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

NCT0531xxxx/NCT05316493.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/NCT05316493</url> </required_header> <id_info> <org_study_id>53211036-02</org_study_id> <nct_id>NCT05316493</nct_id> </id_info> <brief_title>Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia</brief_title> <official_title>Weight Management Plus Levonorgestrel Intrauterine System or Megestrol Acetate in Endometrial Atypical Hyperplasia: Multiple Single-arm, Prospective and Open-label Clinical Study</official_title> <sponsors> <lead_sponsor> <agency>Xiaojun Chen</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fudan 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> To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy. </textblock> </brief_summary> <detailed_description> <textblock> Background:  High-efficacy progesterone, such as levonorgestrel intrauterine system (LNG-IUS), megestrol acetate (MA), and medroxyprogesterone acetate(MPA), is the first-line treatment for women with endometrial atypical hyperplasia (EAH) who want to preserve fertility. About 70% to 80% of those patients can achieve complete remission (CR) with a median CR time of about 6 months, but about 20% to 30% of those patients get no response or need longer time to get CR (over one year or even longer).  Overweight or obesity is an independent risk factor for fertility-sparing treatment response and pregnancy outcomes in young females with EAH or early endometrioid cancer (EEC). Evidence showed that obesity can cause lower CR rates and longer time to get CR and lower birth rates in EAH or EEC patients asking for conservative therapy. Weight management has been proved to improve metabolic disorders, ovarian functions, and pregnancy outcomes. Metformin, as a diabetes drug, has been proved to increase CR rates in EAH or EEC patients treated with MA for fertility. Weight management has raised more and more attention and has been proved to benefit metabolic and pregnancy outcomes. Based on previous research and published studies, the hypothesise is that weight management plus progestin therapy may raise CR rates and pregnancy outcomes in young female EAH patients asking for fertility conservation.  Enhanced lifestyle management (diet control, exercise, and daily behavioral guidance) may improve metabolic conditions, increase CR rates and pregnancy outcomes in obese EAH patients who want to preserve fertility. Till now, no similar studies were found, so this study is designed to explore the efficacy of weight control in EAH fertility-sparing patients to provide new evidence for improving conservative treatment.  Objective:  To investigate whether weight management plus LNG-IUS/MA can improve the efficacy of preserving fertility in obese EAH women who want fertility conservation.  Design:  This study is designed according to Simon's Two-Stage Design. Based on BMI and treatment plans, four single-arms are designed. This study is prospective, open-label. EAH Patients requiring conservation treatment with BMI ≥ 24 kg/m2 will be recruited in this study and they will be divided into four arms, the first group recruits overweight (24kg/ m2≤BMI<28kg/m2) patients treated with LNG-IUS, the second group recruits overweight (24kg/ m2≤BMI<28kg/m2) patients treated with MA, the third group recruits obese (BMI≥28kg/m2) patients treated with LNG-IUS, and the last group recruits obese (BMI≥28kg/m2) patients treated with MA. The sample size is calculated based on Simon's Two-Stage Design and previous CR rates. All enrolled patients will receive enhanced lifestyle management to control weight and take LNG-IUS/MA for treating EAH. Hysteroscopic examination, metabolic and inflammatory indicators will be performed every 12 to16 weeks while other indexes will be evaluated every month, including weight, heart rates, blood pressure, body fat tests, and so on. For the progestin efficacy evaluation, CR is defined as the remission of EAH to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease, and progressive disease (PD) is defined as disease progression in patients. Two months' maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.  Outcomes: Primary outcome is the CR rates of the four arms. Secondary outcomes include pregnancy rates, live birth rates, weight loss, insulin resistance, chronic inflammation indicators, time to achieve CR and recurrence rates, and so on. Safety and side events during the whole trial will be monitored in two years. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 13, 2022</start_date> <completion_date type="Anticipated">February 28, 2026</completion_date> <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date> <phase>Phase 2/Phase 3</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>All enrolled participants will receive enhanced lifestyle management to control weight and take LNG-IUS or Megestrol Acetate (MA) for treating EAH</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Pathological complete response (CR) rates</measure> <time_frame>From date of recruitment until the date of CR, assessed up to 28 weeks.</time_frame> <description>The 28-week CR rates will be calculated in four arms</description> </primary_outcome> <secondary_outcome> <measure>Pregnancy outcomes</measure> <time_frame>up to 2 years after complete response of the last participant</time_frame> <description>For participants have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period.</description> </secondary_outcome> <secondary_outcome> <measure>Weight change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>The investigators will record body weight every month and calculate its change in kilograms.</description> </secondary_outcome> <secondary_outcome> <measure>Body composition change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>The investigators will detect body composition with InBody machine and calculate changes of the indicated indexes.</description> </secondary_outcome> <secondary_outcome> <measure>Blood pressures change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Record blood pressures (systolic and diastolic pressures) every 12-16 weeks and count the change during the trial.</description> </secondary_outcome> <secondary_outcome> <measure>Heart rates change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Record heart rates (beats per minute) every 12-16 weeks and count the change.</description> </secondary_outcome> <secondary_outcome> <measure>Blood glucose change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Assess fasting glucose levels each 3 to 4 months and calculate changes in mmol/L.</description> </secondary_outcome> <secondary_outcome> <measure>Blood lipids change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Assess blood lipids levels each 3 to 4 months and calculate changes during the trial.</description> </secondary_outcome> <secondary_outcome> <measure>Insulin resistance change</measure> <time_frame>Baseline，3months and 6months after enrolled.</time_frame> <description>Test fasting insulin levels each 3 to 4 months, and count HOMA-IR index (Homeostatic Model Assessment for Insulin Resistance) with fasting insulin and fasting glucose as follow: Insulin (pmol/L)*glucose (mmol/L)/22.5, and compare the HOMA-IR change during the treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Ovarian reserve function</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Detect serum Anti-Mullerian Hormone (AMH) each 3 or 4 months and calculate its change.</description> </secondary_outcome> <secondary_outcome> <measure>Quality of life change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Collect the questionnaire SF-36 and count scores change through conservative treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Impact of Weight on Quality of Life</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Collect questionnaire IWQOL- LITE and count scores change through conservative treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Physical activities change</measure> <time_frame>From date of recruitment, assessed up to 28 weeks.</time_frame> <description>Collect physical activities questionnaire(IPAQ) and compare scores changes through conservative treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Chronic inflammatory index (TNF-α) change</measure> <time_frame>baseline, 3 months and 6 months after treatment.</time_frame> <description>The investigators will detect the levels of TNF-α (fmol/ml) in serum and calculate changes through the whole treatment period.</description> </secondary_outcome> <secondary_outcome> <measure>Chronic inflammatory index (IL-1) change</measure> <time_frame>baseline, 3 months and 6 months after treatment.</time_frame> <description>The investigators will detect serum index IL-1 in U/ml and calculate changes through the whole treatment period.</description> </secondary_outcome> <secondary_outcome> <measure>Chronic inflammatory index (IL-6) change</measure> <time_frame>baseline, 3 months and 6 months after treatment.</time_frame> <description>The investigators will detect serum index IL-6 in U/ml and calculate changes through the whole treatment period.</description> </secondary_outcome> <secondary_outcome> <measure>Time of pathological complete response (CR)</measure> <time_frame>From date of recruitment until the date of CR, assessed up to 2 years.</time_frame> <description>Time of histologic regression from EAH to proliferative or secretory endometrium</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of adverse events</measure> <time_frame>From date of recruitment until the date of CR, assessed up to 2 years.</time_frame> <description>Adverse events related with MA, LNG-IUS and weight control. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.</description> </secondary_outcome> <secondary_outcome> <measure>Relapse rates</measure> <time_frame>up to 2 years after the treatment for each patient</time_frame> <description>All enrolled patients will be followed up for 2 years. During the following-up period, if patients recur after complete regression, they will be counted and the number of recurrence will be divided by number of patients followed up, then the investigators can get the relapse rates.</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">172</enrollment> <condition>Atypical Endometrial Hyperplasia</condition> <condition>Fertility Issues</condition> <condition>Overweight and Obesity</condition> <arm_group> <arm_group_label>overweight MA+ILI</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>enrolled overweight (24kg/m2≤BMI<28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management</description> </arm_group> <arm_group> <arm_group_label>overweight LNG-IUS+ILI</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>enrolled overweight (24kg/m2≤BMI<28kg/m2) patients will be treated with LNG-IUS plus weight management</description> </arm_group> <arm_group> <arm_group_label>obese MA+ILI</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>enrolled obese (BMI≥28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management</description> </arm_group> <arm_group> <arm_group_label>obese LNG-IUS+ILI</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>enrolled obese (BMI≥28kg/m2) patients will be treated with LNG-IUS plus weight management</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Intensive Lifestyle Intervention (ILI)</intervention_name> <description>dietary guidance, exercise guidance, lifestyle intervention</description> <arm_group_label>obese LNG-IUS+ILI</arm_group_label> <arm_group_label>obese MA+ILI</arm_group_label> <arm_group_label>overweight LNG-IUS+ILI</arm_group_label> <arm_group_label>overweight MA+ILI</arm_group_label> <other_name>Weight Management</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Megestrol Acetate 160 MG Oral Tablet</intervention_name> <description>enrolled participants will take Megestrol Acetate 160mg daily</description> <arm_group_label>obese MA+ILI</arm_group_label> <arm_group_label>overweight MA+ILI</arm_group_label> <other_name>yilizhi</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg</intervention_name> <description>enrolled patients will be treated with LNG-IUS.</description> <arm_group_label>obese LNG-IUS+ILI</arm_group_label> <arm_group_label>overweight LNG-IUS+ILI</arm_group_label> <other_name>manyuele</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.  5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.  6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.  Exclusion Criteria:  1. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance < 30 mL/min)  2. Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.  3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).  4. Those who require hysterectomy or other methods other than conservative treatment.  5. Known or suspected pregnancy.  6. Those who has contraindications to use progestin.  7. Deep vein thrombosis, stroke, myocardial infarction.  8. Severe joint lesions that prevent walking or movement.  9. untreated or recurrent pelvic inflammatory disease (PID)  10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);  11. Cervical dysplasia  12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus  13. allergic to the LNG-IUS components  14. uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out.  Notes: the last 6 criteria are only applied for patients with LNG-IUS. </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>XIAOJUN CHEN, PhD</last_name> <role>Principal Investigator</role> <affiliation>Obstetrics & Gynecology Hospital of Fudan University</affiliation> </overall_official> <overall_contact> <last_name>WEIWEI SHAN, PhD</last_name> <phone>8613817813106</phone> <email>danweiwei7468@fckyy.org.cn</email> </overall_contact> <overall_contact_backup> <last_name>XIAOJUN CHEN, PhD</last_name> <phone>8613601680784</phone> <email>cxjlhjj@163.com</email> </overall_contact_backup> <location> <facility> <name>Obstetrics and Gynecology Hospital of Fudan University</name> <address> <city>Shanghai</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>WEIWEI SHAN, PhD</last_name> <phone>13817813106</phone> <email>fdsww1024@sina.cn</email> </contact> <contact_backup> <last_name>DANDAN JU, MD</last_name> <phone>021-33189900-8408</phone> </contact_backup> </location> <location_countries> <country>China</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 27, 2023</last_update_submitted> <last_update_submitted_qc>May 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 31, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Fudan University</investigator_affiliation> <investigator_full_name>Xiaojun Chen</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Endometrial Hyperplasia</mesh_term> <mesh_term>Infertility</mesh_term> <mesh_term>Overweight</mesh_term> <mesh_term>Hyperplasia</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Megestrol</mesh_term> <mesh_term>Megestrol Acetate</mesh_term> <mesh_term>Contraceptive Agents</mesh_term> <mesh_term>Levonorgestrel</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy. Background: High-efficacy progesterone, such as levonorgestrel intrauterine system (LNG-IUS), megestrol acetate (MA), and medroxyprogesterone acetate(MPA), is the first-line treatment for women with endometrial atypical hyperplasia (EAH) who want to preserve fertility. About 70% to 80% of those patients can achieve complete remission (CR) with a median CR time of about 6 months, but about 20% to 30% of those patients get no response or need longer time to get CR (over one year or even longer). Overweight or obesity is an independent risk factor for fertility-sparing treatment response and pregnancy outcomes in young females with EAH or early endometrioid cancer (EEC). Evidence showed that obesity can cause lower CR rates and longer time to get CR and lower birth rates in EAH or EEC patients asking for conservative therapy. Weight management has been proved to improve metabolic disorders, ovarian functions, and pregnancy outcomes. Metformin, as a diabetes drug, has been proved to increase CR rates in EAH or EEC patients treated with MA for fertility. Weight management has raised more and more attention and has been proved to benefit metabolic and pregnancy outcomes. Based on previous research and published studies, the hypothesise is that weight management plus progestin therapy may raise CR rates and pregnancy outcomes in young female EAH patients asking for fertility conservation. Enhanced lifestyle management (diet control, exercise, and daily behavioral guidance) may improve metabolic conditions, increase CR rates and pregnancy outcomes in obese EAH patients who want to preserve fertility. Till now, no similar studies were found, so this study is designed to explore the efficacy of weight control in EAH fertility-sparing patients to provide new evidence for improving conservative treatment. Objective: To investigate whether weight management plus LNG-IUS/MA can improve the efficacy of preserving fertility in obese EAH women who want fertility conservation. Design: This study is designed according to Simon's Two-Stage Design. Based on BMI and treatment plans, four single-arms are designed. This study is prospective, open-label. EAH Patients requiring conservation treatment with BMI ≥ 24 kg/m2 will be recruited in this study and they will be divided into four arms, the first group recruits overweight (24kg/ m2≤BMI<28kg/m2) patients treated with LNG-IUS, the second group recruits overweight (24kg/ m2≤BMI<28kg/m2) patients treated with MA, the third group recruits obese (BMI≥28kg/m2) patients treated with LNG-IUS, and the last group recruits obese (BMI≥28kg/m2) patients treated with MA. The sample size is calculated based on Simon's Two-Stage Design and previous CR rates. All enrolled patients will receive enhanced lifestyle management to control weight and take LNG-IUS/MA for treating EAH. Hysteroscopic examination, metabolic and inflammatory indicators will be performed every 12 to16 weeks while other indexes will be evaluated every month, including weight, heart rates, blood pressure, body fat tests, and so on. For the progestin efficacy evaluation, CR is defined as the remission of EAH to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease, and progressive disease (PD) is defined as disease progression in patients. Two months' maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years. Outcomes: Primary outcome is the CR rates of the four arms. Secondary outcomes include pregnancy rates, live birth rates, weight loss, insulin resistance, chronic inflammation indicators, time to achieve CR and recurrence rates, and so on. Safety and side events during the whole trial will be monitored in two years. Inclusion Criteria: 1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University. 5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements. 6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time. Exclusion Criteria: 1. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance < 30 mL/min) 2. Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone. 3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication). 4. Those who require hysterectomy or other methods other than conservative treatment. 5. Known or suspected pregnancy. 6. Those who has contraindications to use progestin. 7. Deep vein thrombosis, stroke, myocardial infarction. 8. Severe joint lesions that prevent walking or movement. 9. untreated or recurrent pelvic inflammatory disease (PID) 10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine); 11. Cervical dysplasia 12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus 13. allergic to the LNG-IUS components 14. uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out. Notes: the last 6 criteria are only applied for patients with LNG-IUS.

NCT0531xxxx/NCT05316506.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/NCT05316506</url> </required_header> <id_info> <org_study_id>20211092</org_study_id> <nct_id>NCT05316506</nct_id> </id_info> <brief_title>Pain and Hysteroscopy</brief_title> <official_title>Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>University of Miami</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Miami</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 1, 2022</start_date> <completion_date type="Anticipated">September 1, 2024</completion_date> <primary_completion_date type="Anticipated">September 1, 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>Supportive Care</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in Pain as measured by Visual Analog Scale (VAS)</measure> <time_frame>Baseline (pre-procedure), Day 1 (post-procedure)</time_frame> <description>Pain will be assessed using the Visual Analog Scale (VAS). Visual Analog Scale (VAS) is score from 0 (no pain) to 10 (worst pain imaginable).</description> </primary_outcome> <secondary_outcome> <measure>Number of participants in each pain category</measure> <time_frame>Day 1 (post-procedure)</time_frame> <description>Number of participants reporting actual pain compared to their anticipated the pain post procedure. Pain Free Less painful than anticipated As painful as anticipated More painful than anticipated Much more painful than anticipated</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">70</enrollment> <condition>Hysteroscopy Surgery</condition> <arm_group> <arm_group_label>Anticipated Discomfort Group</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Participants will be prompted using anticipated discomfort language during the standard of care hysteroscopy.</description> </arm_group> <arm_group> <arm_group_label>Objective Description Group</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Participants will be prompted using objective description language during the standard of care hysteroscopy.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Anticipated Discomfort Language</intervention_name> <description>This language involves pain descriptors provided from physician to patient during procedure.</description> <arm_group_label>Anticipated Discomfort Group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Objective Descriptive Language</intervention_name> <description>This language involves neutral/objective descriptors provided from physician to patients during procedure.</description> <arm_group_label>Objective Description Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Adults 18 years of age and older  2. Scheduled for in office hysteroscopy  3. Able to consent for the study in English or Spanish  Exclusion Criteria:  1. Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions)  2. Previous in-office hysteroscopy  3. Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal  4. Minors, prisoners, or other members of vulnerable populations  5. Patients who cannot communicate in English or Spanish </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>Jose Carugno, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Miami</affiliation> </overall_official> <overall_contact> <last_name>Jaclyn Kwal, MD</last_name> <phone>(305) 585-3771</phone> <email>jaclynkwalmd@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Jose Carugno, MD</last_name> <phone>3052434960</phone> <email>jac209@med.miami.edu</email> </overall_contact_backup> <location> <facility> <name>University of Miami Hospital</name> <address> <city>Miami</city> <state>Florida</state> <zip>33136</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jose Carugno, MD</last_name> <phone>305-243-4960</phone> <email>jac209@med.miami.edu</email> </contact> <investigator> <last_name>Jose Carugno, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>October 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>October 4, 2022</last_update_submitted> <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">October 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Miami</investigator_affiliation> <investigator_full_name>Jose Carugno</investigator_full_name> <investigator_title>Associate Professor Obstetrics and Gynecology Minimally Invasive Gynecology/Robotic Division Director.</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy. Inclusion Criteria: 1. Adults 18 years of age and older 2. Scheduled for in office hysteroscopy 3. Able to consent for the study in English or Spanish Exclusion Criteria: 1. Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions) 2. Previous in-office hysteroscopy 3. Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal 4. Minors, prisoners, or other members of vulnerable populations 5. Patients who cannot communicate in English or Spanish

NCT0531xxxx/NCT05316519.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/NCT05316519</url> </required_header> <id_info> <org_study_id>1619399</org_study_id> <nct_id>NCT05316519</nct_id> </id_info> <brief_title>Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning</brief_title> <official_title>Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential</official_title> <sponsors> <lead_sponsor> <agency>VA Pittsburgh Healthcare System</agency> <agency_class>U.S. Fed</agency_class> </lead_sponsor> </sponsors> <source>VA Pittsburgh Healthcare System</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> Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">August 1, 2024</completion_date> <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Sham-controlled</intervention_model_description> <primary_purpose>Basic Science</primary_purpose> <masking>Single (Participant)</masking> <masking_description>Single-blind</masking_description> </study_design_info> <primary_outcome> <measure>Precision grip stability (coefficient of variation or root-mean-square error)</measure> <time_frame>1 month post training</time_frame> <description>The ability to stabilize precision grip according to target force and/or preload force will be quantified by calculating coefficient of variation (CV) or root-mean-square error (RMSE) which characterize variability in relation to mean force or target force.</description> </primary_outcome> <secondary_outcome> <measure>Force signal composition (Fourier transform)</measure> <time_frame>1 month post training</time_frame> <description>The force signal oscillates at various frequencies and will be decomposed with a Fourier transform to quantify the relative contribution of higher frequencies.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">4</enrollment> <condition>Neurological Injury</condition> <condition>Motor Disorders</condition> <condition>Paresis</condition> <arm_group> <arm_group_label>Transcutaneous Vagus Nerve Stimulation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Transcutaneous vagus nerve stimulation paired with visuomotor task training</description> </arm_group> <arm_group> <arm_group_label>Transcutaneous Stimulation (Sham)</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Transcutaneous stimulation paired with visuomotor task training</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Transcutaneous Vagus Nerve Stimulation</intervention_name> <description>Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker</description> <arm_group_label>Transcutaneous Stimulation (Sham)</arm_group_label> <arm_group_label>Transcutaneous Vagus Nerve Stimulation</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  (For prospective subjects diagnosed with stroke)  - Confirmed diagnosis of a single stroke at least six months prior to participation  Exclusion Criteria:  - History of vestibular disorders or dizziness  - Diagnosis of neurological disorders affecting movement  - Ocular disease and/or impairment in more than one eye  - Pregnant or expecting to become pregnant  - Difficulty maintaining alertness and/or remaining still </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Nicholas Gatto</last_name> <phone>412-822-3700</phone> <email>Nicholas.Gatto@va.gov</email> </overall_contact> <location> <facility> <name>Human Engineering Research Laboratories</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15206</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Nicholas Gatto</last_name> <phone>412-822-3700</phone> <email>Nicholas.Gatto@va.gov</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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>Principal Investigator</responsible_party_type> <investigator_affiliation>VA Pittsburgh Healthcare System</investigator_affiliation> <investigator_full_name>Michael A. Urbin</investigator_full_name> <investigator_title>Scientist</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Paresis</mesh_term> <mesh_term>Trauma, Nervous System</mesh_term> <mesh_term>Motor Disorders</mesh_term> </condition_browse>  </clinical_study>

Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning. Inclusion Criteria: (For prospective subjects diagnosed with stroke) - Confirmed diagnosis of a single stroke at least six months prior to participation Exclusion Criteria: - History of vestibular disorders or dizziness - Diagnosis of neurological disorders affecting movement - Ocular disease and/or impairment in more than one eye - Pregnant or expecting to become pregnant - Difficulty maintaining alertness and/or remaining still

NCT0531xxxx/NCT05316532.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/NCT05316532</url> </required_header> <id_info> <org_study_id>BASEC-2021-00912</org_study_id> <nct_id>NCT05316532</nct_id> </id_info> <brief_title>Novel ECCO2R Device for Hypercapnic Respiratory Failure</brief_title> <official_title>A Novel ECCO2R Device as a Lung Protective Measure in Hypercapnic Respiratory Failure: a Prospective Multicenter Trial</official_title> <sponsors> <lead_sponsor> <agency>University of Zurich</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Triemli Hospital, Switzerland</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Kantonsspital St. Gallen, St. Gallen, Switzerland</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Baxter International Foundation</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Zurich</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 objective of this study is to assess the efficacy and safety of this new Prismalung+ membrane in its intended clinical setting by demonstrating a reduction in ventilatory parameters and pulmonary energy load or the successful maintenance of spontaneous breathing, respectively, the absence of the need to initiate vv-ECMO therapy, and initial survival. </textblock> </brief_summary> <detailed_description> <textblock> Our hypotheses are that decarboxylation therapy by means of the novel Prismalung+ membrane in patients with hypercapnic respiratory failure (I) allows the reduction of tidal volume, peak airway pressure, dP and pulmonary energy load (as measured by AUC over 72 hours) as compared to baseline in mechanically ventilated patients OR is associated with successful continuation of spontaneous breathing despite respiratory exhaustion (no decision to intubate), and that these patients (II) warrant no decision to initiate vv-ECMO therapy and (III) do not experience early mortality.  The primary Objectives of the study are to test our hypotheses I to III by applying the novel Prismalung+ ECCO2R device in mechanically ventilated patients and spontaneously breathing patients experiencing hypercapnic respiratory failure in a multi-central prospective trial in three experienced intensive care units in Switzerland. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">January 1, 2023</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">December 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>Tidal volume</measure> <time_frame>At timepoint 1 (72 hours)</time_frame> <description>Tidal volume (VT [mL/kg]) in mechanically ventilated patients or no intubation in spontaneously breathing patients</description> </primary_outcome> <primary_outcome> <measure>Peak Pressure</measure> <time_frame>At timepoint 1 (72 hours)</time_frame> <description>Peak Pressure (Ppeak [mbar]) in mechanically ventilated patients or no intubation in spontaneously breathing patients</description> </primary_outcome> <primary_outcome> <measure>Driving Pressure</measure> <time_frame>At timepoint 1 (72 hours)</time_frame> <description>Driving Pressure [mbar] in mechanically ventilated patients or no intubation in spontaneously breathing patients</description> </primary_outcome> <primary_outcome> <measure>VV-ECMO therapy</measure> <time_frame>At timepoint 2 (28 days)</time_frame> <description>No initiation of VV-ECMO therapy</description> </primary_outcome> <primary_outcome> <measure>Survival</measure> <time_frame>At timepoint 2 (28 days)</time_frame> <description>Survival</description> </primary_outcome> <secondary_outcome> <measure>Secondary endpoint - respiratory mechanics</measure> <time_frame>72 hours</time_frame> <description>Reduction in pulmonary energy load after initiation of ECCO2R as compared to baseline in mechanically ventilated patients</description> </secondary_outcome> <secondary_outcome> <measure>Secondary endpoint - complications</measure> <time_frame>28 days</time_frame> <description>Incidence of complications such as bleeding, thrombosis, coagulatory activation as evidences by thrombocytopenia, elevated D-Dimer levels, and plasmatic coagulatory failure.</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">60</enrollment> <condition>Hypercapnic Respiratory Failure</condition> <arm_group> <arm_group_label>Mechanically ventilated ECCO2R group</arm_group_label> <description>Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation</description> </arm_group> <arm_group> <arm_group_label>Awake spontaneously breathing ECCO2R group</arm_group_label> <description>Awake, spontaneously breathing critically ill patients suffering from respiratory exhaustion</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Prismalung + treatment</intervention_name> <description>Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy</description> <arm_group_label>Awake spontaneously breathing ECCO2R group</arm_group_label> <arm_group_label>Mechanically ventilated ECCO2R group</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation or respiratory exhausting awake, spontaneously breathing critically ill patients </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT<4 mL/kg, Ppeak <30 mbar, Driving Pressure ≤12 mbar)  - OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa)  - AND Informed Consent as documented by signature  Exclusion Criteria:  - Mechanical Ventilation group: Need for v-v ECMO  - Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated  - Thrombocytopenia (<100G/l)  - Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding)  - Patients under 18 years of age  - Women who are pregnant or breast feeding  - Previous enrolment into the current study  - Enrolment of the investigator, his/her family members, employees and other dependent persons </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>Matthias P Matthias, PD Dr. med.</last_name> <role>Principal Investigator</role> <affiliation>University of Zurich</affiliation> </overall_official> <overall_contact> <last_name>Stefanie Keiser, Dr. Sc. nat.</last_name> <phone>+41797956912</phone> <email>stefanie.keiser@usz.ch</email> </overall_contact> <overall_contact_backup> <last_name>Matthias P Hilty, PD Dr. med.</last_name> <phone>+41442551111</phone> <email>matthias.hilty@usz.ch</email> </overall_contact_backup> <verification_date>November 2022</verification_date> <study_first_submitted>April 21, 2021</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>November 16, 2022</last_update_submitted> <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 21, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Zurich</investigator_affiliation> <investigator_full_name>Matthias Hilty</investigator_full_name> <investigator_title>PD Dr. med. Matthias Hilty</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Respiratory Insufficiency</mesh_term> <mesh_term>Hypercapnia</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The objective of this study is to assess the efficacy and safety of this new Prismalung+ membrane in its intended clinical setting by demonstrating a reduction in ventilatory parameters and pulmonary energy load or the successful maintenance of spontaneous breathing, respectively, the absence of the need to initiate vv-ECMO therapy, and initial survival. Our hypotheses are that decarboxylation therapy by means of the novel Prismalung+ membrane in patients with hypercapnic respiratory failure (I) allows the reduction of tidal volume, peak airway pressure, dP and pulmonary energy load (as measured by AUC over 72 hours) as compared to baseline in mechanically ventilated patients OR is associated with successful continuation of spontaneous breathing despite respiratory exhaustion (no decision to intubate), and that these patients (II) warrant no decision to initiate vv-ECMO therapy and (III) do not experience early mortality. The primary Objectives of the study are to test our hypotheses I to III by applying the novel Prismalung+ ECCO2R device in mechanically ventilated patients and spontaneously breathing patients experiencing hypercapnic respiratory failure in a multi-central prospective trial in three experienced intensive care units in Switzerland. Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation or respiratory exhausting awake, spontaneously breathing critically ill patients Inclusion Criteria: - Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT<4 mL/kg, Ppeak <30 mbar, Driving Pressure ≤12 mbar) - OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa) - AND Informed Consent as documented by signature Exclusion Criteria: - Mechanical Ventilation group: Need for v-v ECMO - Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated - Thrombocytopenia (<100G/l) - Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding) - Patients under 18 years of age - Women who are pregnant or breast feeding - Previous enrolment into the current study - Enrolment of the investigator, his/her family members, employees and other dependent persons

NCT0531xxxx/NCT05316545.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/NCT05316545</url> </required_header> <id_info> <org_study_id>KMUHIRB-E(I)-20210262</org_study_id> <nct_id>NCT05316545</nct_id> </id_info> <brief_title>Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery</brief_title> <official_title>Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery</official_title> <sponsors> <lead_sponsor> <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Kaohsiung Medical University Chung-Ho Memorial 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> Using retrospective medical records to analyze the difference between the analysis of the correlation between operation time, blood loss, anesthesia methods, anesthesia medication, and postoperative recovery time </textblock> </brief_summary> <detailed_description> <textblock> In Orthognathic surgery, facial bones involved in the operation site are more likely to bleed. In order to reduce the amount of bleeding during the operation, intentional hypotensive anesthesia is executed during the operation.  Because the amount of bleeding is controlled within a reasonable range, the surgical field of vision is naturally clear, which can also make the operation go smoothly, shorten the operation time, and increase the postoperative comfort. Therefore, for orthognathic surgery, the maintenance of intraoperative blood pressure is very important. Using inhaled anesthetics can easily achieve deeper anesthesia, but may increase postoperative nausea and vomiting. Generally speaking, these patients will be fixed with steel wires between the upper and lower jaws after the operation. Postoperative nausea and vomiting will increase the risk of aspiration pneumonia, but intravenous anesthesia can reduce postoperative nausea and vomiting.  This research is a retrospective investigation of medical records. The purpose of this study is to understand the differences in the analysis of the correlation between the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery of patients undergoing surgery during orthognathic surgery. In the future, orthognathic surgery (Orthognathic surgery) anesthesia policy and anesthesia target process guidelines can be formulated, and it can help remind medical staff to make an early and appropriate treatment at any time. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">November 16, 2021</start_date> <completion_date type="Actual">November 15, 2022</completion_date> <primary_completion_date type="Actual">November 15, 2022</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>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>medical treatment events performed</measure> <time_frame>During procedure</time_frame> <description>The purpose of the study is to analyze the cases of orthognathic surgery in our hospital from 2010 to 2021 and find out which medical treatment events must be performed while maintaining Intentional hypotension such as inhaled anesthetics, pain relievers, Nitroglycerine, target controlled infusion, Precedex, Opioid, antagonist also the timing when the medical treatment intervene.</description> </primary_outcome> <secondary_outcome> <measure>time of anesthesia,lose of blood and recovery after surgery</measure> <time_frame>During procedure</time_frame> <description>The secondary outcome will be analyzed for whether the medical treatment event would affect the time of anesthesia and loose of blood during the operative, and recovery after surgery,etc. We will collect the following data from electronic medical records: age, gender, weight, height, body mass index (BMI), preoperative American Society of Anesthesiologists (ASA) score, duration of anesthesia, type of anesthesia, anesthetic drugs, operation time, types of operation, estimated intraoperative blood loss (EBL), preoperative and postoperative Hemoglobin (HGB) and hematocrit (HCT), as well as postoperative recovery and statistically analyze the data by t-test and one-way ANOVA to get the mean and standard deviation of them.</description> </secondary_outcome> <enrollment type="Actual">700</enrollment> <condition>Orthognathic Surgery</condition> <eligibility> <study_pop> <textblock> Review the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery evaluation of the operation record sheet and anesthesia-related record sheet (including the recovery room and postoperative visit record sheet) in the patient's medical record. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patients undergoing conventional anesthesia surgery and orthognathic surgery.  Exclusion Criteria:  - Exclude the operation time greater than 8 hours. </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>Kuang-I Cheng, Phd</last_name> <role>Principal Investigator</role> <affiliation>Kaohsiung Medical University Chung-Ho Memorial Hospital</affiliation> </overall_official> <location> <facility> <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name> <address> <city>Kaohsiung</city> <state>Sanmin Dist</state> <zip>80756,</zip> <country>Taiwan</country> </address> </facility> </location> <location_countries> <country>Taiwan</country> </location_countries> <verification_date>December 2021</verification_date> <study_first_submitted>January 10, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 7, 2023</last_update_submitted> <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>orthognathic surgery</keyword> <keyword>anesthesia</keyword> <keyword>retrospective analysis</keyword>  </clinical_study>

Using retrospective medical records to analyze the difference between the analysis of the correlation between operation time, blood loss, anesthesia methods, anesthesia medication, and postoperative recovery time In Orthognathic surgery, facial bones involved in the operation site are more likely to bleed. In order to reduce the amount of bleeding during the operation, intentional hypotensive anesthesia is executed during the operation. Because the amount of bleeding is controlled within a reasonable range, the surgical field of vision is naturally clear, which can also make the operation go smoothly, shorten the operation time, and increase the postoperative comfort. Therefore, for orthognathic surgery, the maintenance of intraoperative blood pressure is very important. Using inhaled anesthetics can easily achieve deeper anesthesia, but may increase postoperative nausea and vomiting. Generally speaking, these patients will be fixed with steel wires between the upper and lower jaws after the operation. Postoperative nausea and vomiting will increase the risk of aspiration pneumonia, but intravenous anesthesia can reduce postoperative nausea and vomiting. This research is a retrospective investigation of medical records. The purpose of this study is to understand the differences in the analysis of the correlation between the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery of patients undergoing surgery during orthognathic surgery. In the future, orthognathic surgery (Orthognathic surgery) anesthesia policy and anesthesia target process guidelines can be formulated, and it can help remind medical staff to make an early and appropriate treatment at any time. Review the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery evaluation of the operation record sheet and anesthesia-related record sheet (including the recovery room and postoperative visit record sheet) in the patient's medical record. Inclusion Criteria: - Patients undergoing conventional anesthesia surgery and orthognathic surgery. Exclusion Criteria: - Exclude the operation time greater than 8 hours.

NCT0531xxxx/NCT05316558.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/NCT05316558</url> </required_header> <id_info> <org_study_id>HAS.21.03.120b</org_study_id> <nct_id>NCT05316558</nct_id> </id_info> <brief_title>Web-Based Body Image Intervention for Coaches of Adolescent Girls - Pilot</brief_title> <official_title>Body Confident Coaching: Acceptability Testing of a Web-Based Body Image Intervention for Coaches of Adolescent Girls</official_title> <sponsors> <lead_sponsor> <agency>University of the West of England</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Unilever R&D</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Nike</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Laureus</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Tucker Center for Research on Girls & Women in Sport</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of the West of England</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> According to the World Health Organization, only 15% of 11-17-year-old girls meet the recommended daily physical movement guidelines (e.g., 60-minutes per day). Despite extensive research highlighting the protective factors associated with sport on both mental and physical health, body image concerns are a key barrier to girls' participation in and enjoyment of sport. Sports-related environments and society more broadly further exacerbate these concerns through harmful gender stereotypes that perpetuate female objectification, discrimination, and harassment. This includes the promotion of unrealistic and sexualized appearances of female athletes, uncomfortable and objectifying uniforms, and appearance and competence-related teasing from male and female peers, as well as coaches.  To date, research has predominantly focused on athletes' perceptions of the extent to which coaches perpetuate athletes' body image concerns. However, several recent studies have been conducted exploring the perception of coaches and their role in addressing body image concerns among girls in sport. The findings of these studies indicate that although coaches are often able to identify body image concerns among their athletes, they are apprehensive to explicitly address these issues for fear of making the concerns worse. As such, systemic strategies are required within sport settings that upskill coaches as well as athletes and significant others in the athletes' environment to address body image concerns among adolescent girls in sport. At present, few such programs exist, and limited body image resources are available to coaches, despite coaches perceiving body image education as a personal and professional requirement for working with young people.  The current research will test the first online body image program for coaches. The Body Confident Coaching program was co-created with girls and coaches through an international multi-disciplinary partnership between academics, health professionals, industry, and community organizations. Multi-disciplinary partnerships can create a supportive landscape by upskilling athletes and coaches in dealing with body image concerns, which will likely lead to sustained sports participation and biopsychosocial benefits.  As such, the aim of the present study is to conduct a randomized controlled trial (RCT) to evaluate the effectiveness, feasibility, and acceptability of the Body Confident Coaching program. The program consists of five 20-minute modules that coaches complete online. Each session tackles a distinct theme related to body image in the sporting context. Outcomes will be assessed at pre- and post-intervention and include coaches' self-efficacy to tackle athletes' body image concerns (primary outcome), coaches' fat phobia and gender essentialist beliefs (secondary outcomes), and feasibility, acceptability, and adherence (process outcomes). The comparison control arm will be a waitlist control condition.  To undertake this project, coaches will be randomized into the intervention group or the control group, with 60 coaches anticipated in each arm. Those in the intervention condition will complete baseline assessments (target outcomes and demographic information), take part in the two-week intervention, and then complete the post-intervention assessments (target outcomes and feasibility and acceptability measures). Those in the waitlist control condition will complete the baseline assessments (target outcomes and demographic information) and a second assessment two weeks later (target outcomes only), after which they will get access to the online intervention. However, their engagement with the intervention will not be monitored or assessed. At completion of the post-intervention survey, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body image and eating concerns. Lastly, to compensate participants for their time, coaches will receive an electronic voucher to the value of $25 dollars.  The investigators hypothesize that coaches who take part in the Body Confident Coaching intervention will report greater self-efficacy in identifying and tackling body image concerns among their athletes, and lower levels of fat phobia and gender essentialism at post-intervention than coaches who do not take part in the intervention. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Actual">September 1, 2022</completion_date> <primary_completion_date type="Actual">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> <primary_purpose>Prevention</primary_purpose> <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in coaches' self-efficacy in body image (assessed via the Coaches' Self-Efficacy in Body Image Scale)</measure> <time_frame>Baseline, pre-intervention; immediately after the intervention (2 weeks later)</time_frame> <description>The Coaches' Self-Efficacy in Body Image Scale (CSEBIS) assesses coaches' ability to describe, recognize, support, and prevent body image concerns among their athletes. CSEBIS scores range from 0-10 with higher scores on the CSEBIS indicating higher levels of self-efficacy.</description> </primary_outcome> <secondary_outcome> <measure>Change in coaches' fat phobia (assessed via the Fat Phobia Scale)</measure> <time_frame>Baseline, pre-intervention; immediately after the intervention (2 weeks later)</time_frame> <description>The Fat Phobia Scale (FPS) is a 14-item questionnaire regarding beliefs and feelings towards people who are fat or obese. FPS scores range from 1-5 with higher scores on the FPS indicating higher levels of fat phobia.</description> </secondary_outcome> <secondary_outcome> <measure>Change in coaches' gender essentialism (assessed via the Gender Essentialism Scale)</measure> <time_frame>Baseline, pre-intervention; immediately after the intervention (2 weeks later)</time_frame> <description>The Gender Essentialism Scale (GES) is a 25-item scale, rated from 1 (strongly disagree) to 5 (strongly agree), and assesses sex-role egalitarianism, support for discriminatory practices, and perceived fairness of gender-based treatment. GES scores range from 1-5 with higher scores on the GES indicating higher levels of gender essentialism.</description> </secondary_outcome> <other_outcome> <measure>Total acceptability of the intervention (assessed via a self-report questionnaire)</measure> <time_frame>Immediately after the intervention</time_frame> <description>Coaches will complete feasibility and acceptability measures via a self-report questionnaire on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree) within the following domains: 1) affective attitude (e.g., I liked this program); 2) burden (e.g., it was easy to follow the content of the program); 3) ethicality (e.g., I think this program is appropriate for coaches in my sport); 4) self-efficacy (e.g., I am confident that I will use the techniques I learned from this program); 5) perceived effectiveness (e.g., the program was successful in improving my knowledge about body image); and 6) content (e.g., how easy or difficult was it to follow the program?).</description> </other_outcome> <other_outcome> <measure>Total intervention adherence (assessed through session completion)</measure> <time_frame>Immediately after the intervention</time_frame> <description>Total intervention adherence will be assessed by the investigators as number of participants who complete the full intervention.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">97</enrollment> <condition>Intervention</condition> <condition>Waitlist Control</condition> <arm_group> <arm_group_label>Body Confident Coaching</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants in the intervention condition will take part in an online program consisting of five modules over two weeks.</description> </arm_group> <arm_group> <arm_group_label>Waitlist control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Participants will not be explicitly told their study condition, although they will be made aware of the assessment time points and whether they receive the intervention between T1 and T2 (intervention) or after T2 (waitlist control). Following completion of post-intervention assessments (T2), the control condition will participate in the intervention; but, they will not be monitored or assessed.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Body Confident Coaching</intervention_name> <description>The Body Confident Coaching program is a five-module online program aimed at upskilling coaches in identifying and tackling body image concerns among girls in sport. Each module will take approximately 20 minutes to complete and consists of educational content, interactive elements (quizzes, checklists, opinion polls, reflective exercises), and additional resources.</description> <arm_group_label>Body Confident Coaching</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Current coaches of adolescent girls  - English speaking  - US resident  Exclusion Criteria:  - Participants under 18 years of age  - Coaches outside of the US  - Coaches who only coach adult women or men/boys </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>Centre for Appearance Research, University of the West of England</name> <address> <city>Bristol</city> <zip>BS16 1QY</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <reference> <citation>Guthold R, Stevens GA, Riley LM, Bull FC. Global trends in insufficient physical activity among adolescents: a pooled analysis of 298 population-based surveys with 1.6 million participants. Lancet Child Adolesc Health. 2020 Jan;4(1):23-35. doi: 10.1016/S2352-4642(19)30323-2. Epub 2019 Nov 21.</citation> <PMID>31761562</PMID> </reference> <reference> <citation>Koulanova, A., Sabiston, C. M., Pila, E., Brunet, J., Sylvester, B., Sandmeyer-Graves, A., & Maginn, D. (2021). Ideas for action: Exploring strategies to address body image concerns for adolescent girls involved in sport. Psychology of Sport and Exercise, 56, 102017.</citation> </reference> <reference> <citation>Neumark-Sztainer D, MacLehose RF, Watts AW, Pacanowski CR, Eisenberg ME. Yoga and body image: Findings from a large population-based study of young adults. Body Image. 2018 Mar;24:69-75. doi: 10.1016/j.bodyim.2017.12.003. Epub 2017 Dec 27.</citation> <PMID>29288970</PMID> </reference> <reference> <citation>Sabiston, C., Pila, E., Vani, M., & Thogersen-Ntoumani, C. (2019). Body image, physical activity, and sport: A scoping review. Psychology Of Sport And Exercise, 42, 48-57. doi: 10.1016/j.psychsport.2018.12.010</citation> </reference> <reference> <citation>Sabiston CM, Pila E, Crocker PRE, Mack DE, Wilson PM, Brunet J, Kowalski KC. Changes in body-related self-conscious emotions over time among youth female athletes. Body Image. 2020 Mar;32:24-33. doi: 10.1016/j.bodyim.2019.11.001. Epub 2019 Nov 14.</citation> <PMID>31734408</PMID> </reference> <reference> <citation>Slater A, Tiggemann M. Gender differences in adolescent sport participation, teasing, self-objectification and body image concerns. J Adolesc. 2011 Jun;34(3):455-63. doi: 10.1016/j.adolescence.2010.06.007. Epub 2010 Jul 31.</citation> <PMID>20643477</PMID> </reference> <reference> <citation>Vani MF, Pila E, Willson E, Sabiston CM. Body-related embarrassment: The overlooked self-conscious emotion. Body Image. 2020 Mar;32:14-23. doi: 10.1016/j.bodyim.2019.10.007. Epub 2019 Nov 13.</citation> <PMID>31733410</PMID> </reference> <results_reference> <citation>Schneider, J., Matheson, E. L., Tinoco, A., Gentili, C., White, P., Boucher, C., Silva-Breen, H., Goorevich, A., Diedrichs, P.C., & LaVoi, N. M. (2023). Body Confident Coaching: A pilot randomized controlled trial evaluating the acceptability of a web-based body image intervention for coaches of adolescent girls. Journal of Applied Sport Psychology. https://doi.org/10.1080/10413200.2023.2212023</citation> </results_reference> <verification_date>May 2023</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 22, 2023</last_update_submitted> <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 24, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Body image</keyword> <keyword>Athletes</keyword> <keyword>Girls</keyword> <keyword>Coaches</keyword> <keyword>Web-based</keyword> <keyword>Coach education</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

According to the World Health Organization, only 15% of 11-17-year-old girls meet the recommended daily physical movement guidelines (e.g., 60-minutes per day). Despite extensive research highlighting the protective factors associated with sport on both mental and physical health, body image concerns are a key barrier to girls' participation in and enjoyment of sport. Sports-related environments and society more broadly further exacerbate these concerns through harmful gender stereotypes that perpetuate female objectification, discrimination, and harassment. This includes the promotion of unrealistic and sexualized appearances of female athletes, uncomfortable and objectifying uniforms, and appearance and competence-related teasing from male and female peers, as well as coaches. To date, research has predominantly focused on athletes' perceptions of the extent to which coaches perpetuate athletes' body image concerns. However, several recent studies have been conducted exploring the perception of coaches and their role in addressing body image concerns among girls in sport. The findings of these studies indicate that although coaches are often able to identify body image concerns among their athletes, they are apprehensive to explicitly address these issues for fear of making the concerns worse. As such, systemic strategies are required within sport settings that upskill coaches as well as athletes and significant others in the athletes' environment to address body image concerns among adolescent girls in sport. At present, few such programs exist, and limited body image resources are available to coaches, despite coaches perceiving body image education as a personal and professional requirement for working with young people. The current research will test the first online body image program for coaches. The Body Confident Coaching program was co-created with girls and coaches through an international multi-disciplinary partnership between academics, health professionals, industry, and community organizations. Multi-disciplinary partnerships can create a supportive landscape by upskilling athletes and coaches in dealing with body image concerns, which will likely lead to sustained sports participation and biopsychosocial benefits. As such, the aim of the present study is to conduct a randomized controlled trial (RCT) to evaluate the effectiveness, feasibility, and acceptability of the Body Confident Coaching program. The program consists of five 20-minute modules that coaches complete online. Each session tackles a distinct theme related to body image in the sporting context. Outcomes will be assessed at pre- and post-intervention and include coaches' self-efficacy to tackle athletes' body image concerns (primary outcome), coaches' fat phobia and gender essentialist beliefs (secondary outcomes), and feasibility, acceptability, and adherence (process outcomes). The comparison control arm will be a waitlist control condition. To undertake this project, coaches will be randomized into the intervention group or the control group, with 60 coaches anticipated in each arm. Those in the intervention condition will complete baseline assessments (target outcomes and demographic information), take part in the two-week intervention, and then complete the post-intervention assessments (target outcomes and feasibility and acceptability measures). Those in the waitlist control condition will complete the baseline assessments (target outcomes and demographic information) and a second assessment two weeks later (target outcomes only), after which they will get access to the online intervention. However, their engagement with the intervention will not be monitored or assessed. At completion of the post-intervention survey, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body image and eating concerns. Lastly, to compensate participants for their time, coaches will receive an electronic voucher to the value of $25 dollars. The investigators hypothesize that coaches who take part in the Body Confident Coaching intervention will report greater self-efficacy in identifying and tackling body image concerns among their athletes, and lower levels of fat phobia and gender essentialism at post-intervention than coaches who do not take part in the intervention. Inclusion Criteria: - Current coaches of adolescent girls - English speaking - US resident Exclusion Criteria: - Participants under 18 years of age - Coaches outside of the US - Coaches who only coach adult women or men/boys

NCT0531xxxx/NCT05316571.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/NCT05316571</url> </required_header> <id_info> <org_study_id>21-3195</org_study_id> <secondary_id>1R01HL157187-01A1</secondary_id> <nct_id>NCT05316571</nct_id> </id_info> <brief_title>Sitting Interruption and Whole-body Cardiovascular Health</brief_title> <acronym>SWITCH</acronym> <official_title>Sitting Interruption and Whole-body Cardiovascular Health: Linking Physiological Responses to Risk Behaviors</official_title> <sponsors> <lead_sponsor> <agency>University of North Carolina, Chapel Hill</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>University of North Carolina, Chapel Hill</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> There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk. </textblock> </brief_summary> <detailed_description> <textblock> Sedentary behaviors (SB) are biologically distinct but understudied heart disease risk factors. National and international agencies have concluded that the level of evidence for an overall and dose-response association between SB and heart disease mortality is moderate-strong. These agencies do not provide specific recommendations for breaking-up SB, though do call on the research community to facilitate policy development by establishing biological plausibility, identifying the optimal dose for SB substitution strategies, and conducting randomized clinical trials to test the efficacy of these strategies. Accordingly, the goal of this study is to identify mechanism-informed, socioecological-based SB substitution recommendations to reduce heart disease risk. To achieve this goal, two aims will be addressed. Aim 1 will identify a feasible SB substitution strategy to prevent the negative cardiovascular responses to prolonged SB (i.e., strategies that people will actually follow). Adverse cardiovascular responses to prolonged SB will be measured using aortic arterial stiffness (AS), a noninvasive test that predicts future heart disease. To accomplish this aim, 56 middle-aged (36-55 years) participants will provide written informed consent, prior to the measurement of aortic AS and associated mechanistic responses to the following over 4 hours, in a randomized crossover manner: (i) SB with a 5-minute walk break once per hour; (ii) SB with a 15-minute standing break once per hour; (iii) SB with two breaks per hour, alternating between a 5-minute walk and a 15-minute stand; and (iv) SB with no breaks (control). These strategies were selected based on extensive prior work by the investigators, and because they are feasible, which is a key component of this study. SB reduction strategies will only decrease heart disease risk if people are willing to adhere to future SB substitution recommendations. To increase the likelihood of feasibility and long-term adherence, Aim 2 will evaluate the determinants of SB using a socioecological model. This recognizes that behavior change is likely to be limited if the physical and sociocultural environments do not support the behavior change. To accomplish Aim 2, a combined inductive-deductive qualitative approach will be used. Participants who complete Aim 1 will participate in one of 6 focus groups (6-8 participants/group). Crucially, the outcomes from this proposal will be instrumental in helping to design a subsequent clinical trial to test a mechanism-informed yet feasible SB reduction intervention, and in doing so directly support the development of SB policy. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 15, 2022</start_date> <completion_date type="Anticipated">February 28, 2026</completion_date> <primary_completion_date type="Anticipated">February 28, 2026</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>Each participant will complete four, 4-hour SB bouts with the following conditions: (i) one 5-minute walk break per hour; (ii) one 15-minute standing break per hour; (iii) two breaks per hour, alternating between 5 minutes of walking and 15 minutes of standing; and (iv) SB with no breaks (control). The order of intervention will be assigned in a randomized, crossover manner with 24 potential unique sequences of intervention assignment.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> <masking_description>Researchers and participants will be blinded to the condition until each day of testing, and the statistician and any technicians processing outcome data will be blinded to the condition.</masking_description> </study_design_info> <primary_outcome> <measure>Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV)</measure> <time_frame>Measurements will be taken immediately before and after each 4-hour SB condition</time_frame> <description>cfPWV (m/sec) will be measured between the carotid and femoral arteries, using a collar around the neck and a cuff around the thigh, with the participant in a supine position. cfPWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements</description> </primary_outcome> <secondary_outcome> <measure>Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)</measure> <time_frame>Measurements will occur continuously throughout each of the 4-hour SB conditions</time_frame> <description>Brain PWV (cm/sec) is the velocity at which a pressure wave travels between the heart and cerebrovascular system. Brain PWV will be calculated from the ECG r-wave to the foot of the Cerebral Blood Flow Velocity (CBFV) waveform</description> </secondary_outcome> <secondary_outcome> <measure>Mean Change in Femoral-ankle PWV</measure> <time_frame>Measurements will be taken immediately before and after each 4-hour SB condition</time_frame> <description>Femoral-ankle PWV (m/sec) is the velocity at which a pressure wave travels between the femoral-ankle arterial segments. Femoral-ankle PWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">56</enrollment> <condition>Sedentary Behavior</condition> <condition>Sedentary Time</condition> <arm_group> <arm_group_label>One 5-Minute Walking Bout Each Hour</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.</description> </arm_group> <arm_group> <arm_group_label>One 15-Minute Standing Bout Each Hour</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.</description> </arm_group> <arm_group> <arm_group_label>One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout and one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.</description> </arm_group> <arm_group> <arm_group_label>Uninterrupted Sitting</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. This uninterrupted sedentary bout will serve as a control. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>One 5-Minute Walking Bout Each Hour</intervention_name> <description>One 5-minute light intensity walking break per hour throughout the 4-hour SB condition</description> <arm_group_label>One 5-Minute Walking Bout Each Hour</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>One 15-Minute Standing Bout Each Hour</intervention_name> <description>One 15-minute standing break per hour throughout the 4-hour SB condition</description> <arm_group_label>One 15-Minute Standing Bout Each Hour</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour</intervention_name> <description>Two breaks per hour throughout the 4-hour SB condition, alternating between a 5-minute light intensity walking break and a 15-minute standing break</description> <arm_group_label>One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Uninterrupted Sitting</intervention_name> <description>No breaks will be provided throughout the 4-hour SB condition. This will be used as the control condition</description> <arm_group_label>Uninterrupted Sitting</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Aged between 36-55 years  - Insufficiently active: self-reported exercise <90 minutes per week for the past 3 months  - Sedentary: self-reported sitting >8 hours per day  - Self-reported ability to walk 4 blocks and climb 2 flights of stairs  - Possession of cellular phone able to receive text messages  Exclusion Criteria:  - Use of assisted-walking devices  - Comorbid condition that would limit the ability to reduce sedentary behavior (e.g., musculoskeletal condition, current chemotherapy)  - Plans for major surgery within next 3 months  - Recent history (<1 year) of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease  - Recent (< 1 year) or planned bariatric surgery  - Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg  - Current or recent (within last 6 months) pregnancy; current or recent (within last 3 months) breastfeeding  - Morbidly obesity (BMI >40 kg/m^2) or underweight (BMI <18.5 kg/m^2)  - Use of anti-hypertensive drugs  - Use of glucose-controlling medication  - Heavy alcohol consumption (>15 drinks per week) </textblock> </criteria> <gender>All</gender> <minimum_age>36 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Lee Stoner, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of North Carolina, Chapel Hill</affiliation> </overall_official> <overall_contact> <last_name>Simon Higgins, PhD</last_name> <phone>(706) 461-6776</phone> <email>higginss@unc.edu</email> </overall_contact> <location> <facility> <name>University of North Carolina at Chapel Hill</name> <address> <city>Chapel Hill</city> <state>North Carolina</state> <zip>27599</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Simon Higgins, PhD</last_name> <phone>706-461-6776</phone> <email>higginss@unc.edu</email> </contact> <investigator> <last_name>Erik D Hanson, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Gaurav J Dave, DrPH</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Christopher P Mack, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Michelle Meyer, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Feng-Chang Lin, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Bethany Barone Gibbs, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Maihan Vu, DrPH</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Higgins S, Cowley ES, Paterson C, Hanson ED, Dave GJ, Meyer ML, Lin FC, Gibbs BB, Vu M, Stoner L. Protocol for a study on Sitting with Interruption and Whole-Body Cardiovascular Health (SWITCH) in middle-aged adults. Contemp Clin Trials. 2023 Feb;125:107048. doi: 10.1016/j.cct.2022.107048. Epub 2022 Dec 9.</citation> <PMID>36509249</PMID> </reference> <verification_date>August 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>January 6, 2023</last_update_submitted> <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Sedentary Behavior</keyword> <keyword>Interruption</keyword> <keyword>Sitting</keyword> <keyword>Cardiovascular</keyword> <keyword>Arterial Stiffness</keyword> <keyword>Pulse Wave Velocity</keyword> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.</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>Beginning 9 months following publication and continuing for 36 months</ipd_time_frame> <ipd_access_criteria>Investigator has IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.</ipd_access_criteria> </patient_data>  </clinical_study>

There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk. Sedentary behaviors (SB) are biologically distinct but understudied heart disease risk factors. National and international agencies have concluded that the level of evidence for an overall and dose-response association between SB and heart disease mortality is moderate-strong. These agencies do not provide specific recommendations for breaking-up SB, though do call on the research community to facilitate policy development by establishing biological plausibility, identifying the optimal dose for SB substitution strategies, and conducting randomized clinical trials to test the efficacy of these strategies. Accordingly, the goal of this study is to identify mechanism-informed, socioecological-based SB substitution recommendations to reduce heart disease risk. To achieve this goal, two aims will be addressed. Aim 1 will identify a feasible SB substitution strategy to prevent the negative cardiovascular responses to prolonged SB (i.e., strategies that people will actually follow). Adverse cardiovascular responses to prolonged SB will be measured using aortic arterial stiffness (AS), a noninvasive test that predicts future heart disease. To accomplish this aim, 56 middle-aged (36-55 years) participants will provide written informed consent, prior to the measurement of aortic AS and associated mechanistic responses to the following over 4 hours, in a randomized crossover manner: (i) SB with a 5-minute walk break once per hour; (ii) SB with a 15-minute standing break once per hour; (iii) SB with two breaks per hour, alternating between a 5-minute walk and a 15-minute stand; and (iv) SB with no breaks (control). These strategies were selected based on extensive prior work by the investigators, and because they are feasible, which is a key component of this study. SB reduction strategies will only decrease heart disease risk if people are willing to adhere to future SB substitution recommendations. To increase the likelihood of feasibility and long-term adherence, Aim 2 will evaluate the determinants of SB using a socioecological model. This recognizes that behavior change is likely to be limited if the physical and sociocultural environments do not support the behavior change. To accomplish Aim 2, a combined inductive-deductive qualitative approach will be used. Participants who complete Aim 1 will participate in one of 6 focus groups (6-8 participants/group). Crucially, the outcomes from this proposal will be instrumental in helping to design a subsequent clinical trial to test a mechanism-informed yet feasible SB reduction intervention, and in doing so directly support the development of SB policy. Inclusion Criteria: - Aged between 36-55 years - Insufficiently active: self-reported exercise <90 minutes per week for the past 3 months - Sedentary: self-reported sitting >8 hours per day - Self-reported ability to walk 4 blocks and climb 2 flights of stairs - Possession of cellular phone able to receive text messages Exclusion Criteria: - Use of assisted-walking devices - Comorbid condition that would limit the ability to reduce sedentary behavior (e.g., musculoskeletal condition, current chemotherapy) - Plans for major surgery within next 3 months - Recent history (<1 year) of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease - Recent (< 1 year) or planned bariatric surgery - Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg - Current or recent (within last 6 months) pregnancy; current or recent (within last 3 months) breastfeeding - Morbidly obesity (BMI >40 kg/m^2) or underweight (BMI <18.5 kg/m^2) - Use of anti-hypertensive drugs - Use of glucose-controlling medication - Heavy alcohol consumption (>15 drinks per week)

NCT0531xxxx/NCT05316584.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/NCT05316584</url> </required_header> <id_info> <org_study_id>22010339</org_study_id> <nct_id>NCT05316584</nct_id> </id_info> <brief_title>A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy</brief_title> <acronym>ASSIST</acronym> <official_title>A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With Inflammatory Bowel DiSease Therapy-ASSIST Study</official_title> <sponsors> <lead_sponsor> <agency>University of Maryland, Baltimore</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University of North Carolina, Chapel Hill</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Vanderbilt University Medical Center</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>New York University</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Cincinnati</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Synchronyx, LLC</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Maryland, Baltimore</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 investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization.  The investigators will address the following specific aims:  1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care.  2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care. </textblock> </brief_summary> <detailed_description> <textblock> The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease (IBD) initiating oral or subcutaneous treatment. The investigators are conducting a 12-month multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization.  Adult participants with IBD with regular access to a mobile device or tablet initiating therapy with an oral or subcutaneous treatment for IBD at one of the five sites will be eligible to participate. Participants will be randomized 2:1 to the intervention or standard care. Eligible participants will complete an informed consent and baseline survey gathering demographic and clinical information.  TapptTM digital health system (developed by Synchronyx) is a remote therapeutic monitoring and digital engagement solution that monitors real-time medication adherence patterns through smart label technologies, capture patient reported outcomes (PROs) and barriers to care, and process patient data through algorithms that trigger personalized digital and human touchpoints between clinical visits. The research team will input information into the system on the intervention participant's medication to be tracked, dose, and frequency of dosing. Participants in the intervention group will be shipped the smart labels to be affixed to the pill bottle, pen, or syringe of the newly prescribed medication. Prior to receiving their medication, participants will receive virtual training on how to attach and use the proprietary labels, set up their participant profile, use the participant-facing web app, and seek technical helpdesk support. At the time of a medication dose, participants will scan the label by tapping it with their mobile device to verify that they are taking the medication. Upon scanning, participants immediately will receive a notification on their device indicating that the label was successfully scanned, and that their medication adherence was updated in their profile. The app offers participants visibility into their medication adherence patterns and upcoming doses, as well as the opportunity to respond to in-app questions that capture barriers towards adherence, IBD symptoms, and patient report outcomes (PROs). This information will also be available to the research and clinical team in real-time via the provider dashboard. Most importantly, the dashboard's artificial intelligence-based algorithm will send email alerts to the clinical team if participant's adherence, symptoms, or PROs fall below predetermined thresholds. For oral medications, mean adherence <86% in a 2-week period will trigger an alert. For SC medications, an alert will be generated if a dose is 10 days late for administration. A PRO 2 score for UC or CD of 2 or more will trigger an alert. If alerts are triggered for non-adherence, a clinical nurse, pharmacist, or social worker will contact the participant to identify barriers to adherence; remediation will be initiated if possible.  The primary outcome of the proposed study will be the difference in mean medication possession ratio (MPR) between the intervention and control group during the 12-month study. Secondary outcomes will include self-reported adherence (MARS-5), clinical response and remission (Harvey Bradshaw Index for CD and partial Mayo score of UC), steroid-free response and remission, PROMIS measures of Fatigue, Sleep Disturbance, Pain Interference, Anxiety, Depression, and Quality of Life, self-efficacy (IBD Self-Efficacy Scale), new steroid use, and health care utilization (urgent care or emergency room visit, unplanned office visit, hospitalization, and/or surgery).  Assuming 2 intervention participants for every 1 control with an adherence rate among controls of 0.65 and 0.9 in intervention participations with a Type 1 error rate of 0.05 and power of 0.9, we will need to enroll 82 intervention participants and 41 controls (n=123). All analyses will be completed using intention to treat principles. For categorical variables, the groups will be compared using the Chi Square test (Fisher's Exact if not normally distributed). For continuous variables, the groups will be compared using t tests (Wilcoxon signed rank if not normally distributed). We will also build logistic and linear regression models to adjust for confounding variable for the outcomes of interest. Possible confounding variables include but are not limited to route of administration, gender, insurance type, disease type, age, concurrent psychiatric disease, smoking, and concurrent steroid and/or narcotic use. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 6, 2022</start_date> <completion_date type="Anticipated">December 31, 2024</completion_date> <primary_completion_date type="Anticipated">July 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>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Multicenter, randomized, controlled trial</intervention_model_description> <primary_purpose>Health Services Research</primary_purpose> <masking>Single (Outcomes Assessor)</masking> <masking_description>It will not be possible to blind participants to their respective group assignment. However, to minimize bias, we will collect all outcome data electronically by study staff at the Data Management Center at the University of North Carolina masked to the group assignment.</masking_description> </study_design_info> <primary_outcome> <measure>Medication adherence</measure> <time_frame>1 year</time_frame> <description>Medication possession ratio</description> </primary_outcome> <primary_outcome> <measure>Self-reported medication adherence</measure> <time_frame>1 year</time_frame> <description>MARS-5, scores from 5 to 25 with higher scores indicated greater adherence</description> </primary_outcome> <secondary_outcome> <measure>Healthcare utilization</measure> <time_frame>1 year</time_frame> <description>Rates of healthcare utilization including office and ER visits, hospitalizations, and diagnostic testing</description> </secondary_outcome> <secondary_outcome> <measure>IBD Disease activity</measure> <time_frame>1 year</time_frame> <description>Harvey Bradshaw Index ( for participants with Crohn's disease only), minimum score 0, no maximum score, higher scores indicated greater disease activity</description> </secondary_outcome> <secondary_outcome> <measure>IBD Disease activity (objective)</measure> <time_frame>1 year</time_frame> <description>C reactive protein, minimum value 0, no maximum value, higher values indicate greater disease activity</description> </secondary_outcome> <secondary_outcome> <measure>Patient Reported Outcomes, Quality of Life</measure> <time_frame>1 year</time_frame> <description>PROMIS Global Health, T scores from 0-100, 50 is the population mean, higher scores indicate better quality of life</description> </secondary_outcome> <secondary_outcome> <measure>Self-efficacy</measure> <time_frame>1 year</time_frame> <description>IBD Self-efficacy scale, scores range from 29-290 with higher scores indicated greater self-efficacy</description> </secondary_outcome> <secondary_outcome> <measure>IBD Disease Activity</measure> <time_frame>1 year</time_frame> <description>Simple clinical colitis activity index (participants with ulcerative colitis only), minimum score 0, maximum score 19, higher scores indicate greater disease activity</description> </secondary_outcome> <secondary_outcome> <measure>IBD Disease Activity (objective)</measure> <time_frame>1 year</time_frame> <description>Fecal calprotectin, minimum value 0, no maximum value, higher values indicate greater disease activity</description> </secondary_outcome> <secondary_outcome> <measure>IBD Disease Activity (objective)</measure> <time_frame>1 year</time_frame> <description>Mayo Endoscopic score (participants with ulcerative colitis only), minimum score 0, maximum score 3, higher scores indicate greater disease activity</description> </secondary_outcome> <secondary_outcome> <measure>IBD Disease Activity (objective)</measure> <time_frame>1 year</time_frame> <description>Simple endoscopic score (participants with Crohn's disease only), minimum score 0, maximum score 60, higher scores indicate greater disease activity</description> </secondary_outcome> <secondary_outcome> <measure>Patient Reported Outcome (Pain interference)</measure> <time_frame>1 year</time_frame> <description>PROMIS Pain Interference, T scores from 0-100, 50 is the population mean, higher scores indicate more pain</description> </secondary_outcome> <secondary_outcome> <measure>Patient Reported Outcome (Anxiety)</measure> <time_frame>1 Year</time_frame> <description>PROMIS Anxiety, T scores from 0-100, 50 is the population mean, higher scores indicate more anxiety</description> </secondary_outcome> <secondary_outcome> <measure>Patient Reported Outcome (Depression)</measure> <time_frame>1 year</time_frame> <description>PROMIS Depression, T scores from 0-100, 50 is the population mean, higher scores indicate more depression</description> </secondary_outcome> <secondary_outcome> <measure>Patient Reported Outcome (Fatigue)</measure> <time_frame>1 year</time_frame> <description>PROMIS Fatigue, T scores from 0-100, 50 is the population mean, higher scores indicate more fatigue</description> </secondary_outcome> <secondary_outcome> <measure>Patient Reported Outcome (Sleep Disturbance)</measure> <time_frame>1 year</time_frame> <description>PROMIS Sleep Disturbance, T scores from 0-100, 50 is the population mean, higher scores indicate more sleep disturbance</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">123</enrollment> <condition>Inflammatory Bowel Diseases</condition> <condition>Crohn Disease</condition> <condition>Ulcerative Colitis</condition> <arm_group> <arm_group_label>Remote Monitoring</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>At the time of a medication dose, participants scan the smart label by tapping it with their mobile device. Participants receive a notification on their device indicating that their medication adherence was updated. Each day a medication is due, patients receive a morning reminder through SMS message notifying them on their medications schedule. If patients fail to scan the label at a given time (as expected by their specific medication regimen), they will receive an end of day text message. Participants will also complete a patient reported outcome (PRO) 2 assessment at baseline, and then monthly for the entire 12 months of the study through an HTML link sent to patients by SMS message. If nonadherence is present and/or moderate to severe symptoms, an alert will be triggered to the research team. The research team can send the PRO2 survey to patients at any given time, at their discretion, if patients are experiencing a flare or at the time of a change in medication dose.</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The standard of care for participants in this study is modeled after the standard of care at all five study sites. Standard of care is based on current evidence-based guidelines including a comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. Personnel used to provide standard of care at each site will vary and may include nurse coordinators, advanced practice providers, social workers, psychologists, dieticians, pharmacists, and other ancillary staff.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Remote monitoring</intervention_name> <description>See prior description of the intervention.</description> <arm_group_label>Remote Monitoring</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. At least 18 years of age or older  2. Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology  3. Initiating treatment with a new oral or subcutaneous treatment for IBD  4. Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access  5. Ability to understand the protocol and provide informed consent in English  Exclusion Criteria:  1. Inability to speak and read English  2. Inability to comply with the study protocol  3. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis  4. Patients initiating oral corticosteroids only (without concurrent use of an oral or subcutaneous maintenance therapy)  5. Imminent surgery (within the next 60 days)  6. History of short bowel syndrome  7. Uncontrolled medical or psychiatric disease at the opinion of the investigator  1. Degenerative neurologic condition  2. Unstable angina  3. Symptomatic peripheral vascular disease  4. Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)  5. Poorly controlled depression, mania, and schizophrenia  6. Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics) </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Raymond K Cross, MD</last_name> <phone>410-706-3387</phone> <email>rcross@som.umaryland.edu</email> </overall_contact> <overall_contact_backup> <last_name>Beth Scism</last_name> <phone>410-706-1423</phone> <email>bscism@som.umaryland.edu</email> </overall_contact_backup> <location> <facility> <name>University of Maryland School of Medicine</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21201</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Bethl Scism</last_name> <phone>410-706-1423</phone> <email>bscism@som.umaryland.edu</email> </contact> <contact_backup> <last_name>Abby Noyes</last_name> <phone>4107061423</phone> <email>anoyes@som.umaryland.edu</email> </contact_backup> <investigator> <last_name>Raymond K Cross, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Seema A Patil, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Lauren George, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>New York University</name> <address> <city>New York</city> <state>New York</state> <zip>10016</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Xavier Lopez</last_name> <phone>646-501-8818</phone> <email>xavier.lopez@nyulangone.org</email> </contact> <contact_backup> <last_name>Gigi Ghiasian</last_name> <phone>6465017822</phone> <email>ghoncheh.ghiasian@nyulangone.org</email> </contact_backup> <investigator> <last_name>Jordan Axelrad</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of North Carolina at Chapel Hill</name> <address> <city>Chapel Hill</city> <state>North Carolina</state> <zip>27599-7080</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Walter Blanchard</last_name> <phone>252-489-8130</phone> <email>walker_blanchard@med.unc.edu</email> </contact> <contact_backup> <last_name>Mikki Sandridge</last_name> <phone>9198433873</phone> <email>mikki_sandridge@med.unc.edu</email> </contact_backup> <investigator> <last_name>Millie D Long, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of Cincinnati College of Medicine</name> <address> <city>Cincinnati</city> <state>Ohio</state> <zip>45267</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Renee Henry</last_name> <phone>513-558-5504</phone> <email>henry4@ucmail.uc.edu</email> </contact> <contact_backup> <last_name>Missy Randolph</last_name> <phone>5135585529</phone> <email>randollj@ucmail.uc.edu</email> </contact_backup> <investigator> <last_name>Kara De Felice, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Anita Afzali, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>Vanderbilt University Medical Center</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37212</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Nisa Patel</last_name> <phone>615-936-7017</phone> <email>nisa.patel@vumc.org</email> </contact> <contact_backup> <last_name>Melissa Beavers</last_name> <phone>6159367017</phone> <email>melissa.beavers@vumc.org</email> </contact_backup> <investigator> <last_name>Sara Horst, MD</last_name> <role>Principal Investigator</role> </investigator> </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 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 26, 2023</last_update_submitted> <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 27, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation> <investigator_full_name>Raymond Cross</investigator_full_name> <investigator_title>Professor of Medicine</investigator_title> </responsible_party> <keyword>Inflammatory bowel disease</keyword> <keyword>Crohn disease</keyword> <keyword>Ulcerative colitis</keyword> <keyword>Adherence</keyword> <keyword>Remote monitoring</keyword> <condition_browse>  <mesh_term>Crohn Disease</mesh_term> <mesh_term>Colitis</mesh_term> <mesh_term>Colitis, Ulcerative</mesh_term> <mesh_term>Intestinal Diseases</mesh_term> <mesh_term>Inflammatory Bowel Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>After publication, raw data will be made available to other investigators upon receipt of a written request. Release of datasets to secondary users will be subject to approval by the investigators. The request must include a reason for review of the data and type of dataset they wish to receive, and a copy of a curriculum vitae. The dataset provided will be deidentified to prevent breach of confidentiality. Investigators requesting to review our data must sign an agreement that they will not attempt to obtain protected health information on participants. In addition to the raw data, investigators will receive a list of variable and coding definitions. The agreement will specify, the data are to be used for IRB-approved research purposes only and data will not be transferred to other users by the recipient. The methodology for the Tappt system and for the proposed trial will be published.</ipd_description> <ipd_time_frame>See above</ipd_time_frame> <ipd_access_criteria>See above</ipd_access_criteria> </patient_data>  </clinical_study>

The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. The investigators will address the following specific aims: 1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care. 2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care. The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease (IBD) initiating oral or subcutaneous treatment. The investigators are conducting a 12-month multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. Adult participants with IBD with regular access to a mobile device or tablet initiating therapy with an oral or subcutaneous treatment for IBD at one of the five sites will be eligible to participate. Participants will be randomized 2:1 to the intervention or standard care. Eligible participants will complete an informed consent and baseline survey gathering demographic and clinical information. TapptTM digital health system (developed by Synchronyx) is a remote therapeutic monitoring and digital engagement solution that monitors real-time medication adherence patterns through smart label technologies, capture patient reported outcomes (PROs) and barriers to care, and process patient data through algorithms that trigger personalized digital and human touchpoints between clinical visits. The research team will input information into the system on the intervention participant's medication to be tracked, dose, and frequency of dosing. Participants in the intervention group will be shipped the smart labels to be affixed to the pill bottle, pen, or syringe of the newly prescribed medication. Prior to receiving their medication, participants will receive virtual training on how to attach and use the proprietary labels, set up their participant profile, use the participant-facing web app, and seek technical helpdesk support. At the time of a medication dose, participants will scan the label by tapping it with their mobile device to verify that they are taking the medication. Upon scanning, participants immediately will receive a notification on their device indicating that the label was successfully scanned, and that their medication adherence was updated in their profile. The app offers participants visibility into their medication adherence patterns and upcoming doses, as well as the opportunity to respond to in-app questions that capture barriers towards adherence, IBD symptoms, and patient report outcomes (PROs). This information will also be available to the research and clinical team in real-time via the provider dashboard. Most importantly, the dashboard's artificial intelligence-based algorithm will send email alerts to the clinical team if participant's adherence, symptoms, or PROs fall below predetermined thresholds. For oral medications, mean adherence <86% in a 2-week period will trigger an alert. For SC medications, an alert will be generated if a dose is 10 days late for administration. A PRO 2 score for UC or CD of 2 or more will trigger an alert. If alerts are triggered for non-adherence, a clinical nurse, pharmacist, or social worker will contact the participant to identify barriers to adherence; remediation will be initiated if possible. The primary outcome of the proposed study will be the difference in mean medication possession ratio (MPR) between the intervention and control group during the 12-month study. Secondary outcomes will include self-reported adherence (MARS-5), clinical response and remission (Harvey Bradshaw Index for CD and partial Mayo score of UC), steroid-free response and remission, PROMIS measures of Fatigue, Sleep Disturbance, Pain Interference, Anxiety, Depression, and Quality of Life, self-efficacy (IBD Self-Efficacy Scale), new steroid use, and health care utilization (urgent care or emergency room visit, unplanned office visit, hospitalization, and/or surgery). Assuming 2 intervention participants for every 1 control with an adherence rate among controls of 0.65 and 0.9 in intervention participations with a Type 1 error rate of 0.05 and power of 0.9, we will need to enroll 82 intervention participants and 41 controls (n=123). All analyses will be completed using intention to treat principles. For categorical variables, the groups will be compared using the Chi Square test (Fisher's Exact if not normally distributed). For continuous variables, the groups will be compared using t tests (Wilcoxon signed rank if not normally distributed). We will also build logistic and linear regression models to adjust for confounding variable for the outcomes of interest. Possible confounding variables include but are not limited to route of administration, gender, insurance type, disease type, age, concurrent psychiatric disease, smoking, and concurrent steroid and/or narcotic use. Inclusion Criteria: 1. At least 18 years of age or older 2. Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology 3. Initiating treatment with a new oral or subcutaneous treatment for IBD 4. Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access 5. Ability to understand the protocol and provide informed consent in English Exclusion Criteria: 1. Inability to speak and read English 2. Inability to comply with the study protocol 3. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis 4. Patients initiating oral corticosteroids only (without concurrent use of an oral or subcutaneous maintenance therapy) 5. Imminent surgery (within the next 60 days) 6. History of short bowel syndrome 7. Uncontrolled medical or psychiatric disease at the opinion of the investigator 1. Degenerative neurologic condition 2. Unstable angina 3. Symptomatic peripheral vascular disease 4. Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin) 5. Poorly controlled depression, mania, and schizophrenia 6. Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)

NCT0531xxxx/NCT05316597.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/NCT05316597</url> </required_header> <id_info> <org_study_id>STUDY00013134</org_study_id> <secondary_id>R21AT011242</secondary_id> <nct_id>NCT05316597</nct_id> </id_info> <brief_title>Do Terpenes Play a Role in the Stress-reducing Effects of a Forest Bathing Intervention?</brief_title> <official_title>Do Terpenes Play a Role in the Stress-reducing Effects of a Forest Bathing Intervention?</official_title> <sponsors> <lead_sponsor> <agency>University of Washington</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>National Center for Complementary and Integrative Health (NCCIH)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>University of Washington</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 pilot study evaluates the role terpenes play in the stress-reducing effects of a forest bathing intervention. Participants will participate in two interventions in random order: 1) terpene exposure and 2) no terpene exposure. </textblock> </brief_summary> <detailed_description> <textblock> The investigators will use an individual-level crossover design in which each session is conducted independently and on different days. Participants will be outfitted with a powered air purifying respirator (PAPR) to selectively modulate exposure to a natural suite of forest-derived volatile organic compounds (VOCs) while present in forest environments. Each participant will undergo two forest bathing sessions, one in which VOCs are not filtered (treatment condition), and one in which they are filtered (control condition). Sessions will be separated by a 7-day washout period for each participant, and order will be counterbalanced. The investigators will estimate the average effect of treatment over 40 distinct treatment days against 40 distinct control/filtered days. The power and sample size calculations (N = 40) were determined using previous nature exposure studies of similar cross-over design. The study is adequately powered assuming the conventional targets of α = 0.05 and β = 0.80 with a 10% anticipated dropout rate, and including temperature, wind, and light variability during treatment days.  The specific aim of this project is to 1) assess whether VOC inhalation regulates increases in the high frequency (HF) (ms2) component of heart rate variability (HRV) as the primary outcome (with decreases in blood pressure, heart rate, self-reported stress, and levels of inflammatory cytokines in serum included as secondary outcomes); and 1a) assess the degree of association of absorbed dose of seven forest-derived VOCs in serum (i.e., α-pinene, β-pinene, β-myrcene, ∆ 3-carene, d-limonene, β- caryophyllene, α-humulene) with these outcomes. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 12, 2022</start_date> <completion_date type="Anticipated">November 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>Crossover Assignment</intervention_model> <intervention_model_description>Participants are assigned to both arms in random order</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Double (Participant, Investigator)</masking> <masking_description>Participants and research staff conducting the intervention will be masked to the exposure</masking_description> </study_design_info> <primary_outcome> <measure>Changes in the HF (ms2) component of HRV</measure> <time_frame>up to 1 hour before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).</time_frame> <description>Assess whether VOC inhalation regulates psychophysiological outcomes of the terpenes-on vs. terpenes-off sessions.</description> </primary_outcome> <secondary_outcome> <measure>Blood pressure (systolic and diastolic in mmHg)</measure> <time_frame>up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).</time_frame> <description>Assessed using mobile physiology equipment</description> </secondary_outcome> <secondary_outcome> <measure>Heart rate (beats per minute)</measure> <time_frame>up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).</time_frame> <description>Assessed using mobile physiology equipment</description> </secondary_outcome> <secondary_outcome> <measure>Skin conductance (μS)</measure> <time_frame>up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).</time_frame> <description>Assessed using mobile physiology equipment</description> </secondary_outcome> <secondary_outcome> <measure>Self-reported affect</measure> <time_frame>up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).</time_frame> <description>Assessed using the shortened Positive and Negative Affect Schedule (PANAS) and/or Profile of Mood States (POMS)</description> </secondary_outcome> <secondary_outcome> <measure>Self-reported anxiety</measure> <time_frame>up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).</time_frame> <description>Assessed using the shortened State-Trait Anxiety Inventory (STAI)</description> </secondary_outcome> <secondary_outcome> <measure>Self-reported stress</measure> <time_frame>up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).</time_frame> <description>Assessed using Perceived Stress Scale 4 (PSS-4)</description> </secondary_outcome> <secondary_outcome> <measure>Levels of inflammatory cytokines (CRP, TNF-alpha, and IL-6 in μg/mL)</measure> <time_frame>Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)</time_frame> <description>Assessed using blood serum collected via standard clinical methods</description> </secondary_outcome> <secondary_outcome> <measure>Levels of cortisol in serum (μg/mL)</measure> <time_frame>Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)</time_frame> <description>Assessed using blood serum collected via standard clinical methods</description> </secondary_outcome> <other_outcome> <measure>Degree of association of absorbed dose of VOCs in serum (μg/mL)</measure> <time_frame>Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)</time_frame> <description>Assess the degree of association of absorbed dose of seven forest-derived VOCs in serum (i.e., α-pinene, β-pinene, β-myrcene, ∆ 3- carene, d-limonene, β-caryophyllene, α-humulene) with primary and secondary outcomes.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Monoterpene Exposure During a Forest Bathing Intervention</condition> <arm_group> <arm_group_label>Terpenes On</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Forest bathing intervention with no filtration of terpenes from inhaled air ("terpenes on")</description> </arm_group> <arm_group> <arm_group_label>Terpenes Off</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Forest bathing intervention with filtration of terpenes from inhaled air ("terpenes off")</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Forest bathing</intervention_name> <description>Participants will be seated in a forest environment for an hour-long exposure to the forest</description> <arm_group_label>Terpenes Off</arm_group_label> <arm_group_label>Terpenes On</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 18 years and older  - Non-smoker  - Physically capable of walking for approximately 15-20 min from the study vehicle to the clinic and experimental locations.  Exclusion Criteria:  - Pregnancy  - Current or prior diagnosis of neurologic, hypertensive, psychiatric, respiratory disorder, or anosmia/hyposmia  - Some types of medication.  - Olfactory sensitivity threshold (assessed via UPSIT® test kit (Sensonics International, Haddon Heights, NJ)  - Positive COVID-19 test  At enrollment, participants will complete a baseline survey on demographics, personality traits, and regular nature contact and perceptions. Study staff will also use the clinically-validated UPSIT® test kit (Sensonics International, Haddon Heights, NJ) to evaluate olfactory sensitivity and identify/exclude participants with undiagnosed smell loss.  Study staff will work with participants to schedule their forest bathing sessions and review instructions on how to prepare (e.g., by avoiding alcohol, marijuana, and certain foods, drinks, and household cleaning products with high terpene concentrations 24 hrs before their session). </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>Gregory Bratman, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of Washington</affiliation> </overall_official> <overall_contact> <last_name>Gregory Bratman, PhD</last_name> <phone>206-543-7591</phone> <email>bratman@uw.edu</email> </overall_contact> <location> <facility> <name>Pack Forest</name> <address> <city>Eatonville</city> <state>Washington</state> <zip>98328</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>October 2022</verification_date> <study_first_submitted>March 9, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>October 31, 2022</last_update_submitted> <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 1, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Washington</investigator_affiliation> <investigator_full_name>Gregory Bratman</investigator_full_name> <investigator_title>Assistant Professor: Environmental and Forest Sciences</investigator_title> </responsible_party>  </clinical_study>

This pilot study evaluates the role terpenes play in the stress-reducing effects of a forest bathing intervention. Participants will participate in two interventions in random order: 1) terpene exposure and 2) no terpene exposure. The investigators will use an individual-level crossover design in which each session is conducted independently and on different days. Participants will be outfitted with a powered air purifying respirator (PAPR) to selectively modulate exposure to a natural suite of forest-derived volatile organic compounds (VOCs) while present in forest environments. Each participant will undergo two forest bathing sessions, one in which VOCs are not filtered (treatment condition), and one in which they are filtered (control condition). Sessions will be separated by a 7-day washout period for each participant, and order will be counterbalanced. The investigators will estimate the average effect of treatment over 40 distinct treatment days against 40 distinct control/filtered days. The power and sample size calculations (N = 40) were determined using previous nature exposure studies of similar cross-over design. The study is adequately powered assuming the conventional targets of α = 0.05 and β = 0.80 with a 10% anticipated dropout rate, and including temperature, wind, and light variability during treatment days. The specific aim of this project is to 1) assess whether VOC inhalation regulates increases in the high frequency (HF) (ms2) component of heart rate variability (HRV) as the primary outcome (with decreases in blood pressure, heart rate, self-reported stress, and levels of inflammatory cytokines in serum included as secondary outcomes); and 1a) assess the degree of association of absorbed dose of seven forest-derived VOCs in serum (i.e., α-pinene, β-pinene, β-myrcene, ∆ 3-carene, d-limonene, β- caryophyllene, α-humulene) with these outcomes. Inclusion Criteria: - 18 years and older - Non-smoker - Physically capable of walking for approximately 15-20 min from the study vehicle to the clinic and experimental locations. Exclusion Criteria: - Pregnancy - Current or prior diagnosis of neurologic, hypertensive, psychiatric, respiratory disorder, or anosmia/hyposmia - Some types of medication. - Olfactory sensitivity threshold (assessed via UPSIT® test kit (Sensonics International, Haddon Heights, NJ) - Positive COVID-19 test At enrollment, participants will complete a baseline survey on demographics, personality traits, and regular nature contact and perceptions. Study staff will also use the clinically-validated UPSIT® test kit (Sensonics International, Haddon Heights, NJ) to evaluate olfactory sensitivity and identify/exclude participants with undiagnosed smell loss. Study staff will work with participants to schedule their forest bathing sessions and review instructions on how to prepare (e.g., by avoiding alcohol, marijuana, and certain foods, drinks, and household cleaning products with high terpene concentrations 24 hrs before their session).

