand two-step instructions  - Having (corrected to) normal vision  - Able to provide written informed consent  Exclusion Criteria:  - Frail elderly with reduced hand function:  - Currently receiving treatment for a disease affecting arm/hand function  - Used the CarbonHand system in the past 3 months  - Severe sensory problems of the most-affected hand  - Severe acute pain of the most-affected hand  - Wounds on the hands that can provide a problem when using the glove  - Severe contractures limiting passive range of motion  - Severe spasticity of the hand (≥2 points on Ashworth Scale)  - Insufficient knowledge of the Dutch language to understand the purpose or methods of the study  - Neuromuscular patients:  - Severe sensory problems of the most-affected hand </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>90 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>G. Prange, PhD</last_name> <role>Principal Investigator</role> <affiliation>Roessingh Research and Development</affiliation> </overall_official> <overall_contact> <last_name>G. Prange, PhD</last_name> <phone>+31 88875777</phone> <email>g.prange@rrd.nl</email> </overall_contact> <location> <facility> <name>Roessingh Research and Development</name> <address> <city>Enschede</city> <state>Overijssel</state> <zip>7522AH</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>G. Prange, PhD</last_name> </contact> </location> <location_countries> <country>Netherlands</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>December 21, 2021</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>September 4, 2023</last_update_submitted> <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Soft-robotic glove</keyword> <keyword>Wearable device</keyword> <keyword>Hand function</keyword> <keyword>Movement analysis</keyword> <condition_browse>  <mesh_term>Sarcopenia</mesh_term> <mesh_term>Neuromuscular Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The hand is important to perform activities of daily living (ADL). However, many people experience a loss of hand function as result of a traumatic brain injury, spinal cord injury, stroke or orthopedic problems, or due to ageing. To improve hand function, or reduce its decline, one can benefit from exercise therapy or use of assistive aids to improve ADL independence. A promising innovative approach combining both is a wearable soft-robotic glove that supports hand grip. With this glove, performance of functional activities can be supported directly, while also facilitating repeated use of the affected arm and hand during functional daily activities. One of our previous studies showed that besides a direct support effect, a therapeutic effect on performance was found after several weeks of using the soft-robotic glove as support during ADL. However, several participants reported complaints of increased pain and/or overload, mainly at the beginning of the trial. Clinicians suspect that a (too) high intensity of hand use compared to normal is contributing to this observation. This might be related to more fatigue experienced when using the glove in high-demand tasks, due to a larger movement capacity (faster, further, more repetitions) and can be associated with decreased blood perfusion/lower saturation levels at muscular level and altered muscle activation and movement coordination. Therefore, the primary objective is to examine the effect of use of the assistive soft-robotic glove during strenuous ADL tasks on the kinematic movement profile, compared to not using the soft-robotic glove. Secondary objectives are to examine whether pain or discomfort is experienced in strenuous activities with the soft-robotic glove as well as the characteristics and locations of such pain/discomfort, and to examine whether use of the glove is associated with increased handgrip strength, larger number of ADL task repetitions, diminished blood perfusion / reduced tissue saturation at the muscle and/or changes in muscle activity. A promising innovative approach to improve hand function is to integrate exercise therapy with support of activities of daily life using an assistive device. This is possible using a wearable soft-robotic glove that supports hand grip. With this glove, performance of functional activities can be supported directly, while also facilitating repeated use of the affected arm and hand during functional daily activities. One of our previous studies showed that besides a direct support effect, a therapeutic effect on performance was found after several weeks of using the soft-robotic glove as support during ADL. However, several participants reported complaints of increased pain and/or overload, mainly at the beginning of the trial. Clinicians suspect that a (too) high intensity of hand use compared to normal is contributing to this observation. This might be related to more fatigue experienced when using the glove in high-demand tasks, due to a larger movement capacity (faster, further, more repetitions) and can be associated with decreased blood perfusion/lower saturation levels at muscular level and altered muscle activation and movement coordination. The primary objective is to examine the effect of use of the assistive soft-robotic glove during strenuous ADL tasks on the kinematic movement profile, compared to not using the soft-robotic glove. Secondary objectives are to examine whether pain or discomfort is experienced in strenuous activities with the soft-robotic glove as well as the characteristics and locations of such pain/discomfort, and to examine whether use of the glove is associated with increased handgrip strength, larger number of ADL task repetitions, diminished blood perfusion / reduced tissue saturation at the muscle and/or changes in muscle activity. The study is set-up as a cross-sectional intervention study with one measurement session, where participants will perform maximum handgrip strength tests and high-demand ADL-tasks with and without the soft-robotic glove. The aim is to include 20 participants in total, 10 of which will be frail elderly and the other 10 will be neuromuscular patients, all suffering from reduced hand function. All participants will perform each movement task with and without the soft-robotic glove. The soft-robotic glove used in the study is the Carbonhand system (Bioservo Technologies, Sweden). It is a CE-marked medical device and it consists of a glove that supports finger flexion via sewn-in tendons and a control unit housing the actuators that pull on the tendons and the batteries. The grip support is activated by applying very light pressure on sensors in the fingertips of the glove, and de-activated by releasing the pressure on the sensors. After execution of all tasks with and without glove, differences in outcome measures will be compared between glove conditions. Inclusion Criteria: - Frail elderly with reduced hand function: - Age between 65 and 90 years - Experience difficulties in performing ADL due to a decline in hand function - Able to make a pinch grip between thumb and middle or ring finger - Sufficient cognitive status to understand two-step instructions - Having (corrected to) normal vision - Able to provide written informed consent - Neuromuscular patients: - Age between 18 and 80 years - Experience difficulties in performing ADL due to a decline in hand function that can be attributed to a diagnosed neuromuscular disease - Being in a chronic and stable phase of disease - Able to make a pinch grip between thumb and middle or ring finger - Sufficient cognitive status to understand two-step instructions - Having (corrected to) normal vision - Able to provide written informed consent Exclusion Criteria: - Frail elderly with reduced hand function: - Currently receiving treatment for a disease affecting arm/hand function - Used the CarbonHand system in the past 3 months - Severe sensory problems of the most-affected hand - Severe acute pain of the most-affected hand - Wounds on the hands that can provide a problem when using the glove - Severe contractures limiting passive range of motion - Severe spasticity of the hand (≥2 points on Ashworth Scale) - Insufficient knowledge of the Dutch language to understand the purpose or methods of the study - Neuromuscular patients: - Severe sensory problems of the most-affected hand

NCT0531xxxx/NCT05318651.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/NCT05318651</url> </required_header> <id_info> <org_study_id>A20273336</org_study_id> <nct_id>NCT05318651</nct_id> </id_info> <brief_title>Use Determinants of Smoking Cessation App</brief_title> <official_title>Determinants of Use of Mobile Apps for Smoking Cessation</official_title> <sponsors> <lead_sponsor> <agency>Paris Nanterre University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Paris Nanterre 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> The development of mobile applications ("mobile apps") is steadily increasing and appears to be a promising treatment method to help people change unwanted behaviors or maintain a regular relationship with the medical system. Mobile apps aimed at smoking cessation have been shown to be effective. However, if a treatment is not used regularly, it will not have the desired effect. The main objective of this study is to identify what makes a person decide to use a smoking cessation app and to do so regularly. The second objective is to determine what is necessary to achieve long-term change with a mobile app. </textblock> </brief_summary> <detailed_description> <textblock> Despite the significant decrease in tobacco consumption in France (30% in 2000 vs. 25.4% in 2018), the prevalence of smokers aged 18 to 75 years is still a public issue. Among the new solutions proposed, mobile applications ("mobile apps") seem to be a promising treatment modality. Several advantages to their use are recognized for patients, health professionals and the health system itself. Mobile applications allow accessibility to care and information, the possibility of transposing several proven effective therapeutic principles, the possibility of integrating certain forms of information transmission such as messaging, behavioural feedback and audiovisual media.  Although mobile app development is a growing market, knowledge about the determinants of intention to use this type of technology is very limited, especially for smoking cessation apps. The investigators propose a theoretical model to examine what determines the regular use of mobile apps for smoking cessation among those who want to quit. The investigators use the TAMII model and the operational variables used in a more general study on e-health applications. A chronological organisation based on a three-part behavioural model (antecedent, target behaviour and outcome) is added to the TAMII model. The main objective is to identify the factors of Mobila App Sustain Use (MASU). All definitions of TAM-II will be used : perceived usefulness (PU), perceived ease of use (PEOU) and social norm (SN), as well as the definitions proposed by Choi et al (2014) on the predictors of PU, PEOU and SN. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 21, 2022</start_date> <completion_date type="Actual">August 8, 2022</completion_date> <primary_completion_date type="Actual">June 21, 2022</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>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>First Use</measure> <time_frame>Day 1 - First use</time_frame> <description>The ratio of people accessing the app after giving them access to it.</description> </primary_outcome> <primary_outcome> <measure>Mobile App Sustain Use (MASU)</measure> <time_frame>90 days post firs use of the mobile apps</time_frame> <description>The ratio of times the application is accessed per week..</description> </primary_outcome> <primary_outcome> <measure>Mobile App Intention Use (MAIU):</measure> <time_frame>Day 15</time_frame> <description>Questionaire : please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of : In the next week In the next month</description> </primary_outcome> <primary_outcome> <measure>Mobile App Intention Use (MAIU):</measure> <time_frame>Day 30</time_frame> <description>Questionaire : please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of : In the next week In the next month</description> </primary_outcome> <primary_outcome> <measure>Mobile App Intention Use (MAIU):</measure> <time_frame>Day 60</time_frame> <description>Questionaire : please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of : In the next 15 days In the next month</description> </primary_outcome> <primary_outcome> <measure>Mobile App Intention Use (MAIU):</measure> <time_frame>Day 90</time_frame> <description>Questionaire : Please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of : In the next week In the next month</description> </primary_outcome> <primary_outcome> <measure>Mobile App Satisfaction assessment (MAS):</measure> <time_frame>Day 15</time_frame> <description>The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5 (25).This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807)</description> </primary_outcome> <primary_outcome> <measure>Mobile App Satisfaction assessment (MAS):</measure> <time_frame>Day 30</time_frame> <description>The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5 (25).This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807)</description> </primary_outcome> <primary_outcome> <measure>Mobile App Satisfaction assessment (MAS):</measure> <time_frame>Day 60</time_frame> <description>The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5 (25).This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807)</description> </primary_outcome> <primary_outcome> <measure>Mobile App Satisfaction assessment (MAS):</measure> <time_frame>Day 90</time_frame> <description>The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5.This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807).</description> </primary_outcome> <secondary_outcome> <measure>Smoking profile (SP)</measure> <time_frame>1 day before the first use of the mobile app</time_frame> <description>The degree of dependence is assessed by the Fagerström Test, which is widely used.</description> </secondary_outcome> <secondary_outcome> <measure>Craving intensity (CI)</measure> <time_frame>1 day before before the first use of the mobile app</time_frame> <description>The visual analog scale or VAS was used to measure the average craving intensity .</description> </secondary_outcome> <secondary_outcome> <measure>Craving intensity (CI)</measure> <time_frame>Day 15</time_frame> <description>The visual analog scale or VAS was used to measure the average craving intensity .</description> </secondary_outcome> <secondary_outcome> <measure>Craving intensity (CI)</measure> <time_frame>Day 30</time_frame> <description>The visual analog scale or VAS was used to measure the average craving intensity .</description> </secondary_outcome> <secondary_outcome> <measure>Craving intensity (CI)</measure> <time_frame>Day 60</time_frame> <description>The visual analog scale or VAS was used to measure the average craving intensity .</description> </secondary_outcome> <secondary_outcome> <measure>Craving intensity (CI)</measure> <time_frame>Day 90</time_frame> <description>The visual analog scale or VAS was used to measure the average craving intensity .</description> </secondary_outcome> <secondary_outcome> <measure>Behavior change : Smoking cessation</measure> <time_frame>Day 15</time_frame> <description>Self-reported 15-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?</description> </secondary_outcome> <secondary_outcome> <measure>Behavior change : Smoking cessation</measure> <time_frame>Day 30</time_frame> <description>Self-reported 30-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?</description> </secondary_outcome> <secondary_outcome> <measure>Behavior change : Smoking cessation</measure> <time_frame>Day 60</time_frame> <description>Self-reported 60-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?</description> </secondary_outcome> <secondary_outcome> <measure>Behavior change : Smoking cessation</measure> <time_frame>Day 90</time_frame> <description>Self-reported 90-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">255</enrollment> <condition>Smoking Cessation</condition> <condition>Technology Acceptance Model</condition> <condition>CBT</condition> <condition>Engagement</condition> <arm_group> <arm_group_label>mobile app users</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Kwit SAS - smoking cessation app</intervention_name> <description>Kwit is a mobile app for smoking cessation. Different CBT techniques are used by the app already been proved as effective : Case analysis craving tool, Achievements badges,Diary, Goal (outcome) setting, A 9-steps preparation program, psychological education, Emotional monitoring, Access to groups on social networks, different strategies ( NRT/water/meditation), Motivational cards.</description> <arm_group_label>mobile app users</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Participants must meet four inclusion criteria for the study:  Inclusion criteria  - Age: Be 18 years of age or older,  - Smoking Status: consider themselves an active smoker  - Motivation to quit: be willing to quit smoking, in the short and medium term.  - Agreement to participate: They must also agree to participate in the study. They will have read the information note where the procedure is described; the researchers presented and their rights to withdraw from the study are recalled.  Exclusion criteria:  - Participants must have a smartphone with an iOS or Android operating system  - Access to the internet to complete the questionnaires  - Download the application and receive the updates it offers. </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>Lucia ROMO</last_name> <role>Principal Investigator</role> <affiliation>Pr. de psychologie clinique UNIVERSITE PARIS NANTERRE</affiliation> </overall_official> <location> <facility> <name>Universite Paris Nanterre, Epscp</name> <address> <city>Paris La Defense</city> <state>Nanterre</state> <zip>92001</zip> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <reference> <citation>Taylor GMJ, Dalili MN, Semwal M, Civljak M, Sheikh A, Car J. Internet-based interventions for smoking cessation. Cochrane Database Syst Rev. 2017 Sep 4;9(9):CD007078. doi: 10.1002/14651858.CD007078.pub5.</citation> <PMID>28869775</PMID> </reference> <reference> <citation>Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.</citation> <PMID>27060875</PMID> </reference> <reference> <citation>Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y, Dobson R. Mobile phone text messaging and app-based interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Oct 22;10(10):CD006611. doi: 10.1002/14651858.CD006611.pub5.</citation> <PMID>31638271</PMID> </reference> <reference> <citation>Regmi K, Kassim N, Ahmad N, Tuah NA. Effectiveness of Mobile Apps for Smoking Cessation: A Review. Tob Prev Cessat. 2017 Apr 12;3:12. doi: 10.18332/tpc/70088. eCollection 2017.</citation> <PMID>32432186</PMID> </reference> <reference> <citation>Hoeppner BB, Hoeppner SS, Seaboyer L, Schick MR, Wu GW, Bergman BG, Kelly JF. How Smart are Smartphone Apps for Smoking Cessation? A Content Analysis. Nicotine Tob Res. 2016 May;18(5):1025-31. doi: 10.1093/ntr/ntv117. Epub 2015 Jun 4.</citation> <PMID>26045249</PMID> </reference> <reference> <citation>Rajani NB, Weth D, Mastellos N, Filippidis FT. Adherence of popular smoking cessation mobile applications to evidence-based guidelines. BMC Public Health. 2019 Jun 13;19(1):743. doi: 10.1186/s12889-019-7084-7.</citation> <PMID>31196062</PMID> </reference> <reference> <citation>Cho J, Quinlan MM, Park D, Noh GY. Determinants of adoption of smartphone health apps among college students. Am J Health Behav. 2014 Nov;38(6):860-70. doi: 10.5993/AJHB.38.6.8.</citation> <PMID>25207512</PMID> </reference> <reference> <citation>Cotten SR, Gupta SS. Characteristics of online and offline health information seekers and factors that discriminate between them. Soc Sci Med. 2004 Nov;59(9):1795-806. doi: 10.1016/j.socscimed.2004.02.020.</citation> <PMID>15312915</PMID> </reference> <reference> <citation>Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422.</citation> <PMID>25760773</PMID> </reference> <reference> <citation>Rajani NB, Mastellos N, Filippidis FT. Self-Efficacy and Motivation to Quit of Smokers Seeking to Quit: Quantitative Assessment of Smoking Cessation Mobile Apps. JMIR Mhealth Uhealth. 2021 Apr 30;9(4):e25030. doi: 10.2196/25030.</citation> <PMID>33929336</PMID> </reference> <reference> <citation>Rahimi B, Nadri H, Lotfnezhad Afshar H, Timpka T. A Systematic Review of the Technology Acceptance Model in Health Informatics. Appl Clin Inform. 2018 Jul;9(3):604-634. doi: 10.1055/s-0038-1668091. Epub 2018 Aug 15.</citation> <PMID>30112741</PMID> </reference> <verification_date>August 2022</verification_date> <study_first_submitted>March 9, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 9, 2022</last_update_submitted> <last_update_submitted_qc>August 9, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 12, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Paris Nanterre University</investigator_affiliation> <investigator_full_name>Luz BUSTAMANTE</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>E health</keyword> <keyword>smoking cessation</keyword> <keyword>engagement determinants</keyword> <keyword>intention to use</keyword> <keyword>TAM model</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The development of mobile applications ("mobile apps") is steadily increasing and appears to be a promising treatment method to help people change unwanted behaviors or maintain a regular relationship with the medical system. Mobile apps aimed at smoking cessation have been shown to be effective. However, if a treatment is not used regularly, it will not have the desired effect. The main objective of this study is to identify what makes a person decide to use a smoking cessation app and to do so regularly. The second objective is to determine what is necessary to achieve long-term change with a mobile app. Despite the significant decrease in tobacco consumption in France (30% in 2000 vs. 25.4% in 2018), the prevalence of smokers aged 18 to 75 years is still a public issue. Among the new solutions proposed, mobile applications ("mobile apps") seem to be a promising treatment modality. Several advantages to their use are recognized for patients, health professionals and the health system itself. Mobile applications allow accessibility to care and information, the possibility of transposing several proven effective therapeutic principles, the possibility of integrating certain forms of information transmission such as messaging, behavioural feedback and audiovisual media. Although mobile app development is a growing market, knowledge about the determinants of intention to use this type of technology is very limited, especially for smoking cessation apps. The investigators propose a theoretical model to examine what determines the regular use of mobile apps for smoking cessation among those who want to quit. The investigators use the TAMII model and the operational variables used in a more general study on e-health applications. A chronological organisation based on a three-part behavioural model (antecedent, target behaviour and outcome) is added to the TAMII model. The main objective is to identify the factors of Mobila App Sustain Use (MASU). All definitions of TAM-II will be used : perceived usefulness (PU), perceived ease of use (PEOU) and social norm (SN), as well as the definitions proposed by Choi et al (2014) on the predictors of PU, PEOU and SN. Participants must meet four inclusion criteria for the study: Inclusion criteria - Age: Be 18 years of age or older, - Smoking Status: consider themselves an active smoker - Motivation to quit: be willing to quit smoking, in the short and medium term. - Agreement to participate: They must also agree to participate in the study. They will have read the information note where the procedure is described; the researchers presented and their rights to withdraw from the study are recalled. Exclusion criteria: - Participants must have a smartphone with an iOS or Android operating system - Access to the internet to complete the questionnaires - Download the application and receive the updates it offers.

NCT0531xxxx/NCT05318664.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/NCT05318664</url> </required_header> <id_info> <org_study_id>EC001</org_study_id> <nct_id>NCT05318664</nct_id> </id_info> <brief_title>Effects of Cryotherapy on Upper Limb Balance Test</brief_title> <official_title>Effects of Cryotherapy on Upper Limb Balance Test: Randomized Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>Flávia Carvalho</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>São Paulo 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> The shoulder joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers </textblock> </brief_summary> <detailed_description> <textblock> Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of shoulder function by the upper quarter y balance test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 25, 2022</start_date> <completion_date type="Anticipated">June 2022</completion_date> <primary_completion_date type="Anticipated">June 2022</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>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>modified Upper Quarter Y Balance Test - mUQYBT)</measure> <time_frame>Change from baseline to 20 minutes</time_frame> <description>test for measuring upper extremity reach distance while in a closed-chain position</description> </primary_outcome> <primary_outcome> <measure>modified Upper Quarter Y Balance Test - mUQYBT)</measure> <time_frame>Change from baseline to 40 minutes</time_frame> <description>test for measuring upper extremity reach distance while in a closed-chain position</description> </primary_outcome> <secondary_outcome> <measure>Skin temperature</measure> <time_frame>Change from baseline to 20 minutes</time_frame> <description>thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)</description> </secondary_outcome> <secondary_outcome> <measure>Skin temperature</measure> <time_frame>Change from baseline to 25 minutes</time_frame> <description>thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)</description> </secondary_outcome> <secondary_outcome> <measure>Skin temperature</measure> <time_frame>Change from baseline to 30 minutes</time_frame> <description>thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)</description> </secondary_outcome> <secondary_outcome> <measure>Skin temperature</measure> <time_frame>Change from baseline to 35 minutes</time_frame> <description>thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)</description> </secondary_outcome> <secondary_outcome> <measure>Skin temperature</measure> <time_frame>Change from baseline to 40 minutes</time_frame> <description>thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)</description> </secondary_outcome> <secondary_outcome> <measure>Thermic comfort</measure> <time_frame>Change from baseline to 20 minutes</time_frame> <description>a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used</description> </secondary_outcome> <secondary_outcome> <measure>Thermic comfort</measure> <time_frame>Change from baseline to 40 minutes</time_frame> <description>a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used</description> </secondary_outcome> <secondary_outcome> <measure>Balance perception</measure> <time_frame>Change from baseline to 20 minutes</time_frame> <description>a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely</description> </secondary_outcome> <secondary_outcome> <measure>Balance perception</measure> <time_frame>Change from baseline to 40 minutes</time_frame> <description>a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely</description> </secondary_outcome> <secondary_outcome> <measure>Muscle tone</measure> <time_frame>Change from baseline to 20 minutes</time_frame> <description>Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Deltoid;</description> </secondary_outcome> <secondary_outcome> <measure>Muscle tone</measure> <time_frame>Change from baseline to 25 minutes</time_frame> <description>Muscle tone will be measured in hertz by the MyotonPRO probe will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Deltoid;</description> </secondary_outcome> <secondary_outcome> <measure>Muscle tone</measure> <time_frame>Change from baseline to 30 minutes</time_frame> <description>Muscle tone will be measured in hertz by the MyotonPRO probe will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Deltoid;</description> </secondary_outcome> <secondary_outcome> <measure>Muscle tone</measure> <time_frame>Change from baseline to 35 minutes</time_frame> <description>Muscle tone will be measured in hertz by the MyotonPRO probe will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Deltoid;</description> </secondary_outcome> <secondary_outcome> <measure>Muscle tone</measure> <time_frame>Change from baseline to 40 minutes</time_frame> <description>Muscle tone will be measured in hertz by the MyotonPRO probe will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Deltoid;</description> </secondary_outcome> <secondary_outcome> <measure>Beliefs</measure> <time_frame>Baseline</time_frame> <description>The participants will respond yes or no to the questions "Do you believe that cryotherapy is an effect treatment for acute injuries?" and "Do you believe cryotherapy have deleterious effects on muscle function?"</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">80</enrollment> <condition>Functional Status</condition> <condition>Muscle Tone</condition> <arm_group> <arm_group_label>Cryotherapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>20 minutes of cryotherapy on the dominant shoulder with ice bags</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>20 minutes of rest</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Cryotherapy</intervention_name> <description>20 minutes of cryotherapy on the dominant shoulder with ice bags</description> <arm_group_label>Cryotherapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 18 to 28 years old  - healthy  - no musculoskeletal complaints  Exclusion Criteria:  - failure to follow protocol  - complaints of injury or pain during the assessments </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>28 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Carlos M Pastre</last_name> <role>Study Director</role> <affiliation>Sao Paulo State University</affiliation> </overall_official> <overall_contact> <last_name>Flávia A Carvalho</last_name> <phone>+5518997443624</phone> <email>fla.acarvalho@hotmail.com</email> </overall_contact> <verification_date>April 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>São Paulo State University</investigator_affiliation> <investigator_full_name>Flávia Carvalho</investigator_full_name> <investigator_title>Principal investigator</investigator_title> </responsible_party> <keyword>shoulder</keyword> <keyword>cryotherapy</keyword> <keyword>balance</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The shoulder joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of shoulder function by the upper quarter y balance test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05. Inclusion Criteria: - 18 to 28 years old - healthy - no musculoskeletal complaints Exclusion Criteria: - failure to follow protocol - complaints of injury or pain during the assessments

NCT0531xxxx/NCT05318677.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/NCT05318677</url> </required_header> <id_info> <org_study_id>OBaskan</org_study_id> <secondary_id>AKitis</secondary_id> <nct_id>NCT05318677</nct_id> </id_info> <brief_title>Sensory and Motor Proficiency For Children With Spina Bifida</brief_title> <official_title>The Relationship Between Sensory and Motor Proficiency For Children With Spina Bifida</official_title> <sponsors> <lead_sponsor> <agency>Pamukkale University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Pamukkale University</source> <brief_summary> <textblock> Spina bifida is one of the neural tube defects that cause neuromuscular dysfunction. Spina bifida is a disease accompanied by motor paralysis, musculoskeletal problems, Arnold-Chiari malformation, osteoporosis, hydrocephalus, upper limb coordination disorder. The affected upper extremity functionality and hand skills are very important for independence in daily living activities.  There are some studies in the literature showing that upper extremity motor function is affected in patients with spina bifida. However, no study was found in which the upper extremity was investigated in terms of sensory and motor proficiency.The social and professional aspects of the upper extremity are of great importance.Therefore, our study aims to investigate the effects of upper extremity sensory and motor proficiency in patients with spina bifida </textblock> </brief_summary> <detailed_description> <textblock> This study aims to examine the relationship between hand skills and upper extremity functional level patients with spina bifida. Fifteen patients with spina bifida and 20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children.  Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.  All sensory evaluations; In a quiet, bright, warm room with only the physiotherapist and the subject, the evaluation was made while the subject was sitting in a chair with back support.  - Stereognosis: For the evaluation of stereognosis, the subject was asked to recognize the materials placed in his hand by using a pen, paper, clip, cotton, and coin while his visual field was closed. Both dominant and nondominant extremities were evaluated.  - Graphesthesia: When the visual field is closed, square, triangle, circle, and cross signs drawn on the palms of the subjects were asked to know these shapes.  - Finger identification: The patient's fingers were numbered and the patient was asked to know which finger was touched by touching his finger while his visual field was closed, verbally or by showing.  - Kinesthetic sense of hands: A total of 9 evaluations were made, the first of which was a trial, while the patient's visual field was closed. The evaluation was made for both dominant and nondominant extremities. The evaluation was made with both eyes open and closed.8 Evaluation under the title of visual and kinesthetic kinesthesia was scored between 0-3.  - The motor proficiency and ability level of the cases were evaluated with the Bruininks-Oseretsky Test, which is used to evaluate the motor abilities of children aged 4.5-14.5 years in pediatric rehabilitation. The test consists of a total of 46 tests, 8 of which are subtests. Subtests to be applied to the patients in the study: Drawing lines through the path and folding paper tests were performed for the fine motor precision test.  Copying a square and copying star tests were applied for fine motor integration.  Transferring coins has been applied for manual dexterity. The case took the coin with the dominant hand and puts it in the box with the non-dominant hand. The number of coins left in the well in 15 seconds is calculated. The case was given 2 attempts.For upper extremity coordination, the tests of dropping and catching the ball with both hands and dribbling the ball with alternating hands were applied. For the test of dropping and catching the ball with both hands, the subject was given a tennis ball and asked to catch the ball by throwing it on the ground with both hands. A trial was allowed before starting the test. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 2010</start_date> <completion_date type="Actual">December 2010</completion_date> <primary_completion_date type="Actual">August 2010</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>Sensory assesment of the children</measure> <time_frame>May 2010</time_frame> <description>Sensory evaluation in the cases was made by evaluating the senses of stereognosis, graphesthesia, finger identification, and kinesthesia.</description> </primary_outcome> <primary_outcome> <measure>Motor proficiency of the children</measure> <time_frame>May 2010</time_frame> <description>Motor proficiency of the children was assessed by Bruiniks Oseretsky test.</description> </primary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Actual">35</enrollment> <condition>Spina Bifida</condition> <condition>Sensory Disorder</condition> <condition>Motor Disorders</condition> <condition>Upper Extremity Dysfunction</condition> <arm_group> <arm_group_label>1</arm_group_label> <description>Fifteen patients with spina bifida aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children. Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.</description> </arm_group> <arm_group> <arm_group_label>2</arm_group_label> <description>20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children. Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.</description> </arm_group> <eligibility> <study_pop> <textblock> Fifteen patients with spina bifida and 20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study.  Exclusion Criteria:  - Children who had a second illness and could not be contacted were not included in the study </textblock> </criteria> <gender>All</gender> <minimum_age>8 Years</minimum_age> <maximum_age>12 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ozden Baskan</last_name> <role>Principal Investigator</role> <affiliation>Pamukkale University</affiliation> </overall_official> <verification_date>April 2022</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Pamukkale University</investigator_affiliation> <investigator_full_name>Ozden Baskan</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>spina bifida</keyword> <keyword>upper extremity function</keyword> <keyword>sense</keyword> <keyword>motor function</keyword> <condition_browse>  <mesh_term>Spinal Dysraphism</mesh_term> <mesh_term>Sensation Disorders</mesh_term> <mesh_term>Motor Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Spina bifida is one of the neural tube defects that cause neuromuscular dysfunction. Spina bifida is a disease accompanied by motor paralysis, musculoskeletal problems, Arnold-Chiari malformation, osteoporosis, hydrocephalus, upper limb coordination disorder. The affected upper extremity functionality and hand skills are very important for independence in daily living activities. There are some studies in the literature showing that upper extremity motor function is affected in patients with spina bifida. However, no study was found in which the upper extremity was investigated in terms of sensory and motor proficiency.The social and professional aspects of the upper extremity are of great importance.Therefore, our study aims to investigate the effects of upper extremity sensory and motor proficiency in patients with spina bifida This study aims to examine the relationship between hand skills and upper extremity functional level patients with spina bifida. Fifteen patients with spina bifida and 20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children. Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist. All sensory evaluations; In a quiet, bright, warm room with only the physiotherapist and the subject, the evaluation was made while the subject was sitting in a chair with back support. - Stereognosis: For the evaluation of stereognosis, the subject was asked to recognize the materials placed in his hand by using a pen, paper, clip, cotton, and coin while his visual field was closed. Both dominant and nondominant extremities were evaluated. - Graphesthesia: When the visual field is closed, square, triangle, circle, and cross signs drawn on the palms of the subjects were asked to know these shapes. - Finger identification: The patient's fingers were numbered and the patient was asked to know which finger was touched by touching his finger while his visual field was closed, verbally or by showing. - Kinesthetic sense of hands: A total of 9 evaluations were made, the first of which was a trial, while the patient's visual field was closed. The evaluation was made for both dominant and nondominant extremities. The evaluation was made with both eyes open and closed.8 Evaluation under the title of visual and kinesthetic kinesthesia was scored between 0-3. - The motor proficiency and ability level of the cases were evaluated with the Bruininks-Oseretsky Test, which is used to evaluate the motor abilities of children aged 4.5-14.5 years in pediatric rehabilitation. The test consists of a total of 46 tests, 8 of which are subtests. Subtests to be applied to the patients in the study: Drawing lines through the path and folding paper tests were performed for the fine motor precision test. Copying a square and copying star tests were applied for fine motor integration. Transferring coins has been applied for manual dexterity. The case took the coin with the dominant hand and puts it in the box with the non-dominant hand. The number of coins left in the well in 15 seconds is calculated. The case was given 2 attempts.For upper extremity coordination, the tests of dropping and catching the ball with both hands and dribbling the ball with alternating hands were applied. For the test of dropping and catching the ball with both hands, the subject was given a tennis ball and asked to catch the ball by throwing it on the ground with both hands. A trial was allowed before starting the test. Fifteen patients with spina bifida and 20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. Inclusion Criteria:Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Exclusion Criteria: - Children who had a second illness and could not be contacted were not included in the study

NCT0531xxxx/NCT05318690.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/NCT05318690</url> </required_header> <id_info> <org_study_id>0047-01</org_study_id> <nct_id>NCT05318690</nct_id> </id_info> <brief_title>PlayGait: A Dynamic Exoskeleton</brief_title> <official_title>PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation</official_title> <sponsors> <lead_sponsor> <agency>Orthocare Innovations, LLC</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>National Institute on Disability, Independent Living, and Rehabilitation Research</agency> <agency_class>U.S. Fed</agency_class> </collaborator> </sponsors> <source>Orthocare Innovations, LLC</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> PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. PlayGait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). The overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with CP. The study will evaluate children with CP's activity levels in the community with and without PlayGait. The study will consist of three lab visits and two, 7-day periods at home. </textblock> </brief_summary> <overall_status>Terminated</overall_status> <why_stopped> Difficulty with recruitment </why_stopped> <start_date type="Actual">March 11, 2022</start_date> <completion_date type="Actual">January 3, 2023</completion_date> <primary_completion_date type="Actual">January 3, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Device Feasibility</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Cadence</measure> <time_frame>7 days with baseline condition; 7 days with PlayGait condition</time_frame> <description>Low, medium, and high activity rate</description> </primary_outcome> <primary_outcome> <measure>Shifts in cadence</measure> <time_frame>7 days with baseline condition; 7 days with PlayGait condition</time_frame> <description>Shifts from low to medium cadence and shifts from medium to high cadence</description> </primary_outcome> <secondary_outcome> <measure>1 minute walk test</measure> <time_frame>1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait</time_frame> <description>The distance walked in one minute</description> </secondary_outcome> <secondary_outcome> <measure>10 meter walk test</measure> <time_frame>1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait</time_frame> <description>The time it takes to walk 10 meters</description> </secondary_outcome> <secondary_outcome> <measure>Pediatric Balance Scale</measure> <time_frame>1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait</time_frame> <description>Participant completes 14 activity items that measure pediatric balance</description> </secondary_outcome> <secondary_outcome> <measure>Average steps per day</measure> <time_frame>Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait</time_frame> <description>Step count per day</description> </secondary_outcome> <secondary_outcome> <measure>Time of PlayGait use</measure> <time_frame>PlayGait condition: 7 days in the community with PlayGait</time_frame> <description>Amount of time each day that PlayGait is worn</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">1</enrollment> <condition>Cerebral Palsy</condition> <arm_group> <arm_group_label>PlayGait (Exoskeleton)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Experimental lower-limb device.</description> </arm_group> <arm_group> <arm_group_label>Baseline</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Baseline condition without using any prescribed lower-limb orthoses.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>PlayGait</intervention_name> <description>PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.</description> <arm_group_label>PlayGait (Exoskeleton)</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Baseline</intervention_name> <description>Baseline condition with no prescribed or intervention lower-limb devices.</description> <arm_group_label>Baseline</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age 3 - 4 years (at time of informed consent)  - Hemiplegic cerebral palsy  - If child uses an ankle-foot orthosis (AFO), parent/caregiver is willing to have the child stop wearing their prescribed AFO during data collections (lab sessions and two 7-day periods at home)  - Ability to walk at least 10 meters without the use of assistive devices or AFOs  - Ability to walk at least 1 minute without the use of assistive devices or AFOs  - Stiff knee gait - less than normal knee flexion during swing phase  - Hip flexion passive range of motion contracture less than 20 degrees  - Gross Motor Function Classification System (GMFCS) Levels I-II  - Modified Ashworth Scale (MAS) <=2 for the gastrocnemius soleus, rectus femoris, and hamstrings  - Family has resources to attend all study sessions (transportation, schedule)  - Ability to speak and understand in English  Exclusion Criteria:  - Orthopedic surgery in the last year  - Foster children or wards of the state  - Use wheelchair or stroller mobility as their primary method of independent mobility  - Severe visual impairment such that the visual impairment itself functionally limits mobility  - Phenol or Botox injections to the legs in the last 3 months  - Uncontrolled seizure disorder, defined as any seizure in the last 3 months that influenced mobility skills and function (seizures which did not affect mobility are acceptable)  - Lower limb fracture in the last 3 months  - Planned surgery or changes to movement disorder medication during the study period  - Inability to understand directions sufficiently to complete the study assessments  - Cognitive, behavioral, or any other issues that may not allow for effective study participation  - Unwilling to complete the study protocol </textblock> </criteria> <gender>All</gender> <minimum_age>3 Years</minimum_age> <maximum_age>4 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Jessica Zistatsis, MSME</last_name> <role>Principal Investigator</role> <affiliation>Orthocare Innovations</affiliation> </overall_official> <location> <facility> <name>Orthocare Innovations, LLC</name> <address> <city>Edmonds</city> <state>Washington</state> <zip>98020</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 21, 2023</last_update_submitted> <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Orthocare Innovations, LLC</investigator_affiliation> <investigator_full_name>Jessica Zistatsis</investigator_full_name> <investigator_title>Project Manager</investigator_title> </responsible_party> <keyword>pediatric</keyword> <keyword>orthosis</keyword> <keyword>exoskeleton</keyword> <condition_browse>  <mesh_term>Cerebral Palsy</mesh_term> </condition_browse>  </clinical_study>

PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. PlayGait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). The overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with CP. The study will evaluate children with CP's activity levels in the community with and without PlayGait. The study will consist of three lab visits and two, 7-day periods at home. Inclusion Criteria: - Age 3 - 4 years (at time of informed consent) - Hemiplegic cerebral palsy - If child uses an ankle-foot orthosis (AFO), parent/caregiver is willing to have the child stop wearing their prescribed AFO during data collections (lab sessions and two 7-day periods at home) - Ability to walk at least 10 meters without the use of assistive devices or AFOs - Ability to walk at least 1 minute without the use of assistive devices or AFOs - Stiff knee gait - less than normal knee flexion during swing phase - Hip flexion passive range of motion contracture less than 20 degrees - Gross Motor Function Classification System (GMFCS) Levels I-II - Modified Ashworth Scale (MAS) <=2 for the gastrocnemius soleus, rectus femoris, and hamstrings - Family has resources to attend all study sessions (transportation, schedule) - Ability to speak and understand in English Exclusion Criteria: - Orthopedic surgery in the last year - Foster children or wards of the state - Use wheelchair or stroller mobility as their primary method of independent mobility - Severe visual impairment such that the visual impairment itself functionally limits mobility - Phenol or Botox injections to the legs in the last 3 months - Uncontrolled seizure disorder, defined as any seizure in the last 3 months that influenced mobility skills and function (seizures which did not affect mobility are acceptable) - Lower limb fracture in the last 3 months - Planned surgery or changes to movement disorder medication during the study period - Inability to understand directions sufficiently to complete the study assessments - Cognitive, behavioral, or any other issues that may not allow for effective study participation - Unwilling to complete the study protocol

NCT0531xxxx/NCT05318703.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/NCT05318703</url> </required_header> <id_info> <org_study_id>AG059546-02S1</org_study_id> <nct_id>NCT05318703</nct_id> </id_info> <brief_title>Virtual Exercise For Older Adults With Mild Cognitive Impairment</brief_title> <official_title>Virtual Exercise Intervention for Older Adults With MCI</official_title> <sponsors> <lead_sponsor> <agency>Oregon Research Institute</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Oregon Research Institute</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> This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI). </textblock> </brief_summary> <detailed_description> <textblock> The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 20, 2021</start_date> <completion_date type="Actual">October 30, 2022</completion_date> <primary_completion_date type="Actual">August 30, 2022</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>Prevention</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>(a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet</measure> <time_frame>16 weeks</time_frame> <description>assess the extent to which interventionists successfully implement the prespecified exercise training protocol.</description> </primary_outcome> <primary_outcome> <measure>number of dropouts from the intervention and study as assessed by a study recording sheet</measure> <time_frame>16 weeks</time_frame> <description>assess intervention dropout rate and retention rate</description> </primary_outcome> <primary_outcome> <measure>Number of participants expressing intervention program satisfaction as assessed by a self-report survey</measure> <time_frame>16 weeks</time_frame> <description>assess the program acceptability among tai ji quan participants</description> </primary_outcome> <primary_outcome> <measure>Change in global cognitive function assessed by Montreal Cognitive Assessment</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline cognitive function at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>Change in attention and working memory as assessed by Digit Span - forward and backward</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in attention and working memory at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>Change in dual-task cost as assessed by Timed Up and Go with a cognitive task</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in the ability to stand up from a chair, walk, and sit down while performing an arithmetic task at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>Change in executive function as assessed by Trail Making B</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline executive function at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>Change in executive function as assessed by Category Fluency for Animals</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline executive function at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>Change in cognitive functioning assessed by Everyday Cognition</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline cognitive functioning at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>Change in physical performance as measured by Timed Up and Go test</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>change in leg strength as assessed by 30-second chair stand test</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in leg strength at 16 weeks</description> </primary_outcome> <primary_outcome> <measure>Change in balance using a 4-stage balance test</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in balance at 16 weeks</description> </primary_outcome> <secondary_outcome> <measure>Change in depression as assessed by Geriatric Depression scale</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in the level of depression at 16 weeks</description> </secondary_outcome> <secondary_outcome> <measure>Change in physical activity as assessed by International Physical Activity Questionnaire</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in physical activity at 16 weeks</description> </secondary_outcome> <secondary_outcome> <measure>Change in quality of life as assessed by EuroQol (EQ-5D-3L)</measure> <time_frame>baseline, 16 weeks</time_frame> <description>assess change from baseline in quality of life at 16 weeks</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">69</enrollment> <condition>Mild Cognitive Impairment</condition> <arm_group> <arm_group_label>cognitively enhanced tai ji quan</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks.</description> </arm_group> <arm_group> <arm_group_label>stretching exercise</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Participants receive a stretching exercise intervention for 16 weeks.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>tai ji quan</intervention_name> <description>cognitively enhanced tai ji quan exercise</description> <arm_group_label>cognitively enhanced tai ji quan</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Stretching</intervention_name> <description>Stretching exercise</description> <arm_group_label>stretching exercise</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria:  - Self-report a change or decline in memory (corroborated by an informant)  - Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant)  - Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE).  Exclusion criteria:  - Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months,  - Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale  - Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner  - Being unable to follow the consent process or sign the study consent form. </textblock> </criteria> <gender>All</gender> <minimum_age>65 Years</minimum_age> <maximum_age>95 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Fuzhong Li, Ph.D.</last_name> <role>Principal Investigator</role> <affiliation>Oregon Research Institute</affiliation> </overall_official> <location> <facility> <name>Oregon Research Institute</name> <address> <city>Eugene</city> <state>Oregon</state> <zip>97403</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 21, 2023</last_update_submitted> <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 22, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>tai chi, ehealth, older adults, cognitive impairment</keyword> <condition_browse>  <mesh_term>Cognitive Dysfunction</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>There is a plan to make IPD and related data dictionaries available.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_time_frame>12 months after the completion of the study.</ipd_time_frame> <ipd_access_criteria>The de-identified data that support the findings of this study are available from the corresponding author upon reasonable request. Restrictions may apply to preserve participant confidentiality.</ipd_access_criteria> </patient_data>  </clinical_study>

This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI). The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI. Inclusion criteria: - Self-report a change or decline in memory (corroborated by an informant) - Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant) - Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE). Exclusion criteria: - Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months, - Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale - Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner - Being unable to follow the consent process or sign the study consent form.