NCT0531xxxx/NCT05316610.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/NCT05316610</url> </required_header> <id_info> <org_study_id>HAS.21.03.120a</org_study_id> <nct_id>NCT05316610</nct_id> </id_info> <brief_title>Coach-Led Body Image Intervention for Girls in Sport - Pilot</brief_title> <official_title>Body Confident Athletes: Acceptability Testing of a Coach-Led Body Image Intervention for Adolescent Girls in Sport</official_title> <sponsors> <lead_sponsor> <agency>University of the West of England</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Unilever R&D</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Nike</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Laureus</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Tucker Center for Research on Girls & Women in Sport</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of the West of England</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> According to the World Health Organization, only 15% of 11-17-year-old girls meet the recommended daily physical movement guidelines (e.g., 60-minutes per day). Despite extensive research highlighting the protective factors associated with sport on both mental and physical health, body image concerns are a key barrier to girls' participation in and enjoyment of sport. Sports-related environments and society more broadly further exacerbate these concerns through harmful gender stereotypes that perpetuate female objectification, discrimination, and harassment. This includes the promotion of unrealistic and sexualized appearances of female athletes, uncomfortable and objectifying uniforms, and appearance and competence-related teasing from male and female peers, as well as coaches.  The magnitude of this issue and how best to address it, can be understood from a socioecological perspective. Researchers suggest developing multi-faceted and multi-tiered approaches that have scope for targeting the individual, interpersonal, organizational, and societal levels. The current research will test the first coach delivered embodying sports program for girls that will be implemented through sporting organizations. The Body Confident Athletes program was co-created with girls and coaches through an international multi-disciplinary partnership between academics, health professionals, industry, and community organizations. Multi-disciplinary partnerships can create a supportive landscape by upskilling girls and influential community members (e.g., coaches) in dealing with body image concerns, which will likely lead to sustained sports participation and biopsychosocial benefits.  As such, the aim of the present study is to conduct a randomized controlled trial (RCT) to evaluate the effectiveness, feasibility, and acceptability of the Body Confident Athletes program. The program consists of five 60-minute sessions delivered by coaches to adolescent girls. Each session tackles a distinct theme related to body image in the sporting context. Outcomes will be assessed at pre- and post-intervention (5 weeks later) and include body image (primary outcome), sport enjoyment and embodied experiences (secondary outcomes), and feasibility, acceptability, and adherence (process outcomes). The comparison control arm will be a waitlist control condition.  To undertake this project, sporting organizations will be cluster-randomized into the intervention group or the control group, with 80 girls anticipated in each arm. Those in the intervention condition will complete baseline assessments (target outcomes and demographic information), take part in the five-week intervention, and then complete the post-intervention assessments (target outcomes and feasibility and acceptability measures). Those in the waitlist control condition will complete the baseline assessments (target outcomes and demographic information) and a second assessment five weeks later (target outcomes only), after which they will get access to the intervention. However, their engagement with the intervention will not be monitored or assessed. At completion of the post-intervention survey, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body image and eating concerns. Lastly, to compensate participants for their time, girls and coaches will receive an electronic voucher to the value of $60 dollars.  The investigators hypothesize that girls who take part in the Body Confident Athletes intervention will report better body image, greater sport enjoyment, and higher levels of embodiment at post-intervention than girls who do not take part in the intervention. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Actual">October 1, 2022</completion_date> <primary_completion_date type="Actual">October 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> <primary_purpose>Prevention</primary_purpose> <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in body esteem (assessed via the Body Esteem Scale for Adults and Adolescents)</measure> <time_frame>Baseline, pre-intervention; immediately after the intervention (5 weeks later)</time_frame> <description>The Body Esteem Scale for Adults and Adolescents (BESAA) assesses body esteem (BE), which refers to self-evaluations of one's body or appearance. The BESAA has 3 subscales: BE-Appearance (general feelings about appearance), BE-Weight (weight satisfaction), and BE-Attribution (evaluations attributed to others about one's body and appearance). BESAA scores range from 0-4 with higher scores on the BESAA indicating higher levels of body esteem.</description> </primary_outcome> <secondary_outcome> <measure>Change in embodiment (assessed via the Youth Experience of Embodiment Scale)</measure> <time_frame>Baseline, pre-intervention; immediately after the intervention (5 weeks later)</time_frame> <description>The Youth Experience of Embodiment Scale (YEES) assesses how girls inhabit their body (e.g., body connection and comfort, attuned self-care) and how they navigate the world (e.g., with agency, resisting self-objectification). YEES scores range from 1-5 with higher scores on the YEES indicating higher levels of embodiment.</description> </secondary_outcome> <secondary_outcome> <measure>Change in sport enjoyment (assessed via the Sources of Enjoyment in Youth Sport Questionnaire)</measure> <time_frame>Baseline, pre-intervention; immediately after the intervention (5 weeks later)</time_frame> <description>The Sources of Enjoyment in Youth Sport Questionnaire (SEYSQ) assesses the source of an athlete's enjoyment in sport according to two spectrums (intrinsic motivation vs. extrinsic motivation and achievement vs. non-achievement factors), resulting in four quadrants indicating the four sources of an athlete's enjoyment. SEYSQ scores range from 1-5.</description> </secondary_outcome> <other_outcome> <measure>Total acceptability of the intervention (assessed via a self-report questionnaire)</measure> <time_frame>Immediately after the intervention</time_frame> <description>Girls and coaches will complete feasibility and acceptability measures via a self-report questionnaire. Firstly, girls and coaches will respond using a 1-5 scale (Strongly Disagree to Strongly Agree) on questions, such as: 1) The program was interesting; 2) The program was easy to understand; 3) The program was enjoyable; and 4) The program discussed things that are important to me. Secondly, girls and coaches will be able to provide further feedback using open-ended responses on questions such as: 1) What did you like about the program and why? 2) What would you change about the program and why? 3) What did you think about the design of the materials? 4) Please tell us anything else you think will help improve the program for girls.</description> </other_outcome> <other_outcome> <measure>Total intervention fidelity (assessed via investigator observation of recorded intervention sessions)</measure> <time_frame>Immediately after the intervention</time_frame> <description>Total intervention fidelity will be assessed by the investigators through observing the program sessions as delivered by coaches and completing a pre-determined checklist to ensure the program was delivered to girls as intended.</description> </other_outcome> <other_outcome> <measure>Total intervention adherence (assessed through session completion)</measure> <time_frame>Immediately after the intervention</time_frame> <description>Total intervention adherence will be assessed by the investigators as number of participants who complete the full intervention.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">18</enrollment> <condition>Intervention</condition> <condition>Waitlist Control</condition> <arm_group> <arm_group_label>Body Confident Athletes</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants in the intervention condition will take part in an in-person program consisting of five sessions over five weeks.</description> </arm_group> <arm_group> <arm_group_label>Waitlist control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Participants will not be explicitly told their study condition, although they will be made aware of the assessment time points and whether they receive the intervention between T1 and T2 (intervention) or after T2 (waitlist control). Following completion of post-intervention assessments (T2), the control condition will participate in the intervention; but, they will not be monitored or assessed.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Body Confident Athletes</intervention_name> <description>The Body Confident Athletes program is a five-session in-person program designed to be delivered by coaches to their athletes. Groups should be of approximately 10 girls. The organizations will work with the community partner and researchers on how to schedule the intervention over a five-week period. These sessions can replace a regular sport practice each week or an additional session can be organized by the sport organizations. Each session will take approximately 60 minutes and will consist of four phases, including The Game Plan (5 mins), The Skills (20 mins), Game Time (20 mins), and The Final Score (15 mins). A variety of activity modalities are utilized to convey learning outcomes, including group and individual activities, and discussion-, writing- and movement-based activities.</description> <arm_group_label>Body Confident Athletes</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Girls aged 11-17 years old  - English speaking  - US resident  Exclusion Criteria:  - n/a </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <minimum_age>11 Years</minimum_age> <maximum_age>17 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Centre for Appearance Research, University of the West of England</name> <address> <city>Bristol</city> <zip>BS16 1QY</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <reference> <citation>Guthold R, Stevens GA, Riley LM, Bull FC. Global trends in insufficient physical activity among adolescents: a pooled analysis of 298 population-based surveys with 1.6 million participants. Lancet Child Adolesc Health. 2020 Jan;4(1):23-35. doi: 10.1016/S2352-4642(19)30323-2. Epub 2019 Nov 21.</citation> <PMID>31761562</PMID> </reference> <reference> <citation>Neumark-Sztainer D, MacLehose RF, Watts AW, Pacanowski CR, Eisenberg ME. Yoga and body image: Findings from a large population-based study of young adults. Body Image. 2018 Mar;24:69-75. doi: 10.1016/j.bodyim.2017.12.003. Epub 2017 Dec 27.</citation> <PMID>29288970</PMID> </reference> <reference> <citation>Sabiston, C., Pila, E., Vani, M., & Thogersen-Ntoumani, C. (2019). Body image, physical activity, and sport: A scoping review. Psychology Of Sport And Exercise, 42, 48-57. doi: 10.1016/j.psychsport.2018.12.010</citation> </reference> <reference> <citation>Sabiston, C. M., Vani, M. F., & Murray, R. M. (2021). Body-related self-conscious emotions in sport and exercise: A self-regulation perspective. In Motivation and Self-regulation in Sport and Exercise (pp. 62-77). Routledge.</citation> </reference> <reference> <citation>Slater A, Tiggemann M. Gender differences in adolescent sport participation, teasing, self-objectification and body image concerns. J Adolesc. 2011 Jun;34(3):455-63. doi: 10.1016/j.adolescence.2010.06.007. Epub 2010 Jul 31.</citation> <PMID>20643477</PMID> </reference> <reference> <citation>Vani MF, Pila E, Willson E, Sabiston CM. Body-related embarrassment: The overlooked self-conscious emotion. Body Image. 2020 Mar;32:14-23. doi: 10.1016/j.bodyim.2019.10.007. Epub 2019 Nov 13.</citation> <PMID>31733410</PMID> </reference> <results_reference> <citation>Matheson EL, Schneider J, Tinoco A, Gentili C, Silva-Breen H, LaVoi NM, White P, Diedrichs PC. The co-creation, initial piloting, and protocol for a cluster randomised controlled trial of a coach-led positive body image intervention for girls in sport. BMC Public Health. 2023 Jul 31;23(1):1467. doi: 10.1186/s12889-023-16360-w.</citation> <PMID>37525161</PMID> </results_reference> <verification_date>August 2023</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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</responsible_party_type> </responsible_party> <keyword>Body image</keyword> <keyword>Embodiment</keyword> <keyword>Girls</keyword> <keyword>Athletes</keyword> <keyword>Coaches</keyword> <keyword>Task shifting</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

According to the World Health Organization, only 15% of 11-17-year-old girls meet the recommended daily physical movement guidelines (e.g., 60-minutes per day). Despite extensive research highlighting the protective factors associated with sport on both mental and physical health, body image concerns are a key barrier to girls' participation in and enjoyment of sport. Sports-related environments and society more broadly further exacerbate these concerns through harmful gender stereotypes that perpetuate female objectification, discrimination, and harassment. This includes the promotion of unrealistic and sexualized appearances of female athletes, uncomfortable and objectifying uniforms, and appearance and competence-related teasing from male and female peers, as well as coaches. The magnitude of this issue and how best to address it, can be understood from a socioecological perspective. Researchers suggest developing multi-faceted and multi-tiered approaches that have scope for targeting the individual, interpersonal, organizational, and societal levels. The current research will test the first coach delivered embodying sports program for girls that will be implemented through sporting organizations. The Body Confident Athletes program was co-created with girls and coaches through an international multi-disciplinary partnership between academics, health professionals, industry, and community organizations. Multi-disciplinary partnerships can create a supportive landscape by upskilling girls and influential community members (e.g., coaches) in dealing with body image concerns, which will likely lead to sustained sports participation and biopsychosocial benefits. As such, the aim of the present study is to conduct a randomized controlled trial (RCT) to evaluate the effectiveness, feasibility, and acceptability of the Body Confident Athletes program. The program consists of five 60-minute sessions delivered by coaches to adolescent girls. Each session tackles a distinct theme related to body image in the sporting context. Outcomes will be assessed at pre- and post-intervention (5 weeks later) and include body image (primary outcome), sport enjoyment and embodied experiences (secondary outcomes), and feasibility, acceptability, and adherence (process outcomes). The comparison control arm will be a waitlist control condition. To undertake this project, sporting organizations will be cluster-randomized into the intervention group or the control group, with 80 girls anticipated in each arm. Those in the intervention condition will complete baseline assessments (target outcomes and demographic information), take part in the five-week intervention, and then complete the post-intervention assessments (target outcomes and feasibility and acceptability measures). Those in the waitlist control condition will complete the baseline assessments (target outcomes and demographic information) and a second assessment five weeks later (target outcomes only), after which they will get access to the intervention. However, their engagement with the intervention will not be monitored or assessed. At completion of the post-intervention survey, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body image and eating concerns. Lastly, to compensate participants for their time, girls and coaches will receive an electronic voucher to the value of $60 dollars. The investigators hypothesize that girls who take part in the Body Confident Athletes intervention will report better body image, greater sport enjoyment, and higher levels of embodiment at post-intervention than girls who do not take part in the intervention. Inclusion Criteria: - Girls aged 11-17 years old - English speaking - US resident Exclusion Criteria: - n/a

NCT0531xxxx/NCT05316623.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/NCT05316623</url> </required_header> <id_info> <org_study_id>2019-2885</org_study_id> <nct_id>NCT05316623</nct_id> </id_info> <brief_title>Using Peripheral Neurostimulation to Improve Work Rehabilitation</brief_title> <official_title>Using Peripheral Neurostimulation to Improve Work Rehabilitation</official_title> <sponsors> <lead_sponsor> <agency>Université de Sherbrooke</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Réseau Provincial De Recherche En Adaptation-Réadaptation (REPAR)</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Réseau québécois de recherche sur le vieillissement (RQRV)</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Université de Sherbrooke</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> Physical exercise plays a central role in work rehabilitation. However, the presence of pain (particularly common in older adults and aging workers) can lead to a fear of movement (kinesiophobia) and hinder rehabilitation. Access to rehabilitation care is also a barrier for many older adults, which could be circumvented through telerehabilitation. The objective of this pilot study is to document the feasibility and explore the effect of a telerehabilitation intervention combining therapeutic exercises and real TENS (experimental group) or placebo TENS (control group) in individuals aged 55 and over who have stopped working (triple-blind randomized controlled study). To do so, various feasibility indicators (e.g., recruitment rate, adherence) and clinical measures (e.g., kinesiophobia, pain during exercise) will be documented before and after the intervention. Together, these measures will help assess the appropriateness of conducting a large-scale study aimed at potentiating work rehabilitation in older populations. </textblock> </brief_summary> <detailed_description> <textblock> Problem and hypotheses:  In 2019, the proportion of Canadians aged 55 and over who were employed was 35.9%, the highest rate recorded to date since 1976. Despite their willingness to remain employed, seniors are more prone to work disability and early retirement. Older workers with disabilities are particularly vulnerable to job retention. In Quebec, the average length of absence following a work-related injury is 134 days for workers aged 55 and over, while it is less than 50 days for those aged 15 to 24. This difference can be explained in part by the presence of persistent pain that disproportionately affects older individuals and can significantly impede rehabilitation to work. The indirect costs associated with unemployment and absenteeism of people living with chronic pain were estimated to be $22.5 billion in Canada in 2019. A recent review conducted and published by our team found that strategies to reduce pain are one of the most important elements to consider in enabling workers to remain in the workplace after an episode of musculoskeletal disorder.  Exercise plays a central role in chronic pain management and work rehabilitation. However, pain can be a major barrier to physical activity. Therefore, finding ways to reduce pain during and after exercise is essential to facilitate rehabilitation. Peripheral neurostimulation (TENS) - an electrotherapeutic modality that uses an electrical current to depolarize peripheral nerve fibers with electrodes applied directly to the skin - is effective in temporarily relieving pain. It represents an interesting avenue for increasing exercise tolerance associated with exercise in the pain subject. To date, 3 studies have investigated the use of TENS during exercise, all showing positive results. None, however, have yet investigated this strategy (TENS + exercise) in aging workers living with persistent pain.  We postulate that telerehabilitation treatments (therapeutic exercises) provided concurrently with actual TENS will be more effective in reducing the biopsychological impacts of pain than the same rehabilitation treatments paired with placebo TENS. Thus, our hypothesis is that the experimental treatment will cause participants to enter a "virtuous circle": the TENS will allow for a punctual reduction of pain and kinesiophobia, which will encourage the realization/resumption of activity and lead to sustained benefits (e.g., physical function, pain, mood).  Objectives:  The primary objective of this pilot study is to explore the feasibility and acceptability of using real TENS, compared to placebo TENS, as a complementary treatment to a telerehabilitation exercise program, in workers who are off work.  The secondary objective is to compare the effect of the two types of intervention (real TENS + exercises vs. placebo TENS + exercises) on clinical outcomes (e.g. pain intensity, functioning in vocational rehabilitation, etc.).  Methods and analysis:  Design:  This project consists of a randomized controlled trial following a quadruple blind design.  Participants:  The target population is aging workers who are off work due to a musculoskeletal injury.  Sampling and recruitment procedures:  Participants will be recruited at the ISO-SANTÉ and Physio-Atlas clinics in Sherbrooke, which specialize in work rehabilitation (volunteer, non-probability sampling). The recruitment of individuals will be done through posters and with the help of clinicians who will be invited to talk to patients about the project.  Conduct of the study:  The purpose of this study is to recruit 24 participants who will take part in an exercise program spread over 3 weeks, with 3 sessions per week. The duration of each session is 30 minutes. The exercise program will be determined by the research team, in collaboration with clinic health professionals, and the exercises will be delivered via the TeraPlus telerehabilitation platform. The TENS (real or simulated) will be worn by participants throughout their telerehabilitation exercises, under the supervision of the student researcher. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 2023</start_date> <completion_date type="Anticipated">November 2023</completion_date> <primary_completion_date type="Anticipated">September 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>Single Group Assignment</intervention_model> <intervention_model_description>One placebo group and one intervention group</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> <masking_description>Quadruple blind</masking_description> </study_design_info> <primary_outcome> <measure>Recruitment rate</measure> <time_frame>4 months</time_frame> <description>The number of participants randomized divided by the number of participants screened.</description> </primary_outcome> <primary_outcome> <measure>Exclusion rate</measure> <time_frame>4 months</time_frame> <description>The number of ineligible participants divided by the number of participants screened.</description> </primary_outcome> <primary_outcome> <measure>Refusal rate</measure> <time_frame>4 months</time_frame> <description>The number of participants who refused to participate in the trial divided by the number of participants screened.</description> </primary_outcome> <primary_outcome> <measure>Adherence rate</measure> <time_frame>3 weeks</time_frame> <description>The number of people who finished intervention divided by the number of participants randomized.</description> </primary_outcome> <primary_outcome> <measure>Attrition rate</measure> <time_frame>3 weeks</time_frame> <description>The number of people who did not finish intervention divided by the number of participants randomized.</description> </primary_outcome> <primary_outcome> <measure>Kinesiophobia</measure> <time_frame>3 weeks</time_frame> <description>excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability due to painful injury or reinjury - Measured with the Tampa scale of kinesiophobia</description> </primary_outcome> <secondary_outcome> <measure>Severity of pain and impact of pain on physical function</measure> <time_frame>3 weeks</time_frame> <description>Measured with the Brief Pain Inventory (BPI)</description> </secondary_outcome> <secondary_outcome> <measure>Pain intensity</measure> <time_frame>3 weeks</time_frame> <description>Measured with a visual analog scale (VAS). Scale from 0 to 100, where 0 indicates no pain and 100 indicates worst pain imaginable</description> </secondary_outcome> <secondary_outcome> <measure>Psychosocial component and impact of pain on the emotional sphere</measure> <time_frame>3 weeks</time_frame> <description>Measured with Beck's depression inventory. Contains 21 items with a 4-point likert scale. The minimum possible score is 0 and the maximum possible score is 63. The higher the score, the more important the psychosocial component is for the individual.</description> </secondary_outcome> <secondary_outcome> <measure>Qualitative component of pain</measure> <time_frame>Intervention period (before first and after last sessions)</time_frame> <description>McGill Pain Questionnaire (MPQ). The MPQ is composed of 20 questions and scores range from 0 (no pain) to 78 (severe pain).</description> </secondary_outcome> <secondary_outcome> <measure>Pain catastrophizing</measure> <time_frame>3 weeks</time_frame> <description>Measured with the Pain Catastrophizing Scale. It consists of 13 thoughts or emotions related to a painful experience. Each thought is scored on 5 points from 0 to 4. The total score is 52 points. If the score is between 20 and 29, the risk of pain chronicization is moderate. If the score is between 29 and 52, the risk is high. The higher the score, the higher the risk.</description> </secondary_outcome> <secondary_outcome> <measure>Disability in work Rehabilitation</measure> <time_frame>3 weeks</time_frame> <description>Measured with the Work Rehabilitation Questionnaire (WORQ). The WORQ is used to better understand the extent of problems in functioning that people may have due to their health condition(s) and who are undergoing work or vocational rehabilitation. In the main section, responders rate the extent of their problem in the past week on a scale from 0 (no problem) to 10 (complete problem / not possible).</description> </secondary_outcome> <secondary_outcome> <measure>Overall treatment satisfaction</measure> <time_frame>3 weeks</time_frame> <description>Measured with The self-report measure Patient Global Impression of Change (PGIC). PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."</description> </secondary_outcome> <secondary_outcome> <measure>Quality of movement</measure> <time_frame>3 weeks</time_frame> <description>Measuring the posture of the participants during the execution of a squat (sagittal view on camera). Based on the Back Squat Assessment.</description> </secondary_outcome> <secondary_outcome> <measure>Quality of movement</measure> <time_frame>3 weeks</time_frame> <description>Measuring the posture of the participants during the execution of a squat (sagittal view on camera). Based on the squat portion of the New Basic Functional Assessment Protocol.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">24</enrollment> <condition>Chronic Pain</condition> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>Simulated TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12</description> </arm_group> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Real TENS and personalized exercise program in telerehabilitation (3 sessions/week over 3 weeks) n = 12</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>TENS</intervention_name> <description>TENS (strong and comfortable intensity) applied during exercises in a telerehabilitation setting.</description> <arm_group_label>Control group</arm_group_label> <arm_group_label>Intervention group</arm_group_label> <other_name>Transcutaneous electrical nerve stimulation</other_name> <other_name>Peripheral neurostimulation</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Being 55 years of age or older  - Being off work completely due to a musculoskeletal injury  - Starting a physical rehabilitation program  - Being in employment  - Experiencing pain of mild intensity (score of 1-3 points on a numerical scale of 0-10 points) to moderate intensity (score of 4-6 points) during movements/exercises  - Being comfortable enough with technology to participate in video conferences, respond to emails or text messages  - Having stable medication and lifestyle habits  - Speaking French  Exclusion Criteria:  - Having a cognitive deficiency  - Wearing a cardiac defibrillator or pacemaker  - Being diagnosed with cancer  - Having already experimented with TENS </textblock> </criteria> <gender>All</gender> <minimum_age>55 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Guillaume Léonard, PhD</last_name> <role>Principal Investigator</role> <affiliation>Université de Sherbrooke</affiliation> </overall_official> <overall_contact> <last_name>Marie-Philippe Harvey, M. Sc.</last_name> <phone>819-780-2220</phone> <phone_ext>45156</phone_ext> <email>Marie.Philippe.Harvey@USherbrooke.ca</email> </overall_contact> <overall_contact_backup> <last_name>Guillaume Léonard, PhD</last_name> <phone>819-821-8000</phone> <phone_ext>72933</phone_ext> <email>Guillaume.Leonard2@Usherbrooke.ca</email> </overall_contact_backup> <location> <facility> <name>Centre de recherche sur le vieillissement (CdRV)</name> <address> <city>Sherbrooke</city> <state>Quebec</state> <zip>J1H 4C4</zip> <country>Canada</country> </address> </facility> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 27, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Université de Sherbrooke</investigator_affiliation> <investigator_full_name>Guillaume Léonard</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Chronic Pain</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Physical exercise plays a central role in work rehabilitation. However, the presence of pain (particularly common in older adults and aging workers) can lead to a fear of movement (kinesiophobia) and hinder rehabilitation. Access to rehabilitation care is also a barrier for many older adults, which could be circumvented through telerehabilitation. The objective of this pilot study is to document the feasibility and explore the effect of a telerehabilitation intervention combining therapeutic exercises and real TENS (experimental group) or placebo TENS (control group) in individuals aged 55 and over who have stopped working (triple-blind randomized controlled study). To do so, various feasibility indicators (e.g., recruitment rate, adherence) and clinical measures (e.g., kinesiophobia, pain during exercise) will be documented before and after the intervention. Together, these measures will help assess the appropriateness of conducting a large-scale study aimed at potentiating work rehabilitation in older populations. Problem and hypotheses: In 2019, the proportion of Canadians aged 55 and over who were employed was 35.9%, the highest rate recorded to date since 1976. Despite their willingness to remain employed, seniors are more prone to work disability and early retirement. Older workers with disabilities are particularly vulnerable to job retention. In Quebec, the average length of absence following a work-related injury is 134 days for workers aged 55 and over, while it is less than 50 days for those aged 15 to 24. This difference can be explained in part by the presence of persistent pain that disproportionately affects older individuals and can significantly impede rehabilitation to work. The indirect costs associated with unemployment and absenteeism of people living with chronic pain were estimated to be $22.5 billion in Canada in 2019. A recent review conducted and published by our team found that strategies to reduce pain are one of the most important elements to consider in enabling workers to remain in the workplace after an episode of musculoskeletal disorder. Exercise plays a central role in chronic pain management and work rehabilitation. However, pain can be a major barrier to physical activity. Therefore, finding ways to reduce pain during and after exercise is essential to facilitate rehabilitation. Peripheral neurostimulation (TENS) - an electrotherapeutic modality that uses an electrical current to depolarize peripheral nerve fibers with electrodes applied directly to the skin - is effective in temporarily relieving pain. It represents an interesting avenue for increasing exercise tolerance associated with exercise in the pain subject. To date, 3 studies have investigated the use of TENS during exercise, all showing positive results. None, however, have yet investigated this strategy (TENS + exercise) in aging workers living with persistent pain. We postulate that telerehabilitation treatments (therapeutic exercises) provided concurrently with actual TENS will be more effective in reducing the biopsychological impacts of pain than the same rehabilitation treatments paired with placebo TENS. Thus, our hypothesis is that the experimental treatment will cause participants to enter a "virtuous circle": the TENS will allow for a punctual reduction of pain and kinesiophobia, which will encourage the realization/resumption of activity and lead to sustained benefits (e.g., physical function, pain, mood). Objectives: The primary objective of this pilot study is to explore the feasibility and acceptability of using real TENS, compared to placebo TENS, as a complementary treatment to a telerehabilitation exercise program, in workers who are off work. The secondary objective is to compare the effect of the two types of intervention (real TENS + exercises vs. placebo TENS + exercises) on clinical outcomes (e.g. pain intensity, functioning in vocational rehabilitation, etc.). Methods and analysis: Design: This project consists of a randomized controlled trial following a quadruple blind design. Participants: The target population is aging workers who are off work due to a musculoskeletal injury. Sampling and recruitment procedures: Participants will be recruited at the ISO-SANTÉ and Physio-Atlas clinics in Sherbrooke, which specialize in work rehabilitation (volunteer, non-probability sampling). The recruitment of individuals will be done through posters and with the help of clinicians who will be invited to talk to patients about the project. Conduct of the study: The purpose of this study is to recruit 24 participants who will take part in an exercise program spread over 3 weeks, with 3 sessions per week. The duration of each session is 30 minutes. The exercise program will be determined by the research team, in collaboration with clinic health professionals, and the exercises will be delivered via the TeraPlus telerehabilitation platform. The TENS (real or simulated) will be worn by participants throughout their telerehabilitation exercises, under the supervision of the student researcher. Inclusion Criteria: - Being 55 years of age or older - Being off work completely due to a musculoskeletal injury - Starting a physical rehabilitation program - Being in employment - Experiencing pain of mild intensity (score of 1-3 points on a numerical scale of 0-10 points) to moderate intensity (score of 4-6 points) during movements/exercises - Being comfortable enough with technology to participate in video conferences, respond to emails or text messages - Having stable medication and lifestyle habits - Speaking French Exclusion Criteria: - Having a cognitive deficiency - Wearing a cardiac defibrillator or pacemaker - Being diagnosed with cancer - Having already experimented with TENS

NCT0531xxxx/NCT05316636.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/NCT05316636</url> </required_header> <id_info> <org_study_id>C.P. - C.I. 15/313</org_study_id> <nct_id>NCT05316636</nct_id> </id_info> <brief_title>Intermittent Vibrational Force During Orthodontic Treatment With Aligners</brief_title> <official_title>Randomized Clinical Trial on the Effect of Intermittent Vibrational Force Application During Orthodontic Treatment With Aligners on RANKL and OPG Concentrations in Crevicular Fluid</official_title> <sponsors> <lead_sponsor> <agency>Universidad Complutense de Madrid</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Spanish Society of Orthodontics (SEDO)</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Universidad Complutense de Madrid</source> <oversight_info> <has_dmc>No</has_dmc> </oversight_info> <brief_summary> <textblock> This three-arm cross-over randomized clinical trial (allocation ratio of 1:1:1) will aim to explore whether the application of intermittent vibratory forces modify RANKL and OPG concentrations in patients undergoing orthodontic treatment with clear aligners. The specific objective will be to compare gingival crevicular fluid concentrations of RANKL and OPG among groups according to the application or not of Acceledent® treatment at different time points and frequencies of aligner changes. </textblock> </brief_summary> <detailed_description> <textblock> Application of intermittent forces by vibration is supposed to be an easy-to-use accelerator of dental movement. The purpose of this study is to determine the effect of intermittent vibrational force application during orthodontic aligner treatment on RANKL and OPG concentrations in crevicular fluid as markers of bone remodelling. This randomized clinical trial will include candidates for malocclusion treatment with aligners, randomly assigned to 3 groups: group A, vibrational forces from onset of treatment; group B, vibrational forces at 6 weeks after treatment onset; and group C, no vibration (controls). The frequency of aligner adjustment will also differ among groups and measurement time points. At different time points, a paper tip will be used to draw crevicular fluid samples from a moving lower incisor for RANKL and OPG analysis using ELISA kits. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 2016</start_date> <completion_date type="Actual">March 1, 2022</completion_date> <primary_completion_date type="Actual">March 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> <primary_purpose>Treatment</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>RANKL concentration Baseline</measure> <time_frame>Baseline</time_frame> <description>Gingival crevicular fluid concentrations of RANKL at baseline</description> </primary_outcome> <primary_outcome> <measure>RANKL concentration at 6 weeks</measure> <time_frame>6 weeks</time_frame> <description>Gingival crevicular fluid concentrations of RANKL at 6 weeks</description> </primary_outcome> <primary_outcome> <measure>RANKL concentration at 12 weeks</measure> <time_frame>12 weeks</time_frame> <description>Gingival crevicular fluid concentrations of RANKL at 12 weeks</description> </primary_outcome> <primary_outcome> <measure>RANKL concentration at 18 weeks</measure> <time_frame>18 weeks</time_frame> <description>Gingival crevicular fluid concentrations of RANKL at 18 weeks</description> </primary_outcome> <primary_outcome> <measure>OPG concentration Baseline</measure> <time_frame>Baseline</time_frame> <description>Gingival crevicular fluid concentrations of OPG at baseline</description> </primary_outcome> <primary_outcome> <measure>OPG concentration at 6 weeks</measure> <time_frame>6 weeks</time_frame> <description>Gingival crevicular fluid concentrations of OPG at 6 weeks</description> </primary_outcome> <primary_outcome> <measure>OPG concentration at 12 weeks</measure> <time_frame>12 weeks</time_frame> <description>Gingival crevicular fluid concentrations of OPG at 12 weeks</description> </primary_outcome> <primary_outcome> <measure>OPG concentration at 18 weeks</measure> <time_frame>18 weeks</time_frame> <description>Gingival crevicular fluid concentrations of OPG at 18 weeks</description> </primary_outcome> <secondary_outcome> <measure>Plaque index</measure> <time_frame>Baseline and 18 weeks</time_frame> <description>Change in Löe and Silness plaque index scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more plaque</description> </secondary_outcome> <secondary_outcome> <measure>Gingival index</measure> <time_frame>Baseline and 18 weeks</time_frame> <description>Change in Lobenne modified gingival index from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival inflammation</description> </secondary_outcome> <secondary_outcome> <measure>Bleeding on probing index</measure> <time_frame>Baseline and 18 weeks</time_frame> <description>Change in Bleeding on probing scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival bleeding</description> </secondary_outcome> <secondary_outcome> <measure>Orthodontic tooth movement achieved</measure> <time_frame>Baseline and 18 weeks</time_frame> <description>Amount of tooth movement from baseline to 18 weeks (in mm), measuring tooth displacement from initial to the final position at week 18.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">45</enrollment> <condition>Orthodontic Tooth Movement</condition> <condition>Gingival Crevicular Fluid</condition> <condition>Biomarkers</condition> <arm_group> <arm_group_label>Group A</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment</description> </arm_group> <arm_group> <arm_group_label>Group B</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>From weeks 0-6, no vibrational forces. Vibrational forces starting at 6 weeks after treatment onset and applied for 6 weeks until week 12</description> </arm_group> <arm_group> <arm_group_label>Group C</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Control, no vibrational forces</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Vibrational forces</intervention_name> <arm_group_label>Group A</arm_group_label> <arm_group_label>Group B</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Orthodontic treatment with clear aligners</intervention_name> <arm_group_label>Group A</arm_group_label> <arm_group_label>Group B</arm_group_label> <arm_group_label>Group C</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients in need of treatment of malocclusion with Invisalign® (Align Technology, San Jose, CAL) using at least 14 sets of aligners  - patients with good general health  Exclusion Criteria:  - smoking habit, poor oral hygiene, the presence of periodontal disease or any other chronic or systemic diseases that could affect bone metabolism or inflammation and the previous or current receipt of medications that could influence bone metabolism (e.g., bisphosphonates). </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>50 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Conchita Martin, Prof</last_name> <role>Principal Investigator</role> <affiliation>Faculty of Odontology, University Complutense Madrid</affiliation> </overall_official> <location> <facility> <name>Faculty of Odontology, University Complutense Madrid</name> <address> <city>Madrid</city> <zip>28040</zip> <country>Spain</country> </address> </facility> </location> <location_countries> <country>Spain</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Vibration forces</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This three-arm cross-over randomized clinical trial (allocation ratio of 1:1:1) will aim to explore whether the application of intermittent vibratory forces modify RANKL and OPG concentrations in patients undergoing orthodontic treatment with clear aligners. The specific objective will be to compare gingival crevicular fluid concentrations of RANKL and OPG among groups according to the application or not of Acceledent® treatment at different time points and frequencies of aligner changes. Application of intermittent forces by vibration is supposed to be an easy-to-use accelerator of dental movement. The purpose of this study is to determine the effect of intermittent vibrational force application during orthodontic aligner treatment on RANKL and OPG concentrations in crevicular fluid as markers of bone remodelling. This randomized clinical trial will include candidates for malocclusion treatment with aligners, randomly assigned to 3 groups: group A, vibrational forces from onset of treatment; group B, vibrational forces at 6 weeks after treatment onset; and group C, no vibration (controls). The frequency of aligner adjustment will also differ among groups and measurement time points. At different time points, a paper tip will be used to draw crevicular fluid samples from a moving lower incisor for RANKL and OPG analysis using ELISA kits. Inclusion Criteria: - Patients in need of treatment of malocclusion with Invisalign® (Align Technology, San Jose, CAL) using at least 14 sets of aligners - patients with good general health Exclusion Criteria: - smoking habit, poor oral hygiene, the presence of periodontal disease or any other chronic or systemic diseases that could affect bone metabolism or inflammation and the previous or current receipt of medications that could influence bone metabolism (e.g., bisphosphonates).

NCT0531xxxx/NCT05316649.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/NCT05316649</url> </required_header> <id_info> <org_study_id>BloodMO0FVZ0000503</org_study_id> <nct_id>NCT05316649</nct_id> </id_info> <brief_title>Blood Loss Quantification During Major Abdominal Surgery</brief_title> <official_title>Blood Loss Quantification During Major Abdominal Surgery: Study Protocol for a Prospective Cohort Trial.</official_title> <sponsors> <lead_sponsor> <agency>University of Defence, Faculty of Military Health Sciences</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University Hospital Hradec Kralove</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Defence, Faculty of Military Health 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> Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 1, 2021</start_date> <completion_date type="Anticipated">August 31, 2022</completion_date> <primary_completion_date type="Anticipated">June 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>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Blood loos quantification</measure> <time_frame>1 year</time_frame> <description>Estimated blood loss by surgeon (sEBL) Estimated blood loss by anesthesiologist (aEBL) Gravimetric blood loss weighted (vGBL) Calculated blood loos based on anthropometric and hematological parameters (vCBL) Spectrophotometric measured hemoglobin mass loss (hbMBL) Measured blood loss using using hbMBL and patient's average pre- and postoperative serum hemoglobin (vMBL)</description> </primary_outcome> <secondary_outcome> <measure>Postoperative complications</measure> <time_frame>1 year</time_frame> <description>The effect of blood loss measured by spectrophotometric method on postoperative complications.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">45</enrollment> <condition>Blood Loss, Surgical</condition> <condition>Blood Loss, Postoperative</condition> <condition>Postoperative Complications</condition> <arm_group> <arm_group_label>HPB group</arm_group_label> <description>Adult patients undergoing for elective liver or pancreas surgery at Department of Surgery, University Hospital Hradec Kralove, Czech Republic.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Measurement of external blood loss</intervention_name> <description>Measurement of external blood loss</description> <arm_group_label>HPB group</arm_group_label> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Serum Hemoglobin concentration</intervention_name> <description>Serum Hemoglobin concentration</description> <arm_group_label>HPB group</arm_group_label> </intervention> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> Serum Hemoglobin concentration Suctioned fluid Hemoglobin concentration </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Adult patients undergoing for elective liver or pancreas surgery. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - patient scheduled for liver or pancreatic surgery  - age of patient ≥ 18 years  - signed informed consent provided  Exclusion Criteria:  - patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants).  - use of cell saver suctioning during operation  - damage/clotting of blood samples </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>Jan Zajak, MD, MA</last_name> <role>Principal Investigator</role> <affiliation>University of Defence, Faculty of Military Health Sciences</affiliation> </overall_official> <overall_contact> <last_name>Jan Zajak, MD, MA</last_name> <phone>00420495833620</phone> <email>jan.zajak@fnhk.cz</email> </overall_contact> <location> <facility> <name>University of Defence, Faculty of Military Health Sciences</name> <address> <city>Hradec Králové</city> <zip>50001</zip> <country>Czechia</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jan Zajak, MD, MA</last_name> <email>jan.zajak@fnhk.cz</email> </contact> </location> <location_countries> <country>Czechia</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 20, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Defence, Faculty of Military Health Sciences</investigator_affiliation> <investigator_full_name>Jan Zajak</investigator_full_name> <investigator_title>Jan Zajak, MD, MA</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Postoperative Complications</mesh_term> <mesh_term>Hemorrhage</mesh_term> <mesh_term>Blood Loss, Surgical</mesh_term> <mesh_term>Postoperative Hemorrhage</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Chrysarobin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Blood loss quantification during surgery remains unreliable and inaccurate. The purpose of the study is compare several methods of blood loss quantification in real surgical settings and to analyze the effect of blood loss on postoperative complications. Serum Hemoglobin concentration Suctioned fluid Hemoglobin concentration Adult patients undergoing for elective liver or pancreas surgery. Inclusion Criteria: - patient scheduled for liver or pancreatic surgery - age of patient ≥ 18 years - signed informed consent provided Exclusion Criteria: - patient coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants). - use of cell saver suctioning during operation - damage/clotting of blood samples

NCT0531xxxx/NCT05316662.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/NCT05316662</url> </required_header> <id_info> <org_study_id>NN9924-4645</org_study_id> <secondary_id>U1111-1240-4396</secondary_id> <nct_id>NCT05316662</nct_id> </id_info> <brief_title>A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Mexico, as Part of Local Clinical Practice</brief_title> <official_title>A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Mexico</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 purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower participant's blood sugar levels. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Participant will be asked to complete a questionnaire about how the participant will take Rybelsus® tablets. Participant will complete this questionnaire during the normally scheduled visit with the study doctor. Participant will be asked to complete some questionnaires about diabetes treatment. Participant will complete these questionnaires during normally scheduled visits with the study doctor. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 6, 2022</start_date> <completion_date type="Anticipated">May 3, 2024</completion_date> <primary_completion_date type="Anticipated">September 20, 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>Change in HbA1c</measure> <time_frame>From baseline (week 0) to End of Study visit (V3) (week 34-44)</time_frame> <description>Measured in percentage (%)-points</description> </primary_outcome> <secondary_outcome> <measure>Relative change in body weight</measure> <time_frame>From baseline (week 0) to End of Study visit (V3) (week 34-44)</time_frame> <description>Measured in percentage (%)</description> </secondary_outcome> <secondary_outcome> <measure>Absolute change in body weight</measure> <time_frame>From baseline (week 0) to End of Study visit (V3) (week 34-44)</time_frame> <description>Measured in Kilogram (Kg)</description> </secondary_outcome> <secondary_outcome> <measure>HbA1c < 7%</measure> <time_frame>End of Study visit (V3) (week 34- 44)</time_frame> <description>Measured as Yes or No</description> </secondary_outcome> <secondary_outcome> <measure>HbA1c reduction >=1%-points and body weight reduction of >=5%</measure> <time_frame>From baseline (week 0) to End of Study visit (V3) (week 34-44)</time_frame> <description>Measured as Yes or No</description> </secondary_outcome> <secondary_outcome> <measure>HbA1c reduction >=1%-points and body weight reduction of >=3%</measure> <time_frame>From baseline (week 0) to End of Study visit (V3) (week 34-44)</time_frame> <description>Measured as Yes or No</description> </secondary_outcome> <secondary_outcome> <measure>DTSQc, relative treatment satisfaction</measure> <time_frame>End of Study visit (V3) (week 34- 44)</time_frame> <description>Measured in Total score</description> </secondary_outcome> <secondary_outcome> <measure>DTSQs, change in absolute treatment satisfaction</measure> <time_frame>From baseline (week 0) to End of Study visit (V3) (week 34-44)</time_frame> <description>Measured in Total score</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">194</enrollment> <condition>Diabetes Mellitus, Type 2</condition> <arm_group> <arm_group_label>Semaglutide</arm_group_label> <description>Participants with T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Semaglutide</intervention_name> <description>Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the participant in this study.</description> <arm_group_label>Semaglutide</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Participants with T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)  - Diagnosed with type 2 diabetes mellitus  - The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study  - Male or female, age above or equal to 18 years at the time of signing informed consent  - Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice  - Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days  Exclusion Criteria:  - Previous participation in this study. Participation is defined as having given informed consent in this study  - Treatment with any investigational drug within 30 days prior to enrolment into the study  - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation </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> <overall_contact> <last_name>Novo Nordisk</last_name> <phone>(+1) 866-867-7178</phone> <email>clinicaltrials@novonordisk.com</email> </overall_contact> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Guadalajara</city> <state>Jalisco</state> <zip>44670</zip> <country>Mexico</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Novo Nordisk Investigational Site</name> <address> <city>Guadalajara</city> <state>Jalisco</state> <zip>44670</zip> <country>Mexico</country> </address> </facility> <status>Enrolling by invitation</status> </location> <location_countries> <country>Mexico</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 10, 2023</last_update_submitted> <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <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 purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower participant's blood sugar levels. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Participant will be asked to complete a questionnaire about how the participant will take Rybelsus® tablets. Participant will complete this questionnaire during the normally scheduled visit with the study doctor. Participant will be asked to complete some questionnaires about diabetes treatment. Participant will complete these questionnaires during normally scheduled visits with the study doctor. Participants with T2D will be assessed for clinical parameters associated with the once-daily use of oral semaglutide who have not previously been treated with injectable glucose-lowering medication in routine clinical practice. Inclusion Criteria: - Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - Diagnosed with type 2 diabetes mellitus - The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study - Male or female, age above or equal to 18 years at the time of signing informed consent - Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice - Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Treatment with any investigational drug within 30 days prior to enrolment into the study - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

NCT0531xxxx/NCT05316675.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/NCT05316675</url> </required_header> <id_info> <org_study_id>aila</org_study_id> <nct_id>NCT05316675</nct_id> </id_info> <brief_title>Impact of Isotretinoin in Different Doses on Quality of Life</brief_title> <official_title>Impact of Different Protocols of Systemic Isotretinoin in Acne Treatment on Quality of Life Among Egyptien Patients:Avalidity and Reliability Study</official_title> <sponsors> <lead_sponsor> <agency>Assiut University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut 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 Cardiff Acne Disability Index is a short five-item questionnaire derived from the longer Acne Disability Index.It is designed for use in teenagers and young adults with acne. It is self explanatory and can be simply handed to the patient who is asked to complete it without the need for detailed explanation( .Abdelrazik etal., 2021).  . </textblock> </brief_summary> <detailed_description> <textblock> Lower doses of isotretinoin can be effective in terms of cost and decreasing systemic side effects. Therefore, other regimens may be used instead of daily conventional dose as alternate, pulse and low doses of oral isotretinoin in acne vulgaris( Agarwal et al., 2011).  To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index (CADI) and dermatology life quality index (DLQI)questionnaires.  To assess validity and reliability of the translated Arabic version of CADI. To compare the clinical efficacy and tolerability of different protocols of systemic isotretinoin in acne treatment. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">December 2022</start_date> <completion_date type="Anticipated">December 2024</completion_date> <primary_completion_date type="Anticipated">October 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>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index</measure> <time_frame>6 months</time_frame> <description>To assess validity and reliability of the translated Arabic version of CADI.CADI is a tool to assess the effect of acne on quality of life with a possible maximum score of 15 and a minimum of 0. (grade of impairment; 0 no impairment, 1-5 mild impairment, 6-10 moderate impairment, and 11-15 severe impairment).The Cardiff Acne Disability Index (CADI) is a short five-item questionnaire derived from the longer Acne Disability Index. CADI is designed for use in teenagers and young adults with acne. It is self explanatory and can be simply handed to the patient who is asked to complete it without the need for detailed explanation (Abdelrazik etal., 2021).the higher the score, the more the quality of life is impaired. The CADI is usually completed in one minute (Motley and Finlay,1992) .</description> </primary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Acne Vulgaris</condition> <arm_group> <arm_group_label>Group 1</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>:(25)patients will be treated by oral isotretinoin; 0.5 -1 mg/kg/day in two divided doses for 6 months.</description> </arm_group> <arm_group> <arm_group_label>Group 2</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>:(25) Patients will be treated by oral isotretinoin; 0.5 -1 mg/kg/day for seven days each month for 6 pulses.</description> </arm_group> <arm_group> <arm_group_label>Group 3</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>:(25) Patients will be treated by oral isotretinoin; 0.1-0.2 mg/kg/day for 6months</description> </arm_group> <arm_group> <arm_group_label>Group 4:</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>(25) Patients will be treated by oral isotretinoin;20mg /day for one month then the dose increased in monthly steps to reach the standard dosing for 6 months</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Isotretinoin</intervention_name> <description>isotretinoin 13-cis-retinoic acid), derived from vitamin A</description> <arm_group_label>Group 1</arm_group_label> <arm_group_label>Group 2</arm_group_label> <arm_group_label>Group 3</arm_group_label> <arm_group_label>Group 4:</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Patients with clinically diagnosed acne vulgaris older than 18 years of age  -  Exclusion Criteria:  Patients having personal or family history of hyperlipidemia. Pregnancy and lactation. Newly married female desiring to get pregnant or using temporary method of contraception.  Patients with a history suggestive of any psychic disturbance - </textblock> </criteria> <gender>All</gender> <minimum_age>12 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <verification_date>March 2022</verification_date> <study_first_submitted>March 19, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Asmaa Goda</investigator_full_name> <investigator_title>principle investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Acne Vulgaris</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Isotretinoin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The Cardiff Acne Disability Index is a short five-item questionnaire derived from the longer Acne Disability Index.It is designed for use in teenagers and young adults with acne. It is self explanatory and can be simply handed to the patient who is asked to complete it without the need for detailed explanation( .Abdelrazik etal., 2021). . Lower doses of isotretinoin can be effective in terms of cost and decreasing systemic side effects. Therefore, other regimens may be used instead of daily conventional dose as alternate, pulse and low doses of oral isotretinoin in acne vulgaris( Agarwal et al., 2011). To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index (CADI) and dermatology life quality index (DLQI)questionnaires. To assess validity and reliability of the translated Arabic version of CADI. To compare the clinical efficacy and tolerability of different protocols of systemic isotretinoin in acne treatment. Inclusion Criteria: Patients with clinically diagnosed acne vulgaris older than 18 years of age - Exclusion Criteria: Patients having personal or family history of hyperlipidemia. Pregnancy and lactation. Newly married female desiring to get pregnant or using temporary method of contraception. Patients with a history suggestive of any psychic disturbance -

NCT0531xxxx/NCT05316688.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/NCT05316688</url> </required_header> <id_info> <org_study_id>RG1122110</org_study_id> <secondary_id>NCI-2022-01734</secondary_id> <secondary_id>FHIRB0020096</secondary_id> <nct_id>NCT05316688</nct_id> </id_info> <brief_title>A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery</brief_title> <official_title>Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent</official_title> <sponsors> <lead_sponsor> <agency>University of Washington</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Blaze Bioscience Inc.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>University of Washington</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 I/II trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. Tozuleristide is an imaging agent that specifically binds to tumor cells. When exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery. </textblock> </brief_summary> <detailed_description> <textblock> OUTLINE:  Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo Canvas near infrared (NIR) imaging. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">September 23, 2023</start_date> <completion_date type="Anticipated">January 20, 2027</completion_date> <primary_completion_date type="Anticipated">January 20, 2026</primary_completion_date> <phase>Phase 1/Phase 2</phase> <study_type>Interventional</study_type> <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>Incidence of adverse events (AEs)</measure> <time_frame>7-21 days after drug administration</time_frame> <description>Adverse events will be summarized as the number and percentage of patients with each type of adverse event, per Criteria for Adverse Events version 5.0.</description> </primary_outcome> <secondary_outcome> <measure>Number of subjects without tumor fluorescence after receiving tozuleristide</measure> <time_frame>Up to 12 months</time_frame> </secondary_outcome> <secondary_outcome> <measure>Sensitivity of tozuleristide fluorescence to detect tumor in tissue biopsies</measure> <time_frame>Up to 12 months</time_frame> <description>Will be estimated by a repeated measure logistic regression modeling the probability of positive tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A general estimating equation (GEE) method will be used to estimate the regression parameters.</description> </secondary_outcome> <secondary_outcome> <measure>Specificity of tozuleristide fluorescence to detect tumor in tissue biopsies</measure> <time_frame>Up to 12 months</time_frame> <description>Will be estimated by a repeated measure logistic regression modeling the probability of negative tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A GEE method will be used to estimate the regression parameters. The repeated measures logistic regression will model the probability of tumor-negative biopsies.</description> </secondary_outcome> <secondary_outcome> <measure>Positive predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies</measure> <time_frame>Up to 12 months</time_frame> </secondary_outcome> <secondary_outcome> <measure>Negative predictive value of tozuleristide fluorescence to detect tumor in tissue biopsies</measure> <time_frame>Up to 12 months</time_frame> </secondary_outcome> <secondary_outcome> <measure>Achievement of negative margins in tozuleristide-guided oral cavity tumor excision</measure> <time_frame>Up to 12 months</time_frame> <description>To investigate the accuracy of tozuleristide fluorescent imaging in identifying tumor and achieving negative margins during excision of oral cavity squamous cell carcinoma and high-grade dysplasia.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">15</enrollment> <condition>Oral Cavity Squamous Cell Carcinoma</condition> <condition>Stage I Lip and Oral Cavity Cancer AJCC v8</condition> <condition>Stage II Lip and Oral Cavity Cancer AJCC v8</condition> <condition>Stage III Lip and Oral Cavity Cancer AJCC v8</condition> <condition>Stage IVA Lip and Oral Cavity Cancer AJCC v8</condition> <arm_group> <arm_group_label>Diagnostic (tozuleristide, surgery, NIR imaging)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Beginning 1 hour before surgery, patients receive tozuleristide IV over 1-5 minutes. Patients then surgical resection per standard of care and undergo Canvas NIR imaging.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Near Infrared Imaging</intervention_name> <description>Undergo NIR imaging</description> <arm_group_label>Diagnostic (tozuleristide, surgery, NIR imaging)</arm_group_label> <other_name>Near-Infrared Imaging</other_name> <other_name>NIR Imaging</other_name> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Therapeutic Conventional Surgery</intervention_name> <description>Undergo surgery</description> <arm_group_label>Diagnostic (tozuleristide, surgery, NIR imaging)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Tozuleristide</intervention_name> <description>Given IV</description> <arm_group_label>Diagnostic (tozuleristide, surgery, NIR imaging)</arm_group_label> <other_name>BLZ-100</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adult patients age >= 18 years (yr)  - Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. Histology confirmation not required prior to surgery  - Able to provide written informed consent  - If of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. Male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential  - Available for all study visits and able to comply with all study requirements  Exclusion Criteria:  - Known or suspected sensitivity to indocyanine green  - In the opinion of the treating physician, patient has received photosensitizing medication that could interfere or confound study results  - Any current medications with the potential to generate fluorescence or photochemical reaction  - Enrolled in any other ongoing study  - Currently lactating or breastfeeding  - Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide  - Any current condition, including psychological and social situations which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data  - Creatinine clearance < 60 mL/min  - Aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN)  - Alanine aminotransferase (ALT) > 1.5 x ULN  - Bilirubin > 1.5 x ULN </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>Emily Marchiano</last_name> <role>Principal Investigator</role> <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation> </overall_official> <overall_contact> <last_name>Rebecca Wood</last_name> <phone>206-606-6970</phone> <email>Rwood1@seattlecca.org</email> </overall_contact> <location> <facility> <name>Fred Hutch/University of Washington Cancer Consortium</name> <address> <city>Seattle</city> <state>Washington</state> <zip>98109</zip> <country>United States</country> </address> </facility> <contact> <last_name>Rebecca Wood</last_name> <phone>206-606-6970</phone> <email>Rwood1@seattlecca.org</email> </contact> <investigator> <last_name>Emily Marchiano</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 17, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 23, 2023</last_update_submitted> <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 25, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Carcinoma, Squamous Cell</mesh_term> <mesh_term>Mouth Neoplasms</mesh_term> <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term> <mesh_term>Lip Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This phase I/II trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. Tozuleristide is an imaging agent that specifically binds to tumor cells. When exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery. OUTLINE: Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo Canvas near infrared (NIR) imaging. Inclusion Criteria: - Adult patients age >= 18 years (yr) - Subjects must have suspected or confirmed oral cavity dysplasia or cT1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. Histology confirmation not required prior to surgery - Able to provide written informed consent - If of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. Male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential - Available for all study visits and able to comply with all study requirements Exclusion Criteria: - Known or suspected sensitivity to indocyanine green - In the opinion of the treating physician, patient has received photosensitizing medication that could interfere or confound study results - Any current medications with the potential to generate fluorescence or photochemical reaction - Enrolled in any other ongoing study - Currently lactating or breastfeeding - Positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide - Any current condition, including psychological and social situations which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data - Creatinine clearance < 60 mL/min - Aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN) - Alanine aminotransferase (ALT) > 1.5 x ULN - Bilirubin > 1.5 x ULN

NCT0531xxxx/NCT05316701.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/NCT05316701</url> </required_header> <id_info> <org_study_id>Precision-T (PhIII component)</org_study_id> <nct_id>NCT05316701</nct_id> </id_info> <brief_title>Precision-T: A Randomized Phase III Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies</brief_title> <acronym>Orca-T</acronym> <official_title>A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft</official_title> <sponsors> <lead_sponsor> <agency>Orca Biosystems, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Orca Biosystems, 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 study will compare the safety and efficacy between patients receiving an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) or standard-of-care (SOC) control in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation (MA-alloHCT) for hematologic malignancies. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685. </textblock> </brief_summary> <detailed_description> <textblock> Cross reference NCT04013685 </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 21, 2022</start_date> <completion_date type="Anticipated">April 2028</completion_date> <primary_completion_date type="Anticipated">April 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> <intervention_model_description>The Phase III is a randomized, open-label, multicenter study comparing outcomes between patients receiving Orca-T followed by single-agent tacrolimus or standard-of-care (SOC) control followed by dual agent, tacrolimus-based Graft-versus-Host-Disease (GVHD) prophylaxis regimen</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Chronic Graft-versus-Host-Disease-free Survival</measure> <time_frame>Randomization through 730 days post transplant</time_frame> <description>An event for this time-to-event outcome is defined as death by any cause or moderate to severe cGVHD as defined by NIH consensus criteria</description> </primary_outcome> <secondary_outcome> <measure>Graft-versus-Host-Disease and Relapse-free survival (GRFS)</measure> <time_frame>Day 0 through 365 days post-transplant</time_frame> <description>An event for this time-to-event outcome is defined as survival free of death from any cause, relapse, Grade 3-4 aGVHD (graded per MAGIC), and moderate to severe cGVHD (graded per NIH consensus criteria).</description> </secondary_outcome> <secondary_outcome> <measure>Moderate to severe chronic graft-versus-host-disease</measure> <time_frame>Day 0 through 365 days post-transplant</time_frame> <description>An event for this time-to-event outcome is defined as moderate to severe cGVHD as defined by NIH consensus criteria.</description> </secondary_outcome> <secondary_outcome> <measure>Relapse-free survival</measure> <time_frame>Day 0 through 730 days post-transplant</time_frame> <description>Survival free of death from relapse.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">174</enrollment> <condition>Acute Myeloid Leukemia</condition> <condition>Acute Lymphoid Leukemia</condition> <condition>Mixed Phenotype Acute Leukemia</condition> <condition>Undifferentiated Leukemia</condition> <condition>High-risk Myelodysplastic Syndrome</condition> <condition>Acute Leukemia</condition> <condition>Therapy-Related Myelodysplastic Syndrome</condition> <condition>MDS</condition> <arm_group> <arm_group_label>Orca-T</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>For patients randomized to the Orca-T arm, Orca-T will be administered after myeloablative conditioning regimen. Single-agent GVHD prophylaxis with tacrolimus will be administered following Tcon infusion (generally Day +3).</description> </arm_group> <arm_group> <arm_group_label>Standard of Care alloHCT Control</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>For patients randomized to the standard-of-care control arm, an unmanipulated allograft derived from the peripheral blood of a matched donor will be administered after a myeloablative conditioning regimen. Dual-agent prophylaxis consisting of tacrolimus plus methotrexate will be administered starting on Day -3.</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Orca-T</intervention_name> <description>engineered donor allograft</description> <arm_group_label>Orca-T</arm_group_label> <other_name>TregGraft</other_name> </intervention> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Standard-of-Care</intervention_name> <description>unmanipulated donor allograft</description> <arm_group_label>Standard of Care alloHCT Control</arm_group_label> <other_name>SOC</other_name> </intervention> <eligibility> <criteria> <textblock> Key Inclusion Criteria:  - Matched to a related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and DRB1  - Diagnosed with one of the following diseases:  - Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease  - Myelodysplastic syndromes (MDS) that are indicated for alloHSCT per 2017 International Expert Panel recommendations and/or have therapy-related/secondary MDS, with ≤ 10% blast burden in the bone marrow  - Planned to undergo MA-alloHCT including one of the following myeloablative conditioning regimens:  - TBI/Cy  - TBI/Etoposide  - BFT  - Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)  - Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%  - Negative serum or urine beta-HCG test in females of childbearing potential  - ALT/AST < 3 times ULN  - Recipients in screening must screen negative for SARS-CoV-2 RNA using a PCR-based test  - Disease Risk Index (DRI) overall risk categorization of intermediate or high  - Total bilirubin ≤ upper limit of normal (ULN)  - Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute  Key Exclusion Criteria:  - Prior allogeneic HCT  - Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.  - Planned donor lymphocyte infusion (DLI)  - Planned pharmaceutical in vivo or ex vivo T cell depletion  - Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor  - Karnofsky performance score < 70%  - Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4  - Uncontrolled bacterial, viral or fungal infections at time of enrollment  - Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, Hepatitis C antibody  - Known allergy or hypersensitivity to, or intolerance of, tacrolimus  - Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins  - Any uncontrolled autoimmune disease requiring active immunosuppressive treatment  - Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected  - Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow up care  - Women who are pregnant or breastfeeding  - Women of childbearing potential (WOCBP) or men who have sexual contact with WOCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>James S McClellan, MD PhD</last_name> <phone>530 414 9743</phone> <email>info@orcabio.com</email> </overall_contact> <location> <facility> <name>City of Hope</name> <address> <city>Duarte</city> <state>California</state> <zip>91010</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Amandeep Salhotra</last_name> </contact> </location> <location> <facility> <name>Ronald Regan UCLA Medical Center</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90095</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Caspian Oliai, MD</last_name> </contact> <contact_backup> <last_name>Bruck Habtemariam</last_name> <email>BHabtemariam@mednet.ucla.edu</email> </contact_backup> </location> <location> <facility> <name>UC Davis</name> <address> <city>Sacramento</city> <state>California</state> <zip>95817</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rasmus Hoeg</last_name> </contact> <contact_backup> <last_name>Dara Feleciano, RN MSN</last_name> <email>djfeleciano@ucdavis.edu</email> </contact_backup> </location> <location> <facility> <name>Stanford Health Care</name> <address> <city>Stanford</city> <state>California</state> <zip>94305</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Everett Meyer, MD, PhD</last_name> </contact> <contact_backup> <last_name>Lindsay Danley</last_name> <email>lindsmd@stanford.edu</email> </contact_backup> </location> <location> <facility> <name>University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center</name> <address> <city>Miami</city> <state>Florida</state> <zip>33136</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Antonio M Jimenez, MD</last_name> </contact> </location> <location> <facility> <name>Moffitt Cancer Center</name> <address> <city>Tampa</city> <state>Florida</state> <zip>33612</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rawan Faramand, MD</last_name> <phone>888-663-3488</phone> <email>Rawan.Faramand@moffitt.org</email> </contact> </location> <location> <facility> <name>Winship Cancer Institute - Emory University</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30322</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Edmund Waller, MD, PhD</last_name> </contact> </location> <location> <facility> <name>University of Chicago</name> <address> <city>Chicago</city> <state>Illinois</state> <zip>60637</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Satyajit Kosuri, MD</last_name> </contact> </location> <location> <facility> <name>Massachusetts General Hospital</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02114</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yi-Bin Chen, MD</last_name> <phone>617-724-3456</phone> <email>ychen6@partners.org</email> </contact> </location> <location> <facility> <name>Weill Cornell Medicine - New York-Presbyterian Hospital</name> <address> <city>New York</city> <state>New York</state> <zip>10021</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Alexandra Gomez Arteaga, MD</last_name> </contact> <contact_backup> <last_name>Meredith Mullane, RN</last_name> <phone>212-746-0702</phone> <email>Met9042@med.cornell.edu</email> </contact_backup> </location> <location> <facility> <name>Memorial Sloan Kettering Cancer Center</name> <address> <city>New York</city> <state>New York</state> <zip>10065</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Roni Tamari, MD</last_name> </contact> <contact_backup> <email>abmttrials@mskcc.org</email> </contact_backup> </location> <location> <facility> <name>Cleveland Clinic</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44195</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Betty K Hamilton, MD</last_name> <phone>216-444-7923</phone> <email>taussigresearch@ccf.org</email> </contact> </location> <location> <facility> <name>OU Health Stephenson Cancer Center</name> <address> <city>Oklahoma City</city> <state>Oklahoma</state> <zip>73104</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jennifer Holter-Chakrabarty, MD</last_name> <phone>405-271-8299</phone> </contact> <contact_backup> <last_name>Silas Day</last_name> <phone>(405) 271-8001</phone> <phone_ext>48748</phone_ext> </contact_backup> </location> <location> <facility> <name>Oregon Health & Sciences University - Knight Cancer Institute</name> <address> <city>Portland</city> <state>Oregon</state> <zip>97239</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Arpita Gandhi, MD</last_name> </contact> </location> <location> <facility> <name>Vanderbilt University</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37232</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Bhagirathbhai Dholaria, MD</last_name> <phone>615-343-6653</phone> </contact> <contact_backup> <last_name>Rohan Goel</last_name> <email>rohan.w.goel@vumc.org</email> </contact_backup> </location> <location> <facility> <name>Sarah Cannon Research Institute</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37239</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jeremy Pantin, MD</last_name> <phone>615-342-3385</phone> </contact> </location> <location> <facility> <name>University of Utah</name> <address> <city>Salt Lake City</city> <state>Utah</state> <zip>84112</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sagar Patel, MD</last_name> </contact> <contact_backup> <last_name>Collind Boyington</last_name> <email>Collind.boyington@hci.utah.edu</email> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>July 20, 2023</last_update_submitted> <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>hematopoietic stem cell transplantation</keyword> <keyword>acute leukemia</keyword> <keyword>Myelodysplastic syndromes</keyword> <keyword>matched related donor</keyword> <keyword>matched unrelated donor</keyword> <keyword>myelodysplastic syndrome</keyword> <condition_browse>  <mesh_term>Leukemia</mesh_term> <mesh_term>Preleukemia</mesh_term> <mesh_term>Hematologic Neoplasms</mesh_term> <mesh_term>Leukemia, Lymphoid</mesh_term> <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term> <mesh_term>Myelodysplastic Syndromes</mesh_term> <mesh_term>Syndrome</mesh_term> <mesh_term>Acute Disease</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study will compare the safety and efficacy between patients receiving an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) or standard-of-care (SOC) control in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation (MA-alloHCT) for hematologic malignancies. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685. Cross reference NCT04013685 Key Inclusion Criteria: - Matched to a related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and DRB1 - Diagnosed with one of the following diseases: - Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease - Myelodysplastic syndromes (MDS) that are indicated for alloHSCT per 2017 International Expert Panel recommendations and/or have therapy-related/secondary MDS, with ≤ 10% blast burden in the bone marrow - Planned to undergo MA-alloHCT including one of the following myeloablative conditioning regimens: - TBI/Cy - TBI/Etoposide - BFT - Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) - Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50% - Negative serum or urine beta-HCG test in females of childbearing potential - ALT/AST < 3 times ULN - Recipients in screening must screen negative for SARS-CoV-2 RNA using a PCR-based test - Disease Risk Index (DRI) overall risk categorization of intermediate or high - Total bilirubin ≤ upper limit of normal (ULN) - Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute Key Exclusion Criteria: - Prior allogeneic HCT - Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. - Planned donor lymphocyte infusion (DLI) - Planned pharmaceutical in vivo or ex vivo T cell depletion - Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor - Karnofsky performance score < 70% - Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 - Uncontrolled bacterial, viral or fungal infections at time of enrollment - Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, Hepatitis C antibody - Known allergy or hypersensitivity to, or intolerance of, tacrolimus - Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins - Any uncontrolled autoimmune disease requiring active immunosuppressive treatment - Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected - Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow up care - Women who are pregnant or breastfeeding - Women of childbearing potential (WOCBP) or men who have sexual contact with WOCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation

NCT0531xxxx/NCT05316714.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/NCT05316714</url> </required_header> <id_info> <org_study_id>IPP_2022_NanoFAT</org_study_id> <nct_id>NCT05316714</nct_id> </id_info> <brief_title>Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment</brief_title> <acronym>IPPNANOFAT</acronym> <official_title>Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment With Penile Lenght Conservation and Non-incisional Albuginea Preservation</official_title> <sponsors> <lead_sponsor> <agency>University of Roma La Sapienza</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Roma La Sapienza</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> Peyronies' disease (PD) is an acquired connective tissue disorder characterized with the growth of fibrous and/or calcified plaques in the tunica albuginea of the penis.  The pathogenesis is still unclear, but the most accepted hypothesis is that in genetically prone individuals, trauma or repetitive microtraumas to the erect penis causes inflammation, and consequent growth of fibrous tissue due to degradation of the elastic fibers and fibrin deposition.  The fibrous plaques in the tunica albuginea of the penis causes typical signs and symptoms: penile abnormal curvature, penile pain, erectile dysfunction, indentation, loss of girth, shortening of the penis, with significant distress experience and psychological bother.  A lot of treatement have been proposed to date but with unsatisfactory results and the surgery results the definitive treatement but with possible risks.  Autologous fat grafting was first described by Neuber in 1893 and since then it has developed over the next century. The initial goal of fat grafting was to treat volume losses created by disease or trauma. Further studies done by Zuk et al. in 2001 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) like in the bone marrow, thereby expanding opportunities in multiple fields. ADSCs have emerged as a key element of regenerative medicine surgery due to their ability to differentiate into a variety of different cell lineages. Moreover, their capacity of paracrine secretion of a broad selection of cytokines, chemokines, and growth factors make them highly clinically attractive. More specific, of particular interest are the anti-apoptotic, anti-inflammatory, proangiogenic, immunomodulatory, and anti-scarring effects that have been demonstrated for ADSCs, which effects on wound healing, soft-tissue restoration and scar remodelling.  Nanofat firstly introduced by Tonnard in 2013, is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but rich in ADSCs and with regenerative properties.  The aim of the study is to investigate the use of nanofat grafting in the treatement of PD. </textblock> </brief_summary> <detailed_description> <textblock> The etiology of PD remains uncertain, but is well accepted that there is a chronic inflammation of tunica albuginea and this reflect perturbations in normal wound healing and aberrant deposition of extracellular matrix components in the soft tissue of the penis.  There appears to be significant pathophysiologic and genetic overlap of PD with other superficial fibrosing disorders such as Dupuytren disease (palmar fibromatosis) and Ledderhose disease (plantar fibromatosis) but not with more diffuse conditions such as systemic sclerosis. Since PD was discovered, a lot of treatment were proposed. In the acute stage of PD treatments aim to alleviate penile pain and minimise disease progression and treatement attempts to mitigate inflammation: oral, intralesional injection, topical treatement were used but with few non significant results.  In the chronic phase, surgical treatments aims to correct the curvature but with not a few negative implications include penile shortening, erectile dysfunction, glans hypoaesthesia, residual or recurrent curvature and palpable or uncomfortable suture knots below the skin.  Recent findings on scar biology explain some factors that influence pro-fibrotic pathways. Preventions and treatment strategies mainly focus on reducing inflammation and hypoxia. Emerging therapies shows that Mesenchymal stem cells (MSCs) have immunomodulatory and antifibrotic effects by secreting paracrine growth factors.  Zuk et al. in 2001 and 2002 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) population comparable to that isolated from the bone marrow. Because of its availability and accessibility, white adipose tissue is considered a "stem cell depot." Nanofat grafting technique firstly reported by Tonnard is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but contains rich in ADSCs, microvascular fragments, growth factors [vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), hepatocyte growth factor (HGF), transforming growth factor-beta (TGF-β), basic fibroblast growth factor (bFGF), insulin-like growth factor 1 (IGF-1), and granulocyte-macrophage colony-stimulating factor (GM-CSF)], biological peptides [lipoxins, resolvins, protectins, neurotrophic factors, angiogenin, matrix metalloproteinase, leukemia inhibitory factor, and macrophage migration inhibitory factor], and cytokines . It is a liquefied, autologous injectable product with the property of biological integration with adjacent cells and tissues due to its homogenous consistency. At the site of injury, these stromal cells initiate a site-specific reparative response comprised of remodeling of extracellular matrix, enhanced and sustained angiogenesis, immune system modulation, and cellular turnover. These properties of stromal cells provide a platform for the usage of cellular therapy in various diseases. Peyronie's "plaque" is a scarred tissue, results from abnormal extracellular matrix production through upregulation of myofibroblast activity and tissue inhibitors of matrix metalloproteinases, among other mechanisms. The aim of the study is to investigate the possible therapeutic role of nanofat grafting in the treatement of PD. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 1, 2021</start_date> <completion_date type="Anticipated">August 15, 2022</completion_date> <primary_completion_date type="Anticipated">July 15, 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>Degree of curvature</measure> <time_frame>Change from Baseline Penile curvature at 6 months</time_frame> <description>Penile curvature assessment with in-office goniometric angle measurement of a pharmacologically induced erection</description> </primary_outcome> <primary_outcome> <measure>PAIN assessment</measure> <time_frame>Change from Baseline PAIN (VAS SCORE) at 6 months</time_frame> <description>Pain wil be assessed by VAT scale</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">35</enrollment> <condition>Peyronie Disease</condition> <arm_group> <arm_group_label>IPP Nanofat Grafting</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Nanofat surgical grafting in albuginea penile tunica</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Nanofat grafing</intervention_name> <description>NANOFAT REGENERATIVE SURGICAL GRAFTING IN PRNILE ALBUGIANEA OF PATIENTS AFFECTED BY PEYRONIES' DISEASE</description> <arm_group_label>IPP Nanofat Grafting</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Presence of albuginea penile plaque due to Peyronies' disease associated with penile curvature and pain. Normal erectile function. Sexual activity.  Exclusion Criteria:  - Erectile dysfunction, no sexual activity. </textblock> </criteria> <gender>Male</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Antonio Luigi Pastore</name> <address> <city>Latina</city> <zip>04100</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Antonio Luigi Pastore, Prof, MD, PhD</last_name> <phone>3401138648</phone> <phone_ext>0039</phone_ext> <email>antopast@hotmail.com</email> </contact> </location> <location_countries> <country>Italy</country> </location_countries> <results_reference> <citation>Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.</citation> <PMID>23783059</PMID> </results_reference> <results_reference> <citation>Osmonov D, Ragheb A, Ward S, Blecher G, Falcone M, Soave A, Dahlem R, van Renterghem K, Christopher N, Hatzichristodoulou G, Preto M, Garaffa G, Albersen M, Bettocchi C, Corona G, Reisman Y. ESSM Position Statement on Surgical Treatment of Peyronie's Disease. Sex Med. 2022 Feb;10(1):100459. doi: 10.1016/j.esxm.2021.100459. Epub 2021 Nov 22.</citation> <PMID>34823053</PMID> </results_reference> <verification_date>July 2022</verification_date> <study_first_submitted>March 20, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>July 5, 2022</last_update_submitted> <last_update_submitted_qc>July 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation> <investigator_full_name>Antonio Luigi Pastore</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Penile Induration</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Outcomes</ipd_description> </patient_data>  </clinical_study>

Peyronies' disease (PD) is an acquired connective tissue disorder characterized with the growth of fibrous and/or calcified plaques in the tunica albuginea of the penis. The pathogenesis is still unclear, but the most accepted hypothesis is that in genetically prone individuals, trauma or repetitive microtraumas to the erect penis causes inflammation, and consequent growth of fibrous tissue due to degradation of the elastic fibers and fibrin deposition. The fibrous plaques in the tunica albuginea of the penis causes typical signs and symptoms: penile abnormal curvature, penile pain, erectile dysfunction, indentation, loss of girth, shortening of the penis, with significant distress experience and psychological bother. A lot of treatement have been proposed to date but with unsatisfactory results and the surgery results the definitive treatement but with possible risks. Autologous fat grafting was first described by Neuber in 1893 and since then it has developed over the next century. The initial goal of fat grafting was to treat volume losses created by disease or trauma. Further studies done by Zuk et al. in 2001 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) like in the bone marrow, thereby expanding opportunities in multiple fields. ADSCs have emerged as a key element of regenerative medicine surgery due to their ability to differentiate into a variety of different cell lineages. Moreover, their capacity of paracrine secretion of a broad selection of cytokines, chemokines, and growth factors make them highly clinically attractive. More specific, of particular interest are the anti-apoptotic, anti-inflammatory, proangiogenic, immunomodulatory, and anti-scarring effects that have been demonstrated for ADSCs, which effects on wound healing, soft-tissue restoration and scar remodelling. Nanofat firstly introduced by Tonnard in 2013, is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but rich in ADSCs and with regenerative properties. The aim of the study is to investigate the use of nanofat grafting in the treatement of PD. The etiology of PD remains uncertain, but is well accepted that there is a chronic inflammation of tunica albuginea and this reflect perturbations in normal wound healing and aberrant deposition of extracellular matrix components in the soft tissue of the penis. There appears to be significant pathophysiologic and genetic overlap of PD with other superficial fibrosing disorders such as Dupuytren disease (palmar fibromatosis) and Ledderhose disease (plantar fibromatosis) but not with more diffuse conditions such as systemic sclerosis. Since PD was discovered, a lot of treatment were proposed. In the acute stage of PD treatments aim to alleviate penile pain and minimise disease progression and treatement attempts to mitigate inflammation: oral, intralesional injection, topical treatement were used but with few non significant results. In the chronic phase, surgical treatments aims to correct the curvature but with not a few negative implications include penile shortening, erectile dysfunction, glans hypoaesthesia, residual or recurrent curvature and palpable or uncomfortable suture knots below the skin. Recent findings on scar biology explain some factors that influence pro-fibrotic pathways. Preventions and treatment strategies mainly focus on reducing inflammation and hypoxia. Emerging therapies shows that Mesenchymal stem cells (MSCs) have immunomodulatory and antifibrotic effects by secreting paracrine growth factors. Zuk et al. in 2001 and 2002 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) population comparable to that isolated from the bone marrow. Because of its availability and accessibility, white adipose tissue is considered a "stem cell depot." Nanofat grafting technique firstly reported by Tonnard is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but contains rich in ADSCs, microvascular fragments, growth factors [vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), hepatocyte growth factor (HGF), transforming growth factor-beta (TGF-β), basic fibroblast growth factor (bFGF), insulin-like growth factor 1 (IGF-1), and granulocyte-macrophage colony-stimulating factor (GM-CSF)], biological peptides [lipoxins, resolvins, protectins, neurotrophic factors, angiogenin, matrix metalloproteinase, leukemia inhibitory factor, and macrophage migration inhibitory factor], and cytokines . It is a liquefied, autologous injectable product with the property of biological integration with adjacent cells and tissues due to its homogenous consistency. At the site of injury, these stromal cells initiate a site-specific reparative response comprised of remodeling of extracellular matrix, enhanced and sustained angiogenesis, immune system modulation, and cellular turnover. These properties of stromal cells provide a platform for the usage of cellular therapy in various diseases. Peyronie's "plaque" is a scarred tissue, results from abnormal extracellular matrix production through upregulation of myofibroblast activity and tissue inhibitors of matrix metalloproteinases, among other mechanisms. The aim of the study is to investigate the possible therapeutic role of nanofat grafting in the treatement of PD. Inclusion Criteria: - Presence of albuginea penile plaque due to Peyronies' disease associated with penile curvature and pain. Normal erectile function. Sexual activity. Exclusion Criteria: - Erectile dysfunction, no sexual activity.

NCT0531xxxx/NCT05316727.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/NCT05316727</url> </required_header> <id_info> <org_study_id>STUDY20020151</org_study_id> <secondary_id>5R01HL140963-04</secondary_id> <nct_id>NCT05316727</nct_id> </id_info> <brief_title>Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury</brief_title> <acronym>ENDALI</acronym> <official_title>Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury</official_title> <sponsors> <lead_sponsor> <agency>University of Pittsburgh</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>University of Pittsburgh</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 an observational - data and specimen collection study. There have been increasing reports of vaping-induced lung injury, including severe lung injury and rare cases of death. The mechanism by which vaping contributes to lung injury in susceptible persons is unknown, as is impact on chronic lung disease. The investigators aim to identify individuals with chronic electronic nicotine delivery device (ENDD) exposure and matched controls within our ongoing cohort of HIV+ and HIV-uninfected individuals, collect PFT data, bank respiratory and stool samples and collect clinical data for studies of clinical risk, inflammation, biomarkers, and the microbiome in the identification and modification of risk of progression to lung injury or chronic pulmonary disease. </textblock> </brief_summary> <detailed_description> <textblock> Participants will be consented and undergo collection of data and specimens as listed below.  - Vaping use will be determined by history.  - No administration, dispensing or use of any vape product will take place as part of the study.  Experimental procedures:  Respiratory questionnaires and data review:  Detailed data regarding smoking history, illicit drug use, ART and other medications, and medical history are obtained using standardized questionnaires and medical record review. The Modified Medical Research Council Dyspnea scale (MMRC), the St. George's Questionnaire(SGQT), Pulmonary questionnaire (PQ) and a Vaping questionnaire will be administered. These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of life, and other lung related issues. Laboratory data including CD4 cell counts and HIV viral levels are obtained from the medical record.  Blood Sample collection:  The subject will be asked to provide a blood sample by venipuncture of approximately 110mls (7.4 tablespoon) at this study visit. The purpose of this collection is to have blood processed for serum, plasma, and PBMCS, and a portion stored for RNA to be used for future use. A hemoglobin and carboxyhemoglobin will be done in order to calculate the DLCO. A CBC will be done to determine overall health and possible infections.  Saliva Collection: Participants will be asked to produce saliva and spit it into a sterile conical.  Stool collection: The investigator will ask participants to provide a stool sample. The subject will be instructed on how to collect a stool specimen at home. The investigator will give the subject instructions and a kit that will provide all the supplies needed to collect the stool and return it via mail at their convenience.  Lung function testing (PFT):  If a PFT was completed for a research study in the past month, that data will be used instead of repeating the test. The routine lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system before and after bronchodilator administration. The system is calibrated for body temperature and pressure of saturated gas and volumes, per American Thoracic Society (ATS) standards . DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms with ATS standards. All testing will be reviewed by a physician associated with this study. If any concerns or abnormal results are discovered during this testing, a member of the research team will notify the subject or the subject's primary care physician, who will assess the need to provide additional evaluation.  Pregnancy Test: A urine pregnancy test will be performed on all women of child bearing potential. Men, and women who are post menopausal for at least 1 year or have been surgically made sterile will not have a pregnancy test.  Collection of the vape product used by the subject. Declining participation in this collection does not mean the subject can't participate in the study.  The product will be sent to the investigators research labs for potential chemical analysis. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 15, 2021</start_date> <completion_date type="Anticipated">December 2024</completion_date> <primary_completion_date type="Anticipated">December 2024</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>Difference in pulmonary function comparing vaping and non vaping participants (1)</measure> <time_frame>Before bronchodilation</time_frame> <description>The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in pulmonary function comparing vaping and non vaping participants (2)</measure> <time_frame>Before bronchodilation</time_frame> <description>The routine lung function endpoints of FEV1, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in pulmonary function comparing vaping and non vaping participants (3)</measure> <time_frame>Before bronchodilation</time_frame> <description>The routine lung function endpoints of FEV1/FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in pulmonary function comparing vaping and non vaping participants (4)</measure> <time_frame>Before bronchodilation</time_frame> <description>The routine lung function endpoints of FEF25-75%, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in pulmonary function comparing vaping and non vaping participants (PB1)</measure> <time_frame>within 10 minutes after bronchodilation</time_frame> <description>The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in pulmonary function comparing vaping and non vaping participants (PB2)</measure> <time_frame>within 10 minutes after bronchodilation</time_frame> <description>The routine lung function endpoints of FEV1 will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in pulmonary function comparing vaping and non vaping participants (PB3)</measure> <time_frame>within 10 minutes after bronchodilation</time_frame> <description>The routine lung function endpoints of FEV1/FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in pulmonary function comparing vaping and non vaping participants (PB4)</measure> <time_frame>within 10 minutes after bronchodilation</time_frame> <description>The routine lung function endpoints of FEF25-75%, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.</description> </primary_outcome> <primary_outcome> <measure>Difference in diffusion capacity comparing vaping and non vaping participants</measure> <time_frame>within 15 minutes after bronchodilation</time_frame> <description>The routine lung function diffusion lung capacity for carbon monoxide (DLCO) will be measured.</description> </primary_outcome> <secondary_outcome> <measure>Change in inflammation</measure> <time_frame>collected at one visit -will complete analysis in 2 years.</time_frame> <description>The investigators will determine inflammation in sputum peripheral cytokine responses</description> </secondary_outcome> <secondary_outcome> <measure>Measurement of the inflammone in vaping and non vaping persons</measure> <time_frame>collection at one visit - will complete analysis in 2 years.</time_frame> <description>The investigators will use this cohort to evaluate biomarkers (type to be determined) of inflammation to determine if the investigator can identify specific HIV vapors phenotypes using novel decision tree analyses. The investigator will examine relationship of the inflammatory signature associated with vaping</description> </secondary_outcome> <secondary_outcome> <measure>comparison of microbial communities in stool</measure> <time_frame>one stool collection at the subjects convenience - will complete analysis in 2 years.</time_frame> <description>The investigators will use stool collected to compare bacterial function between vapers and non vapers</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">120</enrollment> <condition>Acute Lung Injury</condition> <condition>Pulmonary Injury</condition> <condition>Electronic Cigarette Use</condition> <condition>Electronic Cigarette Related Lung Injury</condition> <arm_group> <arm_group_label>Vaping</arm_group_label> <description>At least weekly vape use over the past 3 months of the subjects unspecified product</description> </arm_group> <arm_group> <arm_group_label>Non vapers</arm_group_label> <description>No previous history of vape use and no current history of smoking tobacco for controls</description> </arm_group> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Blood, Stool, oral wash, sputum </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> The investigators will leverage resources from an ongoing cohort of people living with HIV (PLWH) and HIV-uninfected community dwelling individuals as well as a growing dataset of individuals hospitalized with EVALI.  individuals, males or females in all races, ethnicities, and socioeconomic backgrounds greater than 18 years of age. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Men and women age 18 to 80  - Participant in a previous HLRC study, or a participant in the HIV PACT clinic or referred by a PACCM physician  - At least weekly vape use over the past 3 months  - OR No previous history of vape use and no current history of smoking tobacco for controls  - negative pregnancy test (for women of child barring capabilities)  Exclusion Criteria:  - pregnancy or breast-feeding (urine pregnancy done on all females of child bearing potential- - - males and females who are at least 1 year post menopausal or surgically sterile will not be tested)  - Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).  - Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry.  - Acute cardiopulmonary issue in the past 4 months.  - Uncontrolled hypertension at screening visit (systolic > 180 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.  - Active cancer requiring systemic chemotherapy or radiation.  - Active infection of lungs, brain, or abdomen.  - Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator.  - subjects with an upper or lower respiratory tract infection  - Persons who have tested positive for Covid 19 in the past 4 weeks. </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>Alison Morris</last_name> <role>Principal Investigator</role> <affiliation>University of Pittsburgh</affiliation> </overall_official> <overall_contact> <last_name>Cathy J Kessinger</last_name> <phone>412-624-8330</phone> <email>kessingercj@upmc.edu</email> </overall_contact> <overall_contact_backup> <last_name>Shawna Blacka</last_name> <phone>412-383-5972</phone> <email>reekies@upmc.edu</email> </overall_contact_backup> <location> <facility> <name>University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15213</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Cathy J Kessinger, RN</last_name> <phone>412-624-8330</phone> <email>kessingercj@upmc.edu</email> </contact> <investigator> <last_name>Alison M Morris, MD,MS</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>February 23, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>September 11, 2023</last_update_submitted> <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Pittsburgh</investigator_affiliation> <investigator_full_name>Alison Morris</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>electronic nicotine delivery device (ENDD)</keyword> <condition_browse>  <mesh_term>Lung Injury</mesh_term> <mesh_term>Acute Lung Injury</mesh_term> <mesh_term>Wounds and Injuries</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is an observational - data and specimen collection study. There have been increasing reports of vaping-induced lung injury, including severe lung injury and rare cases of death. The mechanism by which vaping contributes to lung injury in susceptible persons is unknown, as is impact on chronic lung disease. The investigators aim to identify individuals with chronic electronic nicotine delivery device (ENDD) exposure and matched controls within our ongoing cohort of HIV+ and HIV-uninfected individuals, collect PFT data, bank respiratory and stool samples and collect clinical data for studies of clinical risk, inflammation, biomarkers, and the microbiome in the identification and modification of risk of progression to lung injury or chronic pulmonary disease. Participants will be consented and undergo collection of data and specimens as listed below. - Vaping use will be determined by history. - No administration, dispensing or use of any vape product will take place as part of the study. Experimental procedures: Respiratory questionnaires and data review: Detailed data regarding smoking history, illicit drug use, ART and other medications, and medical history are obtained using standardized questionnaires and medical record review. The Modified Medical Research Council Dyspnea scale (MMRC), the St. George's Questionnaire(SGQT), Pulmonary questionnaire (PQ) and a Vaping questionnaire will be administered. These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of life, and other lung related issues. Laboratory data including CD4 cell counts and HIV viral levels are obtained from the medical record. Blood Sample collection: The subject will be asked to provide a blood sample by venipuncture of approximately 110mls (7.4 tablespoon) at this study visit. The purpose of this collection is to have blood processed for serum, plasma, and PBMCS, and a portion stored for RNA to be used for future use. A hemoglobin and carboxyhemoglobin will be done in order to calculate the DLCO. A CBC will be done to determine overall health and possible infections. Saliva Collection: Participants will be asked to produce saliva and spit it into a sterile conical. Stool collection: The investigator will ask participants to provide a stool sample. The subject will be instructed on how to collect a stool specimen at home. The investigator will give the subject instructions and a kit that will provide all the supplies needed to collect the stool and return it via mail at their convenience. Lung function testing (PFT): If a PFT was completed for a research study in the past month, that data will be used instead of repeating the test. The routine lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system before and after bronchodilator administration. The system is calibrated for body temperature and pressure of saturated gas and volumes, per American Thoracic Society (ATS) standards . DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms with ATS standards. All testing will be reviewed by a physician associated with this study. If any concerns or abnormal results are discovered during this testing, a member of the research team will notify the subject or the subject's primary care physician, who will assess the need to provide additional evaluation. Pregnancy Test: A urine pregnancy test will be performed on all women of child bearing potential. Men, and women who are post menopausal for at least 1 year or have been surgically made sterile will not have a pregnancy test. Collection of the vape product used by the subject. Declining participation in this collection does not mean the subject can't participate in the study. The product will be sent to the investigators research labs for potential chemical analysis. Blood, Stool, oral wash, sputum The investigators will leverage resources from an ongoing cohort of people living with HIV (PLWH) and HIV-uninfected community dwelling individuals as well as a growing dataset of individuals hospitalized with EVALI. individuals, males or females in all races, ethnicities, and socioeconomic backgrounds greater than 18 years of age. Inclusion Criteria: - Men and women age 18 to 80 - Participant in a previous HLRC study, or a participant in the HIV PACT clinic or referred by a PACCM physician - At least weekly vape use over the past 3 months - OR No previous history of vape use and no current history of smoking tobacco for controls - negative pregnancy test (for women of child barring capabilities) Exclusion Criteria: - pregnancy or breast-feeding (urine pregnancy done on all females of child bearing potential- - - males and females who are at least 1 year post menopausal or surgically sterile will not be tested) - Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.). - Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry. - Acute cardiopulmonary issue in the past 4 months. - Uncontrolled hypertension at screening visit (systolic > 180 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled. - Active cancer requiring systemic chemotherapy or radiation. - Active infection of lungs, brain, or abdomen. - Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator. - subjects with an upper or lower respiratory tract infection - Persons who have tested positive for Covid 19 in the past 4 weeks.

NCT0531xxxx/NCT05316740.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/NCT05316740</url> </required_header> <id_info> <org_study_id>0512-21-HMO</org_study_id> <nct_id>NCT05316740</nct_id> </id_info> <brief_title>Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease</brief_title> <official_title>Vaginal Microbiome and the Risk of Vulvovaginal Graft Versus Host Disease Following Hematopoietic Stem Cell Transplantation</official_title> <sponsors> <lead_sponsor> <agency>Hadassah Medical Organization</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Rambam Health Care Campus</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Tel-Aviv Sourasky Medical Center</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Hadassah Medical Organization</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> Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients.  The suggested study aims to evaluate a possible association between vaginal microorganisms (the "microbiome") to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 15, 2022</start_date> <completion_date type="Anticipated">December 2024</completion_date> <primary_completion_date type="Anticipated">March 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>Microbiome composition</measure> <time_frame>2 years</time_frame> <description>Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing</description> </primary_outcome> <primary_outcome> <measure>CMV presence</measure> <time_frame>2 years</time_frame> <description>Evaluation of CMV in vaginal samples using PCR assay</description> </primary_outcome> <primary_outcome> <measure>Vulvovaginal graft vs host disease presence</measure> <time_frame>2 years</time_frame> <description>Evaluation of presence of vulvovaginal GVHD by gynecologic examination, using the NIH classification system for chronic graft-versus-host disease</description> </primary_outcome> <secondary_outcome> <measure>HPV presence</measure> <time_frame>2 years</time_frame> <description>Evaluation of HPV in vaginal samples</description> </secondary_outcome> <enrollment type="Anticipated">40</enrollment> <condition>Bone Marrow Transplant Complications</condition> <intervention> <intervention_type>Other</intervention_type> <intervention_name>No intervention</intervention_name> <description>Repeated clinical evaluation and sample collection</description> </intervention> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> Vaginal samples will be collected for:  1. Microbiome molecular analysis: aimed to determine whether changes in the vaginal bacterial microbiome precede or follow VV-GVHD.  2. HPV presence.  3. CMV presence </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Female patients planned for HSCT </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Age≥18  - Candidate for allogeneic stem cell transplantation  - Ability to sign an informed consent  Exclusion Criteria:  - Patient does not approve sample collection </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Ahinoam Lev Sagie, MD</last_name> <role>Principal Investigator</role> <affiliation>Hadassah Medical Organization</affiliation> </overall_official> <overall_contact> <last_name>Ahinoam Lev-Sagie, MD</last_name> <phone>0544327178</phone> <email>levsagie@netvision.net.il</email> </overall_contact> <location> <facility> <name>Hadassah Medical Center</name> <address> <city>Jerusalem</city> <zip>9765422</zip> <country>Israel</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ahinoam Lev-Sagie, MD</last_name> </contact> </location> <location_countries> <country>Israel</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Graft vs Host Disease</mesh_term> </condition_browse>  </clinical_study>

Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients. The suggested study aims to evaluate a possible association between vaginal microorganisms (the "microbiome") to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD. Vaginal samples will be collected for: 1. Microbiome molecular analysis: aimed to determine whether changes in the vaginal bacterial microbiome precede or follow VV-GVHD. 2. HPV presence. 3. CMV presence Female patients planned for HSCT Inclusion Criteria: - Age≥18 - Candidate for allogeneic stem cell transplantation - Ability to sign an informed consent Exclusion Criteria: - Patient does not approve sample collection

NCT0531xxxx/NCT05316753.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/NCT05316753</url> </required_header> <id_info> <org_study_id>UniversityNationalHeartH 1</org_study_id> <nct_id>NCT05316753</nct_id> </id_info> <brief_title>BTE and Pulsed Waveforms for Cardioversion of Atrial Fibrillation - Escalation Strategy and Manual Pressure</brief_title> <official_title>Comparison of Biphasic Truncated Exponential and Pulsed Waveforms for Cardioversion of Atrial Fibrillation-High Energy Escalation Strategy and Introduction to Manual Pressure Application</official_title> <sponsors> <lead_sponsor> <agency>University National Heart Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University National Heart 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> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> Background: A Danish study raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols. Maximal energies are usually the final choice of the physicians. Some authors showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome. This is likely due to the impedance decrease linked to MPA.  Objective: This new clinical cardioversion study of atrial fibrillation (AF) patients aims to compare the efficacy and safety of a new high energy escalation strategy. The protocol combines high energy shocks at first shock, jumping to maximal defibrillator energy at second shock and finally complemented by MPA at third shock, if success is not reached using electric shocks only.  Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit, Cardiology Clinic, National Cardiology Hospital (NCH), Sofia, Bulgaria. All eligible patients will sign a written informed consent prior to the cardioversion and will receive the standard hospital procedures during cardioversion.  AF patients will be alternatively randomized to cardioversion using one of the two defibrillators, following the strategy below:  DEFIGARD HD-7 arm: 3 consecutive shocks with escalating selected energy: 150J, 200J, 200J. The third shock is combined with MPA LIFEPAK15 arm: 3 consecutive shocks with escalating selected energy: 150J, 360J, 360J. The third shock is combined with MPA The statistical power analysis will consider a superiority comparison between the cumulative energy actually delivered by both defibrillators.  The secondary cardioversion efficacy outcome measures are: the cumulative success rate (measured at 1 minute post-shock), number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NCH Ethical Committee). Heart rhythm will be measured in continuously recorded peripheral ECG.  The secondary cardioversion safety outcome measures are: markers for myocardial necrosis (high sensitive troponin I, CK-MB) evaluated on blood samples taken before and 8-12 hours after cardioversion; ST-segment changes (post-shock - pre-shock) measured in lead II; Complications after cardioversion measured during 2 hours follow-up period in the ICCU - the presence of apnea, arrhythmias, bradycardia and the need for respective therapy at the discretion of attending physician. </textblock> </brief_summary> <detailed_description> <textblock> Background Commercially available defibrillators generate direct current (DC) shock with various waveforms using distinct technologies. These waveforms are suggested to have different efficacy and safety. Although the superiority of biphasic over monophasic waveforms is well established, the relative efficacy and safety of the available biphasic waveforms is not clear.  Various BTE waveforms apply different potential gradients on the thorax that might produce various defibrillation effects. Apart from efficacy, the most important aspect is the patient safety, considering that larger potential gradients in the myocardium lasting longer could potentially induce an electroporation and then a fibrillation. A frequently observed effect of electroporation are the post-shock ST-segment deviations in the surface ECG, representing the potential difference between the normal tissue and sustained depolarized critical mass of myocardium closest to the associated origin of the electrical current. Although ST-segment changes are an easily ignored phenomenon, occurring acutely and resolving during the first few minutes post-shock, their presence in a short-term basis can identify electroporation by dangerously high potential gradients, while the sustained ST-changes in a long-term basis can identify cases with myocardial injury. The most reliable marker of shock-induced myocardial injuries is the high sensitive cardiac Troponin I (hsTnI).  In a previous study Trendafilova et al. were compared fixed-high energy protocols (200J-200J-200J) delivered by two different defibrillation waveforms: Pulsed (BTE-PE) and High-energy BTE (BTE-HE). This study concluded on non-inferiority between devices. Cumulative energy, efficiency of the waveforms and safety (measured by High-sensitive Troponin) were not reaching significant difference for both waveforms. Delivered energy of the first efficient shock was significantly lower for BTE-PE and although BTE-PE delivered almost 28J lower energy after the whole procedure, significance could not be reached due to wide variance.  In a Danish study Schmidt et al. compared two cardioversion protocols - one is fixed-high energy (360J-360J-360J), the other is low energy escalating (125J-150J-200J). The overall efficacy of fixed-energy protocol was better than escalating. Safety is non significantly different. Schmidt et al. raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols.  There is an ethical consideration to apply maximal energy shocks to all patients without considering patient individuality. Ramirez et al. remind that failed shocks might depend on other factors like transthoracic impedance. Lavignasse et al. found that cumulative energy setting differs with patient characteristics, having significant association with: AF duration, gender, BSA, LV TDD, valvular disease and chronic respiratory disease. Indeed, some authors (Voskoboinik et al. and Ramirez et al.) showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome.  On most defibrillators, increasing the energy level is leading to an increase of the voltage delivered to the patient. This voltage increase implies a current increase in the thorax of the patient. In fact, applying a force on the defibrillation pads or increasing shock voltage by increasing the energy setting would lead to increase the current in the thorax, associated with expectations for higher shock efficiency. MPA is performed by pressing on the pads using a non-connected pair of paddles in order to assure isolation of the practitioner from the patient during the shock.  Objective:  This new clinical cardioversion study of atrial fibrillation (AF) patients aims to compare the efficacy and safety of a new high energy escalation strategy. The protocol combines reasonably high energy shocks complemented by MPA when necessary.  Two biphasic defibrillators - a standard BTE-HE waveform (Lifepak 15, Physio Control) and a BTE-PE waveform (Defigard HD 7, Schiller Medical) with different maximal energy settings of 360J and 200J, respectively are compared.  The proposed high energy escalation strategy is based on the hypothesis that most of the patients do not implicitly require the maximal levels of energy for cardioversion. Thus patients who could be easily cardioverted are removed from the pool that would need a more aggressive treatment.  Methods:  Study population All patients admitted for elective cardioversion of atrial fibrillation in ICCU- NCH will be potentially eligible for the study. Informed consent will be obtained from all eligible patients prior to cardioversion. Patients declining to participate in the study will receive treatment according to the hospital protocol.  Cardiologists will check the eligibility of each patient following the detailed list of inclusion and exclusion criteria, based on the documented pre-treatment data.  Additionally, eligibility will be verified through pre-cardioversion medical exams (blood test within 24 hours before cardioversion): routine blood chemistry, glucose, creatinine, eGFR, K, Na; CK-MB, high sensitive troponin I measurements on the day of cardioversion.  Study design This will be a prospective randomized trial (alternating design) where eligible patients will be randomized to treatment with two different defibrillators. Following the order of patient admittance in ICCU-NCH, the attending cardiologist will assign the odd and even eligible patients to the defibrillators in arm 1 and arm 2, respectively. The cardiologist cannot control the order of patient admittance in ICCU-NCH. The alternative randomization design will equalize the number of subjects on each treatment. This study is not designed to control for sex, age, comorbidity, type of device used for cardioversion, cumulative energy delivered during shocks, number of shocks administered. Randomization is performed to limit these and any other confounding factors.  Patient preparation Patients will be consulted prior to cardioversion (CV) in a quiet setting. Any questions will be answered by the attending cardiologist. Patients will be asked to manually sign their informed consent for study participation before further preparations and data collection. If the patient declines to participate, then he/she will receive treatment according to the hospital protocol without data documentation, as further defined in the study.  Demographic data will be taken. Pre-treatment data will be read from the patient files: concomitant diseases; medications during the previous 7 days; Left atrium dimensions, left ventricle dimensions and volumes, ejection fraction by transthoracic echocardiography during index hospitalization; TEE will be performed for all patients before CV - presence of cardiac thrombus and spontaneous echo contrast will be checked; duration of index AF in days; European Heart Rhythm Association class score of symptoms from index AF; standard blood test will be documented.  Appropriate standard anticoagulation with unfractionated heparin (UFH) or acenocumarol or direct oral anticoagulants (DOAC) is required before and after the CV.  The anesthesia will be conducted by an anesthesiologist with slow intravenous injection of Propofol, adjusted individually to reach deep sedation (Cook' s scale points <7).  Cardioversion protocol:  The CV procedure is performed in ICCU by a cardiologist and anesthesiologist. Defibrillator pads are placed according to the user guides on the pads and respecting >40 cm distance between them. Standard self-adhesive defibrillation pads, recommended by specific defibrillator's manufacturer will be used.  Defibrillator use: The time-interval interval between consecutive shocks is 1 min; The energy of consecutive shocks follows pre-defined protocol; The protocol stops at successful cardioversion (sinus rhythm at 1 min post-shock), otherwise at the last shock of the protocol.  Data collection and Follow up:  - Defibrillator pulse recorder: The shock waveforms delivered by the studied defibrillators is recorded in real-time during the shock by a dedicated measurement device (Defimpulse recorder DR2) connected in the patient circuit. This allows accurate measurement of the delivered energy, which is the primary measured outcome. Additionally, currents, voltages, patient impedances at each shock can be also measured. The device is fully automatic and expert assistance is not need during the CV intervention. The use of the measurement device (Defimpulse recorder DR2) has been approved by the NCH Ethical Committee.  - Blood samples, standard ECG, blood pressure and heart rate at baseline.  - Continuous ECG in 3 peripheral leads is recorded during the whole CV procedure. ST deviation is measured on the first cardiac complex after 10 s post-shock in standard manner (0.080 seconds after J point) in lead II.  - Standard ECG is recorded in 5 min after CV; 24 h after CV; at discharge if the discharge day is different from 24 h after CV.  - Heart rate and blood pressure are measured 3 times after CV during follow-up in ICCU  - Follow-up period in ICCU (2 hours after CV): Potential complications after CV are recorded  - Follow-up period in the Cardiology Clinic (24 hours after CV): blood samples to analyze CK-MB and troponin (8 to 12 h after CV); Clinical exam with heart rate and blood pressure; ECG; Any complications before discharge.  Statistics:  For arm1 (BTE PE waveform), the expected efficacy is 50% at the first shock (150J), 80% at the second shock (200J) and 85% at the third shock (200J combined with MPA).  For arm2 (BTE HE waveform), the expected efficacy is 50% at the first shock (150J), 80% at the second shock (360J) and 85% at the third shock (360J combined with MPA).  Taking into account that BTE PE waveform typically delivers 180J for energy setting of 200J, the estimated cumulative energy at the end of the CV procedure is 258J (+/-120J) and 366J (+/-240J) for arm1 and arm2, respectively.  The statistical analysis is designed for a superiority comparison between the two defibrillation strategies in respect of their delivered cumulative energies hypothesizing similar cardioversion efficacy rate. It is estimated that a total of 94 patients (47 per arm) would allow to reach a statistical power of 80% in a superiority study design with one-sided type I error rate of 0.05.  Continuous variables will be expressed as mean value ± standard deviation or median values (inter-quartile range) and compared with Students t-test or equivalent non-parametric test, respectively. Categorical variables are expressed as percentages and compared using the Chi-square or Fisher's exact test . P<0.05 is considered statistically significant for all comparisons.  Ethics All patients will sign a written informed consent prior to the cardioversion and will receive the standard hospital procedures during cardioversion. Both defibrillators included in this study are approved for clinical use and both are used on a daily basis.  Data anonymization policy will be respected. In order to ensure the medical confidentiality, no information about the patient will be entered in the defibrillators. An identification number will be given to each patient by the dedicated measurement device (Defimpulse recorder DR2). This number and the recording data are properties of the principal investigator. Approval from the NCH Ethical Committee concerning energy strategy and the use of the Defimpulse recorder during the cardioversion intervention has been obtained. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 20, 2022</start_date> <completion_date type="Anticipated">June 30, 2024</completion_date> <primary_completion_date type="Anticipated">May 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> <intervention_model_description>Randomized Interventional study, Alternating Assignment, Open Label</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Defibrillator Efficacy</measure> <time_frame>Delivered energy (Joules) will be measured during each shock with a dedicated pulse recording device</time_frame> <description>The cumulative delivered energy by the consecutive defibrillation shocks during the successful cardioversion procedure.</description> </primary_outcome> <secondary_outcome> <measure>The cumulative success rate at 1 minute</measure> <time_frame>Peripheral ECG will be continuously recorded during cardioversion and the presence of sinus rhythm will be read by a cardiologist at the first minute after each shock</time_frame> <description>The cumulative success rate (at 1 minute) of the consecutive defibrillation shocks during the cardioversion procedure is defined as the conversion to sinus rhythm at 1 minute post shock.</description> </secondary_outcome> <secondary_outcome> <measure>Number of shocks</measure> <time_frame>During the whole cardioversion procedure, each electrical shock delivered to the patient will be counted</time_frame> <description>Number of shocks</description> </secondary_outcome> <secondary_outcome> <measure>Changes in hsTnI at 8-12 hours</measure> <time_frame>the blood samples will be taken before cardioversion (on the same day) and after cardioversion (from 8 to 12 hours after the intervention)</time_frame> <description>Changes in hsTnI before and after the cardioversion procedure</description> </secondary_outcome> <secondary_outcome> <measure>Changes in CK and CK-MB at 8-12 hours</measure> <time_frame>the blood samples will be taken before cardioversion (on the same day) and after cardioversion (from 8 to 12 hours after the intervention)</time_frame> <description>Changes in CK and CK-MB before and after the cardioversion procedure before and after the cardioversion procedure</description> </secondary_outcome> <secondary_outcome> <measure>The cumulative success rate (at 2 hours) of the consecutive defibrillation shocks during the cardioversion procedure</measure> <time_frame>Peripheral ECG will be continuously recorded during cardioversion and the presence of sinus rhythm will be read by a cardiologist at two hours after each shock</time_frame> <description>The cumulative success rate (at 2 hours) of the consecutive defibrillation shocks during the cardioversion procedure, is defined as the conversion to sinus rhythm at 2 hours after the last shock of the procedure.</description> </secondary_outcome> <secondary_outcome> <measure>The cumulative success rate (at 24 hours) of the consecutive defibrillation shocks during the cardioversion procedure</measure> <time_frame>Peripheral ECG will be continuously recorded during cardioversion and the presence of sinus rhythm will be read by a cardiologist at twenty four hours after each shock</time_frame> <description>The cumulative success rate (at 24 hours) of the consecutive defibrillation shocks during the cardioversion procedure, is defined as the conversion to sinus rhythm at 24 hours after the last shock of the procedure.</description> </secondary_outcome> <secondary_outcome> <measure>ST-segment changes after each defibrillation shock</measure> <time_frame>ST-segment will be measured in the continuously recorded lead II 10 seconds after each defibrillation shock (0.080 seconds after J point in the first QRS at 10 seconds post-shock)</time_frame> <description>ST-segment changes after each defibrillation shock</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">94</enrollment> <condition>Atrial Fibrillation</condition> <arm_group> <arm_group_label>Schiller Defigard HD- 7 - DGHD7</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Device: Cardioversion with a pulsed biphasic waveform Cardioversion is performed by a pulsed biphasic (Multipulse Biowave®) waveform (Schiller Defigard HD- 7 - DGHD7, Schiller Medical, France) with adult pads (0-21-0003 Schiller) following an energy protocol of 3 consecutive shocks with escalating selected energy: 150J, 200J, 200J. The third shock is combined with MAP (Manual Pressure Application). The protocol is stopped at successfull cardioversion (sinus rhythm at 1 min post-shock), otherwise after the 3rd shock Other Name: DGHD7</description> </arm_group> <arm_group> <arm_group_label>LIFEPAK 15, Physio-Control - LP15</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Device: Cardioversion with a biphasic truncated exponential waveform Cardioversion is performed by a biphasic truncated exponential waveform (LIFEPAK 15, Physio-Control Inc., Redmond, WA, USA) with recommended by the manufacturer adult pads (Redipak QUICK COMBO, Physio-Control) following an energy protocol of 3 consecutive shocks with escalating selected energy: 150J, 360J, 360J. The third shock is combined with MAP (Manual Pressure Application). The protocol is stopped at successfull cardioversion (sinus rhythm at 1 minute post-shock), otherwise after the 3rd shock. Other Name: LP15</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Cardioversion with a pulsed biphasic waveform</intervention_name> <description>Cardioversion with a pulsed biphasic waveform</description> <arm_group_label>Schiller Defigard HD- 7 - DGHD7</arm_group_label> <other_name>Schiller Defigard HD- 7 - DGHD7, Schiller Medical, France</other_name> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Cardioversion with a biphasic truncated exponential waveform</intervention_name> <description>Cardioversion with a biphasic truncated exponential waveform</description> <arm_group_label>LIFEPAK 15, Physio-Control - LP15</arm_group_label> <other_name>LIFEPAK 15 monitor/defibrillator 41577-000267</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria:  - Indications for elective cardioversion of atrial fibrillation  - Patients > 18 years old and:  - Symptomatic AFIB with a duration of less than 12 months and EHRA score 2-4  - Symptomatic first detected AFIB and EHRA score 2-4  - Persistent AFIB after successful causal therapy  - Rare recurrences of AFIB with long periods of sinus rhythm  - Impossibility to reach a sustained normal ventricular rate in AFIB  Exclusion Criteria:  - Patients with atrial flutter  - Spontaneous HR <60/min  - Digitalis intoxication  - Impossibility to maintain sinus rhythm irrespective to antiarrhythmic therapy and frequent cardioversions  - Conduction disturbances (without fascicular block and AV block 1 degree) in patients without pacemaker  - Asymptomatic patients with AFIB for > 1 year  - Thyroid dysfunction: euthyroid status of at least one month is required (TSH is measured).  - Thrombosis in cardiac cavities, assessment performed using Transesophageal echocardiography (TEE)  - Spontaneous echo contrast > 2 degree (TEE)  - Patients with planned cardiac operation in the next three months  - Patients with embolic event in the last three months  - Patients <18 years of age  - Pregnant woman </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>Elina G Trendafilova, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>UniversityNationalHeartH, ICCU</affiliation> </overall_official> <overall_contact> <last_name>Elina G Trendafilova, MD, PhD</last_name> <phone>+359888718847</phone> <email>elitrendafilova@abv.bg</email> </overall_contact> <overall_contact_backup> <last_name>Elena S Dimitrova, MD, PhD</last_name> <phone>+359887394540</phone> <email>elena.sv@gmail.com</email> </overall_contact_backup> <location> <facility> <name>University National Heart Hospital</name> <address> <city>Sofia</city> <zip>1309</zip> <country>Bulgaria</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Elina G Trendafilova, MD, PhD</last_name> <phone>+359888718847</phone> <email>elitrendafilova@abv.bg</email> </contact> <contact_backup> <last_name>Elena S Dimitrova, MD, PhD</last_name> <phone>+359887394540</phone> <email>elena.sv@gmail.com</email> </contact_backup> <investigator> <last_name>Elena S Dimitrova, MD, PhD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Bulgaria</country> </location_countries> <reference> <citation>Lavignasse D, Trendafilova E, Dimitrova E, Krasteva V. Cardioversion of Atrial Fibrillation and Flutter: Comparative Study of Pulsed vs. Low Energy Biphasic Truncated Exponential Waveforms. J Atr Fibrillation. 2019 Oct 31;12(3):2172. doi: 10.4022/jafib.2172. eCollection 2019 Oct-Nov.</citation> <PMID>32435331</PMID> </reference> <reference> <citation>Coats AJS, Anker SD, Baumbach A, Alfieri O, von Bardeleben RS, Bauersachs J, Bax JJ, Boveda S, Celutkiene J, Cleland JG, Dagres N, Deneke T, Farmakis D, Filippatos G, Hausleiter J, Hindricks G, Jankowska EA, Lainscak M, Leclercq C, Lund LH, McDonagh T, Mehra MR, Metra M, Mewton N, Mueller C, Mullens W, Muneretto C, Obadia JF, Ponikowski P, Praz F, Rudolph V, Ruschitzka F, Vahanian A, Windecker S, Zamorano JL, Edvardsen T, Heidbuchel H, Seferovic PM, Prendergast B. The management of secondary mitral regurgitation in patients with heart failure: a joint position statement from the Heart Failure Association (HFA), European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA), and European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur Heart J. 2021 Mar 31;42(13):1254-1269. doi: 10.1093/eurheartj/ehab086.</citation> <PMID>33734354</PMID> </reference> <reference> <citation>Ramirez FD, Sadek MM, Boileau I, Cleland M, Nery PB, Nair GM, Redpath CJ, Green MS, Davis DR, Charron K, Henne J, Zakutney T, Beanlands RSB, Hibbert B, Wells GA, Birnie DH. Evaluation of a novel cardioversion intervention for atrial fibrillation: the Ottawa AF cardioversion protocol. Europace. 2019 May 1;21(5):708-715. doi: 10.1093/europace/euy285.</citation> <PMID>30535367</PMID> </reference> <reference> <citation>Schmidt AS, Lauridsen KG, Torp P, Bach LF, Rickers H, Lofgren B. Maximum-fixed energy shocks for cardioverting atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):626-631. doi: 10.1093/eurheartj/ehz585.</citation> <PMID>31504412</PMID> </reference> <reference> <citation>Trendafilova E, Dimitrova E, Didon JP, Krasteva V. A Randomized Comparison of Delivered Energy in Cardioversion of Atrial Fibrillation: Biphasic Truncated Exponential Versus Pulsed Biphasic Waveforms. Diagnostics (Basel). 2021 Jun 17;11(6):1107. doi: 10.3390/diagnostics11061107.</citation> <PMID>34204498</PMID> </reference> <reference> <citation>Voskoboinik A, Moskovitch J, Plunkett G, Bloom J, Wong G, Nalliah C, Prabhu S, Sugumar H, Paramasweran R, McLellan A, Ling LH, Goh CY, Noaman S, Fernando H, Wong M, Taylor AJ, Kalman JM, Kistler PM. Cardioversion of atrial fibrillation in obese patients: Results from the Cardioversion-BMI randomized controlled trial. J Cardiovasc Electrophysiol. 2019 Feb;30(2):155-161. doi: 10.1111/jce.13786. Epub 2018 Nov 14.</citation> <PMID>30375104</PMID> </reference> <verification_date>July 2022</verification_date> <study_first_submitted>March 8, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 25, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University National Heart Hospital</investigator_affiliation> <investigator_full_name>Elina Trendafilova</investigator_full_name> <investigator_title>professor</investigator_title> </responsible_party> <keyword>electrical cardioversion</keyword> <condition_browse>  <mesh_term>Atrial Fibrillation</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Background: A Danish study raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols. Maximal energies are usually the final choice of the physicians. Some authors showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome. This is likely due to the impedance decrease linked to MPA. Objective: This new clinical cardioversion study of atrial fibrillation (AF) patients aims to compare the efficacy and safety of a new high energy escalation strategy. The protocol combines high energy shocks at first shock, jumping to maximal defibrillator energy at second shock and finally complemented by MPA at third shock, if success is not reached using electric shocks only. Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit, Cardiology Clinic, National Cardiology Hospital (NCH), Sofia, Bulgaria. All eligible patients will sign a written informed consent prior to the cardioversion and will receive the standard hospital procedures during cardioversion. AF patients will be alternatively randomized to cardioversion using one of the two defibrillators, following the strategy below: DEFIGARD HD-7 arm: 3 consecutive shocks with escalating selected energy: 150J, 200J, 200J. The third shock is combined with MPA LIFEPAK15 arm: 3 consecutive shocks with escalating selected energy: 150J, 360J, 360J. The third shock is combined with MPA The statistical power analysis will consider a superiority comparison between the cumulative energy actually delivered by both defibrillators. The secondary cardioversion efficacy outcome measures are: the cumulative success rate (measured at 1 minute post-shock), number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NCH Ethical Committee). Heart rhythm will be measured in continuously recorded peripheral ECG. The secondary cardioversion safety outcome measures are: markers for myocardial necrosis (high sensitive troponin I, CK-MB) evaluated on blood samples taken before and 8-12 hours after cardioversion; ST-segment changes (post-shock - pre-shock) measured in lead II; Complications after cardioversion measured during 2 hours follow-up period in the ICCU - the presence of apnea, arrhythmias, bradycardia and the need for respective therapy at the discretion of attending physician. Background Commercially available defibrillators generate direct current (DC) shock with various waveforms using distinct technologies. These waveforms are suggested to have different efficacy and safety. Although the superiority of biphasic over monophasic waveforms is well established, the relative efficacy and safety of the available biphasic waveforms is not clear. Various BTE waveforms apply different potential gradients on the thorax that might produce various defibrillation effects. Apart from efficacy, the most important aspect is the patient safety, considering that larger potential gradients in the myocardium lasting longer could potentially induce an electroporation and then a fibrillation. A frequently observed effect of electroporation are the post-shock ST-segment deviations in the surface ECG, representing the potential difference between the normal tissue and sustained depolarized critical mass of myocardium closest to the associated origin of the electrical current. Although ST-segment changes are an easily ignored phenomenon, occurring acutely and resolving during the first few minutes post-shock, their presence in a short-term basis can identify electroporation by dangerously high potential gradients, while the sustained ST-changes in a long-term basis can identify cases with myocardial injury. The most reliable marker of shock-induced myocardial injuries is the high sensitive cardiac Troponin I (hsTnI). In a previous study Trendafilova et al. were compared fixed-high energy protocols (200J-200J-200J) delivered by two different defibrillation waveforms: Pulsed (BTE-PE) and High-energy BTE (BTE-HE). This study concluded on non-inferiority between devices. Cumulative energy, efficiency of the waveforms and safety (measured by High-sensitive Troponin) were not reaching significant difference for both waveforms. Delivered energy of the first efficient shock was significantly lower for BTE-PE and although BTE-PE delivered almost 28J lower energy after the whole procedure, significance could not be reached due to wide variance. In a Danish study Schmidt et al. compared two cardioversion protocols - one is fixed-high energy (360J-360J-360J), the other is low energy escalating (125J-150J-200J). The overall efficacy of fixed-energy protocol was better than escalating. Safety is non significantly different. Schmidt et al. raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols. There is an ethical consideration to apply maximal energy shocks to all patients without considering patient individuality. Ramirez et al. remind that failed shocks might depend on other factors like transthoracic impedance. Lavignasse et al. found that cumulative energy setting differs with patient characteristics, having significant association with: AF duration, gender, BSA, LV TDD, valvular disease and chronic respiratory disease. Indeed, some authors (Voskoboinik et al. and Ramirez et al.) showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome. On most defibrillators, increasing the energy level is leading to an increase of the voltage delivered to the patient. This voltage increase implies a current increase in the thorax of the patient. In fact, applying a force on the defibrillation pads or increasing shock voltage by increasing the energy setting would lead to increase the current in the thorax, associated with expectations for higher shock efficiency. MPA is performed by pressing on the pads using a non-connected pair of paddles in order to assure isolation of the practitioner from the patient during the shock. Objective: This new clinical cardioversion study of atrial fibrillation (AF) patients aims to compare the efficacy and safety of a new high energy escalation strategy. The protocol combines reasonably high energy shocks complemented by MPA when necessary. Two biphasic defibrillators - a standard BTE-HE waveform (Lifepak 15, Physio Control) and a BTE-PE waveform (Defigard HD 7, Schiller Medical) with different maximal energy settings of 360J and 200J, respectively are compared. The proposed high energy escalation strategy is based on the hypothesis that most of the patients do not implicitly require the maximal levels of energy for cardioversion. Thus patients who could be easily cardioverted are removed from the pool that would need a more aggressive treatment. Methods: Study population All patients admitted for elective cardioversion of atrial fibrillation in ICCU- NCH will be potentially eligible for the study. Informed consent will be obtained from all eligible patients prior to cardioversion. Patients declining to participate in the study will receive treatment according to the hospital protocol. Cardiologists will check the eligibility of each patient following the detailed list of inclusion and exclusion criteria, based on the documented pre-treatment data. Additionally, eligibility will be verified through pre-cardioversion medical exams (blood test within 24 hours before cardioversion): routine blood chemistry, glucose, creatinine, eGFR, K, Na; CK-MB, high sensitive troponin I measurements on the day of cardioversion. Study design This will be a prospective randomized trial (alternating design) where eligible patients will be randomized to treatment with two different defibrillators. Following the order of patient admittance in ICCU-NCH, the attending cardiologist will assign the odd and even eligible patients to the defibrillators in arm 1 and arm 2, respectively. The cardiologist cannot control the order of patient admittance in ICCU-NCH. The alternative randomization design will equalize the number of subjects on each treatment. This study is not designed to control for sex, age, comorbidity, type of device used for cardioversion, cumulative energy delivered during shocks, number of shocks administered. Randomization is performed to limit these and any other confounding factors. Patient preparation Patients will be consulted prior to cardioversion (CV) in a quiet setting. Any questions will be answered by the attending cardiologist. Patients will be asked to manually sign their informed consent for study participation before further preparations and data collection. If the patient declines to participate, then he/she will receive treatment according to the hospital protocol without data documentation, as further defined in the study. Demographic data will be taken. Pre-treatment data will be read from the patient files: concomitant diseases; medications during the previous 7 days; Left atrium dimensions, left ventricle dimensions and volumes, ejection fraction by transthoracic echocardiography during index hospitalization; TEE will be performed for all patients before CV - presence of cardiac thrombus and spontaneous echo contrast will be checked; duration of index AF in days; European Heart Rhythm Association class score of symptoms from index AF; standard blood test will be documented. Appropriate standard anticoagulation with unfractionated heparin (UFH) or acenocumarol or direct oral anticoagulants (DOAC) is required before and after the CV. The anesthesia will be conducted by an anesthesiologist with slow intravenous injection of Propofol, adjusted individually to reach deep sedation (Cook' s scale points <7). Cardioversion protocol: The CV procedure is performed in ICCU by a cardiologist and anesthesiologist. Defibrillator pads are placed according to the user guides on the pads and respecting >40 cm distance between them. Standard self-adhesive defibrillation pads, recommended by specific defibrillator's manufacturer will be used. Defibrillator use: The time-interval interval between consecutive shocks is 1 min; The energy of consecutive shocks follows pre-defined protocol; The protocol stops at successful cardioversion (sinus rhythm at 1 min post-shock), otherwise at the last shock of the protocol. Data collection and Follow up: - Defibrillator pulse recorder: The shock waveforms delivered by the studied defibrillators is recorded in real-time during the shock by a dedicated measurement device (Defimpulse recorder DR2) connected in the patient circuit. This allows accurate measurement of the delivered energy, which is the primary measured outcome. Additionally, currents, voltages, patient impedances at each shock can be also measured. The device is fully automatic and expert assistance is not need during the CV intervention. The use of the measurement device (Defimpulse recorder DR2) has been approved by the NCH Ethical Committee. - Blood samples, standard ECG, blood pressure and heart rate at baseline. - Continuous ECG in 3 peripheral leads is recorded during the whole CV procedure. ST deviation is measured on the first cardiac complex after 10 s post-shock in standard manner (0.080 seconds after J point) in lead II. - Standard ECG is recorded in 5 min after CV; 24 h after CV; at discharge if the discharge day is different from 24 h after CV. - Heart rate and blood pressure are measured 3 times after CV during follow-up in ICCU - Follow-up period in ICCU (2 hours after CV): Potential complications after CV are recorded - Follow-up period in the Cardiology Clinic (24 hours after CV): blood samples to analyze CK-MB and troponin (8 to 12 h after CV); Clinical exam with heart rate and blood pressure; ECG; Any complications before discharge. Statistics: For arm1 (BTE PE waveform), the expected efficacy is 50% at the first shock (150J), 80% at the second shock (200J) and 85% at the third shock (200J combined with MPA). For arm2 (BTE HE waveform), the expected efficacy is 50% at the first shock (150J), 80% at the second shock (360J) and 85% at the third shock (360J combined with MPA). Taking into account that BTE PE waveform typically delivers 180J for energy setting of 200J, the estimated cumulative energy at the end of the CV procedure is 258J (+/-120J) and 366J (+/-240J) for arm1 and arm2, respectively. The statistical analysis is designed for a superiority comparison between the two defibrillation strategies in respect of their delivered cumulative energies hypothesizing similar cardioversion efficacy rate. It is estimated that a total of 94 patients (47 per arm) would allow to reach a statistical power of 80% in a superiority study design with one-sided type I error rate of 0.05. Continuous variables will be expressed as mean value ± standard deviation or median values (inter-quartile range) and compared with Students t-test or equivalent non-parametric test, respectively. Categorical variables are expressed as percentages and compared using the Chi-square or Fisher's exact test . P<0.05 is considered statistically significant for all comparisons. Ethics All patients will sign a written informed consent prior to the cardioversion and will receive the standard hospital procedures during cardioversion. Both defibrillators included in this study are approved for clinical use and both are used on a daily basis. Data anonymization policy will be respected. In order to ensure the medical confidentiality, no information about the patient will be entered in the defibrillators. An identification number will be given to each patient by the dedicated measurement device (Defimpulse recorder DR2). This number and the recording data are properties of the principal investigator. Approval from the NCH Ethical Committee concerning energy strategy and the use of the Defimpulse recorder during the cardioversion intervention has been obtained. Inclusion criteria: - Indications for elective cardioversion of atrial fibrillation - Patients > 18 years old and: - Symptomatic AFIB with a duration of less than 12 months and EHRA score 2-4 - Symptomatic first detected AFIB and EHRA score 2-4 - Persistent AFIB after successful causal therapy - Rare recurrences of AFIB with long periods of sinus rhythm - Impossibility to reach a sustained normal ventricular rate in AFIB Exclusion Criteria: - Patients with atrial flutter - Spontaneous HR <60/min - Digitalis intoxication - Impossibility to maintain sinus rhythm irrespective to antiarrhythmic therapy and frequent cardioversions - Conduction disturbances (without fascicular block and AV block 1 degree) in patients without pacemaker - Asymptomatic patients with AFIB for > 1 year - Thyroid dysfunction: euthyroid status of at least one month is required (TSH is measured). - Thrombosis in cardiac cavities, assessment performed using Transesophageal echocardiography (TEE) - Spontaneous echo contrast > 2 degree (TEE) - Patients with planned cardiac operation in the next three months - Patients with embolic event in the last three months - Patients <18 years of age - Pregnant woman

NCT0531xxxx/NCT05316766.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/NCT05316766</url> </required_header> <id_info> <org_study_id>UMadeira</org_study_id> <nct_id>NCT05316766</nct_id> </id_info> <brief_title>Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation</brief_title> <official_title>Multi-user Touch Surfaces for Promoting Social Participation and Self-efficacy in Upper-limb Stroke Rehabilitation</official_title> <sponsors> <lead_sponsor> <agency>Universidade da Madeira</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Universidade da Madeira</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 compare the efficacy of conventional therapy with a framework intervention for upper limb motor rehabilitation based on the promotion of self-efficacy and social participation/interaction through a multi-user touch surface </textblock> </brief_summary> <detailed_description> <textblock> After signing the written informed consent about participating in the study, participants will be assessed for exclusion criteria and their motor, social and depression skills prior to intervention. After this, they will undergo a 12 sessions treatment for 4 weeks in groups of three, randomly distributed for a control group and experimental group. At the end of the intervention, participants will be assessed in the same manner as before the intervention. One month after the end of the intervention, participants will be assessed for follow-up. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 29, 2022</start_date> <completion_date type="Anticipated">November 9, 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>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>Action Research Arm Test (change between three time frames )</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Hand Function</description> </primary_outcome> <primary_outcome> <measure>Box and Blocks (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Coordination</description> </primary_outcome> <primary_outcome> <measure>Dynamometer (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Strength</description> </primary_outcome> <primary_outcome> <measure>Nine Hole Peg Test (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Fine motor skills</description> </primary_outcome> <primary_outcome> <measure>Motor Activity Log (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Quantity and Quality of movement everyday activities</description> </primary_outcome> <primary_outcome> <measure>Reaching Performance Scale in Stroke (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Quality of movement</description> </primary_outcome> <primary_outcome> <measure>Fugl-Meyer Assessment (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Range of movement</description> </primary_outcome> <primary_outcome> <measure>Stroke Self-Efficacy Questionnaire (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Self-efficacy, minimum 0 maximum 130, higher score means better outcome</description> </primary_outcome> <secondary_outcome> <measure>Beck's Depression (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Depressive symptoms</description> </secondary_outcome> <secondary_outcome> <measure>Social Interaction category of ''Functional Limitation Profile'' (specific name of the scale) (change between three time frames)</measure> <time_frame>Assessment (before intervention), Reassessment (after 12 x 45 minutes sessions, 3 sessions per week) and Follow-up (1 month after the end of intervention)</time_frame> <description>Social Interaction</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Social Interaction</condition> <condition>Self Efficacy</condition> <condition>Stroke</condition> <condition>Motor Activity</condition> <arm_group> <arm_group_label>Intervention</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Will receive intervention through the multi-user touch surface</description> </arm_group> <arm_group> <arm_group_label>Treatment as usual</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>This will receive conventional therapy</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Physical rehabilitation</intervention_name> <description>Exercises to rehabilitate upper limb strength, coordination and range of movement, based on conventional therapy</description> <arm_group_label>Treatment as usual</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Physical rehabilitation interactive table</intervention_name> <description>Exercises to rehabilitate upper limb strength, coordination and range of movement, based on multi-user touch surface</description> <arm_group_label>Intervention</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Stroke survivor  Exclusion Criteria:  - Unable to write and read  - Hemispatial neglect  - Previous upper limb motor deficits/lesions that still interfere with function  - History of drugs/alcohol abuse  - Aphasia with difficulties understanding oral communication and/or unability to express orally  - Token equal or under 17  - ARAT score lower than 10 or higher than 54  - Botulinic toxin treatment in the last 4 months  - Beck's Depression Inventory higher than 31 </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>Sergi B Badia</last_name> <role>Principal Investigator</role> <affiliation>Professor</affiliation> </overall_official> <overall_contact> <last_name>Fábio DS Pereira</last_name> <phone>917499898</phone> <email>fabiodsp7@gmail.com</email> </overall_contact> <location> <facility> <name>ARDITI</name> <address> <city>Funchal</city> <state>Madeira</state> <zip>9000-232</zip> <country>Portugal</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Fábio DS Pereira</last_name> <phone>917499898</phone> <email>fabiodsp7@gmail.com</email> </contact> </location> <location_countries> <country>Portugal</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 2, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 10, 2023</last_update_submitted> <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Universidade da Madeira</investigator_affiliation> <investigator_full_name>Sergi Bermúdez i Badia</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Stroke</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to compare the efficacy of conventional therapy with a framework intervention for upper limb motor rehabilitation based on the promotion of self-efficacy and social participation/interaction through a multi-user touch surface After signing the written informed consent about participating in the study, participants will be assessed for exclusion criteria and their motor, social and depression skills prior to intervention. After this, they will undergo a 12 sessions treatment for 4 weeks in groups of three, randomly distributed for a control group and experimental group. At the end of the intervention, participants will be assessed in the same manner as before the intervention. One month after the end of the intervention, participants will be assessed for follow-up. Inclusion Criteria: - Stroke survivor Exclusion Criteria: - Unable to write and read - Hemispatial neglect - Previous upper limb motor deficits/lesions that still interfere with function - History of drugs/alcohol abuse - Aphasia with difficulties understanding oral communication and/or unability to express orally - Token equal or under 17 - ARAT score lower than 10 or higher than 54 - Botulinic toxin treatment in the last 4 months - Beck's Depression Inventory higher than 31

NCT0531xxxx/NCT05316779.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/NCT05316779</url> </required_header> <id_info> <org_study_id>2021-02330</org_study_id> <nct_id>NCT05316779</nct_id> </id_info> <brief_title>Perioperative Cardiac Arrest and Outcome</brief_title> <acronym>POCA</acronym> <official_title>Perioperative Cardiac Arrest: an Observational Mono-centre 8-year Assessment of Outcome</official_title> <sponsors> <lead_sponsor> <agency>Insel Gruppe AG, University Hospital Bern</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Insel Gruppe AG, University Hospital Bern</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> With ethical approvement, the investigators want to assess the incidence, circumstances and outcomes of patients with perioperative cardiac arrests over a period of 8 years.  Currently, there is little data and information about a cardiovascular arrests during anesthesia. Little is also known about the health-related quality of life afterwards. In the investigators research project, the investigators want to find out if there are, for example, specific factors that cause cardiovascular arrests and factors that can improve the chances of survival after a cardiovascular arrest. The investigators are also looking for possible factors and measurements that can minimize or even prevent future events during anesthesia. </textblock> </brief_summary> <detailed_description> <textblock> A perioperative cardiac arrest is a special form of in-hospital cardiac arrest. It was claimed that perioperative cardiac arrests are under-investigated. The spare existing data suggest incidences of perioperative cardiac arrest to be between 0.5 - 3 per 10.000 for adult patients and 2 - 10 per 10.000 for paediatric patients. Data on circumstances, predictors and outcomes of perioperative cardiac arrest are rare, especially for paediatric patients. Some reports suggest that incidence is negatively associated with a country's higher development. As no Swiss data is available on this topic, this retrospective audit aims to bridge the knowledge gap and finally intends to make clinicians aware of potential risks or contributing factors of survival, which might raise safety for all patients undergoing procedures under anaesthesia.  The investigators will include all patients of all ages with a perioperative cardiac arrest at Bern University Hospital from 1st January 2015 until 31st December 2021 (7 year observational period). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 14, 2022</start_date> <completion_date type="Anticipated">September 30, 2023</completion_date> <primary_completion_date type="Anticipated">September 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>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Return of spontaneous circulation (ROSC)</measure> <time_frame>60 minutes</time_frame> <description>Number of patients with a Return of spontaneous circulation (ROSC) during resuscitation</description> </primary_outcome> <secondary_outcome> <measure>Sustained ROSC</measure> <time_frame>60 minutes</time_frame> <description>Number of patients with a Return of spontaneous circulation during resuscitation over 20 minutes</description> </secondary_outcome> <secondary_outcome> <measure>Survival post-anaesthesia care unit or intensive care unit</measure> <time_frame>24 hours</time_frame> <description>Number of patients with a Survival to post-anaesthesia care unit (PACU) or intensive care unit (ICU)</description> </secondary_outcome> <secondary_outcome> <measure>Survival to hospital discharge</measure> <time_frame>4 weeks</time_frame> <description>Number of patients with a Survival to hospital discharge</description> </secondary_outcome> <secondary_outcome> <measure>SF-12 after hospital discharge</measure> <time_frame>1 month</time_frame> <description>Health-related quality of life according (HRQOL) the Short Form Survey (SF-12) after hospital discharge</description> </secondary_outcome> <secondary_outcome> <measure>CPC after hospital discharge</measure> <time_frame>1 month</time_frame> <description>Neurological status according Clinical Performance Category (CPC) after hospital discharge</description> </secondary_outcome> <secondary_outcome> <measure>SF-12 3 month after cardiac arrest</measure> <time_frame>3 months</time_frame> <description>Health-related quality of life (HRQOL) according the Short Form Survey (SF-12) at 3 months after the peri-operative cardiac arrest</description> </secondary_outcome> <secondary_outcome> <measure>CPC 3 month after cardiac arrest</measure> <time_frame>3 months</time_frame> <description>Neurological status according Clinical Performance Category (CPC) at 3 months after the peri-operative cardiac arrest</description> </secondary_outcome> <enrollment type="Anticipated">240</enrollment> <condition>Heart Arrest</condition> <condition>Anesthesia</condition> <eligibility> <study_pop> <textblock> The investigators will include all patients of all ages with a perioperative cardiac arrest at Bern University Hospital from 1st January 2015 until 31st December 2021. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria is a perioperative cardiac arrest between 1st January 2015 and 31st December 2021 at Bern University Hospital.  A perioperative cardiac arrest is defined as:  - ≥5 chest compressions (direct, mechanical or extracorporeal Cardiopulmonary Resuscitation (CPR))  - and/or defibrillation (unsynchronised direct current (DC) shock for ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT) either - external or internal defibrillation with manual or Automated External Defibrillation (AED), shocks by implanted cardioverter defibrillators (ICDs) for VF/pVT, precordial thump)  - In a patient having a procedure under the care of an anaesthesia team (nurse or anaesthesiologist) at the Bern University Hospital: General anaesthesia, regional anaesthesia/ analgesia, sedation, local anaesthesia or monitored anaesthesia care  - Regional block performed by anaesthesiologist outside of operating room  - Obstetric analgesia including remifentanil patient-controlled analgesia (PCA).  Exclusion Criteria:  - A perioperative cardiac arrest before 1st January 2015 or after 31st December 2021  - <5 chest compressions (direct, mechanical or extracorporeal Cardiopulmonary Resuscitation (CPR))  - All in-hospital cardiac arrests, that occur without being under anaesthesia care  - Patients already admitted to a hospital with a cardiac arrest (out-of hospital cardiac arrests) </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>Robert Greif, MD, Prof</last_name> <role>Study Director</role> <affiliation>University of Bern</affiliation> </overall_official> <overall_contact> <last_name>Thomas Riva, MD</last_name> <phone>+41326325201</phone> <email>thomas.riva@insel.ch</email> </overall_contact> <overall_contact_backup> <last_name>Alexander Fuchs, MD</last_name> <phone>+41 31 66 4 14 65</phone> <email>alexander.fuchs@insel.ch</email> </overall_contact_backup> <location> <facility> <name>University Hospital Bern</name> <address> <city>Bern</city> <zip>3010</zip> <country>Switzerland</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Thomas Riva, MD</last_name> <phone>+413265201</phone> <email>thomas.riva@insel.ch</email> </contact> </location> <location_countries> <country>Switzerland</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 11, 2023</last_update_submitted> <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Cardiac arrest</keyword> <keyword>Perioperative cardiac arrest</keyword> <keyword>Neurological outcome</keyword> <keyword>Quality of Life</keyword> <keyword>In-hospital cardiac arrest</keyword> <condition_browse>  <mesh_term>Heart Arrest</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

With ethical approvement, the investigators want to assess the incidence, circumstances and outcomes of patients with perioperative cardiac arrests over a period of 8 years. Currently, there is little data and information about a cardiovascular arrests during anesthesia. Little is also known about the health-related quality of life afterwards. In the investigators research project, the investigators want to find out if there are, for example, specific factors that cause cardiovascular arrests and factors that can improve the chances of survival after a cardiovascular arrest. The investigators are also looking for possible factors and measurements that can minimize or even prevent future events during anesthesia. A perioperative cardiac arrest is a special form of in-hospital cardiac arrest. It was claimed that perioperative cardiac arrests are under-investigated. The spare existing data suggest incidences of perioperative cardiac arrest to be between 0.5 - 3 per 10.000 for adult patients and 2 - 10 per 10.000 for paediatric patients. Data on circumstances, predictors and outcomes of perioperative cardiac arrest are rare, especially for paediatric patients. Some reports suggest that incidence is negatively associated with a country's higher development. As no Swiss data is available on this topic, this retrospective audit aims to bridge the knowledge gap and finally intends to make clinicians aware of potential risks or contributing factors of survival, which might raise safety for all patients undergoing procedures under anaesthesia. The investigators will include all patients of all ages with a perioperative cardiac arrest at Bern University Hospital from 1st January 2015 until 31st December 2021 (7 year observational period). The investigators will include all patients of all ages with a perioperative cardiac arrest at Bern University Hospital from 1st January 2015 until 31st December 2021. Inclusion Criteria is a perioperative cardiac arrest between 1st January 2015 and 31st December 2021 at Bern University Hospital. A perioperative cardiac arrest is defined as: - ≥5 chest compressions (direct, mechanical or extracorporeal Cardiopulmonary Resuscitation (CPR)) - and/or defibrillation (unsynchronised direct current (DC) shock for ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT) either - external or internal defibrillation with manual or Automated External Defibrillation (AED), shocks by implanted cardioverter defibrillators (ICDs) for VF/pVT, precordial thump) - In a patient having a procedure under the care of an anaesthesia team (nurse or anaesthesiologist) at the Bern University Hospital: General anaesthesia, regional anaesthesia/ analgesia, sedation, local anaesthesia or monitored anaesthesia care - Regional block performed by anaesthesiologist outside of operating room - Obstetric analgesia including remifentanil patient-controlled analgesia (PCA). Exclusion Criteria: - A perioperative cardiac arrest before 1st January 2015 or after 31st December 2021 - <5 chest compressions (direct, mechanical or extracorporeal Cardiopulmonary Resuscitation (CPR)) - All in-hospital cardiac arrests, that occur without being under anaesthesia care - Patients already admitted to a hospital with a cardiac arrest (out-of hospital cardiac arrests)

NCT0531xxxx/NCT05316792.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/NCT05316792</url> </required_header> <id_info> <org_study_id>PamukkaleU-Simsek-002</org_study_id> <nct_id>NCT05316792</nct_id> </id_info> <brief_title>Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking</brief_title> <official_title>Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking in Healthy Individuals and Patients With Knee Osteoarthritis</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> The aim of this study is to measure and compare the femoral cartilage deformation after walking on the treadmill and tartan floor in patients with knee osteoarthritis (OA) and healthy volunteers. </textblock> </brief_summary> <detailed_description> <textblock> The investigators will recruit 30 patients who will be applied to Physical Medicine and Rehabilitation outpatient clinic and diagnosed with knee OA according to American College of Rheumatology (ACR) criteria and 30 healthy volunteers matched for age and gender. The sociodemographic characteristics and detailed history of the patients included in the study will be questioned and recorded. After a detailed physical examination of all patients, weight and height will be measured, and body mass indexes (BMI) will be calculated. Participants' physical activity levels will be determined based on the World Health Organization's Global Physical Activity Questionnaire. This questionnaire has been reported to provide a valid and reliable estimate of physical activity, Turkish validity and reliability have been established.  A repeated measures design will be used in which healthy volunteers and patients with knee OA all complete all loading conditions (30min walking on the treadmill and tartan floor). For this, each group (healthy volunteers and knee OA patients) will first walk on the treadmill and then do tartan ground walking 1 week later. Femoral articular cartilage thickness before and immediately after walking will be measured with portable ultrasonography (USG) with a telemedicine feature.  Upon arrival at the treatment unit or area of the tartan track, participants will sit on a treatment table with their knees fully extended for 30 minutes to minimize the effects of previous activity on cartilage. All sessions will be completed at the same time of day to reduce daily variations in cartilage thickness. The dominant leg will be defined as the self-reported limb that the participant chooses to use to kick a ball. All post-load USG procedures will be achieved within 5 minutes after the loading condition. 3 images will be taken from each participant.  Two separate evaluators will measure to determine the reliability among the measurers.  To equalize the loading, the speed at which each participant walks on the treadmill in 30 minutes will be determined by the pedometer as a brisk walking speed (5 km/h). Again, each participant will walk on the tartan floor with a pedometer and walk for 30 minutes at an equal distance at the same pace as on the treadmill. The pedometer will give a warning when it is below or above the desired speed. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">September 15, 2022</start_date> <completion_date type="Anticipated">June 15, 2023</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>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Case-Control Study</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Ultrasonographic Evaluation</measure> <time_frame>just before walking</time_frame> <description>Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.</description> </primary_outcome> <primary_outcome> <measure>Ultrasonographic Evaluation</measure> <time_frame>within 5 minutes after loading condition</time_frame> <description>Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">60</enrollment> <condition>Knee Osteoarthritis</condition> <arm_group> <arm_group_label>knee osteoarthritis</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>In patients with knee osteoarthritis, the thickness of the femoral articular cartilage will be measured with portable USG before and immediately after walking.</description> </arm_group> <arm_group> <arm_group_label>healthy volunteers</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Femoral articular cartilage thickness will be measured with portable USG before and immediately after walking in healthy volunteers.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>walking</intervention_name> <description>30 min walking on the treadmill and tartan floor</description> <arm_group_label>healthy volunteers</arm_group_label> <arm_group_label>knee osteoarthritis</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Be over 40 years old  - Having been diagnosed with knee OA according to the ACR diagnostic criteria  - Being diagnosed with stage 1-2 knee OA according to the Kellgren-Lawrence staging criteria  Exclusion Criteria:  - Having a musculoskeletal or systemic disease that will prevent the exercise  - History or symptoms of lower extremity surgery, ligament injury, balance disorder, lower extremity injury in the last 6 months  - Presence of psychiatric or neurological disease affecting cooperation, cognitive and neurological functions </textblock> </criteria> <gender>All</gender> <minimum_age>40 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</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> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 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>knee osteoarthritis</keyword> <keyword>Cartilage</keyword> <keyword>Ultrasonography</keyword> <condition_browse>  <mesh_term>Osteoarthritis</mesh_term> <mesh_term>Osteoarthritis, Knee</mesh_term> </condition_browse>  </clinical_study>