NCT0531xxxx/NCT05318716.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/NCT05318716</url> </required_header> <id_info> <org_study_id>11811</org_study_id> <nct_id>NCT05318716</nct_id> </id_info> <brief_title>The Fat Analysis Trial (FAT) - Assessing the Impact of Lipo-aspirate Processing</brief_title> <official_title>The Fat Analysis Trial (FAT): The Impact of Lip-aspirate Processing on Fat Resorption in Autologous Fat Grafting to the Breast: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Lawson Health Research Institute</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Lawson Health Research Institute</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_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> Fat grafting has been gaining popularity over the past decade. It is now commonly used for breast augmentation and reconstruction, however a major challenge remains the high rate and unpredictable rate of fat resorption post-operatively, leading to volume loss and patient dissatisfaction. Currently there is no consensus on the ideal technique to process donor fat to minimize the rate of resorption. Our study aims to compare two common processing methods to determine if one is superior for fat volume retention. </textblock> </brief_summary> <detailed_description> <textblock> Fat grafting is a technique used commonly in plastic surgery that has gained popularity in breast augmentation and breast reconstruction. This technique involves harvesting fat using liposuction from donor sites, processing the extracted fat and re-injecting it back into the breast for the desired volume and shape. Fat grafting has gained popularity due to its resulting natural appearance and feel. This technique can also be used in conjunction with implant reconstruction to achieve a more natural contour and symmetry. However, the main issue is a low rate of fat retention, which, based on the literature, is inconsistent and only an average of 60% of the volume of fat injected. Furthermore, there are very few clinical studies studying the long-term clinical survivability of the grafted fat. Therefore, care must be taken in setting patient expectations, and sometimes multiple sessions are required to achieve the desired results.  There are currently multiple techniques used in harvesting and processing fat for grafting, and it is unclear in the current literature if the processing technique used affects the level of fat resorption. General principles of fat grafting include gentle extraction to avoid damage and processing to remove excess infiltration fluid and impurities before injection. The fat is collected from donor areas for extraction, using either manual or power-assisted liposuction. For processing, several products and processing solutions have been developed in recent years, including the Revolve system (AbbVie/Allergan), which is currently used at our institution. Prior to these systems, simple decantation of fat by gravity or centrifugation was used. However, due to damage to fat during processing and lower retention rates in the literature, centrifugation has largely been abandoned as a processing method. However, there is no standard method of donor fat harvest or processing, and there is a lack of well-defined prospective clinical studies comparing popular techniques in the current literature, particularly in the long term. Additionally, the amount of fat injected and patient factors such as previous radiation can affect the amount of fat retention. Further in-vitro studies are required to clarify factors that affect fat survivability.  In order to assess the rate of fat retention in the breast, quantitative imaging tools have been validated in the literature. One of the most popular techniques is 3D body surface scans. These can be taken easily, quickly, and cost-effectively for volume assessment at various time points pre and postoperatively. Comparatively, MRI imaging is costly, time-consuming and therefore not practical for frequent follow-up. Furthermore, as 3D imaging becomes more accessible, its use could become more common in clinical practice for preoperative planning and objective assessment of outcomes.  Methods Aims Currently, there is a lack of prospective clinical studies directly comparing the rate of fat graft retention between processing techniques. Our primary outcome aims to compare two common processing methods; decantation and the Revolve system. Investigators will measure the retention rate using 3D imaging techniques (Vectra H2, Canfield), in the place of traditional 2D photography, for quantitative measurement of breast volume. Our secondary outcomes include the assessment of operating time, cost, and collect secondary outcomes related to surgical complications and outcomes. Investigators will tangentially perform a qualitative review of the patient's pre and post-operatively using the validated Breast-Q questionnaire. This study will be conducted at LHSC sites in London, Ontario. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">July 2022</start_date> <completion_date type="Anticipated">July 2025</completion_date> <primary_completion_date type="Anticipated">July 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>Prospective randomized controlled trial, we aim to recruit patients already scheduled to undergo fat grafting to the breast for reconstruction or cosmetic augmentation.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> <masking_description>When the patients check in at the reception desk, they will be assigned a ticket with a 0 or 1 sequentially. This will be placed in their file. Group 0 patients will receive Decantation, and group 1 will receive Revolve. The nurse will collect this ticket, along with the patient's registration documents to prepare the equipment. Photography will be done by a research assistant/coordinator. The person will be responsible for imaging patients, as well as conducting the volume analysis following training by the software manufacturer. This person will be blinded to which method is used. During subsequent follow ups, the patient will have a 0 or 1 in their chart, to accurately collect data while in follow up. The surgeon, assistants and nurses will not be able to be blinded as they are the person responsible for using the device in the operating room.</masking_description> </study_design_info> <primary_outcome> <measure>1. What is the volume of fat retained between the two most common methods of fat processing?</measure> <time_frame>12 months recruitment and 24 months follow up</time_frame> <description>Volume based Sub-division based on 3D volumetric analysis. Height (in metres) and weight (in kilograms) will be recorded to calculate BMI. This will be needed to assess weight stability during the follow up period. Each of the above groups will be stratified based on breast volume, as well as injected volume. Each group will be divided into low volume, which will be less than 200cc of injected fat or 50% of breast volume, whichever is greater. The high-volume group will include volumes greater than 200cc or 50% of breast volume. Imaging A Vectra H2 (Canfield medical, NJ) will capture a 3D image in place of our traditional 2D imaging, for both pre-operative and post-operative photos. A volumetric analysis will be performed using the proprietary software. With a pre-operative baseline volume, we will be able to track fat survival between the two-methods post-operatively during follow up visits. Total follow up time will be 24 months post-operatively.</description> </primary_outcome> <primary_outcome> <measure>How satisfied are the patients between each method of fat grafting?</measure> <time_frame>36 months total</time_frame> <description>We will tangentially perform a qualitative review of the patient's pre and post-operatively using the validated Breast-Q questionnaire. The BREAST-Q module for women who undergo breast augmentation is a rigorously developed PROM that is comprised of 9 independently functioning scales. It has undergone extensive psychometric evaluation and its developers report that it may be used like interval-scale data. Scores from these instruments are scaled to range from 0 to 100. This study will be conducted at affiliated clinical sites in London, Ontario.</description> </primary_outcome> <secondary_outcome> <measure>3. Does one method of fat processing have a reduced rate of short, or long term complications?</measure> <time_frame>36 months</time_frame> <description>the assessment of operating time (recorded in minutes) from the time tumescence is injected, until the injecting is complete. The additional cost of the device will be accounted for in the analysis (in US dollars), and collect secondary outcomes related to surgical complications and outcomes. These will be recorded prospectively and classified into minor and major, where major would be considered if needing surgery to correct an issue.</description> </secondary_outcome> <other_outcome> <measure>Is the grafted fat incorporated better between the two methods?</measure> <time_frame>3 months</time_frame> <description>We will include a bedside ultrasound (US) image of the breast tissue at 3 months, to assess fat incorporation and the amount of oil and oil cysts. US images will be taken bedside, with a visual analysis of the images done by a blinded assessor. It will be measured with a visual analog scale from 0 to 5, with 0 representing no oil cysts and 5 representing an abundance of oil cysts. The assessors will be two different blinded plastic surgeons.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">200</enrollment> <condition>Breast Asymmetry</condition> <condition>Fat Atrophy</condition> <arm_group> <arm_group_label>Reconstructive group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>This group of patients would be undergoing fat grafting following implant-based reconstruction. We will be excluding patients that have had autologous based reconstruction, including regional and free flaps. This group will be analyzed based on volume (<200cc or 50% and >200cc or 50%) as well as subgroup analysis based on adjuvant chemo or radiation therapy.</description> </arm_group> <arm_group> <arm_group_label>Cosmetic augmentation group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>This group of patients will be undergoing a primary or secondary augmentation for cosmesis. They will be included if this is a primary augmentation using fat grafting or a secondary augmentation with no history of fat grafting to the breasts.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Fat grafting - Revolve device</intervention_name> <description>Standardized fat collection The donor areas previously agreed on by the patient and surgeon for fat harvesting will be injected with pre-standardized formulae and volume of tumescent fluid, and fat will be extracted using a standardized harvesting method between surgeons. Once the fat is collected. It will then be processed in one of two ways depending on the patient's group, using a Revolve system or via decantation. Fat will then be injected into the breast using a 10 or 20cc syringe in the standard retrograde manner to achieve the desired size and shape. A standard gauze-based dressing will be applied post-operatively, with no compression.</description> <arm_group_label>Cosmetic augmentation group</arm_group_label> <arm_group_label>Reconstructive group</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Fat grafting - Decantation</intervention_name> <description>Standardized fat collection The donor areas previously agreed on by the patient and surgeon for fat harvesting will be injected with pre-standardized formulae and volume of tumescent fluid, and fat will be extracted using a standardized harvesting method between surgeons. Once the fat is collected. It will then be processed in one of two ways depending on the patient's group, using a Revolve system or via decantation. Fat will then be injected into the breast using a 10 or 20cc syringe in the standard retrograde manner to achieve the desired size and shape. A standard gauze-based dressing will be applied post-operatively, with no compression.</description> <arm_group_label>Cosmetic augmentation group</arm_group_label> <arm_group_label>Reconstructive group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Any patient above the age of 18 undergoing fat grafting from any donor site to the breast for cosmetic or reconstructive purposes.  - We will accept patient who have an implant for either cosmetic or reconstructive purposes  Exclusion Criteria:  - Previous fat grafting  - Autologous breast reconstruction (regional or free flap)  - unable to consent to the study </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Tanya DeLyzer, BSc MD FRCSC</last_name> <phone>519.685.8108</phone> <email>carrie.deer@lhsc.on.ca</email> </overall_contact> <overall_contact_backup> <last_name>Khalifa AlGhanim, MD</last_name> <email>khalifa.alghanim@lhsc.on.ca</email> </overall_contact_backup> <verification_date>April 2022</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation> <investigator_full_name>Tanya DeLyzer</investigator_full_name> <investigator_title>Associate Professor, Division of Plastic and Reconstructive Surgery</investigator_title> </responsible_party> <keyword>Fat grafting</keyword> <keyword>Fat survival</keyword> <keyword>Breast surgery</keyword> <condition_browse>  <mesh_term>Atrophy</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> <ipd_description>This is an ongoing discussion. At present there is a slight lean towards not making individual participant data available. This is to protect patient information during inclusion in this trial.</ipd_description> </patient_data>  </clinical_study>

Fat grafting has been gaining popularity over the past decade. It is now commonly used for breast augmentation and reconstruction, however a major challenge remains the high rate and unpredictable rate of fat resorption post-operatively, leading to volume loss and patient dissatisfaction. Currently there is no consensus on the ideal technique to process donor fat to minimize the rate of resorption. Our study aims to compare two common processing methods to determine if one is superior for fat volume retention. Fat grafting is a technique used commonly in plastic surgery that has gained popularity in breast augmentation and breast reconstruction. This technique involves harvesting fat using liposuction from donor sites, processing the extracted fat and re-injecting it back into the breast for the desired volume and shape. Fat grafting has gained popularity due to its resulting natural appearance and feel. This technique can also be used in conjunction with implant reconstruction to achieve a more natural contour and symmetry. However, the main issue is a low rate of fat retention, which, based on the literature, is inconsistent and only an average of 60% of the volume of fat injected. Furthermore, there are very few clinical studies studying the long-term clinical survivability of the grafted fat. Therefore, care must be taken in setting patient expectations, and sometimes multiple sessions are required to achieve the desired results. There are currently multiple techniques used in harvesting and processing fat for grafting, and it is unclear in the current literature if the processing technique used affects the level of fat resorption. General principles of fat grafting include gentle extraction to avoid damage and processing to remove excess infiltration fluid and impurities before injection. The fat is collected from donor areas for extraction, using either manual or power-assisted liposuction. For processing, several products and processing solutions have been developed in recent years, including the Revolve system (AbbVie/Allergan), which is currently used at our institution. Prior to these systems, simple decantation of fat by gravity or centrifugation was used. However, due to damage to fat during processing and lower retention rates in the literature, centrifugation has largely been abandoned as a processing method. However, there is no standard method of donor fat harvest or processing, and there is a lack of well-defined prospective clinical studies comparing popular techniques in the current literature, particularly in the long term. Additionally, the amount of fat injected and patient factors such as previous radiation can affect the amount of fat retention. Further in-vitro studies are required to clarify factors that affect fat survivability. In order to assess the rate of fat retention in the breast, quantitative imaging tools have been validated in the literature. One of the most popular techniques is 3D body surface scans. These can be taken easily, quickly, and cost-effectively for volume assessment at various time points pre and postoperatively. Comparatively, MRI imaging is costly, time-consuming and therefore not practical for frequent follow-up. Furthermore, as 3D imaging becomes more accessible, its use could become more common in clinical practice for preoperative planning and objective assessment of outcomes. Methods Aims Currently, there is a lack of prospective clinical studies directly comparing the rate of fat graft retention between processing techniques. Our primary outcome aims to compare two common processing methods; decantation and the Revolve system. Investigators will measure the retention rate using 3D imaging techniques (Vectra H2, Canfield), in the place of traditional 2D photography, for quantitative measurement of breast volume. Our secondary outcomes include the assessment of operating time, cost, and collect secondary outcomes related to surgical complications and outcomes. Investigators will tangentially perform a qualitative review of the patient's pre and post-operatively using the validated Breast-Q questionnaire. This study will be conducted at LHSC sites in London, Ontario. Inclusion Criteria: - Any patient above the age of 18 undergoing fat grafting from any donor site to the breast for cosmetic or reconstructive purposes. - We will accept patient who have an implant for either cosmetic or reconstructive purposes Exclusion Criteria: - Previous fat grafting - Autologous breast reconstruction (regional or free flap) - unable to consent to the study

NCT0531xxxx/NCT05318729.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/NCT05318729</url> </required_header> <id_info> <org_study_id>STU00214664</org_study_id> <nct_id>NCT05318729</nct_id> </id_info> <brief_title>Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures</brief_title> <official_title>Application of a Unique Vibration Modality for Postoperative Pain Control in Patients With Distal Radius Fractures to Reduce Postoperative Pain and Opioid Use</official_title> <sponsors> <lead_sponsor> <agency>Northwestern University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Northwestern University</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_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this research study is to determine if using a vibration tool improves pain control after surgical treatment of distal radius fracture. Additionally, the investigators would like to determine if this tool has any impact on consumption of pain medications postoperatively. </textblock> </brief_summary> <detailed_description> <textblock> Traditionally, occupational therapists have utilized vibration for sensory re-education in compression neuropathies and peripheral nerve injuries. Vibration is also commonly used for desensitization of hypersensitivity following amputation, crush injury, and for hypersensitive scarring. Since the vibration tool is readily available in the hand therapy clinic, vibration analgesia should be further explored in the hand clinic to help reduce pain. Vibration is a simple, and non-invasive, tool and would be easy, economical, and practical to implement into the hand clinic for postoperative pain control. This research project will evaluate whether vibration can be a useful adjunct to current postoperative pain modalities. With a multidisciplinary approach, the investigators hope to highlight the use of non-opioid modalities of pain control in distal radius fractures and believe that the findings from this study may apply to other painful conditions of the hand as well. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">March 2023</start_date> <completion_date type="Anticipated">July 2025</completion_date> <primary_completion_date type="Anticipated">July 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> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire</measure> <time_frame>up to 8 week post-surgery</time_frame> <description>An 11-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb; scored from 0 (no disability) to 100 (most severe disability).</description> </primary_outcome> <primary_outcome> <measure>PROMIS Bank v1.1 - Pain Interference Computer Adaptive Test</measure> <time_frame>up to 8 weeks post-surgery</time_frame> <description>A 4-6 item self-reported questionnaire designed to measure the consequences of pain on relevant aspects of a person's life; the T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10; low scores represent less pain interference, while high scores represent greater interference.</description> </primary_outcome> <primary_outcome> <measure>PROMIS Bank v2.0 - Upper Extremity Computer Adaptive Test</measure> <time_frame>up to 8 weeks post-surgery</time_frame> <description>A 4-6 item self-reported questionnaire designed to measure upper extremity function; the T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10; low scores represent less function, while high scores represent greater function.</description> </primary_outcome> <primary_outcome> <measure>Pain Visual Analog Scale (VAS)</measure> <time_frame>up to 8 weeks post-surgery</time_frame> <description>Scored from 0 (no pain) to 10 (worst possible pain)</description> </primary_outcome> <secondary_outcome> <measure>Opioid Use</measure> <time_frame>up to 8 weeks post-surgery</time_frame> <description>Number of opioid pain medication tablets consumed</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Distal Radius Fracture</condition> <condition>Radius Fracture Distal</condition> <condition>Radius; Fracture, Lower or Distal End</condition> <condition>Postoperative Pain</condition> <arm_group> <arm_group_label>Vibration tool</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Use of the vibration tool 3 times per day for 10 minutes for each session Morning, mid-day, and evening. Volarly for 5 minutes and dorsally for 5 minutes, for a total of 10 minutes during each session:</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Standard of care, no vibration tool.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Vibration tool</intervention_name> <description>Therapeutic mini massager for scar management, desensitization, muscle stimulation, oral stimulation and sensory re-education. Seek pain relief for sore achy muscles, tendons or bones.</description> <arm_group_label>Vibration tool</arm_group_label> <other_name>Norco NC70209 Mini Massager</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients with a distal radius fracture who have undergone an open reduction and internal fixation using a volar FCR approach with a single volar plate  - Patients who can read, write, and follow direction in English  - Willing to undergo occupational therapy at Northwestern Medicine's Hand Surgery clinic  Exclusion Criteria:  - Patients undergoing oncologic surgery  - Patients who undergo simultaneous surgery such as open carpal tunnel  - Patients who only require closed reduction of distal radius fractures  - Operative patients that require dorsal plate fixation or separate radial styloid plate fixation </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>Jason H Ko, MD, MBA</last_name> <role>Principal Investigator</role> <affiliation>Associate Professor</affiliation> </overall_official> <overall_contact> <last_name>Melissa J Shauver, MPH</last_name> <phone>312-472-6024</phone> <email>melissa.shauver@northwestern.edu</email> </overall_contact> <overall_contact_backup> <last_name>Sadie N Sial, BS</last_name> <phone>312-695-4463</phone> <email>saadia.sial@northwestern.edu</email> </overall_contact_backup> <location> <facility> <name>Northwestern Medicine</name> <address> <city>Chicago</city> <state>Illinois</state> <zip>60611</zip> <country>United States</country> </address> </facility> <contact> <last_name>Melissa J Shauver, MPH</last_name> <phone>312-475-6024</phone> <email>melissa.shauver@northwestern.edu</email> </contact> <contact_backup> <last_name>Sadie N Sial, BS</last_name> <phone>312-695-4463</phone> <email>saadia.sial@northwestern.edu</email> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 8, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>February 2, 2023</last_update_submitted> <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 3, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Northwestern University</investigator_affiliation> <investigator_full_name>Jason Ko</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Pain, Postoperative</mesh_term> <mesh_term>Fractures, Bone</mesh_term> <mesh_term>Radius Fractures</mesh_term> <mesh_term>Wrist Fractures</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this research study is to determine if using a vibration tool improves pain control after surgical treatment of distal radius fracture. Additionally, the investigators would like to determine if this tool has any impact on consumption of pain medications postoperatively. Traditionally, occupational therapists have utilized vibration for sensory re-education in compression neuropathies and peripheral nerve injuries. Vibration is also commonly used for desensitization of hypersensitivity following amputation, crush injury, and for hypersensitive scarring. Since the vibration tool is readily available in the hand therapy clinic, vibration analgesia should be further explored in the hand clinic to help reduce pain. Vibration is a simple, and non-invasive, tool and would be easy, economical, and practical to implement into the hand clinic for postoperative pain control. This research project will evaluate whether vibration can be a useful adjunct to current postoperative pain modalities. With a multidisciplinary approach, the investigators hope to highlight the use of non-opioid modalities of pain control in distal radius fractures and believe that the findings from this study may apply to other painful conditions of the hand as well. Inclusion Criteria: - Patients with a distal radius fracture who have undergone an open reduction and internal fixation using a volar FCR approach with a single volar plate - Patients who can read, write, and follow direction in English - Willing to undergo occupational therapy at Northwestern Medicine's Hand Surgery clinic Exclusion Criteria: - Patients undergoing oncologic surgery - Patients who undergo simultaneous surgery such as open carpal tunnel - Patients who only require closed reduction of distal radius fractures - Operative patients that require dorsal plate fixation or separate radial styloid plate fixation

NCT0531xxxx/NCT05318742.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/NCT05318742</url> </required_header> <id_info> <org_study_id>Protocol 0022</org_study_id> <nct_id>NCT05318742</nct_id> </id_info> <brief_title>Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage</brief_title> <official_title>Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount</official_title> <sponsors> <lead_sponsor> <agency>Panhandle Eye Group, LLP</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Panhandle Eye Group, LLP</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> In this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in PDR subjects naïve to PRP undergoing PPV for the indication of VH. </textblock> </brief_summary> <detailed_description> <textblock> Enrolled patients will be randomized into 1 of 2 possible treatment groups: Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV, whereas Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV. Simple randomization will allocate subjects into treatment groups during PPV. Once all applicable maneuvers (including satisfactory hemostasis) are completed by the surgeon apart from endolaser PRP, a coin toss simulation program will randomize subjects into treatment groups. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 15, 2022</start_date> <completion_date type="Anticipated">January 15, 2024</completion_date> <primary_completion_date type="Anticipated">January 15, 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> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Care Provider)</masking> </study_design_info> <primary_outcome> <measure>Postoperative Vitreous Hemorrhage</measure> <time_frame>6 months</time_frame> <description>The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups</description> </primary_outcome> <secondary_outcome> <measure>Postoperative LogMAR visual acuity</measure> <time_frame>6 months</time_frame> <description>6 month LogMAR visual acuity between groups</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">150</enrollment> <condition>Diabetic Vitreous Hemorrhage</condition> <arm_group> <arm_group_label>Fewer Laser Spots</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV</description> </arm_group> <arm_group> <arm_group_label>Higher Laser Spots</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>laser</intervention_name> <description>Endolaser photocoagulation during PPV</description> <arm_group_label>Fewer Laser Spots</arm_group_label> <arm_group_label>Higher Laser Spots</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - The subject has type I or II diabetes mellitus  - The age of the subject is > 18 years old  - Snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye  - Proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision  - The subject is panretinal photocoagulation-naïve  - The vitreoretinal adhesion is Grade 0 or 1 according to the classification system published by Ahn et al in the research eye  Exclusion Criteria:  - The research eye had formerly undergone anterior or posterior vitrectomy.  - An opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.)  - Optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.)  - Amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye  - Neovascular glaucoma with an elevated intraocular pressure (> 30 mm Hg) is present in the research eye  - Uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) is present </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>Sloan Rush, MD</last_name> <role>Study Director</role> <affiliation>panhandle eye group</affiliation> </overall_official> <overall_contact> <last_name>Christi Rush</last_name> <phone>8066740200</phone> <email>christirush123@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Sloan Rush, MD</last_name> <phone>8066740200</phone> <email>sloan.rush@paneye.com</email> </overall_contact_backup> <location> <facility> <name>La Carlota Hospital</name> <address> <city>Montemorelos</city> <state>Nuevo Leon</state> <zip>67512</zip> <country>Mexico</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sloan Rush, MD</last_name> <phone>8066740200</phone> <email>sloan.rush@paneye.com</email> </contact> </location> <location_countries> <country>Mexico</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>January 1, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 6, 2022</last_update_submitted> <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Vitreous Hemorrhage</mesh_term> <mesh_term>Hemorrhage</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

In this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in PDR subjects naïve to PRP undergoing PPV for the indication of VH. Enrolled patients will be randomized into 1 of 2 possible treatment groups: Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV, whereas Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV. Simple randomization will allocate subjects into treatment groups during PPV. Once all applicable maneuvers (including satisfactory hemostasis) are completed by the surgeon apart from endolaser PRP, a coin toss simulation program will randomize subjects into treatment groups. Inclusion Criteria: - The subject has type I or II diabetes mellitus - The age of the subject is > 18 years old - Snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye - Proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision - The subject is panretinal photocoagulation-naïve - The vitreoretinal adhesion is Grade 0 or 1 according to the classification system published by Ahn et al in the research eye Exclusion Criteria: - The research eye had formerly undergone anterior or posterior vitrectomy. - An opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.) - Optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.) - Amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye - Neovascular glaucoma with an elevated intraocular pressure (> 30 mm Hg) is present in the research eye - Uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) is present

NCT0531xxxx/NCT05318755.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/NCT05318755</url> </required_header> <id_info> <org_study_id>CGAHT</org_study_id> <nct_id>NCT05318755</nct_id> </id_info> <brief_title>China Gender-affirming Hormone Therapy Study</brief_title> <acronym>CGAHT</acronym> <official_title>China Gender-affirming Hormone Therapy Study in Transgender Men and Women</official_title> <sponsors> <lead_sponsor> <agency>Peking University Third Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Tsinghua University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Peking University Third Hospital</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>No</is_us_export> </oversight_info> <brief_summary> <textblock> Data about transgender medical care, especially the gender-affirming hormone therapy (GAHT) is extremely insufficient in China. Few evidence exists in the physical and psychological effects of the hormonal treatment in Chinese transgender population. CGAHT is designed to describe the social and mental condition of transgender people who are seeking for formal GAHT, and to investigate the physical and psychological effects of GAHT on this population in China. </textblock> </brief_summary> <detailed_description> <textblock> CGAHT will be conducted in one of the main transgender medical centers in Chinese mainland. Participants who are seeking for the start of GAHT will be enrolled from clinical visitors. Before GAHT, participants will be interviewed with questionaries about their life experience, gender identity and social economic conditions. Evaluations on mental and physical health will be performed at baseline and during the GAHT. Participants will be followed up to 12 months. GAHT will be given to transgender people according to the protocol recommended by the international guideline (doi: 10.1210/jc.2017-01658) . </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 16, 2022</start_date> <completion_date type="Anticipated">December 31, 2028</completion_date> <primary_completion_date type="Anticipated">December 31, 2027</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>Change from Baseline Insulin Sensitivity at 12 months</measure> <time_frame>12 months</time_frame> <description>Insulin sensitivity will be assessed with composite insulin sensitivity index (ISI), which is calculated as 10 000/√[(fasting glucose [mg/dL]) ×(fasting insulin [μU/mL]) × (mean glucose [mg/dL]) × (mean insulin [μU/mL])], using 0 min, 60 min, and 120 min values of oral glucose tolerance test (OGTT). Composite ISI will be evaluated at baseline and every 6 months until 12 months of GAHT.</description> </primary_outcome> <primary_outcome> <measure>Change from Baseline Beta-cell Function at 12 months</measure> <time_frame>12 months</time_frame> <description>Beta-cell function will be assessed with oral glucose tolerance test-derived disposition index (DI). First, 60 min insulinogenic index (IGI60) is calculated as (insulin60 min-insulin0 min[μU/mL])/(glucose60 min-glucose0 min [mmol/L]), using 0 min and 60 min values of OGTT. Then DI is calculated by multiplying IGI60 with composite ISI to reflect beta-cell function adjusting for the insulin sensitivity. DI will be evaluated at baseline and every 6 months until 12 months of GAHT.</description> </primary_outcome> <primary_outcome> <measure>Change from Baseline Bone Mineral Density at 12 months</measure> <time_frame>12 months</time_frame> <description>Bone mineral densities (g/cm^2) of lumber spine and hip will be evaluated by dual-energy X-ray absorptiometry at baseline and 12 months of GAHT.</description> </primary_outcome> <primary_outcome> <measure>Depression Changes from Baseline Psychological Questionnaires at 12 months</measure> <time_frame>12 months</time_frame> <description>Patient Health Questionnaire will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT</description> </primary_outcome> <primary_outcome> <measure>Anxiety Changes from Baseline Psychological Questionnaires at 12 months</measure> <time_frame>12 months</time_frame> <description>Generalized anxiety disorder scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT</description> </primary_outcome> <primary_outcome> <measure>Suicide Ideation Changes from Baseline Psychological Questionnaires at 12 months</measure> <time_frame>12 months</time_frame> <description>Beck scale for suicide ideation will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT</description> </primary_outcome> <primary_outcome> <measure>Gender Dysphoria Changes from Baseline Psychological Questionnaires at 12 months</measure> <time_frame>12 months</time_frame> <description>Utrecht gender dysphoria scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT</description> </primary_outcome> <primary_outcome> <measure>Social Exclusion Changes from Baseline at 12 months</measure> <time_frame>12 months</time_frame> <description>Cyberball task will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT.</description> </primary_outcome> <primary_outcome> <measure>Functional brain Change after 6 months of GAHT</measure> <time_frame>6 months</time_frame> <description>Change of functional connectivity will be analyzed to understand at 6 months of GAHT.</description> </primary_outcome> <secondary_outcome> <measure>Incidence of Treatment-Emergent Adverse Events</measure> <time_frame>Up to 12 months</time_frame> <description>The incidence of adverse events during the 12 months of GAHT will be calculated, including thromboembolic events, drug-induced liver injury, hyperkalemia, newly diagnosed cardiovascular disease, erythrocytosis and newly diagnosed tumor.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline Body Mass Index at 12 months</measure> <time_frame>12 months</time_frame> <description>Body mass index is calculated as [weight (kg) / height (m)^2], which will be evaluated at baseline and every 3 months until 12 months of GAHT.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline Waist-hip Ratio at 12 months</measure> <time_frame>12 months</time_frame> <description>Waist-hip ratio is calculated as [waist (cm)/hip (cm)], which will be evaluated at baseline and every 3 months until 12 months of GAHT.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline Body Composition at 12 months</measure> <time_frame>12 months</time_frame> <description>Fat percentage (%) and lean mass (kg) will be assessed using the InBody S10. The body composition will be evaluated at baseline and 12 months of GAHT.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline Breast Volume of transgender women at 12 months</measure> <time_frame>12 months</time_frame> <description>Breasts of transgender women will be shot in 360° with 3D photography. The volume (ml) of both sides will be measured by the image analysis at baseline and every 6 months until 12 months of GAHT.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline Homeostatic Model Assessment Index (HOMA-IR) at 12 months</measure> <time_frame>12 months</time_frame> <description>HOMA-IR is calculated as [(fasting insulin [µU/mL] × fasting glucose [mmol/L])/22.5]. HOMA-IR will be evaluated at baseline and every 6 months until 12 months of GAHT.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-β) at 12 months</measure> <time_frame>12 months</time_frame> <description>HOMA-β is calculated as [20 × (fasting insulin [μU/mL]) × (fasting glucose -3·5 [mmol/L])]. HOMA-β will be evaluated at baseline and every 6 months until 12 months of GAHT.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline Serum Uric Acid at 12 months</measure> <time_frame>12 months</time_frame> <description>Serum Uric Acid levels (μmol/l) will be evaluated at baseline and every 3 months until 12 months of GAHT.</description> </secondary_outcome> <secondary_outcome> <measure>Comparison of Transgender and Cisgender Functional Brain Patterns</measure> <time_frame>At baseline</time_frame> <description>Functional connectivity will be compared at baseline to understand the brain patterns of transgender.</description> </secondary_outcome> <secondary_outcome> <measure>Comparison of Transgender and Cisgender Cognitive Ability</measure> <time_frame>At baseline</time_frame> <description>Performance of mental rotation task of transgender and cisgender will be compared at baseline to understand the difference.</description> </secondary_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Anticipated">240</enrollment> <condition>Transgender</condition> <condition>Gender Incongruence</condition> <arm_group> <arm_group_label>transgender men</arm_group_label> <description>People whose sex assigned at birth is female but whose self-identified gender is male.</description> </arm_group> <arm_group> <arm_group_label>transgender women</arm_group_label> <description>People whose sex assigned at birth is male but whose self-identified gender is female.</description> </arm_group> <arm_group> <arm_group_label>Healthy cisgender people</arm_group_label> <description>People whose sex assigned at birth corresponds with their self-identified gender.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>GAHT for transgender men</intervention_name> <description>Testosterone undecanoate</description> <arm_group_label>transgender men</arm_group_label> <other_name>Testosterone</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>GAHT for transgender women</intervention_name> <description>Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)</description> <arm_group_label>transgender women</arm_group_label> <other_name>Feminizing drugs</other_name> </intervention> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Blood, urine and stool sample will be taken before and during the course of GAHT. </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> 100 transgender men, 100 trangender women, 20 healthy cisgender men and 20 healthy cisgender women </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Transgender men and women  - Meet criteria of Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) for gender dysphoria  - Aged between 18 to 40 years  - People desire to start the GAHT  - No previous history of gender-affirming interventions  - Having full ability to make informed consent  - Dextromanual  Exclusion Criteria:  - Disorders of sex development  - Who has fertility demand but have not made fertility preservation  - With contradictions of GAHT  - Comorbid diseases are not under control  - Alcohol or drug abuse  - Hormonal and chromosomal disorders  - History of gender affirming surgery  - Current psychiatric disorders  - History of brain trauma or neurological pathologies  - Current use of medications with psychotropic effects within two weeks (antipsychotic or antiepileptic agents, lithium, benzodiazepines or opioid analgesics)  - Claustrophobia  - Implanted metal and medical devices (pacemakers, ceramic teeth, etc.),  - Tattoos or eyebrow tattooing (heavy metal dye) </textblock> </criteria> <gender>All</gender> <gender_based>Yes</gender_based> <gender_description>Men and women are based on self-representation of gender identity</gender_description> <minimum_age>18 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Tianpei Hong, PhD., M.D.</last_name> <role>Principal Investigator</role> <affiliation>Department of Endocrinology and Metabolism, Peking University Third Hospital</affiliation> </overall_official> <overall_contact> <last_name>Ye Liu, PhD., M.D.</last_name> <phone>+86-10-82265025</phone> <email>yeliumed@bjmu.edu.cn</email> </overall_contact> <overall_contact_backup> <last_name>Tianpei Hong, M.D.</last_name> <phone>+86-10-82266918</phone> <email>tpho66@bjmu.edu.cn</email> </overall_contact_backup> <location> <facility> <name>Peking University Third Hospital</name> <address> <city>Peking</city> <state>Beijing</state> <zip>100191</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Tianpei Hong, Pro.</last_name> <phone>8601082265025</phone> <email>tpho66@bjmu.edu.cn</email> </contact> <contact_backup> <last_name>Ye Liu, Dr.</last_name> <phone>8601082265025</phone> <email>yeliumed@bjmu.edu.cn</email> </contact_backup> </location> <location_countries> <country>China</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>February 16, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>September 27, 2022</last_update_submitted> <last_update_submitted_qc>September 27, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 28, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Peking University Third Hospital</investigator_affiliation> <investigator_full_name>Hong Tianpei</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>Transgender Persons</keyword> <keyword>Gender-affirming Hormone Therapy</keyword> <condition_browse>  <mesh_term>Gender Dysphoria</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Testosterone</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> <ipd_description>Dataset is available from the corresponding author on reasonable request.</ipd_description> </patient_data>  </clinical_study>

Data about transgender medical care, especially the gender-affirming hormone therapy (GAHT) is extremely insufficient in China. Few evidence exists in the physical and psychological effects of the hormonal treatment in Chinese transgender population. CGAHT is designed to describe the social and mental condition of transgender people who are seeking for formal GAHT, and to investigate the physical and psychological effects of GAHT on this population in China. CGAHT will be conducted in one of the main transgender medical centers in Chinese mainland. Participants who are seeking for the start of GAHT will be enrolled from clinical visitors. Before GAHT, participants will be interviewed with questionaries about their life experience, gender identity and social economic conditions. Evaluations on mental and physical health will be performed at baseline and during the GAHT. Participants will be followed up to 12 months. GAHT will be given to transgender people according to the protocol recommended by the international guideline (doi: 10.1210/jc.2017-01658) . Blood, urine and stool sample will be taken before and during the course of GAHT. 100 transgender men, 100 trangender women, 20 healthy cisgender men and 20 healthy cisgender women Inclusion Criteria: - Transgender men and women - Meet criteria of Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) for gender dysphoria - Aged between 18 to 40 years - People desire to start the GAHT - No previous history of gender-affirming interventions - Having full ability to make informed consent - Dextromanual Exclusion Criteria: - Disorders of sex development - Who has fertility demand but have not made fertility preservation - With contradictions of GAHT - Comorbid diseases are not under control - Alcohol or drug abuse - Hormonal and chromosomal disorders - History of gender affirming surgery - Current psychiatric disorders - History of brain trauma or neurological pathologies - Current use of medications with psychotropic effects within two weeks (antipsychotic or antiepileptic agents, lithium, benzodiazepines or opioid analgesics) - Claustrophobia - Implanted metal and medical devices (pacemakers, ceramic teeth, etc.), - Tattoos or eyebrow tattooing (heavy metal dye)

NCT0531xxxx/NCT05318768.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/NCT05318768</url> </required_header> <id_info> <org_study_id>PKUPH7</org_study_id> <nct_id>NCT05318768</nct_id> </id_info> <brief_title>Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.</brief_title> <official_title>Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.</official_title> <sponsors> <lead_sponsor> <agency>Peking University People's Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Peking University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Peking University People's Hospital</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> In this study, it is assumed that grip strength is associated with pelvic floor muscle strength. And the outcome of pelvic floor function can be predicted by referring to the status of pelvic floor muscle strength through the value of grip strength, which is labor-saving, time-saving and more convenient for evaluating pelvic floor muscle function. Moderate physical activity and increase the overall strength can activate the potential mechanism of pelvic floor muscle contraction at the same time may be a "core muscles" overall effect, that core muscles mainly includes transverse abdominal muscle, pelvic floor muscles and the muscles around the back, these muscles in the body movement to spontaneous collaboration contract pelvic floor muscles, enhancing pelvic floor muscle function, thus reducing the incidence of pelvic floor dysfunction. </textblock> </brief_summary> <detailed_description> <textblock> This study is a cross-sectional observational study, planned to enroll 942 participants from Gynecology Outpatient Clinic. Uniformly trained physicians as investigators to collect indicators from questionnaires and physical examinations.  Questionnaires may contain general information which include the patient's age, height, body weight before pregnancy and childbirth, weight gain during pregnancy, gestational age, pregnancy time, production time, high palace, delivery mode, neonatal birth weight, body length, blood sugar, blood fat, whether or not to use during pregnancy, childbirth, labor, perineal laceration, forceps midwifery, episiotomy and epidural data, pelvic floor cognition degree, physical activity levels, pelvic floor dysfunction score, pelvic floor functional impact score and sexual function score (including the prenatal and postnatal participants).  Physical examinations will be performed without the results of the questionnaire, including stress tests, pelvic floor POP-Q staging, pelvic floor muscle strength by palpation, vaginal relaxation degree, grip strength value, rectus abdominis separation, waist circumference, waist-hip ratio, etc.  Through univariate analysis of the general data of the patients, the related factors of female PFD were obtained, and the independent influencing factors of PFD were found by binary Logistic regression analysis (the dependent variable in this study was a dichotomous variable). The ROC curve was used to evaluate the predictive value of patients' overall strength level, physical activity level, body shape and other indicators on PFD outcome. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 1, 2021</start_date> <completion_date type="Actual">April 30, 2022</completion_date> <primary_completion_date type="Actual">October 30, 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>Pelvic floor muscle strength grading</measure> <time_frame>through study completion，an average of one day</time_frame> <description>The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contraction.</description> </primary_outcome> <primary_outcome> <measure>Overall body strength measured by hand grip strength</measure> <time_frame>through study completion，an average of one day</time_frame> <description>Grip strength index is used to evaluate adult muscle strength in Chinese National Physical Fitness Standards. Grip strength is an important indicator to evaluate an individual's upper limb strength and can reflect the overall muscle strength level which was used to evaluate the overall strength of participants.</description> </primary_outcome> <primary_outcome> <measure>Physical activity levels</measure> <time_frame>through study completion, an average of the past one week</time_frame> <description>International Physical Activity Questionnaire score- short from is used to measure the overall physical activity level. Paticipants volunteered for the study and filled out questionnaires to rate their levels of physical activity over the past week which can represent the overall physical activity level.</description> </primary_outcome> <primary_outcome> <measure>Pelvic Floor Distress Inventory#PFDI-20#Questionnaire Score</measure> <time_frame>through study completion， an average of the past 3 months</time_frame> <description>The Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) is the short-form version of the Pelvic Floor Distress Inventory (PFDI).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions.The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100.The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.</description> </primary_outcome> <primary_outcome> <measure>FSFI-6 Questionnaire Score</measure> <time_frame>through study completion， an average of the past four weeks</time_frame> <description>The 6-item Female Sexual Function Index (FSFI) is a short form of the original 19-item FSFI that measures sexual function in women.It comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Desire and satisfaction items are rated on a 5-point Likert scale, ranging from 1 to 5, and the other items are rated on a 6-point Likert scale, ranging from 0 to 5. Total scores range from 2 to 30, with lower scores indicating worse sexual functioning.</description> </primary_outcome> <enrollment type="Actual">929</enrollment> <condition>Pelvic Floor Disorders</condition> <condition>Pelvic Floor Muscle Weakness</condition> <eligibility> <study_pop> <textblock> This study is a cross-sectional observational study, planned to enroll 1143 participants from Gynecology Outpatient Clinic. PASS.15 software was used for sample size calculation. α- error level was set as 0.05, U0.05=1.96. For the main indicators, according to the epidemiological investigation of FEMALE PFD by our previous study, the comprehensive selection of PFD prevalence is 10%, and error δ=4%, calculated n=914, proposed to increase the loss rate by 20%. The sample size was about 1143. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Gynecological outpatient clinic patients  - In good condition and able to actively cooperate  - Agree to conduct the study.  - Age range: 18 to 80 years old  Exclusion Criteria:  - Patients who has a history of pelvic surgery or has had pelvic floor functional diseases  - Patients who do not have sex  - Pregnancy  - Patients who have serious medical diseases  - Patients with cardiac dysfunction or wear pacemakers  - Patients with neurological diseases and cognitive impairment who are difficult to cooperate with the study </textblock> </criteria> <gender>Female</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>Xiuli Sun, PHD</last_name> <role>Study Chair</role> <affiliation>Study Chair</affiliation> </overall_official> <location> <facility> <name>Peking University Peoples Hospital</name> <address> <city>Beijing</city> <state>Beijing</state> <zip>10000</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>February 2, 2023</last_update_submitted> <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Peking University People's Hospital</investigator_affiliation> <investigator_full_name>Sun Xiuli</investigator_full_name> <investigator_title>Director</investigator_title> </responsible_party> <keyword>women</keyword> <keyword>physical activity</keyword> <keyword>overall muscle strength</keyword> <keyword>hand grip strength</keyword> <keyword>pelvic floor muscle strength</keyword> <condition_browse>  <mesh_term>Muscle Weakness</mesh_term> <mesh_term>Pelvic Floor Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Date of disclosure of raw data: December 2023. Data content: original recorded data and research proposals; Ways or means of sharing IPDs, contact the researchers.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>2years</ipd_time_frame> <ipd_access_criteria>contact the researchers</ipd_access_criteria> </patient_data>  </clinical_study>

In this study, it is assumed that grip strength is associated with pelvic floor muscle strength. And the outcome of pelvic floor function can be predicted by referring to the status of pelvic floor muscle strength through the value of grip strength, which is labor-saving, time-saving and more convenient for evaluating pelvic floor muscle function. Moderate physical activity and increase the overall strength can activate the potential mechanism of pelvic floor muscle contraction at the same time may be a "core muscles" overall effect, that core muscles mainly includes transverse abdominal muscle, pelvic floor muscles and the muscles around the back, these muscles in the body movement to spontaneous collaboration contract pelvic floor muscles, enhancing pelvic floor muscle function, thus reducing the incidence of pelvic floor dysfunction. This study is a cross-sectional observational study, planned to enroll 942 participants from Gynecology Outpatient Clinic. Uniformly trained physicians as investigators to collect indicators from questionnaires and physical examinations. Questionnaires may contain general information which include the patient's age, height, body weight before pregnancy and childbirth, weight gain during pregnancy, gestational age, pregnancy time, production time, high palace, delivery mode, neonatal birth weight, body length, blood sugar, blood fat, whether or not to use during pregnancy, childbirth, labor, perineal laceration, forceps midwifery, episiotomy and epidural data, pelvic floor cognition degree, physical activity levels, pelvic floor dysfunction score, pelvic floor functional impact score and sexual function score (including the prenatal and postnatal participants). Physical examinations will be performed without the results of the questionnaire, including stress tests, pelvic floor POP-Q staging, pelvic floor muscle strength by palpation, vaginal relaxation degree, grip strength value, rectus abdominis separation, waist circumference, waist-hip ratio, etc. Through univariate analysis of the general data of the patients, the related factors of female PFD were obtained, and the independent influencing factors of PFD were found by binary Logistic regression analysis (the dependent variable in this study was a dichotomous variable). The ROC curve was used to evaluate the predictive value of patients' overall strength level, physical activity level, body shape and other indicators on PFD outcome. This study is a cross-sectional observational study, planned to enroll 1143 participants from Gynecology Outpatient Clinic. PASS.15 software was used for sample size calculation. α- error level was set as 0.05, U0.05=1.96. For the main indicators, according to the epidemiological investigation of FEMALE PFD by our previous study, the comprehensive selection of PFD prevalence is 10%, and error δ=4%, calculated n=914, proposed to increase the loss rate by 20%. The sample size was about 1143. Inclusion Criteria: - Gynecological outpatient clinic patients - In good condition and able to actively cooperate - Agree to conduct the study. - Age range: 18 to 80 years old Exclusion Criteria: - Patients who has a history of pelvic surgery or has had pelvic floor functional diseases - Patients who do not have sex - Pregnancy - Patients who have serious medical diseases - Patients with cardiac dysfunction or wear pacemakers - Patients with neurological diseases and cognitive impairment who are difficult to cooperate with the study

NCT0531xxxx/NCT05318781.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/NCT05318781</url> </required_header> <id_info> <org_study_id>MP-32-2022-2412</org_study_id> <nct_id>NCT05318781</nct_id> </id_info> <brief_title>Impacts of Bariatric Surgery on the Microbiome and Brain Function</brief_title> <acronym>EMBRACE</acronym> <official_title>Understanding the Impact of Radical Changes in Diet and the Microbiome on Brain Function and Structure: the EMBRACE Study</official_title> <sponsors> <lead_sponsor> <agency>Hopital du Sacre-Coeur de Montreal</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Concordia University, Montreal</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Ottawa</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Hopital du Sacre-Coeur de Montreal</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> Emerging evidence suggests that dietary and metabolic interventions could potentially target prevention and supportive therapies as well as treatments that may slow the clinical deterioration of neurodegenerative disorders. Though certain dietary patterns can impair specific cognitive domains, e.g., declines in reasoning and global cognition, there is still no consensus on the optimal diet to maintain brain health. Studies have also shown an association between the gut microbiome and neurocognition, as the microbiota can affect neuronal function through neurotransmitters and neuroactive microbial metabolites. Furthermore, studies indicate that diet may strongly influence the gut microbiota. However, the mechanisms for these complex relationships are still poorly understood. Bariatric procedures [i.e., weight loss surgeries] create a unique environment, in which a fast change in gut microbiota composition and dietary patterns occurs through surgery-induced intestinal and metabolic modifications, leading to changes in gut-brain communication. Interestingly, improvements in neurocognitive domains including memory and executive function have been reported post-bariatric surgery. However, there is large variability in these outcomes, indicating that the benefits are not universal. The goal of the current study is to explore the associations between dietary patterns and gut microbiota with cognition and brain structure, using bariatric surgery as an efficient naturalistic experimental design. This project will also explore potential mediators of diet-microbiome alterations as they relate to improvements in brain function and structure. A total of 120 adult patients (> 30y yrs.) scheduled to undergo a first bariatric surgery along with 60 age-, sex-, and BMI-matched waitlist control group will be recruited from the bariatric surgery clinic at the CIUSSS du Nord-de-l'Île-de-Montréal. These individuals will undergo assessments 3 months before surgery, as well as 6- and 12-months post-surgery, or an equivalent time for those on the waitlist. This study will also include 60 age-and sex-matched individuals who are not eligible for bariatric surgery as an additional healthy Canadian comparison group (only one assessment time point). Assessments taken during the data collection period will include: self-report information [e.g., sociodemographic and background information, health and diet behaviours]; information from medical records [e.g., medications usage, peri- and post-surgical complications, etc.]; physiological measures [i.e., blood, urine and fecal samples collection]; cognitive assessment [i.e., neuropsychological tests battery]; and brain imaging [i.e., structural MRI]. Collectively, this study is designed to provide critical information about potential individually targeted diet-based preventative strategies to reduce the development and progression of neurodegenerative disorders. Moreover, this project will explore potential mediators of diet-microbiome alterations as they relate to improvements in brain function and structure, and as such, it will provide essential information on key mechanisms, stimulating further research and the creation of parallel non-dietary therapeutic options. </textblock> </brief_summary> <detailed_description> <textblock> Dietary patterns are associated with cognitive function and brain morphology. Though certain dietary patterns can impair specific cognitive domains, e.g., declines in reasoning and global cognition, there is still no consensus on the optimal 'brain diet'. Studies have also shown an association between the gut microbiome and neurocognition. The microbiota can affect neuronal function through neurotransmitters and neuroactive microbial metabolites. Furthermore, studies indicate that diet may strongly influence the gut microbiota, likely via intestinal permeability and inflammation. However, the mechanisms for this complex relationship between diet, gut microbiome and cognition are still poorly understood. Most of the work to date has focused on the negative effects of a Western style diet, with its subsequent microbiota alterations leading to cognitive impairment, via reduced barrier integrity, increased neuroinflammation, and impaired insulin signaling. However, very little is known about positive dietary-microbiome interactions, especially in humans. Bariatric surgery is considered the most effective treatment for severe obesity and it's related comorbidities, with the Sleeve gastrectomy (SG) being the most commonly performed procedures worldwide. These procedures create a unique environment, in which a fast change in gut microbiota composition occurs through surgery-induced intestinal and metabolic modifications, leading to changes in gut-brain communication. Moreover, these same post-surgical alterations to the gastrointestinal tract are accompanied by profound changes in dietary patterns that, in turn, influence microbiota composition. Following bariatric surgery, dietary intake is altered both in quantity and quality; however, considerable individual variations in surgically-induced dietary patterns have been previously demonstrated. Interestingly, improvements in neurocognitive domains including memory and executive function have been reported post-bariatric surgery. However, there is large variability in these outcomes, indicating that the benefits are not universal. Additionally, the extant literature is limited by a small number of studies, meaning that the underling mechanisms remain unclear. Importantly, how bariatric surgery-induced modifications in both dietary patterns and the gut microbiome effect cognitive function have yet to be explored. Finally, the overall changes in the gut microbiome and diet post-surgery may enhance biological pathways (e.g., gut hormones, inflammation, and neuroactive metabolites) which can affect brain function and structure, but the nature of these changes have not been studied extensively. The EMBRACE trial (Evaluation the impact of radical nutrition and Microbiome changes on BRAin funCtion and structurE) is a prospective, 15-month longitudinal study that aims to elucidate the associations between dietary patterns and gut microbiota with cognition and brain structure, using an efficient naturalistic experimental design which causes major disruptions to both diet and the microbiome, i.e., bariatric surgery. The main goal of this study is to evaluate how changes in gut microbiota composition and dietary patterns from pre- to post-bariatric surgery are linked to improved cognition and brain structure over the medium-term (12-months post-surgery). This project also aims to explore the potential mediating biological (e.g., inflammatory markers, hormonal changes, altered micronutrients levels and neuroactive microbial metabolites) pathways which might explain these relationships.  Primary aim: To evaluate the effect of surgery-induced changes in gut microbiota composition and dietary patterns from 3-M pre-surgery to 6-M post-surgery on 12-M post-surgical cognition, measured using sensitive neuropsychological tests.  Secondary aim: To evaluate the effect of surgery-induced changes in gut microbiota composition and dietary patterns from 3-M pre-surgery to 6-M post-surgery on 12-M post-surgical brain structure measured with magnetic resonance imaging (MRI) to assess brain volume, white-matter hyperintensities and cortical thickness.  Hypotheses for aims 1 and 2: Better quality microbiota and diet clusters (e.g., increased bacterial richness and diversity and greater low-saturated fat/high fibre intake) will be associated with increased performance on cognitive measures (higher total score on the neuropsychological test battery [primary] and its subscales [secondary]) and positive changes in brain measures (regional brain volume, hippocampal volume, cortical thickness and white-matter hyperintensities).  Exploratory aim: To examine biological changes (e.g., inflammatory state, hormonal changes, altered micronutrients levels and neuroactive microbial metabolites) pre- to post-surgery as potential mediating factors between microbiota/diet changes and cognitive/brain measures. Outcome: We will explore what post-surgical biological measures (e.g., reduced inflammatory markers, lower leptin levels, etc.) might mediate or moderate the links between specific microbiota and diet clusters and changes in cognitive function and brain measures.  A total of 120 adult patients (≥ 30y yrs.) scheduled to undergo a first bariatric surgery along with 60 age-, sex-, and BMI-matched waitlist control group will be recruited and undergo assessments 3 months before surgery, as well as 6- and 12-months post-surgery, or an equivalent time for those on the waitlist. This study will also include the recruitment of 60 age-and sex-matched individuals who are not eligible for bariatric surgery, as an additional non-bariatric comparison group. Evaluations will include standardized questionnaires on demographics, health behaviors and eating habits, physiological assessments (anthropometrics, inflammatory and blood-based measurements, 24-hour urine and fecal sample collection), cognitive assessment by neuropsychological tests, and structural magnetic resonance imaging (MRI).  Cluster analyses of the dietary and microbial alterations will define the various dietary patterns and microbiome profiles, then using repeated-measures mixed models, their associations with global cognitive changes and structural brain alterations will be explored. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">August 1, 2022</start_date> <completion_date type="Anticipated">May 2025</completion_date> <primary_completion_date type="Anticipated">January 2025</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>Changes in cognition from baseline [3 months pre-surgery] to 12 months post-surgery, measured using sensitive neuropsychological test battery [NTB]</measure> <time_frame>3 months pre- and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Global cognition will be assessed using the NTB total score (the primary outcome), a composite NTB score of 14 sub-tests. NTB domain Z scores for executive functioning, processing speed, and memory will also be calculated.</description> </primary_outcome> <secondary_outcome> <measure>Changes in MRI-derived brain volume from baseline [3 months pre-surgery] to 12 months</measure> <time_frame>3 months pre- and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Participants will be scanned on a Siemens 3T Prisma Fit MRI system (Siemens Medical Solutions, Erlangen, Germany). The MRI protocol will use structural sequences of the CIMAQ/Canadian Dementia Imaging Protocol (www.cdip-pcid.ca). The session contains a 3D T1-weighted MRI for volumetric and cortical thickness analyses (TR/TE 2300/2.98 ms; 9° flip angle; voxel size: 1x1x1 mm).</description> </secondary_outcome> <secondary_outcome> <measure>Changes in MRI-derived white-matter hyperintensities from baseline [3 months pre-surgery] to 12 months post-surgery</measure> <time_frame>3 months pre- and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Participants will be scanned on a Siemens 3T Prisma Fit MRI system (Siemens Medical Solutions, Erlangen, Germany). The MRI protocol will use structural sequences of the CIMAQ/Canadian Dementia Imaging Protocol (www.cdip-pcid.ca). The session contains FLAIR sequences (TR/TE 9000/129 ms; voxel size: 1×1×1 mm, for white matter hyperinsities (WMH) analyses.</description> </secondary_outcome> <other_outcome> <measure>Trajectories of clusters of gut microbiota composition measured with Metagenomic shotgun sequencing from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Whole genomes will be sequenced using Illumina paired-end 150bp sequencing to achieve 20-30Gb sequences per sample. Microbiome changes at the levels of the community (richness, diversity), taxa including absolute and relative abundance of microbes classified along the different levels of the tree of life (family, genera, species), and functions (genes and pathways abundances) will be evaluated by metagenomic tools (i.e., R/Bioconductor packages such as vegan, phyloseq, microbiome, and MaAslin2).</description> </other_outcome> <other_outcome> <measure>Trajectories of clusters of gut microbiota composition measured with High-throughput sequencing of 16 S rRNA genes from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Resulting sequences will be clustered into operational taxonomic units (OTUs) by applying a cut-off of 97% similarity using the Greengenes reference database. Alpha-diversity metrics, Shannon [species evenness and diversity]) will be calculated from the rarefied OTUs. The β-diversity will be estimated using UniFrac and Bray-Curtis distances and visualized using principal coordinate analysis (PCoA).</description> </other_outcome> <other_outcome> <measure>Trajectories of macro-level dietary intake from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>A 7-day food diary with photo capture via a mobile application (Keenoa), will be used to collect dietary data. Data from the food diaries will be analyzed using the Canadian Nutrient File, a Government of Canada food database.</description> </other_outcome> <other_outcome> <measure>Trajectories of diet quality measured by the Healthy Eating Index (HEI) from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The Healthy Eating Index (HEI) will be used as an index of overall diet quality, specifically for a Canadian population. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Canadians.</description> </other_outcome> <other_outcome> <measure>Trajectories of dietary inflammatory Index from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The Dietary inflammatory Index [DII] measure the potential impact of a diet on an individual's inflammatory status, and it has been validated mainly in Western countries. A high DII score reflects pro-inflammatory potential of the diet, whereas a low DII score reflects the anti-inflammatory potential of the diet</description> </other_outcome> <other_outcome> <measure>Trajectories of mediterranean diet adherence from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The Mediterranean Diet Adherence Screener (MEDAS) is a 14-item instrument that enables a rapid assessment of adherence to the Mediterranean diet. The final MEDAS score can range between 0 and 14, higher scores reflects higher level of adherence to the mediterranean diet.</description> </other_outcome> <other_outcome> <measure>Trajectories of food tolerance from baseline through to12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Food tolerance after bariatric surgery will be assessed by the validated, self-reported questionnaire for quick assessment of food tolerance after bariatric surgery with a score of 1 to 27. This instrument consists of 4 components, including overall patient satisfaction with alimentation, the timing and content of meals and snacks, the tolerance of different types of foods, and the frequency of vomiting. Higher scores reflects higher level of tolerance to food and eating post-surgery.</description> </other_outcome> <other_outcome> <measure>Trajectories of Eating behavior from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The Dutch Eating Behavior Questionnaire (DEBQ) evaluates emotional eating behaviors, external eating behaviors, and restricted eating behaviors, and is composed of 33 items, that are evaluated by a 5-point Likert scale (one: never, two: rarely, three: sometimes, four: often, and five: very often). Items on the subscales are averaged, with higher mean scores indicative of greater restrained eating, eating in response to emotions, and eating triggered by external cues.</description> </other_outcome> <other_outcome> <measure>Trajectories of binge eating from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The Binge-Eating Disorder Screener (BEDS-7) will be used to identify individuals with probable binge-eating disorder (BED). This is a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED).</description> </other_outcome> <other_outcome> <measure>Trajectories of eating self-efficacy from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The Weight Efficacy Lifestyle Questionnaire (WEL) is a commonly used measure of eating self-efficacy consisting of 20-items and five situational factors. Higher WEL scores indicate higher self-efficacy to resist eating.</description> </other_outcome> <other_outcome> <measure>Trajectories of grazing eating behavior from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The grazing questionnaire will be used, this instrument include seven-item self-report scale measuring the frequency of unplanned, continuous and repetitive eating of small amounts of food [i.e., grazing eating behavior].</description> </other_outcome> <other_outcome> <measure>Trajectories of excess weight loss from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Weight will be measured on a digital medical scale; height will be measured by a stadiometer and BMI will be calculated by weight divided by the height squared. Percentages of excess weight loss (% EWL) will be calculated as follows: [(preoperative weight-postoperative weight)/ (preoperative weight - ideal weight)] × 100. Ideal body weight (IBW) will be considered the weight for a BMI 25 kg/m2.</description> </other_outcome> <other_outcome> <measure>Trajectories of urine nitrogen as a biomarker for dietary protein intake, from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Dietary 24-hour urinary biomarkers measured for objective verification for some of the self-reported food intakes will include urine Nitrogen that will be used as a biomarker for the validation of dietary protein intake. 24-hour urine collection will be performed by participants following each lab visit with the full instructions given by a research assistant at each lab visit.</description> </other_outcome> <other_outcome> <measure>Trajectories of urine Alkylresorcinols (ARs) and their metabolites as a biomarker for fiber and whole grain products intake, from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Dietary 24-hour urinary biomarkers measured for objective verification for some of the self-reported food intakes will include Alkylresorcinols (ARs) and their metabolites (3-(3,5-dihydroxyphenyl)-propanoic acid (DHPPA) and 3,5-dihydroxybenzoic acid (DHBA)) that will be used as markers for fiber and whole grain products.</description> </other_outcome> <other_outcome> <measure>Trajectories of urine fructose as a biomarkers for sugar intake from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Fructose 24 hours urine excretion will be used to assess added, natural, and total sugar intake.</description> </other_outcome> <other_outcome> <measure>Trajectories of urine sodium as a biomarkers for total sodium intake from baseline at 6 through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Sodium and albumin 24 hour excretions will be used to assess sodium intake.</description> </other_outcome> <other_outcome> <measure>Trajectories of urine potassium as a biomarkers for total potassium intake from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Potassium 24 hour excretions will be used to assess potassium intake.</description> </other_outcome> <other_outcome> <measure>Trajectories of Quality of Life from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The European Quality of Life Five Dimensions Questionnaire [EQ-5D] is a standardized measure that will be used to collect data about participant's quality of life, and have been previously used within Quebec population.</description> </other_outcome> <other_outcome> <measure>Trajectories of depressive symptoms from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>The Beck Depression Inventory-II (BDI-II), a 21-item questionnaire self-report measure will be used to assess depressive symptomatology. Sum scores ranging from zero to 13 indicate minimal depression, 14 to 19 indicate mild depression, 20 to 28 indicate moderate depression, and 29 to 63 indicate severe depression.</description> </other_outcome> <other_outcome> <measure>Trajectories of physical activity from baseline through to 12 months post-surgery</measure> <time_frame>3 months pre- and 6 and 12 months post-surgery [or equivalent time point for waitlist participants]</time_frame> <description>Physical activity information will be collected using the Godin Leisure-Time Exercise Questionnaire. Alcohol consumption and smoking behaviour will be assessed using questions adapted from Statistics Canada's alcohol and other drugs survey. The usage of nutritional and vitamin supplements will be assessed.</description> </other_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Anticipated">240</enrollment> <condition>Bariatric Surgery Candidate</condition> <condition>Weight Loss</condition> <arm_group> <arm_group_label>Patients undergoing bariatric surgery</arm_group_label> <description>Adult patients (≥ 30y yrs.) scheduled to undergo a first bariatric surgery recruited from the bariatric surgery clinic at the CIUSSS du Nord-de-l'Île-de-Montréal [N=120]</description> </arm_group> <arm_group> <arm_group_label>Patients on the bariatric surgery waitlist</arm_group_label> <description>Age-, sex-, and BMI-matched waitlist control group [awaiting for bariatric surgery] recruited from the bariatric surgery clinic at the CIUSSS du Nord-de-l'Île-de-Montréal [N=60]</description> </arm_group> <arm_group> <arm_group_label>Non-bariatric eligible individuals</arm_group_label> <description>Age-and sex-matched individuals who are not eligible for bariatric surgery, as an additional non-bariatric comparison group [N=60] *The 60 age-and sex-matched non-bariatric participants will have data captured just once [at baseline] on a limited number of key assessments</description> </arm_group> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> Samples retained include serum, urine, plasma, stool for high-throughput sequencing of 16SrRNA and metagenomic shotgun sequencing </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> A total of 120 adult patients (≥ 30y yrs.) scheduled to undergo a first bariatric surgery (i.e., no previous surgery-related disruption to the gut microbiota), along with 60 age-, sex-, and BMI-matched waitlist control group will be recruited from the bariatric surgery clinic at the CIUSSS du Nord-de-l'Île-de-Montréal, which conducts around 1,000 surgeries per year with a waitlist of approximately 1,000 individuals, with an average wait of 3 years.  Volunteers for the non-bariatric eligible individuals group [healthy control group] will be recruited using advertisements, recruitment materials will include a short description of the study and details of who is eligible to participate. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Age 30 years or older  - Indeviduals planning to be available for two years of follow-up  - Ability ro read and speak French or English  Exclusion Criteria:  - A previous bariatric surgery  - Using long-term antibiotics  - Using commercially available prebiotic/probiotic in the past month  - A history of significant intestinal disease/disorder that would influence the microbiome (e.g., Crohn's disease)  - A non-bariatric surgery in the 6 months before being recruited  - A diagnosed neurologic disorder or deficits (e.g., dementia, stroke, or seizures)  - A diagnosis of a severe axis 1 psychotic disorder (e.g., schizophrenia) or bipolar disorder  - A current infection or a diagnosed infectious disease  - Pregnacy or breast feeding  - Active cancer  - Advanced kidney disease  - Advanced liver disease  - Past organ transplantation  - Having any contraindications for undergoing MRI [i.e., having a cardiac pacemaker (or pacemaker), defibrillator (a heart rhythm device), heart valve prosthesis (a prosthesis in the heart), Swan-Ganz catheter (a tube in the pulmonary artery on the chest), metal insulin or chemotherapy pump under the skin, neurostimulator, brain aneurysm clip (a clip in a blood vessel of the brain), metal prosthesis or rods (following surgery), metal cerclage (metal support on a bone), cochlear or ocular implant (an implant in the ear or eye), penile implant, an intraocular metal fragment (metal debris in the eye), an intrauterine device that does not conform with the MRI, any plastic implants (e.g., breasts) or a patch on the skin for the administration of a medication unless it can remove before scan session]. Additional requirements for MRI includes patients agreement to: 1) have a pregnancy test and remove makeup, 2) the removal of dentures (full or partial), and 3) provide information on all surgery and previous tattoos (tattoos made for many years or those made in some countries, as the ink contains metallic particles).  - For participants included in the non-bariatric eligible comparison group group, individuals with any physician diagnosed major non-communicable chronic disease, defined as cardiovascular disease, chronic obstructive lung disease, cancer, diabetes, or obesity, will be excluded. </textblock> </criteria> <gender>All</gender> <minimum_age>30 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Simon Bacon, PhD</last_name> <role>Principal Investigator</role> <affiliation>Hopital du Sacre-Coeur de Montreal</affiliation> </overall_official> <location> <facility> <name>Hopital du Sacre-Coeur de Montreal</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H4J 1C5</zip> <country>Canada</country> </address> </facility> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>March 11, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 1, 2022</last_update_submitted> <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 3, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Hopital du Sacre-Coeur de Montreal</investigator_affiliation> <investigator_full_name>Simon Bacon</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>Bariatric surgery</keyword> <keyword>Microbiota</keyword> <keyword>Diet</keyword> <keyword>Cognition</keyword> <keyword>Brain structure</keyword> <condition_browse>  <mesh_term>Weight Loss</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Emerging evidence suggests that dietary and metabolic interventions could potentially target prevention and supportive therapies as well as treatments that may slow the clinical deterioration of neurodegenerative disorders. Though certain dietary patterns can impair specific cognitive domains, e.g., declines in reasoning and global cognition, there is still no consensus on the optimal diet to maintain brain health. Studies have also shown an association between the gut microbiome and neurocognition, as the microbiota can affect neuronal function through neurotransmitters and neuroactive microbial metabolites. Furthermore, studies indicate that diet may strongly influence the gut microbiota. However, the mechanisms for these complex relationships are still poorly understood. Bariatric procedures [i.e., weight loss surgeries] create a unique environment, in which a fast change in gut microbiota composition and dietary patterns occurs through surgery-induced intestinal and metabolic modifications, leading to changes in gut-brain communication. Interestingly, improvements in neurocognitive domains including memory and executive function have been reported post-bariatric surgery. However, there is large variability in these outcomes, indicating that the benefits are not universal. The goal of the current study is to explore the associations between dietary patterns and gut microbiota with cognition and brain structure, using bariatric surgery as an efficient naturalistic experimental design. This project will also explore potential mediators of diet-microbiome alterations as they relate to improvements in brain function and structure. A total of 120 adult patients (> 30y yrs.) scheduled to undergo a first bariatric surgery along with 60 age-, sex-, and BMI-matched waitlist control group will be recruited from the bariatric surgery clinic at the CIUSSS du Nord-de-l'Île-de-Montréal. These individuals will undergo assessments 3 months before surgery, as well as 6- and 12-months post-surgery, or an equivalent time for those on the waitlist. This study will also include 60 age-and sex-matched individuals who are not eligible for bariatric surgery as an additional healthy Canadian comparison group (only one assessment time point). Assessments taken during the data collection period will include: self-report information [e.g., sociodemographic and background information, health and diet behaviours]; information from medical records [e.g., medications usage, peri- and post-surgical complications, etc.]; physiological measures [i.e., blood, urine and fecal samples collection]; cognitive assessment [i.e., neuropsychological tests battery]; and brain imaging [i.e., structural MRI]. Collectively, this study is designed to provide critical information about potential individually targeted diet-based preventative strategies to reduce the development and progression of neurodegenerative disorders. Moreover, this project will explore potential mediators of diet-microbiome alterations as they relate to improvements in brain function and structure, and as such, it will provide essential information on key mechanisms, stimulating further research and the creation of parallel non-dietary therapeutic options. Dietary patterns are associated with cognitive function and brain morphology. Though certain dietary patterns can impair specific cognitive domains, e.g., declines in reasoning and global cognition, there is still no consensus on the optimal 'brain diet'. Studies have also shown an association between the gut microbiome and neurocognition. The microbiota can affect neuronal function through neurotransmitters and neuroactive microbial metabolites. Furthermore, studies indicate that diet may strongly influence the gut microbiota, likely via intestinal permeability and inflammation. However, the mechanisms for this complex relationship between diet, gut microbiome and cognition are still poorly understood. Most of the work to date has focused on the negative effects of a Western style diet, with its subsequent microbiota alterations leading to cognitive impairment, via reduced barrier integrity, increased neuroinflammation, and impaired insulin signaling. However, very little is known about positive dietary-microbiome interactions, especially in humans. Bariatric surgery is considered the most effective treatment for severe obesity and it's related comorbidities, with the Sleeve gastrectomy (SG) being the most commonly performed procedures worldwide. These procedures create a unique environment, in which a fast change in gut microbiota composition occurs through surgery-induced intestinal and metabolic modifications, leading to changes in gut-brain communication. Moreover, these same post-surgical alterations to the gastrointestinal tract are accompanied by profound changes in dietary patterns that, in turn, influence microbiota composition. Following bariatric surgery, dietary intake is altered both in quantity and quality; however, considerable individual variations in surgically-induced dietary patterns have been previously demonstrated. Interestingly, improvements in neurocognitive domains including memory and executive function have been reported post-bariatric surgery. However, there is large variability in these outcomes, indicating that the benefits are not universal. Additionally, the extant literature is limited by a small number of studies, meaning that the underling mechanisms remain unclear. Importantly, how bariatric surgery-induced modifications in both dietary patterns and the gut microbiome effect cognitive function have yet to be explored. Finally, the overall changes in the gut microbiome and diet post-surgery may enhance biological pathways (e.g., gut hormones, inflammation, and neuroactive metabolites) which can affect brain function and structure, but the nature of these changes have not been studied extensively. The EMBRACE trial (Evaluation the impact of radical nutrition and Microbiome changes on BRAin funCtion and structurE) is a prospective, 15-month longitudinal study that aims to elucidate the associations between dietary patterns and gut microbiota with cognition and brain structure, using an efficient naturalistic experimental design which causes major disruptions to both diet and the microbiome, i.e., bariatric surgery. The main goal of this study is to evaluate how changes in gut microbiota composition and dietary patterns from pre- to post-bariatric surgery are linked to improved cognition and brain structure over the medium-term (12-months post-surgery). This project also aims to explore the potential mediating biological (e.g., inflammatory markers, hormonal changes, altered micronutrients levels and neuroactive microbial metabolites) pathways which might explain these relationships. Primary aim: To evaluate the effect of surgery-induced changes in gut microbiota composition and dietary patterns from 3-M pre-surgery to 6-M post-surgery on 12-M post-surgical cognition, measured using sensitive neuropsychological tests. Secondary aim: To evaluate the effect of surgery-induced changes in gut microbiota composition and dietary patterns from 3-M pre-surgery to 6-M post-surgery on 12-M post-surgical brain structure measured with magnetic resonance imaging (MRI) to assess brain volume, white-matter hyperintensities and cortical thickness. Hypotheses for aims 1 and 2: Better quality microbiota and diet clusters (e.g., increased bacterial richness and diversity and greater low-saturated fat/high fibre intake) will be associated with increased performance on cognitive measures (higher total score on the neuropsychological test battery [primary] and its subscales [secondary]) and positive changes in brain measures (regional brain volume, hippocampal volume, cortical thickness and white-matter hyperintensities). Exploratory aim: To examine biological changes (e.g., inflammatory state, hormonal changes, altered micronutrients levels and neuroactive microbial metabolites) pre- to post-surgery as potential mediating factors between microbiota/diet changes and cognitive/brain measures. Outcome: We will explore what post-surgical biological measures (e.g., reduced inflammatory markers, lower leptin levels, etc.) might mediate or moderate the links between specific microbiota and diet clusters and changes in cognitive function and brain measures. A total of 120 adult patients (≥ 30y yrs.) scheduled to undergo a first bariatric surgery along with 60 age-, sex-, and BMI-matched waitlist control group will be recruited and undergo assessments 3 months before surgery, as well as 6- and 12-months post-surgery, or an equivalent time for those on the waitlist. This study will also include the recruitment of 60 age-and sex-matched individuals who are not eligible for bariatric surgery, as an additional non-bariatric comparison group. Evaluations will include standardized questionnaires on demographics, health behaviors and eating habits, physiological assessments (anthropometrics, inflammatory and blood-based measurements, 24-hour urine and fecal sample collection), cognitive assessment by neuropsychological tests, and structural magnetic resonance imaging (MRI). Cluster analyses of the dietary and microbial alterations will define the various dietary patterns and microbiome profiles, then using repeated-measures mixed models, their associations with global cognitive changes and structural brain alterations will be explored. Samples retained include serum, urine, plasma, stool for high-throughput sequencing of 16SrRNA and metagenomic shotgun sequencing A total of 120 adult patients (≥ 30y yrs.) scheduled to undergo a first bariatric surgery (i.e., no previous surgery-related disruption to the gut microbiota), along with 60 age-, sex-, and BMI-matched waitlist control group will be recruited from the bariatric surgery clinic at the CIUSSS du Nord-de-l'Île-de-Montréal, which conducts around 1,000 surgeries per year with a waitlist of approximately 1,000 individuals, with an average wait of 3 years. Volunteers for the non-bariatric eligible individuals group [healthy control group] will be recruited using advertisements, recruitment materials will include a short description of the study and details of who is eligible to participate. Inclusion Criteria: - Age 30 years or older - Indeviduals planning to be available for two years of follow-up - Ability ro read and speak French or English Exclusion Criteria: - A previous bariatric surgery - Using long-term antibiotics - Using commercially available prebiotic/probiotic in the past month - A history of significant intestinal disease/disorder that would influence the microbiome (e.g., Crohn's disease) - A non-bariatric surgery in the 6 months before being recruited - A diagnosed neurologic disorder or deficits (e.g., dementia, stroke, or seizures) - A diagnosis of a severe axis 1 psychotic disorder (e.g., schizophrenia) or bipolar disorder - A current infection or a diagnosed infectious disease - Pregnacy or breast feeding - Active cancer - Advanced kidney disease - Advanced liver disease - Past organ transplantation - Having any contraindications for undergoing MRI [i.e., having a cardiac pacemaker (or pacemaker), defibrillator (a heart rhythm device), heart valve prosthesis (a prosthesis in the heart), Swan-Ganz catheter (a tube in the pulmonary artery on the chest), metal insulin or chemotherapy pump under the skin, neurostimulator, brain aneurysm clip (a clip in a blood vessel of the brain), metal prosthesis or rods (following surgery), metal cerclage (metal support on a bone), cochlear or ocular implant (an implant in the ear or eye), penile implant, an intraocular metal fragment (metal debris in the eye), an intrauterine device that does not conform with the MRI, any plastic implants (e.g., breasts) or a patch on the skin for the administration of a medication unless it can remove before scan session]. Additional requirements for MRI includes patients agreement to: 1) have a pregnancy test and remove makeup, 2) the removal of dentures (full or partial), and 3) provide information on all surgery and previous tattoos (tattoos made for many years or those made in some countries, as the ink contains metallic particles). - For participants included in the non-bariatric eligible comparison group group, individuals with any physician diagnosed major non-communicable chronic disease, defined as cardiovascular disease, chronic obstructive lung disease, cancer, diabetes, or obesity, will be excluded.

NCT0531xxxx/NCT05318794.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/NCT05318794</url> </required_header> <id_info> <org_study_id>313621</org_study_id> <nct_id>NCT05318794</nct_id> </id_info> <brief_title>Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer</brief_title> <acronym>SPECTRA</acronym> <official_title>Neoadjuvant Systemic and Peritoneal Chemotherapy for Regionally Advanced Gastric Cancer With Minimal Peritoneal Disease</official_title> <sponsors> <lead_sponsor> <agency>Imperial College London</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Imperial College London</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> Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis.  Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile.  Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease). </textblock> </brief_summary> <detailed_description> <textblock> BACKGROUND:  There remains therefore an important, and as yet unmet, clinic need to improve survival of patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease.  To address this challenge, there has been emerging interest in the use of intraperitoneal chemotherapy for the treatment and suppression of peritoneal disease in patients with regionally advance gastric cancer.  HYPOTHESIS:  Use of combined neoadjuvant systemic chemotherapy and PIPAC in a highly selected group of patients with locally advanced gastric cancer (positive cytology and/or minimal peritoneal disease) is safe and will effectively eradicate all traces of peritoneal metastasis.  STUDY DESIGN:  This will be a non-randomised interventional cohort study of patients with regionally advanced gastric cancer (Tx, Nx) with either positive peritoneal cytology and/or minimal peritoneal disease (peritoneal carcinomatosis index, PCI ≤ 3). All patients will undergo complete cancer staging, including laparoscopy.  Prior to enrolment Potentially eligible patient will be reviewed by the Northwest London Upper Gastrointestinal Cancer Multidisciplinary Team. Study recruitment will also be open to eligible patients referred from other regional cancer networks within England. Study recruitment will also be open to eligible patients referred from other regional cancer networks within England.  Eligible patients will receive systemic chemotherapy (in accordance with local protocols) and PIPAC (Doxorubicin 1.5 mg/m2 body surface area Cisplatin 7.5 mg/m2 body surface area). Patients will receive three cycles of systemic chemotherapy interposed with three PIPAC sessions. Chemotherapy cycles will be occur at six weekly intervals.  Following completion of neoadjuvant systemic chemotherapy and PIPAC patients will be restaged. Patients will be considered eligible for D2 radical gastrectomy if the following conditions are met:  (i) negative peritoneal cytology; (ii) absence of macroscopic peritoneal metastasis (PCI 0); (iii) absence of solid organ metastasis (for T4b disease please see point iv below); (iv) expectation of complete (R0) resection of primary tumour; (v) patient considered medically fit for gastrectomy (performance status ≤ 1, absence of organ failure or uncontrolled co-morbidity), and; (vi) provision of informed written consent for treatment (surgery)  Patients who do not meet these criteria will be offered continued palliative and/or best supportive care. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">November 2023</start_date> <completion_date type="Anticipated">July 2030</completion_date> <primary_completion_date type="Anticipated">July 2025</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>Feasibility and safety of combined neoadjuvant systemic chemotherapy and pressurised intraperitoneal aerosol chemotherapy (PIPAC)</measure> <time_frame>2 years</time_frame> <description>Barrier and mitigating factors or the provision of combined neoadjuvant systemic chemotherapy and PIPAC will be assessed. Safety of this intervention in terms of risks to patients and staff will also be evaluated.</description> </primary_outcome> <secondary_outcome> <measure>Tumour regression</measure> <time_frame>2 years</time_frame> <description>Regression of peritoneal tumour deposits and/or positive peritoneal cytology. Regression will be assesses visually at the time of laparoscopy, by appropriate cross sectional imaging and through histological assessment of acquired samples.</description> </secondary_outcome> <secondary_outcome> <measure>Patient morbidity</measure> <time_frame>2 years</time_frame> <description>Common Toxicity Criteria and Common Terminology Criteria for Adverse Events (Ver. 5) will be used to grade any complications that occur as a consequence of systemic chemotherapy and PIPAC administration. Surgical complications will reported using standard terminologies and graded using the Clavien-Dindo system.</description> </secondary_outcome> <secondary_outcome> <measure>Health related quality of life</measure> <time_frame>2 years</time_frame> <description>Health related quality of life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) generic questionnaire QLQ-C30 (version 3.0).</description> </secondary_outcome> <secondary_outcome> <measure>Disease recurrence and survival</measure> <time_frame>5 years</time_frame> <description>Peritoneal disease recurrence (assessed by conventional methods), overall and disease-free survival following radical gastrectomy.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Gastric Cancer</condition> <condition>Peritoneal Metastases</condition> <condition>Chemotherapy Effect</condition> <arm_group> <arm_group_label>Neoadjuvant systemic and peritoneal chemotherapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Standard neoadjuvant systemic and pressurised intraperitoneal aerosol chemotherapy</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Doxorubicin and Cisplatin</intervention_name> <description>Pressurised intraperitoneal aerosol chemotherapy</description> <arm_group_label>Neoadjuvant systemic and peritoneal chemotherapy</arm_group_label> <other_name>Adriamycin</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Gastric adenocarcinoma (Tx, Nx) 1,2,3  - Peritoneal cytology +ve or PCI ≤ 3  - No solid organ metastasis 2  - HER2 -ve  - Male/female  - Treatment naïve  - BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2  - WHO performance status ≤ 1  - Dysphagia score ≤ 2  - Informed written consent  Exclusion Criteria:  - PCI ≥ 4  - Solid organ metastasis  - Positive lymph node disease beyond field of D2 lymphadenectomy  - Peritoneal adhesions precluding complete laparoscopy  - Ascites (greater than trace amount)  - Malignant pleural effusion  - Mechanical bowel obstruction (with the exception of gastric outlet obstruction)  - HER2 +ve  - Patients eligible for immunotherapy  - Uncontrolled co-morbidity  - single/multiple organ failure  - BMI < 18.5 kg/m2 or > 40 kg/m2  - WHO performance status > 1  - Dysphagia score > 2  - Contraindication to chemotherapy  - Pregnancy or breastfeeding  - Haemoglobin <90 g/dL uncorrected with blood transfusion </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>George B Hanna, FRCS, PhD</last_name> <role>Principal Investigator</role> <affiliation>Imperial College London</affiliation> </overall_official> <overall_contact> <last_name>Piers R Boshier, FRCS, PhD</last_name> <phone>020 7594 8197</phone> <email>prb03@ic.ac.uk</email> </overall_contact> <location> <facility> <name>Imperial College London, Hammersmith Hospital Campus</name> <address> <city>London</city> <zip>W12 0HS</zip> <country>United Kingdom</country> </address> </facility> <contact> <last_name>George B Hanna, FRCS, PhD</last_name> <phone>020 7594 8197</phone> <email>g.hanna@imperial.ac.uk</email> </contact> <contact_backup> <last_name>Piers R Boshier, FRCS, PhD</last_name> <phone>020 7594 8197</phone> <email>prb03@ic.ac.uk</email> </contact_backup> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>March 17, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>September 12, 2023</last_update_submitted> <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Pressurised intraperitoneal aerosol chemotherapy</keyword> <keyword>PIPAC</keyword> <keyword>Neoadjuvant therapy</keyword> <keyword>Gastrectomy</keyword> <keyword>Curative</keyword> <keyword>Doxorubicin</keyword> <keyword>Cisplatin</keyword> <condition_browse>  <mesh_term>Stomach Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Doxorubicin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis. Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile. Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease). BACKGROUND: There remains therefore an important, and as yet unmet, clinic need to improve survival of patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease. To address this challenge, there has been emerging interest in the use of intraperitoneal chemotherapy for the treatment and suppression of peritoneal disease in patients with regionally advance gastric cancer. HYPOTHESIS: Use of combined neoadjuvant systemic chemotherapy and PIPAC in a highly selected group of patients with locally advanced gastric cancer (positive cytology and/or minimal peritoneal disease) is safe and will effectively eradicate all traces of peritoneal metastasis. STUDY DESIGN: This will be a non-randomised interventional cohort study of patients with regionally advanced gastric cancer (Tx, Nx) with either positive peritoneal cytology and/or minimal peritoneal disease (peritoneal carcinomatosis index, PCI ≤ 3). All patients will undergo complete cancer staging, including laparoscopy. Prior to enrolment Potentially eligible patient will be reviewed by the Northwest London Upper Gastrointestinal Cancer Multidisciplinary Team. Study recruitment will also be open to eligible patients referred from other regional cancer networks within England. Study recruitment will also be open to eligible patients referred from other regional cancer networks within England. Eligible patients will receive systemic chemotherapy (in accordance with local protocols) and PIPAC (Doxorubicin 1.5 mg/m2 body surface area Cisplatin 7.5 mg/m2 body surface area). Patients will receive three cycles of systemic chemotherapy interposed with three PIPAC sessions. Chemotherapy cycles will be occur at six weekly intervals. Following completion of neoadjuvant systemic chemotherapy and PIPAC patients will be restaged. Patients will be considered eligible for D2 radical gastrectomy if the following conditions are met: (i) negative peritoneal cytology; (ii) absence of macroscopic peritoneal metastasis (PCI 0); (iii) absence of solid organ metastasis (for T4b disease please see point iv below); (iv) expectation of complete (R0) resection of primary tumour; (v) patient considered medically fit for gastrectomy (performance status ≤ 1, absence of organ failure or uncontrolled co-morbidity), and; (vi) provision of informed written consent for treatment (surgery) Patients who do not meet these criteria will be offered continued palliative and/or best supportive care. Inclusion Criteria: - Gastric adenocarcinoma (Tx, Nx) 1,2,3 - Peritoneal cytology +ve or PCI ≤ 3 - No solid organ metastasis 2 - HER2 -ve - Male/female - Treatment naïve - BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2 - WHO performance status ≤ 1 - Dysphagia score ≤ 2 - Informed written consent Exclusion Criteria: - PCI ≥ 4 - Solid organ metastasis - Positive lymph node disease beyond field of D2 lymphadenectomy - Peritoneal adhesions precluding complete laparoscopy - Ascites (greater than trace amount) - Malignant pleural effusion - Mechanical bowel obstruction (with the exception of gastric outlet obstruction) - HER2 +ve - Patients eligible for immunotherapy - Uncontrolled co-morbidity - single/multiple organ failure - BMI < 18.5 kg/m2 or > 40 kg/m2 - WHO performance status > 1 - Dysphagia score > 2 - Contraindication to chemotherapy - Pregnancy or breastfeeding - Haemoglobin <90 g/dL uncorrected with blood transfusion