The aim of this study is to measure and compare the femoral cartilage deformation after walking on the treadmill and tartan floor in patients with knee osteoarthritis (OA) and healthy volunteers. The investigators will recruit 30 patients who will be applied to Physical Medicine and Rehabilitation outpatient clinic and diagnosed with knee OA according to American College of Rheumatology (ACR) criteria and 30 healthy volunteers matched for age and gender. The sociodemographic characteristics and detailed history of the patients included in the study will be questioned and recorded. After a detailed physical examination of all patients, weight and height will be measured, and body mass indexes (BMI) will be calculated. Participants' physical activity levels will be determined based on the World Health Organization's Global Physical Activity Questionnaire. This questionnaire has been reported to provide a valid and reliable estimate of physical activity, Turkish validity and reliability have been established. A repeated measures design will be used in which healthy volunteers and patients with knee OA all complete all loading conditions (30min walking on the treadmill and tartan floor). For this, each group (healthy volunteers and knee OA patients) will first walk on the treadmill and then do tartan ground walking 1 week later. Femoral articular cartilage thickness before and immediately after walking will be measured with portable ultrasonography (USG) with a telemedicine feature. Upon arrival at the treatment unit or area of the tartan track, participants will sit on a treatment table with their knees fully extended for 30 minutes to minimize the effects of previous activity on cartilage. All sessions will be completed at the same time of day to reduce daily variations in cartilage thickness. The dominant leg will be defined as the self-reported limb that the participant chooses to use to kick a ball. All post-load USG procedures will be achieved within 5 minutes after the loading condition. 3 images will be taken from each participant. Two separate evaluators will measure to determine the reliability among the measurers. To equalize the loading, the speed at which each participant walks on the treadmill in 30 minutes will be determined by the pedometer as a brisk walking speed (5 km/h). Again, each participant will walk on the tartan floor with a pedometer and walk for 30 minutes at an equal distance at the same pace as on the treadmill. The pedometer will give a warning when it is below or above the desired speed. Inclusion Criteria: - Be over 40 years old - Having been diagnosed with knee OA according to the ACR diagnostic criteria - Being diagnosed with stage 1-2 knee OA according to the Kellgren-Lawrence staging criteria Exclusion Criteria: - Having a musculoskeletal or systemic disease that will prevent the exercise - History or symptoms of lower extremity surgery, ligament injury, balance disorder, lower extremity injury in the last 6 months - Presence of psychiatric or neurological disease affecting cooperation, cognitive and neurological functions

NCT0531xxxx/NCT05316805.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/NCT05316805</url> </required_header> <id_info> <org_study_id>PKU202108</org_study_id> <nct_id>NCT05316805</nct_id> </id_info> <brief_title>China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project</brief_title> <acronym>CORNERSTONE</acronym> <official_title>China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study</official_title> <sponsors> <lead_sponsor> <agency>Peking University First Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Peking University First 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> In order to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for type 2 inflammatory skin diseases to systematically and effectively understand the current treatment status of patients with type 2 inflammatory skin diseases, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases and help patients with type 2 inflammatory skin diseases. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 31, 2021</start_date> <completion_date type="Anticipated">December 31, 2031</completion_date> <primary_completion_date type="Anticipated">December 31, 2031</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>Demographics</measure> <time_frame>baseline</time_frame> <description>Age, sex, ethnicity, body weight and height</description> </primary_outcome> <primary_outcome> <measure>Age at Type 2 skin disease onset</measure> <time_frame>baseline</time_frame> <description>Age of study patients at time of Type 2 skin disease onset</description> </primary_outcome> <primary_outcome> <measure>Type of current Type 2 skin disease therapy</measure> <time_frame>Baseline</time_frame> <description>Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)</description> </primary_outcome> <primary_outcome> <measure>Presence of Type 2 skin disease and selected comorbid conditions</measure> <time_frame>Baseline to Month 120</time_frame> <description>Percentage of patients with Type 2 skin disease and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study</description> </primary_outcome> <secondary_outcome> <measure>Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies</measure> <time_frame>Baseline to Month 120</time_frame> <description>Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies</description> </secondary_outcome> <secondary_outcome> <measure>Eczema Area and Severity Index (EASI)</measure> <time_frame>Baseline to Month 120</time_frame> <description>EASI score as assessed by physician</description> </secondary_outcome> <secondary_outcome> <measure>Body Surface Area (BSA) percentage affected by Type 2 skin disease</measure> <time_frame>Baseline to Month 120</time_frame> <description>BSA score as assessed by physician</description> </secondary_outcome> <secondary_outcome> <measure>Patient Oriented Eczema Measure (POEM) questionnaire</measure> <time_frame>Baseline to Month 120</time_frame> <description>POEM score as reported by the participant's caregiver</description> </secondary_outcome> <secondary_outcome> <measure>Dermatology Life Quality Index</measure> <time_frame>Baseline to Month 120</time_frame> <description>DLQI score as reported by the patients or caregivers</description> </secondary_outcome> <secondary_outcome> <measure>Bullous Pemphigoid Disease Area Index(BPDAI)</measure> <time_frame>Baseline to Month 120</time_frame> <description>BPDAI score as assessed by physician</description> </secondary_outcome> <secondary_outcome> <measure>Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)</measure> <time_frame>Baseline to Month 120</time_frame> <description>ABSIS score as assessed by physician</description> </secondary_outcome> <secondary_outcome> <measure>Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)</measure> <time_frame>Baseline to Month 120</time_frame> <description>CU-Q2oL score as assessed by patients or caregivers</description> </secondary_outcome> <secondary_outcome> <measure>Urticaria Activity Score 7a （UAS7a）</measure> <time_frame>Baseline to Month 120</time_frame> <description>UAS7a score as assessed by physician</description> </secondary_outcome> <secondary_outcome> <measure>Urticaria Control test (UCT)</measure> <time_frame>Baseline to Month 120</time_frame> <description>UCT score as assessed by patients or caregivers</description> </secondary_outcome> <enrollment type="Anticipated">100000</enrollment> <condition>Atopic Dermatitis Eczema</condition> <condition>Prurigo Nodularis</condition> <eligibility> <study_pop> <textblock> Patients with Type 2 skin disease. Estimated number of patients: 100,000 (No age limit) </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Patients from the medical units that has passed the data review of the National Clinical Center for Skin and Immune Diseases (see the study sites for data collection for details);  2. patients diagnosed with type 2 inflammatory skin diseases (dermatitis/eczema, urticaria, pemphigoid, prurigo nodularis).  Exclusion Criteria:  1. patients who fail to provide informed consent form;  2. patients who cannot complete the questionnaire independently or under the guidance of investigators </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Yang Wang, Doctor</last_name> <phone>008613811232795</phone> <email>yangwang_dr@bjmu.edu.cn</email> </overall_contact> <location> <facility> <name>Peking University First Hospital</name> <address> <city>Beijing</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yang Wang, Doctor</last_name> <phone>008613811232795</phone> <email>yangwang_dr@bjmu.edu.cn</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Dermatitis</mesh_term> <mesh_term>Skin Diseases</mesh_term> <mesh_term>Prurigo</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

In order to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for type 2 inflammatory skin diseases to systematically and effectively understand the current treatment status of patients with type 2 inflammatory skin diseases, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases and help patients with type 2 inflammatory skin diseases. Patients with Type 2 skin disease. Estimated number of patients: 100,000 (No age limit) Inclusion Criteria: 1. Patients from the medical units that has passed the data review of the National Clinical Center for Skin and Immune Diseases (see the study sites for data collection for details); 2. patients diagnosed with type 2 inflammatory skin diseases (dermatitis/eczema, urticaria, pemphigoid, prurigo nodularis). Exclusion Criteria: 1. patients who fail to provide informed consent form; 2. patients who cannot complete the questionnaire independently or under the guidance of investigators

NCT0531xxxx/NCT05316818.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/NCT05316818</url> </required_header> <id_info> <org_study_id>I-160317</org_study_id> <nct_id>NCT05316818</nct_id> </id_info> <brief_title>Triplet (FOLFOXIRI) vs. Doublet (FOLFOX or FOLFIRI) Regimen as a 1st Line Treatment in Metastatic Colorectal Carcinoma</brief_title> <official_title>The Efficacy and Toxicity of Triplet Regimen (FOLFOXIRI) Versus Doublet Regimen (FOLFOX or FOLFIRI) as First Line Treatment in Locally Advanced, Recurrent or Metastatic Colorectal Carcinoma.</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> <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 prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes & assess tolerance to the intensified treatment </textblock> </brief_summary> <detailed_description> <textblock> Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease, were enrolled and randomized in a 1:1 ratio.  Patients were assigned to receive FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control arm) biweekly up to 12 cycles.  Randomization was done by enclosed envelope method Evaluation of the patients for surgical resection of residual metastases was done every 12 weeks. In the case of secondary resection of metastases, patients completed with the same chemotherapy regimen received before resection up to 12 cycles Maintenance therapy with capecitabine for 6 months was administered for patients who achieved complete or partial tumor response. In case of disease progression, second line chemotherapy was then administered in both groups until tumor progression, the occurrence of an unacceptable adverse event, or patient refusal </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 16, 2018</start_date> <completion_date type="Actual">April 10, 2021</completion_date> <primary_completion_date type="Actual">December 1, 2020</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>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Overall response rate (ORR)</measure> <time_frame>6 months ( from staring treatment till finishing 12 cycles, each cycle every 2 weeks)</time_frame> <description>the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria</description> </primary_outcome> <primary_outcome> <measure>Rate of adverse events</measure> <time_frame>During the study treatment period till 30 days following the end of therapy</time_frame> <description>Adverse events (haematological & non-haematological) were assessed before each cycle using the Common Terminology Criteria for Adverse Events version (CTCAE) 5.0, 2017 with scale from (G0-5) for each event.</description> </primary_outcome> <secondary_outcome> <measure>Progression free survival (PFS)</measure> <time_frame>18 months</time_frame> <description>the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first. Documentation of disease progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival time (OS)</measure> <time_frame>18 months</time_frame> <description>Defined as the length of time from date of randomization to the date of death due to any cause or due to lost follow up</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">64</enrollment> <condition>Metastatic Colorectal Cancer</condition> <arm_group> <arm_group_label>Triplet regimen (FOLFOXIRI)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The treatment planned consisted of irinotecan 160 mg/m² in 250 ml of NaCl 0.9% over 1 hr, followed by 85 mg/m² oxaliplatin in 250 ml dextrose 5% given concurrently with a 400 mg/m² leucovorin intra venous infusion in 250 ml dextrose 5% for 120 min, followed by 2400 mg/m² for 44-hr continuous infusion</description> </arm_group> <arm_group> <arm_group_label>standard duplet regimen (FOLFOX or FOLFIRI)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Regimen consisted of 180 mg/m² intravenous infusion of irinotecan for 60 min OR 85 mg/m² oxaliplatin day 1 only followed by a 200 mg/m² intra venous infusion of leucovorin for 120 min, a 400 mg/m² intravenous bolus of fluorouracil, and a 600 mg/m² continuous infusion of fluorouracil for 22 hr to be repeated on day 2</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>FOLFOXIRI Protocol</intervention_name> <description>Triplet chemotherapy regimen consists from active three cytotoxic agents aiming to improve outcomes</description> <arm_group_label>Triplet regimen (FOLFOXIRI)</arm_group_label> <arm_group_label>standard duplet regimen (FOLFOX or FOLFIRI)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease  - No previous treatment for the metastatic disease was allowed, only previously fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before enrollment in the study  - Adequate haematological parameters (leukocyte count of at least 3,500/mm₃, neutrophil count of at least 1,500/ mm and platelet count of at least 100,000/mm  - Adequate liver and renal function parameters (serum creatinine ≤ 1.3 mg/dL, serum bilirubin ≤ 1.5 mg/dL and AST, ALT and alkaline phosphatase 2.5 x upper normal values or less.  - Patient had no co-morbidity disease  Exclusion Criteria:  - Poor performance status 3-4 according to ECOG score, prior chemotherapy for advanced, recurrent or metastatic disease, other simultaneous malignancies and pregnant or lactating female </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Kasr El AiniH</name> <address> <city>Cairo</city> <state>El Manial</state> <zip>11555</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 7, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 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>Khaled Ahmed Khalil Hassan</investigator_full_name> <investigator_title>Assistant lecturer of clinical oncology</investigator_title> </responsible_party> <keyword>First line chemotherapy</keyword> <keyword>FOLFOXIRI</keyword> <keyword>standard doublet</keyword> <keyword>Efficacy</keyword> <keyword>Toxicity</keyword> <condition_browse>  <mesh_term>Colorectal Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes & assess tolerance to the intensified treatment Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease, were enrolled and randomized in a 1:1 ratio. Patients were assigned to receive FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control arm) biweekly up to 12 cycles. Randomization was done by enclosed envelope method Evaluation of the patients for surgical resection of residual metastases was done every 12 weeks. In the case of secondary resection of metastases, patients completed with the same chemotherapy regimen received before resection up to 12 cycles Maintenance therapy with capecitabine for 6 months was administered for patients who achieved complete or partial tumor response. In case of disease progression, second line chemotherapy was then administered in both groups until tumor progression, the occurrence of an unacceptable adverse event, or patient refusal Inclusion Criteria: - Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease - No previous treatment for the metastatic disease was allowed, only previously fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before enrollment in the study - Adequate haematological parameters (leukocyte count of at least 3,500/mm₃, neutrophil count of at least 1,500/ mm and platelet count of at least 100,000/mm - Adequate liver and renal function parameters (serum creatinine ≤ 1.3 mg/dL, serum bilirubin ≤ 1.5 mg/dL and AST, ALT and alkaline phosphatase 2.5 x upper normal values or less. - Patient had no co-morbidity disease Exclusion Criteria: - Poor performance status 3-4 according to ECOG score, prior chemotherapy for advanced, recurrent or metastatic disease, other simultaneous malignancies and pregnant or lactating female

NCT0531xxxx/NCT05316831.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/NCT05316831</url> </required_header> <id_info> <org_study_id>234041</org_study_id> <nct_id>NCT05316831</nct_id> </id_info> <brief_title>Immune Response After Pneumococcal Vaccination in Patient With Chronic Lymphocytic Leukemia</brief_title> <official_title>Long Term Effect on Immune Response After Pneumococcal Vaccination in Patients With Chronic Lymphocytic Leukemia and Evaluation of the Effect of Revaccination</official_title> <sponsors> <lead_sponsor> <agency>Region Örebro County</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Region Örebro County</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> A randomized, multi-centre trial was conducted between 2013-2016, including 128 patients with untreated CLL from eight hematological clinics in Sweden. Vaccination with polysaccharide pneumococcal vaccine (PPSV23) or conjugated pneumococcal vaccine (PCV13) was performed and the results were published 2018. PCV13 showed a superior immune response, measured as OPA (opsonophagocytic assays) and ELISA (enzyme-linked immunosorbent assay), compared to PPSV23. Immune cells analyses after primary immunization will be performed. Between 2019-2021 a prospective follow up study was conducted of the same cohort and also included a control group. The study participants have been revaccinated with pneumococcal vaccines with the aim to evaluate the effect of repeated dose of PCV13. The antibody response (measured as titer with FMIA (fluorescent multiplexed bead-based immunoassay) and antibody function with MOPA (multiplexed opsonophagocytic assay) will be performed. Studies investigating the dynamics of immune cells before and after primary immunization and revaccination will be performed.  The study will give important answers about the optimal vaccination strategy in patients with CLL and can improve the vaccination recommendations in immunocompromised patients. </textblock> </brief_summary> <detailed_description> <textblock> Chronic lymphocytic leukemia (CLL) patients have increased risk of pneumococcal infection due to defect T-cells, complements and neutrophil/monocyte function or hypogammaglobulinaemia. Side effects of different treatment modalities add further risk of infection.  Two pneumococcal vaccines are available, non-conjugated pneumococcal polysaccharide vaccines (PPSVs) and protein-conjugated vaccines (PCVs). 23-valent Pneumovax (PPSV23) has been recommended for healthy adults to protect against invasive pneumococcal disease (IPD) in Sweden and other countries for >30 years. Patients with reduced adaptive immune function respond inadequately to PPSVs. Instead, the 13-valent Prevenar (PCV13) is recommended for a thymus-dependent immunological memory, yielding increased and persistent immune response .  In 2016, Swedish recommendations on pneumococcal vaccination of risk groups were updated, recommending PCV13 plus PPSV23 after >8 weeks, but only after individual assessment. The evidence in CLL patients is limited but the Swedish CLL-Group has adopted the recommendations. The two vaccines are administrated consecutively to broaden the protection of additional serotype. If previously PPSV23 vaccinated, the PCV13 should be given >12 months after PSV23 to avoid decreasing antibodies, i.e hyporesponse, but this is not studied in CLL patients.  Between 2013-2016, the investigators conducted a phase III trial at 8 hematological clinics in Sweden, including 126 untreated CLL patients, randomized to PCV13 (n=63) or PPSV23 (n=63) . The immune response was analyzed in terms of antibody induction and functionality, measured by enzyme-linked immunosorbent assay (ELISA) and opsonophagocytosis assay (OPA), respectively. The proportion of responding patients was larger for PCV13 than for PPSV23 after 4 weeks (40% vs. 22%, p=0.03) and 6 months (33% vs. 17%, p=0.04).  This study aims to investigate the persistent antibody protection in CLL patients 4-6 years after vaccination with PCV13 (n=63) vs PPSV23 (n=63), and the effect of revaccination with PCV13 in both groups. Also, the aim is to study if a repeated dose of PCV13 results in improved response, similar to controls after one dose of PCV13, and compared to PCV13 plus PPSV23 revaccination. Secondly, the study investigates the effect of pneumococcal vaccination on incidence of pneumococcal infection and colonization. A control group (N=32) has been included. Peripheral blood mononuclear cell (PBMC) have been collected and further studies on the dynamics of immune cells and cytokines before and after primary immunization and revaccination with polysaccharide vaccines and conjugated vaccines will be investigated.  A sub study was initiated february 2021 in the same cohort for sampling after vaccination against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) in the same study cohort, enabling comparison of immune response after administrating mRNA (messenger ribonucleic acid) vaccines. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 1, 2019</start_date> <completion_date type="Actual">October 1, 2022</completion_date> <primary_completion_date type="Actual">June 30, 2021</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> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Immune response 3-5 years after primary vaccination with a single dose of 13-valent pneumococcal conjugated vaccine (PCV13, Prevenar13®) or conventional 23-valent capsular polysaccharide vaccine (PPSV23, Pneumovax®)</measure> <time_frame>3-5 years after vaccination</time_frame> <description>The long-term immune response, comparing the two vaccines PCV13 and PPSV23, 3-5 years after vaccination, measured as the proportion of subjects with a positive vaccination response in each of the two groups. A positive vaccination response is defined as a post vaccination OPA titer ≥ (LLOQ) in 8 of the 12 serotypes common for PCV13 and PPSV23 in serum collected</description> </primary_outcome> <primary_outcome> <measure>Change in immune response after revaccination.</measure> <time_frame>Before and 8, 16 and 52 weeks after first revaccination</time_frame> <description>The change in immune response 8,16 and 52 weeks after first revaccination with PCV 13 (followed by a second revaccination, 8 weeks after first revaccination, with either PPSV23 (group A) or PCV13 (group B). Immune response is measured as the proportion of subjects with a positive vaccination response pre- and post- revaccination.</description> </primary_outcome> <secondary_outcome> <measure>Prevalence of pneumococcal colonization</measure> <time_frame>Before and 8, 16 and 52 weeks after first revaccination</time_frame> <description>To study the incidence of pneumococcal colonization by naso-pharyngeal culturing nasopharyngeal swabs at inclusion after 8 weeks, 16 weeks and 12 months.</description> </secondary_outcome> <secondary_outcome> <measure>Effect of pneumococcal revaccination on T- and B-cell subsets</measure> <time_frame>Before, 7 days and 8 weeks after every revaccination. Twelve months after first revaccination</time_frame> <description>Dynamics of T- and B-cell subsets before and after revaccination will be explored using flow cytometry to determine the proportions of different B- and T-cell subsets</description> </secondary_outcome> <secondary_outcome> <measure>Antibody response after vaccination with PPSV23, PCV13 and mRNA vaccine</measure> <time_frame>Before, 4-8 weeks after every vaccination and 12 months after first pneumococcal revaccination and second mRNA vaccination</time_frame> <description>Antibody titers measured with FMIA regarding pneumococcal antibodies and Diasorins SARS-CoV-2 TrimericS IgG test (COV2TG) regarding Covid-19 antibodies, comparing antibody response to polysaccharide vaccine, conjugated vaccine and mRNA vaccine</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of invasive pneumococcal disease (IPD)</measure> <time_frame>From the initial vaccination to maximum five years after the first dose of revaccination</time_frame> <description>To determine the incidence of IPD among the study participants by collecting data from medical records</description> </secondary_outcome> <secondary_outcome> <measure>Effect of pneumococcal revaccination on cytokine levels</measure> <time_frame>Before and 8, 16 and 52 weeks after first revaccination</time_frame> <description>Investigate the dynamics of cytokine levels before and after revaccination determined by multiplex immunoassays</description> </secondary_outcome> <secondary_outcome> <measure>Immune cell response after vaccination with PPSV23, PCV13 and mRNA vaccine</measure> <time_frame>Before, 4-8 weeks afte0r every vaccination and 12 month after first pneumococcal revaccination and second mRNA vaccination</time_frame> <description>Dynamic of T- and B-cell subsets before and after vaccination with polysaccharide vaccine, conjugated vaccine and mRNA vaccine using flow cytometry</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Actual">77</enrollment> <condition>CLL</condition> <condition>Vaccine Response</condition> <arm_group> <arm_group_label>Group A</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group A CLL patients: Previously immunized with PCV13, in this study receiving PCV13 followed by PPSV23</description> </arm_group> <arm_group> <arm_group_label>Group B</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group B CLL patients: Previously immunized with PPSV23, in this study receiving PCV13 followed by PCV13</description> </arm_group> <arm_group> <arm_group_label>Group C</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group C controls: Previously immunized with PCV13, in this study receiving PCV13</description> </arm_group> <arm_group> <arm_group_label>Group D</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group C controls: Previously immunized with PPPSV23, in this study receiving PCV13</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>PCV13</intervention_name> <description>Pneumococcal polysaccharides conjugated to CRM197 carrier protein</description> <arm_group_label>Group A</arm_group_label> <arm_group_label>Group B</arm_group_label> <arm_group_label>Group C</arm_group_label> <arm_group_label>Group D</arm_group_label> <other_name>Prevenar13</other_name> </intervention> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>PPSV23</intervention_name> <description>Pneumococcal polysaccharides</description> <arm_group_label>Group A</arm_group_label> <other_name>Pneumovax23</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  CLL patients earlier included in the Pneumococcal vaccination study 0887x1-20003 (EudraCT No: 2009-012642-22), who have received either PCV13 or PPSV23 are eligible for evaluation  Exclusion Criteria:  1. Patients receiving high dose corticosteroids ( ≥20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment (criteria for inclusion after discontinuing high dose corticosteroid treatment, see section 7.3)  2. Patients who have had an allergic reaction to any vaccination in the past  3. Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP (immune thrombocytopenia) and Guillain-Barre  4. Patients failing to give informed consent  5. Patients with ongoing immunoglobulin therapy  6. Patients with known HIV infection  7. Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months  8. Active febrile infection  9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3) - </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>Bertil Uggla, Md, PhD</last_name> <role>Principal Investigator</role> <affiliation>Universitetssjukhuset Örebro</affiliation> </overall_official> <location> <facility> <name>Magdalena Kättström</name> <address> <city>Örebro</city> <country>Sweden</country> </address> </facility> </location> <location_countries> <country>Sweden</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>September 26, 2021</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 30, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Region Örebro County</investigator_affiliation> <investigator_full_name>Bertil Uggla</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Leukemia, Lymphoid</mesh_term> <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term> </intervention_browse>  </clinical_study>

A randomized, multi-centre trial was conducted between 2013-2016, including 128 patients with untreated CLL from eight hematological clinics in Sweden. Vaccination with polysaccharide pneumococcal vaccine (PPSV23) or conjugated pneumococcal vaccine (PCV13) was performed and the results were published 2018. PCV13 showed a superior immune response, measured as OPA (opsonophagocytic assays) and ELISA (enzyme-linked immunosorbent assay), compared to PPSV23. Immune cells analyses after primary immunization will be performed. Between 2019-2021 a prospective follow up study was conducted of the same cohort and also included a control group. The study participants have been revaccinated with pneumococcal vaccines with the aim to evaluate the effect of repeated dose of PCV13. The antibody response (measured as titer with FMIA (fluorescent multiplexed bead-based immunoassay) and antibody function with MOPA (multiplexed opsonophagocytic assay) will be performed. Studies investigating the dynamics of immune cells before and after primary immunization and revaccination will be performed. The study will give important answers about the optimal vaccination strategy in patients with CLL and can improve the vaccination recommendations in immunocompromised patients. Chronic lymphocytic leukemia (CLL) patients have increased risk of pneumococcal infection due to defect T-cells, complements and neutrophil/monocyte function or hypogammaglobulinaemia. Side effects of different treatment modalities add further risk of infection. Two pneumococcal vaccines are available, non-conjugated pneumococcal polysaccharide vaccines (PPSVs) and protein-conjugated vaccines (PCVs). 23-valent Pneumovax (PPSV23) has been recommended for healthy adults to protect against invasive pneumococcal disease (IPD) in Sweden and other countries for >30 years. Patients with reduced adaptive immune function respond inadequately to PPSVs. Instead, the 13-valent Prevenar (PCV13) is recommended for a thymus-dependent immunological memory, yielding increased and persistent immune response . In 2016, Swedish recommendations on pneumococcal vaccination of risk groups were updated, recommending PCV13 plus PPSV23 after >8 weeks, but only after individual assessment. The evidence in CLL patients is limited but the Swedish CLL-Group has adopted the recommendations. The two vaccines are administrated consecutively to broaden the protection of additional serotype. If previously PPSV23 vaccinated, the PCV13 should be given >12 months after PSV23 to avoid decreasing antibodies, i.e hyporesponse, but this is not studied in CLL patients. Between 2013-2016, the investigators conducted a phase III trial at 8 hematological clinics in Sweden, including 126 untreated CLL patients, randomized to PCV13 (n=63) or PPSV23 (n=63) . The immune response was analyzed in terms of antibody induction and functionality, measured by enzyme-linked immunosorbent assay (ELISA) and opsonophagocytosis assay (OPA), respectively. The proportion of responding patients was larger for PCV13 than for PPSV23 after 4 weeks (40% vs. 22%, p=0.03) and 6 months (33% vs. 17%, p=0.04). This study aims to investigate the persistent antibody protection in CLL patients 4-6 years after vaccination with PCV13 (n=63) vs PPSV23 (n=63), and the effect of revaccination with PCV13 in both groups. Also, the aim is to study if a repeated dose of PCV13 results in improved response, similar to controls after one dose of PCV13, and compared to PCV13 plus PPSV23 revaccination. Secondly, the study investigates the effect of pneumococcal vaccination on incidence of pneumococcal infection and colonization. A control group (N=32) has been included. Peripheral blood mononuclear cell (PBMC) have been collected and further studies on the dynamics of immune cells and cytokines before and after primary immunization and revaccination with polysaccharide vaccines and conjugated vaccines will be investigated. A sub study was initiated february 2021 in the same cohort for sampling after vaccination against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) in the same study cohort, enabling comparison of immune response after administrating mRNA (messenger ribonucleic acid) vaccines. Inclusion Criteria: CLL patients earlier included in the Pneumococcal vaccination study 0887x1-20003 (EudraCT No: 2009-012642-22), who have received either PCV13 or PPSV23 are eligible for evaluation Exclusion Criteria: 1. Patients receiving high dose corticosteroids ( ≥20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment (criteria for inclusion after discontinuing high dose corticosteroid treatment, see section 7.3) 2. Patients who have had an allergic reaction to any vaccination in the past 3. Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP (immune thrombocytopenia) and Guillain-Barre 4. Patients failing to give informed consent 5. Patients with ongoing immunoglobulin therapy 6. Patients with known HIV infection 7. Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months 8. Active febrile infection 9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3) -

NCT0531xxxx/NCT05316844.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/NCT05316844</url> </required_header> <id_info> <org_study_id>2018.282</org_study_id> <nct_id>NCT05316844</nct_id> </id_info> <brief_title>Investigation of Predictors of Typing Performance in Office Employees With Neck Pain</brief_title> <official_title>The Predictors of Typing Performance in Office Employees With Neck Pain; Neck Disability, Muscle Activity, Posture, and Demographics</official_title> <sponsors> <lead_sponsor> <agency>Afyonkarahisar Health Sciences University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Afyonkarahisar Health Sciences 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> Determining the predictors that are effective on work performance and preventive approaches to be developed for these predictors must be individual and adaptable to every environment, time, and equipment. In this context, the purpose of the present study was to show the relations between neck disability, Upper Trapezius (UT) muscle activation, posture, and demographic characteristics with typing task performance in office employees who have neck pain by using their equipment in their workplaces. </textblock> </brief_summary> <detailed_description> <textblock> The present study was conducted to show the relations between neck disability, UT muscle activation, posture, and demographic characteristics with typing task performance in office employees who have neck pain by using their equipment in their workplaces. We hypothesized that UT muscle activation, working posture, and age might be the main predictors of typing performance in office employees with neck pain. For this purpose, full-time office employees who use computers for at least 3 hours a day and have neck pain were invited to the study. Volunteers without any health concern, upper-body injury, and surgery provided informed, written consent to participate in the study.  The participants were given a 10-minute typing task in their working environments, during which right and left UT muscle activation was recorded with Surface Electromyography (sEMG). Work posture was evaluated with Rapid Upper Limb Assessment (RULA) and Forward Head Posture (FHP) was evaluated with Cervical Range of Motion (CROM) Device. Hierarchical Regression Analysis was conducted to examine the predictors of typing performance. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">September 20, 2021</start_date> <completion_date type="Actual">February 11, 2022</completion_date> <primary_completion_date type="Actual">December 22, 2021</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Neck Disability Index (NDI)</measure> <time_frame>10 minutes</time_frame> <description>The NDI is a self-reported scale consists of pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping and leisure time activities sections. The total score varies between 0-50 and the increase in total score indicates the increase in the severity of the neck disability: "0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, and ≥35 complete disability".</description> </primary_outcome> <primary_outcome> <measure>Maximal Voluntary Isometric Contraction (MVIC)</measure> <time_frame>10 minutes</time_frame> <description>It is measured by Surface Electromyography (sEMG) for upper trapezius muscle. 3 maximum contractions were performed for 6 seconds at the manual muscle testing position. The maximum value among 3 repeats was recorded as Maximal Voluntary Isometric Contraction (MVIC) (mV).</description> </primary_outcome> <primary_outcome> <measure>Muscle Activation of Upper Trapezius</measure> <time_frame>30 minutes</time_frame> <description>It is the measurement of the Electromyographic activity of trapezius muscles during typing task. According to The Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles Project (SENIAM) recommendations for sensors and sensor placement procedures, sEMG was applied for the upper trapezius muscles while performing the computer task in workplace. The mean values (mV) obtained were normalized according to MVIC. Normalized data (%MVIC) was used in the statistical analysis.</description> </primary_outcome> <primary_outcome> <measure>Forward Head Posture</measure> <time_frame>10 minutes</time_frame> <description>The CROM Deluxe is an assessment instrument that lets to measure sagittal, frontal and horizontal plane movements (flexion / extension, lateral flexion, rotation and forward head posture), while resting and also performing a task or work posture.</description> </primary_outcome> <primary_outcome> <measure>Rapid Upper Limb Assessment (RULA)</measure> <time_frame>10 minutes</time_frame> <description>The RULA Assessment Tool is used to evaluate the ergonomic risk factors associated with neck, trunk, and upper extremity musculoskeletal disorders (MSD). The RULA considers biomechanical and postural load requirements of job demands. Scores between 1-7 are classified from "acceptable posture" (no action required) to "very high risk" (implement change now).</description> </primary_outcome> <secondary_outcome> <measure>Body Mass Index (BMI)</measure> <time_frame>1 minutes</time_frame> <description>Body mass index (BMI) is a measurement derived from body mass and body height to evaluate body fat. The BMI is defined as the body mass divided by the square of the body height and is expressed in units of kg/m² (kilogram / square meter). According to the BMI value, it is categorized as underweight (<18.5), normal weight (18.5-24.9), overweight (25-29.9), and Obesity (30 or greater).</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">21</enrollment> <condition>Task Performance and Analysis</condition> <arm_group> <arm_group_label>Office Employees Group</arm_group_label> <description>Office Employees with neck pain</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>There will be no interventions.</intervention_name> <description>Measurements and performance tests were conducted to investigate predictors of work-related performance</description> <arm_group_label>Office Employees Group</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Office workers with neck pain, the sample of the study, were selected from among the people living in Istanbul with the invitation to volunteer. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Full-time and regular employees in the last 1 year,  - Office employees use computers at desk for at least 3 hours per day  - According to RULA, working in a posture that is above the acceptable level,  - No trauma history  - Non-specific neck pain but no chronic conditions of the cervical spine and upper extremity  Exclusion Criteria:  - Volunteer office employees with neck pain who did not meet the inclusion criteria and those who could not complete the study because of pain, discomfort, etc. were excluded from the study (Dropouts; n=3 because of pain and discomfort, n=1 because of incomplete evaluations not completed on their own will) </textblock> </criteria> <gender>All</gender> <minimum_age>22 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Arzu Keskin Aktan, PhD</last_name> <role>Principal Investigator</role> <affiliation>Afyonkarahisar Health Sciences University</affiliation> </overall_official> <overall_official> <last_name>Nilufer Keskin Dilbay, MSc</last_name> <role>Principal Investigator</role> <affiliation>Marmara University</affiliation> </overall_official> <overall_official> <last_name>Zafer Erden, PhD, Prof</last_name> <role>Study Director</role> <affiliation>Hacettepe University</affiliation> </overall_official> <location> <facility> <name>Afyonkarahisar Health Sciences University</name> <address> <city>Afyonkarahisar</city> <zip>03030</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Afyonkarahisar Health Sciences University</investigator_affiliation> <investigator_full_name>Arzu Keskin Aktan</investigator_full_name> <investigator_title>PhD, Asst. Prof.</investigator_title> </responsible_party> <keyword>Neck Pain</keyword> <keyword>Office Employees</keyword> <keyword>Task- Specific Performance</keyword> <keyword>Surface Electromyography</keyword> <keyword>Trapezius Muscle</keyword> <keyword>Forward Head Posture</keyword> <keyword>Posture</keyword> <condition_browse>  <mesh_term>Neck Pain</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>There is no plan to make IPD available.</ipd_description> </patient_data>  </clinical_study>

Determining the predictors that are effective on work performance and preventive approaches to be developed for these predictors must be individual and adaptable to every environment, time, and equipment. In this context, the purpose of the present study was to show the relations between neck disability, Upper Trapezius (UT) muscle activation, posture, and demographic characteristics with typing task performance in office employees who have neck pain by using their equipment in their workplaces. The present study was conducted to show the relations between neck disability, UT muscle activation, posture, and demographic characteristics with typing task performance in office employees who have neck pain by using their equipment in their workplaces. We hypothesized that UT muscle activation, working posture, and age might be the main predictors of typing performance in office employees with neck pain. For this purpose, full-time office employees who use computers for at least 3 hours a day and have neck pain were invited to the study. Volunteers without any health concern, upper-body injury, and surgery provided informed, written consent to participate in the study. The participants were given a 10-minute typing task in their working environments, during which right and left UT muscle activation was recorded with Surface Electromyography (sEMG). Work posture was evaluated with Rapid Upper Limb Assessment (RULA) and Forward Head Posture (FHP) was evaluated with Cervical Range of Motion (CROM) Device. Hierarchical Regression Analysis was conducted to examine the predictors of typing performance. Office workers with neck pain, the sample of the study, were selected from among the people living in Istanbul with the invitation to volunteer. Inclusion Criteria: - Full-time and regular employees in the last 1 year, - Office employees use computers at desk for at least 3 hours per day - According to RULA, working in a posture that is above the acceptable level, - No trauma history - Non-specific neck pain but no chronic conditions of the cervical spine and upper extremity Exclusion Criteria: - Volunteer office employees with neck pain who did not meet the inclusion criteria and those who could not complete the study because of pain, discomfort, etc. were excluded from the study (Dropouts; n=3 because of pain and discomfort, n=1 because of incomplete evaluations not completed on their own will)

NCT0531xxxx/NCT05316857.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/NCT05316857</url> </required_header> <id_info> <org_study_id>ICP-CL-00117</org_study_id> <nct_id>NCT05316857</nct_id> </id_info> <brief_title>DDI Study of Orelabrutinib</brief_title> <official_title>A Phase I, Single-center, Open-label, Fixed-sequence Clinical Study to Evaluate the Effects of Multiple Administrations of Rifampin or Itraconazole on the Pharmacokinetic Characteristics of a Single Administration of Orelabrutinib Tablets in Healthy Subjects</official_title> <sponsors> <lead_sponsor> <agency>Beijing InnoCare Pharma Tech Co., Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Beijing InnoCare Pharma Tech 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 is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">December 16, 2021</start_date> <completion_date type="Actual">June 13, 2022</completion_date> <primary_completion_date type="Actual">January 4, 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>Parallel Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Cmax</measure> <time_frame>up to 3 months</time_frame> <description>To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)</description> </primary_outcome> <secondary_outcome> <measure>Tmax</measure> <time_frame>up to 3 months</time_frame> <description>To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include Time to Maximum Plasma Concentration(Tmax)</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of Treatment-Emergent Adverse Events</measure> <time_frame>up to 3 months</time_frame> <description>To evaluate the safety and tolerability of Orelabrutinib</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">36</enrollment> <condition>Healthy Person</condition> <arm_group> <arm_group_label>Orelabrutinib + Rifampin</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Orelabrutinib is a white, round, uncoated table,Subjects take high dose orelabrutinib in the first day and the tenth day. Rifampin is a capsule,Subjects take 600mg QD rifampin in the third day to the eleventh.</description> </arm_group> <arm_group> <arm_group_label>Orelabrutinib + Itraconazole</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Orelabrutinib is a white, round, uncoated table,Subjects take low dose orelabrutinib in the first day and the eighth day. Itraconazole is a capsule,Subjects take 600mg QD rifampin in the third day to the tenth.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Orelabrutinib + Rifampin</intervention_name> <description>Orelabrutinib + Rifampin</description> <arm_group_label>Orelabrutinib + Rifampin</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Orelabrutinib + Itraconazole</intervention_name> <description>Orelabrutinib + Itraconazole</description> <arm_group_label>Orelabrutinib + Itraconazole</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Subject who can fully understand the objectives, nature, methods and possible adverse reactions of the trial, and volunteers to be the subject, and has signed an informed consent form before the start of any study procedure, and guarantees that any procedure will be participated in by himself/herself;  2. Male or female subjects aged between 18 and 45 years old (inclusive) at the time of screening;  3. Body weight ≥50 kg for male subjects, ≥45 kg for female subjects, and a body mass index (BMI) of 19 to 26.0 kg/m2 (inclusive);  4. Be able to communicate well with investigator, and understand and comply with the requirements of this study.  Exclusion Criteria:  1. Complete physical examination, routine laboratory tests, cardiac color ultrasound and other examinations are abnormal with clinical significance;  2. Hepatitis B surface antigen or E antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody are positive;  3. C-reactive protein for novel coronavirus screening is abnormal with clinical significance, or the novel coronavirus nucleic acid testing is positive;  4. Have received any drugs and therapy which are in the study protocol within 1 month before screening  5. Have taken prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicine within 14 days before the first administration of the investigational drug  6. Have any history of clinically serious diseases, or diseases or conditions that the investigator believes may affect the results of the study.  7. Subject who has a childbirth plan during the study period and within 3 months after the end of the study, or the subject and his/her partner do not agree to take strict contraceptive measures during this period;  8. Other subjects judged by the investigator as unsuitable to participate in this study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>The First Affiliated Hospital of Soochow University</name> <address> <city>Suzhou</city> <state>Jiangsu</state> <zip>215000</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>June 2022</verification_date> <study_first_submitted>March 25, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>July 5, 2022</last_update_submitted> <last_update_submitted_qc>July 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <intervention_browse>  <mesh_term>Itraconazole</mesh_term> <mesh_term>Rifampin</mesh_term> </intervention_browse>  </clinical_study>

This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects. Inclusion Criteria: 1. Subject who can fully understand the objectives, nature, methods and possible adverse reactions of the trial, and volunteers to be the subject, and has signed an informed consent form before the start of any study procedure, and guarantees that any procedure will be participated in by himself/herself; 2. Male or female subjects aged between 18 and 45 years old (inclusive) at the time of screening; 3. Body weight ≥50 kg for male subjects, ≥45 kg for female subjects, and a body mass index (BMI) of 19 to 26.0 kg/m2 (inclusive); 4. Be able to communicate well with investigator, and understand and comply with the requirements of this study. Exclusion Criteria: 1. Complete physical examination, routine laboratory tests, cardiac color ultrasound and other examinations are abnormal with clinical significance; 2. Hepatitis B surface antigen or E antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody are positive; 3. C-reactive protein for novel coronavirus screening is abnormal with clinical significance, or the novel coronavirus nucleic acid testing is positive; 4. Have received any drugs and therapy which are in the study protocol within 1 month before screening 5. Have taken prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicine within 14 days before the first administration of the investigational drug 6. Have any history of clinically serious diseases, or diseases or conditions that the investigator believes may affect the results of the study. 7. Subject who has a childbirth plan during the study period and within 3 months after the end of the study, or the subject and his/her partner do not agree to take strict contraceptive measures during this period; 8. Other subjects judged by the investigator as unsuitable to participate in this study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

NCT0531xxxx/NCT05316870.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/NCT05316870</url> </required_header> <id_info> <org_study_id>CFH 2020-4-7025</org_study_id> <nct_id>NCT05316870</nct_id> </id_info> <brief_title>Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation</brief_title> <acronym>AMS-AF</acronym> <official_title>Construction and Evaluation of Standardized Anticoagulant Management Model of Atrial Fibrillation in Primary Medical Institutions Under Hierarchical Diagnosis and Treatment System</official_title> <sponsors> <lead_sponsor> <agency>Beijing Municipal Health Commission</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Exhibition Road Community Health Service Center of Xicheng District, Beijing, China</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Xinjiekou Community Health Service Center of Xicheng District, Beijing, China</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Guanwai Community Health Service Center of Xicheng District, Beijing, China</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Guannei Community Health Service Center of Xicheng District, Beijing, China</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Beijing Municipal Health Commission</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> Study types and hypotheses: multicenter randomized controlled trials. This study predicts that standardized anticoagulation management of atrial fibrillation in primary health care institutions can reduce the prevalence of atrial fibrillation stroke by 50%.  1. Formulation and revision of standardized anticoagulation management plan and process for atrial fibrillation in primary health care institutions.  Using the mature anticoagulation management model of atrial fibrillation for reference, based on the clinical data and disease management needs of patients with atrial fibrillation in five community health service centers in Xicheng District of Beijing. To formulate the anticoagulation management plan and process of atrial fibrillation suitable for grass-roots medical institutions. After the completion of the first draft of anticoagulation management plan and process, two rounds of multi-disciplinary experts were organized to demonstrate the feasibility and scientific nature of the first draft. Finally, based on the practice and effect evaluation of clinical application management, the scheme is revised and improved.  2. To evaluate the feasibility and clinical application effect of standardized anticoagulation management scheme and process for atrial fibrillation.  First of all, the baseline clinical database of patients with multicenter atrial fibrillation was established; secondly, patients with atrial fibrillation who met the entry criteria were randomly included in the trial group or control group and followed up for two years. The anticoagulation treatment rate, the incidence of bleeding and thromboembolic events, anticoagulation compliance rate and knowledge awareness rate of atrial fibrillation in the two groups were compared, and the effect of standardized anticoagulation management of atrial fibrillation in primary medical institutions was evaluated. </textblock> </brief_summary> <detailed_description> <textblock> To organize experts to formulate a standardized anticoagulation management plan and process for atrial fibrillation in grass-roots medical institutions  1. Write the first draft of "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" By searching the anticoagulation management guidelines and expert consensus of atrial fibrillation at home and abroad, do a comparative study, determine the main points of anticoagulation management; analyzing the baseline clinical database of patients with multicenter atrial fibrillation, combined with quantitative and qualitative research, to explore the anticoagulation management needs of patients with atrial fibrillation. Based on the above results, the first draft of standardized anticoagulation management plan and process of atrial fibrillation in grass-roots medical institutions was written.  2. Organize expert group interviews. A multidisciplinary expert group was identified, including cardiology, neurology, general medicine, nursing and pharmacy, with 1 or 2 middle-level and above professionals selected in each discipline. Design the interview outline, according to the interview outline, a senior general practitioner encourages and guides the team members to express their own views on the subject. The main contents include: how scientific is this anticoagulation management scheme? What is the value of clinical application? What are the difficulties in the implementation process? What are the contents that need to be further improved?  3. Revision and improvement of "standardized anticoagulation management scheme and process for atrial fibrillation in primary medical institutions" According to the results of the expert group interview, revise and further improve the "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" to generate the final intervention plan.  To evaluate the clinical effect of standardized anticoagulation management scheme and process for atrial fibrillation.  1. Observation indicators Main outcome measures: the rate of anticoagulant therapy, the rate of reaching the standard of INR, the incidence of bleeding and thromboembolic events at 3 months, 6 months, 9 months, 12 months, 18 months and 24 months.  Secondary indicators: anticoagulant compliance rate and knowledge awareness rate of atrial fibrillation at 6 months, 12 months and 18 months. Blood routine: hemoglobin, platelet; biochemistry: glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, serum creatinine, urea nitrogen, glomerular filtration rate; electrocardiogram / dynamic electrocardiogram, echocardiography.  2. Follow-up plan Patients' symptoms and signs, diet and exercise in the process of anticoagulation management were followed up once a month, and when unmanageable new symptoms or drug side effects appeared, they were referred to secondary or tertiary hospitals for treatment in time; a regular comprehensive physical examination was arranged once a year, including blood routine, biochemical, ECG / dynamic electrocardiogram, echocardiography, etc., and the follow-up period was 2 years. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 4, 2020</start_date> <completion_date type="Anticipated">December 31, 2022</completion_date> <primary_completion_date type="Anticipated">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>Parallel Assignment</intervention_model> <intervention_model_description>Each community health service center randomly included patients with atrial fibrillation who met the admission criteria into the trial group or the control group. The intervention measures are the standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions.</intervention_model_description> <primary_purpose>Health Services Research</primary_purpose> <masking>Single (Participant)</masking> <masking_description>Single Blind</masking_description> </study_design_info> <primary_outcome> <measure>Anticoagulant treatment rate, %</measure> <time_frame>Change from Baseline Anticoagulant treatment rate at 24 months</time_frame> <description>Anticoagulant therapy rate (%) = number of people actually receiving anticoagulant therapy / number of people who should receive anticoagulant therapy x 100%anticoagulant therapy / the total number of people who should receive anticoagulant therapy x 100%.</description> </primary_outcome> <primary_outcome> <measure>Incidence of bleeding and thromboembolic events</measure> <time_frame>Change from Baseline bleeding and thromboembolic events rate at 24 months</time_frame> <description>Incidence of thromboembolic events / anticoagulation related bleeding events (%) = number of thromboembolic events / anticoagulation related bleeding events in a certain period / number of people observed in the same period x 100% (unit: person year)</description> </primary_outcome> <primary_outcome> <measure>INR compliance rate</measure> <time_frame>Change from 12 months INR compliance rate at 24 months</time_frame> <description>INR compliance rate (%) = the number of INR compliance (2.0 / 3.0) / the total number of INR monitored in the same period × 100%</description> </primary_outcome> <secondary_outcome> <measure>Anticoagulant compliance rate</measure> <time_frame>Change from 12 months INR compliance rate at 24 months</time_frame> <description>Using the Chinese revised version of Morisky Drug Compliance scale</description> </secondary_outcome> <secondary_outcome> <measure>Knowledge awareness rate of atrial fibrillation</measure> <time_frame>Change from 12 months INR compliance rate at 24 months</time_frame> <description>Awareness rate = the number of correct questions answered by the respondents / the total number of questions answered by the respondents x 100%.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">380</enrollment> <condition>Atrial Fibrillation</condition> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The standardized anticoagulation management program of atrial fibrillation in primary medical institutions was implemented for the patients with atrial fibrillation in the intervention group.</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>Other</arm_group_type> <description>The current general practitioner management mode was continued for the patients with atrial fibrillation in the control group.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions</intervention_name> <description>Compared with the current anticoagulation management service, we pay more attention to early initiation of anticoagulant therapy and long-term follow-up management.</description> <arm_group_label>Intervention group</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Conventional general practitioner management model</intervention_name> <description>The current general practitioner anticoagulation management model was continued in the control group.</description> <arm_group_label>Control group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age ≥ 18 years old, regardless of sex.  - It is consistent with the diagnostic basis of atrial fibrillation in "Atrial Fibrillation: current Cognition and treatment recommendations-2018".  - Receive oral anticoagulant therapy, such as warfarin or NOACs, as needed.  - There is a contracted family doctor (if not, they can be included in the study after guiding them to sign up for a family doctor).  - Have certain reading comprehension ability, be able to follow up regularly, have good compliance, and select the residents living in the vicinity.  - Volunteer to participate in this clinical study and sign a written informed consent form  Exclusion Criteria:  - Other diseases requiring anticoagulant therapy, such as pulmonary embolism, were included in the group.  - Suffer from severe mental illness or serious diseases that affect their survival, such as AIDS. </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>Xia J Wang, Master</last_name> <role>Study Chair</role> <affiliation>FuXing Hospital, Capital Medical University</affiliation> </overall_official> <overall_contact> <last_name>lan Ding, Bachelor</last_name> <phone>0086-13621031422</phone> <phone_ext>0086-68056002</phone_ext> <email>ytzxkyb@126.com</email> </overall_contact> <location> <facility> <name>Yuetan Community Health Service Center Fu Xing Hospital, Capital Medical University</name> <address> <city>Beijing</city> <state>Beijing</state> <zip>0086</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>xia J Wang, Master</last_name> <phone>0086-18800159266</phone> <phone_ext>0086-68017528</phone_ext> <email>1457200352@qq.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>January 25, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Atrial fibrillation</keyword> <keyword>Anticoagulation management plan and process</keyword> <keyword>Primary medical institutions</keyword> <condition_browse>  <mesh_term>Atrial Fibrillation</mesh_term> </condition_browse>  </clinical_study>

Study types and hypotheses: multicenter randomized controlled trials. This study predicts that standardized anticoagulation management of atrial fibrillation in primary health care institutions can reduce the prevalence of atrial fibrillation stroke by 50%. 1. Formulation and revision of standardized anticoagulation management plan and process for atrial fibrillation in primary health care institutions. Using the mature anticoagulation management model of atrial fibrillation for reference, based on the clinical data and disease management needs of patients with atrial fibrillation in five community health service centers in Xicheng District of Beijing. To formulate the anticoagulation management plan and process of atrial fibrillation suitable for grass-roots medical institutions. After the completion of the first draft of anticoagulation management plan and process, two rounds of multi-disciplinary experts were organized to demonstrate the feasibility and scientific nature of the first draft. Finally, based on the practice and effect evaluation of clinical application management, the scheme is revised and improved. 2. To evaluate the feasibility and clinical application effect of standardized anticoagulation management scheme and process for atrial fibrillation. First of all, the baseline clinical database of patients with multicenter atrial fibrillation was established; secondly, patients with atrial fibrillation who met the entry criteria were randomly included in the trial group or control group and followed up for two years. The anticoagulation treatment rate, the incidence of bleeding and thromboembolic events, anticoagulation compliance rate and knowledge awareness rate of atrial fibrillation in the two groups were compared, and the effect of standardized anticoagulation management of atrial fibrillation in primary medical institutions was evaluated. To organize experts to formulate a standardized anticoagulation management plan and process for atrial fibrillation in grass-roots medical institutions 1. Write the first draft of "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" By searching the anticoagulation management guidelines and expert consensus of atrial fibrillation at home and abroad, do a comparative study, determine the main points of anticoagulation management; analyzing the baseline clinical database of patients with multicenter atrial fibrillation, combined with quantitative and qualitative research, to explore the anticoagulation management needs of patients with atrial fibrillation. Based on the above results, the first draft of standardized anticoagulation management plan and process of atrial fibrillation in grass-roots medical institutions was written. 2. Organize expert group interviews. A multidisciplinary expert group was identified, including cardiology, neurology, general medicine, nursing and pharmacy, with 1 or 2 middle-level and above professionals selected in each discipline. Design the interview outline, according to the interview outline, a senior general practitioner encourages and guides the team members to express their own views on the subject. The main contents include: how scientific is this anticoagulation management scheme? What is the value of clinical application? What are the difficulties in the implementation process? What are the contents that need to be further improved? 3. Revision and improvement of "standardized anticoagulation management scheme and process for atrial fibrillation in primary medical institutions" According to the results of the expert group interview, revise and further improve the "standardized anticoagulation management plan and process of atrial fibrillation in primary medical institutions" to generate the final intervention plan. To evaluate the clinical effect of standardized anticoagulation management scheme and process for atrial fibrillation. 1. Observation indicators Main outcome measures: the rate of anticoagulant therapy, the rate of reaching the standard of INR, the incidence of bleeding and thromboembolic events at 3 months, 6 months, 9 months, 12 months, 18 months and 24 months. Secondary indicators: anticoagulant compliance rate and knowledge awareness rate of atrial fibrillation at 6 months, 12 months and 18 months. Blood routine: hemoglobin, platelet; biochemistry: glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, serum creatinine, urea nitrogen, glomerular filtration rate; electrocardiogram / dynamic electrocardiogram, echocardiography. 2. Follow-up plan Patients' symptoms and signs, diet and exercise in the process of anticoagulation management were followed up once a month, and when unmanageable new symptoms or drug side effects appeared, they were referred to secondary or tertiary hospitals for treatment in time; a regular comprehensive physical examination was arranged once a year, including blood routine, biochemical, ECG / dynamic electrocardiogram, echocardiography, etc., and the follow-up period was 2 years. Inclusion Criteria: - Age ≥ 18 years old, regardless of sex. - It is consistent with the diagnostic basis of atrial fibrillation in "Atrial Fibrillation: current Cognition and treatment recommendations-2018". - Receive oral anticoagulant therapy, such as warfarin or NOACs, as needed. - There is a contracted family doctor (if not, they can be included in the study after guiding them to sign up for a family doctor). - Have certain reading comprehension ability, be able to follow up regularly, have good compliance, and select the residents living in the vicinity. - Volunteer to participate in this clinical study and sign a written informed consent form Exclusion Criteria: - Other diseases requiring anticoagulant therapy, such as pulmonary embolism, were included in the group. - Suffer from severe mental illness or serious diseases that affect their survival, such as AIDS.

NCT0531xxxx/NCT05316883.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/NCT05316883</url> </required_header> <id_info> <org_study_id>BiCS2019</org_study_id> <nct_id>NCT05316883</nct_id> </id_info> <brief_title>Biomarkers in Clozapine-responding Schizophrenia</brief_title> <acronym>BiCS</acronym> <official_title>Biomarkers in Clozapine-responding Schizophrenia</official_title> <sponsors> <lead_sponsor> <agency>Mental Health Services in the Capital Region, Denmark</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Mental Health Services in the Capital Region, Denmark</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 outline of the current project is to establish a cohort of patients with treatment refractory schizophrenia eligible for clozapine, to identify clinical and biological characteristics of clozapine responding patients. Patients will be offered treatment with clozapine according to national clinical guidelines. Before clozapine is initiated, patients will be offered a thoroughly neurobiological examination, and re-examination will be carried out after 12 weeks of treatment. The primary focus of the examinations will be immunological markers and autoantibodies in the blood and cerebrospinal fluid, permeability of the blood-brain barrier and magnetic resonance imaging of structural, neurochemical and functional brain changes. </textblock> </brief_summary> <detailed_description> <textblock> Patients will be examined before and after 12 weeks of treatment with clozapine  Examinations at baseline and follow up will be:  - Clinical ratings  - Blood inflammatory markers  - Inflammatory markers in cerebro spinal fluid  - MRI : examination of grey & white matter, glutamate and GABA in Anterior Cingulate cortex and glutamate in thalamus,  - selected cognitive measures </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 28, 2021</start_date> <completion_date type="Anticipated">December 31, 2024</completion_date> <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date> <phase>Phase 4</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>To compare biomarkers between clozapine responders and non-responder before and after 12 weeks of treatment</intervention_model_description> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Qalb</measure> <time_frame>Baseline</time_frame> <description>Quotient albumin (Qabl) in cerebrospinal fluid (CSF) compared to plasma</description> </primary_outcome> <primary_outcome> <measure>Change in Qalb</measure> <time_frame>Baseline and after 12 weeks</time_frame> <description>Change in quotient albumin in cerebrospinal fluid compared to plasma</description> </primary_outcome> <primary_outcome> <measure>Change in IL-6 and TGF-beta</measure> <time_frame>Baseline and after 12 weeks</time_frame> <description>Change in interleukin 6 (IL-6) and transcription growth factor beta (TGF-beta)</description> </primary_outcome> <secondary_outcome> <measure>Change in FA, MD, AD and RD</measure> <time_frame>Baseline and after 12 weeks</time_frame> <description>Change in fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD) and radial diffusivity (RD)</description> </secondary_outcome> <secondary_outcome> <measure>Change in cortical thickness as measured with FreeSurfer</measure> <time_frame>Baseline and after 12 weeks</time_frame> <description>Change in cortical thickness as measured with FreeSurfer</description> </secondary_outcome> <secondary_outcome> <measure>Change in glutamate in ACC and thalamus measured with MTI</measure> <time_frame>Baseline and after 12 weeks</time_frame> <description>Change in glutamate in anterior cingulate cortex (ACC) and thalamus measured with magnetic transfer imaging (MTI)</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">200</enrollment> <condition>Schizophrenia</condition> <condition>Psychosis</condition> <arm_group> <arm_group_label>clozapine treatment</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Open label clozapine will be given to all participants in clinical doses adjusted to sideeffects and clinical effect</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Clozapine</intervention_name> <description>clinical doses adjusted to sideeffects and clinical effect</description> <arm_group_label>clozapine treatment</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - According to ICD-10 fulfill diagnostic criteria for schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/F29);  - Age 18-65 years;  - Legally competent;  - Stabil antipsychotic treatment during last month  - Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg chlorpromazine equivalent) for a sufficient time (≥ 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms).  - Recreational use of substances is allowed as long as it does not interfere with compliance  - Fertile females must use safe contraception (spiral or any hormonal contraception).  Exclusion Criteria:  - Involuntarily psychiatric admittance during the study  - Substance abuse that interfere with compliance  - Pregnancy (will be verified by urine-HCG-test in fertile females)  - Toxic or idiosyncratic agranulocytosis in the past  - Reduced bone marrow function according to blood samples  - According to information from patient and available files, noUncontrolled  - Current uncontrolled epilepsy  - Current circulatory collapse and / or CNS depression for any cause  - Current severe kidney, heart or liver disease  - Current paralytic ileus </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>64 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Jimmi Nielsen, PhD</last_name> <role>Principal Investigator</role> <affiliation>Mental health Service, Glostrup</affiliation> </overall_official> <overall_contact> <last_name>Jimmi Nielsen, PhD</last_name> <phone>4538640885</phone> <email>jimmi.nielsen@regionh.dk</email> </overall_contact> <overall_contact_backup> <last_name>Mette Nielsen, PhD</last_name> <email>mette.oedegaard.nielsen@regionh.dk</email> </overall_contact_backup> <location> <facility> <name>Mental Health Services Glostrup, Unit for Complicated Schizophrenia</name> <address> <city>Glostrup</city> <zip>2600</zip> <country>Denmark</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Mette Ødegaard Nielsen, MD, PhD</last_name> <phone>38640884</phone> <email>mette.oedegaard.nielsen@regionh.dk</email> </contact> <contact_backup> <last_name>Bahast Biuk, MD</last_name> <phone>38640884</phone> <email>bahast.biuk.01@regionh.dk</email> </contact_backup> </location> <location_countries> <country>Denmark</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>September 30, 2020</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Schizophrenia</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Clozapine</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The outline of the current project is to establish a cohort of patients with treatment refractory schizophrenia eligible for clozapine, to identify clinical and biological characteristics of clozapine responding patients. Patients will be offered treatment with clozapine according to national clinical guidelines. Before clozapine is initiated, patients will be offered a thoroughly neurobiological examination, and re-examination will be carried out after 12 weeks of treatment. The primary focus of the examinations will be immunological markers and autoantibodies in the blood and cerebrospinal fluid, permeability of the blood-brain barrier and magnetic resonance imaging of structural, neurochemical and functional brain changes. Patients will be examined before and after 12 weeks of treatment with clozapine Examinations at baseline and follow up will be: - Clinical ratings - Blood inflammatory markers - Inflammatory markers in cerebro spinal fluid - MRI : examination of grey & white matter, glutamate and GABA in Anterior Cingulate cortex and glutamate in thalamus, - selected cognitive measures Inclusion Criteria: - According to ICD-10 fulfill diagnostic criteria for schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/F29); - Age 18-65 years; - Legally competent; - Stabil antipsychotic treatment during last month - Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg chlorpromazine equivalent) for a sufficient time (≥ 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms). - Recreational use of substances is allowed as long as it does not interfere with compliance - Fertile females must use safe contraception (spiral or any hormonal contraception). Exclusion Criteria: - Involuntarily psychiatric admittance during the study - Substance abuse that interfere with compliance - Pregnancy (will be verified by urine-HCG-test in fertile females) - Toxic or idiosyncratic agranulocytosis in the past - Reduced bone marrow function according to blood samples - According to information from patient and available files, noUncontrolled - Current uncontrolled epilepsy - Current circulatory collapse and / or CNS depression for any cause - Current severe kidney, heart or liver disease - Current paralytic ileus

NCT0531xxxx/NCT05316896.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/NCT05316896</url> </required_header> <id_info> <org_study_id>MedipolUni</org_study_id> <nct_id>NCT05316896</nct_id> </id_info> <brief_title>Investigation of the Efficacy of Internal and External Perturbation Exercises on Functional Parameters in Stroke Rehabilitation</brief_title> <official_title>Investigation of the Efficacy of Internal and External Perturbation Exercises on Functional Parameters in Stroke Rehabilitation</official_title> <sponsors> <lead_sponsor> <agency>Medipol University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Medipol 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> Stroke is a serious medical condition that causes the death of brain cells as a result of blockage of a blood vessel that feeds the brain (ischemic stroke) or bleeding in or around the brain (hemorrhagic stroke). People who have had a stroke have a higher risk of falling than people who have not had a stroke at the same age. Lack of balance control not only increases the risk of falling, but also leads to fear of falling and reduces the integration of people with stroke into society.  The central nervous system uses two main postural strategies to maintain and restore balance when perturbed. These; are anticipatory and compensatory postural adjustments. Anticipatory postural adjustments control the position of the body's center of mass by activating the trunk and leg muscles prior to a forthcoming body perturbation, thus minimizing the risk of loosing equilibrium. Compensatory postural adjustment are initiated by sensory feedback signals and serve as a mechanism of restoration of the position of the center of mass after a perturbation has already occurred.  In this study, the investigators aimed to determine which one is more effective, unlike previous studies that showed that internal and external perturbation exercises were effective when applied together. For this purpose, the researchers the planned to investigate and compare the effects on balance, performance, activity and participation in individuals to whom only internal perturbations were applied and only external perturbations were applied.  The participants will be divided into 2 groups, as Group A and Group B, with 10 participants in each group, in a randomized controlled manner.  Treatment Protocol:  Conventional treatment was applied to participants included in both groups for 4 weeks, 5 days a week, 40-minute sessions. In addition to conventional treatment, 30 minutes of perturbation-based balance training was given to the participant in the study. Participants in Group A received internal perturbation training, and participants in Group B received external perturbation training. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 20, 2022</start_date> <completion_date type="Anticipated">November 20, 2022</completion_date> <primary_completion_date type="Anticipated">August 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>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Change from baseline in dynamic and static balance on the Berg Balance Scale at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>Berg balance scale is a valid and reliable test that measures both dynamic and static balance. It evaluates the body's ability to maintain position during 14 different activities in which the support surface decreases and the center of gravity changes, by observation. It is scored between 0-4 points, while at 0 the activity cannot be completed, at 4 it is completed independently. The total score is 56. If the score obtained at the end of the test is between 0-20, it is interpreted as poor balance skills, between 21-40 as acceptable balance and between 41-56 as advanced balance skills.</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in balance on the Timed Up and Go Test at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>For the timed up and go test, the patient gets up from the chair without arm support, walks 3 meters, returns and sits back in the chair. The total time it takes to complete the test is recorded in seconds using a stopwatch. The evaluation results are valid as they include maneuvers used in daily life. Individuals with independent balance and mobility skills complete the test in less than 10 seconds, individuals who complete it in more than 30 seconds are dependent on many activities and mobility skills in daily life.</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in balance 10-meter Walking Test at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>In this test, the person is asked to walk at his own normal pace in a pre-measured 10-meter area. The time starts when the person's foot is on the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters/second.</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in balance on the One Leg Standing Test at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>One foot is lifted so that it does not touch the other leg and the time is measured with a stopwatch. At first the eyes are open. When the eye open test is completed, the test is done with the eyes closed and it is expected that he can maintain his balance for 30 seconds. An imbalance is considered if the lifted leg touches the other leg, the foot touches the floor, bounces or bounces, or anything in the environment is touched for support.</description> </primary_outcome> <secondary_outcome> <measure>Change from baseline in daily life activities on the Nottingham Health Profile at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>It is a measurement tool that evaluates the health problems of individuals and how these problems affect their daily activities. Scale; It consists of 6 parameters and 38 items in total. Parameters; energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). The answers are yes-no. The score weight of each question is different. Each field is scored between 0-100. The higher the score, the worse the health condition.</description> </secondary_outcome> <secondary_outcome> <measure>Change from baseline in ambulation ability on the Functional Ambulation Classification (FAS) at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>It is a scale that evaluates the ambulation ability of patients. It is divided into six categories, graded from 0 to 5: FAS 0: no ambulation, FAS 1-2: a person cannot walk without support, FAS 3-5: able to walk 6 meters on their own.</description> </secondary_outcome> <secondary_outcome> <measure>Motor development in stroke patients on the Brunnstrom Hemiplegia Recovery Staging at baseline</measure> <time_frame>baseline</time_frame> <description>It is a short and easily applicable staging system for evaluating motor development in stroke patients. Motor development is defined as 6 stages. The lowest, flaccid period without voluntary movements is considered stage 1, and the presence of isolated movements is considered stage 6. Upper, lower extremity and hand are evaluated separately</description> </secondary_outcome> <secondary_outcome> <measure>Assessment method for spasticity on the Modified Ashworth Scale at baseline</measure> <time_frame>baseline</time_frame> <description>It is the most commonly used assessment method for spasticity in the international platform. The patient is examined in a supine and relaxed position. The joint is moved passively, repetitively and rapidly, and the resistance is staged between 0-4 according to the examination findings.0; no increase in tone 1; there is a slight increase in muscle tone, minimal resistance is felt at the end of the movement when the affected part is flexed or extended 1+; resistance during movement is felt in less than half of joint movement 2; resistance is felt during most joint movement, but the affected part is easily moved 3; passive movement throughout the range of motion is difficult 4; the affected part is rigid in flexion or extension.</description> </secondary_outcome> <secondary_outcome> <measure>Change from baseline in level of disability on the Barthel Index at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>It is used to measure the level of disability experienced by the patient during activities of daily living. It consists of a total of 10 main items. Nutrition, wheelchair-bed transfer, self-care, sitting on the toilet, washing, walking on a smooth surface, going up and down stairs, dressing, undressing, bowel and bladder care are questioned. The total score is evaluated between 0 and 100. 0-20 points: fully dependent, 21-61 points: severely dependent, 62-90 points: moderately dependent, 91-99: mildly dependent, 100 points: fully independent.</description> </secondary_outcome> <secondary_outcome> <measure>Change from baseline in quality of life on the Stroke Impact Scale at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>It is a stroke-specific health-related quality of life scale. There are 59 items in 8 areas. 4 items on strength, 5 items on hand function, 9 items on mobility, 10 items on activities of daily living, 7 items on memory, 9 items on mood, 7 items on communication, and 8 items on social participation. contains substance. The score for each section ranges from 0-100. A high score means a high quality of life. In addition to 8 subsections, it includes the evaluation of the perception of recovery after stroke with a 0-100 point visual analog scale (0: no recovery, 100: complete recovery).</description> </secondary_outcome> <secondary_outcome> <measure>Change from baseline in balance on the 4-Step Climbing Test at 4 weeks</measure> <time_frame>baseline and 4 weeks</time_frame> <description>Participants are instructed to go up and down a 4-step ladder as quickly as possible. The time to go up and down 4 digits is recorded.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Stroke</condition> <arm_group> <arm_group_label>Internal perturbation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The people included in this group did 6 internal perturbation exercises with 10 repetitions in each session. The patients performed a total of 60 perturbation exercises in one session. Perturbations were chosen according to the patient's tolerance, from easy to difficult. Treatment protocols of stroke individuals were determined according to their functional levels. 6 of the exercises given below were chosen according to the levels determined at the beginning of the study and were progressed by getting more difficult.</description> </arm_group> <arm_group> <arm_group_label>Eksternal perturbation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The individuals included in this group performed 6 external perturbation exercises with 10 repetitions in each session. The patients performed a total of 60 perturbation exercises in one session. Perturbations were chosen according to the patient's tolerance, from easy to difficult. Treatment protocols of stroke individuals were determined according to their functional levels. 6 of the exercises given below were chosen according to the levels determined at the beginning of the study and were progressed by getting more difficult.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Internal Perturbation</intervention_name> <description>Raising and lowering arms 90 degrees forward and sideways with eyes open and closed. In tandem stance with eyes open and closed, arms are raised and lowered 90 degrees forward and to the side. While standing on one leg with eyes open and closed, arms are raised and lowered 90 degrees forward and to the side. Step forward and backward with right and left foot alternately Take a step back and step back alternately with right and left foot Put the right foot on the step and take it back, then do the same with the left foot and ask the patient to do it quickly. First step on the step with the right foot and put the left foot next to it, then step down with the right foot and take the left foot with it, repeat the same with the left foot and ask the patient to do this. rapidly. Normal gait, sideways gait, tandem gait, backward gait, raising and lowering the arms forward and sideways 90 degrees, respectively, during back-to-back tandem gait.</description> <arm_group_label>Internal perturbation</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Eksternal Perturbation</intervention_name> <description>Front, side, and rear loading and release, pushing and pulling while standing with eyes open and closed Front, side and rear loading and release, pushing and pulling while standing in tandem with eyes open and closed Loading and releasing from the front, sides and back, pushing and pulling while turning the head left and right while standing Front, side and rear loading and release, pushing and pulling while standing up and down with eyes open and closed Front, side, and rear loading and release, pushing and pulling while standing on one leg with eyes open and closed Holding the ball thrown by physiotherapist Kicking a ball thrown by physiotherapist Holding the ball thrown by the physiotherapist while standing in tandem, walking, walking sideways, walking in tandem, walking backwards.</description> <arm_group_label>Eksternal perturbation</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Unilateral stroke history  - Adults with chronic stroke (>6 months poststroke)  - Ability to stand for at least 30 seconds without support  Exclusion Criteria:  - Those with Parkinson's disease, amputation, severe osteoporosis  - Those with uncontrolled diabetes, hypertension  - In addition to stroke, the presence of any problem that may adversely affect balance  - Areas below 24 in the mini mental state test </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Nagihan BODUR</last_name> <phone>+905365034097</phone> <email>nagihanbdr@gmail.com</email> </overall_contact> <location> <facility> <name>Medipol University Sefakoy Hospital</name> <address> <city>Istanbul</city> <zip>34515</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Nagihan Bodur</last_name> <phone>+905365034097</phone> <email>nagihanbdr@gmail.com</email> </contact> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>July 2022</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 7, 2022</study_first_posted> <last_update_submitted>July 14, 2022</last_update_submitted> <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 15, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Medipol University</investigator_affiliation> <investigator_full_name>Nagihan Bodur</investigator_full_name> <investigator_title>Physiotherapist</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Stroke</mesh_term> </condition_browse>  </clinical_study>

Stroke is a serious medical condition that causes the death of brain cells as a result of blockage of a blood vessel that feeds the brain (ischemic stroke) or bleeding in or around the brain (hemorrhagic stroke). People who have had a stroke have a higher risk of falling than people who have not had a stroke at the same age. Lack of balance control not only increases the risk of falling, but also leads to fear of falling and reduces the integration of people with stroke into society. The central nervous system uses two main postural strategies to maintain and restore balance when perturbed. These; are anticipatory and compensatory postural adjustments. Anticipatory postural adjustments control the position of the body's center of mass by activating the trunk and leg muscles prior to a forthcoming body perturbation, thus minimizing the risk of loosing equilibrium. Compensatory postural adjustment are initiated by sensory feedback signals and serve as a mechanism of restoration of the position of the center of mass after a perturbation has already occurred. In this study, the investigators aimed to determine which one is more effective, unlike previous studies that showed that internal and external perturbation exercises were effective when applied together. For this purpose, the researchers the planned to investigate and compare the effects on balance, performance, activity and participation in individuals to whom only internal perturbations were applied and only external perturbations were applied. The participants will be divided into 2 groups, as Group A and Group B, with 10 participants in each group, in a randomized controlled manner. Treatment Protocol: Conventional treatment was applied to participants included in both groups for 4 weeks, 5 days a week, 40-minute sessions. In addition to conventional treatment, 30 minutes of perturbation-based balance training was given to the participant in the study. Participants in Group A received internal perturbation training, and participants in Group B received external perturbation training. Inclusion Criteria: - Unilateral stroke history - Adults with chronic stroke (>6 months poststroke) - Ability to stand for at least 30 seconds without support Exclusion Criteria: - Those with Parkinson's disease, amputation, severe osteoporosis - Those with uncontrolled diabetes, hypertension - In addition to stroke, the presence of any problem that may adversely affect balance - Areas below 24 in the mini mental state test

NCT0531xxxx/NCT05316909.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/NCT05316909</url> </required_header> <id_info> <org_study_id>21-003</org_study_id> <nct_id>NCT05316909</nct_id> </id_info> <brief_title>Effect of a Newborn Simulator's Fidelity on Nursing Students' Level of Engagement in a Clinical Lactation Encounter</brief_title> <official_title>Effect of a Newborn Simulator's Fidelity on Nursing Students' Level of Engagement in a Clinical Lactation Encounter</official_title> <sponsors> <lead_sponsor> <agency>LiquidGoldConcept</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>LiquidGoldConcept</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> Nursing students (N=32) will be randomized to begin period 1 in either a high-fidelity or low-fidelity simulated experience with a mock patient wearing a breast model and holding a newborn simulator and then cross over in period 2 to the opposite arm. Data on student satisfaction, engagement, self-efficacy, and performance and simulator fidelity will be collected via Qualtrics surveys (defined, 6-point Likert scale), written and oral reflection, audio-video recordings of clinical lactation encounter, and clinical lactation skills checklists and global performance ratings.  Nursing students in the accelerated master's program will be recruited while completing their required simulation coursework. A random number generator will be used to randomly assign students to a treatment arm. Investigators will require at least 8 students per arm (power 80%, alpha 5%). Investigators will recruit 32 students for two study dates to compare the high-fidelity LiquidGoldConcept products to two competitor products.  The Johns Hopkins School of Nursing and Simulation Center will be the only sites where human subjects research will be performed. The collaborating investigators (Drs. Debbie Busch, Joanne Silbert-Flagg, and Nancy Sullivan) have expertise in clinical lactation education and simulation. With the collaborating investigators LiquidGoldConcept has already completed pilot studies to establish the feasibility of our approach and validate the survey instruments. </textblock> </brief_summary> <detailed_description> <textblock> This is a randomized cluster design intervention. Assuming an enrollment ratio of 1, alpha of 0.05, beta of 0.2, investigators will recruit at least 8 students per arm with 16 students in the NORALSim arm and 16 students low-fidelity newborn simulator arm. A random number generator will be used to assign students to a study ID number (1-32). Students will be randomly assigned to a group of four a priori by assigning each student a number between 1 and 4. Three mock patients will be randomized a priori to minimize the confounding effect of a mock patient's acting abilities. Approximate start times are as follows: Groups 1 and 2 will begin at 8:30AM, Groups 3 and 4 will begin at 10AM, Groups 5 and 6 will begin at 1pm, and groups 7 and 8 will begin at 2:30pm. Investigators will alternate the order of the low-fidelity simulators (Lactessa or NeoNatalie) and randomize that order a priori such that 8 students (2 groups) will interact with the Lactessa and another 8 students (2 groups) will interact with Neonatalie.  In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2. All study activities will be audio-video recorded. JHU investigators will view the recorded encounters and assign a performance score using a skills checklist and global performance rating scale. Within a month, students will view their clinical encounters recording and complete a self-reflection to describe moments of engagement or disengagement. Students will also report any breastfeeding experience obtained since the intervention, score their performance, and complete the self-efficacy survey. </textblock> </detailed_description> <overall_status>Withdrawn</overall_status> <why_stopped> Alternate study completed </why_stopped> <start_date type="Anticipated">January 1, 2021</start_date> <completion_date type="Anticipated">January 1, 2021</completion_date> <primary_completion_date type="Anticipated">January 1, 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>Crossover Assignment</intervention_model> <intervention_model_description>Educational intervention with newborn simulators of varying fidelity</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> <masking_description>Participants are unaware of their intervention assignment (order of dolls).</masking_description> </study_design_info> <primary_outcome> <measure>Level of Engagement</measure> <time_frame>Immediately after intervention</time_frame> <description>The primary outcome is the level of engagement. A level of engagement score will be calculated from one qualitative and three quantitative criteria: 1) student self-reported perception of engagement during debriefing and self-reflection (qualitative), 2) time to task completion in both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), 3) engagement survey score after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), and 4) global performance ratings by JHU faculty and students (quantitative, 4-item, 8-points possible).</description> </primary_outcome> <primary_outcome> <measure>Level of Engagement</measure> <time_frame>One Month</time_frame> <description>The primary outcome is the level of engagement. A level of engagement score will be calculated from one qualitative and three quantitative criteria: 1) student self-reported perception of engagement during debriefing and self-reflection (qualitative), 2) time to task completion in both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), 3) engagement survey score after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey), and 4) global performance ratings by JHU faculty and students (quantitative, 4-item, 8-points possible).</description> </primary_outcome> <secondary_outcome> <measure>Satisfaction with the simulation experience</measure> <time_frame>Immediately after intervention</time_frame> <description>Students' satisfaction after both periods (quantitative, defined 6-point Likert scale in Qualtrics survey)</description> </secondary_outcome> <secondary_outcome> <measure>Self-Efficacy in clinical lactation/breastfeeding skills</measure> <time_frame>Immediately after intervention</time_frame> <description>Student self-efficacy in clinical lactation skills (quantitative, defined 6-point Likert scale in Qualtrics survey).</description> </secondary_outcome> <secondary_outcome> <measure>Student performance of breastfeeding skills</measure> <time_frame>Immediately after intervention</time_frame> <description>Student performance (in both periods) using clinical lactation skills checklist and global performance rating</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">0</enrollment> <condition>Breastfeeding</condition> <condition>Education, Nursing</condition> <arm_group> <arm_group_label>Baby doll with remote controlled jaw</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In this arm, standardized patients will use the Newborn Oral Assessment and Latch Simulator (NORALSim) to demonstrate and teach newborn positioning and attachment in the simulation.</description> </arm_group> <arm_group> <arm_group_label>Standard care/doll</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>In this arm, standardized patients will use a cloth doll/standard treatment to demonstrate and teach newborn positioning and attachment in the breastfeeding skills workshop.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Breastfeeding Simulation</intervention_name> <description>In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2.</description> <arm_group_label>Baby doll with remote controlled jaw</arm_group_label> <arm_group_label>Standard care/doll</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Student enrolled at Johns Hopkins University School of Nursing  Exclusion Criteria:  - Younger than 18  - Not able to complete study activities </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>LiquidGoldConcept</name> <address> <city>Ypsilanti</city> <state>Michigan</state> <zip>48197</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Researchers do not plan to share IPD with other researchers.</ipd_description> </patient_data>  </clinical_study>

Nursing students (N=32) will be randomized to begin period 1 in either a high-fidelity or low-fidelity simulated experience with a mock patient wearing a breast model and holding a newborn simulator and then cross over in period 2 to the opposite arm. Data on student satisfaction, engagement, self-efficacy, and performance and simulator fidelity will be collected via Qualtrics surveys (defined, 6-point Likert scale), written and oral reflection, audio-video recordings of clinical lactation encounter, and clinical lactation skills checklists and global performance ratings. Nursing students in the accelerated master's program will be recruited while completing their required simulation coursework. A random number generator will be used to randomly assign students to a treatment arm. Investigators will require at least 8 students per arm (power 80%, alpha 5%). Investigators will recruit 32 students for two study dates to compare the high-fidelity LiquidGoldConcept products to two competitor products. The Johns Hopkins School of Nursing and Simulation Center will be the only sites where human subjects research will be performed. The collaborating investigators (Drs. Debbie Busch, Joanne Silbert-Flagg, and Nancy Sullivan) have expertise in clinical lactation education and simulation. With the collaborating investigators LiquidGoldConcept has already completed pilot studies to establish the feasibility of our approach and validate the survey instruments. This is a randomized cluster design intervention. Assuming an enrollment ratio of 1, alpha of 0.05, beta of 0.2, investigators will recruit at least 8 students per arm with 16 students in the NORALSim arm and 16 students low-fidelity newborn simulator arm. A random number generator will be used to assign students to a study ID number (1-32). Students will be randomly assigned to a group of four a priori by assigning each student a number between 1 and 4. Three mock patients will be randomized a priori to minimize the confounding effect of a mock patient's acting abilities. Approximate start times are as follows: Groups 1 and 2 will begin at 8:30AM, Groups 3 and 4 will begin at 10AM, Groups 5 and 6 will begin at 1pm, and groups 7 and 8 will begin at 2:30pm. Investigators will alternate the order of the low-fidelity simulators (Lactessa or NeoNatalie) and randomize that order a priori such that 8 students (2 groups) will interact with the Lactessa and another 8 students (2 groups) will interact with Neonatalie. In Period 1, one group will begin a simulated session with the NORALSim and the second group will begin with either the Mother's Own Milk Lactessa or Laerdal NeoNatalie, depending on the study date. Baseline level of breastfeeding experience and clinical lactation skills self-efficacy will be collected. Nursing students will teach a mock patient wearing the LSM and holding a newborn simulator how to position and attach the newborn at the breast and identify effective breastfeeding by differentiating between suckling patterns. In Period 2, each group will crossover to complete the same session with a different newborn simulator. After Period 1, each group will debrief to discuss their performance and engagement and use a Qualtrics survey (6-point Likert scale) to rate satisfaction, engagement, simulator fidelity, and self-efficacy. The same quantitative and qualitative data collection protocol will follow Period 2. All study activities will be audio-video recorded. JHU investigators will view the recorded encounters and assign a performance score using a skills checklist and global performance rating scale. Within a month, students will view their clinical encounters recording and complete a self-reflection to describe moments of engagement or disengagement. Students will also report any breastfeeding experience obtained since the intervention, score their performance, and complete the self-efficacy survey. Inclusion Criteria: - Student enrolled at Johns Hopkins University School of Nursing Exclusion Criteria: - Younger than 18 - Not able to complete study activities

NCT0531xxxx/NCT05316922.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/NCT05316922</url> </required_header> <id_info> <org_study_id>INT122/21</org_study_id> <nct_id>NCT05316922</nct_id> </id_info> <brief_title>TSH Suppression During Radiotherapy on Thyroid Site to Prevent Iatrogenic Hypothyroidism in Pediatric Cancer Patients</brief_title> <acronym>WIN-HYPO2021</acronym> <official_title>Protection From Iatrogenic Hypothyroidism Patients With MBL and Pediatric Patients With HL and Non-HL Needing Radiotherapy on Thyroid Site</official_title> <sponsors> <lead_sponsor> <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</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 offer the possibility of a treatment that could achieve a meaningful reduction in the incidence of post-radiation therapy hypothyroidism. Thyroid dysfunction may develop from a few months to several years after patients have completed their radiation treatment. In children with chronic diseases, or given lengthy anti-neoplastic treatments, recurrent or persistent endocrine disorders may have a negative effect on growth and development into adulthood. </textblock> </brief_summary> <detailed_description> <textblock> Patients will undergo basal thyroid ultrasound and FT3, FT4, TSH assay. Simulations with computed tomography, and computer assisted three-dimensional treatment planning with a dose volume histogram will be used to identify thyroid volumes and corresponding RT isodose distributions.  The enrolled patients will be randomly assigned (1:1) to TSH suppression group (experimental group) or non-TSH suppression group (control group). Random allocation will be managed centrally by Clinical epidemiology and Trial organization of the Fondazione IRCCS Istituto Nazionale dei Tumori. The randomization list will be generated by SAS software. Investigators and patients will not be masked to treatment allocation.  From 14 days beforehand and throughout their RT, patients in the experimental arm will receive L-thyroxine in the morning on an empty stomach (half an hour before breakfast), starting with 1-2 μg/kg, and adjusting the dose every 3 days to ensure TSH < 0.3 μIU/mL before RT beginning. The 0.3 μIU/mL threshold is just below normal range not causing hyperthyroidism, and is defined as "mild" TSH suppression. Based on hormone status, L-thyroxine doses will be gradually increased to patients' individual minimum TSH-suppressive dose before starting RT, maintained throughout the treatment, then rapidly tapered off (half dose the next day after RT, 25% the following day and stop). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 13, 2021</start_date> <completion_date type="Anticipated">September 30, 2029</completion_date> <primary_completion_date type="Anticipated">September 30, 2029</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, non-blinded, randomised two cohorts study</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Hypothyroidism-free survival</measure> <time_frame>3 years</time_frame> <description>Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchyma on the intention-to-treat population will be the main end-point.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">68</enrollment> <condition>Hypothyroidism; Irradiation</condition> <arm_group> <arm_group_label>TSH suppression during irradiation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>From 14 days beforehand and throughout their RT, patients in the experimental arm will receive L-thyroxine in the morning, starting with 1-2 μg/kg, and adjusting the dose every 3 days to ensure TSH < 0.3 μIU/mL before RT beginning. The 0.3 μIU/mL threshold is just below normal range not causing hyperthyroidism, and is defined as "mild" TSH suppression. Based on hormone status, L-thyroxine doses will be gradually increased to patients' individual minimum TSH-suppressive dose before starting RT, maintained throughout the treatment, then rapidly tapered off and stopped. During radiation treatment course will be checked twice a week for serum FT3, FT4, TSH assays in order to maintain TSH < 0.3 μIU/mL, possibly without exceeding normal levels of FT3 and FT4. Once a week patients will also have a full visit and any other blood examination according to protocol in use and Institutional practice.</description> </arm_group> <arm_group> <arm_group_label>Any TSH suppression during irradiation</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Patient in the standard arm will perform radiotherapy treatment without any TSH suppression. At the end of radiation they will do serum FT3, FT4, TSH assay and then, after one year from RT, thyroid ultrasound + serum FT3, FT4, TSH assay.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Levothyroxine</intervention_name> <description>Levothyroxine is used to treat hypothyroidism (low thyroid function). This medicine is given when your thyroid does not produce enough of this hormone on its own.</description> <arm_group_label>TSH suppression during irradiation</arm_group_label> <other_name>Thyroid drugs</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma before radiotherapy (RT) planning including thyroid parenchyma without previous primary or secondary hypothyroidism;  2. Written informed consent prior to any study-specific analysis and/or data collection.  Exclusion Criteria:  1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;  2. Not signed consent. </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Maura Massimino, MD</last_name> <phone>+0390223902593</phone> <email>maura.massimino@istitutotumori.mi.it</email> </overall_contact> <overall_contact_backup> <last_name>Luna Boschetti</last_name> <phone>+0390223902590</phone> <email>luna.boschetti@istitutotumori.mi.it</email> </overall_contact_backup> <location> <facility> <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name> <address> <city>Milan</city> <zip>20133</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Luna Boschetti</last_name> <phone>00390223902590</phone> <email>luna.boschetti@istitutotumori.mi.it</email> </contact> <investigator> <last_name>Maura Massimino, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Italy</country> </location_countries> <reference> <citation>Prpic M, Kruljac I, Kust D, Suton P, Purgar N, Bilos LK, Gregov M, Mrcela I, Franceschi M, Djakovic N, Frobe A. Dose-volume derived nomogram as a reliable predictor of radiotherapy-induced hypothyroidism in head and neck cancer patients. Radiol Oncol. 2019 Nov 20;53(4):488-496. doi: 10.2478/raon-2019-0055.</citation> <PMID>31747379</PMID> </reference> <reference> <citation>Alba JR, Basterra J, Ferrer JC, Santonja F, Zapater E. Hypothyroidism in patients treated with radiotherapy for head and neck carcinoma: standardised long-term follow-up study. J Laryngol Otol. 2016 May;130(5):478-81. doi: 10.1017/S0022215116000967. Epub 2016 Mar 15.</citation> <PMID>26975210</PMID> </reference> <reference> <citation>Massimino M, Gandola L, Collini P, Seregni E, Marchiano A, Serra A, Pignoli E, Spreafico F, Pallotti F, Terenziani M, Biassoni V, Bombardieri E, Fossati-Bellani F. Thyroid-stimulating hormone suppression for protection against hypothyroidism due to craniospinal irradiation for childhood medulloblastoma/primitive neuroectodermal tumor. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):404-10. doi: 10.1016/j.ijrobp.2007.03.028. Epub 2007 Jul 2.</citation> <PMID>17601681</PMID> </reference> <reference> <citation>Massimino M, Gandola L, Pignoli E, Seregni E, Marchiano A, Pecori E, Catania S, Cefalo G. TSH suppression as a possible means of protection against hypothyroidism after irradiation for childhood Hodgkins lymphoma. Pediatr Blood Cancer. 2011 Jul 15;57(1):166-8. doi: 10.1002/pbc.22915. Epub 2011 Feb 9.</citation> <PMID>21557462</PMID> </reference> <reference> <citation>Massimino M, Podda M, Gandola L, Pignoli E, Seregni E, Morosi C, Spreafico F, Ferrari A, Pecori E, Terenziani M. Long-term results of suppressing thyroid-stimulating hormone during radiotherapy to prevent primary hypothyroidism in medulloblastoma/PNET and Hodgkin lymphoma: a prospective cohort study. Front Med. 2021 Feb;15(1):101-107. doi: 10.1007/s11684-020-0752-2. Epub 2020 Aug 13.</citation> <PMID>32794013</PMID> </reference> <reference> <citation>Groover TA, Christie AC, Merritt EA, Coe FO, McPeak EM. Roentgen irradiation in the treatment of hyperthyroidism: a statistical evaluation based on three hundred and five cases. JAMA 1929; 92:1730-1734.</citation> </reference> <reference> <citation>Bantle JP, Lee CK, Levitt SH. Thyroxine administration during radiation therapy to the neck does not prevent subsequent thyroid dysfunction. Int J Radiat Oncol Biol Phys. 1985 Nov;11(11):1999-2002. doi: 10.1016/0360-3016(85)90283-4.</citation> <PMID>3932271</PMID> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>September 14, 2021</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Hypothyroidism</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To offer the possibility of a treatment that could achieve a meaningful reduction in the incidence of post-radiation therapy hypothyroidism. Thyroid dysfunction may develop from a few months to several years after patients have completed their radiation treatment. In children with chronic diseases, or given lengthy anti-neoplastic treatments, recurrent or persistent endocrine disorders may have a negative effect on growth and development into adulthood. Patients will undergo basal thyroid ultrasound and FT3, FT4, TSH assay. Simulations with computed tomography, and computer assisted three-dimensional treatment planning with a dose volume histogram will be used to identify thyroid volumes and corresponding RT isodose distributions. The enrolled patients will be randomly assigned (1:1) to TSH suppression group (experimental group) or non-TSH suppression group (control group). Random allocation will be managed centrally by Clinical epidemiology and Trial organization of the Fondazione IRCCS Istituto Nazionale dei Tumori. The randomization list will be generated by SAS software. Investigators and patients will not be masked to treatment allocation. From 14 days beforehand and throughout their RT, patients in the experimental arm will receive L-thyroxine in the morning on an empty stomach (half an hour before breakfast), starting with 1-2 μg/kg, and adjusting the dose every 3 days to ensure TSH < 0.3 μIU/mL before RT beginning. The 0.3 μIU/mL threshold is just below normal range not causing hyperthyroidism, and is defined as "mild" TSH suppression. Based on hormone status, L-thyroxine doses will be gradually increased to patients' individual minimum TSH-suppressive dose before starting RT, maintained throughout the treatment, then rapidly tapered off (half dose the next day after RT, 25% the following day and stop). Inclusion Criteria: 1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma before radiotherapy (RT) planning including thyroid parenchyma without previous primary or secondary hypothyroidism; 2. Written informed consent prior to any study-specific analysis and/or data collection. Exclusion Criteria: 1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma; 2. Not signed consent.

NCT0531xxxx/NCT05316935.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/NCT05316935</url> </required_header> <id_info> <org_study_id>53211030</org_study_id> <nct_id>NCT05316935</nct_id> </id_info> <brief_title>GnRHa + Letrozole in Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients</brief_title> <official_title>Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment</official_title> <sponsors> <lead_sponsor> <agency>Xiaojun Chen</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fudan 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> To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.  To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC and EAH patients. </textblock> </brief_summary> <detailed_description> <textblock> There were more and more women with early endometrioid endometrial cancer (EEC) and atypical endometrial hyperplasia (EAH) who want to preserve fertility. Approximately 70% to 80% of females who meet the criteria for conservation treatment are able to achieve CR after progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no response or need to take longer time to achieve remission (over one year). With long duration of treatment, there will be more side effects such as weight gain, impaired liver function, endometrial injury, ovarian reserve inhibition etc. which will decrease the efficacy of conservative treatment. Previous researches had shown that GnRHa plus letrozole or ethinylestradiol cyproterone plus metformin could be a better second-line treatment for progestin-insensitive patients. Till now, no similar studies were found, so we design this study to explore the efficacy of GnRHa plus letrozole and ethinylestradiol cyproterone plus metformin in progestin-insensitive EEC and EAH patients to provide new evidences for improving conservative treatment efficacy. Considered there will be more thrombotic risks in obese patients using ethinylestradiol cyproterone, we use GnRHa plus letrozole in patients with BMI ≥ 30kg/m2 only.  This will be a single-centred prospective pilot study. Patients diagnosed as progestin-insensitive EAH or EEC by dilatation and curettage (D&C) or hysteroscopy will be enrolled. Non-obese patients will be stratified by pathological diagnosis (EEC or EAH) and then they will be randomly assigned (1:1) to two arms. One will be GnRHa + letrozole group and another will be ethinylestradiol cyproterone + metformin group. And for obese patients,there will be only GnRHa + letrozole group.  The primary endpoint is cumulative complete response (CR) rate at 28 weeks of treatment. The secondary endpoints include adverse events, duration of complete response, recurrent rate, pregnancy rate and quality of life of patients. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 13, 2022</start_date> <completion_date type="Anticipated">March 30, 2025</completion_date> <primary_completion_date type="Anticipated">March 30, 2025</primary_completion_date> <phase>Phase 2/Phase 3</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>Complete response rates within 28 weeks of treatment</measure> <time_frame>From date of randomization until the date of CR, assessed up to 28 weeks</time_frame> <description>The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment.</description> </primary_outcome> <secondary_outcome> <measure>Adverse events</measure> <time_frame>From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks</time_frame> <description>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.</description> </secondary_outcome> <secondary_outcome> <measure>Time to achieve complete response</measure> <time_frame>From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks.</time_frame> <description>The median CR time will be calculated in two groups</description> </secondary_outcome> <secondary_outcome> <measure>Relapse rates</measure> <time_frame>Up to 2 years after the treatment</time_frame> </secondary_outcome> <secondary_outcome> <measure>Rates of fertility outcomes</measure> <time_frame>Up to 2 years after the treatment</time_frame> <description>Including pregnancy and live-birth rates</description> </secondary_outcome> <secondary_outcome> <measure>Compliance</measure> <time_frame>Data on treatment and hysteroscopy management will be collected, and deviations from study protocol will be recorded in writing. For example, the time of drug interruptions due to related toxicities or AEs, and delay of hysteroscopy for personal reasons.</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">118</enrollment> <condition>Endometrial Neoplasms</condition> <condition>Atypical Endometrial Hyperplasia</condition> <condition>Progesterone Resistance</condition> <arm_group> <arm_group_label>Non-obese group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients will be stratified into EEC group with 40 cases and EAH group with 40 cases. Each group will be randomized to GnRHa + Letrozole group and Diane-35 + metformin group.Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.</description> </arm_group> <arm_group> <arm_group_label>Obese group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients will be stratified into EEC group with 19 cases and EAH group with 19 cases. Interventional Study Model was Simon two-stage optimal design. Then every 12 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>GnRHa</intervention_name> <description>Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.</description> <arm_group_label>Non-obese group</arm_group_label> <arm_group_label>Obese group</arm_group_label> <other_name>Triprorelin acetate</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Letrozole 2.5mg</intervention_name> <description>2.5mg po qd and no more than 24 weeks</description> <arm_group_label>Non-obese group</arm_group_label> <arm_group_label>Obese group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Diane-35</intervention_name> <description>Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.</description> <arm_group_label>Non-obese group</arm_group_label> <other_name>ethinylestradiol cyproterone</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>MET</intervention_name> <description>500mg po tid</description> <arm_group_label>Non-obese group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or well-differentiated EEC G1 without myometrial invasion  - No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound  - Using progestin, any of the following therapy, as first-line treatment:  1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not  2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not  3. LNG-IUS inserted  - Progestin-insensitive:  1. remained with stable disease after 7 months of progestin use  2. did not achieve CR after 10 months of progestin use  - Have a desire for remaining reproductive function or uterus  - Good compliance with adjunctive treatment and follow-up  Exclusion Criteria:  - Combined with severe medical disease or severely impaired liver and kidney function  - Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis  - Patients with other types of endometrial cancer or other malignant tumors of the reproductive system  - Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with Diane-35, GnRHa, Letrozole or MET  - Strong request for uterine removal or other conservative treatment  - Known or suspected pregnancy  - Acute severe disease such as stroke or heart infarction or a history of thrombosis disease  - Smoker(>15 cigarettes a day) </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Xiaojun Chen, PhD</last_name> <phone>8602133189900</phone> <phone_ext>6429</phone_ext> <email>cxjlhjj@163.com</email> </overall_contact> <overall_contact_backup> <last_name>Bingyi Yang</last_name> <phone>8602133189900</phone> <phone_ext>6429</phone_ext> <email>xiaomihaoku@163.com</email> </overall_contact_backup> <location> <facility> <name>Obstetrics and Gynecology Hospital, Fudan University</name> <address> <city>Shanghai</city> <state>Shanghai</state> <zip>200011</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Xiaojun Chen, PhD</last_name> <phone>862133189900</phone> <phone_ext>6429</phone_ext> <email>cxjlhjj@163.com</email> </contact> <contact_backup> <last_name>Bingyi Yang, MD</last_name> <phone>862133189900</phone> <phone_ext>6429</phone_ext> <email>xiaomihaoku@163.com</email> </contact_backup> <investigator> <last_name>Xiaojun Chen</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Bingyi Yang</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Pengfei Wu</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>China</country> </location_countries> <link> <url>https://pubmed.ncbi.nlm.nih.gov/34085795/</url> <description>Related Info</description> </link> <reference> <citation>Zhou S, Xu Z, Yang B, Guan J, Shan W, Shi Y, Chen X. Characteristics of progestin-insensitive early stage endometrial cancer and atypical hyperplasia patients receiving second-line fertility-sparing treatment. J Gynecol Oncol. 2021 Jul;32(4):e57. doi: 10.3802/jgo.2021.32.e57.</citation> <PMID>34085795</PMID> </reference> <verification_date>February 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>February 16, 2023</last_update_submitted> <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Fudan University</investigator_affiliation> <investigator_full_name>Xiaojun Chen</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Endometrial Neoplasms</mesh_term> <mesh_term>Endometrial Hyperplasia</mesh_term> <mesh_term>Hyperplasia</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Letrozole</mesh_term> <mesh_term>Ethinyl Estradiol</mesh_term> <mesh_term>Cyproterone</mesh_term> <mesh_term>Cyproterone acetate, ethinyl estradiol drug combination</mesh_term> </intervention_browse>  </clinical_study>

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment. To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC and EAH patients. There were more and more women with early endometrioid endometrial cancer (EEC) and atypical endometrial hyperplasia (EAH) who want to preserve fertility. Approximately 70% to 80% of females who meet the criteria for conservation treatment are able to achieve CR after progestin therapy, with a median time of 6-7 months, but about 20% to 30% of patients get no response or need to take longer time to achieve remission (over one year). With long duration of treatment, there will be more side effects such as weight gain, impaired liver function, endometrial injury, ovarian reserve inhibition etc. which will decrease the efficacy of conservative treatment. Previous researches had shown that GnRHa plus letrozole or ethinylestradiol cyproterone plus metformin could be a better second-line treatment for progestin-insensitive patients. Till now, no similar studies were found, so we design this study to explore the efficacy of GnRHa plus letrozole and ethinylestradiol cyproterone plus metformin in progestin-insensitive EEC and EAH patients to provide new evidences for improving conservative treatment efficacy. Considered there will be more thrombotic risks in obese patients using ethinylestradiol cyproterone, we use GnRHa plus letrozole in patients with BMI ≥ 30kg/m2 only. This will be a single-centred prospective pilot study. Patients diagnosed as progestin-insensitive EAH or EEC by dilatation and curettage (D&C) or hysteroscopy will be enrolled. Non-obese patients will be stratified by pathological diagnosis (EEC or EAH) and then they will be randomly assigned (1:1) to two arms. One will be GnRHa + letrozole group and another will be ethinylestradiol cyproterone + metformin group. And for obese patients,there will be only GnRHa + letrozole group. The primary endpoint is cumulative complete response (CR) rate at 28 weeks of treatment. The secondary endpoints include adverse events, duration of complete response, recurrent rate, pregnancy rate and quality of life of patients. Inclusion Criteria: - Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or well-differentiated EEC G1 without myometrial invasion - No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound - Using progestin, any of the following therapy, as first-line treatment: 1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not 2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not 3. LNG-IUS inserted - Progestin-insensitive: 1. remained with stable disease after 7 months of progestin use 2. did not achieve CR after 10 months of progestin use - Have a desire for remaining reproductive function or uterus - Good compliance with adjunctive treatment and follow-up Exclusion Criteria: - Combined with severe medical disease or severely impaired liver and kidney function - Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis - Patients with other types of endometrial cancer or other malignant tumors of the reproductive system - Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with Diane-35, GnRHa, Letrozole or MET - Strong request for uterine removal or other conservative treatment - Known or suspected pregnancy - Acute severe disease such as stroke or heart infarction or a history of thrombosis disease - Smoker(>15 cigarettes a day)

NCT0531xxxx/NCT05316948.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/NCT05316948</url> </required_header> <id_info> <org_study_id>2021-A03080-41</org_study_id> <nct_id>NCT05316948</nct_id> </id_info> <brief_title>Mental Health and Sexuality in Adolescents and Young Adults</brief_title> <acronym>SEX-T-ADO</acronym> <official_title>Mental Health and Sexuality in Adolescents and Young Adults</official_title> <sponsors> <lead_sponsor> <agency>Fondation Santé des Étudiants de France</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fondation Santé des Étudiants de France</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 the World Health Organization (WHO), "Sexual health is a state of physical, emotional, mental and social well-being in relation to sexuality, not merely the absence of disease, dysfunction or of infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships [...]".  The main objective is to show that a training intervention intended for psychiatric care teams and targeted on the question of the impact of psychiatric disorders and psychotropic drugs on the sexuality of young people, increases the proportion of young people with whom the question of sexual health is discussed (in connection with psychiatric disorders and, if applicable, with the taking of psychotropic treatment, while they are hospitalized for a psychiatric disorder in the clinics of the FSEF and receive, or not, psychotropic treatment ). </textblock> </brief_summary> <detailed_description> <textblock> Non-interventional multicenter prospective mixed study (quantitative and qualitative).  Research process in 3 phases:  1. Inventory with a mixed method evaluation (quantitative survey and qualitative survey),  - Step 1: quantitative survey with self-administered questionnaire offered to all patients attending psychiatric study care during the month of the assessment.  - Step 2: qualitative survey of young people and caregivers.  2. Design and implementation of an intervention adapted to the needs of the field (training for caregivers and tools for young people).  - Step 3: implementation of training programs for professionals based on data from phase 1 and preparation for interventions for young people.  - Step 4: Interventions (interventions with young people in groups and individually).  3. Reassessment after the deployment of the intervention - Step 5: Finally, the quantitative survey of stage 1 with a self-questionnaire offered to all patients present in psychiatric care-study will be repeated during one month of the evaluation in order to measure the impact of the action taken. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">September 2022</start_date> <completion_date type="Anticipated">November 2024</completion_date> <primary_completion_date type="Anticipated">November 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>Comparison</measure> <time_frame>self-questionnaire after the team training (T2 = 1 year)</time_frame> <description>To show that a training intervention intended for the healthcare team makes it possible to increase the proportion of young people with whom the question of sexual health has been approached, in connection with psychiatric disorders and, if necessary, with taking treatment psychotropics; while they are hospitalized for a psychiatric disorder in the clinics of the FSEF and receive, or not, a psychotropic treatment.</description> </primary_outcome> <secondary_outcome> <measure>Description</measure> <time_frame>self-questionnaire (T0 = within three months of the opening of the center)</time_frame> <description>Describe the sexuality of adolescents and young adults hospitalized in a psychiatric establishment within the FSEF with quantitative survey with self-questionnaire exploring sexual adverse effects</description> </secondary_outcome> <secondary_outcome> <measure>Comparison</measure> <time_frame>self-questionnaire (T0 = within three months of the opening of the center)</time_frame> <description>To compare the sexual life of patients hospitalized at the FSEF for a psychiatric illness - according to whether or not they receive psychotropic treatment with quantitative survey with self-questionnaire exploring sexual adverse effects</description> </secondary_outcome> <secondary_outcome> <measure>Comparison</measure> <time_frame>self-questionnaire after the team training (T2 = 1 year)</time_frame> <description>To compare the perceived impact of psychiatric disorders and psychotropic treatments on patients' sexual satisfaction measured by a Likert scale of sexual satisfaction (rated from 1 to 5 with 1 equal to very satisfied and 5 to very dissatisfied) before and after intervention.</description> </secondary_outcome> <enrollment type="Anticipated">770</enrollment> <condition>Psychiatric Disorder</condition> <condition>Adolescent Behavior</condition> <condition>Mental Health Issue</condition> <intervention> <intervention_type>Other</intervention_type> <intervention_name>self-questionnaire</intervention_name> <description>Quantitative survey with self-administered questionnaire offered to all patients attending psychiatry study care during the month of the assessment.</description> </intervention> <eligibility> <study_pop> <textblock> All young people hospitalized in the 13 structures of the FSEF aged 15 or over. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Young people hospitalized in psychiatric care-studies in one of the establishments of the FSEF,  - Age ≥ 15 years (age of sexual majority),  - Receiving or not a psychotropic treatment,  - No opposition to participation (or parents for minors) in the study and use of data  Exclusion Criteria:  - Refusal to participate  - Patient under 15 years old  - Need for emergency care (medicine or psychiatry). </textblock> </criteria> <gender>All</gender> <minimum_age>15 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Anaïs Foussier, IDE</last_name> <phone>02 44 55 20 81</phone> <email>anais.foussier@fsef.net</email> </overall_contact> <overall_contact_backup> <last_name>Margot Bobin</last_name> <phone>01 45 89 43 39</phone> <email>margot.bobin@fsef.net</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>March 17, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>psychotropic treatment</keyword> <keyword>sexuality</keyword> <keyword>teenagers and young adults</keyword> <condition_browse>  <mesh_term>Mental Disorders</mesh_term> <mesh_term>Problem Behavior</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

According to the World Health Organization (WHO), "Sexual health is a state of physical, emotional, mental and social well-being in relation to sexuality, not merely the absence of disease, dysfunction or of infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships [...]". The main objective is to show that a training intervention intended for psychiatric care teams and targeted on the question of the impact of psychiatric disorders and psychotropic drugs on the sexuality of young people, increases the proportion of young people with whom the question of sexual health is discussed (in connection with psychiatric disorders and, if applicable, with the taking of psychotropic treatment, while they are hospitalized for a psychiatric disorder in the clinics of the FSEF and receive, or not, psychotropic treatment ). Non-interventional multicenter prospective mixed study (quantitative and qualitative). Research process in 3 phases: 1. Inventory with a mixed method evaluation (quantitative survey and qualitative survey), - Step 1: quantitative survey with self-administered questionnaire offered to all patients attending psychiatric study care during the month of the assessment. - Step 2: qualitative survey of young people and caregivers. 2. Design and implementation of an intervention adapted to the needs of the field (training for caregivers and tools for young people). - Step 3: implementation of training programs for professionals based on data from phase 1 and preparation for interventions for young people. - Step 4: Interventions (interventions with young people in groups and individually). 3. Reassessment after the deployment of the intervention - Step 5: Finally, the quantitative survey of stage 1 with a self-questionnaire offered to all patients present in psychiatric care-study will be repeated during one month of the evaluation in order to measure the impact of the action taken. All young people hospitalized in the 13 structures of the FSEF aged 15 or over. Inclusion Criteria: - Young people hospitalized in psychiatric care-studies in one of the establishments of the FSEF, - Age ≥ 15 years (age of sexual majority), - Receiving or not a psychotropic treatment, - No opposition to participation (or parents for minors) in the study and use of data Exclusion Criteria: - Refusal to participate - Patient under 15 years old - Need for emergency care (medicine or psychiatry).

NCT0531xxxx/NCT05316961.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/NCT05316961</url> </required_header> <id_info> <org_study_id>2021.150-T</org_study_id> <nct_id>NCT05316961</nct_id> </id_info> <brief_title>Clinical Effectiveness of PEMF as a Treatment Adjunct to Eccentric Exercise for Achilles Tendinopathy</brief_title> <official_title>Clinical Effectiveness of Pulsed Electromagnetic Field Therapy as a Treatment Adjunct to Eccentric Exercise for Achilles Tendinopathy: a Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Chinese University of Hong Kong</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Chinese University of Hong Kong</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 study aims to investigate the clinical effectiveness of PEMF as an adjunct to a program of eccentric exercise for the treatment of Achilles tendinopathy. The study objective is to establish whether PEMF plus eccentric exercise in people with Achilles tendinopathy will improve rehabilitation outcomes compared to eccentric exercise only. This study also investigates the effects of PEMF on pain, functional outcomes, mechanical and morphological properties of tendon among patients with Achilles tendinopathy. Investigators hypothesize that pulsed electromagnetic field therapy is effective in reducing pain, improving functional outcomes, and restoring mechanical and morphological properties of tendons in patients with Achilles tendinopathy.  This study is a double-blinded, randomized controlled trial to investigate the clinical effects of pulsed electromagnetic field therapy (PEMF) for Achilles tendinopathy. Participants will be recruited from the outpatient clinic of the orthopedic and traumatology department at Prince of Wales Hospital. Fifty-four patients aged between 18 and 70 with Achilles tendinopathy will be invited to join this trial after informed consent. Participants will be randomized to any of the 2 groups: the intervention group (n=27; PEMF (Quantum Tx) treatment), and the control group (n=27; sham treatment with dummy exposure to PEMF).  Baseline measurements of all self-reported outcomes, functional outcomes, and ultrasound imaging assessments, such as ankle range of motion, jumping ability, pain level, calf muscle strength, calf muscle endurance, physical activity level, quality of life by SF-36 will be measured. </textblock> </brief_summary> <detailed_description> <textblock> Randomization and blinding Participants will be randomized into 1:1 allocation, blocked randomization with 27 participants in the PEMF group and 27 participants in the sham group. Each allocation will be assigned with a unique RFID (generated during block randomization by the PEMF supplier service) recognizable by the PEMF machine. The participants will be assigned an RFID by which the PEMF or sham treatment will be randomly assigned to the RFID. A biostatistician who does not participate in the recruitment of patients will oversee the randomization. Hence, both participants and the research personnel are blinded, and participants will use the RFID to complete the assigned treatment without knowing which treatment they are receiving.  Intervention The intervention will be held at the Chinese University of Hong Kong. Participants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). The active PEMF device does not produce heat or cause any sensation to the tissue which allows the participants to be blinded to the treatment. Participants in the control group will receive a sham exposure with the same PEMF device. The diseased leg will be exposed to PEMF or sham treatment for 10 minutes per session, and the treatment regime will run twice a week for 8 weeks, summing up 16 sessions of PEMF or sham exposure in total.  The procedure of PEMF treatment is shown as follows:  The subject will be seated at a 90 degrees position on a chair. The solenoids of the PEMF device will be adjusted to be over the foot and ankle (Achilles tendon and lower calf muscle).  The options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes.  In addition to PEMF, all participants will also perform eccentric calf muscle exercise. The first step is stretching exercises for the calf muscles. The stretching is a static stretch of the gastrocnemius (knee in extension) and soleus (knee in flexion). The participants are instructed to hold these at least for 30s and repeat each exercise three times. There is a 1-min rest between each stretch. 3 sets of 10 repetitions of the eccentric exercises are carried out once daily for 6 weeks and after 6 weeks, the participants are instructed to carry out 3 sets of 10 repetitions, 3 times per week for 6 more weeks. The intensity of the exercise should be such that pain, or discomfort, is experienced in the last set of 10 repetitions. Every session ended with the same static stretch exercise as in step 1. If a participant is unable to complete 3 sets of 15 repetitions, the participant is instructed to start with a lower number of repetitions and/or sets (a minimum of 2 sets of 10) and progress to the full amount as able. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">July 1, 2021</start_date> <completion_date type="Anticipated">August 1, 2024</completion_date> <primary_completion_date type="Anticipated">August 1, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Visual Analogue Scale (VAS)</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>The Visual Analogue Scale (VAS) requires participants to rate their pain on a defined scale from 0-10. 0 refers to no pain while 10 refers to severe pain. Lower scores mean a better outcome.</description> </primary_outcome> <primary_outcome> <measure>Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>The Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A) is used to evaluate the clinical severity of patients, monitor the change in symptoms and function following interventions provided for Achilles tendinopathy. The questionnaire contains eight questions, covering three necessary domains: 1) pain, 2) functional status, and 3) activity. The first seven questions have a score out of 10, and question 8 scores a maximum of 30. The minimum value is 0 and the maximum value is 100. Higher scores mean a better outcome. Asymptomatic individuals may score 100 points in VISA-A.</description> </primary_outcome> <secondary_outcome> <measure>Ankle range of motion</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>A standard goniometer will be used to measure the range of motion (ROM) of ankle dorsiflexion. It will be used as an indicator of the flexibility of the gastrocnemius muscle. The participant will maximally dorsiflex the ankle while keeping the knee extended and the heel on the floor.</description> </secondary_outcome> <secondary_outcome> <measure>Calf muscle endurance</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>The heel-rise test will be used to measure calf-muscle endurance. The participant will start from standing on a pressure mat (Tekscan, U.S.). The information on the plantar pressure will be collected for analyses. The participant will be instructed to rise as high as possible on the heel each time until fatigue. The participant should keep the knees straight. The participant can place 2 fingertips per hand on the wall to maintain balance. The rhythm will be set at a frequency of 30 heel rises per minute by following a metronome. The number of repetitions, maximum heel-rise height, and the total amount of work performed are recorded.</description> </secondary_outcome> <secondary_outcome> <measure>Tendon thickness</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>The thickness (mm) of each tendon were measured with axial (i.e., perpendicular to the direction of the fibers) grayscale ultrasound 2 cm and 3 cm from the end of the tendon.</description> </secondary_outcome> <secondary_outcome> <measure>Neovascularity</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>The Achilles tendons were examined in longitudinal plane. The location and number of neovessels observed with Power Doppler Ultrasound were scored using the modified Öhberg score.6,14 This score was recorded as 0 (no vessels visible), 1+ (1 vessel, mostly anterior to the tendon), 2+ (1 or 2 vessels throughout the tendon), 3+ (3 vessels throughout the tendon), or 4+ (more than 3 vessels throughout the tendon).</description> </secondary_outcome> <secondary_outcome> <measure>Tendon elasticity</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>The mechanical properties of tendons will be measured by Shear-wave elastography (SWE) performed using an Aixplorer (Supersonic Imagine, Aix-en-Provence, France), a form of ultrasound imaging. It can detect changes in mechanical properties that are associated with tendon healing that is closely correlated with symptoms. The participant will be positioned in prone lying with feet hanging over the plinth to allow ankle movement during the sonographic exam. The resting ankle range of motion is measured by a goniometer.</description> </secondary_outcome> <secondary_outcome> <measure>Short Form 36 questionnaire (SF-36)</measure> <time_frame>Change from baseline to 6 months</time_frame> <description>Short Form 36 questionnaire (SF-36) will be used to evaluate health-related quality of life. SF-36 covers a variety of domains, including bodily pain, physical function, mental health, and social health of the participants. The minimum value is 0 and the maximum value is 100. Higher scores mean a better outcome.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">54</enrollment> <condition>Achilles Tendinopathy</condition> <arm_group> <arm_group_label>PEMF group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will receive active pulsed electromagnetic field therapy two times a week for eight weeks. The options of the appliance will be adjusted to 1.5 mT, 10Hz on one leg for 10 minutes. A total of 16 sessions will be given to each participant. Each session will last for 10 minutes. Participants will be positioned in sitting on a chair comfortably. They will receive intervention at Prince of Wales hospital. 3 sets of 10 repetitions of the eccentric exercises are carried out once daily for 6 weeks and after 6 weeks, the patients are instructed to carry out 3 sets of 10 repetitions, 3 times per week for 6 more weeks. The intensity of the exercise should be such that pain, or discomfort, is experienced in the last set of 10 repetitions.</description> </arm_group> <arm_group> <arm_group_label>Sham group</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>Participants will receive sham pulsed electromagnetic field therapy two times a week for eight weeks. The options of the appliance will be adjusted to 0 mT, 0Hz on one leg for 10 minutes. A total of 16 sessions will be given to each participant. Each session will last for 10 minutes. Participants will be positioned in sitting on a chair comfortably. They will receive intervention at Prince of Wales hospital. 3 sets of 10 repetitions of the eccentric exercises are carried out once daily for 6 weeks and after 6 weeks, the patients are instructed to carry out 3 sets of 10 repetitions, 3 times per week for 6 more weeks. The intensity of the exercise should be such that pain, or discomfort, is experienced in the last set of 10 repetitions.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Active PEMF</intervention_name> <description>PEMF 1.5mT, 10Hz, 10 minutes</description> <arm_group_label>PEMF group</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Sham PEMF</intervention_name> <description>PEMF 0mT, 0Hz, 10 minutes</description> <arm_group_label>Sham group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Eccentric exercise</intervention_name> <description>Eccentric exercise, 10 repetitions, 3 sets</description> <arm_group_label>PEMF group</arm_group_label> <arm_group_label>Sham group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age between 18 and 70  - Tenderness with palpation 2-6 cm above the Achilles tendon insertion on the calcaneus (midportion Achilles tendinopathy)  - Recurrent complaints in 1 or both Achilles' tendons at rest and/or during exercise for the preceding 3 month  - Structural changes of the tendon were confirmed via sonographic examination during the initial physical exam  - Achilles tendinopathy affecting the insertional and mid-portion of the Achilles tendon  - Clinical symptoms associated with Achilles tendinopathy that do not respond well to conventional conservative treatments before entering the study  - Informed consent  Exclusion Criteria:  - History of surgery on the affected lower limb in the past year  - Mental/physical limitation rendering participant to follow instructions  - With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired)  - Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires  - Fractures of the trained body parts within the past 12 months </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ka-Kin Samuel Ling, MSc</last_name> <role>Principal Investigator</role> <affiliation>Chinese University of Hong Kong</affiliation> </overall_official> <location> <facility> <name>KO Man Chi</name> <address> <city>Hong Kong</city> <zip>999077</zip> <country>Hong Kong</country> </address> </facility> </location> <location_countries> <country>Hong Kong</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>January 12, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation> <investigator_full_name>Samuel KK Ling</investigator_full_name> <investigator_title>Assistant Professor (Clinical) of Orthopaedics & Traumatology</investigator_title> </responsible_party> <keyword>Pulsed electromagnetic field therapy</keyword> <keyword>Eccentric exercise</keyword> <keyword>Rehabilitation</keyword> <condition_browse>  <mesh_term>Tendinopathy</mesh_term> </condition_browse>  </clinical_study>

This study aims to investigate the clinical effectiveness of PEMF as an adjunct to a program of eccentric exercise for the treatment of Achilles tendinopathy. The study objective is to establish whether PEMF plus eccentric exercise in people with Achilles tendinopathy will improve rehabilitation outcomes compared to eccentric exercise only. This study also investigates the effects of PEMF on pain, functional outcomes, mechanical and morphological properties of tendon among patients with Achilles tendinopathy. Investigators hypothesize that pulsed electromagnetic field therapy is effective in reducing pain, improving functional outcomes, and restoring mechanical and morphological properties of tendons in patients with Achilles tendinopathy. This study is a double-blinded, randomized controlled trial to investigate the clinical effects of pulsed electromagnetic field therapy (PEMF) for Achilles tendinopathy. Participants will be recruited from the outpatient clinic of the orthopedic and traumatology department at Prince of Wales Hospital. Fifty-four patients aged between 18 and 70 with Achilles tendinopathy will be invited to join this trial after informed consent. Participants will be randomized to any of the 2 groups: the intervention group (n=27; PEMF (Quantum Tx) treatment), and the control group (n=27; sham treatment with dummy exposure to PEMF). Baseline measurements of all self-reported outcomes, functional outcomes, and ultrasound imaging assessments, such as ankle range of motion, jumping ability, pain level, calf muscle strength, calf muscle endurance, physical activity level, quality of life by SF-36 will be measured. Randomization and blinding Participants will be randomized into 1:1 allocation, blocked randomization with 27 participants in the PEMF group and 27 participants in the sham group. Each allocation will be assigned with a unique RFID (generated during block randomization by the PEMF supplier service) recognizable by the PEMF machine. The participants will be assigned an RFID by which the PEMF or sham treatment will be randomly assigned to the RFID. A biostatistician who does not participate in the recruitment of patients will oversee the randomization. Hence, both participants and the research personnel are blinded, and participants will use the RFID to complete the assigned treatment without knowing which treatment they are receiving. Intervention The intervention will be held at the Chinese University of Hong Kong. Participants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). The active PEMF device does not produce heat or cause any sensation to the tissue which allows the participants to be blinded to the treatment. Participants in the control group will receive a sham exposure with the same PEMF device. The diseased leg will be exposed to PEMF or sham treatment for 10 minutes per session, and the treatment regime will run twice a week for 8 weeks, summing up 16 sessions of PEMF or sham exposure in total. The procedure of PEMF treatment is shown as follows: The subject will be seated at a 90 degrees position on a chair. The solenoids of the PEMF device will be adjusted to be over the foot and ankle (Achilles tendon and lower calf muscle). The options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes. In addition to PEMF, all participants will also perform eccentric calf muscle exercise. The first step is stretching exercises for the calf muscles. The stretching is a static stretch of the gastrocnemius (knee in extension) and soleus (knee in flexion). The participants are instructed to hold these at least for 30s and repeat each exercise three times. There is a 1-min rest between each stretch. 3 sets of 10 repetitions of the eccentric exercises are carried out once daily for 6 weeks and after 6 weeks, the participants are instructed to carry out 3 sets of 10 repetitions, 3 times per week for 6 more weeks. The intensity of the exercise should be such that pain, or discomfort, is experienced in the last set of 10 repetitions. Every session ended with the same static stretch exercise as in step 1. If a participant is unable to complete 3 sets of 15 repetitions, the participant is instructed to start with a lower number of repetitions and/or sets (a minimum of 2 sets of 10) and progress to the full amount as able. Inclusion Criteria: - Age between 18 and 70 - Tenderness with palpation 2-6 cm above the Achilles tendon insertion on the calcaneus (midportion Achilles tendinopathy) - Recurrent complaints in 1 or both Achilles' tendons at rest and/or during exercise for the preceding 3 month - Structural changes of the tendon were confirmed via sonographic examination during the initial physical exam - Achilles tendinopathy affecting the insertional and mid-portion of the Achilles tendon - Clinical symptoms associated with Achilles tendinopathy that do not respond well to conventional conservative treatments before entering the study - Informed consent Exclusion Criteria: - History of surgery on the affected lower limb in the past year - Mental/physical limitation rendering participant to follow instructions - With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired) - Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires - Fractures of the trained body parts within the past 12 months

NCT0531xxxx/NCT05316974.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/NCT05316974</url> </required_header> <id_info> <org_study_id>2020-01066</org_study_id> <nct_id>NCT05316974</nct_id> </id_info> <brief_title>Lymphoedema Among Persons With Head- and Neck Cancer</brief_title> <official_title>Lymphoedema for Persons With Head- and Neck Cancer</official_title> <sponsors> <lead_sponsor> <agency>Lund University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Skane University Hospital</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Lund 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> Lymphedema in the head and neck area is common after treatment for head and neck cancer.  The aim of the research project is:  • to assess the prevalence of lymphedema in patients with head and neck cancer (HNC) by measuring the amount of tissue water in the head and neck area before and after different kinds of cancer treatment, and to evaluate the quality of life before and after cancer treatment. </textblock> </brief_summary> <detailed_description> <textblock> Measurement of tissue water is performed with a device (MoistureMeterD) see appendix 1. In addition, the neck circumference will be assessed with a measuring tape, according to Purcell (9), see appendix 2. The measurement will be completed by Agneta Hagren, or one of her colleagues, with specific education.  The assessments will be performed before treatment begins as part of the clinical routine (baseline), and at 3 months, and 9 months after treatment completion.  Each participant will respond to quality-of-life QLQ-c30 and QLQ H&N35 questionnaires, appendix 3 and 4, at the same time points as the measurements of tissue water. Ratings of physical activity according to Frändin and Grimby will also be performed (23). The questionnaires will be sent home to the patients before the time for follow-up. A modified LyQLI questionnaire will be given to all patients with lymphedema and filled out at 3 and 9 months after treatment completion, appendix 5.  Post-treatment measurements +/- four weeks of the dedicated time point will be considered appropriate.  Discontinuing participation in the trial will be on:  1. Patient request  2. Locoregional tumor progression or failure during the study period. For example, residual neck tumor requiring neck dissection after (C)RT for OPC  3. Locoregional deep infection i.e., suspected abscess at the scheduled time points for measurements.  Any interventional therapy for lymphedema during the follow-up is not cause for exclusion but will be registered. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2022</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">May 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>Change in level of tissue water</measure> <time_frame>Baseline and after 3 and 9 months</time_frame> <description>Change in tissue water in the head and neck before and after cancer treatment</description> </primary_outcome> <secondary_outcome> <measure>QoL</measure> <time_frame>3 and 9 months</time_frame> <description>Quality of life measured by LyQLI</description> </secondary_outcome> <secondary_outcome> <measure>Change in QoL</measure> <time_frame>Baseline and after 3 and 9 months</time_frame> <description>Change in Quality of life measured by QLQ-c30</description> </secondary_outcome> <secondary_outcome> <measure>Change in QoL</measure> <time_frame>Baseline and after 3 and 9 months</time_frame> <description>Change in Quality of life measured by QLQ H&N35</description> </secondary_outcome> <enrollment type="Anticipated">80</enrollment> <condition>Cancer of Head and Neck</condition> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Prevalence of lymphoedema</intervention_name> <description>Measures of lymphoedema</description> </intervention> <eligibility> <study_pop> <textblock> Patients treated for head and neck cancer at the ENT department and the Oncology department at Skane University Hospital </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Biopsy or cytology confirmed HNC (all malignant types are accepted) from the oropharynx (OPC), oral cavity (OC) or neck metastases from unknown primary cancer of the head and neck (CUP).  - Tumour stage T1-4, N0-3.  - Planned for treatment with curative intent as recommended at the multidisciplinary tumour board.  - Age >18 years. Able to give informed consent  Exclusion Criteria:  - Previous treatment of HNC or radiation to the head and neck area.  - Planned surgery that includes free tissue transfer or pedicled flaps in the neck (local facial pedicled flaps are accepted).  - Planned neck dissection involving less than three regions of the neck.  - Planned proton therapy.  - Pre-treatment surgery or Botox injections in the tissue in the head and neck area.  - Pregnancy </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_official> <last_name>Eva Ekvall Hansson, Professor</last_name> <role>Principal Investigator</role> <affiliation>Lund University, Medical Faculty, Dep of Health Sciences</affiliation> </overall_official> <overall_contact> <last_name>Agneta Hagren, MSc</last_name> <phone>+4646175964</phone> <email>agneta.hagren@med.lu.se</email> </overall_contact> <overall_contact_backup> <last_name>Johanna Sjövall, Med Dr, PhD</last_name> <phone>+4646171000</phone> <email>johanna.sjovall@skane.se</email> </overall_contact_backup> <location> <facility> <name>ENT department Skane University Hospital</name> <address> <city>Lund</city> <zip>22100</zip> <country>Sweden</country> </address> </facility> <contact> <last_name>Agneta Hagren, MSc</last_name> <phone>+4646175964</phone> <email>agneta.hagren@med.lu.se</email> </contact> <contact_backup> <last_name>Johanna Sjövall, Med Dr, PhD</last_name> <phone>+4646171000</phone> <email>johanna.sjovall@skane.se</email> </contact_backup> </location> <location_countries> <country>Sweden</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Lund University</investigator_affiliation> <investigator_full_name>Eva Ekvall-Hansson</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>Lymphoedema</keyword> <keyword>Quality of life</keyword> <keyword>Head and neck cancer treatment</keyword> <condition_browse>  <mesh_term>Head and Neck Neoplasms</mesh_term> <mesh_term>Lymphedema</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>According to Swedish law, sharing IPD is not possible. De-identified data can be shared on request</ipd_description> </patient_data>  </clinical_study>

Lymphedema in the head and neck area is common after treatment for head and neck cancer. The aim of the research project is: • to assess the prevalence of lymphedema in patients with head and neck cancer (HNC) by measuring the amount of tissue water in the head and neck area before and after different kinds of cancer treatment, and to evaluate the quality of life before and after cancer treatment. Measurement of tissue water is performed with a device (MoistureMeterD) see appendix 1. In addition, the neck circumference will be assessed with a measuring tape, according to Purcell (9), see appendix 2. The measurement will be completed by Agneta Hagren, or one of her colleagues, with specific education. The assessments will be performed before treatment begins as part of the clinical routine (baseline), and at 3 months, and 9 months after treatment completion. Each participant will respond to quality-of-life QLQ-c30 and QLQ H&N35 questionnaires, appendix 3 and 4, at the same time points as the measurements of tissue water. Ratings of physical activity according to Frändin and Grimby will also be performed (23). The questionnaires will be sent home to the patients before the time for follow-up. A modified LyQLI questionnaire will be given to all patients with lymphedema and filled out at 3 and 9 months after treatment completion, appendix 5. Post-treatment measurements +/- four weeks of the dedicated time point will be considered appropriate. Discontinuing participation in the trial will be on: 1. Patient request 2. Locoregional tumor progression or failure during the study period. For example, residual neck tumor requiring neck dissection after (C)RT for OPC 3. Locoregional deep infection i.e., suspected abscess at the scheduled time points for measurements. Any interventional therapy for lymphedema during the follow-up is not cause for exclusion but will be registered. Patients treated for head and neck cancer at the ENT department and the Oncology department at Skane University Hospital Inclusion Criteria: - Biopsy or cytology confirmed HNC (all malignant types are accepted) from the oropharynx (OPC), oral cavity (OC) or neck metastases from unknown primary cancer of the head and neck (CUP). - Tumour stage T1-4, N0-3. - Planned for treatment with curative intent as recommended at the multidisciplinary tumour board. - Age >18 years. Able to give informed consent Exclusion Criteria: - Previous treatment of HNC or radiation to the head and neck area. - Planned surgery that includes free tissue transfer or pedicled flaps in the neck (local facial pedicled flaps are accepted). - Planned neck dissection involving less than three regions of the neck. - Planned proton therapy. - Pre-treatment surgery or Botox injections in the tissue in the head and neck area. - Pregnancy

NCT0531xxxx/NCT05316987.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/NCT05316987</url> </required_header> <id_info> <org_study_id>MS_ 270_2021</org_study_id> <nct_id>NCT05316987</nct_id> </id_info> <brief_title>Effect of NB-UVB on the Tissue Level of IL 15 and IL-15Rα in Active Non Segmental Vitiligo Cases.</brief_title> <official_title>Effect of Narrow Band Ultraviolet B on the Tissue Level of Interleukin 15 and Interleukin 15 Receptor Alpha Subunit in Active Non Segmental Vitiligo Cases.</official_title> <sponsors> <lead_sponsor> <agency>Cairo University</agency> <agency_class>Other</agency_class> </lead_sponsor> </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> This study aims at evaluating the effect of NB-UVB on tissue level of IL-15 and IL-15 receptor alpha subunit (IL-15Rα)(CD215) in active non segmental vitiligo. This in turn will shed light on the potential role of phototherapy as a safe mean of prevention of vitiligo recurrence as well as evaluating the utility of IL 15 and IL 15 Rα as markers of vitiligo activity/recurrence. </textblock> </brief_summary> <detailed_description> <textblock> Vitiligo is a T cell-mediated, autoimmune cutaneous disorder characterized by loss of functioning melanocytes from the basal layer of epidermis and/or hair follicles, leading to depigmented areas of the skin, mucous membranes, and/or hair (Strassner et al., 2018).  Multiple factors have been involved in disease development, with a prominent role of the immune system, in particular T cells. After repigmentation, vitiligo usually recurs in the same area, drawing attention to the fact that resident memory T cells (TRM) are present at the sites of vitiligo lesions. This was confirmed by a number of studies (Boniface et al., 2018 , Boniface& Seneschal., 2019 , Riding& Harris., 2019) showing that stable and active vitiligo perilesional skin is enriched with a population of CD8 TRM expressing both CD69 and CD103. CD8 TRM expressing CD103 are localized mainly in the epidermis. IL-15 is the only identified cytokine required for maintenance of CD8 TRM cells (Baumann et al., 2018 and Richmond et al., 2018).  Interleukin 15(IL-15) is one of Interleukin 2(IL-2) family members. It plays an important function in the pathogenesis of multiple cutaneous autoimmune diseases as psoriasis (Rückert et al.,2000) , alopecia areata (Ebrahim et al.,2019) and vitiligo (Atwa et al.,2020).  IL-15 receptor (IL-15R) is expressed on natural killer cells, dendritic cells, monocytes, fibroblasts, T cells and keratinocytes . IL-15R is composed of α (CD215), β (CD122), and γ (CD132) chains , The alpha chain occurs as both a soluble and a membrane-attached subunit (Vámosi et al., 2004 , Budagian et al., 2006 and Di Sabatino et al.,2011).  IL-15 stimulates neighbor cells by a trans-presentation mechanism through secretion of (IL-15. IL-15Rα complexes) from the surface of monocytes or dendritic cells into endosomes for its presentation in trans to neighboring cytotoxic cells or Natural killer cells ( Stonier & Schluns .,2010).  IL-15 enhances maturation and survival of natural killer (NK) cells, neutrophils, and Dendritic cells (DCS) (Di Sabatino et al.,2011). Additionally, IL-15 promotes NK cell cytotoxicity and cytokine production such as interferon gamma( IFN-γ )and tumour necrosis factor alfa (TNF-α) (Fehniger & Caligiuri .,2001). As for DCs, they regulate the development and survival of memory cytotoxic cells by IL-15 trans-presentation ( Budagian et al., 2006 and Stonier & Schluns.,2010). Furthermore, IL-15 promotes T-cell receptor-dependent proliferation of Th17 (Di Sabatino et al.,2011).  TRM primarily express the CD122 (IL-15R β) subunit, a shared component of the receptors for IL-2 and IL-15, whereas keratinocytes express more CD215(IL-15Rα) in lesional compared to non lesional skin which is consistent with an ability to present IL-15 to T cells in trans (Richmond et al., 2018).  CD122(IL-15R β) expression is significantly higher on melanocyte-specific T cells in both mouse and human vitiligo compared to endogenous memory T cells, suggesting that autoreactive T cells are more dependent on IL-15 than non-autoreactive T cells. In addition, anti-CD122 blocking antibody inhibit IL-15 mediated T cell survival but not IL-2-mediated proliferation in vitro. This is consistent with the role of IL-15 in mediating T cell survival, but not proliferation (Riding et al., 2018).  These findings are consistent with an important role of IL-15 in maintenance of autoreactive TRM cells in vitiligo and suggest that this could be an effective targeted treatment strategy for vitiligo patients ( Frisoli et al., 2020).  Phototherapy has been considered as a cornerstone in management of vitiligo patients (Esmat et al., 2017). Narrow band ultraviolet B (NB-UVB) has been found to be an effective and well-tolerated treatment option in vitiligo compared to other available photo(chemo)therapy options (Sokolova et al., 2015).  Regarding effect of Ultraviolet B treatment on IL-15 in normal skin, it was found to increase IL-15 expression in epidermal and dermal sheets as well as in cultured keratinocytes and dermal fibro-blasts (Mohamadzadeh et al.,1995). However, this was negated by Blauvet et al. in 1996 who proved that IL-15 expression is down regulated by UVB in cultured keratinocytes in a dose and time dependent manner (Blauvet et al., 1996). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 30, 2022</start_date> <completion_date type="Actual">July 30, 2022</completion_date> <primary_completion_date type="Actual">July 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>Diagnostic</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Effect of NB-UVB on tissue level of IL 15 and IL15Rα in active vitiligo</measure> <time_frame>4 month</time_frame> <description>Change of tissue level of Il-15 and IL-15Rα after 48 session of NB-UVB</description> </primary_outcome> <secondary_outcome> <measure>Effect of activity of vitiligo on tissue level of Il-15 and IL-15Rα</measure> <time_frame>4 months</time_frame> <description>Correlation between tissue level of Il-15 and IL-15Rα before and after NB-UVB with activity score (vitiligo digns of activity score from 0 to 15)</description> </secondary_outcome> <secondary_outcome> <measure>Effect of extent of vitiligo on tissue level of Il-15 and IL-15Rα</measure> <time_frame>4 month</time_frame> <description>Correlation between tissue level of Il-15 and IL-15Rα before and after NB-UVB with extent score (Vitiligo extent plus score )</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Active Non Segmental Vitiligo</condition> <arm_group> <arm_group_label>Active vitiligo patients</arm_group_label> <arm_group_type>Other</arm_group_type> <description>NBUVB</description> </arm_group> <intervention> <intervention_type>Radiation</intervention_type> <intervention_name>Narrow band ultraviolet B</intervention_name> <description>48 sessions of narrow band ultraviolet</description> <arm_group_label>Active vitiligo patients</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria:  - Age: ≥ 18 years.  - Both genders.  - Type of Vitiligo: non segmental vitiligo (NSV).  - Active disease for less than 6 months (VIDA ≥ +2).  - No systemic or topical treatment for vitiligo for at least one month.  Exclusion criteria:  - Patients less than 18 years.  - VIDA ≤ +1.  - Contraindications to phototherapy (precancerous conditions like  - Xeroderma pigmentosum , photosensitivity, history of arsenic intake,  - ionizing radiation, extensive previous exposure to PUVA, patients  - with a history of melanoma, atypical nevi, non-melanoma skin  - cancers and patients taking immunosuppressive medications ( Menter et al., 2010 and Mehta & Lim, 2016).  - Pregnancy and lactation .  - Patients who received systemic or topical treatment for the past  - month.  - patients having any autoimmune diseases . </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>Nourhan Emad</last_name> <role>Principal Investigator</role> <affiliation>Faculty of medicine kasr Elainy</affiliation> </overall_official> <location> <facility> <name>Nourhan Emad</name> <address> <city>Cairo</city> <state>Helwan</state> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>February 18, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 8, 2022</last_update_submitted> <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 10, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Nourhan Emad</investigator_full_name> <investigator_title>Principle investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Vitiligo</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>I will share the deidentified data sheet of the results of the trial</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_time_frame>Beginning 3 month and ending 12 month after article publication</ipd_time_frame> <ipd_access_criteria>Researchers who provide a methodologically sound proposal will be allowed to access the data to achieve aims in the approved proposal Proposal should be directed to nourhanemad693@gmail.com to gain access</ipd_access_criteria> </patient_data>  </clinical_study>

This study aims at evaluating the effect of NB-UVB on tissue level of IL-15 and IL-15 receptor alpha subunit (IL-15Rα)(CD215) in active non segmental vitiligo. This in turn will shed light on the potential role of phototherapy as a safe mean of prevention of vitiligo recurrence as well as evaluating the utility of IL 15 and IL 15 Rα as markers of vitiligo activity/recurrence. Vitiligo is a T cell-mediated, autoimmune cutaneous disorder characterized by loss of functioning melanocytes from the basal layer of epidermis and/or hair follicles, leading to depigmented areas of the skin, mucous membranes, and/or hair (Strassner et al., 2018). Multiple factors have been involved in disease development, with a prominent role of the immune system, in particular T cells. After repigmentation, vitiligo usually recurs in the same area, drawing attention to the fact that resident memory T cells (TRM) are present at the sites of vitiligo lesions. This was confirmed by a number of studies (Boniface et al., 2018 , Boniface& Seneschal., 2019 , Riding& Harris., 2019) showing that stable and active vitiligo perilesional skin is enriched with a population of CD8 TRM expressing both CD69 and CD103. CD8 TRM expressing CD103 are localized mainly in the epidermis. IL-15 is the only identified cytokine required for maintenance of CD8 TRM cells (Baumann et al., 2018 and Richmond et al., 2018). Interleukin 15(IL-15) is one of Interleukin 2(IL-2) family members. It plays an important function in the pathogenesis of multiple cutaneous autoimmune diseases as psoriasis (Rückert et al.,2000) , alopecia areata (Ebrahim et al.,2019) and vitiligo (Atwa et al.,2020). IL-15 receptor (IL-15R) is expressed on natural killer cells, dendritic cells, monocytes, fibroblasts, T cells and keratinocytes . IL-15R is composed of α (CD215), β (CD122), and γ (CD132) chains , The alpha chain occurs as both a soluble and a membrane-attached subunit (Vámosi et al., 2004 , Budagian et al., 2006 and Di Sabatino et al.,2011). IL-15 stimulates neighbor cells by a trans-presentation mechanism through secretion of (IL-15. IL-15Rα complexes) from the surface of monocytes or dendritic cells into endosomes for its presentation in trans to neighboring cytotoxic cells or Natural killer cells ( Stonier & Schluns .,2010). IL-15 enhances maturation and survival of natural killer (NK) cells, neutrophils, and Dendritic cells (DCS) (Di Sabatino et al.,2011). Additionally, IL-15 promotes NK cell cytotoxicity and cytokine production such as interferon gamma( IFN-γ )and tumour necrosis factor alfa (TNF-α) (Fehniger & Caligiuri .,2001). As for DCs, they regulate the development and survival of memory cytotoxic cells by IL-15 trans-presentation ( Budagian et al., 2006 and Stonier & Schluns.,2010). Furthermore, IL-15 promotes T-cell receptor-dependent proliferation of Th17 (Di Sabatino et al.,2011). TRM primarily express the CD122 (IL-15R β) subunit, a shared component of the receptors for IL-2 and IL-15, whereas keratinocytes express more CD215(IL-15Rα) in lesional compared to non lesional skin which is consistent with an ability to present IL-15 to T cells in trans (Richmond et al., 2018). CD122(IL-15R β) expression is significantly higher on melanocyte-specific T cells in both mouse and human vitiligo compared to endogenous memory T cells, suggesting that autoreactive T cells are more dependent on IL-15 than non-autoreactive T cells. In addition, anti-CD122 blocking antibody inhibit IL-15 mediated T cell survival but not IL-2-mediated proliferation in vitro. This is consistent with the role of IL-15 in mediating T cell survival, but not proliferation (Riding et al., 2018). These findings are consistent with an important role of IL-15 in maintenance of autoreactive TRM cells in vitiligo and suggest that this could be an effective targeted treatment strategy for vitiligo patients ( Frisoli et al., 2020). Phototherapy has been considered as a cornerstone in management of vitiligo patients (Esmat et al., 2017). Narrow band ultraviolet B (NB-UVB) has been found to be an effective and well-tolerated treatment option in vitiligo compared to other available photo(chemo)therapy options (Sokolova et al., 2015). Regarding effect of Ultraviolet B treatment on IL-15 in normal skin, it was found to increase IL-15 expression in epidermal and dermal sheets as well as in cultured keratinocytes and dermal fibro-blasts (Mohamadzadeh et al.,1995). However, this was negated by Blauvet et al. in 1996 who proved that IL-15 expression is down regulated by UVB in cultured keratinocytes in a dose and time dependent manner (Blauvet et al., 1996). Inclusion criteria: - Age: ≥ 18 years. - Both genders. - Type of Vitiligo: non segmental vitiligo (NSV). - Active disease for less than 6 months (VIDA ≥ +2). - No systemic or topical treatment for vitiligo for at least one month. Exclusion criteria: - Patients less than 18 years. - VIDA ≤ +1. - Contraindications to phototherapy (precancerous conditions like - Xeroderma pigmentosum , photosensitivity, history of arsenic intake, - ionizing radiation, extensive previous exposure to PUVA, patients - with a history of melanoma, atypical nevi, non-melanoma skin - cancers and patients taking immunosuppressive medications ( Menter et al., 2010 and Mehta & Lim, 2016). - Pregnancy and lactation . - Patients who received systemic or topical treatment for the past - month. - patients having any autoimmune diseases .