NCT0531xxxx/NCT05318807.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/NCT05318807</url> </required_header> <id_info> <org_study_id>22CX7570</org_study_id> <nct_id>NCT05318807</nct_id> </id_info> <brief_title>Personalised Diet, Exercise and Emotional Support for Lung Cancer Patients Having Chemotherapy, Radiotherapy or Immunotherapy Treatment</brief_title> <official_title>A Personalised Prehabilitation Model for Patients Undergoing Chemotherapy, Radiotherapy and/or Immunotherapy Treatment for Lung Cancer: A Feasibility Pilot Study</official_title> <sponsors> <lead_sponsor> <agency>Imperial College Healthcare NHS Trust</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Imperial College Healthcare NHS Trust</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> Background  The term 'prehabilitation' refers to a period of time before treatment and often includes diet, exercise and/or wellbeing plans to help patients through their cancer treatment. Prehabilitation has shown to benefit patients having surgery, but there is little research into its use in the oncological setting.  The United Kingdom sees more deaths from lung cancer than any other cancer. 70-80% of lung cancer patients receive oncological treatment. Treatment side effects can have a significant impact on quality of life. Personalised prehabilitation can take into account the challenges patients face, helping patients through treatment.  Aim  To see if a personalised plan of diet, exercise and emotional support can be used in practice for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer.  Methods  The study will involve lung cancer patients from Imperial College Healthcare NHS Trust who are:  - Over the age of 18 years old  - Have not had previous lung cancer surgery and  - Are about to start chemotherapy, radiotherapy or immunotherapy treatment  The prehabilitation interventions will be based upon patient need and readiness, assessed using:  - A series of questionnaires  - An assessment of walking  - A measure of grip strength  These will be done prior to, at week three and at week six of a patient's oncological treatment regime. Personalised goals will be agreed at each stage.  Throughout treatment, patients will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood. The diary will also be used to monitor goal adherence.  Public involvement  Patients will be part of a study advisory group, helping with research design and dissemination e.g. with the presentation of findings to the lung cancer support group.  Dissemination  All patients will receive a written summary of findings. Results will be shared in a scientific journal and presented at relevant conferences. Patients will not be identifiable. </textblock> </brief_summary> <detailed_description> <textblock> Background  Prehabilitation programmes are increasingly used before surgery to optimise outcomes. However, 55% of patients are treated non-surgically with oncological treatment. Prehabilitation has potential to increase resilience to withstand anticipated treatment deconditioning, but few prehabilitation pathways exist in the non-surgical field.  This is particularly the case for lung cancer, where 70-80% of patients have non-surgical treatment without access to prehabilitation. United Kingdom deaths from lung cancer are higher than any other cancer and outcomes are poor, highlighting an unmet need.  Study design  This is a study to assess if a personalised plan of diet, exercise and emotional support can be used in practice for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer.  To tackle the unmet need within the field of lung cancer, I have co-designed a personalised prehabilitation model with healthcare professionals and patients, informed by theory and evidence. It embodies personalised care with interventions stratified according to need and readiness. However, before I can trial it with lung cancer patients, there are key uncertainties that need to be resolved, including whether patients will sign up, engage and adhere to the prehabilitation interventions.  Methods  The study will involve lung cancer patients from Imperial College Healthcare National Health Service (NHS) Trust who are:  - Over the age of 18 years old  - Have not had previous lung cancer surgery and  - Are about to start chemotherapy or radiotherapy treatment  Patients will be identified by a member of their direct clinical care team, which will be either their lung consultant or their Clinical Nurse Specialist (CNS) from the weekly lung cancer meeting and a referral will be sent to the research team.  A sample size of 30 patients over a 6-month recruitment period is suitable within the time frame of this study and is based upon a recommend sample size of 24 - 50 for a pilot study.  Each patient will receive a patient information sheet either in person or electronically via email depending on their preference. If they agree to participate, they will be asked to complete a written consent form either in person or via email using their personal computer. Following consent, each patient will be asked to complete five validated questionnaires, either on paper or online. The five questionnaires will take approximately 30 minutes to complete. These five questionnaires will be used to assess a patient's level of readiness and need.  Each patient will then be invited to see a specialist dietitian for a separate one hour face-to-face personalised prehabilitation appointment at Charing Cross Hospital to:  - Review the initial questionnaires  - Complete a further four validated questionnaires related to quality of life, diet and activity (= 9 questionnaires in total)  - Measure grip strength. This will involve a patient sitting in a chair. The dietitian will ask the patient to squeeze the device as hard as they can using their non-dominant arm. Each patient will repeat this three times and the dietitian will record the average  - Undergo an assessment of walking. This will involve a patient walking at their own pace as far as they can in 6 minutes  The above assessments will then be repeated at week three and week six of a patients oncological treatment regime. Personalised goals will be agreed at each stage.  Owing to the nature of the above appointments and the need for measurements to be taken, a virtual consultation would not be practical.  Throughout treatment, patients will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood. The diary will be given to patients by the research team at the start for the duration of the study. The research team will not need these to be sent back to them. Patients will receive a weekly telephone call to see how they are getting on. The language used during the phone calls and the face to face consultations is effective for building self-efficacy and to sustain behaviour change. Validation and compassion is at the core.  The personalised prehabilitation model is in line with the Macmillan universal, targeted and specialist approach for prehabilitation. All patients will receive universal interventions which involve signposting for support and/or information on emotional support, nutrition and/or exercise as required. If a patient identifies an emotional, nutritional and/or exercise need, they will then receive the appropriate intervention according to their level of need and readiness.  All patients who participate in the study will be offered the opportunity to provide feedback on their experience of the personalised prehabilitation model via the use of a short free text questionnaire. This feedback will be invaluable, as it will help inform future model adjustments and will have the potential to improve patient experience.  All patients will be given a unique study number that will be used from the start of the study. All data will be stored stored securely in accordance with the Trust policy on either a Trust computer, password protected, or under lock and key. Patient data will not be shared with parties outside of the patient's direct clinical care team or local research team.  The data will be analysed by the research team and all patients will receive a written summary of the findings. The results will be also be shared in scientific journals and conferences, so that others can learn from this as well. Patients will not be identifiable from any report or publication. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 28, 2022</start_date> <completion_date type="Anticipated">September 1, 2023</completion_date> <primary_completion_date type="Anticipated">June 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>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Feasibility pilot study</intervention_model_description> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Feasible eligibility, recruitment and refusal rates</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of descriptive statistics - number approached, eligible, recruited, refused</description> </primary_outcome> <primary_outcome> <measure>How many participants do not participate in the personalised prehabilitation programme and explore the reasons why</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of descriptive statistics, field notes taken during the Lung Cancer Multi-Disciplinary Team (LCMDT) and participant discussion</description> </primary_outcome> <primary_outcome> <measure>Number of participants who are not suitable for the personalised prehabilitation programme and the reasons why</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of descriptive statistics and field notes taken during the LCMDT, where discussions of eligibility will take place</description> </primary_outcome> <primary_outcome> <measure>Attrition rate throughout the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of descriptive statistics - number who drop out and at what stage</description> </primary_outcome> <primary_outcome> <measure>Number of participants who adhere to the goals set for the personalised prehabilitation interventions</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Adherence to goals set measured through participant discussion at the weekly telephone consultations</description> </primary_outcome> <primary_outcome> <measure>Barriers and facilitators to adherence and intervention fidelity</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of the emotion thermometer questionnaire used for the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of the modified Godin leisure time exercise questionnaire used for the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of the patient generated subjective global assessment questionnaire used for the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of the patient activation measure questionnaire used for the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of the cancer behaviour inventory questionnaire used for the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of the patient generated index used for the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of measuring body weight in kilograms for the personalised prehabilitation progamme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of measuring functional capacity by the distance covered in meters using the six minute walk test as part of the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of participant acceptability of measuring grip strength in kilograms using a handgrip dynamometer as part of the personalised prehabilitation programme</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of contextual or implementation factors which may influence acceptability of the intervention/s</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations; participant reflection, participant needs and priorities, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Evaluation of contextual or implementation factors which may influence effectiveness of the intervention/s</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations; participant reflection, participant needs and priorities, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>The 'prehabilitation window' (length of time between diagnosis and the start of treatment)</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of descriptive statistics - date of diagnosis, date of start of treatment, date of start and finish of prehabilitation</description> </primary_outcome> <primary_outcome> <measure>The extent to which the prehabilitation programme has had an impact on psychological wellbeing</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of the emotional thermometer questionnaire which will be used to assess psychological wellbeing - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>The extent to which the prehabilitation programme has had an impact on nutrition</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of the Patient Generated Subjective Global Assessment (PG-SGA) tool which will be used to assess nutritional status - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>The extent to which the prehabilitation programme has had an impact on physical activity</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of the Modified Godin leisure time exercise questionnaire which will be used to assess physical activity - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically</description> </primary_outcome> <primary_outcome> <measure>Number of participants who require universal, targeted and specialist intervention</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Use of questionnaires to assess level of need and readiness and descriptive statistics</description> </primary_outcome> <secondary_outcome> <measure>Quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 questionnaire</measure> <time_frame>Baseline; pre-treatment, during treatment and immediately after treatment</time_frame> <description>Incidence of change between baseline and immediately after treatment assessed by any differences in the EORTC questionnaire</description> </secondary_outcome> <secondary_outcome> <measure>Quality of life assessed using the EuroQOL Group EQ-5D-5L questionnaire</measure> <time_frame>Baseline; pre-treatment, during treatment and immediately after treatment</time_frame> <description>Incidence of change between baseline and immediately after treatment assessed by any differences in the EQ-5D-5L questionnaire</description> </secondary_outcome> <secondary_outcome> <measure>Patient experience</measure> <time_frame>Immediately after week six of oncological treatment</time_frame> <description>Assessed via a short free text questionnaire. Patients will be able to openly give written feedback on their experience and offer any comments or suggestions</description> </secondary_outcome> <secondary_outcome> <measure>Functional capacity</measure> <time_frame>Baseline; pre-treatment, during treatment and immediately after treatment</time_frame> <description>Assessed by patients undertaking a six minute walk test</description> </secondary_outcome> <secondary_outcome> <measure>Handgrip strength</measure> <time_frame>Baseline; pre-treatment, during treatment and immediately after treatment</time_frame> <description>Assessed using a handgrip dynamometer to measure grip strength</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Lung Cancer</condition> <arm_group> <arm_group_label>Personalised prehabilitation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>A personalised plan of diet, exercise and emotional support for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Assessment of level of readiness and need for personalised prehabilitation</intervention_name> <description>Patients asked to complete five validated questionnaires to assess their level of need and readiness: Cancer Behaviour Inventory brief form - to measure self-efficacy for coping with cancer Patient Activation Measure - to measure patient activation Modified Godin Leisure Time Exercise Questionnaire - to monitor activity Patient Generated Subjective Global Assessment - to identify malnutrition risk Emotions thermometer - to detect emotional disorders and identify risk</description> <arm_group_label>Personalised prehabilitation</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Formation of a personalised prehabilitation plan</intervention_name> <description>Prior to starting treatment, at week three and at week six, each patient will be invited to see a specialist dietitian for a one hour face-to-face personalised prehabilitation appointment to: Review the initial questionnaires to inform the personalised plan and goal setting Complete a further four questionnaires related to quality of life, diet and exercise Measure handgrip strength Assess functional capacity by completing the six minute walk test A personalised plan is then agreed using SMART goals, taking into account the patient's priorities as indicated in their Patient Generated Index.</description> <arm_group_label>Personalised prehabilitation</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Daily diary</intervention_name> <description>Each patient will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood throughout their treatment as well as their adherence to goals. This will provide an indication of the impact of symptoms.</description> <arm_group_label>Personalised prehabilitation</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adults (aged ≥ 18 years) diagnosed with lung cancer  - Able to give informed consent  - Due to embark on a chemotherapy, radiotherapy and/or immunotherapy treatment pathway  Exclusion Criteria:  - On a surgical pathway  - Have had previous lung cancer surgery  - Unable to understand verbal or written English  - Unable to give informed consent </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>99 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Kelly Wade-Mcbane</last_name> <role>Principal Investigator</role> <affiliation>Imperial College Healthcare NHS Trust</affiliation> </overall_official> <overall_contact> <last_name>Kelly Wade-Mcbane</last_name> <phone>0203 311 7135</phone> <email>k.wade-mcbane@nhs.net</email> </overall_contact> <location> <facility> <name>Imperial College Healthcare NHS Trust</name> <address> <city>London</city> <zip>W6 8RF</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kelly Wade-Mcbane</last_name> <phone>0203 311 7135</phone> <email>k.wade-mcbane@nhs.net</email> </contact> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 27, 2023</last_update_submitted> <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 1, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>prehabilitation</keyword> <keyword>radiotherapy</keyword> <keyword>chemotherapy</keyword> <keyword>feasibility</keyword> <keyword>immunotherapy</keyword> <keyword>nutrition</keyword> <keyword>physical activity</keyword> <keyword>psychological wellbeing</keyword> <condition_browse>  <mesh_term>Lung Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>All participants will be given a unique study number that will be used from the start of the study. Files (e.g. paper consent forms and questionnaires) will be stored in research offices and secured by either lock and key or key code and accessible by only departmental staff or the Trust's security department. Personal data (e.g. patient demographics and results of assessments) will be retained and stored on a networked and password protected NHS computer. Patient data will not be shared with parties outside of the patient's direct clinical care team or local research team. Stored data will be pseudonymised at the time of collection/storage. Data will be collected according to the data protection act 2018 and in line with general data Protection regulation GDPR). Results will be shared in a scientific journal and presented at relevant conferences. Patients will not be identifiable.</ipd_description> </patient_data>  </clinical_study>

Background The term 'prehabilitation' refers to a period of time before treatment and often includes diet, exercise and/or wellbeing plans to help patients through their cancer treatment. Prehabilitation has shown to benefit patients having surgery, but there is little research into its use in the oncological setting. The United Kingdom sees more deaths from lung cancer than any other cancer. 70-80% of lung cancer patients receive oncological treatment. Treatment side effects can have a significant impact on quality of life. Personalised prehabilitation can take into account the challenges patients face, helping patients through treatment. Aim To see if a personalised plan of diet, exercise and emotional support can be used in practice for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer. Methods The study will involve lung cancer patients from Imperial College Healthcare NHS Trust who are: - Over the age of 18 years old - Have not had previous lung cancer surgery and - Are about to start chemotherapy, radiotherapy or immunotherapy treatment The prehabilitation interventions will be based upon patient need and readiness, assessed using: - A series of questionnaires - An assessment of walking - A measure of grip strength These will be done prior to, at week three and at week six of a patient's oncological treatment regime. Personalised goals will be agreed at each stage. Throughout treatment, patients will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood. The diary will also be used to monitor goal adherence. Public involvement Patients will be part of a study advisory group, helping with research design and dissemination e.g. with the presentation of findings to the lung cancer support group. Dissemination All patients will receive a written summary of findings. Results will be shared in a scientific journal and presented at relevant conferences. Patients will not be identifiable. Background Prehabilitation programmes are increasingly used before surgery to optimise outcomes. However, 55% of patients are treated non-surgically with oncological treatment. Prehabilitation has potential to increase resilience to withstand anticipated treatment deconditioning, but few prehabilitation pathways exist in the non-surgical field. This is particularly the case for lung cancer, where 70-80% of patients have non-surgical treatment without access to prehabilitation. United Kingdom deaths from lung cancer are higher than any other cancer and outcomes are poor, highlighting an unmet need. Study design This is a study to assess if a personalised plan of diet, exercise and emotional support can be used in practice for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer. To tackle the unmet need within the field of lung cancer, I have co-designed a personalised prehabilitation model with healthcare professionals and patients, informed by theory and evidence. It embodies personalised care with interventions stratified according to need and readiness. However, before I can trial it with lung cancer patients, there are key uncertainties that need to be resolved, including whether patients will sign up, engage and adhere to the prehabilitation interventions. Methods The study will involve lung cancer patients from Imperial College Healthcare National Health Service (NHS) Trust who are: - Over the age of 18 years old - Have not had previous lung cancer surgery and - Are about to start chemotherapy or radiotherapy treatment Patients will be identified by a member of their direct clinical care team, which will be either their lung consultant or their Clinical Nurse Specialist (CNS) from the weekly lung cancer meeting and a referral will be sent to the research team. A sample size of 30 patients over a 6-month recruitment period is suitable within the time frame of this study and is based upon a recommend sample size of 24 - 50 for a pilot study. Each patient will receive a patient information sheet either in person or electronically via email depending on their preference. If they agree to participate, they will be asked to complete a written consent form either in person or via email using their personal computer. Following consent, each patient will be asked to complete five validated questionnaires, either on paper or online. The five questionnaires will take approximately 30 minutes to complete. These five questionnaires will be used to assess a patient's level of readiness and need. Each patient will then be invited to see a specialist dietitian for a separate one hour face-to-face personalised prehabilitation appointment at Charing Cross Hospital to: - Review the initial questionnaires - Complete a further four validated questionnaires related to quality of life, diet and activity (= 9 questionnaires in total) - Measure grip strength. This will involve a patient sitting in a chair. The dietitian will ask the patient to squeeze the device as hard as they can using their non-dominant arm. Each patient will repeat this three times and the dietitian will record the average - Undergo an assessment of walking. This will involve a patient walking at their own pace as far as they can in 6 minutes The above assessments will then be repeated at week three and week six of a patients oncological treatment regime. Personalised goals will be agreed at each stage. Owing to the nature of the above appointments and the need for measurements to be taken, a virtual consultation would not be practical. Throughout treatment, patients will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood. The diary will be given to patients by the research team at the start for the duration of the study. The research team will not need these to be sent back to them. Patients will receive a weekly telephone call to see how they are getting on. The language used during the phone calls and the face to face consultations is effective for building self-efficacy and to sustain behaviour change. Validation and compassion is at the core. The personalised prehabilitation model is in line with the Macmillan universal, targeted and specialist approach for prehabilitation. All patients will receive universal interventions which involve signposting for support and/or information on emotional support, nutrition and/or exercise as required. If a patient identifies an emotional, nutritional and/or exercise need, they will then receive the appropriate intervention according to their level of need and readiness. All patients who participate in the study will be offered the opportunity to provide feedback on their experience of the personalised prehabilitation model via the use of a short free text questionnaire. This feedback will be invaluable, as it will help inform future model adjustments and will have the potential to improve patient experience. All patients will be given a unique study number that will be used from the start of the study. All data will be stored stored securely in accordance with the Trust policy on either a Trust computer, password protected, or under lock and key. Patient data will not be shared with parties outside of the patient's direct clinical care team or local research team. The data will be analysed by the research team and all patients will receive a written summary of the findings. The results will be also be shared in scientific journals and conferences, so that others can learn from this as well. Patients will not be identifiable from any report or publication. Inclusion Criteria: - Adults (aged ≥ 18 years) diagnosed with lung cancer - Able to give informed consent - Due to embark on a chemotherapy, radiotherapy and/or immunotherapy treatment pathway Exclusion Criteria: - On a surgical pathway - Have had previous lung cancer surgery - Unable to understand verbal or written English - Unable to give informed consent

NCT0531xxxx/NCT05318820.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/NCT05318820</url> </required_header> <id_info> <org_study_id>2021-523-00CH1</org_study_id> <nct_id>NCT05318820</nct_id> </id_info> <brief_title>A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers</brief_title> <official_title>A Phase I Monocentric, Open-label, Randomized, Crossover Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers in Healthy Chinese Subjects</official_title> <sponsors> <lead_sponsor> <agency>Hutchison Medipharma Limited</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Hutchmed</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 monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. </textblock> </brief_summary> <detailed_description> <textblock> This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).  The study includes three periods expected to last for 2 months: screening period, treatment period (for three cycles), and follow-up period </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Actual">September 30, 2022</completion_date> <primary_completion_date type="Actual">July 31, 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>Crossover Assignment</intervention_model> <intervention_model_description>This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>maximum plasma concentration (Cmax)</measure> <time_frame>through study completion, an average of 2 months</time_frame> <description>To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects</description> </primary_outcome> <primary_outcome> <measure>time to maximum plasma concentration (Tmax)</measure> <time_frame>Time Frame: through study completion, an average of 2 months</time_frame> <description>To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects</description> </primary_outcome> <primary_outcome> <measure>terminal elimination half-life (t1/2)</measure> <time_frame>through study completion, an average of 2 months</time_frame> <description>To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects</description> </primary_outcome> <primary_outcome> <measure>Area under plasma drug concentration-time curve (AUC0-t, AUC0-∞)</measure> <time_frame>through study completion, an average of 2 months</time_frame> <description>To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects</description> </primary_outcome> <secondary_outcome> <measure>Ratio between AUCs of two HMPL-523 Tablets</measure> <time_frame>through study completion, an average of 2 months</time_frame> <description>To compare the relative bioavailability of HMPL-523 Tablet 300 mg (100 mg/tablet ×3) produced by two different manufacturers</description> </secondary_outcome> <secondary_outcome> <measure>safety information/AE,SAE</measure> <time_frame>through study completion, an average of 2 months</time_frame> <description>To observe the safety of HMPL-523 Tablet 300 mg (100 mg/tablet ×3) taken orally in a single dose after a standard meal in healthy Chinese subjects</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">39</enrollment> <condition>Healthy Subject</condition> <arm_group> <arm_group_label>HMPL-523-TRR</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Three cycle dose: TRR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA</description> </arm_group> <arm_group> <arm_group_label>HMPL-523-RTR</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Three cycle dose:RTR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA</description> </arm_group> <arm_group> <arm_group_label>HMPL-523-RRT</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Three cycle dose:RRT Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>HMPL-523</intervention_name> <description>This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).</description> <arm_group_label>HMPL-523-RRT</arm_group_label> <arm_group_label>HMPL-523-RTR</arm_group_label> <arm_group_label>HMPL-523-TRR</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Subjects can communicate well with investigators, must be voluntary and sign the ICF, and agree to comply with the requirements in the study protocol;  2. Healthy male and female subjects aged 18-55 years (inclusive);  3. Weight ≥50 kg, Body Mass Index (BMI) between 19-26 kg/m2 (inclusive);  4. Subjects with good health condition  5. Subjects of childbearing potential must promise to use reliable contraceptive measures.  Exclusion Criteria:  1. History or clinical characterization of clinically significant metabolic/endocrine, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric diseases within 3 months prior to the screening period and in the screening period (judged by investigators);  2. creatinine clearance estimated using Cockcroft-Gault formula [(140-age) × body weight (kg) × gender correction factor] /[0.818×Scr (umol/L)] (male: 1.00, female: 0.85) < 80 mL/min;  3. History of gastrointestinal surgery, kidney surgery, cholecystectomy and other surgeries that might affect drug absorption or excretion judged by the investigator;  4. History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy, in particular allergy to the active ingredient or excipient of study drug, within two weeks prior to screening;  5. Previous history of hypertension;  6. Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;  7. Female subjects who have a positive pregnancy test;  8. Subjects who smoked >10 cigarettes per day within 3 months prior to screening, or are unable to quit smoking completely during the study;  9. Subjects who drank on a regular basis within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);  10. Subjects with drug abuse (including but not limited to Morphine, 3,4-methylenedioxy-methamphetamine (MDMA), methamphetamine, tetrahydrocannabinolic acid, Ketamine, Cocaine or subjects whose urine drug abuse screen showed positive);  11. Use of blood products within 2 months before screening; donation of blood (including blood component) or loss of blood ≥400 mL within 3 months prior to screening, ≥200 mL within 1 month prior to screening, or plan to donate blood or blood component during the study or within 1 month after end of the study;  12. Subjects who have a fear of needles, hemophobia or whose venous blood is hard to collect;  13. Positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody;  14. Use of any prescription drug and Chinese herbal tonic within 30 days prior to the first dose;  15. Use of any over-the-counter drug (including but not limited to vitamins, prophylactic treatments, plant health products, etc.) within 14 days prior to the first dose;  16. Having participated in clinical trials for other drugs/medical devices within 3 months prior to screening;  17. Having consumed foods, juices and beverages containing alcohol, grapefruit, bigarade and caffeine within 72 hours prior to the first dose;  18. Subjects vaccinated with a live-attenuated vaccine within 8 weeks prior to screening or planning to get vaccinated during participation of this clinical trial;  19. Previous history of serious gastrointestinal disease, such as dysphagia, active gastric ulcer, inability to take drugs orally or absorption disorder for oral drugs;  20. Subjects who have special requirements for diet and cannot comply with uniform diet;  21. Lactating female subjects;  22. According to the investigator's judgment, the subjects had any other disease or status that might affect the normal completion of the study or the evaluation of the study data, or had any other condition that was not suitable for the study. </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>Jingying Jia</last_name> <role>Principal Investigator</role> <affiliation>Shanghai Xuhui Central Hospital</affiliation> </overall_official> <location> <facility> <name>Shanghai Xuhui Central Hospital</name> <address> <city>Shanghai</city> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 9, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 24, 2023</last_update_submitted> <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 25, 2023</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>

This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA). The study includes three periods expected to last for 2 months: screening period, treatment period (for three cycles), and follow-up period Inclusion Criteria: 1. Subjects can communicate well with investigators, must be voluntary and sign the ICF, and agree to comply with the requirements in the study protocol; 2. Healthy male and female subjects aged 18-55 years (inclusive); 3. Weight ≥50 kg, Body Mass Index (BMI) between 19-26 kg/m2 (inclusive); 4. Subjects with good health condition 5. Subjects of childbearing potential must promise to use reliable contraceptive measures. Exclusion Criteria: 1. History or clinical characterization of clinically significant metabolic/endocrine, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric diseases within 3 months prior to the screening period and in the screening period (judged by investigators); 2. creatinine clearance estimated using Cockcroft-Gault formula [(140-age) × body weight (kg) × gender correction factor] /[0.818×Scr (umol/L)] (male: 1.00, female: 0.85) < 80 mL/min; 3. History of gastrointestinal surgery, kidney surgery, cholecystectomy and other surgeries that might affect drug absorption or excretion judged by the investigator; 4. History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy, in particular allergy to the active ingredient or excipient of study drug, within two weeks prior to screening; 5. Previous history of hypertension; 6. Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg; 7. Female subjects who have a positive pregnancy test; 8. Subjects who smoked >10 cigarettes per day within 3 months prior to screening, or are unable to quit smoking completely during the study; 9. Subjects who drank on a regular basis within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine); 10. Subjects with drug abuse (including but not limited to Morphine, 3,4-methylenedioxy-methamphetamine (MDMA), methamphetamine, tetrahydrocannabinolic acid, Ketamine, Cocaine or subjects whose urine drug abuse screen showed positive); 11. Use of blood products within 2 months before screening; donation of blood (including blood component) or loss of blood ≥400 mL within 3 months prior to screening, ≥200 mL within 1 month prior to screening, or plan to donate blood or blood component during the study or within 1 month after end of the study; 12. Subjects who have a fear of needles, hemophobia or whose venous blood is hard to collect; 13. Positive test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody; 14. Use of any prescription drug and Chinese herbal tonic within 30 days prior to the first dose; 15. Use of any over-the-counter drug (including but not limited to vitamins, prophylactic treatments, plant health products, etc.) within 14 days prior to the first dose; 16. Having participated in clinical trials for other drugs/medical devices within 3 months prior to screening; 17. Having consumed foods, juices and beverages containing alcohol, grapefruit, bigarade and caffeine within 72 hours prior to the first dose; 18. Subjects vaccinated with a live-attenuated vaccine within 8 weeks prior to screening or planning to get vaccinated during participation of this clinical trial; 19. Previous history of serious gastrointestinal disease, such as dysphagia, active gastric ulcer, inability to take drugs orally or absorption disorder for oral drugs; 20. Subjects who have special requirements for diet and cannot comply with uniform diet; 21. Lactating female subjects; 22. According to the investigator's judgment, the subjects had any other disease or status that might affect the normal completion of the study or the evaluation of the study data, or had any other condition that was not suitable for the study.

NCT0531xxxx/NCT05318833.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/NCT05318833</url> </required_header> <id_info> <org_study_id>HRS7415-I-101</org_study_id> <nct_id>NCT05318833</nct_id> </id_info> <brief_title>A Study of HRS7415 Tablets in Patients With Advanced Malignant Tumors</brief_title> <official_title>A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS7415 Tablets in Patients With Advanced Malignant Tumors</official_title> <sponsors> <lead_sponsor> <agency>Jiangsu HengRui Medicine Co., Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Jiangsu HengRui Medicine Co., Ltd.</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> This study is a multicenter, open phase I clinical study of dose escalation and dose extension of HRS7415 in subjects with advanced malignant tumors. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS7415 tablets. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 15, 2022</start_date> <completion_date type="Anticipated">October 30, 2023</completion_date> <primary_completion_date type="Anticipated">February 28, 2023</primary_completion_date> <phase>Phase 1</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> <intervention_model_description>The study was divided into two phases, the dose escalation phase and the dose extension phase of HRS7415 in subjects with advanced malignant tumors.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Dose-limiting toxicity (DLT)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months</time_frame> </primary_outcome> <primary_outcome> <measure>maximum tolerated dose (MTD)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months</time_frame> </primary_outcome> <primary_outcome> <measure>Phase II recommended dose (RP2D)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months</time_frame> </primary_outcome> <secondary_outcome> <measure>Incidence, severity, duration, and association of adverse events (AE) and severe adverse events (SAE) with the study drug, in addition to abnormalities in vital signs, electrocardiogram, and laboratory tests</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Single dose parameters: Peak plasma concentration (Cmax) of HRS7415 and its main metabolite after single dosing</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Single dose parameters: Time to peak (Tmax) of HRS7415 and its main metabolite after single dosing</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 year</time_frame> </secondary_outcome> <secondary_outcome> <measure>Single dose parameters: Area under the curve from 0 to the last measurable concentration time point t (AUC0-t) of HRS7415 and its main metabolite after single dosing (if applicable)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Single dose parameters: Area under the time curve from 0 to infinity (AUC0-inf) of HRS7415 and its main metabolite after single dosing (if applicable)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Single dose parameters: Half-value period (t1/2) of HRS7415 and its main metabolite after single dosing (if applicable)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Single dose parameters: Apparent volume of distribution (Vz/F) of HRS7415 and its main metabolite after single dosing (if applicable)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Single dose parameters: Apparent clearance (CL/F) of HRS7415 and its main metabolite after single dosing (if applicable)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Multiple dose parameters: Steady state peak concentration (Cmax，ss) of HRS7415 and its main metabolite after multiple dosing</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Multiple dose parameters: Time to peak (Tmax, ss) of HRS7415 and its main metabolite after multiple dosing</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Multiple dose parameters: Steady valley concentration (Cmin，ss) of HRS7415 and its main metabolite after multiple dosing</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Multiple dose parameters: Area under steady-state drug concentration-time curve (AUCss) of HRS7415 and its main metabolite after multiple dosing</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Multiple dose parameters: Drug storage ratio (Rac) of HRS7415 and its main metabolite after multiple dosing</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Efficacy endpoints: Objective response rate (ORR)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Efficacy endpoints: Disease control rate (DCR)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Efficacy endpoints: Duration of response (DoR)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Efficacy endpoints: Progression-free survival (PFS)</measure> <time_frame>From the beginning of first patient in (FPI) to the end of study up to approximately 2 years</time_frame> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">67</enrollment> <condition>Advanced Malignant Tumor</condition> <arm_group> <arm_group_label>HRS7415</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>HRS7415</intervention_name> <description>Drug: HRS7415</description> <arm_group_label>HRS7415</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person.  2. 18 to 75 years old, male or female.  3. ECOG Performance Status of 0 or 1.  4. The estimated survival time is ≥12 weeks.  5. Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology.  6. Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria.  7. Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol.  8. Male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; Fertile female subjects must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation.  Exclusion Criteria:  1. Subjects plan to receive any other antitumor therapy during the study period.  2. Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing.  3. Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing.  4. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing.  5. The damage caused by any previous antineoplastic therapy has not recovered to grade ≤1.  6. Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain.  7. Active heart disease in the 6 months prior to initial dosing.  8. Had other malignancies within 5 years prior to first dosing.  9. Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy.  10. Having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion;  11. Active hepatitis B and C;  12. Serious infections that require intravenous antibiotics, antivirals or antifungals to control;  13. History of immune deficiency or organ transplantation;  14. Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Denghui Gao</last_name> <phone>+0518-81220121</phone> <email>denghui.gao@hengrui.com</email> </overall_contact> <overall_contact_backup> <last_name>Huan Li</last_name> <phone>+0518-81220121</phone> <email>huan.li@hengrui.com</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

This study is a multicenter, open phase I clinical study of dose escalation and dose extension of HRS7415 in subjects with advanced malignant tumors. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS7415 tablets. Inclusion Criteria: 1. Subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person. 2. 18 to 75 years old, male or female. 3. ECOG Performance Status of 0 or 1. 4. The estimated survival time is ≥12 weeks. 5. Subjects with advanced or metastatic malignancy confirmed by histopathology or cytology. 6. Solid tumor subjects had measurable lesions that met RECIST 1.1 criteria. 7. Adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol. 8. Male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; Fertile female subjects must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation. Exclusion Criteria: 1. Subjects plan to receive any other antitumor therapy during the study period. 2. Subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing. 3. Major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing. 4. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing. 5. The damage caused by any previous antineoplastic therapy has not recovered to grade ≤1. 6. Imaging diagnosis showed tumor lesion or meningeal metastasis in the brain. 7. Active heart disease in the 6 months prior to initial dosing. 8. Had other malignancies within 5 years prior to first dosing. 9. Subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy. 10. Having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion; 11. Active hepatitis B and C; 12. Serious infections that require intravenous antibiotics, antivirals or antifungals to control; 13. History of immune deficiency or organ transplantation; 14. Comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.

NCT0531xxxx/NCT05318846.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/NCT05318846</url> </required_header> <id_info> <org_study_id>HRS4800-201</org_study_id> <nct_id>NCT05318846</nct_id> </id_info> <brief_title>A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.</brief_title> <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery</official_title> <sponsors> <lead_sponsor> <agency>Jiangsu HengRui Medicine Co., Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Jiangsu HengRui Medicine Co., Ltd.</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 study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">January 14, 2022</start_date> <completion_date type="Actual">March 22, 2022</completion_date> <primary_completion_date type="Actual">February 28, 2022</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> <intervention_model_description>A multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trial</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-8 hours after drug administration</measure> <time_frame>0-8 hours after drug administration</time_frame> </primary_outcome> <secondary_outcome> <measure>the Differences of Pain Intensity (PID) form each evaluating timepoint to baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) after drug administration</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-4 hours after drug administration</measure> <time_frame>0-4 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-12 hours after drug administrationadministration</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Pain relief degree at each evaluating timepoint using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Sum of pain relief degree within 4 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)</measure> <time_frame>0-4 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Sum of pain relief degree within 8 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)</measure> <time_frame>0-8 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Sum of pain relief degree within 12 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Proportion of subjects who reaches a 50% reduction in pain intensity from baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) at each evaluating timepoint</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time from drug administration to the first NRS score≤3</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time from drug administration to the first use of rescue medication</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Proportion of subjects who receive rescue therapy during the treatment period</measure> <time_frame>0-12 hours after drug administration</time_frame> </secondary_outcome> <secondary_outcome> <measure>Subject's overall satisfaction score of the study medication using subject satisfaction scale (ranging from 0-10, the larger the number, the higher the satisfaction)</measure> <time_frame>12 hours after drug administration</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">38</enrollment> <condition>Pain</condition> <arm_group> <arm_group_label>Treatment group A</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Treatment group B</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>HRS4800 tablets</intervention_name> <description>Dosing frequency: single dose; Route of administration: oral</description> <arm_group_label>Treatment group A</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo tablets</intervention_name> <description>Dosing frequency: single dose; Route of administration: oral</description> <arm_group_label>Treatment group B</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. 18 to 65 years old.  2. Scheduled to remove the impacted tooth.  3. Any NRS score ≥5 within 4 hours after the surgery.  4. Willing to comply with the study procedures and requirements.  5. Willing and able to provide written informed consent for this study.  Exclusion Criteria:  1. Subjects who had used other drugs that affect the analgesic effect.  2. Subjects who have infection or other complications on the planned oral surgical site.  3. Subjects with uncontrolled hypertension or hypotension.  4. Subjects with severe cardiovascular and cerebrovascular diseases.  5. Subjects with severe gastrointestinal disease.  6. Subjects with a history of drug or alcohol abuse.  7. Subjects with significant abnormal electrocardiogram.  8. Subjects with significant abnormal laboratory value.  9. Subject who were allergic to the study drug and ingredients.  10. Pregnancy, lactation or having recent pregnant plan.  11. Subjects who participated in other clinical research study 30 days before entering this study.  12. Other conditions unsuitable for participation in the study. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>West China Hospital of Stomatology Sichuan University</name> <address> <city>Chengdu</city> <state>Sichuan</state> <zip>610041</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 4, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Tooth, Impacted</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery. Inclusion Criteria: 1. 18 to 65 years old. 2. Scheduled to remove the impacted tooth. 3. Any NRS score ≥5 within 4 hours after the surgery. 4. Willing to comply with the study procedures and requirements. 5. Willing and able to provide written informed consent for this study. Exclusion Criteria: 1. Subjects who had used other drugs that affect the analgesic effect. 2. Subjects who have infection or other complications on the planned oral surgical site. 3. Subjects with uncontrolled hypertension or hypotension. 4. Subjects with severe cardiovascular and cerebrovascular diseases. 5. Subjects with severe gastrointestinal disease. 6. Subjects with a history of drug or alcohol abuse. 7. Subjects with significant abnormal electrocardiogram. 8. Subjects with significant abnormal laboratory value. 9. Subject who were allergic to the study drug and ingredients. 10. Pregnancy, lactation or having recent pregnant plan. 11. Subjects who participated in other clinical research study 30 days before entering this study. 12. Other conditions unsuitable for participation in the study.

NCT0531xxxx/NCT05318859.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/NCT05318859</url> </required_header> <id_info> <org_study_id>JS-CT-2021-17</org_study_id> <nct_id>NCT05318859</nct_id> </id_info> <brief_title>The Safety of Pharmacopuncture on Musculoskeletal Patients</brief_title> <official_title>The Safety Assessment of Pharmacopuncture on Musculoskeletal Patients: a Multi-center, Registry</official_title> <sponsors> <lead_sponsor> <agency>Jaseng Medical Foundation</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Jaseng Medical Foundation</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 study is to evaluate the safety of pharmacopuncture by observing any adverse events that may occur after pharmacopuncture treatment in with spinal joint disease hospitalized patients at 7 Korean medicine hospitals and analyzing blood test results. </textblock> </brief_summary> <detailed_description> <textblock> This study was an registry observational study, and was conducted in 7 Korean medicine hospitals (160 patients at Jaseng Korean medicine Hospital, 140 patients at Daejeon Jaseng Hospital of Korean Medicine, 140 patients at Bucheon Jaseng Hospital of Korean Medicine, 140 patients at Haeundae Jaseng Korean medicine Hospital, 140 patients at Kyunghee University of Korean medicine Hospital, 140 patients at Kyung Hee University of Korean Medicine Hospital at Gangdong, and 140 patients at Dongguk University Bundang Oriental Hospital). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 27, 2022</start_date> <completion_date type="Anticipated">December 31, 2025</completion_date> <primary_completion_date type="Anticipated">February 1, 2025</primary_completion_date> <study_type>Observational [Patient Registry]</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> <target_duration>1 Month</target_duration> <primary_outcome> <measure>Incidence of infection cases</measure> <time_frame>1 month</time_frame> <description>Infection is one of the representative adverse events for subcutaneous and intramuscular interventions. Infection cases will be collected to evaluate the safety of pharmacopuncture.</description> </primary_outcome> <secondary_outcome> <measure>Adverse events</measure> <time_frame>during admission (from day 2 to until discharge), 1 month</time_frame> <description>Adverse events refers to undesirable and unintended signs (eg, abnormalities in laboratory test values), symptoms, or diseases that appear after a procedure in the course of a clinical study. Any reported adverse events will be collected to evaluate the safety of pharmacopuncture.</description> </secondary_outcome> <secondary_outcome> <measure>Number of abnormal cases that appeared on the blood analysis</measure> <time_frame>Day 2, discharge day, 1 month</time_frame> <description>Any blood analysis result including liver function and renal function will be measured at admission day and discharge moment. The researcher records every abnormal result cases that appeared on the blood analysis and number of abnormal cases will be counted, to evaluate the safety of pharmacopuncture.</description> </secondary_outcome> <enrollment type="Anticipated">1000</enrollment> <condition>Musculoskeletal Diseases or Conditions</condition> <condition>Spine; Arthrosis</condition> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Pharmacopuncture</intervention_name> <description>Registry (observational study)</description> </intervention> <eligibility> <study_pop> <textblock> Inpatients with diagnosed spinal joint disease who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine, Kyung Hee University Korean Medicine Hospital at Gangdong, Kyung Hee University Korean Medicine Hospital, Dongguk Traditional Herbal Medicine Clinic. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Inpatients with diagnosed spinal joint disease  - Patients who received pharmacopuncture treatment during hospitalization  - Patients who are 19 years of age or older and less than 70 years old  - Patients who agreed to participate in the clinical study and voluntarily given written informed consent  Exclusion Criteria:  - Patients with difficulty or refusal to give sign written informed consent  - Patients for whom the researchers judge participation in the clinical study to be difficult </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>69 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>In-Hyuk Ha, Ph.D.</last_name> <role>Study Director</role> <affiliation>Jaseng Medical Foundation</affiliation> </overall_official> <overall_contact> <last_name>In-Hyuk Ha, Ph.D.</last_name> <phone>82-2-2222-2740</phone> <email>hanihata@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Sook Hyun Lee, Ph.D.</last_name> <phone>82-2-2222-2740</phone> <email>sh00god@khu.ac.kr</email> </overall_contact_backup> <location> <facility> <name>Jaseng Hospital of Korean Medicine</name> <address> <city>Seoul</city> <state>Gangnam-Gu</state> <zip>135-896</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kyoung Sun Park, Dr</last_name> <phone>+82-2-2222-2749</phone> <email>lovepks0116@jaseng.co.kr</email> </contact> </location> <location> <facility> <name>Bucheon Jaseng Hospital of Korean Medicine</name> <address> <city>Bucheon</city> <state>Gyeonggi Province</state> <zip>14598</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ji Yeon Seo, KMD</last_name> <phone>82-2-2222-2745</phone> <email>wownpan21@gmail.com</email> </contact> </location> <location> <facility> <name>Haeundae Jaseng Hospital of Korean Medicine</name> <address> <city>Busan</city> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Hyun-Woo Cho, KMD</last_name> <email>kamui0328@jaseng.org</email> </contact> </location> <location> <facility> <name>Daejeon Jaseng Hospital of Korean Medicine</name> <address> <city>Daejeon</city> <zip>35262</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sunah Kim, KMD</last_name> <phone>+82-42-1577-0007</phone> <email>tnsdk2648@jaseng.org</email> </contact> </location> <location> <facility> <name>Kyung Hee University Korean Medicine Hospital</name> <address> <city>Seoul</city> <zip>02447</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dongwoo Nam, KMD</last_name> </contact> <investigator> <last_name>Dongwoo Nam, KMD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Kyung Hee University Hospital at Gangdong</name> <address> <city>Seoul</city> <zip>05278</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yeoncheol Park, Professor</last_name> <email>icarus08@hanmail.net</email> </contact> </location> <location> <facility> <name>Dongguk University Bundang Oriental Hospital</name> <address> <city>Seoul</city> <zip>13601</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Eun-Jung Kim, KMD</last_name> </contact> <investigator> <last_name>Eun-Jung Kim, KMD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Korea, Republic of</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>February 11, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>June 13, 2023</last_update_submitted> <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 15, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Jaseng Medical Foundation</investigator_affiliation> <investigator_full_name>In-Hyuk Ha, KMD</investigator_full_name> <investigator_title>Hospital director, Research director</investigator_title> </responsible_party> <keyword>Spinal joint</keyword> <keyword>Safety</keyword> <keyword>Pharmacopuncture</keyword> <keyword>Adverse Event</keyword> <condition_browse>  <mesh_term>Musculoskeletal Diseases</mesh_term> <mesh_term>Osteoarthritis</mesh_term> </condition_browse>  </clinical_study>

The purpose of this study is to evaluate the safety of pharmacopuncture by observing any adverse events that may occur after pharmacopuncture treatment in with spinal joint disease hospitalized patients at 7 Korean medicine hospitals and analyzing blood test results. This study was an registry observational study, and was conducted in 7 Korean medicine hospitals (160 patients at Jaseng Korean medicine Hospital, 140 patients at Daejeon Jaseng Hospital of Korean Medicine, 140 patients at Bucheon Jaseng Hospital of Korean Medicine, 140 patients at Haeundae Jaseng Korean medicine Hospital, 140 patients at Kyunghee University of Korean medicine Hospital, 140 patients at Kyung Hee University of Korean Medicine Hospital at Gangdong, and 140 patients at Dongguk University Bundang Oriental Hospital). Inpatients with diagnosed spinal joint disease who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine, Kyung Hee University Korean Medicine Hospital at Gangdong, Kyung Hee University Korean Medicine Hospital, Dongguk Traditional Herbal Medicine Clinic. Inclusion Criteria: - Inpatients with diagnosed spinal joint disease - Patients who received pharmacopuncture treatment during hospitalization - Patients who are 19 years of age or older and less than 70 years old - Patients who agreed to participate in the clinical study and voluntarily given written informed consent Exclusion Criteria: - Patients with difficulty or refusal to give sign written informed consent - Patients for whom the researchers judge participation in the clinical study to be difficult

NCT0531xxxx/NCT05318872.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/NCT05318872</url> </required_header> <id_info> <org_study_id>38RC22.0028</org_study_id> <nct_id>NCT05318872</nct_id> </id_info> <brief_title>Prospective Evaluation of ENDOSWIR Device Versus Pathology for Squamous Cell Carcinoma of Upper Aerodigestive Tract (ENDOSWIR-VADS)</brief_title> <acronym>ENDOSWIR-VADS</acronym> <official_title>Preliminary Evaluation of the Analytical Performance of the ENDOSWIR Medical Device (DM-DIV) Versus Anatomical Pathology Examination in Patients Operated for Squamous Cell Carcinoma of Upper Aerodigestive Tract: Prospective Pilot Study</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Grenoble</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Institute for Advanced Biosciences (IAB), Grenoble</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Commissariat A L'energie Atomique</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University Hospital, Grenoble</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> A new medical optical device named ENDOSWIR is tested to determine its ability to determine if tissues are cancer or normal tissue on ex-vivo condition for specimen of ENT squamous cell cancers. </textblock> </brief_summary> <detailed_description> <textblock> In vivo short infrared imaging is a real-time, sensitive technique that can be used in the operating room during surgical removal of tumors.  It is essential in the surgery of cancers of the upper aerodigestive tract to be in healthy margins in order to avoid heavier surgical resumption or complementary treatments such as radiotherapy.  The optical imaging device in the short infrared range called ENDOSWIR and tested on tonsil samples has shown its safety on the analysis of tissues and seems to be promising for the detection of tumor tissues or, on the contrary, their absence in the resection margins (animal studies).  The principal objective is to determine the ability of the ENDOSWIR DM-DIV to distinguish healthy tissue from tumor tissue on an ENT squamous cell carcinoma specimen by Concordance rate (in %) between the ENDOSWIR result and the final pathology examination of each tissue portion of a subject (8 per subject)..  secondary objectives are : to demonstrate that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis, the safety of SWIR. An ancillary analysis of areas of particular interest such as resection margins or carcinoma in situ/dysplasia areas etc... </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 11, 2022</start_date> <completion_date type="Anticipated">June 30, 2023</completion_date> <primary_completion_date type="Anticipated">September 30, 2022</primary_completion_date> <study_type>Observational [Patient Registry]</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> <target_duration>1 Month</target_duration> <primary_outcome> <measure>Ability of the ENDOSWIR in-vitro diagnostic medical device to distinguish healthy tissue from tumoral tissue on an ENT squamous cell carcinoma resection</measure> <time_frame>1 day</time_frame> <description>Concordance rate (in %) between the ENDOSWIR result and the final pathological examination.</description> </primary_outcome> <secondary_outcome> <measure>Demonstration that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis</measure> <time_frame>1 day</time_frame> <description>Time (in minutes) for ENDOSWIR data acquisition and processing.</description> </secondary_outcome> <secondary_outcome> <measure>Demonstration of the safety of SWIR.</measure> <time_frame>1 day</time_frame> <description>No perceptible tissue change on the SWIR exposed sample</description> </secondary_outcome> <secondary_outcome> <measure>Ancillary analysis of special interest areas</measure> <time_frame>1 day</time_frame> <description>Concordance rate and descriptive qualitative analysis between the ENDOSWIR result and the final pathological examination of tissue portions located in a subject's areas of special interest</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">10</enrollment> <condition>Head and Neck Neoplasms</condition> <arm_group> <arm_group_label>ENT cancers</arm_group_label> <description>patients with ENT cancer in the active care line for who a surgical resection is planned.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>ENDOSWIR</intervention_name> <description>Patients were enrolled for surgery of their cancer and give their consents to the participation to that study. Characteristics of anonymized patient (sex, age, medical history, and tumoral characteristics) will be collected. During surgery, the excisional specimen will be sent in a fresh state for pathological examination (gold standard). The pathologist will determine 10 zones on a cross-section of the specimen which will be analyzed by SWIR, and compared between the two techniques.</description> <arm_group_label>ENT cancers</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> The population is selected from the subjects operated on for ENT carcinoma in a programmed manner and as part of the management at the CHUGA.  The active file of the CHUGA for an exeresis of squamous cell carcinoma of the oral cavity or oropharynx is about 1 subject per week which should allow to finalize the project in 6 months by supposing that it will be possible to include 50% of the subjects. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - ENT cancer (buccal or oropharyngeal) for which a surgical resection is planned  - affiliated to the social security  - Having given his non-opposition to participate in the trial.  Exclusion Criteria:  - Patient protected by law (minor, pregnant or breastfeeding woman, patient under guardianship, subject deprived of liberty or hospitalized under restraint).  - Patients who have received radiotherapy treatment in the VADS area  - Patient with a history of VADS cancer or a synchronous location of VADS cancer. </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>Christian Righini, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>CHU Grenoble Alpes</affiliation> </overall_official> <overall_contact> <last_name>Christian Righini, MD, PhD</last_name> <phone>0476765656</phone> <email>crighini@chu-grenoble.fr</email> </overall_contact> <results_reference> <citation>Wilson RH, Nadeau KP, Jaworski FB, Tromberg BJ, Durkin AJ. Review of short-wave infrared spectroscopy and imaging methods for biological tissue characterization. J Biomed Opt. 2015 Mar;20(3):030901. doi: 10.1117/1.JBO.20.3.030901.</citation> <PMID>25803186</PMID> </results_reference> <results_reference> <citation>Kenry, Duan Y, Liu B. Recent Advances of Optical Imaging in the Second Near-Infrared Window. Adv Mater. 2018 Nov;30(47):e1802394. doi: 10.1002/adma.201802394. Epub 2018 Sep 4.</citation> <PMID>30182451</PMID> </results_reference> <results_reference> <citation>Hu Z, Fang C, Li B, Zhang Z, Cao C, Cai M, Su S, Sun X, Shi X, Li C, Zhou T, Zhang Y, Chi C, He P, Xia X, Chen Y, Gambhir SS, Cheng Z, Tian J. First-in-human liver-tumour surgery guided by multispectral fluorescence imaging in the visible and near-infrared-I/II windows. Nat Biomed Eng. 2020 Mar;4(3):259-271. doi: 10.1038/s41551-019-0494-0. Epub 2019 Dec 23.</citation> <PMID>31873212</PMID> </results_reference> <results_reference> <citation>Schols RM, ter Laan M, Stassen LP, Bouvy ND, Amelink A, Wieringa FP, Alic L. Differentiation between nerve and adipose tissue using wide-band (350-1,830 nm) in vivo diffuse reflectance spectroscopy. Lasers Surg Med. 2014 Sep;46(7):538-45. doi: 10.1002/lsm.22264. Epub 2014 Jun 4.</citation> <PMID>24895321</PMID> </results_reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 11, 2022</last_update_submitted> <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 12, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Head and neck neoplasms</keyword> <keyword>Fluorescence</keyword> <keyword>Short Wave Infra-Red</keyword> <condition_browse>  <mesh_term>Carcinoma, Squamous Cell</mesh_term> <mesh_term>Head and Neck Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

A new medical optical device named ENDOSWIR is tested to determine its ability to determine if tissues are cancer or normal tissue on ex-vivo condition for specimen of ENT squamous cell cancers. In vivo short infrared imaging is a real-time, sensitive technique that can be used in the operating room during surgical removal of tumors. It is essential in the surgery of cancers of the upper aerodigestive tract to be in healthy margins in order to avoid heavier surgical resumption or complementary treatments such as radiotherapy. The optical imaging device in the short infrared range called ENDOSWIR and tested on tonsil samples has shown its safety on the analysis of tissues and seems to be promising for the detection of tumor tissues or, on the contrary, their absence in the resection margins (animal studies). The principal objective is to determine the ability of the ENDOSWIR DM-DIV to distinguish healthy tissue from tumor tissue on an ENT squamous cell carcinoma specimen by Concordance rate (in %) between the ENDOSWIR result and the final pathology examination of each tissue portion of a subject (8 per subject).. secondary objectives are : to demonstrate that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis, the safety of SWIR. An ancillary analysis of areas of particular interest such as resection margins or carcinoma in situ/dysplasia areas etc... The population is selected from the subjects operated on for ENT carcinoma in a programmed manner and as part of the management at the CHUGA. The active file of the CHUGA for an exeresis of squamous cell carcinoma of the oral cavity or oropharynx is about 1 subject per week which should allow to finalize the project in 6 months by supposing that it will be possible to include 50% of the subjects. Inclusion Criteria: - ENT cancer (buccal or oropharyngeal) for which a surgical resection is planned - affiliated to the social security - Having given his non-opposition to participate in the trial. Exclusion Criteria: - Patient protected by law (minor, pregnant or breastfeeding woman, patient under guardianship, subject deprived of liberty or hospitalized under restraint). - Patients who have received radiotherapy treatment in the VADS area - Patient with a history of VADS cancer or a synchronous location of VADS cancer.

NCT0531xxxx/NCT05318885.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/NCT05318885</url> </required_header> <id_info> <org_study_id>0000-0001-7140-6540</org_study_id> <nct_id>NCT05318885</nct_id> </id_info> <brief_title>The Effect of Nebulization Positions in Asthmatic Children</brief_title> <official_title>Effect of Forward-leaning Position on Vital Signs, Pain and Anxiety of Children With Acute Asthma Attacks: A Randomized Controlled Study</official_title> <sponsors> <lead_sponsor> <agency>Istanbul University - Cerrahpasa (IUC)</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Istanbul University - Cerrahpasa (IUC)</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 was to establish the effect on pulse rate, oxygen saturation, respiratory rate, pain and anxiety levels of Fowler's and the forward-leaning positions during nebulization in children experiencing asthma attacks. </textblock> </brief_summary> <detailed_description> <textblock> In the first stage, data on the children who agreed to participate in the study were recorded on the "Patient Identification Form" 10 minutes before the procedure by the researcher during a face-to-face interview. The children's body temperature, oxygen saturation, pulse rate and respiratory rate were measured. Upon explaining the FPS-R, the children were asked whether they had experienced pain before treatment, and to point at the pain level felt from among the faces on the scale. Then, CSA was explained and the children, and their level of anxiety on the scale was recorded. The pre-nebulization findings were recorded.  In the second stage, the salbutamol therapy prescribed by the physician was administered to the participating children with a nebulizer three times at 20-minute intervals. During nebulization, the study group patients were placed in forward-leaning position, placing a pillow on their knees, while the control group was placed in Fowler's position on a chair. Nebulization took an average of 10 minutes for each child. Oxygen saturation, pulse and respiratory rate were recorded immediately after the mask was removed. The children were allowed to rest for 20 minutes in Fowler's position.  In the third stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following a 10-minute second nebulization. The values determined were recorded, and the children were allowed to rest for 20 minutes in Fowler's position.  In the fourth stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following the 10-minute third nebulization. The children were asked whether they had pain, and to point at the pain level represented by the faces on the scale. The patients then marked their level of anxiety on the CSA. The post-nebulization findings were recorded. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 15, 2019</start_date> <completion_date type="Actual">February 20, 2020</completion_date> <primary_completion_date type="Actual">February 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> <intervention_model_description>A randomized controlled study</intervention_model_description> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in Oxygen Saturation</measure> <time_frame>90 minute</time_frame> <description>Oxygen saturation will be monitored</description> </primary_outcome> <primary_outcome> <measure>Change in respiratory rate</measure> <time_frame>90 minute</time_frame> <description>Respiratory rate will be monitored</description> </primary_outcome> <primary_outcome> <measure>Change in Pulse Rate</measure> <time_frame>90 minute</time_frame> <description>Heart rate will be monitored</description> </primary_outcome> <primary_outcome> <measure>Change in chest pain score</measure> <time_frame>90 minute</time_frame> <description>Pain score will be evaluated with The faces pain scale-revised (FPS-R).</description> </primary_outcome> <primary_outcome> <measure>Change in anxiety score</measure> <time_frame>90 minute</time_frame> <description>Anxiety score will be evaluated with The children state anxiety scale (CSA).</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">86</enrollment> <condition>Asthma Attack</condition> <condition>Asthma in Children</condition> <condition>Asthma Acute</condition> <condition>Asthma</condition> <arm_group> <arm_group_label>Forward leaning position</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The children in asthma attacks were administered nebulization three times, during which the study group children were placed in the forward-leaning position.</description> </arm_group> <arm_group> <arm_group_label>Fowler position</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The children in asthma attacks were administered nebulization three times, during which the control group children in the routine Fowler's position.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>A Randomized Controlled Study</intervention_name> <description>For forward-leaning position, the child is first placed on a suitable chair with a soft pillow on their knees. The child will remain in the same position for the duration of the nebulization, and the pillow provides support, ensuring the child does not get tired. The child leans forward at an angle of 45°, places their arms on the pillow as shown in the figure and holds their head upright with their eyes facing forward (slight hyperextension). The upright head position of the child prevents spillage of the liquid medicine from the nebulizer chamber.</description> <arm_group_label>Forward leaning position</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - To be between 6-11 ages,  - Having a body temperature below 37.2°C at admission,  - Having been prescribed nebulized salbutamol by the physician during data collection,  - Having not using bronchodilators or corticosteroid drugs within the last 6 hours,  - Having no other respiratory system disease,  - Verbal and written consent of the child and parent to participate in the study.  Exclusion Criteria:  - Administering drugs other than nebulized salbutamol to the child during data collection,  - Having an obstacle for positioning (Lordosis, kyphosis, scoliosis, chest wall deformities, previous surgical procedure, etc.),  - Child and parent not knowing Turkish. </textblock> </criteria> <gender>All</gender> <minimum_age>6 Years</minimum_age> <maximum_age>11 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Gamze KAŞ ALAY, Msc</last_name> <role>Principal Investigator</role> <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation> </overall_official> <location> <facility> <name>Istanbul University-Cerrahpaşa</name> <address> <city>Istanbul</city> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <reference> <citation>Wilder C, Shiralkar S. Childhood asthma in the emergency department: an audit. Int Emerg Nurs. 2015 Apr;23(2):197-202. doi: 10.1016/j.ienj.2014.09.001. Epub 2014 Sep 6.</citation> <PMID>25263689</PMID> </reference> <reference> <citation>Sheldon G, Heaton PA, Palmer S, Paul SP. Nursing management of paediatric asthma in emergency departments. Emerg Nurse. 2018 Nov 6;26(4):32-42. doi: 10.7748/en.2018.e1770. Epub 2018 Oct 17.</citation> <PMID>30362669</PMID> </reference> <reference> <citation>Kocaaslan EN, Akgun Kostak M. Effect of disease management education on the quality of life and self-efficacy levels of children with asthma. J Spec Pediatr Nurs. 2019 Apr;24(2):e12241. doi: 10.1111/jspn.12241. Epub 2019 Mar 19.</citation> <PMID>30887669</PMID> </reference> <reference> <citation>Camargo CA Jr, Spooner CH, Rowe BH. Continuous versus intermittent beta-agonists in the treatment of acute asthma. Cochrane Database Syst Rev. 2003;2003(4):CD001115. doi: 10.1002/14651858.CD001115.</citation> <PMID>14583926</PMID> </reference> <reference> <citation>Iramain R, Castro-Rodriguez JA, Jara A, Cardozo L, Bogado N, Morinigo R, De Jesus R. Salbutamol and ipratropium by inhaler is superior to nebulizer in children with severe acute asthma exacerbation: Randomized clinical trial. Pediatr Pulmonol. 2019 Apr;54(4):372-377. doi: 10.1002/ppul.24244. Epub 2019 Jan 22.</citation> <PMID>30672140</PMID> </reference> <reference> <citation>Myint WW, Htay MNN, Soe HHK, Renjue L, Shirying G, Yuan NSB, et al. Effect of body positions on lungs volume in asthmatic patients: A cross-sectional study. Journal of Advances in Medical and Pharmaceutical Sciences 2017;13(4):1-6. http://doi.org/10.9734/JAMPS/2017/33901</citation> </reference> <reference> <citation>Ganapathi LV, Vinoth S. The estimation of pulmonary functions in various body postures in normal subjects. International Journal of Advances in Medicine 2015;2(3):250-4. https://doi.org/10.18203/2349-3933.IJAM20150554</citation> </reference> <reference> <citation>Martinez JA, Rodrigues HB, Portelinha AM. A novel position for postural relief of dyspnea. J Bras Pneumol. 2011 Nov-Dec;37(6):829-30. doi: 10.1590/s1806-37132011000600020. No abstract available. English, Portuguese.</citation> <PMID>22241044</PMID> </reference> <reference> <citation>Sharp JT, Drutz WS, Moisan T, Foster J, Machnach W. Postural relief of dyspnea in severe chronic obstructive pulmonary disease. Am Rev Respir Dis. 1980 Aug;122(2):201-11. doi: 10.1164/arrd.1980.122.2.201. No abstract available.</citation> <PMID>7416599</PMID> </reference> <reference> <citation>Tuncer M, Khorshtd L. Obez bireylerde pozisyonların oksijen satürasyonuna etkisi. Ege Üniversitesi Hemşirelik Fakültesi Dergisi 2018;34:54-65. https://dergipark.org.tr/tr/download/article-file/456669</citation> </reference> <reference> <citation>Korkmaz M, Kızılcı S. Posture and ıts effect on peripheral oxygen saturation, and some hemodynamic parameters in patients with heart failure. Turkiye Klinikleri Journal of Nursing Science 2012;4(2):85-93. https://www.turkiyeklinikleri.com/article/posture-and-its-effect-on-peripheral-oxygen-saturation-and-some-hemodynamic-parameters-in-patients-with-heart-failure-63546.html</citation> </reference> <reference> <citation>Baysal E, Midilli ST, Ergin E. Effects of different position changes on hemodynamic parameters and dyspnea severity in patients with dyspnea. Clinical and Experimental Health Sciences 2018;8:261-7. doi: 10.5152/clinexphealthsci.2017.751</citation> </reference> <reference> <citation>Mohammed J, Abdulateef A, Shittu A, Sumaila FG. Effect of different body positioning on lung function variables among patients with bronchial asthma. Archives of Physiotherapy and Global Researches 2017;21(3):7-12. http://apgr.wssp.edu.pl/wp-content/uploads/2017/12/APGR-21-3-A.pdf</citation> </reference> <reference> <citation>Hojat B, Mahdi E. Effect of different sitting posture on pulmonary function in students. Journal of Physiology and Pathophysiology 2011;2(2):29-33. https://academicjournals.org/article/article1381307359_Hojat%20and%20mahdi%20PDF.pdf</citation> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 6, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Kastamonu University</investigator_affiliation> <investigator_full_name>Gamze Kas Alay</investigator_full_name> <investigator_title>Research Assistant</investigator_title> </responsible_party> <keyword>Asthma attack</keyword> <keyword>Child</keyword> <keyword>Nurse</keyword> <keyword>Nebulization</keyword> <keyword>Chest Pain</keyword> <condition_browse>  <mesh_term>Asthma</mesh_term> </condition_browse>  </clinical_study>

The purpose of this study was to establish the effect on pulse rate, oxygen saturation, respiratory rate, pain and anxiety levels of Fowler's and the forward-leaning positions during nebulization in children experiencing asthma attacks. In the first stage, data on the children who agreed to participate in the study were recorded on the "Patient Identification Form" 10 minutes before the procedure by the researcher during a face-to-face interview. The children's body temperature, oxygen saturation, pulse rate and respiratory rate were measured. Upon explaining the FPS-R, the children were asked whether they had experienced pain before treatment, and to point at the pain level felt from among the faces on the scale. Then, CSA was explained and the children, and their level of anxiety on the scale was recorded. The pre-nebulization findings were recorded. In the second stage, the salbutamol therapy prescribed by the physician was administered to the participating children with a nebulizer three times at 20-minute intervals. During nebulization, the study group patients were placed in forward-leaning position, placing a pillow on their knees, while the control group was placed in Fowler's position on a chair. Nebulization took an average of 10 minutes for each child. Oxygen saturation, pulse and respiratory rate were recorded immediately after the mask was removed. The children were allowed to rest for 20 minutes in Fowler's position. In the third stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following a 10-minute second nebulization. The values determined were recorded, and the children were allowed to rest for 20 minutes in Fowler's position. In the fourth stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following the 10-minute third nebulization. The children were asked whether they had pain, and to point at the pain level represented by the faces on the scale. The patients then marked their level of anxiety on the CSA. The post-nebulization findings were recorded. Inclusion Criteria: - To be between 6-11 ages, - Having a body temperature below 37.2°C at admission, - Having been prescribed nebulized salbutamol by the physician during data collection, - Having not using bronchodilators or corticosteroid drugs within the last 6 hours, - Having no other respiratory system disease, - Verbal and written consent of the child and parent to participate in the study. Exclusion Criteria: - Administering drugs other than nebulized salbutamol to the child during data collection, - Having an obstacle for positioning (Lordosis, kyphosis, scoliosis, chest wall deformities, previous surgical procedure, etc.), - Child and parent not knowing Turkish.

NCT0531xxxx/NCT05318898.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/NCT05318898</url> </required_header> <id_info> <org_study_id>3986-22-22-1</org_study_id> <nct_id>NCT05318898</nct_id> </id_info> <brief_title>Effect of Dietary Protein on the Regulation of Exosome microRNA Expression in Patients With Insulin Resistance.</brief_title> <official_title>Effect of Dietary Protein on the Regulation of Exosome microRNA Expression in Patients</official_title> <sponsors> <lead_sponsor> <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</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> miRNAs are small non-coding RNAs of approximately 22 nucleotides in length, which have the function of regulating gene expression at the post-transcriptional level through base complementation of protein-coding transcripts, this interaction leading to translational repression by destabilizing the messenger RNA. Evidence demonstrates an association between differences in miRNA expression and the development of various pathologies, including obesity, type 2 diabetes, cardiovascular disease, neurodegenerative disorders and cancer. Other factors that could also modulate miRNA expression include nutritional status, diet and even exercise. The aim of this study is to identify exosome microRNAs that modify their expression in plasma from patients with insulin resistance fed different dietary protein sources. A randomized controlled clinical trial will be performed where the selected participants will be assigned by lottery to a dietary intervention of usual diet with protein of plant or animal origin for 4 weeks. The study will consist of 3 visits where anthropometric parameters, body composition, systolic and diastolic blood pressure, dietary compliance through 24-hour recall and food logs, biochemical tests (insulin, glucose, triglycerides, total cholesterol, HDL, LDL), the relative expression of plasma exosome miRNAs and markers of oxidative stress will be evaluated. Participants will receive a weekly food pantry during the first two visits in order to improve compliance to the dietary intervention. </textblock> </brief_summary> <detailed_description> <textblock> The study will evaluate the effect of 2 dietary interventions on the regulation of plasma exosome microRNA expression in patients with insulin resistance.  STUDY PROGRAM  The study will consist of 3 visits  Planned (selection of participants)  1. Participants will be invited through advertisements.  2. Participants will be corroborated to ensure that they meet the criteria for selection.  3. If they are candidates for the protocol, participants will be provided with the letter of consent to read carefully and any doubts that may arise will be resolved. Participants will be informed about the characteristics of the study as well as the expected risks and benefits. If they agree, the participant will be asked to sign the consent form.  4. Anthropometric measurements such as weight, height, blood pressure and body composition will be determined by means of bioelectrical impedance.  5. A 24-hour reminder of food consumption will be made.  6. A whole blood sample will be taken for glucose and insulin determination, in order to determine the HOMA-Insulin Resistance index.  Once the insulin resistance patients are identified (HOMA- Insulin Resistance ≥ 2.5) the study will begin and participants will be randomized into two intervention groups.  Visit 1 (baseline)  1. A medical and nutritional assessment will be performed.  2. The physical activity questionnaire (IPAQ long version) will be administered and participants will be advised not to change their physical activity.  3. Anthropometric and blood pressure measurements will be taken.  4. Oral glucose tolerance test will be performed for 2 hours after a 12-hour fast to determine the area under the insulin and glucose curve and determination of insulinemic and glycemic indices.  5. A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection.  6. The patient will be assigned to an intervention group (vegetable protein vs. animal protein) by block randomization.  7. The participants will continue their usual diet, And the consumption of animal protein or the consumption of vegetable protein will be recommended, according to the assigned group. They will be given and explained a list of foods that provide proteins of animal and vegetable origin, which they could integrate into their usual diet, these lists will indicate which foods to consume and which not to consume, according to the intervention group to which they were assigned.  9. They will be given a logbook to write down their daily food consumption and they will be taught how to fill it out.  10. An online questionnaire will be explained how to fill out every third day to detect the consumption of recommended and non-recommended foods from the list provided, according to the assigned group.  11. They will be given a pantry with foods rich in protein only (animal protein vs. vegetable protein) according to the assigned group (explained in the section on pantries).  Visit 2 (intermediate)  1. Consumption logs will be collected.  2. The weekly pantry will be delivered  3. Clarification of doubts  Visit 3 (final)  1. A medical and nutritional assessment will be performed. 2.  2. The physical activity questionnaire (IPAQ long version) will be completed.  3. Anthropometric and blood pressure measurements will be performed.  4. Oral glucose tolerance test will be performed for 2 hours after a 12 hour fast to determine the area under the insulin and glucose curve and determination of insulinemic and glycemic indices.  5. A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection.  6. Body temperature will be determined and if female, the date of last menstrual period will be questioned as a confounding variable.  7. The food log will be collected.  8. Clarification of doubts and thanks will be given for their participation. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 1, 2022</start_date> <completion_date type="Anticipated">May 1, 2024</completion_date> <primary_completion_date type="Anticipated">December 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> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> <masking_description>The person performing the analysis of the study results should be unaware of the assigned intervention so that such knowledge does not influence the results. Therefore, it will be a person outside the study.</masking_description> </study_design_info> <primary_outcome> <measure>Change in the expression profile of microRNAs from exosomes with real -time quantitative polymerase chain reaction in fold change</measure> <time_frame>4 weeks</time_frame> <description>Fold change in the expression profile of microRNAs from exosomes after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) with real -time quantitative polymerase chain reaction</description> </primary_outcome> <secondary_outcome> <measure>Change on HOMA index</measure> <time_frame>4 weeks</time_frame> <description>Change in the HOMA index after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).</description> </secondary_outcome> <secondary_outcome> <measure>Change in body weight in kg</measure> <time_frame>4 weeks</time_frame> <description>Change in the body weight in kg after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) using a standard calibrated electronic balance.</description> </secondary_outcome> <secondary_outcome> <measure>Change in biochemical parameters in mg/dL</measure> <time_frame>4 weeks</time_frame> <description>Change the biochemical parameters in mg/dL ( glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) analysed by an enzymatic colorimetric method using the Cobas C111 analyser (Roche Diagnostic. Indianapolis. IN).</description> </secondary_outcome> <secondary_outcome> <measure>Change in body composition in percentage</measure> <time_frame>4 weeks</time_frame> <description>Change in the body composition in percentage after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) by multifrequency bioimpedance analysis.</description> </secondary_outcome> <secondary_outcome> <measure>Change in C Reactive Protein in mg/L</measure> <time_frame>4 weeks</time_frame> <description>Change in C Reactive Protein in mg/L after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) analysed by an enzymatic colorimetric method using the Cobas C111 analyser (Roche Diagnostic. Indianapolis. IN).</description> </secondary_outcome> <secondary_outcome> <measure>Amino acid profile in mmol/L</measure> <time_frame>4 weeks</time_frame> <description>Change in amino acid profile in mmol/L after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) determinated by High performance liquid chromatography</description> </secondary_outcome> <secondary_outcome> <measure>Change in the area under curve of glucose in mg/dL per 2 hours</measure> <time_frame>4 weeks</time_frame> <description>Change in the area under curve of glucose in mg/dL per 2 hours after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).</description> </secondary_outcome> <secondary_outcome> <measure>Change in the area under curve of insulin in microIU/mL per 2 hours</measure> <time_frame>4 weeks</time_frame> <description>Change in the area under curve of insulin in micro IU/mL per 2 hours after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).</description> </secondary_outcome> <secondary_outcome> <measure>Change in the waist circumference in centimeters</measure> <time_frame>4 weeks</time_frame> <description>Change in the waist circumference in centimeters after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) using a flexible tape measure.</description> </secondary_outcome> <secondary_outcome> <measure>Change in the blood pressure in mmHg</measure> <time_frame>4 weeks</time_frame> <description>Change in the blood pressure in mmHg after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).</description> </secondary_outcome> <secondary_outcome> <measure>Change in the Malondialdehyde in micromol/L</measure> <time_frame>4 weeks</time_frame> <description>Change in the Malondialdehyde in micromol/L after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) measured by ELISA</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Insulin Resistance</condition> <arm_group> <arm_group_label>Regular diet with vegetable protein</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from vegetable protein sources.</description> </arm_group> <arm_group> <arm_group_label>Regular diet with animal protein</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from animal protein sources.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Vegetal protein</intervention_name> <description>Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from vegetal protein sources</description> <arm_group_label>Regular diet with vegetable protein</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Animal protein</intervention_name> <description>Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from animal protein sources.</description> <arm_group_label>Regular diet with animal protein</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adults (men and women) between the ages of 18 and 60.  - Patients with obesity (BMI ≥ 30 and ≤ 50 kg / m2) and with insulin resistance (HOMA - Insulin Resistance Index ≥ 2.5).  - Signature of letter of consent  Exclusion Criteria:  - Patients with any type of diabetes.  - Patients with kidney disease diagnosed by a medical or with creatinine> 1.3 mg / dL for men and > 1.1 mg / dL for women and / or blood urea nitrogen > 20 mg / dL.  - Patients with acquired diseases that produce obesity and diabetes secondarily.  - Patients who have suffered a cardiovascular event.  - Patients with weight loss > 3 kg in the last 3 months.  - Patients with any catabolic diseases.  - Gravidity status  - Positive smoking and alcoholism  - Treatment with any medication </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Martha Guevara-Cruz, Doctor</last_name> <role>Principal Investigator</role> <affiliation>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran</affiliation> </overall_official> <overall_contact> <last_name>Martha Guevara-Cruz, Doctor</last_name> <phone>525554870900</phone> <phone_ext>2802</phone_ext> <email>marthaguevara8@yahoo.com.mx</email> </overall_contact> <overall_contact_backup> <last_name>Laura M Velazquez-Villegas, Doctor</last_name> <phone>525554870900</phone> <phone_ext>2802</phone_ext> <email>laura.velazquezv@incmnsz.mx</email> </overall_contact_backup> <location> <facility> <name>Martha Guevara Cruz</name> <address> <city>Mexico City</city> <zip>14060</zip> <country>Mexico</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Martha Guevara Cruz, Dr</last_name> <phone>5554870900</phone> <email>marthaguevara8@yahoo.com.mx</email> </contact> </location> <location> <facility> <name>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name> <address> <city>Mexico City</city> <zip>14080</zip> <country>Mexico</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Martha Guevara-Cruz, Dr</last_name> <phone>55 5487 0900</phone> <phone_ext>2802</phone_ext> <email>marthaguevara8@yahoo.com.mx</email> </contact> <investigator> <last_name>Karla Guadalupe Hernández-Gómez, M.S.</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Aurora E Zuñiga-Serralde, PhD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Mexico</country> </location_countries> <results_reference> <citation>Lasser C. Mapping Extracellular RNA Sheds Lights on Distinct Carriers. Cell. 2019 Apr 4;177(2):228-230. doi: 10.1016/j.cell.2019.03.027.</citation> <PMID>30951666</PMID> </results_reference> <results_reference> <citation>Mori MA, Ludwig RG, Garcia-Martin R, Brandao BB, Kahn CR. Extracellular miRNAs: From Biomarkers to Mediators of Physiology and Disease. Cell Metab. 2019 Oct 1;30(4):656-673. doi: 10.1016/j.cmet.2019.07.011. Epub 2019 Aug 22.</citation> <PMID>31447320</PMID> </results_reference> <results_reference> <citation>Safdar A, Tarnopolsky MA. Exosomes as Mediators of the Systemic Adaptations to Endurance Exercise. Cold Spring Harb Perspect Med. 2018 Mar 1;8(3):a029827. doi: 10.1101/cshperspect.a029827.</citation> <PMID>28490541</PMID> </results_reference> <results_reference> <citation>Huang Y, Yan Y, Xv W, Qian G, Li C, Zou H, Li Y. A New Insight into the Roles of MiRNAs in Metabolic Syndrome. Biomed Res Int. 2018 Dec 17;2018:7372636. doi: 10.1155/2018/7372636. eCollection 2018.</citation> <PMID>30648107</PMID> </results_reference> <results_reference> <citation>Castano C, Kalko S, Novials A, Parrizas M. Obesity-associated exosomal miRNAs modulate glucose and lipid metabolism in mice. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):12158-12163. doi: 10.1073/pnas.1808855115. Epub 2018 Nov 14.</citation> <PMID>30429322</PMID> </results_reference> <results_reference> <citation>Jimenez-Lucena R, Alcala-Diaz JF, Roncero-Ramos I, Lopez-Moreno J, Camargo A, Gomez-Delgado F, Quintana-Navarro GM, Vals-Delgado C, Rodriguez-Cantalejo F, Luque RM, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Rangel-Zuniga OA, Lopez-Miranda J. MiRNAs profile as biomarkers of nutritional therapy for the prevention of type 2 diabetes mellitus: From the CORDIOPREV study. Clin Nutr. 2021 Mar;40(3):1028-1038. doi: 10.1016/j.clnu.2020.06.035. Epub 2020 Jul 15.</citation> <PMID>32723508</PMID> </results_reference> <results_reference> <citation>Min KH, Yang WM, Lee W. Saturated fatty acids-induced miR-424-5p aggravates insulin resistance via targeting insulin receptor in hepatocytes. Biochem Biophys Res Commun. 2018 Sep 10;503(3):1587-1593. doi: 10.1016/j.bbrc.2018.07.084. Epub 2018 Jul 20.</citation> <PMID>30033101</PMID> </results_reference> <verification_date>July 2022</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>January 22, 2023</last_update_submitted> <last_update_submitted_qc>January 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 25, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</investigator_affiliation> <investigator_full_name>Martha Guevara Cruz</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Insulin Resistance</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

miRNAs are small non-coding RNAs of approximately 22 nucleotides in length, which have the function of regulating gene expression at the post-transcriptional level through base complementation of protein-coding transcripts, this interaction leading to translational repression by destabilizing the messenger RNA. Evidence demonstrates an association between differences in miRNA expression and the development of various pathologies, including obesity, type 2 diabetes, cardiovascular disease, neurodegenerative disorders and cancer. Other factors that could also modulate miRNA expression include nutritional status, diet and even exercise. The aim of this study is to identify exosome microRNAs that modify their expression in plasma from patients with insulin resistance fed different dietary protein sources. A randomized controlled clinical trial will be performed where the selected participants will be assigned by lottery to a dietary intervention of usual diet with protein of plant or animal origin for 4 weeks. The study will consist of 3 visits where anthropometric parameters, body composition, systolic and diastolic blood pressure, dietary compliance through 24-hour recall and food logs, biochemical tests (insulin, glucose, triglycerides, total cholesterol, HDL, LDL), the relative expression of plasma exosome miRNAs and markers of oxidative stress will be evaluated. Participants will receive a weekly food pantry during the first two visits in order to improve compliance to the dietary intervention. The study will evaluate the effect of 2 dietary interventions on the regulation of plasma exosome microRNA expression in patients with insulin resistance. STUDY PROGRAM The study will consist of 3 visits Planned (selection of participants) 1. Participants will be invited through advertisements. 2. Participants will be corroborated to ensure that they meet the criteria for selection. 3. If they are candidates for the protocol, participants will be provided with the letter of consent to read carefully and any doubts that may arise will be resolved. Participants will be informed about the characteristics of the study as well as the expected risks and benefits. If they agree, the participant will be asked to sign the consent form. 4. Anthropometric measurements such as weight, height, blood pressure and body composition will be determined by means of bioelectrical impedance. 5. A 24-hour reminder of food consumption will be made. 6. A whole blood sample will be taken for glucose and insulin determination, in order to determine the HOMA-Insulin Resistance index. Once the insulin resistance patients are identified (HOMA- Insulin Resistance ≥ 2.5) the study will begin and participants will be randomized into two intervention groups. Visit 1 (baseline) 1. A medical and nutritional assessment will be performed. 2. The physical activity questionnaire (IPAQ long version) will be administered and participants will be advised not to change their physical activity. 3. Anthropometric and blood pressure measurements will be taken. 4. Oral glucose tolerance test will be performed for 2 hours after a 12-hour fast to determine the area under the insulin and glucose curve and determination of insulinemic and glycemic indices. 5. A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection. 6. The patient will be assigned to an intervention group (vegetable protein vs. animal protein) by block randomization. 7. The participants will continue their usual diet, And the consumption of animal protein or the consumption of vegetable protein will be recommended, according to the assigned group. They will be given and explained a list of foods that provide proteins of animal and vegetable origin, which they could integrate into their usual diet, these lists will indicate which foods to consume and which not to consume, according to the intervention group to which they were assigned. 9. They will be given a logbook to write down their daily food consumption and they will be taught how to fill it out. 10. An online questionnaire will be explained how to fill out every third day to detect the consumption of recommended and non-recommended foods from the list provided, according to the assigned group. 11. They will be given a pantry with foods rich in protein only (animal protein vs. vegetable protein) according to the assigned group (explained in the section on pantries). Visit 2 (intermediate) 1. Consumption logs will be collected. 2. The weekly pantry will be delivered 3. Clarification of doubts Visit 3 (final) 1. A medical and nutritional assessment will be performed. 2. 2. The physical activity questionnaire (IPAQ long version) will be completed. 3. Anthropometric and blood pressure measurements will be performed. 4. Oral glucose tolerance test will be performed for 2 hours after a 12 hour fast to determine the area under the insulin and glucose curve and determination of insulinemic and glycemic indices. 5. A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection. 6. Body temperature will be determined and if female, the date of last menstrual period will be questioned as a confounding variable. 7. The food log will be collected. 8. Clarification of doubts and thanks will be given for their participation. Inclusion Criteria: - Adults (men and women) between the ages of 18 and 60. - Patients with obesity (BMI ≥ 30 and ≤ 50 kg / m2) and with insulin resistance (HOMA - Insulin Resistance Index ≥ 2.5). - Signature of letter of consent Exclusion Criteria: - Patients with any type of diabetes. - Patients with kidney disease diagnosed by a medical or with creatinine> 1.3 mg / dL for men and > 1.1 mg / dL for women and / or blood urea nitrogen > 20 mg / dL. - Patients with acquired diseases that produce obesity and diabetes secondarily. - Patients who have suffered a cardiovascular event. - Patients with weight loss > 3 kg in the last 3 months. - Patients with any catabolic diseases. - Gravidity status - Positive smoking and alcoholism - Treatment with any medication

NCT0531xxxx/NCT05318911.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/NCT05318911</url> </required_header> <id_info> <org_study_id>2022_01_01_S&E</org_study_id> <nct_id>NCT05318911</nct_id> </id_info> <brief_title>Antithrombotic Activities of a Novel Yogurt Drink</brief_title> <official_title>Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study</official_title> <sponsors> <lead_sponsor> <agency>University of Limerick</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Limerick</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> This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers </textblock> </brief_summary> <detailed_description> <textblock> This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease.  In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Actual">September 30, 2022</completion_date> <primary_completion_date type="Actual">September 30, 2022</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>Prevention</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Platelet aggregation of PRP samples in the presence of PAF</measure> <time_frame>Participants' platelet activity will be assessed for up to roughly 6 months through study completion</time_frame> <description>Platelet aggregation of participants' platelet-rich plasma samples (PRP) in the presence of the platelet agonist PAF will be assessed, using EC50 as a parameter.</description> </primary_outcome> <primary_outcome> <measure>Screening of plasma levels of cholesterol ( PL, LDL, HDL, VLDL).</measure> <time_frame>The outcomes of this testing will be assessed for up to roughly 6 months through study completion.</time_frame> <description>Platelet-rich plasma (PRP) levels of cholesterol ( PL, LDL, HDL, VLDL levels) will be assessed.</description> </primary_outcome> <primary_outcome> <measure>Screening plasma levels of inflammatory markers.</measure> <time_frame>The outcomes of this testing will be assessed for up to roughly 6 months through study completion.</time_frame> <description>Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-α, VEGF, VCAM-1 and PAFR) will all be screened.</description> </primary_outcome> <primary_outcome> <measure>Screening plasma levels of triglycerides.</measure> <time_frame>The outcomes of this testing will be assessed for up to roughly 6 months through study completion.</time_frame> <description>PRP levels of triglycerides will also be screened.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">20</enrollment> <condition>Cardiovascular Diseases</condition> <arm_group> <arm_group_label>Supplement Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of novel yogurt drink per day for a period of 28 days. Then, after a 2-week washout period in which the subjects do not take any yoghurt drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.</description> </arm_group> <arm_group> <arm_group_label>Placebo Group</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of placebo drink per day for a period of 28 days. Then, after a 2-week washout period in which the subjects do not take any placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Novel yogurt drink</intervention_name> <description>Novel ovine yogurt drink containing polar lipids</description> <arm_group_label>Supplement Group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo Drink</intervention_name> <description>Placebo drink (skimmed milk)</description> <arm_group_label>Placebo Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Healthy adults  Exclusion Criteria:  - Volunteers need to be off medication and off any dietary supplements.  - Subjects must not have any blood clotting disorders or dyslipidaemia.  - Dairy intake needs to be within a normal range of 1-2 portions a week.  - Unwilling to follow the study requirements. </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> <location> <facility> <name>University of Limerick</name> <address> <city>Limerick</city> <country>Ireland</country> </address> </facility> </location> <location_countries> <country>Ireland</country> </location_countries> <reference> <citation>Tsoupras A, Zabetakis I, Lordan R. Platelet aggregometry assay for evaluating the effects of platelet agonists and antiplatelet compounds on platelet function in vitro. MethodsX. 2018 Dec 26;6:63-70. doi: 10.1016/j.mex.2018.12.012. eCollection 2019.</citation> <PMID>30619728</PMID> </reference> <verification_date>November 2022</verification_date> <study_first_submitted>March 4, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>November 2, 2022</last_update_submitted> <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Limerick</investigator_affiliation> <investigator_full_name>Ioannis Zabetakis</investigator_full_name> <investigator_title>Head of Department of Biological Sciences</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Cardiovascular Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease. In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis. Inclusion Criteria: - Healthy adults Exclusion Criteria: - Volunteers need to be off medication and off any dietary supplements. - Subjects must not have any blood clotting disorders or dyslipidaemia. - Dairy intake needs to be within a normal range of 1-2 portions a week. - Unwilling to follow the study requirements.