NCT0531xxxx/NCT05317000.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/NCT05317000</url> </required_header> <id_info> <org_study_id>2000025632</org_study_id> <nct_id>NCT05317000</nct_id> </id_info> <brief_title>5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC</brief_title> <official_title>A Window Trial of 5-Azacytidine or Nivolumab or Combination Nivolumab Plus 5-Azacytidine in Resectable HPV-Associated Head and Neck Squamous Cell Cancer</official_title> <sponsors> <lead_sponsor> <agency>Barbara Burtness</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Yale University</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 study is being done because both 5-azacytidine and nivolumab can influence the immune system's response to HPV-associated head and neck cancer, and we wish to evaluate whether taking 5-azacytidine will make HPV-associated head and neck cancer more sensitive to treatment with nivolumab.  5-Azacytidine (5-AZA) is a chemotherapy, and nivolumab is an immunotherapy. Both drugs are approved for use in the US by the Food and Drug Administration (FDA) for use in the treatment of different types of cancer, and nivolumab is approved for use in head and neck cancer that has previously been treated with chemotherapy. Because they are not approved to be used together in HPV-associated head and neck cancer, these drugs are considered experimental in this study. For this study, the drugs will be used either together or separately. </textblock> </brief_summary> <detailed_description> <textblock> This Phase 0 study is a 3-arm window trial, randomizing patients to pre-operative treatment with 5-azacytidine alone, to nivolumab alone, or the combination of 5-azacytidine and nivolumab. The primary endpoint is immune-related pathologic response, employing the quantitative immune-related pathologic response criteria (ir-PRC) of Cottrell et al. The secondary endpoint is augmentation of tumor infiltration of the tumor microenvironment as determined by a quantitative immunofluorescence score (QIF) measuring CD3+ lymphocytes and granzyme B expression. Secondary endpoints are objective response by modified RECIST, change in Ki-67, change in caspase activity, toxicity and hyperprogression. Patients are eligible with T1-3, N0-2, M0 p16-positive squamous cell carcinoma of the oropharynx deemed resectable by a surgical co-investigator. Patients must have normal absolute lymphocyte count, adequate end organ function, and not require full dose anticoagulation. Patients must be capable of providing, and provide, written informed consent. Patients on Arm A receive 5-azacytidine 75mg/m2 IV once daily day 1-5. Patients on Arm B receive nivolumab 240 mg IV days 1 and 15. Patients on Arm C receive 5-azacytidine as described above and receive nivolumab 240 mg IV days 2 and 16. On arms A and B surgery is performed during the period of days 16 to 18, and on Arm C during the period of days 17 to 18. The study will enroll 8 patients to 5-azacytidine monotherapy and 20 patients per arm to nivolumab or 5-azacytidine/nivolumab combination and has an 80% power to detect a significant difference in immune-related pathologic response, according to the criteria of Cottrell, between the combination arm and each of the monotherapy arms considered separately, using a one-sided Fisher's exact test at a significance level of 0.10. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 23, 2023</start_date> <completion_date type="Anticipated">February 2026</completion_date> <primary_completion_date type="Anticipated">September 2025</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> <intervention_model_description>This Phase 0 study is a 3-arm window trial, randomizing patients to pre-operative treatment with 5-azacytidine alone, to nivolumab alone, or the combination of 5-azacytidine and nivolumab.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Increased response for combination therapy compared with either monotherapy</measure> <time_frame>Day 16-18</time_frame> <description>As assessed by the ir-PRC of Cottrell.</description> </primary_outcome> <secondary_outcome> <measure>Increased activated T cell infiltration in 5-Aza containing arms compared to Nivolumab monotherapy arm</measure> <time_frame>Day 16-18</time_frame> <description>As confirmed by quantitative immunofluorescence for CD3+ cells and granzyme B expression.</description> </secondary_outcome> <secondary_outcome> <measure>Objective response proportion</measure> <time_frame>Day 16-18</time_frame> <description>As determined with modified RECIST.</description> </secondary_outcome> <secondary_outcome> <measure>Secondary correlative evidence of anti-tumor response</measure> <time_frame>Screening pre-treatment specimen Day - 8 through day -1; post treatment specimen Day 16-18</time_frame> <description>As captured with tumoral Ki-67 and caspase staining on pre- and post-treatment specimens.</description> </secondary_outcome> <secondary_outcome> <measure>Occurrence of toxicity</measure> <time_frame>Time of 1st treatment to 30 days post</time_frame> <description>Adverse Events occurrence (Common Toxicity Criteria for Adverse Events), Immune-related adverse events of special interest, and hyperprogression will be captured.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">50</enrollment> <condition>Squamous Cell Carcinoma of Head and Neck</condition> <arm_group> <arm_group_label>Arm A: 5-azacytidine</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients will receive 5-azacytidine 75mg/m2 IV daily x 5. Treatment must begin on a Monday. Patients will receive anti-emetic premedication with prochlorperazine 10 mg IV, a 5HT3 antagonist per institutional guidelines, aprepitant or fos-aprepitant, and prn lorazepam on day 1. Day 2-5 patients will receive prochlorperazine 10 mg IV. Subsequent day 5HT3 antagonist therapy will be determined per institutional guidelines, as recommendations vary based on the half-life of the agent chosen. PRN lorazepam can be used days 2-5. Dexamethasone will be reserved for patients who are not controlled by the initial regimen. A single cycle of 5-azacytidine will be administered and the patient scheduled for surgery in the period of day 16 through day 18.</description> </arm_group> <arm_group> <arm_group_label>Arm B: Nivolumab</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Nivolumab will be administered at a dose of 240 mg IV day 1 and day 15. Treatment must be given on a Monday or Tuesday. No premedication will be given. Patients will be observed following the initial dose of nivolumab per institutional Surgery will be scheduled in the period of day 16 through day 18.</description> </arm_group> <arm_group> <arm_group_label>Arm C: Combination 5-azacytidine and Nivolumab</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients will receive 5-azacytidine 75mg/m2 IV daily x 5. Treatment must begin on a Monday. 5-azacytidine will be given prior to nivolumab on day 2. Patients will receive anti-emetic premedication with prochlorperazine 10 mg IV, a 5HT3 antagonist per institutional guidelines, aprepitant or fos-aprepitant, and prn lorazepam on day 1. Day 2-5 patients will receive prochlorperazine 10 mg IV. Subsequent day 5HT3 antagonist therapy will be determined per institutional guidelines, as recommendations vary based on the half-life of the agent chosen. PRN lorazepam can be used days 2-5. Nivolumab will be administered at a dose of 240 mg IV day 2 and day 16. No additional premedication will be given on day 16. Dexamethasone will be reserved for patients whose nausea and/or emesis is not controlled by the initial regimen. Surgery will be scheduled in the period of day 17 through day 18.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Combination 5-azacytidine and nivolumab</intervention_name> <description>The primary objective of the study is to determine whether exposure to the demethylating agent 5-azacytidine will sensitize HPV-associated oropharynx cancer to nivolumab by induction of interferon response, neoantigen expression, and augmentation of lymphocyte infiltration of the tumor microenvironment.</description> <arm_group_label>Arm C: Combination 5-azacytidine and Nivolumab</arm_group_label> <other_name>Vidaza and Opdivo</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>5-azacytidine</intervention_name> <description>Chemotherapy is the use of drugs to destroy cancer cells. It usually works by keeping the cancer cells from growing, dividing, and making more cells. Because cancer cells usually grow and divide faster than normal cells, chemotherapy has more of an effect on cancer cells. 5-azacytidine works by slowing down the growth of cancer cells. 5-azacytidine has been demonstrated to improve the cell's ability to make some proteins which signal to the immune system.</description> <arm_group_label>Arm A: 5-azacytidine</arm_group_label> <other_name>Vidaza</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Nivolumab</intervention_name> <description>Immunotherapy is a type of treatment that uses your body's own immune system to help fight cancer. Specifically, Nivolumab belongs to a class of anti-cancer drugs known as immune checkpoint inhibitors. Cancer cells are able to "turn off" the immune system by increasing the production of a protein called PD-1. Nivolumab can block PD-1 and may be able to re-activate the immune response to kill head and neck cancer cells.</description> <arm_group_label>Arm B: Nivolumab</arm_group_label> <other_name>Opdivo</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patients with resectable histologically or cytologically confirmed squamous cell carcinoma of the oropharynx.  2. T1-T3, N0-N2, M0 stage by AJCC 8th edition for HPV-initiated oropharynx cancer.  3. Resectability confirmed by a surgical co-investigator; evaluation may include operative endoscopy to discover second primaries and map tumor extent with biopsy  4. In addition to diagnostic biopsies, biopsies in clinic or at the time of operative endoscopy are required to yield primary tumor for research purposes equivalent to or greater than 3mm cup forceps biopsies X 3.  5. HPV-association confirmed by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells).  6. Age > 18 years. 5-azacytidine and nivolumab are tolerated in the elderly and there is no upper age limit for patients with adequate performance status.  7. Males and females are eligible.  8. ECOG performance status 0 or 1.  9. Absolute neutrophil count (ANC) > 1500/microliter, absolute lymphocyte count (ALC) > 1000/microliter, hemoglobin > 9 g/dl, platelets > 100,000/microliter.  10. AST and ALT < 2.5 x upper limit of normal. Bilirubin < 1.5 x upper limit of normal.  11. Albumin > 3.0 g/dl.  12. Creatinine < 1.5 x upper limit of normal.  13. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window.  14. Willing and able to provide written informed consent.  Exclusion Criteria:  1. Medical contraindication to transoral surgery.  2. Full dose anticoagulation.  3. Concomitant invasive malignancy, or malignancy within 2 years except for hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma.  4. Inability to give informed consent.  5. Prior systemic therapy, radiation, or gross resection for the tumor under study.  6. Women may not be pregnant or breast-feeding.  7. Patients with active autoimmune disease, supraphysiologic systemic corticosteroid use within 7 days, and/or allergies/contraindications to the study drugs are excluded. </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>Barbara Burtness, MD</last_name> <role>Principal Investigator</role> <affiliation>Yale University</affiliation> </overall_official> <overall_contact> <last_name>Maxime Oriol</last_name> <phone>203-785-6497</phone> <email>maxime.oriol@yale.edu</email> </overall_contact> <overall_contact_backup> <last_name>Julie Holub</last_name> <email>Julie.holub@yale.edu</email> </overall_contact_backup> <location> <facility> <name>Yale University</name> <address> <city>New Haven</city> <state>Connecticut</state> <zip>06511</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kwasi Boateng</last_name> <email>kwasi.boateng@yale.edu</email> </contact> <contact_backup> <last_name>Barbara Burtness, MD</last_name> <phone>(203) 737-7636</phone> <email>barbara.burtness@yale.edu</email> </contact_backup> <investigator> <last_name>Barbara Burtness, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <results_reference> <citation>Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.</citation> <PMID>20530316</PMID> </results_reference> <results_reference> <citation>Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.</citation> <PMID>27718784</PMID> </results_reference> <results_reference> <citation>Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ; KEYNOTE-040 investigators. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019 Jan 12;393(10167):156-167. doi: 10.1016/S0140-6736(18)31999-8. Epub 2018 Nov 30. Erratum In: Lancet. 2019 Jan 12;393(10167):132.</citation> <PMID>30509740</PMID> </results_reference> <results_reference> <citation>Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1. Erratum In: Lancet. 2020 Jan 25;395(10220):272. Lancet. 2020 Feb 22;395(10224):564. Lancet. 2021 Jun 12;397(10291):2252.</citation> <PMID>31679945</PMID> </results_reference> <results_reference> <citation>Vos JL, Elbers JBW, Krijgsman O, Traets JJH, Qiao X, van der Leun AM, Lubeck Y, Seignette IM, Smit LA, Willems SM, van den Brekel MWM, Dirven R, Baris Karakullukcu M, Karssemakers L, Klop WMC, Lohuis PJFM, Schreuder WH, Smeele LE, van der Velden LA, Bing Tan I, Onderwater S, Jasperse B, Vogel WV, Al-Mamgani A, Keijser A, van der Noort V, Broeks A, Hooijberg E, Peeper DS, Schumacher TN, Blank CU, de Boer JP, Haanen JBAG, Zuur CL. Neoadjuvant immunotherapy with nivolumab and ipilimumab induces major pathological responses in patients with head and neck squamous cell carcinoma. Nat Commun. 2021 Dec 22;12(1):7348. doi: 10.1038/s41467-021-26472-9.</citation> <PMID>34937871</PMID> </results_reference> <results_reference> <citation>Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14. Erratum In: Clin Cancer Res. 2021 Jan 1;27(1):357.</citation> <PMID>32665297</PMID> </results_reference> <results_reference> <citation>Schoenfeld JD, Hanna GJ, Jo VY, Rawal B, Chen YH, Catalano PS, Lako A, Ciantra Z, Weirather JL, Criscitiello S, Luoma A, Chau N, Lorch J, Kass JI, Annino D, Goguen L, Desai A, Ross B, Shah HJ, Jacene HA, Margalit DN, Tishler RB, Wucherpfennig KW, Rodig SJ, Uppaluri R, Haddad RI. Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Untreated Oral Cavity Squamous Cell Carcinoma: A Phase 2 Open-Label Randomized Clinical Trial. JAMA Oncol. 2020 Oct 1;6(10):1563-1570. doi: 10.1001/jamaoncol.2020.2955.</citation> <PMID>32852531</PMID> </results_reference> <results_reference> <citation>Cannataro VL, Gaffney SG, Sasaki T, Issaeva N, Grewal NKS, Grandis JR, Yarbrough WG, Burtness B, Anderson KS, Townsend JP. APOBEC-induced mutations and their cancer effect size in head and neck squamous cell carcinoma. Oncogene. 2019 May;38(18):3475-3487. doi: 10.1038/s41388-018-0657-6. Epub 2019 Jan 15.</citation> <PMID>30647454</PMID> </results_reference> <results_reference> <citation>Hajek M, Sewell A, Kaech S, Burtness B, Yarbrough WG, Issaeva N. TRAF3/CYLD mutations identify a distinct subset of human papillomavirus-associated head and neck squamous cell carcinoma. Cancer. 2017 May 15;123(10):1778-1790. doi: 10.1002/cncr.30570. Epub 2017 Mar 13.</citation> <PMID>28295222</PMID> </results_reference> <results_reference> <citation>Cancer Genome Atlas Network. Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature. 2015 Jan 29;517(7536):576-82. doi: 10.1038/nature14129.</citation> <PMID>25631445</PMID> </results_reference> <results_reference> <citation>Biktasova A, Hajek M, Sewell A, Gary C, Bellinger G, Deshpande HA, Bhatia A, Burtness B, Judson B, Mehra S, Yarbrough WG, Issaeva N. Demethylation Therapy as a Targeted Treatment for Human Papillomavirus-Associated Head and Neck Cancer. Clin Cancer Res. 2017 Dec 1;23(23):7276-7287. doi: 10.1158/1078-0432.CCR-17-1438. Epub 2017 Sep 15.</citation> <PMID>28916527</PMID> </results_reference> <results_reference> <citation>Faden DL, Ding F, Lin Y, Zhai S, Kuo F, Chan TA, Morris LG, Ferris RL. APOBEC mutagenesis is tightly linked to the immune landscape and immunotherapy biomarkers in head and neck squamous cell carcinoma. Oral Oncol. 2019 Sep;96:140-147. doi: 10.1016/j.oraloncology.2019.07.020. Epub 2019 Jul 30.</citation> <PMID>31422205</PMID> </results_reference> <results_reference> <citation>Cristescu R, Mogg R, Ayers M, Albright A, Murphy E, Yearley J, Sher X, Liu XQ, Lu H, Nebozhyn M, Zhang C, Lunceford JK, Joe A, Cheng J, Webber AL, Ibrahim N, Plimack ER, Ott PA, Seiwert TY, Ribas A, McClanahan TK, Tomassini JE, Loboda A, Kaufman D. Pan-tumor genomic biomarkers for PD-1 checkpoint blockade-based immunotherapy. Science. 2018 Oct 12;362(6411):eaar3593. doi: 10.1126/science.aar3593. Erratum In: Science. 2019 Mar 1;363(6430):</citation> <PMID>30309915</PMID> </results_reference> <results_reference> <citation>Glimelius B, Lahn M. Window-of-opportunity trials to evaluate clinical activity of new molecular entities in oncology. Ann Oncol. 2011 Aug;22(8):1717-25. doi: 10.1093/annonc/mdq622. Epub 2011 Jan 13.</citation> <PMID>21239400</PMID> </results_reference> <results_reference> <citation>Zandberg DP, Ferris RL. Window Studies in Squamous Cell Carcinoma of the Head and Neck: Values and Limits. Curr Treat Options Oncol. 2018 Oct 27;19(12):68. doi: 10.1007/s11864-018-0587-0.</citation> <PMID>30367283</PMID> </results_reference> <results_reference> <citation>Levy BP, Giaccone G, Besse B, Felip E, Garassino MC, Domine Gomez M, Garrido P, Piperdi B, Ponce-Aix S, Menezes D, MacBeth KJ, Risueno A, Slepetis R, Wu X, Fandi A, Paz-Ares L. Randomised phase 2 study of pembrolizumab plus CC-486 versus pembrolizumab plus placebo in patients with previously treated advanced non-small cell lung cancer. Eur J Cancer. 2019 Feb;108:120-128. doi: 10.1016/j.ejca.2018.11.028. Epub 2019 Jan 14.</citation> <PMID>30654297</PMID> </results_reference> <results_reference> <citation>Cottrell TR, Thompson ED, Forde PM, Stein JE, Duffield AS, Anagnostou V, Rekhtman N, Anders RA, Cuda JD, Illei PB, Gabrielson E, Askin FB, Niknafs N, Smith KN, Velez MJ, Sauter JL, Isbell JM, Jones DR, Battafarano RJ, Yang SC, Danilova L, Wolchok JD, Topalian SL, Velculescu VE, Pardoll DM, Brahmer JR, Hellmann MD, Chaft JE, Cimino-Mathews A, Taube JM. Pathologic features of response to neoadjuvant anti-PD-1 in resected non-small-cell lung carcinoma: a proposal for quantitative immune-related pathologic response criteria (irPRC). Ann Oncol. 2018 Aug 1;29(8):1853-1860. doi: 10.1093/annonc/mdy218.</citation> <PMID>29982279</PMID> </results_reference> <results_reference> <citation>Gettinger SN, Choi J, Mani N, Sanmamed MF, Datar I, Sowell R, Du VY, Kaftan E, Goldberg S, Dong W, Zelterman D, Politi K, Kavathas P, Kaech S, Yu X, Zhao H, Schlessinger J, Lifton R, Rimm DL, Chen L, Herbst RS, Schalper KA. A dormant TIL phenotype defines non-small cell lung carcinomas sensitive to immune checkpoint blockers. Nat Commun. 2018 Aug 10;9(1):3196. doi: 10.1038/s41467-018-05032-8.</citation> <PMID>30097571</PMID> </results_reference> <results_reference> <citation>Schalper KA, Brown J, Carvajal-Hausdorf D, McLaughlin J, Velcheti V, Syrigos KN, Herbst RS, Rimm DL. Objective measurement and clinical significance of TILs in non-small cell lung cancer. J Natl Cancer Inst. 2015 Feb 3;107(3):dju435. doi: 10.1093/jnci/dju435. Print 2015 Mar.</citation> <PMID>25650315</PMID> </results_reference> <verification_date>April 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 19, 2023</last_update_submitted> <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 20, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Yale University</investigator_affiliation> <investigator_full_name>Barbara Burtness</investigator_full_name> <investigator_title>Professor of Medicine, Medical Oncology</investigator_title> </responsible_party> <keyword>HPV- Associated Head and Neck Squamous Cell Cancer</keyword> <condition_browse>  <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Nivolumab</mesh_term> <mesh_term>Azacitidine</mesh_term> </intervention_browse>  </clinical_study>

This study is being done because both 5-azacytidine and nivolumab can influence the immune system's response to HPV-associated head and neck cancer, and we wish to evaluate whether taking 5-azacytidine will make HPV-associated head and neck cancer more sensitive to treatment with nivolumab. 5-Azacytidine (5-AZA) is a chemotherapy, and nivolumab is an immunotherapy. Both drugs are approved for use in the US by the Food and Drug Administration (FDA) for use in the treatment of different types of cancer, and nivolumab is approved for use in head and neck cancer that has previously been treated with chemotherapy. Because they are not approved to be used together in HPV-associated head and neck cancer, these drugs are considered experimental in this study. For this study, the drugs will be used either together or separately. This Phase 0 study is a 3-arm window trial, randomizing patients to pre-operative treatment with 5-azacytidine alone, to nivolumab alone, or the combination of 5-azacytidine and nivolumab. The primary endpoint is immune-related pathologic response, employing the quantitative immune-related pathologic response criteria (ir-PRC) of Cottrell et al. The secondary endpoint is augmentation of tumor infiltration of the tumor microenvironment as determined by a quantitative immunofluorescence score (QIF) measuring CD3+ lymphocytes and granzyme B expression. Secondary endpoints are objective response by modified RECIST, change in Ki-67, change in caspase activity, toxicity and hyperprogression. Patients are eligible with T1-3, N0-2, M0 p16-positive squamous cell carcinoma of the oropharynx deemed resectable by a surgical co-investigator. Patients must have normal absolute lymphocyte count, adequate end organ function, and not require full dose anticoagulation. Patients must be capable of providing, and provide, written informed consent. Patients on Arm A receive 5-azacytidine 75mg/m2 IV once daily day 1-5. Patients on Arm B receive nivolumab 240 mg IV days 1 and 15. Patients on Arm C receive 5-azacytidine as described above and receive nivolumab 240 mg IV days 2 and 16. On arms A and B surgery is performed during the period of days 16 to 18, and on Arm C during the period of days 17 to 18. The study will enroll 8 patients to 5-azacytidine monotherapy and 20 patients per arm to nivolumab or 5-azacytidine/nivolumab combination and has an 80% power to detect a significant difference in immune-related pathologic response, according to the criteria of Cottrell, between the combination arm and each of the monotherapy arms considered separately, using a one-sided Fisher's exact test at a significance level of 0.10. Inclusion Criteria: 1. Patients with resectable histologically or cytologically confirmed squamous cell carcinoma of the oropharynx. 2. T1-T3, N0-N2, M0 stage by AJCC 8th edition for HPV-initiated oropharynx cancer. 3. Resectability confirmed by a surgical co-investigator; evaluation may include operative endoscopy to discover second primaries and map tumor extent with biopsy 4. In addition to diagnostic biopsies, biopsies in clinic or at the time of operative endoscopy are required to yield primary tumor for research purposes equivalent to or greater than 3mm cup forceps biopsies X 3. 5. HPV-association confirmed by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells). 6. Age > 18 years. 5-azacytidine and nivolumab are tolerated in the elderly and there is no upper age limit for patients with adequate performance status. 7. Males and females are eligible. 8. ECOG performance status 0 or 1. 9. Absolute neutrophil count (ANC) > 1500/microliter, absolute lymphocyte count (ALC) > 1000/microliter, hemoglobin > 9 g/dl, platelets > 100,000/microliter. 10. AST and ALT < 2.5 x upper limit of normal. Bilirubin < 1.5 x upper limit of normal. 11. Albumin > 3.0 g/dl. 12. Creatinine < 1.5 x upper limit of normal. 13. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. 14. Willing and able to provide written informed consent. Exclusion Criteria: 1. Medical contraindication to transoral surgery. 2. Full dose anticoagulation. 3. Concomitant invasive malignancy, or malignancy within 2 years except for hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma. 4. Inability to give informed consent. 5. Prior systemic therapy, radiation, or gross resection for the tumor under study. 6. Women may not be pregnant or breast-feeding. 7. Patients with active autoimmune disease, supraphysiologic systemic corticosteroid use within 7 days, and/or allergies/contraindications to the study drugs are excluded.

NCT0531xxxx/NCT05317013.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/NCT05317013</url> </required_header> <id_info> <org_study_id>710022US1314</org_study_id> <nct_id>NCT05317013</nct_id> </id_info> <brief_title>CBD in Postmenopausal Women With Osteopenia</brief_title> <official_title>A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Preliminary Effects of CHI-554 in Postmenopausal Women With Osteopenia</official_title> <sponsors> <lead_sponsor> <agency>Canopy Growth Corporation</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>NM Clinical Research & Osteoporosis Center, Inc.</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Canopy Growth Corporation</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 is a Phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of CHI-554 in postmenopausal women ages 50-80 years who have osteopenia. </textblock> </brief_summary> <overall_status>Terminated</overall_status> <why_stopped> Low enrollment </why_stopped> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Actual">September 22, 2022</completion_date> <primary_completion_date type="Actual">September 22, 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>Parallel Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>Triple (Participant, Care Provider, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Safety and Tolerability: Adverse Events/Serious Adverse Events</measure> <time_frame>Week 4</time_frame> <description>Adverse Events/Serious Adverse Events</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Adverse Events/Serious Adverse Events</measure> <time_frame>Week 8</time_frame> <description>Adverse Events/Serious Adverse Events</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Adverse Events/Serious Adverse Events</measure> <time_frame>Week 12</time_frame> <description>Adverse Events/Serious Adverse Events</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Alanine aminotransferase (ALT)</measure> <time_frame>Week 4</time_frame> <description>Alanine aminotransferase</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Alanine aminotransferase (ALT)</measure> <time_frame>Week 12</time_frame> <description>Alanine aminotransferase</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Aspartate aminotransferase (AST)</measure> <time_frame>Week 4</time_frame> <description>Aspartate aminotransferase</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Aspartate aminotransferase (AST)</measure> <time_frame>Week 12</time_frame> <description>Aspartate aminotransferase</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Total bilirubin</measure> <time_frame>Week 4</time_frame> <description>Total bilirubin</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Total bilirubin</measure> <time_frame>Week 12</time_frame> <description>Total bilirubin</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Blood pressure</measure> <time_frame>Week 4</time_frame> <description>Blood pressure - Systolic and diastolic blood pressure</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Blood pressure</measure> <time_frame>Week 12</time_frame> <description>Blood pressure - Systolic and diastolic blood pressure</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Heart rate</measure> <time_frame>Week 4</time_frame> <description>Heart rate</description> </primary_outcome> <primary_outcome> <measure>Safety and Tolerability: Heart rate</measure> <time_frame>Week 12</time_frame> <description>Heart rate</description> </primary_outcome> <secondary_outcome> <measure>Serum CTx</measure> <time_frame>Week 4</time_frame> <description>Serum CTx</description> </secondary_outcome> <secondary_outcome> <measure>Serum CTx</measure> <time_frame>Week 12</time_frame> <description>Serum CTx</description> </secondary_outcome> <secondary_outcome> <measure>Serum P1NP</measure> <time_frame>Week 4</time_frame> <description>Serum P1NP</description> </secondary_outcome> <secondary_outcome> <measure>Serum P1NP</measure> <time_frame>Week 12</time_frame> <description>Serum P1NP</description> </secondary_outcome> <secondary_outcome> <measure>Serum Osteocalcin</measure> <time_frame>Week 4</time_frame> <description>Serum Osteocalcin</description> </secondary_outcome> <secondary_outcome> <measure>Serum Osteocalcin</measure> <time_frame>Week 12</time_frame> <description>Serum Osteocalcin</description> </secondary_outcome> <secondary_outcome> <measure>Serum Bone-specific alkaline phosphatase</measure> <time_frame>Week 4</time_frame> <description>Serum Bone-specific alkaline phosphatase</description> </secondary_outcome> <secondary_outcome> <measure>Serum Bone-specific alkaline phosphatase</measure> <time_frame>Week 12</time_frame> <description>Serum Bone-specific alkaline phosphatase</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">2</enrollment> <condition>Osteopenia</condition> <arm_group> <arm_group_label>Group A - 100 mg CBD</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>100 mg CBD per day</description> </arm_group> <arm_group> <arm_group_label>Group B - 300 mg CBD</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>300 mg CBD per day</description> </arm_group> <arm_group> <arm_group_label>Group C - Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Placebo</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>CBD</intervention_name> <description>CBD</description> <arm_group_label>Group A - 100 mg CBD</arm_group_label> <arm_group_label>Group B - 300 mg CBD</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo</description> <arm_group_label>Group C - Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Is a female aged 50-80 years, inclusive, at the time of screening.  - Is postmenopausal, defined as > or = 12 months amenorrhoea.  - Has osteopenia, defined as T score at lumbar spine or femoral neck or total femur of less than -1.0, but not less than or equal to -2.5, according to dual energy x-ray absorptiometry (DXA) completed at the Screening Visit or performed at NM Clinical Research & Osteoporosis Center up to 6 months prior to the Screening Visit.  - Has been on a stable dose of 500 mg calcium daily for at least 7 days prior to Visit 1.  - Has a body mass index between 18 and 35 kg/m2 (inclusive).  - Is judged by the Investigator to be in generally good health at screening based on participants' medical history.  - Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.  Exclusion Criteria:  - Has a history of epilepsy, hepatitis, or human immunodeficiency virus.  - Current or history of use of one or more prohibited medications (as described in Section 8.2.1.1).  - Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the 4 weeks prior to the Screening Visit.  - Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal (ULN), or bilirubin >2× ULN.  - Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.  - Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).  - Has taken grapefruit products and/or Seville oranges within the 7 days prior to Visit 1.  - Positive urine dipstick results for THC at the Screening Visit.  - Has a history or current diagnosis of a significant psychiatric disorder, including alcohol or substance use disorder, that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.  - Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.  - Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.  - History of Osteoporosis diagnosis. </textblock> </criteria> <gender>Female</gender> <minimum_age>50 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Lance Rudolph, MD</last_name> <role>Principal Investigator</role> <affiliation>NM Clinical Research & Osteoporosis Center, Inc.</affiliation> </overall_official> <location> <facility> <name>NM Clinical Research & Osteoporosis Center, Inc.</name> <address> <city>Albuquerque</city> <state>New Mexico</state> <zip>87106</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>September 22, 2022</last_update_submitted> <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 23, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Bone Diseases, Metabolic</mesh_term> </condition_browse>  </clinical_study>

This is a Phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of CHI-554 in postmenopausal women ages 50-80 years who have osteopenia. Inclusion Criteria: - Is a female aged 50-80 years, inclusive, at the time of screening. - Is postmenopausal, defined as > or = 12 months amenorrhoea. - Has osteopenia, defined as T score at lumbar spine or femoral neck or total femur of less than -1.0, but not less than or equal to -2.5, according to dual energy x-ray absorptiometry (DXA) completed at the Screening Visit or performed at NM Clinical Research & Osteoporosis Center up to 6 months prior to the Screening Visit. - Has been on a stable dose of 500 mg calcium daily for at least 7 days prior to Visit 1. - Has a body mass index between 18 and 35 kg/m2 (inclusive). - Is judged by the Investigator to be in generally good health at screening based on participants' medical history. - Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening. Exclusion Criteria: - Has a history of epilepsy, hepatitis, or human immunodeficiency virus. - Current or history of use of one or more prohibited medications (as described in Section 8.2.1.1). - Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the 4 weeks prior to the Screening Visit. - Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal (ULN), or bilirubin >2× ULN. - Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP. - Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides). - Has taken grapefruit products and/or Seville oranges within the 7 days prior to Visit 1. - Positive urine dipstick results for THC at the Screening Visit. - Has a history or current diagnosis of a significant psychiatric disorder, including alcohol or substance use disorder, that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements. - Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study. - Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol. - History of Osteoporosis diagnosis.

NCT0531xxxx/NCT05317026.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/NCT05317026</url> </required_header> <id_info> <org_study_id>2022-10542</org_study_id> <nct_id>NCT05317026</nct_id> </id_info> <brief_title>Increased Early Pain Relief by Adding Vertebroplasty to SBRT</brief_title> <official_title>Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief</official_title> <sponsors> <lead_sponsor> <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Centre hospitalier de l'Université de Montréal (CHUM)</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 goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 3, 2023</start_date> <completion_date type="Anticipated">August 31, 2026</completion_date> <primary_completion_date type="Anticipated">April 4, 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>Pain change at 1 month</measure> <time_frame>1 month following the treatment</time_frame> <description>Visual Analogue Scale, from 0 to 10, 10 being the highest pain</description> </primary_outcome> <secondary_outcome> <measure>Pain change</measure> <time_frame>1 week, 1 month, 3 months and 6 months post treatment</time_frame> <description>Visual Analogue Scale, from 0 to 10, 10 being the highest pain</description> </secondary_outcome> <secondary_outcome> <measure>Change in level of physical, psychological and social functions</measure> <time_frame>at 1 week, 1 month, 3 months and 6 months post treatment</time_frame> <description>EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)</description> </secondary_outcome> <secondary_outcome> <measure>Change in symptoms related to bone metastasis</measure> <time_frame>at 1 week, 1 month, 3 months and 6 months post treatment</time_frame> <description>QLQ-Bone metastases : BM22 questionnaire (All of the scales range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems, whilst a high score for the functional scales represents a high level of functioning)</description> </secondary_outcome> <secondary_outcome> <measure>Change in performance for activities of daily living</measure> <time_frame>at 1 week, 1 month, 3 months and 6 months post treatment</time_frame> <description>Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance)</description> </secondary_outcome> <secondary_outcome> <measure>Post-treatment fracture rates</measure> <time_frame>at 3, 6, 12 and 24 months post treatment</time_frame> <description>evaluation by MRI +/- CT imaging</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">50</enrollment> <condition>Spine Metastases</condition> <condition>Radiation Therapy</condition> <condition>Pain</condition> <arm_group> <arm_group_label>V-SBRT</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)</description> </arm_group> <arm_group> <arm_group_label>SBRT</arm_group_label> <arm_group_type>Other</arm_group_type> <description>SBRT is the actual standard of care.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Vertebroplasty</intervention_name> <description>SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume. The vertebroplasty will be performed according to the usual procedure at the center in the angiography suite under local anesthesia and conscious sedation Introduction of a vertebral needle, under biplanar fluoroscopic guidance, polymethylmethacrylate (PMMA) cement injection. Cone-beam volume-CT at the end of the procedure, with the angiography table and c-arm, to evaluate the cement distribution and detect any leak. Decubitus position for 2 hours following procedure, then hospital discharge on the same day.</description> <arm_group_label>V-SBRT</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Stereotactic Body Radiation Therapy only</intervention_name> <description>SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume</description> <arm_group_label>SBRT</arm_group_label> <other_name>SBRT</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Histological evidence of cancer.  - Spinal and vertebral bone metastases (T5 to L5) documented by imaging.  - Pain related to metastases ≥ 4 on a numerical scale 0-10.  - Karnofsky performance index > 60 (ecog 0-2)  - Candidate for SBRT  - Less than 3 consecutive levels reached.  - Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment.  - Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (> or = 7)  Exclusion Criteria:  - Pregnancy or breastfeeding.  - Contraindications to MRI.  - Histology: myeloma, lymphoma or plasmacytoma.  - Radiotherapy prior to the level to be treated.  - Previous surgery at the site to be treated.  - Surgical indication:  spinal instability neoplastic score (SINS) > 13 or according to tumor board consensus.  Bilsky score > or = 2 Severe or progressive neurological signs (motor, incontinence).  - Lesion too large for safe vertebroplasty.  - High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above).  - Non-reversible coagulation disorders.  - Uncontrolled local or systemic infection.  - Estimated survival of less than 6 months.  - Inability or refusal to undergo SBRT treatment or vertebroplasty </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>Véronique Freire, MD</last_name> <role>Principal Investigator</role> <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation> </overall_official> <overall_contact> <last_name>Véronique Freire, MD</last_name> <phone>514-890-8000</phone> <email>veronique.freire.med@ssss.gouv.qc.ca</email> </overall_contact> <overall_contact_backup> <last_name>Fidaa Al-Shakfa, M.sc.</last_name> <phone>514-890-8000</phone> <email>f.alshakfa.crchum@gmail.com</email> </overall_contact_backup> <location> <facility> <name>CHUM</name> <address> <city>Montréal</city> <state>Quebec</state> <zip>H2X0C1</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Veronique Freire, MD</last_name> <phone>514-883-6154</phone> <email>veronique.freire.med@ssss.gouv.qc.ca</email> </contact> <contact_backup> <last_name>Mom PHAT</last_name> <phone>514 890-8000</phone> <phone_ext>11171</phone_ext> </contact_backup> </location> <location> <facility> <name>Véronique Freire</name> <address> <city>Montréal</city> <state>Quebec</state> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Véronique Freire, MD</last_name> </contact> <investigator> <last_name>Laura Masucci, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>David Donath, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>David Roberge, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Taussky Daniel, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Shedid Daniel, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Sung-Joo Yuh, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Zhi Wang, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 8, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 19, 2023</last_update_submitted> <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 20, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Neoplasm Metastasis</mesh_term> </condition_browse>  </clinical_study>

The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain. Inclusion Criteria: - Histological evidence of cancer. - Spinal and vertebral bone metastases (T5 to L5) documented by imaging. - Pain related to metastases ≥ 4 on a numerical scale 0-10. - Karnofsky performance index > 60 (ecog 0-2) - Candidate for SBRT - Less than 3 consecutive levels reached. - Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment. - Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (> or = 7) Exclusion Criteria: - Pregnancy or breastfeeding. - Contraindications to MRI. - Histology: myeloma, lymphoma or plasmacytoma. - Radiotherapy prior to the level to be treated. - Previous surgery at the site to be treated. - Surgical indication: spinal instability neoplastic score (SINS) > 13 or according to tumor board consensus. Bilsky score > or = 2 Severe or progressive neurological signs (motor, incontinence). - Lesion too large for safe vertebroplasty. - High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above). - Non-reversible coagulation disorders. - Uncontrolled local or systemic infection. - Estimated survival of less than 6 months. - Inability or refusal to undergo SBRT treatment or vertebroplasty

NCT0531xxxx/NCT05317039.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/NCT05317039</url> </required_header> <id_info> <org_study_id>Piezosurgery_2021</org_study_id> <nct_id>NCT05317039</nct_id> </id_info> <brief_title>Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation</brief_title> <official_title>Evaluation of Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation Comparing Between Two Different Grafting Materials (a Randomized Clinical Trial)</official_title> <sponsors> <lead_sponsor> <agency>Hams Hamed Abdelrahman</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Alexandria 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> Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">August 15, 2021</start_date> <completion_date type="Anticipated">June 30, 2022</completion_date> <primary_completion_date type="Anticipated">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>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>change in alveolar ridge width</measure> <time_frame>at baseline and 6 months</time_frame> <description>All patients will receive a CBCT scan; immediately after surgery and at 6 months post-operatively. The images will be analyzed using OnDemand3D software (Cybermed Inc) CBCT analyzing software and compared to the pre-operative scan for alveolar ridge width evaluation.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">18</enrollment> <condition>Alveolar Bone Loss</condition> <arm_group> <arm_group_label>Group A</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group A will be treated with the buccal plate repositioning technique and grafted with SCPC.</description> </arm_group> <arm_group> <arm_group_label>Group B</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group B will be similarly managed and grafted using DFDBA</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>silica-calcium phosphate nanocomposite SCPC</intervention_name> <description>Patients will be treated with the buccal plate repositioning technique and grafted with SCPC then the grafted defect will be covered with a platelet-rich fibrin membrane.</description> <arm_group_label>Group A</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>freezed dried bone</intervention_name> <description>Patients will be treated with the buccal plate repositioning technique and grafted using DFDBA. then the grafted defect will be covered with a platelet-rich fibrin membrane.</description> <arm_group_label>Group B</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.  - Augmented area length in the mesial-distal direction of less than 20 mm.  - Adequate physically healthy condition.  Exclusion Criteria:  - A systemic disease that would contraindicate oral surgical treatment.  - Treated patients who had undergone therapy involving radiation  - Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.  - Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure. </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>50 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Alexandria Faculty of Dentistry</name> <address> <city>Alexandria</city> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Alexandria University</investigator_affiliation> <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name> <investigator_title>Assistant lecturer of DPH and Clinical statistician</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Alveolar Bone Loss</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Calcium</mesh_term> </intervention_browse>  </clinical_study>

Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed. Inclusion Criteria: - Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm. - Augmented area length in the mesial-distal direction of less than 20 mm. - Adequate physically healthy condition. Exclusion Criteria: - A systemic disease that would contraindicate oral surgical treatment. - Treated patients who had undergone therapy involving radiation - Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure. - Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.

NCT0531xxxx/NCT05317052.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/NCT05317052</url> </required_header> <id_info> <org_study_id>Amasya U</org_study_id> <nct_id>NCT05317052</nct_id> </id_info> <brief_title>The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development</brief_title> <official_title>From Non-Pharmacologıcal Methods Applied to Primipars in Travay; The Effect of Massage And Music Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development: A Randomized Controlled Study</official_title> <sponsors> <lead_sponsor> <agency>Amasya University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Amasya 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> Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research. </textblock> </brief_summary> <detailed_description> <textblock> Birth pain is one of the most severe and difficult to control pains known. Non-pharmacological methods used to cope with labor pain are cheap and reliable. Massage and music therapy in the first stage of labor are non-pharmacological methods used to reduce labor pain. The purpose of this research; non-pharmacological methods applied to primiparous in labor; The aim of this study is to examine the effects of massage and music therapy on labor pain, postpartum comfort and posttraumatic development. A total of 114 primiparous pregnant women who had a normal delivery expectation and were in the active phase of labor (4-5 cm dilatation) were planned to be included in the study. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 15, 2022</start_date> <completion_date type="Actual">July 1, 2022</completion_date> <primary_completion_date type="Actual">June 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> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Visual Analog Scale (VAS) Score</measure> <time_frame>In the labour (active and transition phase)</time_frame> <description>The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort</description> </primary_outcome> <secondary_outcome> <measure>Postpartum Comfort Scale</measure> <time_frame>At the enf of the delivery (In the 24 th hours)</time_frame> <description>It is possible to score between 34 and 170 on the scale. An increase in the scores obtained from the scale represents a high level of comfort.</description> </secondary_outcome> <secondary_outcome> <measure>Posttraumatic Growth Inventory</measure> <time_frame>At the enf of the delivery (In the 24 th hours)</time_frame> <description>A minimum of 0 and a maximum of 105 points can be obtained from the scale. As the score obtained from the scale increases, it is thought that the level of post-traumatic development is higher.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">105</enrollment> <condition>Labor Pain</condition> <condition>Posttraumatic Growth</condition> <arm_group> <arm_group_label>Massage</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Massage therapy</description> </arm_group> <arm_group> <arm_group_label>Music</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Music therapy</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Control</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Massage group</intervention_name> <description>Massage and music therapy</description> <arm_group_label>Massage</arm_group_label> <arm_group_label>Music</arm_group_label> <other_name>Music group</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Expectation of normal vaginal delivery  - Having a term pregnancy  - Being primiparous - Being in the active phase of labor (Cervical dilatation 4 cm)  - Single pregnancy  - Being in vertex presentation  - Uncomplicated prenatal process  - Volunteering to participate in the study  - Being pregnant without back pain  Exclusion Criteria:  - Pregnant women whose birth resulted in cesarean section due to failure of labor to progress during labor  - Pregnant women who did not undergo induction  - Pregnant women who underwent pharmacological intervention for labor pain </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Primiparous pregnant women</gender_description> <minimum_age>19 Years</minimum_age> <maximum_age>35 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Amasya University</name> <address> <city>Amasya</city> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>February 23, 2023</last_update_submitted> <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 24, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Amasya University</investigator_affiliation> <investigator_full_name>Emine Akca</investigator_full_name> <investigator_title>Clinical Researcher of the Amasya University Midwifery Department</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Labor Pain</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research. Birth pain is one of the most severe and difficult to control pains known. Non-pharmacological methods used to cope with labor pain are cheap and reliable. Massage and music therapy in the first stage of labor are non-pharmacological methods used to reduce labor pain. The purpose of this research; non-pharmacological methods applied to primiparous in labor; The aim of this study is to examine the effects of massage and music therapy on labor pain, postpartum comfort and posttraumatic development. A total of 114 primiparous pregnant women who had a normal delivery expectation and were in the active phase of labor (4-5 cm dilatation) were planned to be included in the study. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research. Inclusion Criteria: - Expectation of normal vaginal delivery - Having a term pregnancy - Being primiparous - Being in the active phase of labor (Cervical dilatation 4 cm) - Single pregnancy - Being in vertex presentation - Uncomplicated prenatal process - Volunteering to participate in the study - Being pregnant without back pain Exclusion Criteria: - Pregnant women whose birth resulted in cesarean section due to failure of labor to progress during labor - Pregnant women who did not undergo induction - Pregnant women who underwent pharmacological intervention for labor pain

NCT0531xxxx/NCT05317065.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/NCT05317065</url> </required_header> <id_info> <org_study_id>Amasya Univesity</org_study_id> <nct_id>NCT05317065</nct_id> </id_info> <brief_title>The Effect of Mindfulness-Based Stress Reduction Program (MBSR) in Risky Pregnants</brief_title> <official_title>The Effect of Mindfulness-Based Stress Reduction Program (MBSR) on Stress, Anxiety and Prenatal Attachment in Risky Pregnants</official_title> <sponsors> <lead_sponsor> <agency>Amasya University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Amasya 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> Risky pregnant women need various physical and mental health needs, they need to be informed and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group. </textblock> </brief_summary> <detailed_description> <textblock> Risky pregnancies are a situation that can negatively affect the health of the mother and the fetus, result in the loss of the baby, and bring about physical, social and mental changes. Mindfulness-based approaches have been used in solving both physical and mental problems in pregnant women and very positive results have been obtained. The aim of this study, which was carried out to determine the effect of mindfulness-based stress reduction program (MBSR) on stress, anxiety and prenatal attachment in high-risk pregnant women, is aimed at creating appropriate intervention programs for high-risk pregnancies and contributing to the improvement of pregnancy outcomes. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Actual">August 31, 2022</completion_date> <primary_completion_date type="Actual">July 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>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Prenatal Distress Scale</measure> <time_frame>At the end of the 1 months</time_frame> <description>The minimum score that can be obtained from the scale is "0", the maximum score is "34", and as the score obtained from the scale increases, prenatal distress levels also increase.</description> </primary_outcome> <primary_outcome> <measure>Pregnancy-Related Anxiety Scale</measure> <time_frame>At the end of the 1 months</time_frame> <description>For primiparas, a minimum of 11 points and a maximum of 55 points is obtained, and for multipars, a minimum of 10 and a maximum of 50 points are obtained. As the score obtained from the scale increases, it is accepted that the level of anxiety in pregnancy is higher.</description> </primary_outcome> <secondary_outcome> <measure>The Prenatal Attachment Inventory</measure> <time_frame>At the end of the 1 months</time_frame> <description>A minimum of 21 and a maximum of 84 points can be obtained from the scale. The increase in the score obtained by the pregnant indicates that the level of attachment also increases.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">94</enrollment> <condition>Stress</condition> <condition>Pregnancy, High Risk</condition> <arm_group> <arm_group_label>Mindfullness Based Stress Reduction</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Mindfullness Based Stress Reduction (MBSR) therapy</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Control</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Mindfullness Based Stress Reduction (MBSR) intervention</intervention_name> <description>Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program</description> <arm_group_label>Mindfullness Based Stress Reduction</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  risky pregnant women  Exclusion Criteria:  mental disabilities </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Pregnant</gender_description> <minimum_age>15 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Amasya University</name> <address> <city>Amasya</city> <zip>05000</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>February 23, 2023</last_update_submitted> <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 24, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Amasya University</investigator_affiliation> <investigator_full_name>Emine Akca</investigator_full_name> <investigator_title>Clinical Researcher of the Amasya University Midwifery Department</investigator_title> </responsible_party> <keyword>prenatal attachment</keyword> <keyword>Anxiety</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Risky pregnant women need various physical and mental health needs, they need to be informed and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group. Risky pregnancies are a situation that can negatively affect the health of the mother and the fetus, result in the loss of the baby, and bring about physical, social and mental changes. Mindfulness-based approaches have been used in solving both physical and mental problems in pregnant women and very positive results have been obtained. The aim of this study, which was carried out to determine the effect of mindfulness-based stress reduction program (MBSR) on stress, anxiety and prenatal attachment in high-risk pregnant women, is aimed at creating appropriate intervention programs for high-risk pregnancies and contributing to the improvement of pregnancy outcomes. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group. Inclusion Criteria: risky pregnant women Exclusion Criteria: mental disabilities

NCT0531xxxx/NCT05317078.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/NCT05317078</url> </required_header> <id_info> <org_study_id>20210007</org_study_id> <nct_id>NCT05317078</nct_id> </id_info> <brief_title>A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications</brief_title> <official_title>Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 794 in Participants With Claudin 6-positive Advanced/Metastatic Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications</official_title> <sponsors> <lead_sponsor> <agency>Amgen</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Amgen</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 objectives of this study are to evaluate the safety and tolerability of AMG 794 in adult participants and to determine the optimal biological active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">February 28, 2023</start_date> <completion_date type="Anticipated">June 22, 2027</completion_date> <primary_completion_date type="Anticipated">December 22, 2025</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Sequential Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Number of Participants Who Experience a Dose Limiting Toxicity (DLT)</measure> <time_frame>Day 1 to Day 28</time_frame> </primary_outcome> <primary_outcome> <measure>Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.</description> </primary_outcome> <primary_outcome> <measure>Number of Participants Who Experience a Treatment-related AE</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> </primary_outcome> <secondary_outcome> <measure>Minimum Efficacious Dose (MED)</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>Defined as the first unconfirmed partial response (PR) or better.</description> </secondary_outcome> <secondary_outcome> <measure>Maximum Observed Serum Concentration (Cmax) of AMG 794</measure> <time_frame>Cycle 1 Day 1 to Cycle 5 Day 1 (28 day cycle length)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Minimum Observed Serum Concentration (Cmin) of AMG 794</measure> <time_frame>Cycle 1 Day 1 to Cycle 5 Day 1 (28 day cycle length)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 794</measure> <time_frame>Cycle 1 Day 1 to Cycle 5 Day 1 (28 day cycle length)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Confirmed objective response (OR)</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>Defined as best overall response [BOR] of complete response [CR] or PR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).</description> </secondary_outcome> <secondary_outcome> <measure>Confirmed OR</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>Defined as immune BOR (iBOR) of immune CR (iCR) or immune PR (iPR) based on Immune RECIST (iRECIST).</description> </secondary_outcome> <secondary_outcome> <measure>Cancer Antigen (CA) 125 Response</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>CA 125 response will be analyzed in the Ovarian Cancer Analysis Set, defined as all participants with a primary tumor type of ovarian cancer who are enrolled and receive at least 1 dose of AMG 794.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of Response</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>Defined as the time from the first documentation of OR until the first documentation of disease progression or death due to any cause, whichever occurs first.</description> </secondary_outcome> <secondary_outcome> <measure>Time to Progression</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>Defined as the time from enrollment until the first documentation of radiological disease progression.</description> </secondary_outcome> <secondary_outcome> <measure>Progression-free Survival (PFS)</measure> <time_frame>Day 1 to a maximum of 2 years</time_frame> <description>Defined as the time from enrollment until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first.</description> </secondary_outcome> <secondary_outcome> <measure>1-year Overall Survival (OS)</measure> <time_frame>1 year</time_frame> </secondary_outcome> <secondary_outcome> <measure>2-year OS</measure> <time_frame>2 years</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">98</enrollment> <condition>Non-squamous Non-small Cell Lung Cancer</condition> <condition>Epithelial Ovarian Cancer</condition> <condition>Claudin 6-positive Advanced/Metastatic Malignant Solid Tumors</condition> <arm_group> <arm_group_label>Part 1: AMG 794 Monotherapy Dose Exploration</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants with claudin 6 (CLDN6)-positive advanced/metastatic non-squamous non-small cell lung cancer (NSCLC), epithelial ovarian cancer (EOC), or other solid tumor indications will be treated in up to 8 multiple ascending cohorts with additional participants optionally enrolled in dose exploration cohorts with target dose levels that have previously been shown to be safe and tolerable.</description> </arm_group> <arm_group> <arm_group_label>Part 2: AMG 794 Monotherapy Dose Expansion</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants with CLDN6-positive advanced/metastatic NSCLC, EOC, or other solid tumor indications will be treated with the OBD of AMG 794 identified in Part 1.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>AMG 794</intervention_name> <description>Short-term intravenous (IV) infusion.</description> <arm_group_label>Part 1: AMG 794 Monotherapy Dose Exploration</arm_group_label> <arm_group_label>Part 2: AMG 794 Monotherapy Dose Expansion</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Pre-screening:  - Age ≥ 18 years.  - Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1.  - Participants with histologically or cytologically documented malignant solid tumor diseases expressing claudin-6 (CLDN6) including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, and the cancer is at least either locally advanced or metastatic at pre-screening.  - Participant has provided informed consent prior to initiation of any study specific activities/procedures.  Main study:  - Age ≥ 18 years.  - Participant has provided informed consent prior to initiation of any study specific activities/procedures.  - ECOG performance status of 0 to 1.  - Participants with histologically or cytologically documented malignant solid tumor diseases expressing CLDN6 including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, that is metastatic or unresectable at screening time point. Participants should have exhausted available SOC systemic therapy or should not be candidates for such available therapy.  - For participants enrolling in cohort 3 or higher dose cohort, available positive test result for CLDN6 expression resulting from testing of an available archival tissue sample in pre-screening or obtained from biopsy in a screening procedure. For participants enrolling in cohorts 1 or 2 during dose escalation, consent to provide archival or fresh tumor tissue slides for immunohistochemistry assessment is sufficient and the enrolment is not dependent on availability of the CLDN6 expression test result.  - For dose expansion cohorts: Participants with at least 1 measurable lesion ≥ 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.  - Life expectancy > 3 months.  - Adequate organ functions.  Exclusion Criteria:  Main study:  - Positive test for human immunodeficiency virus, hepatitis B or hepatitis C.  - History of other malignancy within the past 2 years.  - Ongoing or active infection requiring IV anti-infective therapy less than 1 week prior to administration of a first dose of study treatment.  - Evidence of new or growing central nervous system metastases, leptomeningeal disease, or spinal cord compression. Participants with known brain metastases may be eligible if they completed radiotherapy, surgery or stereotactic surgery for the brain metastases and do not present with neurological symptoms and/or have stable disease assessed by imaging within 4 weeks of signing consent to this study and not requiring acute corticosteroid therapy or steroid taper.  - History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with Medical Monitor and meeting the following criteria:  - Negative test for SARS-CoV-2 ribonucleic acid by reverse transcriptase-polymerase chain reaction within 72 hours of first dose of investigational product (IP).  - No acute symptoms of coronavirus (COVID-19) disease within 10 days prior to first dose of IP (counted from day of positive test for asymptomatic participants).  - Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.  - Anticancer therapies including radiotherapy, chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of administration of a first dose of study treatment; immunotherapies/monoclonal antibodies within 3 weeks of administration of a first dose of study treatment.  - Has had a major surgery within 4 weeks of administration of a first dose of study treatment (excluded: biopsies and central venous catheter insertion).  - Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, (e.g., ulcerative colitis, Crohn's disease). Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary.  - Female participants who are of childbearing potential unwilling to use protocol specified method of contraception, who are breastfeeding and/or planning to become pregnant.  - Male participants who have a female partner of childbearing potential who are unwilling to practice sexual abstinence or use protocol-specified contraception and/or who are unwilling to abstain from donating sperm.  - Participant has known sensitivity to any of the products or components to be administered during dosing.  - Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.  - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion. </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>MD</last_name> <role>Study Director</role> <affiliation>Amgen</affiliation> </overall_official> <location> <facility> <name>City of Hope National Medical Center</name> <address> <city>Duarte</city> <state>California</state> <zip>91010</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>University of California Irvine</name> <address> <city>Orange</city> <state>California</state> <zip>92868</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Inselspital Bern</name> <address> <city>Bern</city> <zip>3010</zip> <country>Switzerland</country> </address> </facility> </location> <location_countries> <country>Switzerland</country> <country>United States</country> </location_countries> <link> <url>http://www.amgentrials.com</url> <description>AmgenTrials clinical trials website</description> </link> <verification_date>May 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 8, 2023</last_update_submitted> <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Malignant solid tumors</keyword> <keyword>Claudin 6-positive</keyword> <keyword>AMG 794</keyword> <keyword>CLDN6</keyword> <condition_browse>  <mesh_term>Neoplasms</mesh_term> <mesh_term>Lung Neoplasms</mesh_term> <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term> <mesh_term>Ovarian Neoplasms</mesh_term> <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame> <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria> <ipd_url>http://www.amgen.com/datasharing</ipd_url> </patient_data>  </clinical_study>

The primary objectives of this study are to evaluate the safety and tolerability of AMG 794 in adult participants and to determine the optimal biological active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose. Inclusion Criteria: Pre-screening: - Age ≥ 18 years. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1. - Participants with histologically or cytologically documented malignant solid tumor diseases expressing claudin-6 (CLDN6) including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, and the cancer is at least either locally advanced or metastatic at pre-screening. - Participant has provided informed consent prior to initiation of any study specific activities/procedures. Main study: - Age ≥ 18 years. - Participant has provided informed consent prior to initiation of any study specific activities/procedures. - ECOG performance status of 0 to 1. - Participants with histologically or cytologically documented malignant solid tumor diseases expressing CLDN6 including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, that is metastatic or unresectable at screening time point. Participants should have exhausted available SOC systemic therapy or should not be candidates for such available therapy. - For participants enrolling in cohort 3 or higher dose cohort, available positive test result for CLDN6 expression resulting from testing of an available archival tissue sample in pre-screening or obtained from biopsy in a screening procedure. For participants enrolling in cohorts 1 or 2 during dose escalation, consent to provide archival or fresh tumor tissue slides for immunohistochemistry assessment is sufficient and the enrolment is not dependent on availability of the CLDN6 expression test result. - For dose expansion cohorts: Participants with at least 1 measurable lesion ≥ 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study. - Life expectancy > 3 months. - Adequate organ functions. Exclusion Criteria: Main study: - Positive test for human immunodeficiency virus, hepatitis B or hepatitis C. - History of other malignancy within the past 2 years. - Ongoing or active infection requiring IV anti-infective therapy less than 1 week prior to administration of a first dose of study treatment. - Evidence of new or growing central nervous system metastases, leptomeningeal disease, or spinal cord compression. Participants with known brain metastases may be eligible if they completed radiotherapy, surgery or stereotactic surgery for the brain metastases and do not present with neurological symptoms and/or have stable disease assessed by imaging within 4 weeks of signing consent to this study and not requiring acute corticosteroid therapy or steroid taper. - History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with Medical Monitor and meeting the following criteria: - Negative test for SARS-CoV-2 ribonucleic acid by reverse transcriptase-polymerase chain reaction within 72 hours of first dose of investigational product (IP). - No acute symptoms of coronavirus (COVID-19) disease within 10 days prior to first dose of IP (counted from day of positive test for asymptomatic participants). - Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. - Anticancer therapies including radiotherapy, chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of administration of a first dose of study treatment; immunotherapies/monoclonal antibodies within 3 weeks of administration of a first dose of study treatment. - Has had a major surgery within 4 weeks of administration of a first dose of study treatment (excluded: biopsies and central venous catheter insertion). - Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, (e.g., ulcerative colitis, Crohn's disease). Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary. - Female participants who are of childbearing potential unwilling to use protocol specified method of contraception, who are breastfeeding and/or planning to become pregnant. - Male participants who have a female partner of childbearing potential who are unwilling to practice sexual abstinence or use protocol-specified contraception and/or who are unwilling to abstain from donating sperm. - Participant has known sensitivity to any of the products or components to be administered during dosing. - Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

NCT0531xxxx/NCT05317091.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/NCT05317091</url> </required_header> <id_info> <org_study_id>tulay24</org_study_id> <nct_id>NCT05317091</nct_id> </id_info> <brief_title>The Effect of Laughter Yoga on Nurses' Perceived Stress Burnout and Life Satisfaction During the Pandemic Period</brief_title> <official_title>The Effect of Laughter Yoga on Nurses' Perceived Stress Burnout and Life Satisfaction During the Pandemic Period: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Ataturk University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Ataturk 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 aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. A total of 120 nurses, determined by power analysis, were included in the randomized controlled study. The study included 2 groups. (A group of nurses who have active contact with patients diagnosed with or at risk of covid-19, group B: nurses who have active contact with patients diagnosed with or at risk of covid-19 and participate in laughter yoga practice. Laughter yoga; immune system antibodies and endorphin hormone. It has been proven by experimental studies that there is a connection between the two, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels. </textblock> </brief_summary> <detailed_description> <textblock> The study data were collected by the researchers using online systems with the snowball method due to the pandemic. The inclusion criteria of the study (not having undergone abdominal surgery in the last three months, not having uncontrolled hypertension, not having glaucoma, hernia, epilepsy, not having received a psychiatric diagnosis-treatment, not having received a diagnosis-treatment for sleep problems, having done laughter yoga before) The study consisted of 100 nurses who agreed to participate in the study. Introductory features form consisting of 13 questions, Maslach Burnout Scale and Life Satisfaction Scale, Perceived Stress Scale and life satisfaction scale were used to collect data. Research data were collected in 3 months. During the study, 9 people from the experimental group (8 people did not attend the sessions regularly, 1 person left voluntarily), 10 people from the control group (he left voluntarily) quit the study. Finally, the research was completed with 101 nurses, 51 of whom were in the experimental group and 50 in the control group. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 15, 2021</start_date> <completion_date type="Actual">March 15, 2022</completion_date> <primary_completion_date type="Actual">August 30, 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>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Introductory Information Form (questionnaire)</measure> <time_frame>up to 2 weeks</time_frame> <description>In this form prepared by the researchers; There are a total of 9 questions including age, gender, education level, marital status, working year, frequently worked shift, Covid-19 passing and being vaccinated, whether or not he has knowledge about laughter yoga.</description> </primary_outcome> <primary_outcome> <measure>Perceived Stress Scale</measure> <time_frame>up to 5 weeks]</time_frame> <description>The scale, which was created in order to understand how stressful individuals perceive certain events they experience, consists of 14 items, graded in a 5-point Likert type. In the scale, 7 items containing positive statements are reverse scored. The score range of the scale ranges from 0 to 56, and a high score indicates a high level of stress. The internal consistency coefficient of the scale was calculated as 0.84. In this study, the Cronbach alpha internal consistency coefficient was found to be 0.75.</description> </primary_outcome> <primary_outcome> <measure>Maslach Burnout Scale</measure> <time_frame>up to 5 weeks</time_frame> <description>The scale, consisting of 22 items and three sub-dimensions, is in the 5-point Likert type. The sub-dimensions of the scale are emotional exhaustion, depersonalization and personal achievement. Positive statements in the dimension of personal achievement are reverse coded. The high mean score of the emotional exhaustion and depersonalization sub-dimensions and low personal achievement mean scores indicate high burnout. The lowest score that can be obtained from the scale is 0 and the highest score is 88. The Cronhbach Alpha values of the scale were found to be 0.83 for emotional exhaustion, 0.65 for depersonalization and 0.72 for personal achievement.</description> </primary_outcome> <primary_outcome> <measure>Life Satisfaction Scale</measure> <time_frame>up to 5 weeks</time_frame> <description>There are 5 items in the scale, and each item is arranged according to a 7-point answer system. A score between 5-35 can be obtained from the scale. Higher scores indicate higher life satisfaction. The Cronbach Alpha value of the scale is .88. In this study, the Cronbach Alpha coefficient was found to be .87.</description> </primary_outcome> <secondary_outcome> <measure>Perceived Stress Scale</measure> <time_frame>up to 5 weeks</time_frame> <description>The scale, which was created in order to understand how stressful individuals perceive certain events they experience, consists of 14 items, graded in a 5-point Likert type. In the scale, 7 items containing positive statements are reverse scored. The score range of the scale ranges from 0 to 56, and a high score indicates a high level of stress. The internal consistency coefficient of the scale was calculated as 0.84. In this study, the Cronbach alpha internal consistency coefficient was found to be 0.75.</description> </secondary_outcome> <secondary_outcome> <measure>Maslach Burnout Scale</measure> <time_frame>up to 5 weeks</time_frame> <description>The scale, consisting of 22 items and three sub-dimensions, is in the 5-point Likert type. The sub-dimensions of the scale are emotional exhaustion, depersonalization and personal achievement. Positive statements in the dimension of personal achievement are reverse coded. The high mean score of the emotional exhaustion and depersonalization sub-dimensions and low personal achievement mean scores indicate high burnout. The lowest score that can be obtained from the scale is 0 and the highest score is 88. The Cronhbach Alpha values of the scale were found to be 0.83 for emotional exhaustion, 0.65 for depersonalization and 0.72 for personal achievement.</description> </secondary_outcome> <secondary_outcome> <measure>Life Satisfaction Scale</measure> <time_frame>up to 5 weeks</time_frame> <description>There are 5 items in the scale, and each item is arranged according to a 7-point answer system. A score between 5-35 can be obtained from the scale. Higher scores indicate higher life satisfaction. The Cronbach Alpha value of the scale is .88. In this study, the Cronbach Alpha coefficient was found to be .87.</description> </secondary_outcome> <number_of_arms>5</number_of_arms> <enrollment type="Actual">101</enrollment> <condition>Abdominal Surgery</condition> <condition>Hypertension</condition> <condition>Done Laughter Yoga Before</condition> <condition>Epilepsy</condition> <arm_group> <arm_group_label>Laughter yoga practice</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Laughter yoga for nurses The experimental group was divided into three groups as 18-17-16 people. Sessions 1st group Monday-Thursday between 12:00-13:00; 2nd group Tuesday-Friday between 17:00-18:00; The third group was held on Wednesday Saturday between 20:00-21:00.laughter yoga for nurses-Deep breathing exercises Deep breathing exercises (5 minutes), Warm-up exercises (10 minutes) laughter yoga for nurses-Childish games Childish games (10 minutes), Laughter exercises (15 minutes).</description> </arm_group> <arm_group> <arm_group_label>Laughter yoga session parts-1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Deep breathing exercises (5 minutes) Breathing is held for 4-5 seconds after deep inspiration. While the arms are brought to the normal position, exhale slowly and rhythmically. When expressing after deep inspiration, the lips can be pursed as if whistling or exhaled with laughter.</description> </arm_group> <arm_group> <arm_group_label>Laughter yoga session parts-2</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Warm-up exercises (10 minutes) Rhythm of 1-2, 1-2-3 is added to increase the energy level even more and synchronize the movements of the group. After a few rhythmic clapping movements, another movement is added. Whisking hands left and right. Then an audible rhythm of ho, ho, ha-ha-ha is added to the clapping gesture. Make eye contact with people in the group and smile at them.</description> </arm_group> <arm_group> <arm_group_label>Laughter yoga session parts-3</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Childish games (10 minutes) Childlike games are used to help laugh without reason just like a child. The group is motivated by visualizing these games in their minds, raising the arms up in the form of a "Y" letter, and saying "very good (applause), very good (applause), hey" with palms facing the sky.</description> </arm_group> <arm_group> <arm_group_label>Laughter yoga session parts-4</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Laughter exercises (15 minutes) This section includes a variety of laughter exercises such as greetings, strawberry milk, conductor, bonus, hot soup, lion, aloha, bird, appreciation, laughter lotion, elevator, cream cake, and bursting balloon laughter.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Laughter yoga practiced</intervention_name> <description>In this study, 8 sessions of laughter yoga were applied to the nurses in the experimental group as an intervention, twice a week for 4 weeks. Due to the Covid-19 pandemic; Laughter Yoga sessions were held on the web through the 'ZOOM' program. For this reason, it is recommended that the laughter yoga sessions be done with a group and that the group should consist of at least five people in order to provide group dynamics. Sessions are planned according to the days and hours that nurses can attend. Sessions 1st group Monday-Thursday between 12:00-13:00; 2nd group Tuesday-Friday between 17:00-18:00; The third group was held on Wednesday-Saturday between 20:00-21:00. The nurses were constantly contacted (whatsapp, phone) to ensure that they attend the sessions regularly and that there is no interruption in the sessions. No experiment was performed on the control group during the study. However, after the research, a 4-week laughter yoga was given to the nurses who wanted it.</description> <arm_group_label>Laughter yoga practice</arm_group_label> <arm_group_label>Laughter yoga session parts-1</arm_group_label> <arm_group_label>Laughter yoga session parts-2</arm_group_label> <arm_group_label>Laughter yoga session parts-3</arm_group_label> <arm_group_label>Laughter yoga session parts-4</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Not have undergone abdominal surgery in the past three months  - Uncontrollable hypertension  - Without epilepsy  Exclusion Criteria:  - Antidepressant etc. nurses using drugs  - Not attending sessions regularly </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> <location> <facility> <name>Tülay Kılınç</name> <address> <city>Erzurum</city> <state>Palandöken</state> <zip>25000</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Ataturk University</investigator_affiliation> <investigator_full_name>Tülay KILINÇ</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Pandemic, Nurse, Stress, Burnout, Life satisfaction, Laughter yoga</keyword> <condition_browse>  <mesh_term>Burnout, Psychological</mesh_term> </condition_browse>  </clinical_study>

This study aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. A total of 120 nurses, determined by power analysis, were included in the randomized controlled study. The study included 2 groups. (A group of nurses who have active contact with patients diagnosed with or at risk of covid-19, group B: nurses who have active contact with patients diagnosed with or at risk of covid-19 and participate in laughter yoga practice. Laughter yoga; immune system antibodies and endorphin hormone. It has been proven by experimental studies that there is a connection between the two, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels. The study data were collected by the researchers using online systems with the snowball method due to the pandemic. The inclusion criteria of the study (not having undergone abdominal surgery in the last three months, not having uncontrolled hypertension, not having glaucoma, hernia, epilepsy, not having received a psychiatric diagnosis-treatment, not having received a diagnosis-treatment for sleep problems, having done laughter yoga before) The study consisted of 100 nurses who agreed to participate in the study. Introductory features form consisting of 13 questions, Maslach Burnout Scale and Life Satisfaction Scale, Perceived Stress Scale and life satisfaction scale were used to collect data. Research data were collected in 3 months. During the study, 9 people from the experimental group (8 people did not attend the sessions regularly, 1 person left voluntarily), 10 people from the control group (he left voluntarily) quit the study. Finally, the research was completed with 101 nurses, 51 of whom were in the experimental group and 50 in the control group. Inclusion Criteria: - Not have undergone abdominal surgery in the past three months - Uncontrollable hypertension - Without epilepsy Exclusion Criteria: - Antidepressant etc. nurses using drugs - Not attending sessions regularly

NCT0531xxxx/NCT05317104.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/NCT05317104</url> </required_header> <id_info> <org_study_id>Esport-05/03/2022</org_study_id> <nct_id>NCT05317104</nct_id> </id_info> <brief_title>The Effect of Aerobic Exercise Training on Collegiate eSport Team Players</brief_title> <official_title>The Effect of Aerobic Exercise Training in Collegiate eSport Team Players on Reaction Time and Cognitive Functions- A Randomized, Single Blind, Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Bahçeşehir University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Bahçeşehir 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> E-sports, which is called video games that are played in a competitive and organized way in a virtual environment, individually or in like teams, continues to increase its popularity by reaching individuals of all ages with the acceleration it has gained to worldwide.  The major keys to performance in e-sports, which include games in many different categories; tactical and cognitive abilities that depend on executive functions such as attention, perception, memory, and multitasking. It also requires play skills that include fluent and coordinated movements, such as hand-eye coordination. Therefore, the reaction time among the players plays a decisive role in the performance.  The sedentary life-induced physical, mental and spiritual health of the e-sports player who is in front of the screen for a long time is negatively affected, and it is seen that the accuracy in the executive functions of the athlete decreases and results in impulsivity. Physical activity can be considered as a good opportunity for performance, as physical, cognitive and spiritual improvements will contribute positively to the performance of the athlete. Aerobic exercise, which is widely performed today for physical activity, has positive effects on both physical, cognitive and psychosocial aspects.  This study was designed as a randomized controlled, single-blind, prospective study to examine the effect of aerobic exercise training on reaction time, neuropsychological parameters and mood in e-sports players playing in university e-sports team. </textblock> </brief_summary> <detailed_description> <textblock> E-sports, which are called video games that are played in a competitive and organized manner in a virtual environment, individually or in teams, in line with a certain goal, are taking place today based on the principle of directing virtual avatars. Following the increase in personal computer use, it continues to increase its popularity by reaching individuals of all ages, while gaining a worldwide popularity with players predominantly consisting of younger population.  The major keys to performance in e-sports, which include games in many different categories; Tactical and cognitive abilities that depend on executive functions such as attention, perception, memory, and multitasking. It also requires play skills that include fluent and coordinated movements, such as hand-eye coordination. Therefore, the reaction time among the players plays a decisive role in the performance.  Since the e-sports player, whose average career years are known to be short, will regularly train 5.5-10 hours a day in order to continue with maximum performance and improve their skills, many of the players earn a sedentary life by not participating in any physical activity. Although the increase in the time spent in front of the screen brings success, physical and mental health due to the sedentary life gained is negatively affected, and it is seen that the accuracy in executive functions decreases and results in impulsivity as it is continued without rest. In addition to these, it will be possible to say the presence of depression and anxiety.  According to the guidelines published by the World Health Organization, it has been observed that individuals aged 18-64 are recommended at least 150-300 minutes of moderate-intensity aerobic activities per week or at least 75-150 minutes of vigorous aerobic activities.  Physical activity can be considered as a good opportunity for performance, since the physical-cognitive system that works smoothly in e-sports players will contribute positively to the performance of the athlete. Since physical activity also contributes to mental healing, it is thought that the athlete's chance of success will be higher by causing a positive effect on the performance of the player.  Aerobic exercise, known as activities in which the major muscle groups of the body are moved rhythmically for a continuous period of time, increase synaptic plasticity, while aerobic exercise is known to improve attention and affect reaction times in direct proportion to attention. Positive effects of aerobic exercise are observed in psychosocial aspects as well as in cognitive development.  Reaction time; 3 separate tests, visual, auditory and audio-visual, will be evaluated with computer aided Microgate-Optojump Next measuring device. Neuropsychological evaluation; short-term memory, attention, information processing speed, and problem-solving skills will be evaluated with Corsi Block Task, Stroop Test, Wisconsin Card Sorting Test, Fitts Law Test and Digit Span Test. Mood evaluation will be done with Beck Depression Inventory and Beck Anxiety Inventory. Before people are included in the exercise training protocol, knowing the person's maximum exercise capacity will determine an effective program and the person/situation where we need to end the exercise, so aerobic exercise capacity will be done with the '20 Meter Shuttle Run Test', which is a maximal field test.  This study was designed as a randomized controlled, single-blind, prospective study to examine the effect of aerobic exercise training on reaction time, neuropsychological parameters and mood in e-sports players playing in university e-sports team. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 10, 2022</start_date> <completion_date type="Actual">September 25, 2022</completion_date> <primary_completion_date type="Actual">August 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>30 esports players aged 18-25, playing in the university esports team, will be included in the study.</intervention_model_description> <primary_purpose>Supportive Care</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> <masking_description>All outcomes and measurements are done by a blinded assessor.</masking_description> </study_design_info> <primary_outcome> <measure>Reaction Time</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>Reaction Time: Reaction time; 3 separate tests, visual, auditory and audio-visual, will be evaluated with a computer-aided Microgate-Optojump measuring device. Evaluation; using a fixed chair, the athlete's feet should be made in full contact position on the floor.</description> </primary_outcome> <secondary_outcome> <measure>Corsi Block Task</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>The test aiming to measure visual-spatial short-term memory will be done on a digital platform. In the test, which starts with two blocks and increases in difficulty, the test will continue until nine blocks are completed correctly in the desired order. The test will automatically terminate if completed without errors or if repeated errors are made at the same level.</description> </secondary_outcome> <secondary_outcome> <measure>Stroop Test</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>Although there are different standardizations of the Stroop test, which is used as the gold standard in attention measurements, its two tasks will be tested. The participant will be tested with the tasks of reading the colored words and telling the color of the colored words. The test will be able to record the desired color with the correct data and will be measured by the elapsed time. The time difference between the two missions will give the score.</description> </secondary_outcome> <secondary_outcome> <measure>Wisconsin Card Sorting Test</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>The test used to evaluate cognitive flexibility will be done on a digital platform. Test; It is based on matching the response cards with the stimulus cards through the feedbacks (True/False) given by a series of cards with 4 different stimulus cards at each stage, and a total of 64 response cards, categorized by subject, color, shape and number types. After the card to be matched is shown, it is stated that the selected figure is only true or false, while it is not specified under which category the choice is desired. Test score criteria; The total obtained will include data such as error, number of trials, perseverative and non-perseverative data. The main purpose is to measure how well it adapts to changing rules.</description> </secondary_outcome> <secondary_outcome> <measure>Fitts Law Test:</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>The test, which aims to measure the speed of information processing, will be held on a digital platform. Maximum performance will be based on the ability to follow the constantly changing box with hand-eye coordination. In the test, the speed and accuracy of the movement will be calculated by the movement of the mouse cursor in the direction of the instructions given to the participants, and the time it takes to reach the shapes in the targeted sizes and intervals.</description> </secondary_outcome> <secondary_outcome> <measure>Digit Span Test</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>It will be done to measure attention and working memory. The main task of the test is to recall the data in the desired order. Only the Forward part of the test, which consists of two parts, will be done. After listening to the previously recorded data one by one, the participant will be expected to write it down on a piece of paper after each recording. The test will be terminated if wrong at the same level twice. The level reached will be the test score.</description> </secondary_outcome> <secondary_outcome> <measure>Beck Depression Inventory</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>A 21-item inventory will be used as an aid in quantitatively measuring the presence and intensity of depression symptoms. 0-9 points are interpreted as minimal, 10-16 points as mild, 17-29 points as moderate and 30-63 points as severe depression.</description> </secondary_outcome> <secondary_outcome> <measure>Beck Anxiety Inventory</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>The inventory created to differentiate anxiety from depression will be used to measure the level of anxiety. In the 21-item inventory, 0-7 points indicate the presence of minimal anxiety, 8-15 points mild, 16-25 points moderate and 26-63 points severe anxiety.</description> </secondary_outcome> <secondary_outcome> <measure>20 Meter Shuttle Run Test:</measure> <time_frame>Begining of the study, 6 weeks after the baseline</time_frame> <description>The '20 Meter Shuttle Run Test' will be used because knowing the person's maximum exercise capacity before being included in the exercise training protocol will determine the person/situation we need to end the exercise with. The test will be performed in accordance with the established procedures. The test will be terminated if it fails to cover the required path before the 'beep' stimulus twice, or if there is a desire to quit the test due to fatigue during the test. The number of shuttles and vital signs will be recorded.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">26</enrollment> <condition>Screen Time</condition> <condition>Performance Enhancing</condition> <condition>Injury Prevention</condition> <condition>Executive Function</condition> <condition>Cardiovascular Training</condition> <arm_group> <arm_group_label>Aerobic Exercise Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Intervention group will be included in a program consisting of warm-up, loading and cool-down periods. Maximum Heart Rate (MHR) method will be used to determine the intensity of aerobic exercise training. Since moderate aerobic exercise training was aimed, exercise training will be given in 55-74% of MHRs. Exercise training will be started at mild-moderate intensity. Afterwards, within the limits that the person can tolerate and does not cause complications, with 5-10 minute increments every 1-2 weeks, the person will progress without muscle pain, injury, respiratory distress or fatigue due to overload. Polar H9 Heart Rate Sensor, which will be worn on the chest, will be used to monitor heart rate during exercise training. Aerobic exercise training will be given in accordance with the procedures determined on the treadmill in the laboratory environment, with a program consisting of 6-week.</description> </arm_group> <arm_group> <arm_group_label>Control Group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>No intervention will be made other than evaluations. However, in order for the participants in this group to achieve the same health gains, they will remain under follow-up and control to apply the same aerobic exercise training program after the study is completed.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Aerobic exercise</intervention_name> <description>For 6 weeks, 3 times a week, aerobic exercise will be performed with a treadmill at 55-74% of the maximal heart rate.</description> <arm_group_label>Aerobic Exercise Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Be between the ages of 18-25  - Playing e-sports for at least 1 year  - Training at least 2 hours per a day  - Playing one of the types of games played using a computer  - Playing on a university esports team  - Volunteer  Exclusion Criteria:  - Being diagnosed with any neurological, psychiatric, cardiopulmonary, rheumatological, orthopedic and oncological disease  - Having a history of injuries involving the musculoskeletal system  - Having a congenital/acquired mental or physical disability that prevents participation in the study  - Using sleeping pills due to the sleep problem experienced  - Playing games with devices such as mobile phones, consoles  - Failure to complete exercise capacity measurement </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>25 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Beyza Çoban, PT</last_name> <role>Principal Investigator</role> <affiliation>Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation</affiliation> </overall_official> <overall_official> <last_name>Sena Vargel, PhD (c), PT</last_name> <role>Study Chair</role> <affiliation>Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation</affiliation> </overall_official> <overall_official> <last_name>Selen Gür Özmen, MD, Associate Prof.</last_name> <role>Study Chair</role> <affiliation>Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation</affiliation> </overall_official> <overall_official> <last_name>Pelin Pişirici, PhD, PT</last_name> <role>Study Director</role> <affiliation>Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation</affiliation> </overall_official> <location> <facility> <name>Bahcesehir University</name> <address> <city>Istanbul</city> <state>Besiktas</state> <zip>34353</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>September 25, 2022</last_update_submitted> <last_update_submitted_qc>September 25, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 27, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Bahçeşehir University</investigator_affiliation> <investigator_full_name>Pelin Pişirici</investigator_full_name> <investigator_title>Assistant Professor, PT</investigator_title> </responsible_party>  </clinical_study>

E-sports, which is called video games that are played in a competitive and organized way in a virtual environment, individually or in like teams, continues to increase its popularity by reaching individuals of all ages with the acceleration it has gained to worldwide. The major keys to performance in e-sports, which include games in many different categories; tactical and cognitive abilities that depend on executive functions such as attention, perception, memory, and multitasking. It also requires play skills that include fluent and coordinated movements, such as hand-eye coordination. Therefore, the reaction time among the players plays a decisive role in the performance. The sedentary life-induced physical, mental and spiritual health of the e-sports player who is in front of the screen for a long time is negatively affected, and it is seen that the accuracy in the executive functions of the athlete decreases and results in impulsivity. Physical activity can be considered as a good opportunity for performance, as physical, cognitive and spiritual improvements will contribute positively to the performance of the athlete. Aerobic exercise, which is widely performed today for physical activity, has positive effects on both physical, cognitive and psychosocial aspects. This study was designed as a randomized controlled, single-blind, prospective study to examine the effect of aerobic exercise training on reaction time, neuropsychological parameters and mood in e-sports players playing in university e-sports team. E-sports, which are called video games that are played in a competitive and organized manner in a virtual environment, individually or in teams, in line with a certain goal, are taking place today based on the principle of directing virtual avatars. Following the increase in personal computer use, it continues to increase its popularity by reaching individuals of all ages, while gaining a worldwide popularity with players predominantly consisting of younger population. The major keys to performance in e-sports, which include games in many different categories; Tactical and cognitive abilities that depend on executive functions such as attention, perception, memory, and multitasking. It also requires play skills that include fluent and coordinated movements, such as hand-eye coordination. Therefore, the reaction time among the players plays a decisive role in the performance. Since the e-sports player, whose average career years are known to be short, will regularly train 5.5-10 hours a day in order to continue with maximum performance and improve their skills, many of the players earn a sedentary life by not participating in any physical activity. Although the increase in the time spent in front of the screen brings success, physical and mental health due to the sedentary life gained is negatively affected, and it is seen that the accuracy in executive functions decreases and results in impulsivity as it is continued without rest. In addition to these, it will be possible to say the presence of depression and anxiety. According to the guidelines published by the World Health Organization, it has been observed that individuals aged 18-64 are recommended at least 150-300 minutes of moderate-intensity aerobic activities per week or at least 75-150 minutes of vigorous aerobic activities. Physical activity can be considered as a good opportunity for performance, since the physical-cognitive system that works smoothly in e-sports players will contribute positively to the performance of the athlete. Since physical activity also contributes to mental healing, it is thought that the athlete's chance of success will be higher by causing a positive effect on the performance of the player. Aerobic exercise, known as activities in which the major muscle groups of the body are moved rhythmically for a continuous period of time, increase synaptic plasticity, while aerobic exercise is known to improve attention and affect reaction times in direct proportion to attention. Positive effects of aerobic exercise are observed in psychosocial aspects as well as in cognitive development. Reaction time; 3 separate tests, visual, auditory and audio-visual, will be evaluated with computer aided Microgate-Optojump Next measuring device. Neuropsychological evaluation; short-term memory, attention, information processing speed, and problem-solving skills will be evaluated with Corsi Block Task, Stroop Test, Wisconsin Card Sorting Test, Fitts Law Test and Digit Span Test. Mood evaluation will be done with Beck Depression Inventory and Beck Anxiety Inventory. Before people are included in the exercise training protocol, knowing the person's maximum exercise capacity will determine an effective program and the person/situation where we need to end the exercise, so aerobic exercise capacity will be done with the '20 Meter Shuttle Run Test', which is a maximal field test. This study was designed as a randomized controlled, single-blind, prospective study to examine the effect of aerobic exercise training on reaction time, neuropsychological parameters and mood in e-sports players playing in university e-sports team. Inclusion Criteria: - Be between the ages of 18-25 - Playing e-sports for at least 1 year - Training at least 2 hours per a day - Playing one of the types of games played using a computer - Playing on a university esports team - Volunteer Exclusion Criteria: - Being diagnosed with any neurological, psychiatric, cardiopulmonary, rheumatological, orthopedic and oncological disease - Having a history of injuries involving the musculoskeletal system - Having a congenital/acquired mental or physical disability that prevents participation in the study - Using sleeping pills due to the sleep problem experienced - Playing games with devices such as mobile phones, consoles - Failure to complete exercise capacity measurement