NCT0531xxxx/NCT05318924.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/NCT05318924</url> </required_header> <id_info> <org_study_id>DFG KR 4555/7-1</org_study_id> <nct_id>NCT05318924</nct_id> </id_info> <brief_title>Effects of Ghrelin Administration on Dopamine and Effort</brief_title> <official_title>Will Work for Reward: Effects of Ghrelin Administration on Dopamine and Effort</official_title> <sponsors> <lead_sponsor> <agency>University Hospital Tuebingen</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>German Research Foundation</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University Hospital Tuebingen</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> Ghrelin is a stomach-derived hormone and the only known circulating peptide that stimulates appetite. Animal studies have conclusively shown that ghrelin increases dopaminergic neurotransmission and, thereby, enhances effort. However, similar evidence on the putative role of ghrelin in humans is still lacking. Here, the investigators propose to conduct a [11C]-raclopride PET/MR study after intravenous administration of ghrelin vs. saline in healthy individuals. First, during an intake visit, the investigators will assess fasting blood levels of hormones involved in appetitive behavior such as ghrelin, leptin, and insulin. In addition, the investigators will conduct a set of tasks that have been associated with dopamine function (i.e., effort and reinforcement learning). Second, the investigators will assess the effects of intravenous administration of ghrelin on dopamine signaling using a double-blind randomized cross-over design. To this end, participants will be infused with ghrelin (vs. saline) while we determine dopamine release (via PET imaging) and assess cerebral blood flow and functional connectivity at rest (via concurrent MR imaging). Furthermore, the investigators will conduct an instrumental motivation task (IMT) where participants have to exert physical effort to obtain rewards. Based on preclinical studies and indirect evidence from human studies, the investigators hypothesize that ghrelin will increase dopamine release in the striatum and that this will, in turn, lead to an increase in the willingness to work for rewards. Moreover, the investigators expect that ghrelin-induced dopamine release will be associated with an elevated tracking of reward utility in the mesolimbic circuit during the IMT, which is known to be associated with response vigor. Collectively, the proposed project would provide a unique resource to test an important link between the gut and the brain in the regulation of appetitive behavior. If ghrelin were to enhance effort expenditure for rewards via dopamine signaling in humans, then restoring sensitivity to ghrelin might be the more promising therapeutic approach compared to antagonizing the ghrelin receptor. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 21, 2022</start_date> <completion_date type="Anticipated">October 31, 2024</completion_date> <primary_completion_date type="Anticipated">December 20, 2023</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>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <intervention_model_description>The investigators will assess the effects of intravenous administration of ghrelin on dopamine signaling using a double-blind randomized cross-over design. To this end, 26 healthy participants will be infused with ghrelin (vs. saline) while we determine dopamine release (via PET imaging) and assess cerebral blood flow and functional connectivity at rest (via concurrent MR imaging). These 26 healthy participants will be drawn from a larger sample of 100 participants (including 50 patients with major depressive disorders), who will complete a reward task battery that will be associated with fasting blood levels of ghrelin.</intervention_model_description> <primary_purpose>Basic Science</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> <masking_description>Neither participants nor investigators will know whether the participant receives a ghrelin or saline infusion, which will be prepared by independent members of the university hospital.</masking_description> </study_design_info> <primary_outcome> <measure>Ghrelin-induced changes in dopamine release</measure> <time_frame>During the infusion (up to 90 min)</time_frame> <description>[11C]raclopride binding potential after ghrelin infusion vs. saline infusion</description> </primary_outcome> <primary_outcome> <measure>Ghrelin-induced changes in motivation</measure> <time_frame>During the infusion (60-90 min after start of the infusion)</time_frame> <description>Force exerted on grip force controller to obtain rewards after ghrelin infusion vs. saline infusion</description> </primary_outcome> <primary_outcome> <measure>Ghrelin-induced changes in functional connectivity and perfusion</measure> <time_frame>During the infusion (up to 90 min)</time_frame> <description>Functional connectivity and perfusion of regions of the reward circuit (i.e., Nucleus Accumbens and Ventral Tegmental Area/Substantia Nigra) after ghrelin infusion vs. saline infusion</description> </primary_outcome> <primary_outcome> <measure>Changes (Ghrelin-induced) in hunger and satiety from baseline</measure> <time_frame>Pre infusion and 20 minutes post infusion (compared to saline)</time_frame> <description>Change in visual analogue scale (0-100) measures of subjective hunger and satiety after ghrelin infusion vs. saline infusion</description> </primary_outcome> <secondary_outcome> <measure>Ghrelin-induced changes in mood</measure> <time_frame>Pre infusion and 20 minutes post infusion (compared to saline)</time_frame> <description>Changes operationalized via visual analogue ratings (0-100) of positive and negative affect schedule mood items after ghrelin infusion vs. saline infusion</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Major Depressive Disorder</condition> <arm_group> <arm_group_label>Ghrelin infusion</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>To achieve approximately stable elevated ghrelin levels during the infusion procedure, the investigators will use a loading dose of 1 mcg/kg as well as an infusion rate of 0.051 mcg/kg/min in line with recent studies (Farokhnia, Grodin, Lee et al., 2017) and general recommendations (Garin, Burns, Kaul et al., 2013).</description> </arm_group> <arm_group> <arm_group_label>Placebo infusion</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Saline</description> </arm_group> <arm_group> <arm_group_label>Patients with MDD</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Patients with major depressive disorder will be enrolled for comparison to healthy participants on the reward task battery, but not randomized to the ghrelin vs. saline infusion.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ghrelin</intervention_name> <description>Participants will receive an infusion that is intended to raise ghrelin level up to a steady plateau.</description> <arm_group_label>Ghrelin infusion</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Participants will receive a saline infusion as the placebo control condition.</description> <arm_group_label>Placebo infusion</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Healthy control participants: never fulfilled the criteria of any mood or anxiety disorder (except specific phobia)  - Patients with major depressive disorder: diagnosis according to DSM-5 within 12 months before enrollment and presence of at least mild symptoms at enrollment (BDI II >= 14)  Exclusion Criteria:  - lifetime history of a brain injury, schizophrenia, bipolar disorder, and a severe substance use disorder according to DSM-5  - obsessive-compulsive disorder, trauma- and stressor-related disorder, somatic symptom disorder, and eating disorder within a 12-month interval before the test day.  - Neuroimaging Study involving ghrelin infusion: contraindication for PET/MR (e.g., metal implants or prostheses, pregnancy, claustrophobia) </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>50 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Nils B Kroemer, PhD</last_name> <phone>+4970712982021</phone> <email>nils.kroemer@uni-tuebingen.de</email> </overall_contact> <overall_contact_backup> <last_name>Johannes Klaus, M.D.</last_name> <email>Johannes.Klaus@med.uni-tuebingen.de</email> </overall_contact_backup> <location> <facility> <name>Department of Psychiatry & Psychotherapy, University of Tübingen</name> <address> <city>Tübingen</city> <state>BW</state> <zip>72076</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Andrea Heberle</last_name> <email>Andrea.Heberle@med.uni-tuebingen.de</email> </contact> <investigator> <last_name>Nils B Kroemer, PhD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Matthias Reimold, M.D.</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Martin Walter, M.D.</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>February 2022</verification_date> <study_first_submitted>February 22, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>energy homeostasis</keyword> <keyword>PET/MR</keyword> <keyword>dopamine</keyword> <keyword>motivation</keyword> <keyword>ghrelin</keyword> <condition_browse>  <mesh_term>Depressive Disorder</mesh_term> <mesh_term>Depressive Disorder, Major</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>After the publication of the key results of the study, all anonymized imaging data will be made publicly available (e.g., at openfmri.org). Behavioral data will be shared after aggregation at the trial or participant level.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Analytic Code</ipd_info_type> <ipd_time_frame>Data will become available after an embargo period of 12 months after completion of the study.</ipd_time_frame> <ipd_access_criteria>Until the data is publicly available, researchers may contact the lead PI to gain access.</ipd_access_criteria> <ipd_url>http://neuromadlab.org</ipd_url> </patient_data>  </clinical_study>

Ghrelin is a stomach-derived hormone and the only known circulating peptide that stimulates appetite. Animal studies have conclusively shown that ghrelin increases dopaminergic neurotransmission and, thereby, enhances effort. However, similar evidence on the putative role of ghrelin in humans is still lacking. Here, the investigators propose to conduct a [11C]-raclopride PET/MR study after intravenous administration of ghrelin vs. saline in healthy individuals. First, during an intake visit, the investigators will assess fasting blood levels of hormones involved in appetitive behavior such as ghrelin, leptin, and insulin. In addition, the investigators will conduct a set of tasks that have been associated with dopamine function (i.e., effort and reinforcement learning). Second, the investigators will assess the effects of intravenous administration of ghrelin on dopamine signaling using a double-blind randomized cross-over design. To this end, participants will be infused with ghrelin (vs. saline) while we determine dopamine release (via PET imaging) and assess cerebral blood flow and functional connectivity at rest (via concurrent MR imaging). Furthermore, the investigators will conduct an instrumental motivation task (IMT) where participants have to exert physical effort to obtain rewards. Based on preclinical studies and indirect evidence from human studies, the investigators hypothesize that ghrelin will increase dopamine release in the striatum and that this will, in turn, lead to an increase in the willingness to work for rewards. Moreover, the investigators expect that ghrelin-induced dopamine release will be associated with an elevated tracking of reward utility in the mesolimbic circuit during the IMT, which is known to be associated with response vigor. Collectively, the proposed project would provide a unique resource to test an important link between the gut and the brain in the regulation of appetitive behavior. If ghrelin were to enhance effort expenditure for rewards via dopamine signaling in humans, then restoring sensitivity to ghrelin might be the more promising therapeutic approach compared to antagonizing the ghrelin receptor. Inclusion Criteria: - Healthy control participants: never fulfilled the criteria of any mood or anxiety disorder (except specific phobia) - Patients with major depressive disorder: diagnosis according to DSM-5 within 12 months before enrollment and presence of at least mild symptoms at enrollment (BDI II >= 14) Exclusion Criteria: - lifetime history of a brain injury, schizophrenia, bipolar disorder, and a severe substance use disorder according to DSM-5 - obsessive-compulsive disorder, trauma- and stressor-related disorder, somatic symptom disorder, and eating disorder within a 12-month interval before the test day. - Neuroimaging Study involving ghrelin infusion: contraindication for PET/MR (e.g., metal implants or prostheses, pregnancy, claustrophobia)

NCT0531xxxx/NCT05318937.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/NCT05318937</url> </required_header> <id_info> <org_study_id>718-CNP-202</org_study_id> <nct_id>NCT05318937</nct_id> </id_info> <brief_title>A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment</brief_title> <official_title>A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment</official_title> <sponsors> <lead_sponsor> <agency>Sage Therapeutics</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Sage Therapeutics</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 primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Parkinson's disease mild cognitive impairment (PD-MCI). </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 6, 2022</start_date> <completion_date type="Anticipated">September 2023</completion_date> <primary_completion_date type="Anticipated">September 2023</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>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change from Baseline to Day 42 in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score</measure> <time_frame>Baseline up to Day 42</time_frame> <description>WAIS-IV coding test is a valid and sensitive measure of cognitive dysfunction that correlates with real-world functional outcomes (e.g., the ability to accomplish everyday tasks) and recovery from functional disability used to assess processing speed. The participant is required to identify the symbols matched to numbers using a key and write in the symbol beneath the associated number. The total score ranges from 0 to 135 and is based on the total number of codes correctly completed over a 120-second time limit. Higher scores indicate better processing speed. Positive change from baseline indicates better processing speed.</description> </primary_outcome> <secondary_outcome> <measure>Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) and TEAEs by Severity</measure> <time_frame>Up to Day 70</time_frame> </secondary_outcome> <secondary_outcome> <measure>Number of Participants who Withdraw Due to Adverse Events (AEs)</measure> <time_frame>Up to Day 70</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">76</enrollment> <condition>Parkinson Disease</condition> <condition>Cognitive Dysfunction</condition> <arm_group> <arm_group_label>SAGE-718</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will receive SAGE-718 capsules, orally, once daily in the morning for 42 days.</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Participants will receive SAGE-718-matching placebo capsules, orally, once daily in the morning for 42 days.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>SAGE-718</intervention_name> <description>Softgel capsules</description> <arm_group_label>SAGE-718</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>SAGE-718-matching placebo</intervention_name> <description>Softgel capsules</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic Parkinson's disease (PD) according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria and meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria).  2. Meet the following criteria for MoCA: For participants meeting Level 1 PD-MCI criteria, have a Montreal Cognitive Assessment (MoCA) score of 20 to 25 (inclusive) at Screening; For participants meeting Level 2 PD-MCI criteria (within the past year), have a MoCA score of 18 to 25 (inclusive) at Screening.  3. Meet criteria for modified Hoehn & Yahr Stage I to III (mild to moderate motor severity) at Screening.  4. Have stable motor symptoms for at least 4 weeks prior to Screening, in the opinion of the investigator.  5. Must be able to complete the Color Trails Test 1 (including the ability to follow rater redirection and correct errors), and, based on participant's performance and investigator's opinion, participant is expected to be capable of engaging in prolonged cognitive testing for the duration of the study.  Exclusion Criteria:  1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia with Lewy bodies, Alzheimer's dementia, and vascular dementia.  2. Have any parkinsonism other than PD, including secondary parkinsonism or atypical parkinsonism.  3. In the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with PD that will interfere with completing study procedures.  4. Have an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study.  5. Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator.  6. Have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury.  7. Have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion). </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Adnan Mahmood, MD</last_name> <phone>1-617-982-9295</phone> <email>Adnan.Mahmood@sagerx.com</email> </overall_contact> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Sun City</city> <state>Arizona</state> <zip>85351</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Fresno</city> <state>California</state> <zip>93710</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Long Beach</city> <state>California</state> <zip>90806</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Reseda</city> <state>California</state> <zip>91335</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Englewood</city> <state>Colorado</state> <zip>80113</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Vernon</city> <state>Connecticut</state> <zip>06066</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Boca Raton</city> <state>Florida</state> <zip>33486</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Hialeah</city> <state>Florida</state> <zip>33012</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Miami</city> <state>Florida</state> <zip>33032</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Orlando</city> <state>Florida</state> <zip>32789</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Port Orange</city> <state>Florida</state> <zip>32127</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Tampa</city> <state>Florida</state> <zip>33613</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Decatur</city> <state>Georgia</state> <zip>30030</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Chicago</city> <state>Illinois</state> <zip>60611</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Kansas City</city> <state>Kansas</state> <zip>66160</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Albany</city> <state>New York</state> <zip>12208</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>New York</city> <state>New York</state> <zip>10019</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Stony Brook</city> <state>New York</state> <zip>11794-8121</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Woodmere</city> <state>New York</state> <zip>11598</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Cincinnati</city> <state>Ohio</state> <zip>45221</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43221</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Toledo</city> <state>Ohio</state> <zip>43614</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Memphis</city> <state>Tennessee</state> <zip>38157</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37232</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78229</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Burlington</city> <state>Vermont</state> <zip>05401</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location> <facility> <name>Sage Investigational Site</name> <address> <city>Virginia Beach</city> <state>Virginia</state> <zip>23502</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <email>clinicaltrialsinquiry@sagerx.com</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 3, 2023</last_update_submitted> <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 4, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Parkinson Disease</mesh_term> <mesh_term>Cognitive Dysfunction</mesh_term> <mesh_term>Cognition Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.</ipd_description> </patient_data>  </clinical_study>

The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance in participants with Parkinson's disease mild cognitive impairment (PD-MCI). Inclusion Criteria: 1. Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic Parkinson's disease (PD) according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria and meet MDS Task Force criteria for MCI in PD (excluding requirement for United Kingdom PD Brain Bank diagnostic criteria). 2. Meet the following criteria for MoCA: For participants meeting Level 1 PD-MCI criteria, have a Montreal Cognitive Assessment (MoCA) score of 20 to 25 (inclusive) at Screening; For participants meeting Level 2 PD-MCI criteria (within the past year), have a MoCA score of 18 to 25 (inclusive) at Screening. 3. Meet criteria for modified Hoehn & Yahr Stage I to III (mild to moderate motor severity) at Screening. 4. Have stable motor symptoms for at least 4 weeks prior to Screening, in the opinion of the investigator. 5. Must be able to complete the Color Trails Test 1 (including the ability to follow rater redirection and correct errors), and, based on participant's performance and investigator's opinion, participant is expected to be capable of engaging in prolonged cognitive testing for the duration of the study. Exclusion Criteria: 1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia with Lewy bodies, Alzheimer's dementia, and vascular dementia. 2. Have any parkinsonism other than PD, including secondary parkinsonism or atypical parkinsonism. 3. In the opinion of the investigator, be experiencing fluctuations in motor symptoms associated with PD that will interfere with completing study procedures. 4. Have an ongoing central nervous system condition other than PD that in the opinion of the investigator could influence the outcome of the study. 5. Have experienced significant psychotic symptoms, including hallucinations or delusions, within the past 3 months, in the opinion of the investigator. 6. Have a history of brain surgery, deep brain stimulation, or any history of hospitalization due to a brain injury. 7. Have a history, presence, and/or current evidence clinically relevant intracranial abnormality (e.g., stroke, hemorrhage, space-occupying lesion).

NCT0531xxxx/NCT05318950.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/NCT05318950</url> </required_header> <id_info> <org_study_id>NL66484.029.18</org_study_id> <nct_id>NCT05318950</nct_id> </id_info> <brief_title>A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon</brief_title> <acronym>UPHILL</acronym> <official_title>A nUtrition and Lifestyle Intervention in Patients With Pulmonary Arterial HypertensIon: Effect on quaLity of Life</official_title> <sponsors> <lead_sponsor> <agency>Amsterdam UMC, location VUmc</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Reinier de Graaf Groep</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Janssen-Cilag B.V.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Amsterdam UMC, location VUmc</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> Rationale: Nutrition and lifestyle interventions are currently not implemented in usual clinical care of PAH-patients. Mainly because there is little known on the relation between pathology, nutrition and lifestyle. Patients who suffer from Pulmonary Arterial Hypertension feel insecure about their nutrition and lifestyle. The investigators hypothesize that an intervention on nutrition and lifestyle can improve the patients' quality of life.  Objective: To explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from PAH.  Study design: Investigator initiated intervention study with control group. Study population: investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug related PAH, who have been stable for at least three months and are self-sufficient and/or have a family who's willing to participate in the lifestyle changes.  Intervention (if applicable): Nutritional status, - education, - intervention and - compliance.  Main study parameters/endpoints: This is an intervention study in which the investigators will asses the effect of a nutrition and lifestyle intervention on quality of life measured by SF-36 overall outcome with a significant difference of 6.35.  Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patient exists of 12 extra visits to the hospital and contact moments, over a period of 11 months, as well compliance to the diet and lifestyle. There is minimal risk in participation. </textblock> </brief_summary> <detailed_description> <textblock> Baseline nutritional assessment  Nutritional education:  8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding PH. All participants recieve workbook with assignments.  Nutritional intervention:  Group A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Group B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Control group: no diet.  Follow-up:  Patients in intervention arm followed for a period of 6 months to assess compliance. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 20, 2019</start_date> <completion_date type="Actual">February 16, 2022</completion_date> <primary_completion_date type="Actual">January 20, 2021</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>Sequential Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> <masking_description>Randomisation control and E-learning Randomisation Diet A and B</masking_description> </study_design_info> <primary_outcome> <measure>Change in quality of life</measure> <time_frame>Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)</time_frame> <description>To asses quality of life, the SF-36 questionnaire is used.</description> </primary_outcome> <secondary_outcome> <measure>Change in nutritional intake</measure> <time_frame>Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)</time_frame> <description>To asses dietary intake a food frequency questionnaire is used (HELIUS)</description> </secondary_outcome> <secondary_outcome> <measure>Change in vitamin and mineral status</measure> <time_frame>Baseline (week 0), after nutritional education (week 10), after nutritional intervention (week 24), after follow up (week 48)</time_frame> <description>A complete serum analyses is performed to asses vitamin and mineral status.</description> </secondary_outcome> <other_outcome> <measure>Change in exercise capacity</measure> <time_frame>Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks)</time_frame> <description>To determine exercise capacity subjects have to perform a six minute walking test</description> </other_outcome> <other_outcome> <measure>Change in heart rate variability</measure> <time_frame>Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks)</time_frame> <description>To determine heart rate variability all patients will receive a Fitbit smartwatch.</description> </other_outcome> <other_outcome> <measure>Change in daily activity</measure> <time_frame>Baseline (week 0), after nutritional intervention (week 24), after follow up (week 48). The Fitbit is worn by intervention group over total study time (48 weeks)</time_frame> <description>To determine changes in daily activity the number of steps will be assess by a Fitbit smartwatch</description> </other_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Pulmonary Arterial Hypertension</condition> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>No intervention</description> </arm_group> <arm_group> <arm_group_label>E-learning</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>E-learning: 8 lessons about nutrition and lifestyle</description> </arm_group> <arm_group> <arm_group_label>Diet A</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids)</description> </arm_group> <arm_group> <arm_group_label>Diet B</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>E-learning</intervention_name> <description>8 lessons about nutrition and lifestyle</description> <arm_group_label>Diet A</arm_group_label> <arm_group_label>Diet B</arm_group_label> <arm_group_label>E-learning</arm_group_label> </intervention> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Diet</intervention_name> <description>Diet A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Diet B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids)</description> <arm_group_label>Diet A</arm_group_label> <arm_group_label>Diet B</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Diagnosis of idiopathic PAH, hereditable PAH or drug related PAH  - Age between 18 and 80  - NYHA II or III and stable for at least 3 months, determined by a stable 6minute walk test with a difference of <10%.  - Self-sufficient and/or compliance from partner and/or family  - Creatinine > 30 ml/min  - Able to understand and willing to sign the Informed Consent Form  Exclusion Criteria:  - - Pregnant subjects  - Fat percentage < 10% > 50 %  - One or more of the following comorbidities: diabetes mellitus type one or two, clinically relevant thyroid disease  - Known history of noncompliance considering therapies </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>Anton Vonk Noordegraaf, prof. dr.</last_name> <role>Principal Investigator</role> <affiliation>VUMC</affiliation> </overall_official> <location> <facility> <name>VU medical center</name> <address> <city>Amsterdam</city> <state>Noord Holland</state> <zip>1008MB</zip> <country>Netherlands</country> </address> </facility> </location> <location_countries> <country>Netherlands</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>December 10, 2021</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation> <investigator_full_name>A. Vonk Noordegraaf</investigator_full_name> <investigator_title>Prof. Dr.</investigator_title> </responsible_party> <keyword>Nutrition</keyword> <keyword>Lifestyle</keyword> <condition_browse>  <mesh_term>Pulmonary Arterial Hypertension</mesh_term> <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term> <mesh_term>Hypertension</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Data of the study will be kept by the principal investigators and will be available for regulatory authorities. Subjects' personal data will be stored confidentially according to institutional routine. In principle, results will be published in peer-reviewed international journals.</ipd_description> </patient_data>  </clinical_study>

Rationale: Nutrition and lifestyle interventions are currently not implemented in usual clinical care of PAH-patients. Mainly because there is little known on the relation between pathology, nutrition and lifestyle. Patients who suffer from Pulmonary Arterial Hypertension feel insecure about their nutrition and lifestyle. The investigators hypothesize that an intervention on nutrition and lifestyle can improve the patients' quality of life. Objective: To explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from PAH. Study design: Investigator initiated intervention study with control group. Study population: investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug related PAH, who have been stable for at least three months and are self-sufficient and/or have a family who's willing to participate in the lifestyle changes. Intervention (if applicable): Nutritional status, - education, - intervention and - compliance. Main study parameters/endpoints: This is an intervention study in which the investigators will asses the effect of a nutrition and lifestyle intervention on quality of life measured by SF-36 overall outcome with a significant difference of 6.35. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patient exists of 12 extra visits to the hospital and contact moments, over a period of 11 months, as well compliance to the diet and lifestyle. There is minimal risk in participation. Baseline nutritional assessment Nutritional education: 8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding PH. All participants recieve workbook with assignments. Nutritional intervention: Group A: MedDASH diet (55% carbohydrates, 25% amino acids, 20% fatty acids) Group B: MedDASHfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) Control group: no diet. Follow-up: Patients in intervention arm followed for a period of 6 months to assess compliance. Inclusion Criteria: - Diagnosis of idiopathic PAH, hereditable PAH or drug related PAH - Age between 18 and 80 - NYHA II or III and stable for at least 3 months, determined by a stable 6minute walk test with a difference of <10%. - Self-sufficient and/or compliance from partner and/or family - Creatinine > 30 ml/min - Able to understand and willing to sign the Informed Consent Form Exclusion Criteria: - - Pregnant subjects - Fat percentage < 10% > 50 % - One or more of the following comorbidities: diabetes mellitus type one or two, clinically relevant thyroid disease - Known history of noncompliance considering therapies

NCT0531xxxx/NCT05318963.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/NCT05318963</url> </required_header> <id_info> <org_study_id>BM2L202102</org_study_id> <nct_id>NCT05318963</nct_id> </id_info> <brief_title>Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma</brief_title> <official_title>A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-AIO, a Triple-targeted Cell Preparation Targeting CD19/CD20/CD22, in Patients With Relapsed/Refractory B-cell Lymphoma</official_title> <sponsors> <lead_sponsor> <agency>Qiu Lugui</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Nanjing Legend Biotech Co.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Institute of Hematology & Blood Diseases Hospital, China</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> A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell lymphoma. </textblock> </brief_summary> <detailed_description> <textblock> This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LCAR-AIO in the patient ≥ 18 years of age with relapsed or refractory B cell lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LCAR-AIO injection. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment, and follow-up. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 14, 2022</start_date> <completion_date type="Anticipated">June 30, 2026</completion_date> <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date> <phase>Phase 1</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>Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)</measure> <time_frame>Minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description> </primary_outcome> <primary_outcome> <measure>Pharmacokinetics in peripheral blood</measure> <time_frame>Minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>CAR positive T cells and CAR transgene levels in peripheral blood after LCAR-AIO infusion.</description> </primary_outcome> <primary_outcome> <measure>Pharmacokinetics in bone marrow</measure> <time_frame>Minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>CAR positive T cells and CAR transgene levels in bone marrow after LCAR-AIO infusion.</description> </primary_outcome> <primary_outcome> <measure>The recommended Phase II dose (RP2D) for this cell therapy</measure> <time_frame>30 days after LCAR-AIO infusion</time_frame> <description>RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion</description> </primary_outcome> <secondary_outcome> <measure>Overall Response Rate (ORR)</measure> <time_frame>Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-AIO cell infusion</description> </secondary_outcome> <secondary_outcome> <measure>Progression-free survival (PFS)</measure> <time_frame>Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-AIO to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first</description> </secondary_outcome> <secondary_outcome> <measure>Overall Survival (OS)</measure> <time_frame>Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AIO to death of the subject</description> </secondary_outcome> <secondary_outcome> <measure>Time to Response (TTR)</measure> <time_frame>Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-AIO to the date of the first response evaluation of the subject who has met all criteria for CR or PR.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of Response (DoR)</measure> <time_frame>Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders</description> </secondary_outcome> <secondary_outcome> <measure>Immunogenicity assessment of LCAR-AIO cells</measure> <time_frame>Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)</time_frame> <description>The incidence of Anti-LCAR-AIO antibody in patients who received LCAR-AIO cells infusion</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">34</enrollment> <condition>B-cell Lymphoma Recurrent</condition> <condition>B-cell Lymphoma Refractory</condition> <arm_group> <arm_group_label>LCAR-AIO cells product</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level.</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>LCAR-AIO cells product</intervention_name> <description>before treatment with LCAR-AIO cells, subjects will receive a conditioning regimen (IV infusion of cyclophosphamide 300 mg/m^2 and fludarabine 30mg/m^2 once daily (QD) for 3 days.</description> <arm_group_label>LCAR-AIO cells product</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.  2. Aged 18-75 years (inclusive).  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.  4. Histologically confirmed B-cell lymphoma that expresses at least one of CD19/CD20/CD22.  5. At least one measurable tumor lesion determined according to Lugano 2014 criteria.  6. Response to prior therapy is consistent with one of the following:  1. Primary refractory: it means that the best response to first-line therapy (at least 2 cycles) is PD, or best response to first-line therapy (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;  2. Relapsed or refractory after 2 or more lines of therapy. Refractory is defined that best respond to the most recent treatment regimen (at least 2 cycles) is PD, or best response to the most recent treatment regimen (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;  3. Progression or relapse within 12 months after hematopoietic stem cell transplantation; if salvage therapy is applied after transplantation, the patient must be unresponsive or relapsed to the last line of therapy;  7. Life expectancy≥ 3 months  8. Clinical laboratory values meet screening visit criteria  9. Adequate organ function;  Exclusion Criteria:  Subject eligible for this study must not meet any of the following criteria:  1. Prior antitumor therapy with insufficient washout period ;  2. Patients who received dual-targeted CAR-T cell therapy (including but not limited to sequential infusion) at any time in the past, or who received CAR-T cell therapy of cameloid origin;  3. With acute or chronic graft-versus-host disease (GvHD);  4. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).  5. Known life-threatening allergies, hypersensitivity, or intolerance to LCAR-AIO CAR-T cell or its excipients, including DMSO (refer to Investigator's Brochure).  6. Pregnant or lactating women; </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Wei Liu</last_name> <phone>86-022-23909282</phone> <email>liuwei@ihcams.ac.cn</email> </overall_contact> <location> <facility> <name>Beijing Gobroad Boren Hospital</name> <address> <city>Beijing</city> <state>Beijing</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kai Hu</last_name> <phone>15010390336</phone> <email>xiaohu7079@sina.com</email> </contact> <investigator> <last_name>Kai Hu</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Institute of Hematology & Blood Diseases Hospital</name> <address> <city>Tianjin</city> <state>Tianjin</state> <zip>300020</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Wei Liu, MD</last_name> <phone>86-022-23909282</phone> <email>liuwei@ihcams.ac.cn</email> </contact> <investigator> <last_name>Lugui Qiu, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>China</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 1, 2023</last_update_submitted> <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 3, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Institute of Hematology & Blood Diseases Hospital, China</investigator_affiliation> <investigator_full_name>Qiu Lugui</investigator_full_name> <investigator_title>Leading site Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Lymphoma</mesh_term> <mesh_term>Lymphoma, B-Cell</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell lymphoma. This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LCAR-AIO in the patient ≥ 18 years of age with relapsed or refractory B cell lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LCAR-AIO injection. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment, and follow-up. Inclusion Criteria: 1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent. 2. Aged 18-75 years (inclusive). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically confirmed B-cell lymphoma that expresses at least one of CD19/CD20/CD22. 5. At least one measurable tumor lesion determined according to Lugano 2014 criteria. 6. Response to prior therapy is consistent with one of the following: 1. Primary refractory: it means that the best response to first-line therapy (at least 2 cycles) is PD, or best response to first-line therapy (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD; 2. Relapsed or refractory after 2 or more lines of therapy. Refractory is defined that best respond to the most recent treatment regimen (at least 2 cycles) is PD, or best response to the most recent treatment regimen (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD; 3. Progression or relapse within 12 months after hematopoietic stem cell transplantation; if salvage therapy is applied after transplantation, the patient must be unresponsive or relapsed to the last line of therapy; 7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria 9. Adequate organ function; Exclusion Criteria: Subject eligible for this study must not meet any of the following criteria: 1. Prior antitumor therapy with insufficient washout period ; 2. Patients who received dual-targeted CAR-T cell therapy (including but not limited to sequential infusion) at any time in the past, or who received CAR-T cell therapy of cameloid origin; 3. With acute or chronic graft-versus-host disease (GvHD); 4. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab). 5. Known life-threatening allergies, hypersensitivity, or intolerance to LCAR-AIO CAR-T cell or its excipients, including DMSO (refer to Investigator's Brochure). 6. Pregnant or lactating women;

NCT0531xxxx/NCT05318976.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/NCT05318976</url> </required_header> <id_info> <org_study_id>XPro1595-AD-02</org_study_id> <nct_id>NCT05318976</nct_id> </id_info> <brief_title>Study to Assess the Efficacy of XPro1595 in Patients With Mild Alzheimer's Disease With Biomarkers of Inflammation</brief_title> <acronym>MINDFuL</acronym> <official_title>A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Mild Alzheimer's Disease With Biomarkers of Inflammation.</official_title> <sponsors> <lead_sponsor> <agency>Inmune Bio, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Inmune Bio, Inc.</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> The purpose of this study is to measure cognitive and biological biomarkers in subcutaneously administered XPro1595 or placebo in patients with mild ADi. </textblock> </brief_summary> <detailed_description> <textblock> This study is designed as a double-blind randomized, placebo-controlled, study investigating the safety, tolerability, and efficacy of XPro1595 in patients with mild AD with inflammation (ADi). The planned dose is 1.0 mg/kg of XPro1595 and matching placebo. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 28, 2022</start_date> <completion_date type="Anticipated">June 19, 2024</completion_date> <primary_completion_date type="Anticipated">June 19, 2024</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> <intervention_model_description>(2:1) XPro1595 (1mg/kg), placebo Weekly subcutaneous injections</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)</measure> <time_frame>24 Weeks</time_frame> <description>Change in the Early and Mild Alzheimer's cognitive composite (EMACC) from Baseline to Week 24 in the following assessments: International Shopping List Test-Immediate recall (Word List learning Test) Digit Span Forward and Backward Category Fluency Test (DKEFS) Letter Fluency Test (DKEFS) Trail Making Test Parts A and B Digit Symbol Coding Test To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with mild AD</description> </primary_outcome> <secondary_outcome> <measure>Change in Clinical Dementia Rating (CDR)</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in Clinical Dementia Rating Scale (CDR) The CDR scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgement, and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None = 0, Questionable = 0.5, Mild = 1, Moderate = 2, and Severe = 3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment. To assess the effect of XPro1595 compared with placebo on cognition and global function in patients with mild AD</description> </secondary_outcome> <secondary_outcome> <measure>Change in apparent fiber density (AFD)</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in apparent fiber density (AFD) To assess the efficacy of XPro1595 compared with placebo on axonal integrity in patients with mild AD</description> </secondary_outcome> <secondary_outcome> <measure>Change in Everyday Cognition (E-Cog)</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in Everyday Cognition (E-Cog) To evaluate the effect of XPro1595 compared with placebo on E-Cog</description> </secondary_outcome> <secondary_outcome> <measure>Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) To assess the effect of XPro1595 compared with placebo on ADL in patients with mild AD.</description> </secondary_outcome> <secondary_outcome> <measure>Change in myelin content</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in free-water-corrected tissue Radial diffusivity and 1 of the following i) MRI-specific myelin contrast: ii) a magnetization transfer ratio (MTR) iii) an inhomogeneous magnetization transfer (MT) or iv) an myelin water fraction (MWF) map To assess the efficacy of XPro1595 compared with placebo on myelin in patients with mild AD.</description> </secondary_outcome> <secondary_outcome> <measure>Change in non-cognitive behavioral symptoms</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in (Neuropsychiatric Inventory [NPI] caregiver items) To assess the effect of XPro1595 compared with placebo on noncognitive behavioral symptoms in patients with mild AD</description> </secondary_outcome> <secondary_outcome> <measure>Change in gray matter integrity</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in Cortical Disarray Measurement (CDM®) To assess the efficacy of XPro1595 compared with placebo on gray matter integrity in patients with mild AD</description> </secondary_outcome> <secondary_outcome> <measure>Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)</measure> <time_frame>24 Weeks</time_frame> <description>Number of participants with a reduction in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration amyloid) from Baseline to Week 24. To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid).</description> </secondary_outcome> <secondary_outcome> <measure>Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)</measure> <time_frame>24 Weeks</time_frame> <description>Change from Baseline to Week 24 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau) To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)</description> </secondary_outcome> <secondary_outcome> <measure>Change in brain structure neurodegeneration</measure> <time_frame>24 Weeks</time_frame> <description>Changes from Baseline to Week 24 in volumetric magnetic resonance imaging (MRI) To assess the efficacy of XPro1595 compared with placebo on brain structure neurodegeneration</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants who experience adverse events and serious adverse events</measure> <time_frame>Baseline up to 28 days post last dose</time_frame> <description>Clinically significant abnormalities of laboratory values, physical findings, electrocardiogram findings and other safety assessments will be recorded as adverse events if the findings meet the defined criteria for adverse events.</description> </secondary_outcome> <other_outcome> <measure>Change in Goal Attainment Scale (GAS)</measure> <time_frame>24 Weeks</time_frame> <description>Change in individual goals based on the Goal Attainment Scale (GAS) The achievement of each goal is rated on a 5-point attainment scale (-2, -1, 0, +1, +2) to allow standardized scoring of personalized outcomes. A participant's overall goal attainment is quantified using a formula that takes into account the number of goals that have been set, and the extent to which they are correlated with each other. For each identified goal area, the caregiver will be asked to give a detailed description of the patient's current (baseline) status and goal status, which will be recorded at the -1 and 0 levels on the 5-point scale, respectively. The remaining levels of the scale will then be set: somewhat better than the goal (+1), much better than the goal (+2), and much worse than the goal (-2). To evaluate the effect of XPro1595 compared with placebo on goal attainment scores</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">201</enrollment> <condition>Alzheimer Disease</condition> <condition>Dementia</condition> <condition>Brain Diseases</condition> <condition>Central Nervous System Diseases</condition> <condition>Nervous System Diseases</condition> <condition>Tauopathies</condition> <condition>Neurodegenerative Diseases</condition> <condition>Neurocognitive Disorders</condition> <condition>Mental Disorders</condition> <arm_group> <arm_group_label>1.0 mg/kg XPro1595</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.</description> </arm_group> <arm_group> <arm_group_label>1.0 mg/kg Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>XPro1595</intervention_name> <description>XPro1595 will be delivered by subcutaneous injection once a week</description> <arm_group_label>1.0 mg/kg XPro1595</arm_group_label> <other_name>INB03/XPro™</other_name> <other_name>XENP1595</other_name> <other_name>DN-TNF</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo will be delivered by subcutaneous injection once a week</description> <arm_group_label>1.0 mg/kg Placebo</arm_group_label> <other_name>Matching Placebo</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  To be eligible for study entry, patients must satisfy all of the following criteria:  - Adult patients ≥ 60 years to ≤ 85 years of age at the time of consent;  - Diagnosed with mild dementia as clinically described in McKhann, (2011) and corresponding to stage 4 of the revised AD staging system (Jack, 2018). Patients who have received previous therapy for Alzheimer's disease may still be eligible;  - Amyloid positive (documented in medical history or assessed during screening through blood test);  - Either currently or previously (in pre-AD condition) literate and capable of reading, writing, and communicating effectively with others;  - Residence in an assisted living is allowed as is personal assistances provided in the home, however at time of enrollment participant must be able to perform most ADL with minimal assistance, and participant must be permitted sufficient independence to allow assessment of change in ADL;  - Has a caregiver willing to serve as a study partner for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which caregiver assessments are performed.  Exclusion Criteria:  Patients will be excluded from the study if 1 or more of the following criteria are applicable:  - Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners);  - Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility;  - Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer's prodrome. History of suicidality. History of substance abuse within 12 months; use of cannabis or cannabis products within 6 months of consent;  - Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have received treatment on another AD clinical trial within the last 60 days from Day 1;  - A prior organ or stem cell transplant;  - Seated blood pressure of ≥ 165/105 mmHg at Screening. </textblock> </criteria> <gender>All</gender> <minimum_age>60 Years</minimum_age> <maximum_age>85 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Therese Blomberg</last_name> <role>Study Director</role> <affiliation>INmune Bio</affiliation> </overall_official> <overall_contact> <last_name>INmune Bio</last_name> <phone>(858)964-3720</phone> <email>trials@inmunebio.com</email> </overall_contact> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Darlinghurst</city> <state>New South Wales</state> <zip>2010</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Macquarie Park</city> <state>New South Wales</state> <zip>2113</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Adelaide</city> <state>South Australia</state> <zip>5011</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Box Hill</city> <state>Victoria</state> <zip>3128</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Ivanhoe</city> <state>Victoria</state> <zip>3079</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Melbourne</city> <state>Victoria</state> <zip>3174</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Parkville</city> <state>Victoria</state> <zip>3050</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Perth</city> <state>Western Australia</state> <zip>6009</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Ottawa</city> <state>Ontario</state> <zip>K1Z 1G3</zip> <country>Canada</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location> <facility> <name>INmune Bio Investigational Site</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M4G 3E8</zip> <country>Canada</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>INmune Bio, Inc.</last_name> </contact> </location> <location_countries> <country>Australia</country> <country>Canada</country> </location_countries> <link> <url>https://www.alz.org/alzheimers-dementia/facts-figures</url> <description>Alzheimer's Association annual report releasing statistics regarding Alzheimer's disease</description> </link> <reference> <citation>Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006 May 17;295(19):2275-85. doi: 10.1001/jama.295.19.2275. Erratum In: JAMA. 2006 Jun 7;295(21):2482.</citation> <PMID>16705109</PMID> </reference> <reference> <citation>Chance SA, Clover L, Cousijn H, Currah L, Pettingill R, Esiri MM. Microanatomical correlates of cognitive ability and decline: normal ageing, MCI, and Alzheimer's disease. Cereb Cortex. 2011 Aug;21(8):1870-8. doi: 10.1093/cercor/bhq264. Epub 2011 Jan 14.</citation> <PMID>21239393</PMID> </reference> <reference> <citation>Chou RC, Kane M, Ghimire S, Gautam S, Gui J. Treatment for Rheumatoid Arthritis and Risk of Alzheimer's Disease: A Nested Case-Control Analysis. CNS Drugs. 2016 Nov;30(11):1111-1120. doi: 10.1007/s40263-016-0374-z.</citation> <PMID>27470609</PMID> </reference> <reference> <citation>Clark I, Atwood C, Bowen R, Paz-Filho G, Vissel B. Tumor necrosis factor-induced cerebral insulin resistance in Alzheimer's disease links numerous treatment rationales. Pharmacol Rev. 2012 Oct;64(4):1004-26. doi: 10.1124/pr.112.005850. Epub 2012 Sep 10.</citation> <PMID>22966039</PMID> </reference> <verification_date>March 2023</verification_date> <study_first_submitted>March 7, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 29, 2023</last_update_submitted> <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 31, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Inflammation</keyword> <keyword>Biomarker</keyword> <keyword>TNF</keyword> <condition_browse>  <mesh_term>Alzheimer Disease</mesh_term> <mesh_term>Nervous System Diseases</mesh_term> <mesh_term>Neurodegenerative Diseases</mesh_term> <mesh_term>Brain Diseases</mesh_term> <mesh_term>Central Nervous System Diseases</mesh_term> <mesh_term>Tauopathies</mesh_term> <mesh_term>Inflammation</mesh_term> <mesh_term>Mental Disorders</mesh_term> <mesh_term>Neurocognitive Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to measure cognitive and biological biomarkers in subcutaneously administered XPro1595 or placebo in patients with mild ADi. This study is designed as a double-blind randomized, placebo-controlled, study investigating the safety, tolerability, and efficacy of XPro1595 in patients with mild AD with inflammation (ADi). The planned dose is 1.0 mg/kg of XPro1595 and matching placebo. Inclusion Criteria: To be eligible for study entry, patients must satisfy all of the following criteria: - Adult patients ≥ 60 years to ≤ 85 years of age at the time of consent; - Diagnosed with mild dementia as clinically described in McKhann, (2011) and corresponding to stage 4 of the revised AD staging system (Jack, 2018). Patients who have received previous therapy for Alzheimer's disease may still be eligible; - Amyloid positive (documented in medical history or assessed during screening through blood test); - Either currently or previously (in pre-AD condition) literate and capable of reading, writing, and communicating effectively with others; - Residence in an assisted living is allowed as is personal assistances provided in the home, however at time of enrollment participant must be able to perform most ADL with minimal assistance, and participant must be permitted sufficient independence to allow assessment of change in ADL; - Has a caregiver willing to serve as a study partner for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which caregiver assessments are performed. Exclusion Criteria: Patients will be excluded from the study if 1 or more of the following criteria are applicable: - Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners); - Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility; - Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer's prodrome. History of suicidality. History of substance abuse within 12 months; use of cannabis or cannabis products within 6 months of consent; - Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have received treatment on another AD clinical trial within the last 60 days from Day 1; - A prior organ or stem cell transplant; - Seated blood pressure of ≥ 165/105 mmHg at Screening.

NCT0531xxxx/NCT05318989.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/NCT05318989</url> </required_header> <id_info> <org_study_id>1</org_study_id> <nct_id>NCT05318989</nct_id> </id_info> <brief_title>Genetic Aspects of Vaginal Aging</brief_title> <official_title>Epigenetic Profile of Vaginal Epithelial Cells in Postmenopausal Women and as a Result of Local Hormone Therapy, Assessed on the Basis of the Analysis of DNA Methylation Level and Expression of TET 1-3 Genes in Terms of the Aging Process</official_title> <sponsors> <lead_sponsor> <agency>Żelazna Medical Centre, LLC</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Laboratory of Genetics and Human Genomics, University of Gdańsk</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Żelazna Medical Centre, LLC</source> <oversight_info> <has_dmc>No</has_dmc> </oversight_info> <brief_summary> <textblock> Life expectancy depends on a number of different factors, of which only about 20-30% are genetically determined. The overwhelming majority are non-genetic determinants. One of the proposed mechanisms explaining this aging phenomenon is related to epigenome variability. Epigenetic regulation is mainly based on cytosine methylation / demethylation in DNA and modification of histone proteins. DNA methylation, unlike modification of histone proteins, is a permanent change, the effects of which can be very distant, and the methylation patterns are fixed during subsequent cell divisions. This type of epigenetic modification plays an important role in a variety of cellular processes, such as differentiation, transformation and aging. The most commonly methylated are cytosines within two nucleotide sequences in DNA called CpG islands. Numerous studies confirm the age-related reduction in methylcitosine (5-mC) levels in both the nuclear and mitochondrial genome of cells in various tissues. The enzymes that catalyze this process belong to the family of methyltransferases (DNMTs). Cytosine methylation appears to be one of the key processes in tissue aging. Depending on the type of tissue and DNA region, there is an increase or decrease in cytosine methylation with age. The main process of both passive and active demethylation is the hydroxymethylation of methylcytosine leading to the formation of hydroxymethylcytosine (5-hmC). This process is of great importance in the regulation of gene expression. Three hydroxylases, TET 1-3 enzymes (ten-eleven translocation), take part in the 5mC hydroxylation process in mammalian cells. The resulting 5-hmC is an important intermediate in the process of DNA demethylation. The significant decrease in the level of CpG island methylation in the genome also seems to be of key importance. So far, the role of 5mC, and thus the activity of TET enzymes in the aging process, has not been clearly defined. Previous studies have shown that it can play an important role in the development and aging of the body. In a woman's life, the consequences of the aging process are most severely manifested during the menopause. The deficiency of sex hormones determines a number of processes also occurring in the lower urinary tract. Estrogens are an essential regulator of the physiological function of the vagina. 40-60% of postmenopausal women complain of atrophic changes in the vaginal epithelium (VVA - vulvovaginal atrophy). Vaginal topical estrogens are currently the "gold standard" in VVA therapy. The molecular mechanism of action of estrogens is based on their activation of the estrogen receptors ER-alpha and ER-beta located in the nuclear envelope of cells in target organs. After the ligand binds to the appropriate receptor, a cascade of signals activating the appropriate chromatin-binding transcription factors is triggered. As a result of this process, the expression of genes involved in the processes of proliferation, differentiation as well as apoptosis changes. Therefore, local administration of estrogens is the most effective in improving the physiological condition of the vaginal mucosa epithelium. The question arises, how do hormonal deficiencies appearing in the menopausal period affect epigenetic changes in the genome and, consequently, the modification of gene expression related to the aging processes of the organism? Does the use of hormone therapy affect the regulation of gene expression through changes in the level of genome methylation? Can the determination of the level of total methylation in vaginal mucosa cells serve as a marker of the advancement of the aging process? Additionally, will the assessment of the degree of demethylation of the genome of vaginal mucosa cells by analyzing the level of expression of genes encoding TET 1-3 enzymes and the total level of 5mC allow characterizing epigenetic changes occurring in menopausal women? Is it possible to identify specific genes whose methylation-dependent expression regulates aging? Obtaining answers to such questions may contribute to understanding the role of the epigenome in the aging process of cells, and opening up new possibilities for the implementation of more effective therapies. It is also crucial that the vaginal epithelium is generally not exposed to known environmental factors influencing the course of aging (e.g. UV radiation), and thus the observed epigenetic changes in vaginal epithelial cells should reflect the impact of hormonal disorders on the molecular mechanism of aging. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">February 8, 2021</start_date> <completion_date type="Actual">July 10, 2023</completion_date> <primary_completion_date type="Actual">June 28, 2023</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>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>5-hmC content</measure> <time_frame>30 days</time_frame> <description>- 5-hmC content and 5-mC increase in tissues with urogenital atrophy</description> </primary_outcome> <primary_outcome> <measure>TET expressiion</measure> <time_frame>30 days</time_frame> <description>- TET expression in tissues with urogenital atrophy</description> </primary_outcome> <primary_outcome> <measure>Changes in the 5-hmC</measure> <time_frame>30 days</time_frame> <description>- changes in the 5-hmC content and the 5-mC content in vaginal cells after hormone therapy (topical application of estrogens)</description> </primary_outcome> <primary_outcome> <measure>TET expression change</measure> <time_frame>30 days</time_frame> <description>- TET expression change after hormone therapy</description> </primary_outcome> <secondary_outcome> <measure>Promoter methylation of specific genes involved in the aging process</measure> <time_frame>30 days</time_frame> <description>- Methylome analysis to identify promoter methylation of specific genes involved in the aging process</description> </secondary_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Actual">120</enrollment> <condition>Genitourinary Agents</condition> <arm_group> <arm_group_label>Premenopausal women (PREM)</arm_group_label> <description>Control group</description> </arm_group> <arm_group> <arm_group_label>Postmenopausal women (POSMA)</arm_group_label> <description>Test group A : postmenopausal women not treated with topical estrogens</description> </arm_group> <arm_group> <arm_group_label>Postmenopausal women (POSMB)</arm_group_label> <description>Test group B: postmenopausal women treated with topical estrogens</description> </arm_group> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> vaginal swabs, buccal swabs, vaginal wall samples </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Study population description: Women treated in Urogynecological Unit of St. Sophia Hospital in Warsaw (outpatients and hospitalized) who meet the inclusion criteria. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - informed consent of the patient  - patient's age> 18 years  - POP-Q < = II  - non-smoker  - without prior vaginal surgery  Exclusion Criteria:  - refusal to participate in the study  - POP-Q > II  - smoking  - internal diseases (diabetes, disorders of the thyroid gland, obesity, cancer, malnutrition, exhaustion) </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Centrum Medyczne "ŻELAZNA"</name> <address> <city>Warsaw</city> <zip>01-004</zip> <country>Poland</country> </address> </facility> </location> <location_countries> <country>Poland</country> </location_countries> <reference> <citation>Palma F, Volpe A, Villa P, Cagnacci A; Writing group of AGATA study. Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. Maturitas. 2016 Jan;83:40-4. doi: 10.1016/j.maturitas.2015.09.001. Epub 2015 Sep 14.</citation> <PMID>26421474</PMID> </reference> <reference> <citation>Borkowska J, Domaszewska-Szostek A, Kolodziej P, Wicik Z, Polosak J, Buyanovskaya O, Charzewski L, Stanczyk M, Noszczyk B, Puzianowska-Kuznicka M. Alterations in 5hmC level and genomic distribution in aging-related epigenetic drift in human adipose stem cells. Epigenomics. 2020 Mar;12(5):423-437. doi: 10.2217/epi-2019-0131. Epub 2020 Feb 7.</citation> <PMID>32031421</PMID> </reference> <reference> <citation>Truong TP, Sakata-Yanagimoto M, Yamada M, Nagae G, Enami T, Nakamoto-Matsubara R, Aburatani H, Chiba S. Age-Dependent Decrease of DNA Hydroxymethylation in Human T Cells. J Clin Exp Hematop. 2015;55(1):1-6. doi: 10.3960/jslrt.55.1.</citation> <PMID>26105999</PMID> </reference> <reference> <citation>Gorodeski GI. Aging and estrogen effects on transcervical-transvaginal epithelial permeability. J Clin Endocrinol Metab. 2005 Jan;90(1):345-51. doi: 10.1210/jc.2004-1223. Epub 2004 Oct 13.</citation> <PMID>15483084</PMID> </reference> <reference> <citation>Li D, Guo B, Wu H, Tan L, Lu Q. TET Family of Dioxygenases: Crucial Roles and Underlying Mechanisms. Cytogenet Genome Res. 2015;146(3):171-80. doi: 10.1159/000438853. Epub 2015 Aug 21.</citation> <PMID>26302812</PMID> </reference> <verification_date>July 2023</verification_date> <study_first_submitted>February 24, 2022</study_first_submitted> <study_first_submitted_qc>April 7, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 11, 2023</last_update_submitted> <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Żelazna Medical Centre, LLC</investigator_affiliation> <investigator_full_name>Jacek Szymański</investigator_full_name> <investigator_title>Jacek Szymański MD, PhD</investigator_title> </responsible_party> <keyword>vulvovaginal atrophy</keyword> <keyword>genitourinary syndrome of menopause</keyword> <keyword>aging</keyword> <keyword>5-hydroxymethylcytosine</keyword> <keyword>5-hmC</keyword> <keyword>5-methylcytosine</keyword> <keyword>ten-eleven translocation</keyword> <keyword>TET enzymes</keyword>  </clinical_study>

Life expectancy depends on a number of different factors, of which only about 20-30% are genetically determined. The overwhelming majority are non-genetic determinants. One of the proposed mechanisms explaining this aging phenomenon is related to epigenome variability. Epigenetic regulation is mainly based on cytosine methylation / demethylation in DNA and modification of histone proteins. DNA methylation, unlike modification of histone proteins, is a permanent change, the effects of which can be very distant, and the methylation patterns are fixed during subsequent cell divisions. This type of epigenetic modification plays an important role in a variety of cellular processes, such as differentiation, transformation and aging. The most commonly methylated are cytosines within two nucleotide sequences in DNA called CpG islands. Numerous studies confirm the age-related reduction in methylcitosine (5-mC) levels in both the nuclear and mitochondrial genome of cells in various tissues. The enzymes that catalyze this process belong to the family of methyltransferases (DNMTs). Cytosine methylation appears to be one of the key processes in tissue aging. Depending on the type of tissue and DNA region, there is an increase or decrease in cytosine methylation with age. The main process of both passive and active demethylation is the hydroxymethylation of methylcytosine leading to the formation of hydroxymethylcytosine (5-hmC). This process is of great importance in the regulation of gene expression. Three hydroxylases, TET 1-3 enzymes (ten-eleven translocation), take part in the 5mC hydroxylation process in mammalian cells. The resulting 5-hmC is an important intermediate in the process of DNA demethylation. The significant decrease in the level of CpG island methylation in the genome also seems to be of key importance. So far, the role of 5mC, and thus the activity of TET enzymes in the aging process, has not been clearly defined. Previous studies have shown that it can play an important role in the development and aging of the body. In a woman's life, the consequences of the aging process are most severely manifested during the menopause. The deficiency of sex hormones determines a number of processes also occurring in the lower urinary tract. Estrogens are an essential regulator of the physiological function of the vagina. 40-60% of postmenopausal women complain of atrophic changes in the vaginal epithelium (VVA - vulvovaginal atrophy). Vaginal topical estrogens are currently the "gold standard" in VVA therapy. The molecular mechanism of action of estrogens is based on their activation of the estrogen receptors ER-alpha and ER-beta located in the nuclear envelope of cells in target organs. After the ligand binds to the appropriate receptor, a cascade of signals activating the appropriate chromatin-binding transcription factors is triggered. As a result of this process, the expression of genes involved in the processes of proliferation, differentiation as well as apoptosis changes. Therefore, local administration of estrogens is the most effective in improving the physiological condition of the vaginal mucosa epithelium. The question arises, how do hormonal deficiencies appearing in the menopausal period affect epigenetic changes in the genome and, consequently, the modification of gene expression related to the aging processes of the organism? Does the use of hormone therapy affect the regulation of gene expression through changes in the level of genome methylation? Can the determination of the level of total methylation in vaginal mucosa cells serve as a marker of the advancement of the aging process? Additionally, will the assessment of the degree of demethylation of the genome of vaginal mucosa cells by analyzing the level of expression of genes encoding TET 1-3 enzymes and the total level of 5mC allow characterizing epigenetic changes occurring in menopausal women? Is it possible to identify specific genes whose methylation-dependent expression regulates aging? Obtaining answers to such questions may contribute to understanding the role of the epigenome in the aging process of cells, and opening up new possibilities for the implementation of more effective therapies. It is also crucial that the vaginal epithelium is generally not exposed to known environmental factors influencing the course of aging (e.g. UV radiation), and thus the observed epigenetic changes in vaginal epithelial cells should reflect the impact of hormonal disorders on the molecular mechanism of aging. vaginal swabs, buccal swabs, vaginal wall samples Study population description: Women treated in Urogynecological Unit of St. Sophia Hospital in Warsaw (outpatients and hospitalized) who meet the inclusion criteria. Inclusion Criteria: - informed consent of the patient - patient's age> 18 years - POP-Q < = II - non-smoker - without prior vaginal surgery Exclusion Criteria: - refusal to participate in the study - POP-Q > II - smoking - internal diseases (diabetes, disorders of the thyroid gland, obesity, cancer, malnutrition, exhaustion)

NCT0531xxxx/NCT05319002.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/NCT05319002</url> </required_header> <id_info> <org_study_id>HTC-01</org_study_id> <nct_id>NCT05319002</nct_id> </id_info> <brief_title>Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC)</brief_title> <acronym>HTC</acronym> <official_title>Randomized Trial on the Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: a Path Analytic and Supervised Machine Learning Approach</official_title> <sponsors> <lead_sponsor> <agency>University of Pisa</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Pisa</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> Background and study aims:  The Eye Movement Desensitization and Reprocessing Group Protocol with Children (EMDR-GP/C) was first developed by Korkmazlar following the Marmara earthquake in Turkey in 1999 and can be adapted for different populations. The aim of this study is to assess if a EMDR-GP program may help primary school students in improving narrative complexity and specificity of autobiographical memories, as well as their subjective unit of distress (SUD) and validity of cognition (VoC).  Who can participate? Students attending the fourth or fifth year of primary school  What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo a 3-week EMDR-GP with weekly 60-minute group sessions (3 sessions), while the control group will follow routine daily school activities.  Questionnaires will be used to assess narrative complexity, specificity of autobiographical memories, SUD and VoC before and after the intervention.  What are the possible benefits and risks of participating? Benefits of participating in the study may include an improvement of narrative complexity, specificity of autobiographical memories, and their SUD and VoC. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">August 20, 2021</start_date> <completion_date type="Actual">November 30, 2021</completion_date> <primary_completion_date type="Actual">October 31, 2021</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>Supportive Care</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Event coding - Pre-intervention</measure> <time_frame>Event coding is measured before the 3-week group EMDR intervention</time_frame> <description>Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome</description> </primary_outcome> <primary_outcome> <measure>Memory specificity level - Pre-intervention</measure> <time_frame>Memory specificity level is measured before the 3-week group EMDR intervention</time_frame> <description>Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome</description> </primary_outcome> <primary_outcome> <measure>Narrative complexity level - Pre-intervention</measure> <time_frame>Narrative complexity level is measured before the 3-week group EMDR intervention</time_frame> <description>Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.</description> </primary_outcome> <primary_outcome> <measure>Subjective Unit of Distress - Pre-intervention</measure> <time_frame>Subjective Unit of Distress is measured before the 3-week group EMDR intervention</time_frame> <description>Subjective Unit of Distress is measured using a self-reporting scale with a 0- to 10-point rating scale. Higher scores mean a worse outcome</description> </primary_outcome> <primary_outcome> <measure>Validity of Cognition - Pre-intervention</measure> <time_frame>Validity of Cognition is measured before the 3-week group EMDR intervention</time_frame> <description>Validity of Cognition is measured using a self-reporting scale with a 1- to 7-point rating scale. Higher scores mean a better outcome</description> </primary_outcome> <primary_outcome> <measure>Event coding - Post-intervention</measure> <time_frame>Event coding is measured after the 3-week group EMDR intervention</time_frame> <description>Event coding is measured using Manual for Coding Events in Self Defining Memories. "Relationship" nominal score means a better outcome</description> </primary_outcome> <primary_outcome> <measure>Memory specificity level - Post-intervention</measure> <time_frame>Memory specificity level is measured after the 3-week group EMDR intervention</time_frame> <description>Memory specificity level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Specific" nominal score means a better outcome</description> </primary_outcome> <primary_outcome> <measure>Narrative complexity level - Post-intervention</measure> <time_frame>Narrative complexity level is measured after the 3-week group EMDR intervention</time_frame> <description>Narrative complexity level is measured using Coding System for autobiographical Memory Narratives in Psychotherapy. Higher scores mean a better outcome.</description> </primary_outcome> <primary_outcome> <measure>Subjective Unit of Distress - Post-intervention</measure> <time_frame>Subjective Unit of Distress is measured after the 3-week group EMDR intervention</time_frame> <description>Subjective Unit of Distress is measured using a self-reporting scale with a 0- to 10-point rating scale. Higher scores mean a worse outcome</description> </primary_outcome> <primary_outcome> <measure>Validity of Cognition - Post-intervention</measure> <time_frame>Validity of Cognition is measured after the 3-week group EMDR intervention</time_frame> <description>Validity of Cognition is measured using a self-reporting scale with a 1- to 7-point rating scale. Higher scores mean a better outcome</description> </primary_outcome> <secondary_outcome> <measure>Autobiographical memory definition - Pre-intervention</measure> <time_frame>Autobiographical memory definition is measured before the 3-week group EMDR intervention</time_frame> <description>Autobiographical memory definition is measured using Coding System for Autobiographical Memory Narratives in Psychotherapy. "Autobiographic" nominal score means a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Memory integration level - Pre-intervention</measure> <time_frame>Memory integration level is measured before the 3-week group EMDR intervention</time_frame> <description>Memory integration level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Integrated" nominal score means a better outcome</description> </secondary_outcome> <secondary_outcome> <measure>Autobiographical memory definition - Post-intervention</measure> <time_frame>Autobiographical memory definition is measured after the 3-week group EMDR intervention</time_frame> <description>Autobiographical memory definition is measured using Coding System for Autobiographical Memory Narratives in Psychotherapy. "Autobiographic" nominal score means a better outcome.</description> </secondary_outcome> <secondary_outcome> <measure>Memory integration level - Post-intervention</measure> <time_frame>Memory integration level is measured after the 3-week group EMDR intervention</time_frame> <description>Memory integration level is measured using Classification System and Scoring for Self-defining Autobiographical Memories. "Integrated" nominal score means a better outcome</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">27</enrollment> <condition>Child, Only</condition> <condition>Narration</condition> <condition>Memory Dysfunction</condition> <condition>Distress, Emotional</condition> <condition>Cognitive Change</condition> <arm_group> <arm_group_label>Group EMDR</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants in the experimental group will undergo a 3-week group EMDR intervention with weekly 60-minute group sessions.</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The control group will follow routine daily school activities</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Group EMDR</intervention_name> <description>The eight phases of the adapted group EMDR protocol was administered during each session: 1. Meeting: Explaining the nature of trauma, group rules, name tags, filling in the scales. 2. Preparation: Exploring children's support system, explaining EMDR, safe place, resource exercise, and installation with bilateral stimulation (BLS, butterfly hug or knee tapping). 3. Assessment: Drawing the worst image on a small separate sheet of paper, SUD level, (negative cognition, emotions, body sensations - if possible). 4. Desensitization: It is done with drawing on 4 separate papers with BLS (butterfly hug or knee tapping). 5. Installation: With the healing story written according to the adaptive information processing (AIP) model, the installation is accompanied BLS. 6. Body scan: A positive body state is installed with the relaxation technique. 7. Closure & future template: Strong closure with artwork. 8. Re-evaluation: if possible.</description> <arm_group_label>Group EMDR</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Children aged 9 to 11 years  2. Children have reasonable comprehension of spoken language and can follow simple instructions  3. Children and their parents are willing to attend all intervention sessions  4. Children and parents have an adequate understanding of Italian  Exclusion Criteria:  1. Concurrent enrollment in other intervention trials  2. Child regularly practices EMDR intervention, or other therapeutical interventions, such as cognitive behavioral therapy or meditation. </textblock> </criteria> <gender>All</gender> <minimum_age>9 Years</minimum_age> <maximum_age>11 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Andrea Poli, Psy.D.</last_name> <role>Principal Investigator</role> <affiliation>University of Pisa</affiliation> </overall_official> <location> <facility> <name>University of Pisa</name> <address> <city>Pisa</city> <zip>56126</zip> <country>Italy</country> </address> </facility> </location> <location_countries> <country>Italy</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 31, 2022</last_update_submitted> <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Pisa</investigator_affiliation> <investigator_full_name>Andrea Poli</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Child</keyword> <keyword>EMDR</keyword> <keyword>Narrative complexity</keyword> <keyword>Autobiographical memories</keyword> <keyword>Distress</keyword> <keyword>Cognition</keyword> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Raw data are available on request.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> </patient_data>  </clinical_study>

Background and study aims: The Eye Movement Desensitization and Reprocessing Group Protocol with Children (EMDR-GP/C) was first developed by Korkmazlar following the Marmara earthquake in Turkey in 1999 and can be adapted for different populations. The aim of this study is to assess if a EMDR-GP program may help primary school students in improving narrative complexity and specificity of autobiographical memories, as well as their subjective unit of distress (SUD) and validity of cognition (VoC). Who can participate? Students attending the fourth or fifth year of primary school What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo a 3-week EMDR-GP with weekly 60-minute group sessions (3 sessions), while the control group will follow routine daily school activities. Questionnaires will be used to assess narrative complexity, specificity of autobiographical memories, SUD and VoC before and after the intervention. What are the possible benefits and risks of participating? Benefits of participating in the study may include an improvement of narrative complexity, specificity of autobiographical memories, and their SUD and VoC. Inclusion Criteria: 1. Children aged 9 to 11 years 2. Children have reasonable comprehension of spoken language and can follow simple instructions 3. Children and their parents are willing to attend all intervention sessions 4. Children and parents have an adequate understanding of Italian Exclusion Criteria: 1. Concurrent enrollment in other intervention trials 2. Child regularly practices EMDR intervention, or other therapeutical interventions, such as cognitive behavioral therapy or meditation.

NCT0531xxxx/NCT05319015.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/NCT05319015</url> </required_header> <id_info> <org_study_id>STU-2021-1240</org_study_id> <nct_id>NCT05319015</nct_id> </id_info> <brief_title>Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus</brief_title> <official_title>Safety and Efficacy of Neoadjuvant Lenvatinib and Pembrolizumab in Patients With Renal Cell Carcinoma and IVC Tumor Thrombus</official_title> <sponsors> <lead_sponsor> <agency>University of Texas Southwestern Medical Center</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Texas Southwestern Medical Center</source> <oversight_info> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study will be evaluating safety and efficacy of the combination of lenvatinib and pembolizumab neoaadjuvant therapy prior to surgical resection of locally advanced renal cell carcinoma with IVC tumor thrombus. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 6, 2023</start_date> <completion_date type="Anticipated">August 2025</completion_date> <primary_completion_date type="Anticipated">August 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>Disease Control Rate</measure> <time_frame>12 weeks</time_frame> <description>Evaluation of changes in size of primary tumor and size and level of IVC tumor thrombus on imaging due to neoadjuvant therapy prior to surgery.</description> </primary_outcome> <primary_outcome> <measure>Local and Metastatic Progression Rate</measure> <time_frame>12 weeks</time_frame> <description>Evaluation of local or metastatic progression on imaging prior to surgery following neoadjuvant therapy.</description> </primary_outcome> <primary_outcome> <measure>90 Day Post-Operative Complications</measure> <time_frame>13 weeks</time_frame> <description>Assessment of 90 day post-operative safety and morbidity of neoadjuvant therapy by evaluating the incidence of 90 day post-operative grade 3-5 adverse events.</description> </primary_outcome> <secondary_outcome> <measure>Estimated blood loss</measure> <time_frame>1 week</time_frame> <description>Estimated blood loss in mL during surgery</description> </secondary_outcome> <secondary_outcome> <measure>Operative time</measure> <time_frame>1 week</time_frame> <description>Operative time in minutes of surgery, length of stay, and intra-operative and post-operative complications</description> </secondary_outcome> <secondary_outcome> <measure>Length of stay</measure> <time_frame>1 week</time_frame> <description>Length of stay of hospital stay for surgery in days, and intra-operative and post-operative complications</description> </secondary_outcome> <secondary_outcome> <measure>Intra-operative complications</measure> <time_frame>1 week</time_frame> <description>Complications that occur during surgery</description> </secondary_outcome> <secondary_outcome> <measure>Post-operative complications</measure> <time_frame>12 weeks</time_frame> <description>Complications that occur in the post-operative period</description> </secondary_outcome> <secondary_outcome> <measure>Survival Outcomes</measure> <time_frame>3 years</time_frame> <description>Evaluation of post-operative survival outcomes including recurrence-free survival and overall survival.</description> </secondary_outcome> <other_outcome> <measure>Exploratory Outcomes</measure> <time_frame>24 weeks</time_frame> <description>Identify metabolic signatures in plasma that are noninvasive predictors of therapy response and identify metabolic alterations following neoadjuvant therapy in patients who do and do not respond.</description> </other_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Renal Cell Carcinoma</condition> <arm_group> <arm_group_label>Treatment Arm</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients receive neoadjuvant lenvatinib (20 mg PO daily) for 12 weeks and pembrolizumab (200 mg IV every 3 weeks for four doses) prior to surgical resection of locally advanced RCC with IVC tumor thrombus. Following surgery, patients will receive adjuvant pembrolizumab (200 mg IV every 3 weeks for up to thirteen doses).</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Neoadjuvant Lenvatinib</intervention_name> <description>20 mg PO daily for 12 weeks prior to surgery</description> <arm_group_label>Treatment Arm</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Neoadjuvant Pembrolizumab</intervention_name> <description>200 mg IV every 3 weeks for 4 doses prior to surgery</description> <arm_group_label>Treatment Arm</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Radical nephrectomy, IVC thrombectomy, retroperitoneal lymph node dissection</intervention_name> <description>Resection of locally advanced RCC with IVC tumor thrombus</description> <arm_group_label>Treatment Arm</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Adjuvant Pembrolizumab</intervention_name> <description>200 mg IV every 3 weeks for up to 13 doses after surgery</description> <arm_group_label>Treatment Arm</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Male/female participants who are at least 18 years of age  - Have histologically confirmed cT3-4,N0-1,M0-1 (clinical stage III-IV) diagnosis of renal cell carcinoma (any subtype) with level II-IV inferior vena cava tumor thrombus  - The primary tumor and thrombus may be assessed to be resectable or unresectable at the time of enrollment  - Male participants: A male participant must agree to use a protocol-approved contraception during the 120 day neoadjuvant treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.  - Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:  1. Not a woman of childbearing potential (WOCBP) OR  2. A WOCBP who agrees to follow the protocol-approved contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.  - The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.  - Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.  - Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.  - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.  - Have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study intervention.  - Absolute neutrophil count (ANC): ≥1500/µL  - Platelets: ≥100 000/µL  - Hemoglobin: ≥9.0 g/dL or ≥ 5.6 mmol/La  - Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN  - Total bilirubin: ≤1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN  - AST (SGOT) and ALT (SGPT): ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)  - International normalized ratio (INR) OR prothrombin time (PT) OR Activated partial thromboplastin time (aPTT): ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants  - ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.  - Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.  - Creatinine clearance (CrCl) should be calculated per institutional standard.  - Note: This includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.  Exclusion Criteria:  - A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.  - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).  - Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.  - Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.  - Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccines are permitted provided they are not live attenuated vaccines.  - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.  - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.  - Has a known additional malignancy that is progressing or has required active treatment within the past year. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer, bladder in situ) that have undergone potentially curative therapy are not excluded.  - Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.  - Has more than three different sites of metastatic renal cell carcinoma.  - Has severe hypersensitivity (≥Grade 3) to pembrolizumab and lenvatinib and/or any of its excipients.  - Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.  - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.  - Has an active infection requiring systemic therapy.  - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.  - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.  - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.  - Has had an allogenic tissue/solid organ transplant.  - Has prolongation of QTcF interval to >480 ms.  - Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)  - Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted  - Has urine protein ≥1 g/24 hours. Note: Participants with proteinuria ≥2+>1+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.  - Uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication. </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>Vitaly Margulis, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Texas Southwestern Medical Center</affiliation> </overall_official> <overall_contact> <last_name>Donna Mitchell</last_name> <phone>214-645-8787</phone> <email>donna.mitchell@utsouthwestern.edu</email> </overall_contact> <overall_contact_backup> <last_name>Doreen Simonsen</last_name> <phone>214-645-8790</phone> <email>doreen.simonsen@utsouthwestern.edu</email> </overall_contact_backup> <location> <facility> <name>University of Texas Southwestern Medical Center</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75390</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Vitaly Margulis</last_name> <phone>214-648-0567</phone> <email>vitaly.margulis@utsouthwestern.edu</email> </contact> <contact_backup> <last_name>MD</last_name> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>February 6, 2023</last_update_submitted> <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 8, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation> <investigator_full_name>Vitaly Margulis</investigator_full_name> <investigator_title>Professor of Medicine</investigator_title> </responsible_party> <keyword>Renal Cell Carcinoma</keyword> <keyword>IVC tumor thrombus</keyword> <keyword>Neoadjuvant therapy</keyword> <keyword>Immunotherapy</keyword> <keyword>Nephrectomy</keyword> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Carcinoma, Renal Cell</mesh_term> <mesh_term>Thrombosis</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Pembrolizumab</mesh_term> <mesh_term>Lenvatinib</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study will be evaluating safety and efficacy of the combination of lenvatinib and pembolizumab neoaadjuvant therapy prior to surgical resection of locally advanced renal cell carcinoma with IVC tumor thrombus. Inclusion Criteria: - Male/female participants who are at least 18 years of age - Have histologically confirmed cT3-4,N0-1,M0-1 (clinical stage III-IV) diagnosis of renal cell carcinoma (any subtype) with level II-IV inferior vena cava tumor thrombus - The primary tumor and thrombus may be assessed to be resectable or unresectable at the time of enrollment - Male participants: A male participant must agree to use a protocol-approved contraception during the 120 day neoadjuvant treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. - Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the protocol-approved contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment. - The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. - Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. - Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. - Have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study intervention. - Absolute neutrophil count (ANC): ≥1500/µL - Platelets: ≥100 000/µL - Hemoglobin: ≥9.0 g/dL or ≥ 5.6 mmol/La - Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN - Total bilirubin: ≤1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN - AST (SGOT) and ALT (SGPT): ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) - International normalized ratio (INR) OR prothrombin time (PT) OR Activated partial thromboplastin time (aPTT): ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants - ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. - Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. - Creatinine clearance (CrCl) should be calculated per institutional standard. - Note: This includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies. Exclusion Criteria: - A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137). - Has received prior systemic anti-cancer therapy including investigational agents prior to allocation. - Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. - Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccines are permitted provided they are not live attenuated vaccines. - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. - Has a known additional malignancy that is progressing or has required active treatment within the past year. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer, bladder in situ) that have undergone potentially curative therapy are not excluded. - Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. - Has more than three different sites of metastatic renal cell carcinoma. - Has severe hypersensitivity (≥Grade 3) to pembrolizumab and lenvatinib and/or any of its excipients. - Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Has an active infection requiring systemic therapy. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. - Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. - Has had an allogenic tissue/solid organ transplant. - Has prolongation of QTcF interval to >480 ms. - Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO) - Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted - Has urine protein ≥1 g/24 hours. Note: Participants with proteinuria ≥2+>1+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria. - Uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication.

NCT0531xxxx/NCT05319028.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/NCT05319028</url> </required_header> <id_info> <org_study_id>CX-659-401</org_study_id> <nct_id>NCT05319028</nct_id> </id_info> <brief_title>Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)</brief_title> <official_title>A Phase 2 Study of Mivavotinib in Biomarker-Defined Subgroups of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)</official_title> <sponsors> <lead_sponsor> <agency>Calithera Biosciences, Inc</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Calithera Biosciences, Inc</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>No</is_us_export> </oversight_info> <brief_summary> <textblock> Study CX-659-401 is a multicenter, open-label, phase 2 study of mivavotinib to evaluate the single-agent activity of mivavotinib in patients with relapsed/refractory non-GCB/ABC DLBCL, incorporating ctDNA-based next-generation sequencing (NGS) to identify DLBCL patients harboring MyD88 and/or CD79B mutations within the study. This goal of this strategy is to evaluate its activity both in the cell-of-origin subgroup of non-GCB/ABC DLBCL and in the genetically defined subgroups of MyD88/CD79B-mutated and wild type DLBCL. </textblock> </brief_summary> <detailed_description> <textblock> Approximately 50 patients will be randomized 1:1 to one of two dose/schedule cohorts: one with a continuous dosing schedule (100 mg QD) and one with an induction dosing schedule (120 mg QD x 14 days, then 80 mg QD starting Day 15). Patients will receive treatment with mivavotinib until disease progression, unacceptable toxicity, withdrawal of consent, or death. </textblock> </detailed_description> <overall_status>Terminated</overall_status> <why_stopped> Sponsor Decision </why_stopped> <start_date type="Actual">June 23, 2022</start_date> <completion_date type="Actual">February 24, 2023</completion_date> <primary_completion_date type="Actual">February 24, 2023</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>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Overall Response Rate (ORR) as assessed by an independent radiology review committee (IRC) according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).</measure> <time_frame>Start of treatment up to 21 months</time_frame> <description>Overall response is defined as a complete response (CR) or partial response (PR). ORR is the proportion of participants who have overall responses.</description> </primary_outcome> <primary_outcome> <measure>Safety as measured by type, incidence, severity, seriousness, and study drug-relatedness of adverse events per Common Terminology Criteria for Adverse Events, version 5</measure> <time_frame>Start of treatment up to 21 months</time_frame> <description>Type, incidence, severity, seriousness, and study drug-relatedness of AEs assessed by CTCAE v5.0</description> </primary_outcome> <secondary_outcome> <measure>Duration of Response (DOR) Rate as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).</measure> <time_frame>Start of treatment up to 21 months</time_frame> <description>DOR per IRC. DOR will be calculated as the time between the first documentation of partial response (PR) or a complete response (CR) to the first documentation of progressive disease or death, whichever occurs first.</description> </secondary_outcome> <secondary_outcome> <measure>Progression-Free Survival (PFS) as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).</measure> <time_frame>Start of treatment up to 21 months</time_frame> <description>PFS per IRC. PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the IRC or death from any cause, whichever occurs first.</description> </secondary_outcome> <secondary_outcome> <measure>Complete Response (CR) Rate as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).</measure> <time_frame>Start of treatment to 21 months</time_frame> <description>CR rate per IRC according to the 2014 IWG Lugano criteria (Cheson, 2014)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">2</enrollment> <condition>Non-GCB/ABC Diffuse Large B-Cell Lymphoma</condition> <condition>With and Without MyD88 and/or CD79B Mutations</condition> <arm_group> <arm_group_label>Continuous Dosing Schedule</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Mivavotinib 100 mg once daily (QD)</description> </arm_group> <arm_group> <arm_group_label>Induction Dosing Schedule</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Mivavotinib 120 mg QD for 14 days, then 80 mg QD starting Day 15</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Mivavotinib</intervention_name> <description>oral tablet</description> <arm_group_label>Continuous Dosing Schedule</arm_group_label> <arm_group_label>Induction Dosing Schedule</arm_group_label> <other_name>CB-659</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Male or female patients aged 18 years or older  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2  3. Life expectancy of > 3 months  4. Histologically confirmed de novo or transformed non-GCB DLBCL.  5. Relapsed or refractory to ≥ 2 prior lines of chemotherapy based on standard of care  6. Patients should not have failed more than 5 prior lines of therapy  7. Must have [18F]Fluorodeoxyglucose-positron emission tomography (FDG-PET)-avid measurable disease that meets the size criteria per International Working Group (IWG) criteria.  8. Must have recovered from adverse events of prior anti-cancer therapy to severity ≤ Grade 1.  9. Adequate organ function as assessed by laboratory values.  10. If female of childbearing potential, agreement to use protocol specified contraception methods. If male, agreement to use an effective barrier method of contraception.  Exclusion Criteria:  1. DLBCL with central nervous system (CNS) involvement with active brain or leptomeningeal disease  2. Known human immunodeficiency (HIV; testing not required) or HIV-related malignancy  3. Known hepatitis B surface antigen positive or known or active hepatitis C infection  4. Prior autologous stem cell transplant (ASCT) or chimeric antigen receptor T-cell (CAR-T) cell infusion within 90 days of screening  5. Prior allogeneic stem cell transplantation  6. Unstable/inadequate cardiac function  7. Known gastrointestinal (GI) disease or GI procedure that interferes with swallowing/absorption of oral drug  8. Major surgery within 14 days before the first dose of study drug  9. Serious infection (bacterial/fungal/viral) requiring parenteral antibiotic/antiviral therapy for >5 days within 21 days prior to first dose of study drug  10. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of mivavotinib.  11. Use of medication known to be inhibitors or inducers of P-glycoprotein (P-gp) and/or Cytochrome P (CYP)3A  12. Female patients who are pregnant, lactating or breastfeeding.  13. Any radiation therapy within 3 weeks prior to first dose of study treatment.  14. Systemic anticancer treatment within 3 weeks before first dose of study treatment </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>100 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Northwestern University</name> <address> <city>Evanston</city> <state>Illinois</state> <zip>60208</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Henry Ford Health</name> <address> <city>Detroit</city> <state>Michigan</state> <zip>48202</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>University Hospitals Cleveland Medical Center</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44106</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Toledo Clinic Cancer Center</name> <address> <city>Toledo</city> <state>Ohio</state> <zip>43623</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>University of Pennsylvania</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19104</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>The University of Texas, M. D. Anderson Cancer Center</name> <address> <city>Houston</city> <state>Texas</state> <zip>77030</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>The University of Texas Health Science Center at San Antonio</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78229</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>March 31, 2023</last_update_submitted> <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 4, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Mivavotinib</keyword> <keyword>DLBCL</keyword> <keyword>MyD88</keyword> <keyword>CD79b</keyword> <keyword>non-GCB</keyword> <keyword>ABC</keyword> <keyword>NHL</keyword> <keyword>CB-659</keyword> <keyword>Relapsed/Refractory</keyword> <condition_browse>  <mesh_term>Lymphoma</mesh_term> <mesh_term>Lymphoma, B-Cell</mesh_term> <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term> </condition_browse>  </clinical_study>

Study CX-659-401 is a multicenter, open-label, phase 2 study of mivavotinib to evaluate the single-agent activity of mivavotinib in patients with relapsed/refractory non-GCB/ABC DLBCL, incorporating ctDNA-based next-generation sequencing (NGS) to identify DLBCL patients harboring MyD88 and/or CD79B mutations within the study. This goal of this strategy is to evaluate its activity both in the cell-of-origin subgroup of non-GCB/ABC DLBCL and in the genetically defined subgroups of MyD88/CD79B-mutated and wild type DLBCL. Approximately 50 patients will be randomized 1:1 to one of two dose/schedule cohorts: one with a continuous dosing schedule (100 mg QD) and one with an induction dosing schedule (120 mg QD x 14 days, then 80 mg QD starting Day 15). Patients will receive treatment with mivavotinib until disease progression, unacceptable toxicity, withdrawal of consent, or death. Inclusion Criteria: 1. Male or female patients aged 18 years or older 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 3. Life expectancy of > 3 months 4. Histologically confirmed de novo or transformed non-GCB DLBCL. 5. Relapsed or refractory to ≥ 2 prior lines of chemotherapy based on standard of care 6. Patients should not have failed more than 5 prior lines of therapy 7. Must have [18F]Fluorodeoxyglucose-positron emission tomography (FDG-PET)-avid measurable disease that meets the size criteria per International Working Group (IWG) criteria. 8. Must have recovered from adverse events of prior anti-cancer therapy to severity ≤ Grade 1. 9. Adequate organ function as assessed by laboratory values. 10. If female of childbearing potential, agreement to use protocol specified contraception methods. If male, agreement to use an effective barrier method of contraception. Exclusion Criteria: 1. DLBCL with central nervous system (CNS) involvement with active brain or leptomeningeal disease 2. Known human immunodeficiency (HIV; testing not required) or HIV-related malignancy 3. Known hepatitis B surface antigen positive or known or active hepatitis C infection 4. Prior autologous stem cell transplant (ASCT) or chimeric antigen receptor T-cell (CAR-T) cell infusion within 90 days of screening 5. Prior allogeneic stem cell transplantation 6. Unstable/inadequate cardiac function 7. Known gastrointestinal (GI) disease or GI procedure that interferes with swallowing/absorption of oral drug 8. Major surgery within 14 days before the first dose of study drug 9. Serious infection (bacterial/fungal/viral) requiring parenteral antibiotic/antiviral therapy for >5 days within 21 days prior to first dose of study drug 10. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of mivavotinib. 11. Use of medication known to be inhibitors or inducers of P-glycoprotein (P-gp) and/or Cytochrome P (CYP)3A 12. Female patients who are pregnant, lactating or breastfeeding. 13. Any radiation therapy within 3 weeks prior to first dose of study treatment. 14. Systemic anticancer treatment within 3 weeks before first dose of study treatment