NCT0531xxxx/NCT05317117.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/NCT05317117</url> </required_header> <id_info> <org_study_id>1807405</org_study_id> <nct_id>NCT05317117</nct_id> </id_info> <brief_title>Evaluating the Clinical Performance and Usability of Novel Malaria RDTs in Brazil</brief_title> <official_title>Evaluating the Clinical Performance and Usability of Novel Malaria Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Malaria Infections in Brazil</official_title> <sponsors> <lead_sponsor> <agency>PATH</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Centro de Pesquisa em Medicina Tropical de Rondonia</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>PATH</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 cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clinics. At the point of care, study staff will collect capillary blood samples and conduct malaria microscopy (both the standard of care and study specific research-grade microscopy) and two index tests: the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT. Venous blood will be collected and transferred to the laboratory where the reference PCR assay and three comparator RDTs will be run. The index RDTs will also be repeated in the laboratory. All clinical management of study participants will follow the standard of care for malaria diagnosis in Brazil and will be based on the standard microscopy result. Confirmatory testing may also be conducted, such as typing and sequencing of Plasmodium genes and antigens of interest, including but not limited to HRP2, HRP3, and pLDH as well as the human inflammatory response marker CRP.  The lay provider/health worker participants will include intended users of the index tests. They will be surveyed to assess index test usability through a questionnaire to assess label and packaging comprehension as well as results interpretation. </textblock> </brief_summary> <detailed_description> <textblock> Primary Objectives  1.1 To assess the sensitivity, specificity and, when applicable, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTek™ Malaria Pf Plus in intended use settings for detecting P. falciparum infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria.  1.2 To assess the diagnostic accuracy of NxTek™ Malaria Pf/Pv Plus in intended use settings for detecting P. falciparum and P. vivax infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria.  Secondary Objectives  2.1 To assess the diagnostic accuracy of the study comparator tests in intended use settings for detecting P. falciparum and P. vivax infections in venous whole blood samples collected prospectively from patients with symptoms suggestive of malaria.  1.3 To determine the frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations and assess the impact of those on HRP2-based RDT diagnostic accuracy.  1.4 To assess the comprehension of the test packaging and labeling among intended users (trained lay providers and trained health care workers).  1.5 To assess the ability to read and interpret the test result outputs among intended users (trained lay providers and trained health care workers). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 4, 2022</start_date> <completion_date type="Anticipated">December 31, 2022</completion_date> <primary_completion_date type="Anticipated">December 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>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>Diagnostic accuracy of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections</measure> <time_frame>5 months</time_frame> <description>1.1 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections in patients with symptoms suggestive of malaria.</description> </primary_outcome> <primary_outcome> <measure>Diagnostic accuracy of of NxTek™ Malaria Pf/Pv Plus for the detection of P. falciparum and P.vivax infections</measure> <time_frame>5 months</time_frame> <description>1.2 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of NxTek™ Malaria Pf/Pv Plus for the detection of P. falciparum and P.vivax infections in patients with symptoms suggestive of malaria.</description> </primary_outcome> <secondary_outcome> <measure>Diagnostic accuracy of comparator tests for the detection of P. falciparum and, when relevant, P.vivax infections</measure> <time_frame>5 months</time_frame> <description>2.1 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of comparator tests for the detection of P. falciparum and, when relevant, P.vivax infections in patients with symptoms suggestive of malaria.</description> </secondary_outcome> <secondary_outcome> <measure>Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations.</measure> <time_frame>5 months</time_frame> <description>2.2 Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations.</description> </secondary_outcome> <secondary_outcome> <measure>Diagnostic accuracy of the index tests for the detection of P. falciparum infections with HRP2 and/or HRP3 deletions</measure> <time_frame>5 months</time_frame> <description>2.3 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of the index tests for the detection of P. falciparum infections with HRP2 and/or HRP3 deletions in patients with symptoms suggestive of malaria.</description> </secondary_outcome> <secondary_outcome> <measure>Usability: label comprehension</measure> <time_frame>1 week</time_frame> <description>2.4 Percent of end users who can accurately comprehend key messaging included in the investigational device packaging and labels.</description> </secondary_outcome> <secondary_outcome> <measure>Usability: results interpretation</measure> <time_frame>1 week</time_frame> <description>2.5 Percent of end users who can accurately interpret the investigational device result output.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">1030</enrollment> <condition>Malaria</condition> <arm_group> <arm_group_label>NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT</arm_group_label> <arm_group_type>Other</arm_group_type> <description>All participants will be tested with two investigational IVDs at the point of care, the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT, in addition to comparator tests and the standard of care (microscopy). The investigational tests will not be used to determine any treatment or case management.</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT</intervention_name> <description>The NxTek (TM) Malaria Pf Plus, developed by Abbott, is a sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and pLDH on a single test line of Pf malaria in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms. The NxTek (TM) Malaria Pf/Pv Plus, developed by Abbott, is a sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH) of Plasmodium falciparum (Pf) on one test line and of pLDH of Plasmodium vivax (Pv) malaria on a second test line in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms.</description> <arm_group_label>NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria (diagnostic accuracy):  - Aged 2 years of age or older  - Presenting at the study site with fever or a history of fever during the preceding 48-hours  - Freely agreeing to participate by providing informed consent (and assent, as applicable)  Exclusion Criteria (diagnostic accuracy):  - Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines  Inclusion Criteria (usability):  - Aged 18 years of age or older  - Provides malaria case management at the study site  - Considered an intended user of the index tests (lay user or healthcare worker)  - Freely agreeing to participate by providing informed consent  Exclusion Criteria (usability):  None </textblock> </criteria> <gender>All</gender> <minimum_age>2 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Gonzalo Domingo, PhD</last_name> <role>Principal Investigator</role> <affiliation>PATH</affiliation> </overall_official> <overall_contact> <last_name>Gonzalo Domingo, PhD</last_name> <phone>(206) 285-3500</phone> <email>gdomingo@path.org</email> </overall_contact> <overall_contact_backup> <last_name>Stephanie Zobrist, MPH</last_name> <phone>(206) 285-3500</phone> <email>szobrist@path.org</email> </overall_contact_backup> <location> <facility> <name>Centro de Pesquisa em Medicina Tropical de Rondônia (CEPEM)</name> <address> <city>Porto Velho</city> <state>Rondônia</state> <zip>76812-329</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dhélio Pereira, MD, PhD</last_name> </contact> <investigator> <last_name>Dhélio Pereira, MD, PhD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>Brazil</country> </location_countries> <verification_date>October 2021</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 27, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Malaria</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>There is no plan to share any IPD with other researchers.</ipd_description> </patient_data>  </clinical_study>

Prospective cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clinics. At the point of care, study staff will collect capillary blood samples and conduct malaria microscopy (both the standard of care and study specific research-grade microscopy) and two index tests: the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT. Venous blood will be collected and transferred to the laboratory where the reference PCR assay and three comparator RDTs will be run. The index RDTs will also be repeated in the laboratory. All clinical management of study participants will follow the standard of care for malaria diagnosis in Brazil and will be based on the standard microscopy result. Confirmatory testing may also be conducted, such as typing and sequencing of Plasmodium genes and antigens of interest, including but not limited to HRP2, HRP3, and pLDH as well as the human inflammatory response marker CRP. The lay provider/health worker participants will include intended users of the index tests. They will be surveyed to assess index test usability through a questionnaire to assess label and packaging comprehension as well as results interpretation. Primary Objectives 1.1 To assess the sensitivity, specificity and, when applicable, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTek™ Malaria Pf Plus in intended use settings for detecting P. falciparum infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria. 1.2 To assess the diagnostic accuracy of NxTek™ Malaria Pf/Pv Plus in intended use settings for detecting P. falciparum and P. vivax infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria. Secondary Objectives 2.1 To assess the diagnostic accuracy of the study comparator tests in intended use settings for detecting P. falciparum and P. vivax infections in venous whole blood samples collected prospectively from patients with symptoms suggestive of malaria. 1.3 To determine the frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations and assess the impact of those on HRP2-based RDT diagnostic accuracy. 1.4 To assess the comprehension of the test packaging and labeling among intended users (trained lay providers and trained health care workers). 1.5 To assess the ability to read and interpret the test result outputs among intended users (trained lay providers and trained health care workers). Inclusion Criteria (diagnostic accuracy): - Aged 2 years of age or older - Presenting at the study site with fever or a history of fever during the preceding 48-hours - Freely agreeing to participate by providing informed consent (and assent, as applicable) Exclusion Criteria (diagnostic accuracy): - Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines Inclusion Criteria (usability): - Aged 18 years of age or older - Provides malaria case management at the study site - Considered an intended user of the index tests (lay user or healthcare worker) - Freely agreeing to participate by providing informed consent Exclusion Criteria (usability): None

NCT0531xxxx/NCT05317130.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/NCT05317130</url> </required_header> <id_info> <org_study_id>Safeparasport</org_study_id> <nct_id>NCT05317130</nct_id> </id_info> <brief_title>A Complex Health Promotion Intervention in Parasport - The Safe & Healthy Parasport Project</brief_title> <official_title>A Complex Health Promotion Intervention in Parasport - The Safe & Healthy Parasport Project</official_title> <sponsors> <lead_sponsor> <agency>Lund University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University of Stellenbosch</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Lund 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 interest in Para sport is steadily increasing. A concern is, though, that elite Para athletes report a high incidence of injuries and illnesses. Altogether, there is an urgent need to prevent such incidents among athletes already suffering from an impairment. However, most of the existing training-based prevention programmes are not adapted or accessible to Para athletes. Also, recent research suggests that sports safety work advantageously should facilitate disease prevention and health promotion. Such intervention would hypothetically also have the potential to reduce injuries, illnesses and improve health among Para athletes. To allow full implementation, the intervention would need to be adapted to the Para athletes´ various impairments, abilities and sports.  MAIN QUESTIONS TO BE ADRESSED  - Can an evidence-based eHealth health promotion platform prevent sports injuries and illnesses in elite para athletes over 6 months, 12 months and 5 years?  - Can such platform improve overall health parameters such as sleep, nutrition and mental health in elite para athletes and influence the performance parameters training quantity and training quality over 6 months, 12 months and 5 years?  - Can such platform improve health literacy among Para athletes? </textblock> </brief_summary> <detailed_description> <textblock> Introduction Sport is today one of the largest movements in Sweden, with more than three million people being members of a sports club. Participation in sport leads to several health benefits as it improves both physical and mental health. For example, it reduces the risk for cardiometabolic disease, fractures, dementia, mental illness and some cancer types. Sport also supports the development of social skills during different periods in people's lifetime. Sport has therefore a great impact on the quality of life for the individual person as well as for our health economics, as it can prevent and treat disease. The interest in sport and its associated benefits for persons with an impairment (Para sport) has also increased in the last few decades. Para sport is, however, still a young sporting discipline and despite the fact that sport poses the athlete at a risk for suffering a sports-related injury or illness few studies have assessed the burden of such incidents in Para sport.  The Para athlete and Paralympic athlete What characterises Para and Paralympic athletes is the existing impairment, whether it is physical, visual or intellectual. According to the World Health Organization the definition of an impairment is: "a problem in body function or structure" (WHO). Depending on the nature of the impairment the athlete may also have a greater risk for suffering from secondary health complaints, early age related health conditions, health risk behaviours and higher rates of premature death.  For example, individuals with SCI may be predisposed to infections, skin breakdown, osteoporosis, contractures, spasticity, pain, depression, fatigue, hyperthermia, bowel dysfunction and cardiorespiratory insufficiency. Several of these health complaints may also be present in individuals with other neurological diseases such as multiple sclerosis (MS), stroke, traumatic brain injury and cerebral palsy (CP). Individuals with more rare diagnosis such as Becker muscular dystrophy, Duchenne muscular dystrophy and Friedreich's ataxia may in addition suffer from health complaints such as heart arrhythmias and a malformed skeleton. Joint contractures and muscle fibrosis are present in individuals with arthrogryposis, which often leads to musculoskeletal problems. The biomechanics is often altered among individuals with limb deficiency, which may cause stress fractures, tendinopathies and osteoarthritis. Also stump conditions such as phantom pain, rashes and heterotopic ossification are common. Furthermore, alterations in the vascular physiology may induce cardiac disease.  Individuals with visual impairment have in general a greater risk for morbidity and unintentional injury and illness such as cardiometabolic disease, depression, falls and fractures. Other health conditions that are sometimes present with diagnoses related to visual impairments are joint problems, obesity, hearing impairment, diabetes and development delay. Individuals with intellectual impairments have more often a poor mental and physical health compared to the rest of population. Higher rates of health complaints, such as gastrointestinal disease, obesity, epilepsy, cardiometabolic disease and mental illness have been reported. Altogether, the Para athlete has other conditions due to the impairment and the sometimes associated health complaints when entering sports in comparison with an able-bodied athlete, which possibly could affect training behaviour as well as the epidemiology and consequences of sports-related injuries and illnesses.  Epidemiology of sports-related injuries and illnesses Despite all the positive health effects of sports, sports-related injuries and illnesses are a concern in most elite sports settings, as they may lead to morbidity, an ending of the sport career, long- term disability and mortality. Sports-related injuries are also a cost and burden for society.  Traumatic sports injuries, such as concussion, ligament sprains, joint distortions or fractures may, for example, lead to brain damage, osteoarthritis and chronic pain for the individual athlete. Catastrophic injuries leading to spinal injuries and death are less common, but still a concern in several sports. Overuse-related injuries may also cause several health complaints such as inflammation, degeneration and chronic pain. Recent research has suggested that the risks associated with sports- related injuries and its consequences are unacceptable when evaluated against acceptable criteria from occupational health.  Sports-related illnesses have also received more focus during the last decade. However, studies concerning the epidemiology of sports-related illnesses are still underrepresented in comparison to sports injury epidemiology. A concern is that there still are few cohort studies concerning sports injury and illness epidemiology in Para sport. Moreover, definitions and data collection methods have not been adapted to the Para athletes´ various impairments. To assist the development of evidence-based preventive measures the aim of my PhD-thesis was to gain an in-depth understanding of the epidemiology and data collection methods of sports injuries and illnesses in Para athletes. First an eHealth application for self-reported data collection of injuries and illnesses adapted to the Web Content Accessibility guidelines and Para athletes was developed and evaluated in a pilot feasibility and usability study. Thereafter, 107 Swedish elite para athletes were followed prospectively during 52 weeks. In the thesis, which is the first study globally that prospectively has followed a large cohort of Para athletes, it was shown that 68% reported an injury and 77% an illness, which is a higher incidence compared to able-bodied athletes in Sweden. One third of the injuries were classified as severe and the athletes´ impairment was involved in the mechanism in 59% of the injuries. For example, wheelchair athletes reported a high proportion of shoulder injuries and athletes with VI reported falls. Also diagnoses such as spasticity and neurogenic bladder were reported, which are not seen in able-bodied athletes. Two thirds of the athletes reported poor sleep, 48% reported persistent pain and 34% reported anxiety. Data also show that more injuries are reported at the Paralympic Games compared to the Olympic Games. Altogether, there is an urgent need to further understand the epidemiology of sports injuries and illnesses, and to prevent injuries and illnesses in Para athletes.  A concern is that the development and evaluation of evidence-based prevention strategies take time. However, research among able-bodied athletes has shown that regular athlete health monitoring with accompanied medical guidance may reduce the burden of sports injuries and illnesses, and shorten the time loss from sport when injured/ill. The medical team following up the athlete should consist of qualified and experienced individuals operating in synergy with the coach and the athlete towards a common performance and health goal. It has been proposed that this system facilitate a balanced approach to training and competing decisions, especially while the athlete is ill or injured. This method can be supported by results from my PhD-thesis, in which it it was shown that 90% of the athletes found it important to conduct athlete health monitoring also in the future. Moreover, qualitative data have revealed that Para athletes´ perceptions are that they do not have the same prerequisites as able-bodied athletes when being injured or ill. In summary, it can be hypothesized that regular athlete health monitoring over time will help us to further improve our understanding of the epidemiology of sports injuries and illnesses in Parasport, and that immediate medical guidance also can minimize the impact of a sports injury or illness.  Health promotion in sports Another concern in Parasport is that the existing prevention programmes in sports such as the knee control are not adapted to Para athletes, as several athletes are wheelchair users or amputees. Among able-bodied athletes, it has been recommended that sports safety work should facilitate health promotion, including health education. A recent study of able-bodied Swedish athletes have shown that a health promotion webpage for elite athletics athletes can reduce the injury risk. However, there is no health promotion webpage for Swedish Para athletes.  Taken together an accessible eHealh based health promotion platform will first be developed in this project using a participatory action based research design. Thereafter the following research questions will be adressed:  - Can an evidence-based eHealth health promotion platform prevent sports injuries and illnesses in elite para athletes over 6 months, 12 months and 5 years?  - Can such platform improve overall health parameters such as sleep, nutrition and mental health in elite para athletes and influence the performance parameters training quantity and training quality over 6 months, 12 months and 5 years?  - Can such platform improve health literacy among Para athletes? </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">September 1, 2022</start_date> <completion_date type="Anticipated">September 1, 2027</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>Incidence of sports injuries and illnesses 6 months following study start</measure> <time_frame>The incidence will be followed up 6 months following study start</time_frame> <description>The incidence of sports injuries and illnesses is the primary outcome. Incidence data will be calculated as the number of injuries and illnesses per 1000 hours of sports exposure.</description> </primary_outcome> <primary_outcome> <measure>Incidence of sports injuries and illnesses 12 months following study start</measure> <time_frame>The incidence will be followed up 12 months following study start</time_frame> <description>The incidence of sports injuries and illnesses is the primary outcome. Incidence data will be calculated as the number of injuries and illnesses per 1000 hours of sports exposure.</description> </primary_outcome> <primary_outcome> <measure>Incidence of sports injuries and illnesses 4 years following study start</measure> <time_frame>The incidence will be followed up 4 years following study start</time_frame> <description>The incidence of sports injuries and illnesses is the primary outcome. Incidence data will be calculated as the number of injuries and illnesses per 1000 hours of sports exposure.</description> </primary_outcome> <secondary_outcome> <measure>Mental health 6 months following study start.</measure> <time_frame>Athlete mental health data will be followed up 6 months following study start.</time_frame> <description>A secondary outcome is mental health (anxiety and depressing using the PHQ4-questionniare)</description> </secondary_outcome> <secondary_outcome> <measure>Mental health 12 months following study start.</measure> <time_frame>Athlete mental health data will be followed up 12 months following study start.</time_frame> <description>A secondary outcome is mental health (anxiety and depressing using the PHQ4-questionniare)</description> </secondary_outcome> <secondary_outcome> <measure>Mental health 4 years following study start.</measure> <time_frame>Athlete mental health data will be followed up 4 years following study start.</time_frame> <description>A secondary outcome is mental health (anxiety and depressing using the PHQ4-questionniare)</description> </secondary_outcome> <secondary_outcome> <measure>Health literacy 6 months following study start.</measure> <time_frame>Health literacy data will be followed up 6 months following study start.</time_frame> <description>A secondary outcome is health literacy (using theThe European Health Literacy Survey Questionnaire (HLS-EU-Q47)</description> </secondary_outcome> <secondary_outcome> <measure>Health literacy 12 months following study start.</measure> <time_frame>Health literacy data will be followed up 12 months following study start.</time_frame> <description>A secondary outcome is health literacy (using theThe European Health Literacy Survey Questionnaire (HLS-EU-Q47)</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">150</enrollment> <condition>Sport Injury</condition> <condition>Diabetes</condition> <condition>Health Behavior</condition> <condition>Illness Behavior</condition> <condition>Literacy</condition> <arm_group> <arm_group_label>This is an observational study.</arm_group_label> <description>The cohort will consist of elite Para athletes (athletes with an impairment).</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Athlete health monitoring</intervention_name> <description>Observational study</description> <arm_group_label>This is an observational study.</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Participants from the Swedish and South African Paralympic programmes will be invited to participate in the study. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Being an registered para athlete in Sweden or South Africa  - Having an athlete classification according to the International Paralympic Committee  Exclusion Criteria:  - Age below 18 years, or older than 66  - Being a non-classified athlete </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>66 Years</maximum_age> </eligibility> <overall_contact> <last_name>Kristina Fagher, PhD</last_name> <phone>+46702970764</phone> <email>kristina.fagher@med.lu.se</email> </overall_contact> <overall_contact_backup> <last_name>Jan Lexell, PhD</last_name> <email>jan.lexell@med.lu.se</email> </overall_contact_backup> <location> <facility> <name>Lund University</name> <address> <city>Lund</city> <state>Skane</state> <zip>221 00</zip> <country>Sweden</country> </address> </facility> <contact> <last_name>Kristina Fagher, PhD</last_name> <phone>+46702970764</phone> <email>kristina.fagher@med.lu.se</email> </contact> <contact_backup> <last_name>Jan Lexell, PhD</last_name> <email>jan.lexell@med.lu.se</email> </contact_backup> </location> <location_countries> <country>Sweden</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>February 14, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Lund University</investigator_affiliation> <investigator_full_name>Kristina Fagher</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Para sport</keyword> <keyword>Sports injuries</keyword> <keyword>Athlete health</keyword> <keyword>Health promotion</keyword> <keyword>Health literacy</keyword> <condition_browse>  <mesh_term>Athletic Injuries</mesh_term> <mesh_term>Illness Behavior</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>The is no plan to share IPD data with other researchers.</ipd_description> </patient_data>  </clinical_study>

The interest in Para sport is steadily increasing. A concern is, though, that elite Para athletes report a high incidence of injuries and illnesses. Altogether, there is an urgent need to prevent such incidents among athletes already suffering from an impairment. However, most of the existing training-based prevention programmes are not adapted or accessible to Para athletes. Also, recent research suggests that sports safety work advantageously should facilitate disease prevention and health promotion. Such intervention would hypothetically also have the potential to reduce injuries, illnesses and improve health among Para athletes. To allow full implementation, the intervention would need to be adapted to the Para athletes´ various impairments, abilities and sports. MAIN QUESTIONS TO BE ADRESSED - Can an evidence-based eHealth health promotion platform prevent sports injuries and illnesses in elite para athletes over 6 months, 12 months and 5 years? - Can such platform improve overall health parameters such as sleep, nutrition and mental health in elite para athletes and influence the performance parameters training quantity and training quality over 6 months, 12 months and 5 years? - Can such platform improve health literacy among Para athletes? Introduction Sport is today one of the largest movements in Sweden, with more than three million people being members of a sports club. Participation in sport leads to several health benefits as it improves both physical and mental health. For example, it reduces the risk for cardiometabolic disease, fractures, dementia, mental illness and some cancer types. Sport also supports the development of social skills during different periods in people's lifetime. Sport has therefore a great impact on the quality of life for the individual person as well as for our health economics, as it can prevent and treat disease. The interest in sport and its associated benefits for persons with an impairment (Para sport) has also increased in the last few decades. Para sport is, however, still a young sporting discipline and despite the fact that sport poses the athlete at a risk for suffering a sports-related injury or illness few studies have assessed the burden of such incidents in Para sport. The Para athlete and Paralympic athlete What characterises Para and Paralympic athletes is the existing impairment, whether it is physical, visual or intellectual. According to the World Health Organization the definition of an impairment is: "a problem in body function or structure" (WHO). Depending on the nature of the impairment the athlete may also have a greater risk for suffering from secondary health complaints, early age related health conditions, health risk behaviours and higher rates of premature death. For example, individuals with SCI may be predisposed to infections, skin breakdown, osteoporosis, contractures, spasticity, pain, depression, fatigue, hyperthermia, bowel dysfunction and cardiorespiratory insufficiency. Several of these health complaints may also be present in individuals with other neurological diseases such as multiple sclerosis (MS), stroke, traumatic brain injury and cerebral palsy (CP). Individuals with more rare diagnosis such as Becker muscular dystrophy, Duchenne muscular dystrophy and Friedreich's ataxia may in addition suffer from health complaints such as heart arrhythmias and a malformed skeleton. Joint contractures and muscle fibrosis are present in individuals with arthrogryposis, which often leads to musculoskeletal problems. The biomechanics is often altered among individuals with limb deficiency, which may cause stress fractures, tendinopathies and osteoarthritis. Also stump conditions such as phantom pain, rashes and heterotopic ossification are common. Furthermore, alterations in the vascular physiology may induce cardiac disease. Individuals with visual impairment have in general a greater risk for morbidity and unintentional injury and illness such as cardiometabolic disease, depression, falls and fractures. Other health conditions that are sometimes present with diagnoses related to visual impairments are joint problems, obesity, hearing impairment, diabetes and development delay. Individuals with intellectual impairments have more often a poor mental and physical health compared to the rest of population. Higher rates of health complaints, such as gastrointestinal disease, obesity, epilepsy, cardiometabolic disease and mental illness have been reported. Altogether, the Para athlete has other conditions due to the impairment and the sometimes associated health complaints when entering sports in comparison with an able-bodied athlete, which possibly could affect training behaviour as well as the epidemiology and consequences of sports-related injuries and illnesses. Epidemiology of sports-related injuries and illnesses Despite all the positive health effects of sports, sports-related injuries and illnesses are a concern in most elite sports settings, as they may lead to morbidity, an ending of the sport career, long- term disability and mortality. Sports-related injuries are also a cost and burden for society. Traumatic sports injuries, such as concussion, ligament sprains, joint distortions or fractures may, for example, lead to brain damage, osteoarthritis and chronic pain for the individual athlete. Catastrophic injuries leading to spinal injuries and death are less common, but still a concern in several sports. Overuse-related injuries may also cause several health complaints such as inflammation, degeneration and chronic pain. Recent research has suggested that the risks associated with sports- related injuries and its consequences are unacceptable when evaluated against acceptable criteria from occupational health. Sports-related illnesses have also received more focus during the last decade. However, studies concerning the epidemiology of sports-related illnesses are still underrepresented in comparison to sports injury epidemiology. A concern is that there still are few cohort studies concerning sports injury and illness epidemiology in Para sport. Moreover, definitions and data collection methods have not been adapted to the Para athletes´ various impairments. To assist the development of evidence-based preventive measures the aim of my PhD-thesis was to gain an in-depth understanding of the epidemiology and data collection methods of sports injuries and illnesses in Para athletes. First an eHealth application for self-reported data collection of injuries and illnesses adapted to the Web Content Accessibility guidelines and Para athletes was developed and evaluated in a pilot feasibility and usability study. Thereafter, 107 Swedish elite para athletes were followed prospectively during 52 weeks. In the thesis, which is the first study globally that prospectively has followed a large cohort of Para athletes, it was shown that 68% reported an injury and 77% an illness, which is a higher incidence compared to able-bodied athletes in Sweden. One third of the injuries were classified as severe and the athletes´ impairment was involved in the mechanism in 59% of the injuries. For example, wheelchair athletes reported a high proportion of shoulder injuries and athletes with VI reported falls. Also diagnoses such as spasticity and neurogenic bladder were reported, which are not seen in able-bodied athletes. Two thirds of the athletes reported poor sleep, 48% reported persistent pain and 34% reported anxiety. Data also show that more injuries are reported at the Paralympic Games compared to the Olympic Games. Altogether, there is an urgent need to further understand the epidemiology of sports injuries and illnesses, and to prevent injuries and illnesses in Para athletes. A concern is that the development and evaluation of evidence-based prevention strategies take time. However, research among able-bodied athletes has shown that regular athlete health monitoring with accompanied medical guidance may reduce the burden of sports injuries and illnesses, and shorten the time loss from sport when injured/ill. The medical team following up the athlete should consist of qualified and experienced individuals operating in synergy with the coach and the athlete towards a common performance and health goal. It has been proposed that this system facilitate a balanced approach to training and competing decisions, especially while the athlete is ill or injured. This method can be supported by results from my PhD-thesis, in which it it was shown that 90% of the athletes found it important to conduct athlete health monitoring also in the future. Moreover, qualitative data have revealed that Para athletes´ perceptions are that they do not have the same prerequisites as able-bodied athletes when being injured or ill. In summary, it can be hypothesized that regular athlete health monitoring over time will help us to further improve our understanding of the epidemiology of sports injuries and illnesses in Parasport, and that immediate medical guidance also can minimize the impact of a sports injury or illness. Health promotion in sports Another concern in Parasport is that the existing prevention programmes in sports such as the knee control are not adapted to Para athletes, as several athletes are wheelchair users or amputees. Among able-bodied athletes, it has been recommended that sports safety work should facilitate health promotion, including health education. A recent study of able-bodied Swedish athletes have shown that a health promotion webpage for elite athletics athletes can reduce the injury risk. However, there is no health promotion webpage for Swedish Para athletes. Taken together an accessible eHealh based health promotion platform will first be developed in this project using a participatory action based research design. Thereafter the following research questions will be adressed: - Can an evidence-based eHealth health promotion platform prevent sports injuries and illnesses in elite para athletes over 6 months, 12 months and 5 years? - Can such platform improve overall health parameters such as sleep, nutrition and mental health in elite para athletes and influence the performance parameters training quantity and training quality over 6 months, 12 months and 5 years? - Can such platform improve health literacy among Para athletes? Participants from the Swedish and South African Paralympic programmes will be invited to participate in the study. Inclusion Criteria: - Being an registered para athlete in Sweden or South Africa - Having an athlete classification according to the International Paralympic Committee Exclusion Criteria: - Age below 18 years, or older than 66 - Being a non-classified athlete

NCT0531xxxx/NCT05317143.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/NCT05317143</url> </required_header> <id_info> <org_study_id>1091459C</org_study_id> <nct_id>NCT05317143</nct_id> </id_info> <brief_title>Evaluation of Prostate Cancer Margins</brief_title> <official_title>Evaluation of Prostate Cancer Margins</official_title> <sponsors> <lead_sponsor> <agency>Intuitive Surgical</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Intuitive Surgical</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> Pathological assessment of prostate tissue </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">February 22, 2022</start_date> <completion_date type="Actual">November 10, 2022</completion_date> <primary_completion_date type="Actual">November 10, 2022</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>Positive Margin</measure> <time_frame>Immediately postoperatively, expected same day as surgery</time_frame> <description>Detection of positive margin</description> </primary_outcome> <enrollment type="Actual">100</enrollment> <condition>Prostate Cancer</condition> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Evaluation of prostate cancer margins</intervention_name> <description>Evaluation of prostate cancer margins</description> </intervention> <biospec_retention>None Retained</biospec_retention> <biospec_descr> <textblock> Prostate </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Patients with prostate cancer who undergo robotic-assisted prostatectomy </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Diagnosed with prostate cancer  - Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.  Exclusion Criteria:  - None </textblock> </criteria> <gender>Male</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Jörn Hinrich Witt, PD Dr. med</last_name> <role>Principal Investigator</role> <affiliation>St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany</affiliation> </overall_official> <overall_official> <last_name>Sami-Ramzi Leyh-Bannurah, PD Dr. med</last_name> <role>Principal Investigator</role> <affiliation>St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany</affiliation> </overall_official> <location> <facility> <name>St. Antonius Hospital, Prostatazentrum Nordwest</name> <address> <city>Gronau</city> <zip>48599</zip> <country>Germany</country> </address> </facility> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>February 2, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>January 5, 2023</last_update_submitted> <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 6, 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>No</sharing_ipd> </patient_data>  </clinical_study>

Pathological assessment of prostate tissue Prostate Patients with prostate cancer who undergo robotic-assisted prostatectomy Inclusion Criteria: - Diagnosed with prostate cancer - Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site. Exclusion Criteria: - None

NCT0531xxxx/NCT05317156.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/NCT05317156</url> </required_header> <id_info> <org_study_id>IstanbulMU13</org_study_id> <nct_id>NCT05317156</nct_id> </id_info> <brief_title>The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period</brief_title> <official_title>The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period</official_title> <sponsors> <lead_sponsor> <agency>Istanbul Medeniyet University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Maltepe University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Istanbul Medeniyet 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> Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur. </textblock> </brief_summary> <detailed_description> <textblock> Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. In addition, similar complaints may be encountered after extubation due to the displacement of the cuff of the EI and changes in the cuff pressure during the head and body positioning of the patient for surgical intervention after the EI. In the literature, studies examining the effect of intraoperative patient position on symptoms associated with postoperative intubation are limited. Baran Akkuş and Çaparlar (2020) evaluated the postoperative period of sore throat, hoarseness, dysphagia, and cough by controlling the cuff pressure in patients with hyperextension and supine position, and they did not find a significant difference between the groups. Although the severity of intubation-related complaints, which usually regress within 24 to 72 hours in the postoperative period, varies from patient to patient, it can affect the comfort of the patients in the early postoperative period.  In the literature, there are many studies conducted to relieve the symptoms of sore throat, cough, hoarseness, and dysphagia in patients after extubation. In these studies, pharmacological analgesic agents such as nonsteroidal anti-inflammatory drugs, steroids, opioids, local anesthetics; different anesthetic techniques, the use of different sized endotracheal tubes, intubation after complete muscle relaxation, minimizing cuff pressure, and lubricating gels such as local anesthetics or oral lozenges, sprays and mouthwash solutions are used around or inside the intubation tube cuff. There are many studies in the literature on the successful application of non-pharmacological agents in the treatment of pain. Patients with post-operative throat complaints are recommended to take warm liquids, avoid solid food, suck ice chips, use lozenges, and apply steam. The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or by inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur. Although it is seen in the literature that pharmacological, non-pharmacological, and herbal methods are applied to reduce postoperative sore throat, cough, hoarseness, and dysphagia, no study has been found examining the effect of the cold steam application on symptoms associated with IE. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 18, 2022</start_date> <completion_date type="Anticipated">November 1, 2022</completion_date> <primary_completion_date type="Anticipated">October 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>Patients who were hospitalized for surgical intervention in the supine and prone position and met the sample selection criteria will be included in the experimental and control groups by block randomization method using the random numbers table on the computer.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Cold vapor</measure> <time_frame>First 24 hours after surgery</time_frame> <description>The sore throat, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 10 is taken from the Visual Analogue Scale (VAS). It is good that the score on the scales has decreased.</description> </primary_outcome> <primary_outcome> <measure>Cold vapor</measure> <time_frame>First 24 hours after surgery</time_frame> <description>The cough, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 4 is taken from the Cough Severity Form (CSF). It is good that the score on the scales has decreased.</description> </primary_outcome> <primary_outcome> <measure>Cold vapor</measure> <time_frame>First 24 hours after surgery</time_frame> <description>Swallowing, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 24 is taken from the Swallowing Impairment Score (SIS). It is good that the score on the scales has decreased.</description> </primary_outcome> <primary_outcome> <measure>Cold vapor</measure> <time_frame>First 24 hours after surgery</time_frame> <description>The hoarseness, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 3 is taken from the Shout's Hoarseness Scale (SHS). It is good that the score on the scales has decreased.</description> </primary_outcome> <primary_outcome> <measure>Cold vapor</measure> <time_frame>24th hour after surgery</time_frame> <description>The Perianesthesia Comfort Scale (PCS) of the patients for comfort who underwent cold vapor is decreased compared to those who do not. A score between 24 and 144 is taken from the PCS. It is good that the score from the PCS has increased.</description> </primary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">120</enrollment> <condition>Intubation Complication</condition> <condition>Cold</condition> <condition>Sore Throat</condition> <condition>Cough</condition> <condition>Hoarseness</condition> <condition>Dysphagia</condition> <arm_group> <arm_group_label>Prone position-Cold vapor group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Cold vapor will be applied to the prone position experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtimeun600aultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of sore throat, cough, hoarseness, and dysphagia before and 15 minutes after the cold vapor application in the recovery room and at the 6th, 12th, and 24th hours after the cold vapor application in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour.</description> </arm_group> <arm_group> <arm_group_label>Supine position-Cold vapor group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Cold vapor will be applied to the supine position experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtimeun600aultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of sore throat, cough, hoarseness, and dysphagia before and 15 minutes after the cold vapor application in the recovery room and at the 6th, 12th, and 24th hours after the cold vapor application in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour.</description> </arm_group> <arm_group> <arm_group_label>Prone position-Control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Patients in the prone position control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of sore throat, cough, hoarseness, and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour.</description> </arm_group> <arm_group> <arm_group_label>Supine position-Control Group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Patients in the supine position control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of sore throat, cough, hoarseness, and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Cold vapor</intervention_name> <description>Before surgery, the socio-demographic data of the patients will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of sore throat, cough, hoarseness, and dysphagia before and 15 minutes after the cold vapor application in the recovery room and at the 6th,12th, and 24th hours after the cold vapor application in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour.</description> <arm_group_label>Prone position-Cold vapor group</arm_group_label> <arm_group_label>Supine position-Cold vapor group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Being 18 years or older  - Having an ASA score of 1-2  - Not having any respiratory problems before the operation  - Not having a neurological disease related to swallowing  - Not having a sore throat due to cancer and chronic diseases  - Not having hoarseness before surgery  - With endotracheal intubation, the duration of the operation is at least 60 minutes under general anesthesia.  - Having surgery in one of the prone and supine positions  - Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room.  - Having a Modified Aldrete score of at least 9 in the postoperative recovery room  - To be willing to participate in the study.  Exclusion Criteria:  - To undergo emergency surgery  - Being under the age of 18  - Having an ASA score of 3 and above  - Having any respiratory problems in the preoperative period  - Having a neurological disease related to swallowing  - Having a sore throat due to cancer and chronic diseases  - Having throat surgery  - The duration of the operation is less than 60 minutes  - Having surgery in a position other than the prone and supine positions  - Not agreeing 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_contact> <last_name>Özlem İbrahimoğlu, PhD</last_name> <phone>+905436195971</phone> <email>oogutlu@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Hatice Erdoğan, PhD</last_name> <phone>+905536199454</phone> <email>haticeerdogan74@hotmail.com</email> </overall_contact_backup> <link> <url>https://dergipark.org.tr/en/download/article-file/458973</url> <description>Paltura, C., & Yüceant, G. A. (2018). Kısa süreli endotrakeal entübasyonun ses kalitesi ve aralığına etkisi. Çağdaş Tıp Dergisi, 8(1), 26-28.</description> </link> <link> <url>https://jag.journalagent.com/ejm/pdfs/EJM-18189-ORIGINAL_ARTICLE-KARAHAN.pdf</url> <description>Zaman, F., & Karahan, E. (2020). The Effect of Cold Vapor Treated to Thyroidectomy Patients During Early Postoperative Period. Eastern Journal of Medicine, 25(1), 118-125.</description> </link> <link> <url>http://www.usa-journals.com/wp-content/uploads/2013/10/Ghaleb_Vol111.pdf</url> <description>Ghaleb, M. A., Falatah, S., & Al-Amoudi, F. A. (2013). The efficacy of licorice gargle for attenuating postoperative sore throat. Am J Res Commun, 1(11), 379-94.</description> </link> <link> <url>https://pdfs.semanticscholar.org/6ef9/44253f36d5f11c2b39c42fd0f2b87995c7d7.pdf</url> <description>AKKUŞ, İ. B., & ÇAPARLAR, C. Ö. (2020). Başın Hiperekstansiyonu Endotrakeal Kaf Basıncını Etkiler mi?. Turkiye Klinikleri J Anest Reanim, 18(1), 1-7.</description> </link> <reference> <citation>Bulut H, Erden S, Demir SG, Cakar B, Erdogan Z, Demir N, Ay A, Aydin E. The Effect of Cold Vapor Applied for Sore Throat in the Early Postoperative Period. J Perianesth Nurs. 2016 Aug;31(4):291-7. doi: 10.1016/j.jopan.2014.10.005. Epub 2016 Feb 24.</citation> <PMID>27444760</PMID> </reference> <reference> <citation>Chang JE, Min SW, Kim CS, Han SH, Kwon YS, Hwang JY. Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can J Anaesth. 2015 Oct;62(10):1097-103. doi: 10.1007/s12630-015-0432-x. Epub 2015 Jul 7.</citation> <PMID>26149601</PMID> </reference> <reference> <citation>Kim D, Jeon B, Son JS, Lee JR, Ko S, Lim H. The changes of endotracheal tube cuff pressure by the position changes from supine to prone and the flexion and extension of head. Korean J Anesthesiol. 2015 Feb;68(1):27-31. doi: 10.4097/kjae.2015.68.1.27. Epub 2015 Jan 28.</citation> <PMID>25664152</PMID> </reference> <reference> <citation>Jung TH, Rho JH, Hwang JH, Lee JH, Cha SC, Woo SC. The effect of the humidifier on sore throat and cough after thyroidectomy. Korean J Anesthesiol. 2011 Dec;61(6):470-4. doi: 10.4097/kjae.2011.61.6.470. Epub 2011 Dec 20.</citation> <PMID>22220223</PMID> </reference> <reference> <citation>Kim D, Jeong H, Kwon J, Kang S, Han B, Lee EK, Lee SM, Choi JW. The effect of benzydamine hydrochloride on preventing postoperative sore throat after total thyroidectomy: a randomized-controlled trial. Can J Anaesth. 2019 Aug;66(8):934-942. doi: 10.1007/s12630-019-01371-2. Epub 2019 Apr 16.</citation> <PMID>30993537</PMID> </reference> <reference> <citation>Komasawa N, Mihara R, Imagawa K, Hattori K, Minami T. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial. Biomed Res Int. 2015;2015:386080. doi: 10.1155/2015/386080. Epub 2015 Oct 5.</citation> <PMID>26509152</PMID> </reference> <reference> <citation>Paltura C, Guvenc A, Develioglu ON, Yelken K, Kulekci M. Original Research: Aerosolized Lidocaine: Effective for Safer Arousal After Suspension Laryngoscopy. J Voice. 2020 Jan;34(1):130-133. doi: 10.1016/j.jvoice.2018.08.012. Epub 2018 Sep 15.</citation> <PMID>30227980</PMID> </reference> <reference> <citation>Stout DM, Bishop MJ, Dwersteg JF, Cullen BF. Correlation of endotracheal tube size with sore throat and hoarseness following general anesthesia. Anesthesiology. 1987 Sep;67(3):419-21. doi: 10.1097/00000542-198709000-00025. No abstract available.</citation> <PMID>3307536</PMID> </reference> <reference> <citation>Sahbaz M, Khorshid L. The Effect of Cold Vapor and Ice Cube Absorption in the Early Postoperative Period on Sore Throat and Hoarseness Induced by Intubation. J Perianesth Nurs. 2020 Oct;35(5):518-524. doi: 10.1016/j.jopan.2019.12.007. Epub 2020 May 10.</citation> <PMID>32402773</PMID> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 8, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation> <investigator_full_name>Dr. Özlem İbrahimoğlu</investigator_full_name> <investigator_title>Assisstant Professor</investigator_title> </responsible_party> <keyword>Intubation</keyword> <keyword>Nursing care</keyword> <condition_browse>  <mesh_term>Pharyngitis</mesh_term> <mesh_term>Hoarseness</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>A decision will be made after consultation with other researchers.</ipd_description> </patient_data>  </clinical_study>

Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur. Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. In addition, similar complaints may be encountered after extubation due to the displacement of the cuff of the EI and changes in the cuff pressure during the head and body positioning of the patient for surgical intervention after the EI. In the literature, studies examining the effect of intraoperative patient position on symptoms associated with postoperative intubation are limited. Baran Akkuş and Çaparlar (2020) evaluated the postoperative period of sore throat, hoarseness, dysphagia, and cough by controlling the cuff pressure in patients with hyperextension and supine position, and they did not find a significant difference between the groups. Although the severity of intubation-related complaints, which usually regress within 24 to 72 hours in the postoperative period, varies from patient to patient, it can affect the comfort of the patients in the early postoperative period. In the literature, there are many studies conducted to relieve the symptoms of sore throat, cough, hoarseness, and dysphagia in patients after extubation. In these studies, pharmacological analgesic agents such as nonsteroidal anti-inflammatory drugs, steroids, opioids, local anesthetics; different anesthetic techniques, the use of different sized endotracheal tubes, intubation after complete muscle relaxation, minimizing cuff pressure, and lubricating gels such as local anesthetics or oral lozenges, sprays and mouthwash solutions are used around or inside the intubation tube cuff. There are many studies in the literature on the successful application of non-pharmacological agents in the treatment of pain. Patients with post-operative throat complaints are recommended to take warm liquids, avoid solid food, suck ice chips, use lozenges, and apply steam. The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or by inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur. Although it is seen in the literature that pharmacological, non-pharmacological, and herbal methods are applied to reduce postoperative sore throat, cough, hoarseness, and dysphagia, no study has been found examining the effect of the cold steam application on symptoms associated with IE. Inclusion Criteria: - Being 18 years or older - Having an ASA score of 1-2 - Not having any respiratory problems before the operation - Not having a neurological disease related to swallowing - Not having a sore throat due to cancer and chronic diseases - Not having hoarseness before surgery - With endotracheal intubation, the duration of the operation is at least 60 minutes under general anesthesia. - Having surgery in one of the prone and supine positions - Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room. - Having a Modified Aldrete score of at least 9 in the postoperative recovery room - To be willing to participate in the study. Exclusion Criteria: - To undergo emergency surgery - Being under the age of 18 - Having an ASA score of 3 and above - Having any respiratory problems in the preoperative period - Having a neurological disease related to swallowing - Having a sore throat due to cancer and chronic diseases - Having throat surgery - The duration of the operation is less than 60 minutes - Having surgery in a position other than the prone and supine positions - Not agreeing to participate in the study.

NCT0531xxxx/NCT05317169.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/NCT05317169</url> </required_header> <id_info> <org_study_id>16-001867</org_study_id> <nct_id>NCT05317169</nct_id> </id_info> <brief_title>Aneurysm Genetic Risk in Patients With QIB Changes</brief_title> <acronym>AnGen</acronym> <official_title>Aneurysm Genetic Risk in Patients With Changes in Quantitative Imaging Biomarkers Over Time</official_title> <sponsors> <lead_sponsor> <agency>University of California, Los Angeles</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of California, Los Angeles</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> Intracranial aneurysm rupture is a leading cause of hemorrhagic strokes which carry high mortality and disability rates as well as high healthcare costs. Unruptured intracranial aneurysms (UIA) are common in the general population, occurring in 1-2% of individuals. Previous studies have shown that UIA growth and rupture are strongly associated with each other, with growing aneurysms 9-12 times more likely to rupture, and nearly all aneurysms growing prior to rupture. Thanks to advanced medical imaging, UIA are now more and more often detected incidentally. However not all aneurysms qualify for preventive surgical or interventional procedures according to current International Study of Unruptured Intracranial Aneurysms (ISUIA) guidelines, and some must therefore be monitored for growth. Current guidelines are based heavily on size, an inconsistent predictor of future growth. To improve management strategies for individual patients and more comprehensively assess aneurysm risk, the investigators propose to identify risk factors related to growth.  Aneurysm etiology is multifactorial, with both genetic and environmental contributions to aneurysm formation, growth, and rupture. Exploring new risk factors based on aneurysm natural history and understanding the mechanisms underlying aneurysm rupture have been extensive research areas. As previous studies have shown that quantitative imaging biomarkers (QIB) can provide a more accurate assessment of the characteristics of aneurysms, the investigators propose a combined study which identifies QIB associated with aneurysm growth to identify factors related to growth. </textblock> </brief_summary> <detailed_description> <textblock> The objective of this study is to investigate intracranial aneurysms that have been followed with clinical 3D aneurysm images and create a matrix that can identify the risk of growth by integrating QIB with genetic predisposition risk factors. 120 Patients who have been followed by clinical aneurysm imaging study will be enrolled in this study. The study team will collect blood samples from the patients for genetic analysis.  To find the genetic factors, the blood samples will be processed with a focus on genetic variants 1) in pathways involved in endothelial and vascular function and 2) previously identified in genome-wide association studies of aneurysm risk. These analyses will include both common polymorphisms and rare alterations. These biomarkers have important implications for facilitating identification of high-risk subgroups for aneurysm growth and the development of improved evidence-based decision-making.  The investigators will perform aneurysm 3D analysis based on the aneurysm images to extract aneurysm QIB for these cases. Shape parameters such as aneurysm surface area shape indices will be collected for individual aneurysms as well as parameters capturing the aneurysm blood flow pattern. The study plans to address whether certain genetic variants for vascular function are present in patients with QIB change over time. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 12, 2018</start_date> <completion_date type="Anticipated">September 27, 2023</completion_date> <primary_completion_date type="Anticipated">September 27, 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>Quantitative imaging biomarkers (QIB) change</measure> <time_frame>3 years</time_frame> <description>Number of participants with changes in quantitative imaging biomarkers</description> </primary_outcome> <secondary_outcome> <measure>Genetic biomarkers in QIB change</measure> <time_frame>3 years</time_frame> <description>Number of participants with genetic biomarkers</description> </secondary_outcome> <enrollment type="Anticipated">120</enrollment> <condition>Brain Aneurysm</condition> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> whole blood </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> UCLA patients who come for yearly CT or MR angiography for cerebral aneurysm surveillance. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  Patients with unruptured cerebral aneurysms followed yearly using non-invasive imaging techniques including Computed tomography (CT) and Magnetic resonance (MR) angiography.  Exclusion Criteria:  Patients with bleeding disorders. Patients who have severe intravenous CT or MR contrast allergy. Patients with evidence of kidney failure. Patients with severe claustrophobia. Patients with religious objections to phlebotomy. </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>Aichi Chien, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of California, Los Angeles</affiliation> </overall_official> <overall_contact> <last_name>Aichi Chien, PhD</last_name> <phone>310-267-6837</phone> <email>achien@mednet.ucla.edu</email> </overall_contact> <location> <facility> <name>University of California, Los Angeles</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90024</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Aichi Chien, PhD</last_name> <email>achien@mednet.ucla.edu</email> </contact> <contact_backup> <last_name>Victoria Rueda</last_name> <phone>310-562-9694</phone> <email>vrueda@mednet.ucla.edu</email> </contact_backup> <investigator> <last_name>Aichi Chien, PhD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Gary Duckwiler, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Viktor Szeder, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Geoffrey Colby, MD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Pablo Villablanca, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>December 14, 2021</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 4, 2023</last_update_submitted> <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 8, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of California, Los Angeles</investigator_affiliation> <investigator_full_name>Aichi Chien, PhD</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>Brain Aneurysm</keyword> <keyword>Ruptured Brain Aneurysm</keyword> <keyword>Aneurysm Growth</keyword> <keyword>Brain Aneurysm Genetic Markers</keyword> <keyword>Vascular Malformation</keyword> <condition_browse>  <mesh_term>Intracranial Aneurysm</mesh_term> <mesh_term>Aneurysm</mesh_term> </condition_browse>  </clinical_study>

Intracranial aneurysm rupture is a leading cause of hemorrhagic strokes which carry high mortality and disability rates as well as high healthcare costs. Unruptured intracranial aneurysms (UIA) are common in the general population, occurring in 1-2% of individuals. Previous studies have shown that UIA growth and rupture are strongly associated with each other, with growing aneurysms 9-12 times more likely to rupture, and nearly all aneurysms growing prior to rupture. Thanks to advanced medical imaging, UIA are now more and more often detected incidentally. However not all aneurysms qualify for preventive surgical or interventional procedures according to current International Study of Unruptured Intracranial Aneurysms (ISUIA) guidelines, and some must therefore be monitored for growth. Current guidelines are based heavily on size, an inconsistent predictor of future growth. To improve management strategies for individual patients and more comprehensively assess aneurysm risk, the investigators propose to identify risk factors related to growth. Aneurysm etiology is multifactorial, with both genetic and environmental contributions to aneurysm formation, growth, and rupture. Exploring new risk factors based on aneurysm natural history and understanding the mechanisms underlying aneurysm rupture have been extensive research areas. As previous studies have shown that quantitative imaging biomarkers (QIB) can provide a more accurate assessment of the characteristics of aneurysms, the investigators propose a combined study which identifies QIB associated with aneurysm growth to identify factors related to growth. The objective of this study is to investigate intracranial aneurysms that have been followed with clinical 3D aneurysm images and create a matrix that can identify the risk of growth by integrating QIB with genetic predisposition risk factors. 120 Patients who have been followed by clinical aneurysm imaging study will be enrolled in this study. The study team will collect blood samples from the patients for genetic analysis. To find the genetic factors, the blood samples will be processed with a focus on genetic variants 1) in pathways involved in endothelial and vascular function and 2) previously identified in genome-wide association studies of aneurysm risk. These analyses will include both common polymorphisms and rare alterations. These biomarkers have important implications for facilitating identification of high-risk subgroups for aneurysm growth and the development of improved evidence-based decision-making. The investigators will perform aneurysm 3D analysis based on the aneurysm images to extract aneurysm QIB for these cases. Shape parameters such as aneurysm surface area shape indices will be collected for individual aneurysms as well as parameters capturing the aneurysm blood flow pattern. The study plans to address whether certain genetic variants for vascular function are present in patients with QIB change over time. whole blood UCLA patients who come for yearly CT or MR angiography for cerebral aneurysm surveillance. Inclusion Criteria: Patients with unruptured cerebral aneurysms followed yearly using non-invasive imaging techniques including Computed tomography (CT) and Magnetic resonance (MR) angiography. Exclusion Criteria: Patients with bleeding disorders. Patients who have severe intravenous CT or MR contrast allergy. Patients with evidence of kidney failure. Patients with severe claustrophobia. Patients with religious objections to phlebotomy.

NCT0531xxxx/NCT05317182.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/NCT05317182</url> </required_header> <id_info> <org_study_id>REST-ECL-2021-07</org_study_id> <nct_id>NCT05317182</nct_id> </id_info> <brief_title>Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®.</brief_title> <official_title>"Comparative Study of the Accuracy of Dental Contacts of an Occlusal Splint Made According to Conventional or Digital Techniques Using GeoMagic®."</official_title> <sponsors> <lead_sponsor> <agency>Universitat Internacional de Catalunya</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Universitat Internacional de Catalunya</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 compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled. </textblock> </brief_summary> <detailed_description> <textblock> Forty participants received two different occlusal devices from two different workflows (fully conventional and fully digital). Every splint was scanned before and after the occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were compared in a software Geomagic® Control X calculates and measures the distance from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">February 17, 2022</start_date> <completion_date type="Actual">April 30, 2022</completion_date> <primary_completion_date type="Actual">April 15, 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>Factorial Assignment</intervention_model> <intervention_model_description>This clinical study has three arms of equal size: occlusal splints made by conventional impression and conventional fabrication (Group 1), occlusal splints made by conventional impression and digital design and fabrication (Group 2), and occlusal splints performed by intra-oral scanner and digital design and fabrication (Group 3). Otherwise, the allocation of each subject to each group will be done at random by a list made with specialized software until the sample will be fulfilled when the patient is recruited.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Volumetric changes assessed in Root Mean Square (RMS)</measure> <time_frame>1 week</time_frame> <description>The software of automatically graphical comparisons called Geomagic® Control X (Geomagic Inc., 3D Systems Inc., USA) will be used to calculate the accuracy by measuring the distance (positive or negative) from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment). This approach will give us the mean of the simple arithmetic difference.</description> </primary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Occlusal Splints</condition> <arm_group> <arm_group_label>Analogic-Analogic</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Occlusal splints made by conventional impression and conventional fabrication.</description> </arm_group> <arm_group> <arm_group_label>Analogic-Digital</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Occlusal splints made by conventional impression and digital design and fabrication.</description> </arm_group> <arm_group> <arm_group_label>Digital-Digital</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Occlusal splints performed by intra-oral scanner and digital design and fabrication.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Occlusal Splints Analogic-Analogic</intervention_name> <description>Take a conventional impression to the patient and conventional fabrication of the splint.</description> <arm_group_label>Analogic-Analogic</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Occlusal Splints Analogic-Digital</intervention_name> <description>Take a conventional impression to the patient and digital fabrication of the splint.</description> <arm_group_label>Analogic-Digital</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Occlusal Splints Digital-Digital</intervention_name> <description>Take a digital impression to the patient and digital fabrication of the splint.</description> <arm_group_label>Digital-Digital</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients between 18 to 70 years old.  - Patients who maintain until first molar in both arches.  - Patients who need occlusal splints due to bruxism.  Exclusion Criteria:  - Pregnant patients.  - Patients with removable prostheses.  - Patients with fixed prostheses between six to six in both arches.  - Patients with partial edentulism, do not maintain until first molar in both arches.  - Patients with Temporomandibular Disorders (TMD): articular noises, pain on palpation, limited opening. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Miguel Roig, DDS, PhD</last_name> <role>Study Director</role> <affiliation>Universitat Internacional de Catalunya</affiliation> </overall_official> <location> <facility> <name>Blasi Clinica Dental Barcelona</name> <address> <city>Barcelona</city> <zip>08021</zip> <country>Spain</country> </address> </facility> </location> <location_countries> <country>Spain</country> </location_countries> <verification_date>May 2022</verification_date> <study_first_submitted>March 6, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 16, 2022</last_update_submitted> <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc> <last_update_posted type="Actual">May 18, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Universitat Internacional de Catalunya</investigator_affiliation> <investigator_full_name>Alvaro Blasi</investigator_full_name> <investigator_title>Principal investigator</investigator_title> </responsible_party> <keyword>Digital Dentistry</keyword> <keyword>Occlusal records</keyword> <keyword>Intraoral scan</keyword> <intervention_browse>  <mesh_term>Salicylic Acid</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To compare the accuracy of the occlusal splints made by conventional impression and milled with the splint made by intraoral scanner and milled. Forty participants received two different occlusal devices from two different workflows (fully conventional and fully digital). Every splint was scanned before and after the occlusal adjustments in order to compare the volumetric changes. Furthermore, the scans were compared in a software Geomagic® Control X calculates and measures the distance from every surface point from the initial dataset (occlusal devices before adjustment) to the final dataset (occlusal device after adjustment). Inclusion Criteria: - Patients between 18 to 70 years old. - Patients who maintain until first molar in both arches. - Patients who need occlusal splints due to bruxism. Exclusion Criteria: - Pregnant patients. - Patients with removable prostheses. - Patients with fixed prostheses between six to six in both arches. - Patients with partial edentulism, do not maintain until first molar in both arches. - Patients with Temporomandibular Disorders (TMD): articular noises, pain on palpation, limited opening.

NCT0531xxxx/NCT05317195.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/NCT05317195</url> </required_header> <id_info> <org_study_id>P5-PK-01-EXP</org_study_id> <nct_id>NCT05317195</nct_id> </id_info> <brief_title>Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers</brief_title> <official_title>A Single-center, Randomized, Controlled, Open-label Study to Investigate the Nicotine Pharmacokinetic Profiles and Subjective Effects of Four Variants of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers</official_title> <sponsors> <lead_sponsor> <agency>Philip Morris Products S.A.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Philip Morris Products S.A.</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, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over). </textblock> </brief_summary> <detailed_description> <textblock> The purpose of the study is to evaluate the nicotine PK profiles of 4 variants of NP 1.0 versus Velo-NP and Zyn-NP following a 30-minute use period. In addition, PD, including subjective effects and related behavioral assessments will be evaluated, to provide further insights on NP 1.0 product acceptance and abuse liability. Safety will be assessed throughout the study.  The aim is to evaluate if NP 1.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for smokers who would otherwise continue smoking cigarettes. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 15, 2022</start_date> <completion_date type="Actual">August 18, 2022</completion_date> <primary_completion_date type="Actual">May 7, 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>Basic Science</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Background-corrected maximum plasma concentration [Cmax]</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure the background-corrected maximum plasma concentration [Cmax] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.</description> </primary_outcome> <primary_outcome> <measure>Background-corrected time to the maximum concentration [Tmax]</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure the background-corrected time to the maximum concentration [Tmax] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.</description> </primary_outcome> <primary_outcome> <measure>Area under the background-corrected concentration-time curve (AUC) from start of product use</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure the area under the background-corrected concentration-time curve (AUC) from start of product use of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.</description> </primary_outcome> <secondary_outcome> <measure>Score of cigarette craving by the visual analog sale (VAS)-craving assessment</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure cigarette craving by the visual analog sale (VAS)-craving assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP.</description> </secondary_outcome> <secondary_outcome> <measure>Score of "in the moment" product liking by the VAS-liking assessment</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure "in the moment" product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP.</description> </secondary_outcome> <secondary_outcome> <measure>Score of overall product liking by the VAS-liking assessment</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure overall product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP.</description> </secondary_outcome> <secondary_outcome> <measure>Score of product satisfaction by the VAS-satisfaction assessment</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure product satisfaction by the VAS-satisfaction assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP.</description> </secondary_outcome> <secondary_outcome> <measure>Score of product intention to use again by the VAS-intention to use again assessment</measure> <time_frame>Measured at baseline (day 1), day 2, and day 3</time_frame> <description>To measure intention to use product again by the VAS-intention to use again assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP.</description> </secondary_outcome> <number_of_arms>6</number_of_arms> <enrollment type="Actual">24</enrollment> <condition>Smoking</condition> <condition>Nicotine</condition> <arm_group> <arm_group_label>NP-1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Nicotine Pouch 1.0 (variant NP-1)</description> </arm_group> <arm_group> <arm_group_label>NP-2</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Nicotine Pouch 1.0 (variant NP-2)</description> </arm_group> <arm_group> <arm_group_label>NP-3</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Nicotine Pouch 1.0 (variant NP-3)</description> </arm_group> <arm_group> <arm_group_label>NP-4</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Nicotine Pouch 1.0 (variant NP-4)</description> </arm_group> <arm_group> <arm_group_label>Velo-NP</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Velo® Ice Cool</description> </arm_group> <arm_group> <arm_group_label>Zyn-NP</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Zyn® Cool Mint Mini Dry</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>NP-1</intervention_name> <description>NP-1; 8.4 mg nicotine; pH 8.0; moisture 30</description> <arm_group_label>NP-1</arm_group_label> <arm_group_label>NP-2</arm_group_label> <arm_group_label>NP-3</arm_group_label> <arm_group_label>NP-4</arm_group_label> <arm_group_label>Velo-NP</arm_group_label> <arm_group_label>Zyn-NP</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>NP-2</intervention_name> <description>NP-2; 8.4 mg nicotine; pH 9.0; moisture 30</description> <arm_group_label>NP-1</arm_group_label> <arm_group_label>NP-2</arm_group_label> <arm_group_label>NP-3</arm_group_label> <arm_group_label>NP-4</arm_group_label> <arm_group_label>Velo-NP</arm_group_label> <arm_group_label>Zyn-NP</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>NP-3</intervention_name> <description>NP-3; 3.6 mg nicotine; pH 8.0; moisture 15</description> <arm_group_label>NP-1</arm_group_label> <arm_group_label>NP-2</arm_group_label> <arm_group_label>NP-3</arm_group_label> <arm_group_label>NP-4</arm_group_label> <arm_group_label>Velo-NP</arm_group_label> <arm_group_label>Zyn-NP</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>NP-4</intervention_name> <description>NP-4; 3.6 mg nicotine; pH 8.0; moisture 30</description> <arm_group_label>NP-1</arm_group_label> <arm_group_label>NP-2</arm_group_label> <arm_group_label>NP-3</arm_group_label> <arm_group_label>NP-4</arm_group_label> <arm_group_label>Velo-NP</arm_group_label> <arm_group_label>Zyn-NP</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Velo-NP</intervention_name> <description>Velo-NP; 10 mg nicotine;</description> <arm_group_label>NP-1</arm_group_label> <arm_group_label>NP-2</arm_group_label> <arm_group_label>NP-3</arm_group_label> <arm_group_label>NP-4</arm_group_label> <arm_group_label>Velo-NP</arm_group_label> <arm_group_label>Zyn-NP</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Zyn-NP</intervention_name> <description>Zyn-NP; 3 mg nicotine;</description> <arm_group_label>NP-1</arm_group_label> <arm_group_label>NP-2</arm_group_label> <arm_group_label>NP-3</arm_group_label> <arm_group_label>NP-4</arm_group_label> <arm_group_label>Velo-NP</arm_group_label> <arm_group_label>Zyn-NP</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Main Inclusion Criteria:  - Subject has smoked continuously for at least the last 3 years prior to the Screening visit.  - Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 500 ng/mL).  - Subject does not plan to quit using tobacco and/or nicotine products within the next 3 months.  - Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.  Main Exclusion Criteria:  - As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.  - Subject is legally incompetent, or physically or mentally incapable of giving consent.  - Subject has a clinically relevant disease that requires medication, which as per the judgment of the Investigator would jeopardize the safety of the subject.  - Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.  - Subject has a BMI < 18.5 kg/m2 or > 32.0 kg/m2 (Europe) or > 35.0 kg/m2 (USA).  - For women only: subject is pregnant (does not have negative pregnancy test at Screening Visit and at Admission) or is breastfeeding. </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Rajkumar Chetty, MD</last_name> <role>Principal Investigator</role> <affiliation>Celerion</affiliation> </overall_official> <location> <facility> <name>Celerion</name> <address> <city>Belfast</city> <state>Northern Ireland</state> <zip>BT9 6AD</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 30, 2022</last_update_submitted> <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 31, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Nicotine-containing products</keyword> <keyword>Nicotine delivery</keyword> <pending_results> <submitted>May 17, 2023</submitted> </pending_results>  </clinical_study>

This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over). The purpose of the study is to evaluate the nicotine PK profiles of 4 variants of NP 1.0 versus Velo-NP and Zyn-NP following a 30-minute use period. In addition, PD, including subjective effects and related behavioral assessments will be evaluated, to provide further insights on NP 1.0 product acceptance and abuse liability. Safety will be assessed throughout the study. The aim is to evaluate if NP 1.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for smokers who would otherwise continue smoking cigarettes. Main Inclusion Criteria: - Subject has smoked continuously for at least the last 3 years prior to the Screening visit. - Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 500 ng/mL). - Subject does not plan to quit using tobacco and/or nicotine products within the next 3 months. - Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period. Main Exclusion Criteria: - As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical. - Subject is legally incompetent, or physically or mentally incapable of giving consent. - Subject has a clinically relevant disease that requires medication, which as per the judgment of the Investigator would jeopardize the safety of the subject. - Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit. - Subject has a BMI < 18.5 kg/m2 or > 32.0 kg/m2 (Europe) or > 35.0 kg/m2 (USA). - For women only: subject is pregnant (does not have negative pregnancy test at Screening Visit and at Admission) or is breastfeeding.