NCT0531xxxx/NCT05319041.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/NCT05319041</url> </required_header> <id_info> <org_study_id>R1675/72/2019</org_study_id> <secondary_id>2019/2957</secondary_id> <nct_id>NCT05319041</nct_id> </id_info> <brief_title>Herbal Medication to Treat Dry Eye in Peri/ Post-menopausal Women</brief_title> <official_title>Randomised Placebo Controlled Study of Herbal Medication to Treat Dry Eye in Peri/ Post-menopausal Women</official_title> <sponsors> <lead_sponsor> <agency>Singapore National Eye Centre</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Singapore Chung Hwa Medical Institute</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Singapore National Eye Centre</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> Dry eye disease (DED) in less severe forms are very common, and should ideally be treated outside hospitals, eg., through primary care services and exploiting holistic therapies such as traditional medicine. This will keep the care affordable and accessible despite a large burden of care.  Postmenopausal women, compared to others in the population, have a higher incidence of DED. Large-scale epidemiological studies done in the United States have shown that the rate of DED in women over 50 years old is nearly double that in men over 50, at 7% and 4%, respectively. Studies have demonstrated that there is a hormonal etiology behind this group's susceptibility to DED, although the precise hormonal imbalance and mechanistic pathway for DED are still unclear.  A significant number of women seen at the dry eye clinic are post-menopausal, and very symptomatic, though many do not have the corneal epitheliopathy evidenced by dye staining. Such patients are not likely to benefit from conventional prescription drugs for dry eye, such as cyclosporine and corticosteroids. Hormonal replacement therapy for menopausal women has not been universally accepted, and there may be an increased risk of carcinomas, on the other hand, topical hormonal therapy for dry eye is not widely available, and still controversial, so there is a definite unmet need for new therapeutic modalities to treat dry eye in post-menopausal women.  Traditional Chinese Medicine (TCM) is a form of complementary medicine that aims to treat yin or yang deficiency syndromes, using modalities like herbs, acupuncture or moxibustion. Menopause in women, particularly in Asia, has been linked to yin-deficiency, in one study, 73% of Chinese post-menopausal women suffered from kidney yin-deficiency. A review of randomized controlled trials of TCM treatment showed that certain modalities like soy and phytoestrogens have been useful in the treatment of syndromes in menopause, such as hot flushes. </textblock> </brief_summary> <detailed_description> <textblock> The overall hypothesis is that the Traditional Chinese Medicine (TCM) modality of a specific herbal formulation can improve the symptoms and signs of post-menopausal dry eye in women, and objectively, these improvements are associated with improvement of dry eye symptoms, and alteration of levels of tear eicosanoids or cytokines.  TCM in the treatment of dry eye A meta-analysis of TCM in treatment of Sjogren's syndrome showed that TCM is promising but there were some flaws in the studies reviewed.  Jiang et al, in particular has found that mistletoe, in combination with carboxymethylcellulose eyedrops were effective in reducing dry eye symptoms and signs, compared to normal saline eyedrops, in post-menopausal women.Unfortunately, the authors did not compare the effect of this combination with carboxymetholycellulose eyedrops, a commonly used artificial tear, per se.  In postmenopausal women, dry eye is not only more common, but the symptoms may be confused/related to mood changes like depression and anxiety, and sleep disorders, all of which were linked to the post-menopausal state, where there may be yin deficiency.  Recently the investigators found acupuncture to be useful in the treatment of elderly people with lung-kidney yin-deficiency type of dry eye in Singapore. In addition, TCM Practitioners in Singapore were interested in the treatment of dry eye. However, no study has evaluated the use of TCM herbs in peri-menopausal patients with dry eye in robust way.  Previous studies by the senior TCM collaborator, Prof Wei QP has concluded that steaming treatment by (Wei's Qi Ju Gan Lu Formula) combined with sodium hyaluronate eye drops could improve the objective indexes like TBUT and corneal staining as well as subjective symptoms in peri-menopausal patients with aqueous tear deficiency dry eye of liver and kidney deficiency. Prof Wei has also studied treatment of dry eye through oral medication (with the method of strengthening the water element to nourish wood element under the TCM perspective) combined with artificial tears, and concluded that the prescription can effectively treat dry eyes by promoting the tear secretion and prolonging BUT. Recently, the investigators have also discovered that herbal medication have a trend to lower the tear levels of inflammatory proteins (journal under review). Hence, this current study intends to follow-up with the effectiveness of oral medication of (Wei's Qi Ju Gan Lu Formula) for patients suffering from peri/ post-menopausal dry eye disease of the "Liver-Kidney yin deficiency" pattern differentiation.  1.1.1 Rationale for the Study Purpose Clinical significance Traditional Chinese Medicine (TCM), when combined with psychotherapy, has been shown to be effective in targeting yin-deficiency in the treatment of menopause, although the effect of such treatment on dry eye symptoms has not been specifically investigated.  If TCM is effective in the treatment of post-menopausal women, it can be implemented at the primary care level, so relieving the specialist centers of this type of patients, thereby saving health-care costs. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 11, 2022</start_date> <completion_date type="Anticipated">November 2024</completion_date> <primary_completion_date type="Anticipated">November 2024</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>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Change in SPEED score</measure> <time_frame>3 months</time_frame> <description>To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic)</description> </primary_outcome> <secondary_outcome> <measure>Change in SPEED score</measure> <time_frame>4 months</time_frame> <description>To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic)</description> </secondary_outcome> <secondary_outcome> <measure>Change in Sleep score</measure> <time_frame>3 months</time_frame> <description>To assess the improvement of sleep score. 0 score is the minimum (no sleeping issue); 24 score is the maximum (high risk of Epworth Sleepiness Scale)</description> </secondary_outcome> <secondary_outcome> <measure>Change in Depression score</measure> <time_frame>3 months</time_frame> <description>To assess the improvement in depression score. 0 score is the minimum (no sign of depression); 48 score is the maximum (very likely to have depression)</description> </secondary_outcome> <secondary_outcome> <measure>Change in TCM score (Liver-Kidney Yin Deficiency)</measure> <time_frame>3 months</time_frame> <description>To assess the change in TCM score. Liver-Kidney Yin deficiency is within the range from 14-30. (score <14 not diagnosed as Liver-Kidney Yin Deficiency); (score 14-20 Liver-Kidney Yin deficiency Type I- Level 1 mild); (score 21-30 Liver-Kidney Yin deficiency Type II- Level 2 moderate); (score >30 Liver-Kidney Yin deficiency Type III- Level 3 severe)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">150</enrollment> <condition>Dry Eye</condition> <arm_group> <arm_group_label>Active herbal capsules</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Wei's Qi Ju Gan Lu Formula is a herbal formulation initiated by the senior TCM collaborator, Prof Wei QP. This TCM formulation is prescribed to treat the dry eye patients with "liver-kidney yin deficiency". The treatment regulation aims to nourish the Liver and Kidney, enrich yin deficiency, in order to promote tears production, hence treatment of Dry Eye.</description> </arm_group> <arm_group> <arm_group_label>Placebo capsules</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Placebo capsule which contains 0.5g maltodextrin without any herbs medicine.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Wei's Qi Ju Gan Lu Formula</intervention_name> <description>The formulation, Wei's Qi Ju Gan Lu Formula, is initiated by the senior TCM collaborator, Prof Wei QP, is formulated to treat the dry eye patients with "liver-kidney yin deficiency". The treatment regulation aims to nourish the Liver and Kidney, enrich yin deficiency, in order to promote tears production, hence treatment of Dry Eye.</description> <arm_group_label>Active herbal capsules</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>0.5g maltodextrin without any herbs medicine</description> <arm_group_label>Placebo capsules</arm_group_label> <other_name>0.5g maltodextrin without any herbs medicine</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Age 40-79 years old women  2. Peri and Post-menopausal women  3. Chief complaint of participant should be consistent with dry eye symptoms based on SPEED Questionnaire, with a score of > 6 (Appendix 5)  4. History of presenting TCM score symptoms:  4.1. TCM dry eye assessment score (Appendix 3) The pattern deviation can be determined if 3 or more main symptoms are present (one of which is a localized eye symptom and one of which is a system symptom), together with at least one accompanying symptom.  4.2 Liver-Kidney yin deficiency assessment score (Appendix 4) This form is to determine the extent of Liver-Kidney Yin Deficiency (assessed at SCHMI).  Any score<14 will not satisfy the criterion for Liver Kidney Yin Deficiency and will not be recruited. This detailed TCM score will also be a secondary outcome measure in the analysis of pre/post herbal treatment (see below).  5. Clinical signs:  5.1. Tear break up time (TBUT) ≤10s or Schirmer I test ≤10mm/5 mins  6. Normal renal and liver function at baseline, i.e., all parameters within the reference value  Exclusion Criteria:  1. Currently or intention to use hormonal therapy (eg. cancer patients who is on tamoxifen)  2. Currently pregnant or breastfeeding  3. Hysterectomy procedure done previously  4. Removal of cysts or polyp procedure done previously  5. Requirement to wear contact lens, and having worn such lenses in week preceding eligibility  6. Glaucoma, significant cataract, age related macular degeneration or other ophthalmic disease, eg. Extraocular muscle palsies, facial paralysis, ectropion, entropion, trichiasis  7. Requirement of any eyedrops other than artificial tears.  8. Previous eye surgeries including LASIK (within 6 months) or punctal plugs in-situ  9. Autoimmune systemic diseases: Steven-Johnson syndrome, Sjogren's syndrome, Rheumatoid Arthritis, Lupus  10. Systemic disease requiring regular medication (except hypertension and lipidemia) </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Peri and Post-menopausal women age between 40-79 years old</gender_description> <minimum_age>40 Years</minimum_age> <maximum_age>79 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Louis Tong, PhD</last_name> <role>Principal Investigator</role> <affiliation>Singapore National Eye Centre</affiliation> </overall_official> <overall_contact> <last_name>Cynthia Boo, BsC</last_name> <phone>98206648</phone> <email>cynthia.boo.s.k@singhealth.com.sg</email> </overall_contact> <location> <facility> <name>Singapore National Eye Centre</name> <address> <city>Singapore</city> <country>Singapore</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Louis Tong, PhD</last_name> <email>louis.tong.h.t@singhealth.com.sg</email> </contact> </location> <location_countries> <country>Singapore</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 31, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>April 10, 2023</last_update_submitted> <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Singapore National Eye Centre</investigator_affiliation> <investigator_full_name>Louis Tong</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Menopausal women</keyword> <keyword>Herbal treatment</keyword> <keyword>Quality of Life</keyword> <keyword>eicosanoids</keyword> <keyword>cytokines</keyword> <condition_browse>  <mesh_term>Dry Eye Syndromes</mesh_term> <mesh_term>Keratoconjunctivitis Sicca</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Dry eye disease (DED) in less severe forms are very common, and should ideally be treated outside hospitals, eg., through primary care services and exploiting holistic therapies such as traditional medicine. This will keep the care affordable and accessible despite a large burden of care. Postmenopausal women, compared to others in the population, have a higher incidence of DED. Large-scale epidemiological studies done in the United States have shown that the rate of DED in women over 50 years old is nearly double that in men over 50, at 7% and 4%, respectively. Studies have demonstrated that there is a hormonal etiology behind this group's susceptibility to DED, although the precise hormonal imbalance and mechanistic pathway for DED are still unclear. A significant number of women seen at the dry eye clinic are post-menopausal, and very symptomatic, though many do not have the corneal epitheliopathy evidenced by dye staining. Such patients are not likely to benefit from conventional prescription drugs for dry eye, such as cyclosporine and corticosteroids. Hormonal replacement therapy for menopausal women has not been universally accepted, and there may be an increased risk of carcinomas, on the other hand, topical hormonal therapy for dry eye is not widely available, and still controversial, so there is a definite unmet need for new therapeutic modalities to treat dry eye in post-menopausal women. Traditional Chinese Medicine (TCM) is a form of complementary medicine that aims to treat yin or yang deficiency syndromes, using modalities like herbs, acupuncture or moxibustion. Menopause in women, particularly in Asia, has been linked to yin-deficiency, in one study, 73% of Chinese post-menopausal women suffered from kidney yin-deficiency. A review of randomized controlled trials of TCM treatment showed that certain modalities like soy and phytoestrogens have been useful in the treatment of syndromes in menopause, such as hot flushes. The overall hypothesis is that the Traditional Chinese Medicine (TCM) modality of a specific herbal formulation can improve the symptoms and signs of post-menopausal dry eye in women, and objectively, these improvements are associated with improvement of dry eye symptoms, and alteration of levels of tear eicosanoids or cytokines. TCM in the treatment of dry eye A meta-analysis of TCM in treatment of Sjogren's syndrome showed that TCM is promising but there were some flaws in the studies reviewed. Jiang et al, in particular has found that mistletoe, in combination with carboxymethylcellulose eyedrops were effective in reducing dry eye symptoms and signs, compared to normal saline eyedrops, in post-menopausal women.Unfortunately, the authors did not compare the effect of this combination with carboxymetholycellulose eyedrops, a commonly used artificial tear, per se. In postmenopausal women, dry eye is not only more common, but the symptoms may be confused/related to mood changes like depression and anxiety, and sleep disorders, all of which were linked to the post-menopausal state, where there may be yin deficiency. Recently the investigators found acupuncture to be useful in the treatment of elderly people with lung-kidney yin-deficiency type of dry eye in Singapore. In addition, TCM Practitioners in Singapore were interested in the treatment of dry eye. However, no study has evaluated the use of TCM herbs in peri-menopausal patients with dry eye in robust way. Previous studies by the senior TCM collaborator, Prof Wei QP has concluded that steaming treatment by (Wei's Qi Ju Gan Lu Formula) combined with sodium hyaluronate eye drops could improve the objective indexes like TBUT and corneal staining as well as subjective symptoms in peri-menopausal patients with aqueous tear deficiency dry eye of liver and kidney deficiency. Prof Wei has also studied treatment of dry eye through oral medication (with the method of strengthening the water element to nourish wood element under the TCM perspective) combined with artificial tears, and concluded that the prescription can effectively treat dry eyes by promoting the tear secretion and prolonging BUT. Recently, the investigators have also discovered that herbal medication have a trend to lower the tear levels of inflammatory proteins (journal under review). Hence, this current study intends to follow-up with the effectiveness of oral medication of (Wei's Qi Ju Gan Lu Formula) for patients suffering from peri/ post-menopausal dry eye disease of the "Liver-Kidney yin deficiency" pattern differentiation. 1.1.1 Rationale for the Study Purpose Clinical significance Traditional Chinese Medicine (TCM), when combined with psychotherapy, has been shown to be effective in targeting yin-deficiency in the treatment of menopause, although the effect of such treatment on dry eye symptoms has not been specifically investigated. If TCM is effective in the treatment of post-menopausal women, it can be implemented at the primary care level, so relieving the specialist centers of this type of patients, thereby saving health-care costs. Inclusion Criteria: 1. Age 40-79 years old women 2. Peri and Post-menopausal women 3. Chief complaint of participant should be consistent with dry eye symptoms based on SPEED Questionnaire, with a score of > 6 (Appendix 5) 4. History of presenting TCM score symptoms: 4.1. TCM dry eye assessment score (Appendix 3) The pattern deviation can be determined if 3 or more main symptoms are present (one of which is a localized eye symptom and one of which is a system symptom), together with at least one accompanying symptom. 4.2 Liver-Kidney yin deficiency assessment score (Appendix 4) This form is to determine the extent of Liver-Kidney Yin Deficiency (assessed at SCHMI). Any score<14 will not satisfy the criterion for Liver Kidney Yin Deficiency and will not be recruited. This detailed TCM score will also be a secondary outcome measure in the analysis of pre/post herbal treatment (see below). 5. Clinical signs: 5.1. Tear break up time (TBUT) ≤10s or Schirmer I test ≤10mm/5 mins 6. Normal renal and liver function at baseline, i.e., all parameters within the reference value Exclusion Criteria: 1. Currently or intention to use hormonal therapy (eg. cancer patients who is on tamoxifen) 2. Currently pregnant or breastfeeding 3. Hysterectomy procedure done previously 4. Removal of cysts or polyp procedure done previously 5. Requirement to wear contact lens, and having worn such lenses in week preceding eligibility 6. Glaucoma, significant cataract, age related macular degeneration or other ophthalmic disease, eg. Extraocular muscle palsies, facial paralysis, ectropion, entropion, trichiasis 7. Requirement of any eyedrops other than artificial tears. 8. Previous eye surgeries including LASIK (within 6 months) or punctal plugs in-situ 9. Autoimmune systemic diseases: Steven-Johnson syndrome, Sjogren's syndrome, Rheumatoid Arthritis, Lupus 10. Systemic disease requiring regular medication (except hypertension and lipidemia)

NCT0531xxxx/NCT05319054.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/NCT05319054</url> </required_header> <id_info> <org_study_id>8238</org_study_id> <secondary_id>307764</secondary_id> <nct_id>NCT05319054</nct_id> </id_info> <brief_title>Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study</brief_title> <acronym>POLARiS</acronym> <official_title>A Feasibility, Multicentre Randomised Control Trial Assessing the Treatment Options for Patient With Major Low Anterior Resection Syndrome to Establish a Pathway Of Low Anterior Resection Syndrome Relief After Surgery</official_title> <sponsors> <lead_sponsor> <agency>Cardiff and Vale University Health Board</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University of Leeds</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Aneurin Bevan University Health Board</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University Hospital Southampton NHS Foundation Trust</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Bowel Research UK</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>The Leeds Teaching Hospitals NHS Trust</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Cardiff and Vale University Health Board</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> Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial. </textblock> </brief_summary> <detailed_description> <textblock> Rectal cancer (cancer of the lower part of the bowel) is one of the most prevalent forms of cancer, and affects approximately 14,000 people each year in the UK. The treatment for the majority of these patients is surgical removal of the affected part of the bowel, following which the bowel is joined back together. Some patients may also require chemotherapy and radiotherapy. One consequence of the treatment of bowel cancer is a severe form of bowel dysfunction called major Low Anterior Resection Syndrome (LARS).  LARS is a constellation of symptoms including incontinence to stool, urgency and frequency of bowel movements and incomplete evacuation; it is diagnosed using the LARS scoring tool. Major LARS can have a huge impact on the persons quality of life resulting in social isolation. Currently there are no guidelines for the management of LARS. The aim of the POLARiS study is to investigate three different treatments for major LARS; optimised conservative management, a combination of diet, medication, bowel retraining and pelvic floor exercises; transanal irrigation, washing out the back passage of stool with warmed water; and sacral nerve stimulation where an electrical impulse delivered to the sacral nerve to help with bowel function. This feasibility study aims to test the study design ahead of a larger fully powered randomised control trial. The study will firstly recruit any consenting adult who has had surgery for rectal cancer (called an anterior resection) and who does not have a stoma, into a cohort and then follow up those patients every 3 months with bowel function and quality of life assessments. Any patient found to have major LARS (LARS score over 30) will be invited into the randomised control trial where the above three treatments will be tested. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">May 23, 2022</start_date> <completion_date type="Anticipated">September 30, 2023</completion_date> <primary_completion_date type="Anticipated">September 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>Parallel Assignment</intervention_model> <intervention_model_description>Trials within Cohorts</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Recruitment rate of to cohort arm of study</measure> <time_frame>9 months</time_frame> <description>The total number of participants enrolled into the study over the recruitment period.</description> </primary_outcome> <primary_outcome> <measure>Assess characteristics of patients recruited to the cohort</measure> <time_frame>9 months</time_frame> <description>We will record basic demographics, medical history and prevalence of relative symptoms of participants enrolled in the cohort study to describe the characteristics of no- minor- and major- LARS patients</description> </primary_outcome> <primary_outcome> <measure>Prevalence of 'major LARS' in the patient cohort</measure> <time_frame>12 months</time_frame> <description>The number of participants in the cohort that meet the criteria for 'major low anterior resection syndrome (LARS)', as measured by the LARS scoring tool. LARS scoring tool produces a score from 0 - 42, which represents the severity of symptoms, where 0 is least severe and 42 is most severe. Score =>30 is considered 'major LARS'. LARS score will be measured at 5 times at 3-monthly intervals over 12 months.</description> </primary_outcome> <primary_outcome> <measure>Onset of 'major LARS' symptoms in relation to surgery</measure> <time_frame>Time from surgery to onset of major LARS, up to 10 years.</time_frame> <description>The time (in months) from resection surgery to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.</description> </primary_outcome> <primary_outcome> <measure>Onset of 'major LARS' symptoms in relation to radiotherapy treatment</measure> <time_frame>Time from ending radiotherapy treatment to onset of major LARS, up to 10 years.</time_frame> <description>The time (in months) from completing radiotherapy treatment to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.</description> </primary_outcome> <primary_outcome> <measure>Recruitment rate to randomised trial part of the study</measure> <time_frame>9 months</time_frame> <description>The total number of cohort participants that are enrolled into the randomised trial part of the study, over the recruitment period.</description> </primary_outcome> <primary_outcome> <measure>Proportion of randomised participants that are allocated to each trial arm</measure> <time_frame>9 months</time_frame> <description>The proportion of randomised participants that meet the criteria for, and are allocated to, each of the three trial arms (transanal irrigation; sacral neuromodulation; optimised conservative management).</description> </primary_outcome> <primary_outcome> <measure>Describe variation in clinical practice across UK sites</measure> <time_frame>Up to 10 years prior to recruitment</time_frame> <description>Where possible, we will record patient's previous treatments and interactions with health services in relation to their bowel dysfunction symptoms. This will be used to describe the variation in UK clinical practice in terms of diagnosis, management and treatment pathways.</description> </primary_outcome> <primary_outcome> <measure>Compliance of participants to the study programme</measure> <time_frame>12 months</time_frame> <description>The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).</description> </primary_outcome> <primary_outcome> <measure>Adherence of participants to the treatment programme</measure> <time_frame>12 months</time_frame> <description>The proportion of patients that continue to receive the treatment assigned to them at the end of the follow-up period.</description> </primary_outcome> <secondary_outcome> <measure>Change in LARS score</measure> <time_frame>12 months.</time_frame> <description>LARS score will be measured at 5 time points (at 3-monthly intervals from baseline to 12 months) to assess severity of bowel dysfunction. Self-reported by participants using the LARS scoring tool (min 0, max 42) where higher score denotes greater severity of symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Change in EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L)</measure> <time_frame>12 months</time_frame> <description>Patient-reported quality of life will be measured using the EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L) at 5 time-points (3-monthly intervals from baseline to 12 months). Quality of life total score will be calculated (min 5; max 25), where reduction in total score represents improvement in quality of life.</description> </secondary_outcome> <secondary_outcome> <measure>Change in European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire</measure> <time_frame>12 months</time_frame> <description>Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire (EORTC QLQ-CR29) at 5 time-points (3-monthly intervals, from baseline to 12 months). Quality of life total score will be calculated (min 26; max 104) where reduction in total score represents improvement in quality of life.</description> </secondary_outcome> <secondary_outcome> <measure>Change in European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire</measure> <time_frame>12 months</time_frame> <description>Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This will be recorded at 5 time-points (3-monthly intervals, from baseline to 12 months). Total score will be calculated (min 30; max 128), where reduction in total score represents improvement in quality of life.</description> </secondary_outcome> <secondary_outcome> <measure>Change in medical outcome profile score</measure> <time_frame>12 months</time_frame> <description>Measure Yourself Medical Outcome Profile (MYMOP) 2 will be used to record patient-reported medical outcome profile at 5 time-points (3-montly intervals from baseline to 12 months). Change in patient-reported severity (min 0; max 5) will be measured, where change ≥ 1.0 is considered clinically significant.</description> </secondary_outcome> <secondary_outcome> <measure>Patient-reported adverse events</measure> <time_frame>12 months</time_frame> <description>We will record any adverse events reported by randomised patients in relation to each of the treatments they receive, which impairs their adherence to the study protocol, treatment programme or safety.</description> </secondary_outcome> <secondary_outcome> <measure>LARS treatment history</measure> <time_frame>12 months</time_frame> <description>Treatments offered to manage individual patient's LARS symptoms will be recorded, along with duration of treatment and reasons for stopping. This will be used to support the description of standard care variation and patient characteristics.</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Actual">187</enrollment> <condition>Low Anterior Resection Syndrome</condition> <arm_group> <arm_group_label>Cohort</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals.</description> </arm_group> <arm_group> <arm_group_label>Optimised Conservative Management</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Cohort participants who are identified as having 'major LARS' at any point are treated with Optimised Conservative Managements, consisting of medication, dietary advice, lifestyle advice and physiotherapy.</description> </arm_group> <arm_group> <arm_group_label>Trans-Anal Irrigation</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Cohort participants who are identified as having 'major LARS' at any point are treated with Trans-anal irrigation, in additional to receiving optimised conservative management. Transanal irrigation system will be decided upon with the participant and procured locally.</description> </arm_group> <arm_group> <arm_group_label>Sacral NeuroModulation</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Cohort participants who are identified as having 'major LARS' at any point are treated with Sacral Neuromodulation system, in addition to receiving optimised conservative management. Medtronic Interstim system will be used.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Sacral NeuroModulation</intervention_name> <description>Sacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device.</description> <arm_group_label>Sacral NeuroModulation</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Trans-Anal Irrigation</intervention_name> <description>Trans-Anal irrigation group will include up-to 20 patients with major LARS. Specific system will be agreed with the patient, depending on eligibility and preference.</description> <arm_group_label>Trans-Anal Irrigation</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Optimised Conservative Management</intervention_name> <description>Optimised conservative management will include up-to 30 patients with major LARS. They will be provided with a resource booklet which includes dietary and lifestyle advice as well as exercises that can be undertaken independently.</description> <arm_group_label>Optimised Conservative Management</arm_group_label> <arm_group_label>Sacral NeuroModulation</arm_group_label> <arm_group_label>Trans-Anal Irrigation</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - For cohort:  - Diagnosis of rectal or sigmoid cancer  - Low or high anterior resection (colorectal resection with anastomosis to the rectum)  - Functioning anastomosis  - Aged 18 years and older  - Primary surgery/reversal of ileostomy less than 10 years before recruitment  - Reversal of ileostomy at least 12 weeks prior to recruitment with at least a further 12 weeks of standard care to manage symptoms following reversal  - Willing and able to provide valid informed consent  - For randomisation:  - Recruited to cohort study  - Willing and able to provide valid informed consent for randomisation  - Major LARS symptoms (Defined as score of 30+ on LARS scoring tool)  - Previous unsuccessful conservative treatment determined by treating clinician and patient  Exclusion Criteria:  - For cohort  - Inability to understand and complete study questionnaires independently. (Due to cognitive or intellectual impairment, Due to insufficient English language skills)  - For randomised control trial  - Pregnancy  - No previous conservative treatment plan for the management of LARS  - Does not meet any treatment-specific criteria  - For TAI randomisation:  - Unable to perform TAI  - History of anastomotic leak with evidence of ongoing leak/sinus  - Previous use of TAI for LARS  - Site unable to offer TAI as a treatment  - Any other contraindications advised by the care team, product manufacturer or distributor  - For SNM randomisation:  - <12months since primary cancer surgery  - Palliative disease  - Site unable to offer SNM as a treatment  - Previous SNM  - Specific contraindications to implantation  - Any other contraindications advised by the care team, product manufacturer or distributor. </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>Julie A Cornish</last_name> <role>Principal Investigator</role> <affiliation>Cardiff and Vale University Health Board</affiliation> </overall_official> <location> <facility> <name>University Hospital Southampton NHS Foundation Trust</name> <address> <city>Southampton</city> <state>Hampshire</state> <zip>SO16 6YD</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Leeds Teaching Hospital NHS Trust</name> <address> <city>Leeds</city> <state>Yorkshire</state> <zip>LS9 7TF</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Julie Cornish</name> <address> <city>Cardiff</city> <zip>CF14 4XW</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Royal Gwent Hospital</name> <address> <city>Newport</city> <zip>NP20 2UB</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>July 19, 2023</last_update_submitted> <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 20, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Sacral Neuromodulation</keyword> <keyword>Transanal Irrigation</keyword> <keyword>Trials within cohorts</keyword> <keyword>Colorectal cancer</keyword> <keyword>Quality of Life</keyword> <condition_browse>  <mesh_term>Low Anterior Resection Syndrome</mesh_term> <mesh_term>Syndrome</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial. Rectal cancer (cancer of the lower part of the bowel) is one of the most prevalent forms of cancer, and affects approximately 14,000 people each year in the UK. The treatment for the majority of these patients is surgical removal of the affected part of the bowel, following which the bowel is joined back together. Some patients may also require chemotherapy and radiotherapy. One consequence of the treatment of bowel cancer is a severe form of bowel dysfunction called major Low Anterior Resection Syndrome (LARS). LARS is a constellation of symptoms including incontinence to stool, urgency and frequency of bowel movements and incomplete evacuation; it is diagnosed using the LARS scoring tool. Major LARS can have a huge impact on the persons quality of life resulting in social isolation. Currently there are no guidelines for the management of LARS. The aim of the POLARiS study is to investigate three different treatments for major LARS; optimised conservative management, a combination of diet, medication, bowel retraining and pelvic floor exercises; transanal irrigation, washing out the back passage of stool with warmed water; and sacral nerve stimulation where an electrical impulse delivered to the sacral nerve to help with bowel function. This feasibility study aims to test the study design ahead of a larger fully powered randomised control trial. The study will firstly recruit any consenting adult who has had surgery for rectal cancer (called an anterior resection) and who does not have a stoma, into a cohort and then follow up those patients every 3 months with bowel function and quality of life assessments. Any patient found to have major LARS (LARS score over 30) will be invited into the randomised control trial where the above three treatments will be tested. Inclusion Criteria: - For cohort: - Diagnosis of rectal or sigmoid cancer - Low or high anterior resection (colorectal resection with anastomosis to the rectum) - Functioning anastomosis - Aged 18 years and older - Primary surgery/reversal of ileostomy less than 10 years before recruitment - Reversal of ileostomy at least 12 weeks prior to recruitment with at least a further 12 weeks of standard care to manage symptoms following reversal - Willing and able to provide valid informed consent - For randomisation: - Recruited to cohort study - Willing and able to provide valid informed consent for randomisation - Major LARS symptoms (Defined as score of 30+ on LARS scoring tool) - Previous unsuccessful conservative treatment determined by treating clinician and patient Exclusion Criteria: - For cohort - Inability to understand and complete study questionnaires independently. (Due to cognitive or intellectual impairment, Due to insufficient English language skills) - For randomised control trial - Pregnancy - No previous conservative treatment plan for the management of LARS - Does not meet any treatment-specific criteria - For TAI randomisation: - Unable to perform TAI - History of anastomotic leak with evidence of ongoing leak/sinus - Previous use of TAI for LARS - Site unable to offer TAI as a treatment - Any other contraindications advised by the care team, product manufacturer or distributor - For SNM randomisation: - <12months since primary cancer surgery - Palliative disease - Site unable to offer SNM as a treatment - Previous SNM - Specific contraindications to implantation - Any other contraindications advised by the care team, product manufacturer or distributor.

NCT0531xxxx/NCT05319067.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/NCT05319067</url> </required_header> <id_info> <org_study_id>NIMAO/2021-2/AF-01</org_study_id> <nct_id>NCT05319067</nct_id> </id_info> <brief_title>Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups</brief_title> <acronym>PROPHYBIOTA</acronym> <official_title>Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups</official_title> <sponsors> <lead_sponsor> <agency>Centre Hospitalier Universitaire de Nīmes</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Centre Hospitalier Universitaire de Nīmes</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> Urinary tract infections are very common in pediatrics. Urinary antibiotic prophylaxis is commonly used in children with malformative uropathies. Long-term, low-dose antibiotic prophylaxis with trimethoprim-sulfamethoxazole has been associated with a decrease in the number of urinary tract infections in susceptible children, but not systematically with a decrease in the risk of renal scarring (depending of uropathy stage).  Long-term antibiotic prophylaxis has implications for the acquisition of antibiotic resistance. A child receiving antibiotic prophylaxis for urinary tract infection is around 6 times more likely to develop a multidrug-resistant infection. In the general population, the microbiota of children treated with curative antibiotics is less diverse in terms of species and strains. In addition, short-term compositional changes are observed between consecutive samples of children treated with antibiotics.  The gut microbiota modulates the immune system, in particular via metabolites (SCFA, polysaccharide A) produced by bacteria that modify the expansion and function of regulatory T-cells. The disturbances of the intestinal microbiota play a role in the medium and long term on the acquisition of pathologies, such as atopy.  The study authors wish to describe the intestinal microbiota of children with vesico-ureteral reflux treated long-term with trimethoprim-sulfamethoxazole and compared it those not receiving antibiotic prophylaxis and to healthy children. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">May 1, 2017</start_date> <completion_date type="Anticipated">November 2023</completion_date> <primary_completion_date type="Anticipated">November 2023</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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>α-diversity of the gut microbiota between groups</measure> <time_frame>Day 0</time_frame> <description>N index of a stool sample measured by the Shannon index (H^') which incorporates the total number of different Operational Taxonomic Units and the relative proportions of these Operational Taxonomic Units.</description> </primary_outcome> <secondary_outcome> <measure>The β-diversity of the gut microbiota between groups</measure> <time_frame>Day 0</time_frame> <description>Operational Taxonomic Units measured by Bray Curtis Index</description> </secondary_outcome> <secondary_outcome> <measure>The number of bacterial genera present in the gut microbiota between groups</measure> <time_frame>Day 0</time_frame> <description>Relative abundance Operational Taxonomic Units present</description> </secondary_outcome> <secondary_outcome> <measure>The prevalence of multi-resistant bacteria</measure> <time_frame>Day 0</time_frame> <description>% of isolated bacteria producing extended spectrum betalactamase, carbapenemase-producing Enterococcus faecium and glycopeptide-resistant Enterococcus faecium and bacteria resistant to trimethoprim-sulfamethoxazole</description> </secondary_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Anticipated">150</enrollment> <condition>Vesicoureteral Reflux 3</condition> <arm_group> <arm_group_label>Cases</arm_group_label> <description>Children aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis</description> </arm_group> <arm_group> <arm_group_label>Controls</arm_group_label> <description>Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis</description> </arm_group> <arm_group> <arm_group_label>Healthy Controls</arm_group_label> <description>Healthy children aged 1 to 3 years.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Stool sampling</intervention_name> <description>Stool sample taken at home 24 hours before hospital visit</description> <arm_group_label>Cases</arm_group_label> <arm_group_label>Controls</arm_group_label> <arm_group_label>Healthy Controls</arm_group_label> </intervention> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Stool samples </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> For the purpose of the study three groups of children will be constituted:  Children aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis; Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis; Controls: Healthy children aged 1 to 3 years. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - The patient must be a member or beneficiary of a health insurance plan  - Patient with no objection to participation in the study from the parent or guardian  - Child with a diversified diet.  o Specific inclusion criteria for group 1 (cases):  - Child with grade 3 or higher vesicoureteral reflux.  - Child on trimethoprim-sulfamethoxazole therapy for at least 5 months.  o Specific inclusion criteria for group 2 (controls):  - Child with uropathy and without long-term trimethoprim-sulfamethoxazole treatment.  o Specific inclusion criteria for group 3 (healthy controls):  - Child without uropathy or long-term trimethoprim-sulfamethoxazole treatment.  Exclusion Criteria:  - Chronic digestive pathology  - Acute gastroenteritis or infectious colitis within last 15 days.  - Curative antibiotic therapy taken less than one month ago.  - Chronic inflammatory bowel disease or other localizations  - Congenital or acquired immune deficiency (current treatment with methotrexate, biotherapies, immunosuppressants)  - Patient participating in a category 1 trial likely to modify the intestinal microbiota.  - Patient in an exclusion period determined by another study.  - Patient under court protection, guardianship or curatorship.  - Patient for whom it is impossible to give informed information to person with parental authority. </textblock> </criteria> <gender>All</gender> <minimum_age>1 Year</minimum_age> <maximum_age>3 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Anne Filleron</last_name> <role>Principal Investigator</role> <affiliation>CHU de Nimes</affiliation> </overall_official> <location> <facility> <name>CHU de Montpellier</name> <address> <city>Montpellier</city> <country>France</country> </address> </facility> </location> <location> <facility> <name>CHU de Nîmes</name> <address> <city>Nîmes</city> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>April 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>September 23, 2022</last_update_submitted> <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 26, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Antibiotic prophylaxis</keyword> <keyword>Microbiota</keyword> <condition_browse>  <mesh_term>Gastroesophageal Reflux</mesh_term> <mesh_term>Vesico-Ureteral Reflux</mesh_term> </condition_browse>  </clinical_study>

Urinary tract infections are very common in pediatrics. Urinary antibiotic prophylaxis is commonly used in children with malformative uropathies. Long-term, low-dose antibiotic prophylaxis with trimethoprim-sulfamethoxazole has been associated with a decrease in the number of urinary tract infections in susceptible children, but not systematically with a decrease in the risk of renal scarring (depending of uropathy stage). Long-term antibiotic prophylaxis has implications for the acquisition of antibiotic resistance. A child receiving antibiotic prophylaxis for urinary tract infection is around 6 times more likely to develop a multidrug-resistant infection. In the general population, the microbiota of children treated with curative antibiotics is less diverse in terms of species and strains. In addition, short-term compositional changes are observed between consecutive samples of children treated with antibiotics. The gut microbiota modulates the immune system, in particular via metabolites (SCFA, polysaccharide A) produced by bacteria that modify the expansion and function of regulatory T-cells. The disturbances of the intestinal microbiota play a role in the medium and long term on the acquisition of pathologies, such as atopy. The study authors wish to describe the intestinal microbiota of children with vesico-ureteral reflux treated long-term with trimethoprim-sulfamethoxazole and compared it those not receiving antibiotic prophylaxis and to healthy children. Stool samples For the purpose of the study three groups of children will be constituted: Children aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis; Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis; Controls: Healthy children aged 1 to 3 years. Inclusion Criteria: - The patient must be a member or beneficiary of a health insurance plan - Patient with no objection to participation in the study from the parent or guardian - Child with a diversified diet. o Specific inclusion criteria for group 1 (cases): - Child with grade 3 or higher vesicoureteral reflux. - Child on trimethoprim-sulfamethoxazole therapy for at least 5 months. o Specific inclusion criteria for group 2 (controls): - Child with uropathy and without long-term trimethoprim-sulfamethoxazole treatment. o Specific inclusion criteria for group 3 (healthy controls): - Child without uropathy or long-term trimethoprim-sulfamethoxazole treatment. Exclusion Criteria: - Chronic digestive pathology - Acute gastroenteritis or infectious colitis within last 15 days. - Curative antibiotic therapy taken less than one month ago. - Chronic inflammatory bowel disease or other localizations - Congenital or acquired immune deficiency (current treatment with methotrexate, biotherapies, immunosuppressants) - Patient participating in a category 1 trial likely to modify the intestinal microbiota. - Patient in an exclusion period determined by another study. - Patient under court protection, guardianship or curatorship. - Patient for whom it is impossible to give informed information to person with parental authority.

NCT0531xxxx/NCT05319080.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/NCT05319080</url> </required_header> <id_info> <org_study_id>8116</org_study_id> <nct_id>NCT05319080</nct_id> </id_info> <brief_title>Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations</brief_title> <official_title>A Pilot Open-label Trial of Individualized Repetitive Transcranial Magnetic Stimulation for Patients With Auditory Verbal Hallucinations</official_title> <sponsors> <lead_sponsor> <agency>Columbia University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Columbia University</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_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The Repetitive Transcranial Magnetic Stimulation (rTMS) is a type of brain stimulation that uses a magnet to change activity in the brain. rTMS uses magnetic pulses to induce an electrical current in the brain to alter brain activity and function in specific areas. For example, stimulating the part of the brain controlling movement will cause parts of the foot or leg to twitch. TMS is proposed as a novel treatment for people with schizophrenia. The investigators want to see if low frequency rTMS can lessen some of the symptoms of schizophrenia, specifically auditory verbal hallucinations. Auditory verbal hallucinations describe the experience of hearing voices that are not really there. </textblock> </brief_summary> <detailed_description> <textblock> The large majority of patients with schizophrenia (Sz) experience auditory verbal hallucinations (AVH) as a core feature of their disorder. Treatment-resistant auditory verbal hallucinations (AVH) affect a third of patients with schizophrenia and can cause increased aggression, distress, suicide, and social dysfunction. The current standard of care is antipsychotic medication which can cause metabolic syndrome, sedation, orthostatic hypotension, extrapyramidal symptoms, and tardive dyskinesia among other adverse effects. Transcranial magnetic stimulation (TMS) emits a rapidly changing magnetic field over the scalp which induces current flow in underling brain tissue, either enhancing or disrupting function depending on the frequency of stimulation. It is generally well tolerated and repetitive TMS (rTMS) is currently FDA approved for treatment of depression. rTMS carries potential as an alternative treatment for schizophrenia patients with AVH who either do not respond to or do not tolerate medication. Inhibitory (1-Hz) standard TMS approaches, which use scalp-based targeting of speech perception areas such as left temperoparietal junction (TPJ) have yielded mixed results in reducing AVH, possibly due to variability of underlying brain anatomy between individual subjects. The influence of anatomical variability could be eliminated by individually positioning the TMS coil according to each patient's structural brain MRI. The proposed pilot project will investigate the clinical efficacy of open-label individualized MRI-guided TMS applied to the left TPJ in ten patients with schizophrenia or schizoaffective disorder. If the results of the pilot study show promising reductions in AVH, it will set up the foundation for a larger sham-controlled clinical trial. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">August 1, 2022</start_date> <completion_date type="Actual">April 7, 2023</completion_date> <primary_completion_date type="Actual">March 31, 2023</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> <intervention_model_description>This is an open-label study for participants with a diagnosis of either schizophrenia or schizoaffective disorder with persistent auditory verbal hallucinations (AVH) that are eligible to have repetitive transcranial magnetic stimulation (rTMS) targeting the left temperoparietal junction (TPJ).</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Total number of rTMS sessions completed</measure> <time_frame>2 weeks.</time_frame> <description>The total number of rTMS sessions completed. A session is defined as 20 minutes of rTMS.</description> </primary_outcome> <primary_outcome> <measure>Total number of treatment emergent adverse events</measure> <time_frame>2 weeks.</time_frame> <description>The total number of treatment emergent adverse events. An emergent adverse event is defined as any rTMS risk induced incident in research such as headache and seizure.</description> </primary_outcome> <secondary_outcome> <measure>Change in Auditory Hallucination Rating Scale (AHRS)</measure> <time_frame>Up to 4 weeks.</time_frame> <description>The AHRS is an investigator-administered scale assessing multiple characteristics of auditory verbal hallucinations. The total score ranges from 2 to 41, with higher scores indicating more severe symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Psychotic Symptom Rating Scale (PSYRATS)</measure> <time_frame>Up to 4 weeks.</time_frame> <description>The PSYRATS consists of 17 items on delusions and auditory hallucinations, with each item being rated from 0 (absent) to 4 (severe).</description> </secondary_outcome> <secondary_outcome> <measure>Change in Scale for the Assessment of Positive Symptoms (SAPS)</measure> <time_frame>Up to 4 weeks.</time_frame> <description>The SAPS includes 34 items that focus on the positive symptoms on schizophrenia. Each item is rated on a severity scale that ranges from 0 (none) to 5 (severe).</description> </secondary_outcome> <secondary_outcome> <measure>Change in Positive and Negative Syndrome Scale (PANSS)</measure> <time_frame>Up to 4 weeks.</time_frame> <description>The PANSS rates the presence and severity of positive and negative symptoms, as well as general psychopathology associated with schizophrenia. Each item is rated from 1 to 7 (range=30-210). Higher scores indicate more severe symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Cardiff Anomalous Perceptions Scale (CAPS)</measure> <time_frame>Up to 4 weeks.</time_frame> <description>The CAPS is a 32 item scale for measuring perceptual anomalies, that includes subscales for measuring distress, intrusiveness and frequency. A higher score indicates a higher number of perceptual anomalies, scores range from 0 (low) to 32 (high).</description> </secondary_outcome> <secondary_outcome> <measure>Change in Clinical Global Impression Improvement (CGI-I) Scale</measure> <time_frame>2 weeks</time_frame> <description>The CGI-I is a clinician-rated scale to quantify overall clinician impression of improvements in level of illness. The CGI-I is rated on a 7-point scale, to assess illness improvement. CGI-I scores range from 1 (very much improved) through to 7 (very much worse).</description> </secondary_outcome> <secondary_outcome> <measure>Change in Clinical Global Impression Severity (CGI-S) Scale</measure> <time_frame>2 weeks</time_frame> <description>The CGI-S is a clinician-rated scale to quantify overall clinician impression of illness severity. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">11</enrollment> <condition>Schizophrenia and Related Disorders</condition> <arm_group> <arm_group_label>Individualized magnetic resonance imaging (MRI) guided rTMS</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive a 20-min once-daily rTMS sessions over a period of 2 weeks (weekends off), and therefore accrue a total of 10 rTMS stimulation sessions. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Repetitive Transcranial Magnetic Stimulation (rTMS)</intervention_name> <description>During the rTMS session, an electromagnetic coil is placed against the subjects scalp on the left side of the head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception.</description> <arm_group_label>Individualized magnetic resonance imaging (MRI) guided rTMS</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder  - Capacity and willingness to provide informed consent  - Mean AHRS item score of greater or equal to 2  - If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an intrauterine device (IUD) which was implanted at least 2 months prior to screening, or "double-barrier" contraception. Women of child bearing potential must have a negative pregnancy test at screening  - Right handed  - Normal hearing  - Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable.  Exclusion Criteria:  - Substance use disorder (excluding nicotine) within last 90 days, or positive toxicology screen for any substance of abuse  - Pregnancy  - Participation in study of investigational medication/device within 4 weeks  - History of seizure, epilepsy and neurologic conditions with structural cerebral damage, including stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers, dementia, developmental disability, cerebrovascular disease, increased intracranial pressure, or central nervous system (CNS) tumors, brain surgery, head injury with loss of consciousness >1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion  - Subjects with devices that may be affected by TMS (pacemaker, cardioverter defibrillator, medication pump, intracardiac line, cochlear implant, implanted brain stimulator/neurostimulator)  - Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator  - Frequent and persistent migraines  - Clinically significant skin disease  - Presence of unstable medical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension, previous stroke, brain lesions, or heart disease  - History of prior clinically significant, adverse response to neurostimulation  - Current treatment with ototoxic medications (amino-glycosides, cisplatin)  - MRI incompatible implants  - Claustrophobia </textblock> </criteria> <gender>All</gender> <minimum_age>22 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Michael Avissar, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>New York State Psychiatric Institute</affiliation> </overall_official> <location> <facility> <name>New York State Psychiatric Institute</name> <address> <city>New York</city> <state>New York</state> <zip>10032</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 8, 2022</study_first_posted> <last_update_submitted>August 9, 2023</last_update_submitted> <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Columbia University</investigator_affiliation> <investigator_full_name>Michael Avissar</investigator_full_name> <investigator_title>Assistant Professor of Psychiatry</investigator_title> </responsible_party> <keyword>Hallucinations</keyword> <keyword>Auditory Verbal Hallucinations</keyword> <condition_browse>  <mesh_term>Hallucinations</mesh_term> <mesh_term>Schizophrenia</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The Repetitive Transcranial Magnetic Stimulation (rTMS) is a type of brain stimulation that uses a magnet to change activity in the brain. rTMS uses magnetic pulses to induce an electrical current in the brain to alter brain activity and function in specific areas. For example, stimulating the part of the brain controlling movement will cause parts of the foot or leg to twitch. TMS is proposed as a novel treatment for people with schizophrenia. The investigators want to see if low frequency rTMS can lessen some of the symptoms of schizophrenia, specifically auditory verbal hallucinations. Auditory verbal hallucinations describe the experience of hearing voices that are not really there. The large majority of patients with schizophrenia (Sz) experience auditory verbal hallucinations (AVH) as a core feature of their disorder. Treatment-resistant auditory verbal hallucinations (AVH) affect a third of patients with schizophrenia and can cause increased aggression, distress, suicide, and social dysfunction. The current standard of care is antipsychotic medication which can cause metabolic syndrome, sedation, orthostatic hypotension, extrapyramidal symptoms, and tardive dyskinesia among other adverse effects. Transcranial magnetic stimulation (TMS) emits a rapidly changing magnetic field over the scalp which induces current flow in underling brain tissue, either enhancing or disrupting function depending on the frequency of stimulation. It is generally well tolerated and repetitive TMS (rTMS) is currently FDA approved for treatment of depression. rTMS carries potential as an alternative treatment for schizophrenia patients with AVH who either do not respond to or do not tolerate medication. Inhibitory (1-Hz) standard TMS approaches, which use scalp-based targeting of speech perception areas such as left temperoparietal junction (TPJ) have yielded mixed results in reducing AVH, possibly due to variability of underlying brain anatomy between individual subjects. The influence of anatomical variability could be eliminated by individually positioning the TMS coil according to each patient's structural brain MRI. The proposed pilot project will investigate the clinical efficacy of open-label individualized MRI-guided TMS applied to the left TPJ in ten patients with schizophrenia or schizoaffective disorder. If the results of the pilot study show promising reductions in AVH, it will set up the foundation for a larger sham-controlled clinical trial. Inclusion Criteria: - The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder - Capacity and willingness to provide informed consent - Mean AHRS item score of greater or equal to 2 - If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an intrauterine device (IUD) which was implanted at least 2 months prior to screening, or "double-barrier" contraception. Women of child bearing potential must have a negative pregnancy test at screening - Right handed - Normal hearing - Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable. Exclusion Criteria: - Substance use disorder (excluding nicotine) within last 90 days, or positive toxicology screen for any substance of abuse - Pregnancy - Participation in study of investigational medication/device within 4 weeks - History of seizure, epilepsy and neurologic conditions with structural cerebral damage, including stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers, dementia, developmental disability, cerebrovascular disease, increased intracranial pressure, or central nervous system (CNS) tumors, brain surgery, head injury with loss of consciousness >1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion - Subjects with devices that may be affected by TMS (pacemaker, cardioverter defibrillator, medication pump, intracardiac line, cochlear implant, implanted brain stimulator/neurostimulator) - Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator - Frequent and persistent migraines - Clinically significant skin disease - Presence of unstable medical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension, previous stroke, brain lesions, or heart disease - History of prior clinically significant, adverse response to neurostimulation - Current treatment with ototoxic medications (amino-glycosides, cisplatin) - MRI incompatible implants - Claustrophobia