NCT0531xxxx/NCT05317208.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/NCT05317208</url> </required_header> <id_info> <org_study_id>CECB-CU-2022-3-3</org_study_id> <nct_id>NCT05317208</nct_id> </id_info> <brief_title>Prevalence of Periodontitis in Sample of Egyptian Population</brief_title> <acronym>prevalence</acronym> <official_title>Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional Study III</official_title> <sponsors> <lead_sponsor> <agency>Cairo University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cairo 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> Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional study </textblock> </brief_summary> <detailed_description> <textblock> The aim of this study is to assess the prevalence, severity, and extent of periodontitis through full-mouth examination of CAL, and its association withsociodemographic, behavioral and environmental risk factors, in anEgyptian sample will be recruited from diagnostic center at Faculty of Dentistry, Cairo University, Egypt. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 5, 2019</start_date> <completion_date type="Actual">March 1, 2022</completion_date> <primary_completion_date type="Actual">May 5, 2021</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Quetionaire on Percentage of periodontitis on egypt</measure> <time_frame>Two months</time_frame> <description>Description of prevalence of periodontitis on sample of Egyptians by filling a questionaire</description> </primary_outcome> <secondary_outcome> <measure>Socioeconomic level and periodontitis (questionaire)</measure> <time_frame>Two months</time_frame> <description>Relation between Socioeconomic level and its impact on prevalence of periodontitis.</description> </secondary_outcome> <enrollment type="Actual">581</enrollment> <condition>Periodontitis</condition> <eligibility> <study_pop> <textblock> All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - - All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.  Exclusion criteria:  1. patients undergone periodontal therapy in the last 6 months.  2. patients with psychomotor dysfunction.  3. Patients less than 18 years old.  4. Edentulous patients </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_official> <last_name>Reham O Ibrahim, PHD</last_name> <role>Study Director</role> <affiliation>lecturer</affiliation> </overall_official> <location> <facility> <name>Faculty of Dentistry</name> <address> <city>Cairo</city> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 3, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Mohamed Ashraf Mohamed Abdelbary</investigator_full_name> <investigator_title>Director</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Periodontitis</mesh_term> </condition_browse>  </clinical_study>

Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional study The aim of this study is to assess the prevalence, severity, and extent of periodontitis through full-mouth examination of CAL, and its association withsociodemographic, behavioral and environmental risk factors, in anEgyptian sample will be recruited from diagnostic center at Faculty of Dentistry, Cairo University, Egypt. All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old. Inclusion Criteria: - - All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old. Exclusion criteria: 1. patients undergone periodontal therapy in the last 6 months. 2. patients with psychomotor dysfunction. 3. Patients less than 18 years old. 4. Edentulous patients

NCT0531xxxx/NCT05317221.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/NCT05317221</url> </required_header> <id_info> <org_study_id>Organoids Breast</org_study_id> <nct_id>NCT05317221</nct_id> </id_info> <brief_title>Developing Breast (Cancer) Organoids</brief_title> <official_title>Developing Breast (Cancer) Organoids</official_title> <sponsors> <lead_sponsor> <agency>Maastricht Radiation Oncology</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Maastricht University Medical Center</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Maastricht University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Maastricht Radiation Oncology</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, only a few validated biomarkers and models exist guiding or predicting treatment response for specific patient groups. Therefore, a patient-tailored clinical model needs to be developed to address tumour heterogeneity and thereby guide treatment selection on an individualized level. Organoids are patient-derived aggregates that grow in 3D and maintain self- renewal pluripotency and lineage-specific differentiation. Therefore, in contrast with conventional cell lines, they are thought to sustain patient heterogeneity and characteristics and are consequently already in use for drug response screening.  This now offers the opportunity to investigate if the primary patient breast cancer organoid platform reflects disease progression, treatment response and relapse in patients with different clinical breast cancer subtypes.  Goal: To develop a living biobank from prospective patient-derived breast cancer tissue. The questions we will address are:  1. Do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour?  2. Can BC organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions?  3. Can the investigators utilize BC organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients?  4. Can BC organoids be used to discover mechanisms of treatment resistance and relapse? </textblock> </brief_summary> <detailed_description> <textblock> The investigators will select patients with a diagnosis of breast cancer who undergo breast surgery. Patients will be asked informed consent for the use of a small (0,2-1 cm3) sample of the excised breast tumour and the collection of a blood sample (6ml)for whole-exome sequencing (WES) to compare the genetic profile of the patients with the organoids and the patient biopsy. The patients will not undergo any additional treatment or procedure in addition to the planned routine procedure for the surgical resection of their primary breast tumour.  Patient will undergo standard diagnostic procedures and treatment according to the Dutch breast cancer surgery guidelines. After surgery, the pathologist will provide -after pathological diagnosis- rest (tumour) tissue from the resection to the lab. This material will then be used to develop breast cancer organoids. As part of the routine surgical procedure, 6 ml of blood will be collected. Participation in this study does not lead to additional actions other than reading the patient information and signing the informed consent. Therefore, participation does not change the patient's treatment or outcome. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 1, 2022</start_date> <completion_date type="Anticipated">May 1, 2028</completion_date> <primary_completion_date type="Anticipated">April 1, 2028</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>Living biobank</measure> <time_frame>12 months</time_frame> <description>The development of a patient derived breast cancer living biobank using 3D organoid technology reflecting the most prominent clinical subtypes.</description> </primary_outcome> <secondary_outcome> <measure>Organoids.</measure> <time_frame>12 months</time_frame> <description>Cultivate breast cancer organoids that can be used to predict the treatment response to existing and novel combination treatments.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">60</enrollment> <condition>Breast Cancer</condition> <arm_group> <arm_group_label>All patients</arm_group_label> <description>The is only 1 arm: all breast cancer patients undergoing surgery.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Not an extra intervention, tissue taken in routine practice will be used.</intervention_name> <description>No extra intervention: using tumour tissue taken during surgery in standard of care.</description> <arm_group_label>All patients</arm_group_label> </intervention> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Extra tube of blood </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> All breast cancer patients that meet the criteria mentioned above. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Female,  - >18 years,  - Family Anamneses  - Breast cancer (proven by histopathology), Included subtypes; (ER-,PR- HER2-); (ER+, PR+, HER2-); (ER+, PR+ HER2+).  - Primary surgery (lumpectomy or mastectomy)  Exclusion Criteria:  - Physically or mentally incapable or incompetent to sign informed consent </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>Marc Vooijs, PhD</last_name> <role>Principal Investigator</role> <affiliation>Maastricht University</affiliation> </overall_official> <overall_official> <last_name>Marjolein Smidt, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Maastricht University Medical Center</affiliation> </overall_official> <overall_official> <last_name>Loes Kooreman, MD</last_name> <role>Principal Investigator</role> <affiliation>Maastricht University Hospital (MUMC+)</affiliation> </overall_official> <overall_official> <last_name>Maaike De Boer, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Maastricht University Hospital (MUMC+)</affiliation> </overall_official> <overall_contact> <last_name>Chantal Overhof</last_name> <phone>+31 88 44 55 683</phone> <email>chantal.overhof@maastro.nl</email> </overall_contact> <overall_contact_backup> <last_name>Ann Claessens</last_name> <phone>+31 88 44 55 600</phone> <email>ann.claessens@maastro.nl</email> </overall_contact_backup> <location> <facility> <name>Maastricht University Medical Center</name> <address> <city>Maastricht</city> <zip>6202 AZ</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Netherlands</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 14, 2023</last_update_submitted> <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 16, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party>  </clinical_study>

Currently, only a few validated biomarkers and models exist guiding or predicting treatment response for specific patient groups. Therefore, a patient-tailored clinical model needs to be developed to address tumour heterogeneity and thereby guide treatment selection on an individualized level. Organoids are patient-derived aggregates that grow in 3D and maintain self- renewal pluripotency and lineage-specific differentiation. Therefore, in contrast with conventional cell lines, they are thought to sustain patient heterogeneity and characteristics and are consequently already in use for drug response screening. This now offers the opportunity to investigate if the primary patient breast cancer organoid platform reflects disease progression, treatment response and relapse in patients with different clinical breast cancer subtypes. Goal: To develop a living biobank from prospective patient-derived breast cancer tissue. The questions we will address are: 1. Do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour? 2. Can BC organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions? 3. Can the investigators utilize BC organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients? 4. Can BC organoids be used to discover mechanisms of treatment resistance and relapse? The investigators will select patients with a diagnosis of breast cancer who undergo breast surgery. Patients will be asked informed consent for the use of a small (0,2-1 cm3) sample of the excised breast tumour and the collection of a blood sample (6ml)for whole-exome sequencing (WES) to compare the genetic profile of the patients with the organoids and the patient biopsy. The patients will not undergo any additional treatment or procedure in addition to the planned routine procedure for the surgical resection of their primary breast tumour. Patient will undergo standard diagnostic procedures and treatment according to the Dutch breast cancer surgery guidelines. After surgery, the pathologist will provide -after pathological diagnosis- rest (tumour) tissue from the resection to the lab. This material will then be used to develop breast cancer organoids. As part of the routine surgical procedure, 6 ml of blood will be collected. Participation in this study does not lead to additional actions other than reading the patient information and signing the informed consent. Therefore, participation does not change the patient's treatment or outcome. Extra tube of blood All breast cancer patients that meet the criteria mentioned above. Inclusion Criteria: - Female, - >18 years, - Family Anamneses - Breast cancer (proven by histopathology), Included subtypes; (ER-,PR- HER2-); (ER+, PR+, HER2-); (ER+, PR+ HER2+). - Primary surgery (lumpectomy or mastectomy) Exclusion Criteria: - Physically or mentally incapable or incompetent to sign informed consent

NCT0531xxxx/NCT05317234.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/NCT05317234</url> </required_header> <id_info> <org_study_id>69HCL21_0849</org_study_id> <nct_id>NCT05317234</nct_id> </id_info> <brief_title>Genetic Predisposition in Cerebral Palsy</brief_title> <acronym>PREGENE PC</acronym> <official_title>Genetic Predisposition in Cerebral Palsy</official_title> <sponsors> <lead_sponsor> <agency>Hospices Civils de Lyon</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Hospices Civils de Lyon</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> Cerebral palsy (CP) is a major neurodevelopmental disorder with an estimated prevalence of approximately one in 500 children. It is characterised by permanent developmental disorders of movement and posture, responsible for activity limitations, caused by non-progressive damage to the brain of the fetus, newborn or infant during development. The neurobiological mechanisms involved in CP remain poorly understood, although the interruption of cerebral oxygen supply during pregnancy or at the time of delivery is classically considered to be the main factor causing neurodevelopmental sequelae. CP also occurs in full-term infants without a clearly identifiable etiology.  Data from the literature suggest the existence of other pathophysiological processes than only acquired brain lesions related to pregnancy and delivery, such as genetic or epigenetic factors. According to some research teams, nearly one third of CP could have a genetic cause or could be favoured by genetic variants.  Preliminary research has made significant progress in revealing unusual copy number variants and/or mutations in single genes in children with CP. Several of the identified genes are involved in neurodevelopment and neuronal connectivity. Nevertheless, the identification of these abnormalities in CP may contribute to a better understanding of the pathophysiology of this complex and multifactorial disorder. It could also shed new light on the analysis of medico-legal files and bring encouraging perspectives by targeting new therapeutic interventions.  The main hypothesis is that a certain number of cerebral palsies are related to - or favoured by - genetic abnormalities that we will search for with genetic screening tests. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 8, 2023</start_date> <completion_date type="Anticipated">March 8, 2028</completion_date> <primary_completion_date type="Anticipated">March 8, 2028</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>Patients between 2 and 15 years old, born after 34 weeks' gestation, with a diagnosis of cerebral palsy.</intervention_model_description> <primary_purpose>Screening</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Proportion of patients for whom a significant genetic variant was identified on the exome by the High-throughput sequencing technique after comparison with the databases of human polymorphisms and pathogenic variants up to date during the analysis.</measure> <time_frame>Until the end of study, an average of 4.5 years</time_frame> <description>Are considered positive for a significant genetic variant, patients for whom a or several class 4 or 5 variants have been identified, and explain the phenotype of pc. Genetic variants will be classified according to the recommendations of the American College of Genetics Medical (ACMG: American College of Medical Genetics) from 1 to 5.</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">250</enrollment> <condition>Cerebral Palsy</condition> <arm_group> <arm_group_label>children with cerebral palsy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients between 2 and 15 years old, born after 34 weeks' gestation, with a diagnosis of cerebral palsy.</description> </arm_group> <intervention> <intervention_type>Genetic</intervention_type> <intervention_name>Whole-exome sequencing</intervention_name> <description>The whole-exome sequencing will be performed via a blood sample from a patient with a diagnosis of cerebral palsy.</description> <arm_group_label>children with cerebral palsy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Child between 2 and 15 years old with a clinical diagnostic of cerebral paralysis with bilateral somatic involvement  - Child born from 34 SA  - Agreement of the legal representatives for the genetic study  - Both parents available for a parental genetic study (if detection of class 3 variant)  - Affiliation to the social security system  Exclusion Criteria:  - Genetic syndrome identified or malformative or infectious etiologies identified  - Neonatal encephalopathy criteria in a clear obstetrical etiological context responsible for major perinatal anoxia with Sarnat 2 or 3  - Unilateral motor disorders in the term child (congenital hemiplegia) </textblock> </criteria> <gender>All</gender> <minimum_age>2 Years</minimum_age> <maximum_age>15 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Cyril Huissoud, Pr</last_name> <phone>+33427856565</phone> <email>Cyril.huissoud@chu-lyon.fr</email> </overall_contact> <overall_contact_backup> <last_name>Fanny Joubert</last_name> <phone>+33426732727</phone> <email>Fanny.joubert@chu-lyon.fr</email> </overall_contact_backup> <location> <facility> <name>Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant</name> <address> <city>Bron</city> <zip>69677</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Carole VUILLEROT, MD</last_name> <phone>+33 4 72 12 94 50</phone> <email>carole.vuillerot@chu-lyon.fr</email> </contact> <contact_backup> <last_name>Valérie LAUDY, CRA</last_name> <phone>+33 4 72 35 75 51</phone> <email>valerie.laudy@chu-lyon.fr</email> </contact_backup> </location> <location_countries> <country>France</country> </location_countries> <verification_date>September 2023</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 7, 2022</study_first_posted> <last_update_submitted>September 8, 2023</last_update_submitted> <last_update_submitted_qc>September 8, 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>Cerebral Palsy</keyword> <keyword>Genetic predisposition</keyword> <keyword>Neurodevelopmental disorder</keyword> <condition_browse>  <mesh_term>Paralysis</mesh_term> <mesh_term>Cerebral Palsy</mesh_term> <mesh_term>Disease Susceptibility</mesh_term> <mesh_term>Genetic Predisposition to Disease</mesh_term> </condition_browse>  </clinical_study>

Cerebral palsy (CP) is a major neurodevelopmental disorder with an estimated prevalence of approximately one in 500 children. It is characterised by permanent developmental disorders of movement and posture, responsible for activity limitations, caused by non-progressive damage to the brain of the fetus, newborn or infant during development. The neurobiological mechanisms involved in CP remain poorly understood, although the interruption of cerebral oxygen supply during pregnancy or at the time of delivery is classically considered to be the main factor causing neurodevelopmental sequelae. CP also occurs in full-term infants without a clearly identifiable etiology. Data from the literature suggest the existence of other pathophysiological processes than only acquired brain lesions related to pregnancy and delivery, such as genetic or epigenetic factors. According to some research teams, nearly one third of CP could have a genetic cause or could be favoured by genetic variants. Preliminary research has made significant progress in revealing unusual copy number variants and/or mutations in single genes in children with CP. Several of the identified genes are involved in neurodevelopment and neuronal connectivity. Nevertheless, the identification of these abnormalities in CP may contribute to a better understanding of the pathophysiology of this complex and multifactorial disorder. It could also shed new light on the analysis of medico-legal files and bring encouraging perspectives by targeting new therapeutic interventions. The main hypothesis is that a certain number of cerebral palsies are related to - or favoured by - genetic abnormalities that we will search for with genetic screening tests. Inclusion Criteria: - Child between 2 and 15 years old with a clinical diagnostic of cerebral paralysis with bilateral somatic involvement - Child born from 34 SA - Agreement of the legal representatives for the genetic study - Both parents available for a parental genetic study (if detection of class 3 variant) - Affiliation to the social security system Exclusion Criteria: - Genetic syndrome identified or malformative or infectious etiologies identified - Neonatal encephalopathy criteria in a clear obstetrical etiological context responsible for major perinatal anoxia with Sarnat 2 or 3 - Unilateral motor disorders in the term child (congenital hemiplegia)

NCT0531xxxx/NCT05317247.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/NCT05317247</url> </required_header> <id_info> <org_study_id>M21/10/022</org_study_id> <nct_id>NCT05317247</nct_id> </id_info> <brief_title>Cough Audio Classification as a TB Triage Test</brief_title> <acronym>CAGE-TB</acronym> <official_title>Automated Smartphone-based Cough Audio Classification for Rapid Tuberculosis Triage Testing (Cough Audio triaGE for TB; CAGE-TB)</official_title> <sponsors> <lead_sponsor> <agency>University of Stellenbosch</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Amsterdam Institute for Global Health and Development</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Göttingen</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Makerere University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Stellenbosch</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> TB is the single biggest infectious cause of death (1.5 million died in 2018), killing more HIV-positive people than any other disease, and is arguably the most important poverty-related disease in the world. TB's estimated incidence in Africa has been declining over recent years but progress is slow and plateauing. To avert stagnation, truly innovative and ambitious technologies are needed, especially those that improve case finding and time-to-diagnosis as, in mathematical models based on the TB care cascade framework, interventions that accomplish this will have the most impact on disrupting population-level transmission, including when deployed at facilities where patients are readily accessible. Critically, these interventions (triage tests) must promote access to confirmatory testing (e.g., Xpert MTB/RIF Ultra) by enabling patients to be referred rapidly and efficiently during the same visit. The investigators will optimise and evaluate a technology that, aside from the investigators early case-controlled study to show feasibility, is hitherto not meaningfully investigated for TB. This gap is alarming given, on one hand, the enormity of the TB epidemic and the need for a triage test and, on the other hand, promising proofs-of-concept that demonstrate high diagnostic accuracy of cough audio classifier for respiratory diseases such as pneumonia, asthma. pertussis, croup, and COPD. In some cases, these classification systems are CE-marked, awaiting FDA-approval, and subject to late-stage clinical trials. This demonstrates the promise of the underlying technological principle. CAGE-TB's innovation is further enhanced by: applying advanced machine learning methods that the team have specifically developed for TB patient cough audio analysis, use of mixed methods research - drawing from health economics, implementation science, and medical anthropology - to inform product design and assess barriers and facilitators to implementation, and uniquely for a TB diagnostic test, its potential deployment as a pure mHealth (smartphone-based) innovation that mitigates many barriers that typically jeopardise TPP criteria fulfilment. </textblock> </brief_summary> <detailed_description> <textblock> CAGE-TB is a diagnostic evaluation study that assesses a TB cough audio signature's potential to be used in a smartphone application to detect potential TB from a cough sound to screen (triage) TB. The purpose of CAGE-TB is to promote the adoption of mobile health (mHealth) based cough audio triage testing for active pulmonary TB in health facilities located in high burden settings. The study is funded by the EDCTP2 programme supported by the European Union and involves four international partners. The study participants, older than 12 years, include participants who have a cough for a duration exceeding two weeks that present to healthcare clinics where the investigators have clinical recruitment infrastructure and permissions to conduct TB research. In this two-phase observational, cross-sectional study, each participant will be seen once only, at diagnosis, and no intervention is planned. In the first phase, the investigators will collect data from a discovery cohort, which will be used to train a machine learning algorithm. During the second phase, data will be collected from a validation cohort, comprising a larger number of participants from two geographically distinct study sites, which will be used to evaluate the performance of the algorithm. The aims of this study are to: (1) generate and separately validate a cough audio classifier that meets WHO triage test TPP sensitivity and specificity criteria. This aim lays the foundation for CAGE-TB by generating a classifier and a common public resource (cough sounds database) for potential later use in other studies. (2) Produce data on potential cost savings of cough audio app for triage by collecting primary data to demonstrate potential cost savings estimated using state-of-the-art methods to satisfy a key TPP criterion (<USD 2 per patient). This aim will support the further independent evaluation of the classifier, including in clinical trials focused on patient endpoints. (3) Package the technology into an easy-to-use smartphone app. Many TB tests offer improvements in accuracy and cost, but are not widely adopted. This aim is designed to mitigate this risk with the cough classifier and by using the advantages of mHealth, a product may be delivered that is readily usable by nurses, trusted by patients, and capitalised upon by healthcare providers. Accomplishing this requires incorporating important features into the mobile application, such as connectivity, automated reporting, build-in guidance, and quality control, which are important but often neglected components of the WHO triage test TPP profile. (4) Form a foundation for subsequent studies where the app will be evaluated to measure its impact on patient care, to build evidence for global policy change and adoption. The objectives of CAGE-TB include: (1.1) sampling (cough audio, sputum microbiology) all patients with a prolonged cough entering primary health facilities irrespective of reason for presentation (n=473 in Cape Town discovery cohort); (1.2) use machine learning to develop a cough audio classifier to differentiate between TB and non-TB coughs; (1.3) evaluation of the classifier for sensitivity and specificity in new validation cohorts (n=511 in Cape Town, n=767 in Kampala); (2) in both settings, the investigators will use validated tools to calculate potential provider costs averted and conduct mixed methods research to identify barriers and facilitators to inform development of the mHealth solution (smartphone app) intended for use by minimally trained health workers with the final product ideally functioning offline without necessarily needed to sync to an online server for processing done at Stichting-Amsterdam Institute for Global Health and Development (AIGHD); (3) the app will be further refined and made user-friendly, simple and visually intuitive based on study feedback towards a more final product which is free for any person to use; and (4) this mHealth solution packaged into a smartphone app will be sent for review to large international stakeholders such as the Foundation for Innovation and Diagnostics (FIND) and the World Health Organization (WHO) and lead by colleagues at AIGHD with Stellenbosch University and Makerere University input to make this TB triage application relevant for use in African settings and populations. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 19, 2022</start_date> <completion_date type="Anticipated">September 30, 2024</completion_date> <primary_completion_date type="Anticipated">June 2024</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Develop and validate algorithms that can distinguish between TB and non-TB coughs</measure> <time_frame>24 months</time_frame> <description>Cough audio data will be collected and used to define the cough audio signal specific for TB. The optimised TB audio signature will then have its sensitivity and specificity measured in new patients to evaluate the performance of the algorithms.</description> </primary_outcome> <primary_outcome> <measure>Finalised smartphone-based mHealth application</measure> <time_frame>30 months</time_frame> <description>The best-performing algorithm will be incorporated into a smartphone app, which will be designed with human-centered approach, that can be used as a point-of-care triage test for TB.</description> </primary_outcome> <primary_outcome> <measure>Avert unnecessary Ultra tests</measure> <time_frame>24 months</time_frame> <description>The investigators will calculate potential cost savings that the application will be able to facilitate to avoid unnecessary tests.</description> </primary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">1751</enrollment> <condition>Tuberculosis</condition> <arm_group> <arm_group_label>Discovery Cohort</arm_group_label> <description>An anticipated number of 473 participants will be recruited in Cape Town, South Africa. Data (cough audio) will be collected and used to train a machine learning algorithm. The cough audio signal specific for TB will be refined. During the discovery phase, the ground truth obtained through biological testing of sputum specimens will be used to inform the machine learning.</description> </arm_group> <arm_group> <arm_group_label>Validation Cohort</arm_group_label> <description>In the validation phase, the cough audio signature will have its sensitivity and specificity measured in new patients in Cape Town, South Africa (n=511) and Kampala, Uganda (n=767). The data will be used to evaluate the performance of the algorithm.</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Cough sounds</intervention_name> <description>The investigators will discover a cough audio signature and then validate it.</description> <arm_group_label>Discovery Cohort</arm_group_label> <arm_group_label>Validation Cohort</arm_group_label> </intervention> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> Sputum will be collected to test for TB. Other samples will be collected to test for TB markers in blood and urine. No human DNA will be collected </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Patients with a cough of at least two weeks duration self-reporting to primary care clinics in Cape Town and Kampala, in areas with a high prevalence of TB. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - participant must be at least 12 years old  - participant must have a prolonged cough (for at least two weeks)  - participant must provide informed consent  - participant shall have a known HIV status or be willing to undergo standard of care HIV testing and counseling  Exclusion Criteria:  - individuals who refuse informed consent  - individuals who have received treatment for TB in the 60 days prior to enrolment  - individuals who are unable to provide a sputum specimen for microbiological testing  - individuals who have haemoptysis or a bloody cough with any forced coughs for audio recordings </textblock> </criteria> <gender>All</gender> <minimum_age>12 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Grant Theron, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of Stellenbosch</affiliation> </overall_official> <overall_contact> <last_name>Grant Theron, PhD</last_name> <phone>+27 21 9389693</phone> <email>gtheron@sun.ac.za</email> </overall_contact> <overall_contact_backup> <last_name>Daphne Naidoo, Hons</last_name> <phone>+27 60 5037703</phone> <email>daphnenaidoo@sun.ac.za</email> </overall_contact_backup> <location> <facility> <name>Stellenbosch University</name> <address> <city>Cape Town</city> <state>Western Cape</state> <zip>7505</zip> <country>South Africa</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Grant Theron, PhD</last_name> <phone>0219389693</phone> <email>gtheron@sun.ac.za</email> </contact> <contact_backup> <last_name>Daphne Naidoo, Hons</last_name> <email>daphnenaidoo@sun.ac.za</email> </contact_backup> </location> <location> <facility> <name>Makerere University</name> <address> <city>Kampala</city> <zip>7062</zip> <country>Uganda</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Moses Joloba, PhD</last_name> <email>moses.joloba@case.edu</email> </contact> <contact_backup> <last_name>Willy Ssengooba, PhD</last_name> <email>willyssengooba@gmail.com</email> </contact_backup> </location> <location_countries> <country>South Africa</country> <country>Uganda</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>July 21, 2022</last_update_submitted> <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 26, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Stellenbosch</investigator_affiliation> <investigator_full_name>Grant Theron</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>Triage</keyword> <keyword>Cough audio classification</keyword> <keyword>Smartphone application</keyword> <condition_browse>  <mesh_term>Tuberculosis</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Individual data will be stored and handled confidentially and anonymously. Research data will be stored under an identification code that relates to individual participants. Only the code number will be used for study documentation, annual progress reports and research publications. To trace data to an individual participant, an identification code list will be made to link the encoded data to the subject. Only the members of the research team, the site-independent monitors, members of the health care inspection, and members of the relevant Medical Ethics Committee can view research data that can be linked to individual participants. Access to the central database will be controlled via a combination of user roles and study configuration. Users are only granted privileges defined for their role in the study. The applicants will need to submit a proposal to the Trial Steering Committee for review, the applicants will also need to sign a DTA with Stellenbosch University.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_time_frame>Data will be shared one year after study completion.</ipd_time_frame> <ipd_access_criteria>Applicants will need to submit an application to the Trial Steering Committee for data access. The Trial Steering Committee will review the application. The applicant will also need to sign a DTA with Stellenbosch University.</ipd_access_criteria> </patient_data>  </clinical_study>

TB is the single biggest infectious cause of death (1.5 million died in 2018), killing more HIV-positive people than any other disease, and is arguably the most important poverty-related disease in the world. TB's estimated incidence in Africa has been declining over recent years but progress is slow and plateauing. To avert stagnation, truly innovative and ambitious technologies are needed, especially those that improve case finding and time-to-diagnosis as, in mathematical models based on the TB care cascade framework, interventions that accomplish this will have the most impact on disrupting population-level transmission, including when deployed at facilities where patients are readily accessible. Critically, these interventions (triage tests) must promote access to confirmatory testing (e.g., Xpert MTB/RIF Ultra) by enabling patients to be referred rapidly and efficiently during the same visit. The investigators will optimise and evaluate a technology that, aside from the investigators early case-controlled study to show feasibility, is hitherto not meaningfully investigated for TB. This gap is alarming given, on one hand, the enormity of the TB epidemic and the need for a triage test and, on the other hand, promising proofs-of-concept that demonstrate high diagnostic accuracy of cough audio classifier for respiratory diseases such as pneumonia, asthma. pertussis, croup, and COPD. In some cases, these classification systems are CE-marked, awaiting FDA-approval, and subject to late-stage clinical trials. This demonstrates the promise of the underlying technological principle. CAGE-TB's innovation is further enhanced by: applying advanced machine learning methods that the team have specifically developed for TB patient cough audio analysis, use of mixed methods research - drawing from health economics, implementation science, and medical anthropology - to inform product design and assess barriers and facilitators to implementation, and uniquely for a TB diagnostic test, its potential deployment as a pure mHealth (smartphone-based) innovation that mitigates many barriers that typically jeopardise TPP criteria fulfilment. CAGE-TB is a diagnostic evaluation study that assesses a TB cough audio signature's potential to be used in a smartphone application to detect potential TB from a cough sound to screen (triage) TB. The purpose of CAGE-TB is to promote the adoption of mobile health (mHealth) based cough audio triage testing for active pulmonary TB in health facilities located in high burden settings. The study is funded by the EDCTP2 programme supported by the European Union and involves four international partners. The study participants, older than 12 years, include participants who have a cough for a duration exceeding two weeks that present to healthcare clinics where the investigators have clinical recruitment infrastructure and permissions to conduct TB research. In this two-phase observational, cross-sectional study, each participant will be seen once only, at diagnosis, and no intervention is planned. In the first phase, the investigators will collect data from a discovery cohort, which will be used to train a machine learning algorithm. During the second phase, data will be collected from a validation cohort, comprising a larger number of participants from two geographically distinct study sites, which will be used to evaluate the performance of the algorithm. The aims of this study are to: (1) generate and separately validate a cough audio classifier that meets WHO triage test TPP sensitivity and specificity criteria. This aim lays the foundation for CAGE-TB by generating a classifier and a common public resource (cough sounds database) for potential later use in other studies. (2) Produce data on potential cost savings of cough audio app for triage by collecting primary data to demonstrate potential cost savings estimated using state-of-the-art methods to satisfy a key TPP criterion (<USD 2 per patient). This aim will support the further independent evaluation of the classifier, including in clinical trials focused on patient endpoints. (3) Package the technology into an easy-to-use smartphone app. Many TB tests offer improvements in accuracy and cost, but are not widely adopted. This aim is designed to mitigate this risk with the cough classifier and by using the advantages of mHealth, a product may be delivered that is readily usable by nurses, trusted by patients, and capitalised upon by healthcare providers. Accomplishing this requires incorporating important features into the mobile application, such as connectivity, automated reporting, build-in guidance, and quality control, which are important but often neglected components of the WHO triage test TPP profile. (4) Form a foundation for subsequent studies where the app will be evaluated to measure its impact on patient care, to build evidence for global policy change and adoption. The objectives of CAGE-TB include: (1.1) sampling (cough audio, sputum microbiology) all patients with a prolonged cough entering primary health facilities irrespective of reason for presentation (n=473 in Cape Town discovery cohort); (1.2) use machine learning to develop a cough audio classifier to differentiate between TB and non-TB coughs; (1.3) evaluation of the classifier for sensitivity and specificity in new validation cohorts (n=511 in Cape Town, n=767 in Kampala); (2) in both settings, the investigators will use validated tools to calculate potential provider costs averted and conduct mixed methods research to identify barriers and facilitators to inform development of the mHealth solution (smartphone app) intended for use by minimally trained health workers with the final product ideally functioning offline without necessarily needed to sync to an online server for processing done at Stichting-Amsterdam Institute for Global Health and Development (AIGHD); (3) the app will be further refined and made user-friendly, simple and visually intuitive based on study feedback towards a more final product which is free for any person to use; and (4) this mHealth solution packaged into a smartphone app will be sent for review to large international stakeholders such as the Foundation for Innovation and Diagnostics (FIND) and the World Health Organization (WHO) and lead by colleagues at AIGHD with Stellenbosch University and Makerere University input to make this TB triage application relevant for use in African settings and populations. Sputum will be collected to test for TB. Other samples will be collected to test for TB markers in blood and urine. No human DNA will be collected Patients with a cough of at least two weeks duration self-reporting to primary care clinics in Cape Town and Kampala, in areas with a high prevalence of TB. Inclusion Criteria: - participant must be at least 12 years old - participant must have a prolonged cough (for at least two weeks) - participant must provide informed consent - participant shall have a known HIV status or be willing to undergo standard of care HIV testing and counseling Exclusion Criteria: - individuals who refuse informed consent - individuals who have received treatment for TB in the 60 days prior to enrolment - individuals who are unable to provide a sputum specimen for microbiological testing - individuals who have haemoptysis or a bloody cough with any forced coughs for audio recordings

NCT0531xxxx/NCT05317260.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/NCT05317260</url> </required_header> <id_info> <org_study_id>043/2560(EC2)</org_study_id> <nct_id>NCT05317260</nct_id> </id_info> <brief_title>Steatohepatitis in Chronic Hepatitis B</brief_title> <official_title>Prognostic Relevance of Fatty Liver Disease for Patients With Chronic Hepatitis B</official_title> <sponsors> <lead_sponsor> <agency>Mahidol University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Mahidol 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> Fatty liver disease is increasingly recognized in patients with chronic hepatitis B (CHB). Whether concurrent fatty liver disease affects the long-term outcomes of CHB is unclear. The investigators performed a longitudinal study to investigate the prognostic relevance of concurrent fatty liver disease for patients with CHB receiving antiviral therapy. </textblock> </brief_summary> <detailed_description> <textblock> Chronic hepatitis B virus (HBV) infection is a global public health problem affecting more than 250 million people at high risk of death from cirrhosis and liver cancer. The goal of therapy for patients with chronic hepatitis B (CHB) is to improve survival and quality of life by preventing disease progression to cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). This can be achieved by elimination of HBV or sustained suppression of viral replication with antiviral treatment. In recent years, accompanied by the growing prevalence of obesity, fatty liver disease is commonly observed in patients with CHB. The prevalence of the fatty liver disease is approximately 14-67% in Asian individuals with CHB, similar to Western countries. The coexistence of CHB and hepatic steatosis, particularly steatohepatitis, can aggravate liver damage and increase the risk of fibrosis. A recent histological study showed a significant association between steatohepatitis and advanced fibrosis in CHB patients.  Fatty liver disease has been shown to increase the risk of fibrosis progression in patients with CHB receiving antiviral treatment. According to a follow-up study of cirrhotic patients treated with tenofovir disoproxil fumarate for CHB, patients with possible concurrent NAFLD were less likely to have fibrosis regression despite viral suppression. Likewise, another prospective study showed that lower body mass index was independently associated with fibrosis regression in CHB patients who achieved undetectable HBV viral load during long-term nucleoside analogue therapy. Hence, monitoring the development of unfavorable outcomes is recommended in this population. However, there are limited data on the impact of concurrent fatty liver disease on clinical outcomes (e.g., cirrhotic complications, HCC, and death) during comprehensive treatment for CHB. Therefore, this longitudinal cohort study aimed to determine the effect of concurrent fatty liver disease on overall survival and liver-related complications among CHB patients receiving antiviral therapy to improve our understanding of the prognostic value of concurrent fatty liver disease in these patients.  METHODS The investigators conduct a retrospective analysis of a prospectively collected database of patients with chronic HBV infection who underwent a liver biopsy between 2002 and 2008 at the Faculty of Medicine Siriraj Hospital in Bangkok, Thailand. This cohort includes only patients who had at least moderate necroinflammation and/or liver fibrosis stage 2 or higher according to the METAVIR system and have been treated with antiviral agents. Patients will be excluded from analysis if they had co-infection with hepatitis C virus or human immunodeficiency virus; had the presence of alcohol dependence; had follow-up data less than six months in our clinic; had no available liver histology for review; had intermittent or persistent HBV DNA >2000 IU/ml after stopping antiviral agents during follow-up. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 1, 2002</start_date> <completion_date type="Actual">December 31, 2021</completion_date> <primary_completion_date type="Actual">December 31, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Overall mortality</measure> <time_frame>From date of liver biopsy until the date of liver transplantation or date of death from any cause, whichever came first, assessed up to 22 years</time_frame> <description>Death from any cause</description> </primary_outcome> <secondary_outcome> <measure>Liver-related complications</measure> <time_frame>From date of liver biopsy until the date of first documented liver-related complications, whichever came first, assessed up to 22 years</time_frame> <description>Liver-related complications such as hepatocellular carcinoma, spontaneous bacterial peritonitis, variceal hemorrhage, portosystemic encephalopathy, and hepatorenal syndrome</description> </secondary_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Actual">408</enrollment> <condition>Fatty Liver</condition> <condition>Chronic Hepatitis b</condition> <arm_group> <arm_group_label>Chronic hepatitis B patients without hepatic steatosis</arm_group_label> <description>Patients with chronic hepatitis B will be defined as the non-steatosis group if they had histological evidence of visible lipid droplets in hepatocytes less than 5%.</description> </arm_group> <arm_group> <arm_group_label>Chronic hepatitis B with steatosis but no steatohepatitis</arm_group_label> <description>Patients with chronic hepatitis B will be categorized as the steatosis but not steatohepatitis group if they had histological evidence of visible lipid droplets in hepatocytes more than 5% in the absence of steatohepatitis feature.</description> </arm_group> <arm_group> <arm_group_label>Chronic hepatitis B patients with steatohepatitis</arm_group_label> <description>Patients with chronic hepatitis B will be classified as the steatohepatitis group if they had histological evidence of steatosis, hepatocyte ballooning, mixed lobular acute and chronic inflammation, and intra-acinar perisinusoidal fibrosis according to Brunt's classification.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Antiviral Agents</intervention_name> <description>The type of antiviral agents for the individual patient was selected by physicians based on a policy to reimburse a patient's health and comorbidity.</description> <arm_group_label>Chronic hepatitis B patients with steatohepatitis</arm_group_label> <arm_group_label>Chronic hepatitis B patients without hepatic steatosis</arm_group_label> <arm_group_label>Chronic hepatitis B with steatosis but no steatohepatitis</arm_group_label> <other_name>Nucleoside analogue</other_name> <other_name>Nucleotide analogue</other_name> <other_name>Peginterferon</other_name> </intervention> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> All liver biopsies were stained with Hematoxylin and Eosin, and Masson's trichrome. In cases of faded tissue slides, stored paraffin-embedded tissue block will be cut and re-stained. </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Chronic hepatitis B patients who underwent liver biopsy during 2002-2008 and then received antiviral therapy. The studied patients had achieved undetectable HBV DNA or hepatitis B surface antigen (HBsAg) loss during antiviral therapy, and those who had hepatitis B e antigen (HBeAg) seroconversion with serum HBV DNA persistently <2,000 IU/ml and normalization of aminotransferase levels after discontinuing antiviral therapy. According to Brunt's classification, patients will be categorized into three groups, including non-steatosis, steatosis but no steatohepatitis, and steatohepatitis groups based on the histological features of the liver specimens. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - All CHB patients who had significant histologic features, defined as at least moderate necroinflammation and/or liver fibrosis stage 2 or higher according to the METAVIR system, required antiviral therapy and have been managed in our institution.  - HBV-treated patients who had achieved undetectable HBV DNA or hepatitis B surface antigen (HBsAg) loss during antiviral therapy, and those who had hepatitis B e antigen (HBeAg) seroconversion with serum HBV DNA persistently <2,000 IU/ml and normalization of aminotransferase levels after discontinuing antiviral therapy.  Exclusion Criteria:  - Patients who had viremia >2000 IU/ml after stopping antiviral agents will be excluded.  - Patients with a history of alcohol dependence or co-infections with hepatitis C virus or human immunodeficiency virus before liver biopsy will be excluded. </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>Phunchai Charatcharoenwitthaya, MD.</last_name> <role>Principal Investigator</role> <affiliation>Faculty of Medicine Siriraj Hospital</affiliation> </overall_official> <location> <facility> <name>Faculty of Medicine Siriraj Hospital</name> <address> <city>Bangkoknoi</city> <state>Bangkok</state> <zip>10700</zip> <country>Thailand</country> </address> </facility> </location> <location_countries> <country>Thailand</country> </location_countries> <reference> <citation>Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.</citation> <PMID>26231459</PMID> </reference> <reference> <citation>European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.</citation> <PMID>28427875</PMID> </reference> <reference> <citation>Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.</citation> <PMID>29405329</PMID> </reference> <reference> <citation>Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.</citation> <PMID>26563120</PMID> </reference> <reference> <citation>Powell EE, Wong VW, Rinella M. Non-alcoholic fatty liver disease. Lancet. 2021 Jun 5;397(10290):2212-2224. doi: 10.1016/S0140-6736(20)32511-3. Epub 2021 Apr 21.</citation> <PMID>33894145</PMID> </reference> <reference> <citation>Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.</citation> <PMID>32044314</PMID> </reference> <reference> <citation>Charatcharoenwitthaya P, Pongpaibul A, Kaosombatwattana U, Bhanthumkomol P, Bandidniyamanon W, Pausawasdi N, Tanwandee T. The prevalence of steatohepatitis in chronic hepatitis B patients and its impact on disease severity and treatment response. Liver Int. 2017 Apr;37(4):542-551. doi: 10.1111/liv.13271. Epub 2016 Oct 31.</citation> <PMID>27740738</PMID> </reference> <reference> <citation>Mak LY, Seto WK, Hui RW, Fung J, Wong DK, Lai CL, Yuen MF. Fibrosis evolution in chronic hepatitis B e antigen-negative patients across a 10-year interval. J Viral Hepat. 2019 Jul;26(7):818-827. doi: 10.1111/jvh.13095. Epub 2019 Apr 16.</citation> <PMID>30895682</PMID> </reference> <reference> <citation>Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, Washington MK, Germanidis G, Flaherty JF, Aguilar Schall R, Bornstein JD, Kitrinos KM, Subramanian GM, McHutchison JG, Heathcote EJ. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013 Feb 9;381(9865):468-75. doi: 10.1016/S0140-6736(12)61425-1. Epub 2012 Dec 10.</citation> <PMID>23234725</PMID> </reference> <reference> <citation>Seto WK, Fung J, Cheung KS, Mak LY, Hui RW, Liu KS, Lai CL, Yuen MF. Body-mass index is associated with fibrosis regression during long-term nucleoside analogue therapy in chronic hepatitis B. Aliment Pharmacol Ther. 2016 Nov;44(10):1071-1079. doi: 10.1111/apt.13804. Epub 2016 Sep 22.</citation> <PMID>27659292</PMID> </reference> <reference> <citation>Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.</citation> <PMID>15915461</PMID> </reference> <reference> <citation>Brunt EM, Janney CG, Di Bisceglie AM, Neuschwander-Tetri BA, Bacon BR. Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions. Am J Gastroenterol. 1999 Sep;94(9):2467-74. doi: 10.1111/j.1572-0241.1999.01377.x.</citation> <PMID>10484010</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 11, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Mahidol University</investigator_affiliation> <investigator_full_name>Phunchai Charatcharoenwitthaya</investigator_full_name> <investigator_title>Associated Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Hepatitis A</mesh_term> <mesh_term>Hepatitis B</mesh_term> <mesh_term>Hepatitis B, Chronic</mesh_term> <mesh_term>Hepatitis</mesh_term> <mesh_term>Hepatitis, Chronic</mesh_term> <mesh_term>Fatty Liver</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Antiviral Agents</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>The datasets generated and analyzed during the current study are not publicly available due to our University's institutional review boards (IRB) and the health insurance portability and accountability act (HIPAA) privacy rule but are available from the corresponding author on reasonable request.</ipd_description> </patient_data> <provided_document_section> <provided_document> <document_type>Study Protocol</document_type> <document_has_protocol>Yes</document_has_protocol> <document_has_icf>No</document_has_icf> <document_has_sap>No</document_has_sap> <document_date>December 31, 2021</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT05317260/Prot_000.pdf</document_url> </provided_document> <provided_document> <document_type>Statistical Analysis Plan</document_type> <document_has_protocol>No</document_has_protocol> <document_has_icf>No</document_has_icf> <document_has_sap>Yes</document_has_sap> <document_date>December 31, 2021</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT05317260/SAP_001.pdf</document_url> </provided_document> </provided_document_section>  </clinical_study>

Fatty liver disease is increasingly recognized in patients with chronic hepatitis B (CHB). Whether concurrent fatty liver disease affects the long-term outcomes of CHB is unclear. The investigators performed a longitudinal study to investigate the prognostic relevance of concurrent fatty liver disease for patients with CHB receiving antiviral therapy. Chronic hepatitis B virus (HBV) infection is a global public health problem affecting more than 250 million people at high risk of death from cirrhosis and liver cancer. The goal of therapy for patients with chronic hepatitis B (CHB) is to improve survival and quality of life by preventing disease progression to cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). This can be achieved by elimination of HBV or sustained suppression of viral replication with antiviral treatment. In recent years, accompanied by the growing prevalence of obesity, fatty liver disease is commonly observed in patients with CHB. The prevalence of the fatty liver disease is approximately 14-67% in Asian individuals with CHB, similar to Western countries. The coexistence of CHB and hepatic steatosis, particularly steatohepatitis, can aggravate liver damage and increase the risk of fibrosis. A recent histological study showed a significant association between steatohepatitis and advanced fibrosis in CHB patients. Fatty liver disease has been shown to increase the risk of fibrosis progression in patients with CHB receiving antiviral treatment. According to a follow-up study of cirrhotic patients treated with tenofovir disoproxil fumarate for CHB, patients with possible concurrent NAFLD were less likely to have fibrosis regression despite viral suppression. Likewise, another prospective study showed that lower body mass index was independently associated with fibrosis regression in CHB patients who achieved undetectable HBV viral load during long-term nucleoside analogue therapy. Hence, monitoring the development of unfavorable outcomes is recommended in this population. However, there are limited data on the impact of concurrent fatty liver disease on clinical outcomes (e.g., cirrhotic complications, HCC, and death) during comprehensive treatment for CHB. Therefore, this longitudinal cohort study aimed to determine the effect of concurrent fatty liver disease on overall survival and liver-related complications among CHB patients receiving antiviral therapy to improve our understanding of the prognostic value of concurrent fatty liver disease in these patients. METHODS The investigators conduct a retrospective analysis of a prospectively collected database of patients with chronic HBV infection who underwent a liver biopsy between 2002 and 2008 at the Faculty of Medicine Siriraj Hospital in Bangkok, Thailand. This cohort includes only patients who had at least moderate necroinflammation and/or liver fibrosis stage 2 or higher according to the METAVIR system and have been treated with antiviral agents. Patients will be excluded from analysis if they had co-infection with hepatitis C virus or human immunodeficiency virus; had the presence of alcohol dependence; had follow-up data less than six months in our clinic; had no available liver histology for review; had intermittent or persistent HBV DNA >2000 IU/ml after stopping antiviral agents during follow-up. All liver biopsies were stained with Hematoxylin and Eosin, and Masson's trichrome. In cases of faded tissue slides, stored paraffin-embedded tissue block will be cut and re-stained. Chronic hepatitis B patients who underwent liver biopsy during 2002-2008 and then received antiviral therapy. The studied patients had achieved undetectable HBV DNA or hepatitis B surface antigen (HBsAg) loss during antiviral therapy, and those who had hepatitis B e antigen (HBeAg) seroconversion with serum HBV DNA persistently <2,000 IU/ml and normalization of aminotransferase levels after discontinuing antiviral therapy. According to Brunt's classification, patients will be categorized into three groups, including non-steatosis, steatosis but no steatohepatitis, and steatohepatitis groups based on the histological features of the liver specimens. Inclusion Criteria: - All CHB patients who had significant histologic features, defined as at least moderate necroinflammation and/or liver fibrosis stage 2 or higher according to the METAVIR system, required antiviral therapy and have been managed in our institution. - HBV-treated patients who had achieved undetectable HBV DNA or hepatitis B surface antigen (HBsAg) loss during antiviral therapy, and those who had hepatitis B e antigen (HBeAg) seroconversion with serum HBV DNA persistently <2,000 IU/ml and normalization of aminotransferase levels after discontinuing antiviral therapy. Exclusion Criteria: - Patients who had viremia >2000 IU/ml after stopping antiviral agents will be excluded. - Patients with a history of alcohol dependence or co-infections with hepatitis C virus or human immunodeficiency virus before liver biopsy will be excluded.

NCT0531xxxx/NCT05317273.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/NCT05317273</url> </required_header> <id_info> <org_study_id>2022_1</org_study_id> <nct_id>NCT05317273</nct_id> </id_info> <brief_title>Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention</brief_title> <official_title>Incidence and Risk Factors of Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention</official_title> <sponsors> <lead_sponsor> <agency>Mahidol University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Mahidol 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> Urosepsis is one of major cause of the overall sepsis leading to high morbidity and mortality, which commonly resulted from urinary tract calculi. The investigator aim to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital. </textblock> </brief_summary> <detailed_description> <textblock> Sepsis is one of the leading cause of death of hospitalized patients in Thailand. Urosepsis or sepsis which originate from urinary tract infection was reported around 9-31% of the overall sepsis syndrome. Urinary tract calculi requiring surgical procedure was reported as a common cause of urinary tract infection. Therefore, the investigators aimed to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital.  Moreover, the patients with sepsis syndrome will be suffered from many complications such as acute respiratory distress syndrome, acute kidney injury, etc. Currently, there were many early waring scores to predict the risk of complications to help promptly treatment and decrease the severity. The investigator would like to compare the systemic inflammatory response syndrome (SIRS) criteria,Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) score to the prediction of postoperative complications in this group of patients.  The last primary objective of this study is to follow the course of the patients diagnosed as urosepsis if they had been treated properly according to the sepsis bundle guideline and their outcome. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 1, 2022</start_date> <completion_date type="Anticipated">April 30, 2024</completion_date> <primary_completion_date type="Anticipated">December 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>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Rate of urosepsis diagnosis</measure> <time_frame>7 days after surgery</time_frame> <description>According to urine exam and SIRS criteria of sepsis</description> </primary_outcome> <primary_outcome> <measure>Date of urosepsis diagnosis</measure> <time_frame>7 days after surgery</time_frame> <description>date of diagnosis of urosepsis</description> </primary_outcome> <primary_outcome> <measure>Mortality rate</measure> <time_frame>30 days after surgery</time_frame> <description>Number of deceased patient after surgery</description> </primary_outcome> <secondary_outcome> <measure>Length of stay</measure> <time_frame>7 days after surgery</time_frame> <description>hospital stay intensive care unit stay</description> </secondary_outcome> <secondary_outcome> <measure>Rate of intensive care unit admission</measure> <time_frame>7 days after surgery</time_frame> <description>Number of patients required ICU admission</description> </secondary_outcome> <secondary_outcome> <measure>Rate of blood transfusion</measure> <time_frame>7 days after surgery</time_frame> <description>Amount of blood transfusion in unit during admission</description> </secondary_outcome> <secondary_outcome> <measure>Rate of mechanical ventilation requirement</measure> <time_frame>7 days after surgery</time_frame> <description>Number of patient required mechanical ventilation support</description> </secondary_outcome> <secondary_outcome> <measure>Rate of re-operation</measure> <time_frame>7 days after surgery</time_frame> <description>Number of patients require second procedure at the same admission</description> </secondary_outcome> <secondary_outcome> <measure>Prevalence of acute kidney injury</measure> <time_frame>30 days after surgery</time_frame> <description>According to KDIGO criteria</description> </secondary_outcome> <secondary_outcome> <measure>Rate of renal replacement therapy requirement</measure> <time_frame>30 days after surgery</time_frame> <description>Number of patients require renal replacement therapy</description> </secondary_outcome> <enrollment type="Anticipated">865</enrollment> <condition>Urosepsis</condition> <condition>Urinary Tract Stone</condition> <eligibility> <study_pop> <textblock> Adult patients with urinary tract calculi requiring surgical procedure; percutaneous nephro-ureterolithotrypsy (PCNL), Retrograde intrarenal surgery (RIRS), Ureteroscopic lithotrypsy (URSL) and open lithotomy in tertiary-care university hospital. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Adult patients with urinary tract calculi requiring surgical procedure  Exclusion Criteria:  - Incomplete data </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>Aphichat Suphathamwit, M.D.</last_name> <role>Principal Investigator</role> <affiliation>Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, THAILAND</affiliation> </overall_official> <overall_contact> <last_name>Aphichat Suphathamwit, M.D.</last_name> <phone>0982786069</phone> <email>aphichat.suh@mahidol.edu</email> </overall_contact> <overall_contact_backup> <last_name>Annop Piriyapatsom, M.D.</last_name> <phone>0922819241</phone> <email>annop.pir@gmail.com</email> </overall_contact_backup> <location> <facility> <name>Faculty of Medicine Siriraj Hospital, Mahidol University</name> <address> <city>Bangkok Noi</city> <state>Bangkok</state> <zip>10700</zip> <country>Thailand</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Aphichat Suphathamwit, M.D.</last_name> <phone>66982786069</phone> <email>aphichat.suh@mahidol.edu</email> </contact> </location> <location_countries> <country>Thailand</country> </location_countries> <reference> <citation>Southern JB, Higgins AM, Young AJ, Kost KA, Schreiter BR, Clifton M, Fulmer BR, Garg T. Risk Factors for Postoperative Fever and Systemic Inflammatory Response Syndrome After Ureteroscopy for Stone Disease. J Endourol. 2019 Jul;33(7):516-522. doi: 10.1089/end.2018.0789. Epub 2019 Jan 22.</citation> <PMID>30569755</PMID> </reference> <reference> <citation>Blackmur JP, Maitra NU, Marri RR, Housami F, Malki M, McIlhenny C. Analysis of Factors' Association with Risk of Postoperative Urosepsis in Patients Undergoing Ureteroscopy for Treatment of Stone Disease. J Endourol. 2016 Sep;30(9):963-9. doi: 10.1089/end.2016.0300. Epub 2016 Jul 13.</citation> <PMID>27317017</PMID> </reference> <reference> <citation>Amier Y, Zhang Y, Zhang J, Yao W, Wang S, Wei C, Yu X. Analysis of Preoperative Risk Factors for Postoperative Urosepsis After Mini-Percutaneous Nephrolithotomy in Patients with Large Kidney Stones. J Endourol. 2022 Mar;36(3):292-297. doi: 10.1089/end.2021.0406.</citation> <PMID>34569289</PMID> </reference> <reference> <citation>Grosso AA, Sessa F, Campi R, Viola L, Polverino P, Crisci A, Salvi M, Liatsikos E, Feu OA, DI Maida F, Tellini R, Traxer O, Cocci A, Mari A, Fiori C, Porpiglia F, Carini M, Tuccio A, Minervini A. Intraoperative and postoperative surgical complications after ureteroscopy, retrograde intrarenal surgery, and percutaneous nephrolithotomy: a systematic review. Minerva Urol Nephrol. 2021 Jun;73(3):309-332. doi: 10.23736/S2724-6051.21.04294-4. Epub 2021 Apr 22.</citation> <PMID>33887891</PMID> </reference> <reference> <citation>Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.</citation> <PMID>26903338</PMID> </reference> <reference> <citation>Churpek MM, Snyder A, Han X, Sokol S, Pettit N, Howell MD, Edelson DP. Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Apr 1;195(7):906-911. doi: 10.1164/rccm.201604-0854OC.</citation> <PMID>27649072</PMID> </reference> <reference> <citation>Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.</citation> <PMID>15273542</PMID> </reference> <verification_date>August 2022</verification_date> <study_first_submitted>March 20, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 22, 2022</last_update_submitted> <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 25, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Mahidol University</investigator_affiliation> <investigator_full_name>Aphichat Suphathamwit,</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Urinary Calculi</mesh_term> <mesh_term>Calculi</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Urosepsis is one of major cause of the overall sepsis leading to high morbidity and mortality, which commonly resulted from urinary tract calculi. The investigator aim to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital. Sepsis is one of the leading cause of death of hospitalized patients in Thailand. Urosepsis or sepsis which originate from urinary tract infection was reported around 9-31% of the overall sepsis syndrome. Urinary tract calculi requiring surgical procedure was reported as a common cause of urinary tract infection. Therefore, the investigators aimed to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital. Moreover, the patients with sepsis syndrome will be suffered from many complications such as acute respiratory distress syndrome, acute kidney injury, etc. Currently, there were many early waring scores to predict the risk of complications to help promptly treatment and decrease the severity. The investigator would like to compare the systemic inflammatory response syndrome (SIRS) criteria,Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) score to the prediction of postoperative complications in this group of patients. The last primary objective of this study is to follow the course of the patients diagnosed as urosepsis if they had been treated properly according to the sepsis bundle guideline and their outcome. Adult patients with urinary tract calculi requiring surgical procedure; percutaneous nephro-ureterolithotrypsy (PCNL), Retrograde intrarenal surgery (RIRS), Ureteroscopic lithotrypsy (URSL) and open lithotomy in tertiary-care university hospital. Inclusion Criteria: - Adult patients with urinary tract calculi requiring surgical procedure Exclusion Criteria: - Incomplete data

NCT0531xxxx/NCT05317286.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/NCT05317286</url> </required_header> <id_info> <org_study_id>CathEF</org_study_id> <nct_id>NCT05317286</nct_id> </id_info> <brief_title>LVEF Prediction During ACS Using AI Algorithm Applied on Coronary Angiogram Videos</brief_title> <acronym>CathEF</acronym> <official_title>Prospective Validation of a Deep Learning Algorithm for Prediction of the Left Ventricular Ejection Fraction From Coronary Angiogram Videos in Patients With Acute Coronary Syndrome</official_title> <sponsors> <lead_sponsor> <agency>Montreal Heart Institute</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Ottawa Heart Institute Research Corporation</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Montreal Heart Institute</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> Left ventricular ejection fraction (LVEF) is one of the strongest predictors of mortality and morbidity in patients with acute coronary syndrome (ACS). Transthoracic echocardiography (TTE) remains the gold standard for LVEF measurement. Currently, LVEF can be estimated at the time of the coronary angiogram but requires a ventriculography. This latter is performed at the price of an increased amount of contrast media injected and puts the patients at risk for mechanical complications, ventricular arrhythmia or atrio-ventricular blocks. Artificial intelligence (AI) has previously been shown to be an accurate method for determining LVEF using different data sources. Fur the purpose of this study, we aim at validating prospectively an AI algorithm, called CathEF, for the prediction of real-time LVEF (AI-LVEF) compared to TTE-LVEF and ventriculography in patients undergoing coronary angiogram for ACS. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">February 29, 2024</completion_date> <primary_completion_date type="Anticipated">December 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>Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF</measure> <time_frame>Either 7 days before or up to 7 days after the coronary angiogram</time_frame> </primary_outcome> <secondary_outcome> <measure>Comparing AUC-ROC of CathEF and ventriculography for differentiating a LVEF ≤ or >50%</measure> <time_frame>Either 7 days before or up to 7 days after the coronary angiogram</time_frame> </secondary_outcome> <secondary_outcome> <measure>Sensitivity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.</measure> <time_frame>Either 7 days before or up to 7 days after the coronary angiogram</time_frame> </secondary_outcome> <secondary_outcome> <measure>Specificity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.</measure> <time_frame>Either 7 days before or up to 7 days after the coronary angiogram</time_frame> </secondary_outcome> <secondary_outcome> <measure>Number of participants with major adverse cardiovascular events (Combined outcome of combined outcomeof mortality, ventricular arrhythmia requiring an intervention, heart failure, need for inotropic support, renal failure KDIGO≥2 and stroke)</measure> <time_frame>At 7 days or before discharge, if earlier.</time_frame> </secondary_outcome> <secondary_outcome> <measure>AUC-ROC of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%</measure> <time_frame>Either 7 days before or up to 7 days after the coronary angiogram</time_frame> </secondary_outcome> <secondary_outcome> <measure>Sensitivity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%</measure> <time_frame>Either 7 days before or up to 7 days after the coronary angiogram</time_frame> </secondary_outcome> <secondary_outcome> <measure>Specificity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%</measure> <time_frame>Either 7 days before or up to 7 days after the coronary angiogram</time_frame> </secondary_outcome> <secondary_outcome> <measure>Likert scale on the impact on the procedure, ease of use and utility of the CathEF algorithm in the clinical practice, as assessed by interventional cardiologists</measure> <time_frame>Through study completion, an average of 1 year.</time_frame> </secondary_outcome> <enrollment type="Anticipated">240</enrollment> <condition>Acute Coronary Syndrome</condition> <condition>Left Ventricular Dysfunction</condition> <eligibility> <study_pop> <textblock> All adults treated by percutaneous coronary intervention for ACS in whom left ventriculography is not contra-indicated and TTE-LVEF is expected to be measured in the next 24h to 7 days. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Informed consent signed by the participant  - Acute coronary syndrome  - Creatinine clearance ≥30 ml/min/m2 according to MDRD  Exclusion Criteria:  - Creatinine clearance <30 ml/min/m2 according to MDRD  - No indication to perform TTE in the 7 days following coronary angiogram  - Right bundle branch block  - Suspected or confirmed left ventricular thrombus  - Suspected or confirmed aortic dissection  - Ventriculography not feasible  - No left coronary system angiogram </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>Robert Avram</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H1T1C8</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Robert Avram, MD</last_name> <email>robert.avram.md@gmail.com</email> </contact> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 6, 2023</last_update_submitted> <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 7, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Montreal Heart Institute</investigator_affiliation> <investigator_full_name>Robert Avram</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence</keyword> <condition_browse>  <mesh_term>Acute Coronary Syndrome</mesh_term> <mesh_term>Ventricular Dysfunction</mesh_term> <mesh_term>Ventricular Dysfunction, Left</mesh_term> <mesh_term>Syndrome</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> <ipd_description>Data will be shared to other researchers on reasonable request to the principal investigator.</ipd_description> </patient_data>  </clinical_study>

Left ventricular ejection fraction (LVEF) is one of the strongest predictors of mortality and morbidity in patients with acute coronary syndrome (ACS). Transthoracic echocardiography (TTE) remains the gold standard for LVEF measurement. Currently, LVEF can be estimated at the time of the coronary angiogram but requires a ventriculography. This latter is performed at the price of an increased amount of contrast media injected and puts the patients at risk for mechanical complications, ventricular arrhythmia or atrio-ventricular blocks. Artificial intelligence (AI) has previously been shown to be an accurate method for determining LVEF using different data sources. Fur the purpose of this study, we aim at validating prospectively an AI algorithm, called CathEF, for the prediction of real-time LVEF (AI-LVEF) compared to TTE-LVEF and ventriculography in patients undergoing coronary angiogram for ACS. All adults treated by percutaneous coronary intervention for ACS in whom left ventriculography is not contra-indicated and TTE-LVEF is expected to be measured in the next 24h to 7 days. Inclusion Criteria: - Informed consent signed by the participant - Acute coronary syndrome - Creatinine clearance ≥30 ml/min/m2 according to MDRD Exclusion Criteria: - Creatinine clearance <30 ml/min/m2 according to MDRD - No indication to perform TTE in the 7 days following coronary angiogram - Right bundle branch block - Suspected or confirmed left ventricular thrombus - Suspected or confirmed aortic dissection - Ventriculography not feasible - No left coronary system angiogram

NCT0531xxxx/NCT05317299.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/NCT05317299</url> </required_header> <id_info> <org_study_id>220023/30</org_study_id> <nct_id>NCT05317299</nct_id> </id_info> <brief_title>Comparison of the Effects of Different Exercise Types</brief_title> <official_title>Comparison of the Effects of Different Exercise Types on Lower Extremity Muscle Thickness, Tendon Thickness, Muscle Strength, Proprioception and Balance</official_title> <sponsors> <lead_sponsor> <agency>Dilara Özen Oruk</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Muğla Sıtkı Koçman University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Muğla Sıtkı Koçman 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 perform to investigate the comparison of the effects of different exercise types on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception and balance. </textblock> </brief_summary> <detailed_description> <textblock> The choice of exercise type is affected by many different factors. The purpose of exercise and the physical fitness parameter they want to develop gain importance in this choice.  Resistance exercises (RE) specifically designed to increase muscle strength and hypertrophy; Plyometric exercises (PE) based on energy storage of the muscle during the deceleration phase and release of this energy during the acceleration period and high-intensity interval training (HIIT), which is an advanced form of interval training that includes shorter and lighter recovery periods following short to heavy anaerobic exercise are some of the many types of exercises in the literature and practice.  The purpose of the study is investigate the comparison of the effects of different exercise types on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception and balance. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Anticipated">July 30, 2023</completion_date> <primary_completion_date type="Actual">July 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> <intervention_model_description>Randomized 3 exercise group (RE, PE and HIIT)</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> <masking_description>Double</masking_description> </study_design_info> <primary_outcome> <measure>Muscle Thickness assessment with B-mode Ultrasonography</measure> <time_frame>8 weeks</time_frame> <description>Changes of lower extremity muscle thickness</description> </primary_outcome> <primary_outcome> <measure>Tendon Thickness assessment with B-mode Ultrasonography</measure> <time_frame>8 weeks</time_frame> <description>Changes of lower extremity tendon thickness</description> </primary_outcome> <primary_outcome> <measure>Muscle Strength assessment with manual dinamometer</measure> <time_frame>8 weeks</time_frame> <description>Changes of lower extremity muscle strength</description> </primary_outcome> <primary_outcome> <measure>Joint position sense assessment with angle repetition test</measure> <time_frame>8 weeks</time_frame> <description>Changes of lower extremity joint position sense</description> </primary_outcome> <primary_outcome> <measure>a kinesthetic ability trainer (Sport KAT Model 650-TS)</measure> <time_frame>8 weeks</time_frame> <description>Changes of static and dynamic balance</description> </primary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">66</enrollment> <condition>Healthy</condition> <arm_group> <arm_group_label>Resistance Exercise Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>During 8 week progressive resistance exercises (three times a week)</description> </arm_group> <arm_group> <arm_group_label>Plyometric Exercise Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>During 8 week progressive plyometric exercises (three times a week)</description> </arm_group> <arm_group> <arm_group_label>High Intensity Interval Training Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>During 8 week progressive Hight Intensity Interval Training (three times a week)</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>3 different type of exercise</intervention_name> <description>Group 1: Resistance Exercise Group 2: Plyometric Exercise Group 3: Hight Intensity Interval Training</description> <arm_group_label>High Intensity Interval Training Group</arm_group_label> <arm_group_label>Plyometric Exercise Group</arm_group_label> <arm_group_label>Resistance Exercise Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Being 18-30 years old  2. Being a man  3. Volunteering to participate in the study  4. Having a normal BMI (18.5-24.9) according to the World Health Organization criteria  Exclusion Criteria:  1. Having any physical, mental or psychological illness that may affect participation in the study  2. Having a history of trauma to the lower extremity requiring medical, conservative and surgical treatment in the last 6 months  3. Consuming alcohol or pharmaceuticals up to 24 hours before the assessment </textblock> </criteria> <gender>Male</gender> <minimum_age>18 Years</minimum_age> <maximum_age>30 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Mugla Sıtkı Koçman University</name> <address> <city>Muğla</city> <zip>48000</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dilara Özen Oruk, MSc</last_name> <phone>+905542039899</phone> <email>fztdilaraozen@gmail.com</email> </contact> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 14, 2023</last_update_submitted> <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 15, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation> <investigator_full_name>Dilara Özen Oruk</investigator_full_name> <investigator_title>PT, M.Sc., PhD (c) Research Assistant</investigator_title> </responsible_party> <keyword>muscle structure</keyword> <keyword>muscle thickness</keyword> <keyword>joint position sense</keyword> <keyword>postural stability</keyword> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

This study perform to investigate the comparison of the effects of different exercise types on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception and balance. The choice of exercise type is affected by many different factors. The purpose of exercise and the physical fitness parameter they want to develop gain importance in this choice. Resistance exercises (RE) specifically designed to increase muscle strength and hypertrophy; Plyometric exercises (PE) based on energy storage of the muscle during the deceleration phase and release of this energy during the acceleration period and high-intensity interval training (HIIT), which is an advanced form of interval training that includes shorter and lighter recovery periods following short to heavy anaerobic exercise are some of the many types of exercises in the literature and practice. The purpose of the study is investigate the comparison of the effects of different exercise types on lower extremity muscle thickness, tendon thickness, muscle strength, proprioception and balance. Inclusion Criteria: 1. Being 18-30 years old 2. Being a man 3. Volunteering to participate in the study 4. Having a normal BMI (18.5-24.9) according to the World Health Organization criteria Exclusion Criteria: 1. Having any physical, mental or psychological illness that may affect participation in the study 2. Having a history of trauma to the lower extremity requiring medical, conservative and surgical treatment in the last 6 months 3. Consuming alcohol or pharmaceuticals up to 24 hours before the assessment

NCT0531xxxx/NCT05317312.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/NCT05317312</url> </required_header> <id_info> <org_study_id>MELO-TFZ-2001</org_study_id> <nct_id>NCT05317312</nct_id> </id_info> <brief_title>Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.</brief_title> <official_title>A Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Response Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.</official_title> <sponsors> <lead_sponsor> <agency>Mylan Specialty, LP</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Viatris 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> MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">March 31, 2022</start_date> <completion_date type="Actual">June 20, 2022</completion_date> <primary_completion_date type="Actual">June 15, 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>Double (Participant, Investigator)</masking> <masking_description>double blind, placebo controlled</masking_description> </study_design_info> <primary_outcome> <measure>Overall Summed Pain Intensity Difference (SPID)</measure> <time_frame>24 hours after the first dose</time_frame> <description>Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 18 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.</description> </primary_outcome> <secondary_outcome> <measure>Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)</measure> <time_frame>24 hours after first dose</time_frame> <description>10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 6-hour windowed last observation carried forward (W6LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 6 hours when calculating SPIDs</description> </secondary_outcome> <secondary_outcome> <measure>Time to Perceptible Pain Relief.</measure> <time_frame>24 hours after first dose</time_frame> <description>Measured by double stopwatch technique. The time to onset of first perceptible relief (time that the first watch is stopped) is defined as the postdose time at which the subject first begins to feel pain relief at their estimation.</description> </secondary_outcome> <secondary_outcome> <measure>Time to Meaningful Pain Relief</measure> <time_frame>24 hours after first dose</time_frame> <description>Measured by double stopwatch technique The time to meaningful pain relief (time that the second watch is stopped) is defined as the postdose time at which the subject begins to feel meaningful pain relief at their estimation</description> </secondary_outcome> <secondary_outcome> <measure>Patient's Global Assessment of Pain Control</measure> <time_frame>24 hours</time_frame> <description>5 point PGA (Patient's Global Assessment) of pain control scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent Responder = 2 is good, 3 is very good, and 4 is excellent Non-responder = 1 is fair, 0 is poor, and missing values.</description> </secondary_outcome> <secondary_outcome> <measure>Rescue Medication Use</measure> <time_frame>24 hours after first dose</time_frame> <description>Percentage of subjects using rescue medication from 0-24 hours</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Actual">111</enrollment> <condition>Acute Pain</condition> <condition>Post Operative Pain</condition> <condition>Pain</condition> <arm_group> <arm_group_label>MR-107A-02 1.25 mg twice in a 24 hour period</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Oral tablet, one day of dosing</description> </arm_group> <arm_group> <arm_group_label>MR-107A-02 5 mg twice in a 24 hour period</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Oral tablet, one day of dosing</description> </arm_group> <arm_group> <arm_group_label>MR-107A-02 15 mg twice in a 24 hour period</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Oral tablet, one day of dosing</description> </arm_group> <arm_group> <arm_group_label>Placebo twice in a 24 hour period</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Oral tablet, one day of dosing</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>MR-107A-02</intervention_name> <description>MR-107A-02 oral tablet</description> <arm_group_label>MR-107A-02 1.25 mg twice in a 24 hour period</arm_group_label> <arm_group_label>MR-107A-02 15 mg twice in a 24 hour period</arm_group_label> <arm_group_label>MR-107A-02 5 mg twice in a 24 hour period</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo oral tablet</description> <arm_group_label>Placebo twice in a 24 hour period</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Males and females ≥18 years of age.  2. Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which involves partial or complete mandibular bony impaction.  3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery in the eligibility assessment as well as in the baseline assessment immediately pre-dosing.  4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery.  Exclusion Criteria:  1. Previously dosed with MR-107A-02.  2. Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).  3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may affect coagulation.  4. Moderate or severe hypertension, prior stroke or transient ischemic attack.  5. Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer.  6. Use of medications with the potential to interact with MR-107A-02.  7. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator. </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>Research Facility 201</name> <address> <city>Salt Lake City</city> <state>Utah</state> <zip>84107</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 16, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <results_first_submitted>June 14, 2023</results_first_submitted> <results_first_submitted_qc>August 3, 2023</results_first_submitted_qc> <results_first_posted type="Actual">August 7, 2023</results_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 7, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Pain, Postoperative</mesh_term> <mesh_term>Acute Pain</mesh_term> </condition_browse> <provided_document_section> <provided_document> <document_type>Study Protocol</document_type> <document_has_protocol>Yes</document_has_protocol> <document_has_icf>No</document_has_icf> <document_has_sap>No</document_has_sap> <document_date>February 15, 2022</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT05317312/Prot_000.pdf</document_url> </provided_document> <provided_document> <document_type>Statistical Analysis Plan</document_type> <document_has_protocol>No</document_has_protocol> <document_has_icf>No</document_has_icf> <document_has_sap>Yes</document_has_sap> <document_date>July 23, 2022</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT05317312/SAP_001.pdf</document_url> </provided_document> </provided_document_section> <clinical_results> <participant_flow> <recruitment_details>111 subjects were enrolled / randomized but only 110 subjects were treated.</recruitment_details> <group_list> <group group_id="P1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="P2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="P3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="P4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <period_list> <period> <title>Overall Study</title> <milestone_list> <milestone> <title>STARTED</title> <participants_list> <participants group_id="P1" count="28"/> <participants group_id="P2" count="28"/> <participants group_id="P3" count="27"/> <participants group_id="P4" count="27"/> </participants_list> </milestone> <milestone> <title>COMPLETED</title> <participants_list> <participants group_id="P1" count="28"/> <participants group_id="P2" count="27"/> <participants group_id="P3" count="26"/> <participants group_id="P4" count="26"/> </participants_list> </milestone> <milestone> <title>NOT COMPLETED</title> <participants_list> <participants group_id="P1" count="0"/> <participants group_id="P2" count="1"/> <participants group_id="P3" count="1"/> <participants group_id="P4" count="1"/> </participants_list> </milestone> </milestone_list> <drop_withdraw_reason_list> <drop_withdraw_reason> <title>Withdrawal by Subject</title> <participants_list> <participants group_id="P1" count="0"/> <participants group_id="P2" count="1"/> <participants group_id="P3" count="0"/> <participants group_id="P4" count="0"/> </participants_list> </drop_withdraw_reason> <drop_withdraw_reason> <title>Lost to Follow-up</title> <participants_list> <participants group_id="P1" count="0"/> <participants group_id="P2" count="0"/> <participants group_id="P3" count="0"/> <participants group_id="P4" count="1"/> </participants_list> </drop_withdraw_reason> <drop_withdraw_reason> <title>Excluded as exclusion criteria was met.</title> <participants_list> <participants group_id="P1" count="0"/> <participants group_id="P2" count="0"/> <participants group_id="P3" count="1"/> <participants group_id="P4" count="0"/> </participants_list> </drop_withdraw_reason> </drop_withdraw_reason_list> </period> </period_list> </participant_flow> <baseline> <group_list> <group group_id="B1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="B2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="B3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="B4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> <group group_id="B5"> <title>Total</title> <description>Total of all reporting groups</description> </group> </group_list> <analyzed_list> <analyzed> <units>Participants</units> <scope>Overall</scope> <count_list> <count group_id="B1" value="28"/> <count group_id="B2" value="28"/> <count group_id="B3" value="27"/> <count group_id="B4" value="27"/> <count group_id="B5" value="110"/> </count_list> </analyzed> </analyzed_list> <measure_list> <measure> <title>Age</title> <units>years</units> <param>Mean</param> <dispersion>Standard Deviation</dispersion> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="B1" value="18.9" spread="1.45"/> <measurement group_id="B2" value="19" spread="1.52"/> <measurement group_id="B3" value="19.3" spread="1.94"/> <measurement group_id="B4" value="18.7" spread="1.13"/> <measurement group_id="B5" value="19" spread="1.53"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <measure> <title>Sex: Female, Male</title> <units>Participants</units> <param>Count of Participants</param> <class_list> <class> <category_list> <category> <title>Female</title> <measurement_list> <measurement group_id="B1" value="17"/> <measurement group_id="B2" value="16"/> <measurement group_id="B3" value="16"/> <measurement group_id="B4" value="14"/> <measurement group_id="B5" value="63"/> </measurement_list> </category> <category> <title>Male</title> <measurement_list> <measurement group_id="B1" value="11"/> <measurement group_id="B2" value="12"/> <measurement group_id="B3" value="11"/> <measurement group_id="B4" value="13"/> <measurement group_id="B5" value="47"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <measure> <title>Ethnicity (NIH/OMB)</title> <units>Participants</units> <param>Count of Participants</param> <class_list> <class> <category_list> <category> <title>Hispanic or Latino</title> <measurement_list> <measurement group_id="B1" value="2"/> <measurement group_id="B2" value="4"/> <measurement group_id="B3" value="2"/> <measurement group_id="B4" value="4"/> <measurement group_id="B5" value="12"/> </measurement_list> </category> <category> <title>Not Hispanic or Latino</title> <measurement_list> <measurement group_id="B1" value="26"/> <measurement group_id="B2" value="24"/> <measurement group_id="B3" value="25"/> <measurement group_id="B4" value="23"/> <measurement group_id="B5" value="98"/> </measurement_list> </category> <category> <title>Unknown or Not Reported</title> <measurement_list> <measurement group_id="B1" value="0"/> <measurement group_id="B2" value="0"/> <measurement group_id="B3" value="0"/> <measurement group_id="B4" value="0"/> <measurement group_id="B5" value="0"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <measure> <title>Region of Enrollment</title> <units>participants</units> <param>Number</param> <class_list> <class> <title>United States</title> <category_list> <category> <measurement_list> <measurement group_id="B1" value="28"/> <measurement group_id="B2" value="28"/> <measurement group_id="B3" value="27"/> <measurement group_id="B4" value="27"/> <measurement group_id="B5" value="110"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> </measure_list> </baseline> <outcome_list> <outcome> <type>Primary</type> <title>Overall Summed Pain Intensity Difference (SPID)</title> <description>Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 18 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.</description> <time_frame>24 hours after the first dose</time_frame> <population>Modified Intent-to-treat Analysis Set</population> <group_list> <group group_id="O1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <measure> <title>Overall Summed Pain Intensity Difference (SPID)</title> <description>Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 18 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.</description> <population>Modified Intent-to-treat Analysis Set</population> <units>score on a scale x hours</units> <param>Mean</param> <dispersion>Standard Deviation</dispersion> <analyzed_list> <analyzed> <units>Participants</units> <scope>Measure</scope> <count_list> <count group_id="O1" value="28"/> <count group_id="O2" value="28"/> <count group_id="O3" value="27"/> <count group_id="O4" value="27"/> </count_list> </analyzed> </analyzed_list> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="O1" value="74.5" spread="46.49"/> <measurement group_id="O2" value="82.4" spread="37.78"/> <measurement group_id="O3" value="96.8" spread="35.31"/> <measurement group_id="O4" value="50.5" spread="37.26"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <analysis_list> <analysis> <group_id_list> <group_id>O1</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.123</p_value> <method>Emax</method> <param_type>Mean Difference (Final Values)</param_type> <param_value>18.7</param_value> <dispersion_type>Standard Error of the Mean</dispersion_type> <dispersion_value>12.08</dispersion_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>-5.2</ci_lower_limit> <ci_upper_limit>42.7</ci_upper_limit> <estimate_desc>The estimated difference between 1.25mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.</estimate_desc> </analysis> <analysis> <group_id_list> <group_id>O2</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value><0.001</p_value> <method>Emax</method> <param_type>Mean Difference (Final Values)</param_type> <param_value>34.7</param_value> <dispersion_type>Standard Error of the Mean</dispersion_type> <dispersion_value>10.25</dispersion_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>14.4</ci_lower_limit> <ci_upper_limit>55.0</ci_upper_limit> <other_analysis_desc>The estimated difference between 5mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.</other_analysis_desc> </analysis> <analysis> <group_id_list> <group_id>O3</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value><0.001</p_value> <method>Emax</method> <param_type>Mean Difference (Final Values)</param_type> <param_value>42.8</param_value> <dispersion_type>Standard Error of the Mean</dispersion_type> <dispersion_value>9.53</dispersion_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>23.9</ci_lower_limit> <ci_upper_limit>61.7</ci_upper_limit> <estimate_desc>The estimated difference between 15mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.</estimate_desc> </analysis> </analysis_list> </outcome> <outcome> <type>Secondary</type> <title>Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)</title> <description>10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 6-hour windowed last observation carried forward (W6LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 6 hours when calculating SPIDs</description> <time_frame>24 hours after first dose</time_frame> <population>Modified Intent-to-treat Analysis Set</population> <group_list> <group group_id="O1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <measure> <title>Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)</title> <description>10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 6-hour windowed last observation carried forward (W6LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 6 hours when calculating SPIDs</description> <population>Modified Intent-to-treat Analysis Set</population> <units>score on a scale</units> <param>Mean</param> <dispersion>Standard Deviation</dispersion> <analyzed_list> <analyzed> <units>Participants</units> <scope>Measure</scope> <count_list> <count group_id="O1" value="28"/> <count group_id="O2" value="27"/> <count group_id="O3" value="27"/> <count group_id="O4" value="27"/> </count_list> </analyzed> </analyzed_list> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="O1" value="2.5" spread="1.88"/> <measurement group_id="O2" value="3.1" spread="2.32"/> <measurement group_id="O3" value="2.4" spread="1.72"/> <measurement group_id="O4" value="3.5" spread="2.29"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <analysis_list> <analysis> <group_id_list> <group_id>O1</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <param_type>Mean Difference (Final Values)</param_type> <param_value>-0.9</param_value> <dispersion_type>Standard Error of the Mean</dispersion_type> <dispersion_value>0.56</dispersion_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>-2.0</ci_lower_limit> <ci_upper_limit>0.2</ci_upper_limit> <estimate_desc>The estimated difference between 1.5mg bid and placebo is based on Mixed Model Repeated Measures.The values in the Outcome Measure Data are observed mean values.</estimate_desc> </analysis> <analysis> <group_id_list> <group_id>O2</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <param_type>Mean Difference (Final Values)</param_type> <param_value>-0.7</param_value> <dispersion_type>Standard Error of the Mean</dispersion_type> <dispersion_value>0.56</dispersion_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>-1.8</ci_lower_limit> <ci_upper_limit>0.4</ci_upper_limit> <estimate_desc>The estimated difference between 5mg bid and placebo is based on Mixed Model Repeated Measures. The values in the Outcome Measure Data are observed mean values</estimate_desc> </analysis> <analysis> <group_id_list> <group_id>O3</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <param_type>Mean Difference (Final Values)</param_type> <param_value>-0.8</param_value> <dispersion_type>Standard Error of the Mean</dispersion_type> <dispersion_value>0.56</dispersion_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>-1.9</ci_lower_limit> <ci_upper_limit>0.3</ci_upper_limit> <estimate_desc>The estimated difference between 15mg bid and placebo is based on Mixed Model Repeated Measures.. The values in the Outcome Measure Data are observed mean values</estimate_desc> </analysis> </analysis_list> </outcome> <outcome> <type>Secondary</type> <title>Time to Perceptible Pain Relief.</title> <description>Measured by double stopwatch technique. The time to onset of first perceptible relief (time that the first watch is stopped) is defined as the postdose time at which the subject first begins to feel pain relief at their estimation.</description> <time_frame>24 hours after first dose</time_frame> <population>Modified Intent-to-treat Analysis Set</population> <group_list> <group group_id="O1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <measure> <title>Time to Perceptible Pain Relief.</title> <description>Measured by double stopwatch technique. The time to onset of first perceptible relief (time that the first watch is stopped) is defined as the postdose time at which the subject first begins to feel pain relief at their estimation.</description> <population>Modified Intent-to-treat Analysis Set</population> <units>hours</units> <param>Median</param> <dispersion>95% Confidence Interval</dispersion> <analyzed_list> <analyzed> <units>Participants</units> <scope>Measure</scope> <count_list> <count group_id="O1" value="21"/> <count group_id="O2" value="21"/> <count group_id="O3" value="26"/> <count group_id="O4" value="10"/> </count_list> </analyzed> </analyzed_list> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="O1" value="0.9" lower_limit="0.6" upper_limit="3.4"/> <measurement group_id="O2" value="0.7" lower_limit="0.5" upper_limit="0.9"/> <measurement group_id="O3" value="0.6" lower_limit="0.4" upper_limit="0.7"/> <measurement group_id="O4" value="NA" lower_limit="0.8" upper_limit="NA">Values marked NA (not applicable) have insufficient counts of events to be estimable from the K-M methodology.</measurement> </measurement_list> </category> </category_list> </class> </class_list> </measure> <analysis_list> <analysis> <group_id_list> <group_id>O1</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.036</p_value> <method>Log Rank</method> </analysis> <analysis> <group_id_list> <group_id>O2</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.006</p_value> <method>Log Rank</method> </analysis> <analysis> <group_id_list> <group_id>O3</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value><0.001</p_value> <method>Log Rank</method> </analysis> </analysis_list> </outcome> <outcome> <type>Secondary</type> <title>Time to Meaningful Pain Relief</title> <description>Measured by double stopwatch technique The time to meaningful pain relief (time that the second watch is stopped) is defined as the postdose time at which the subject begins to feel meaningful pain relief at their estimation</description> <time_frame>24 hours after first dose</time_frame> <population>Modified Intent-to-treat Analysis Set</population> <group_list> <group group_id="O1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <measure> <title>Time to Meaningful Pain Relief</title> <description>Measured by double stopwatch technique The time to meaningful pain relief (time that the second watch is stopped) is defined as the postdose time at which the subject begins to feel meaningful pain relief at their estimation</description> <population>Modified Intent-to-treat Analysis Set</population> <units>hours</units> <param>Median</param> <dispersion>95% Confidence Interval</dispersion> <analyzed_list> <analyzed> <units>Participants</units> <scope>Measure</scope> <count_list> <count group_id="O1" value="14"/> <count group_id="O2" value="13"/> <count group_id="O3" value="21"/> <count group_id="O4" value="6"/> </count_list> </analyzed> </analyzed_list> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="O1" value="4.5" lower_limit="3.0" upper_limit="6.8"/> <measurement group_id="O2" value="5.0" lower_limit="1.5" upper_limit="NA">Values marked NA (not applicable) have insufficient counts of events to be estimable from the K-M methodology.</measurement> <measurement group_id="O3" value="1.5" lower_limit="1.0" upper_limit="2.3"/> <measurement group_id="O4" value="3.9" lower_limit="2.9" upper_limit="NA">Values marked NA (not applicable) have insufficient counts of events to be estimable from the K-M methodology.</measurement> </measurement_list> </category> </category_list> </class> </class_list> </measure> <analysis_list> <analysis> <group_id_list> <group_id>O1</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.411</p_value> <method>Log Rank</method> </analysis> <analysis> <group_id_list> <group_id>O2</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.383</p_value> <method>Log Rank</method> </analysis> <analysis> <group_id_list> <group_id>O3</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value><0.001</p_value> <method>Log Rank</method> </analysis> </analysis_list> </outcome> <outcome> <type>Secondary</type> <title>Patient's Global Assessment of Pain Control</title> <description>5 point PGA (Patient's Global Assessment) of pain control scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent Responder = 2 is good, 3 is very good, and 4 is excellent Non-responder = 1 is fair, 0 is poor, and missing values.</description> <time_frame>24 hours</time_frame> <population>Subjects reporting a PGA score of 2 (good) or better defined as a responder</population> <group_list> <group group_id="O1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <measure> <title>Patient's Global Assessment of Pain Control</title> <description>5 point PGA (Patient's Global Assessment) of pain control scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent Responder = 2 is good, 3 is very good, and 4 is excellent Non-responder = 1 is fair, 0 is poor, and missing values.</description> <population>Subjects reporting a PGA score of 2 (good) or better defined as a responder</population> <units>percentage of PGA responders</units> <param>Number</param> <analyzed_list> <analyzed> <units>Participants</units> <scope>Measure</scope> <count_list> <count group_id="O1" value="28"/> <count group_id="O2" value="28"/> <count group_id="O3" value="27"/> <count group_id="O4" value="27"/> </count_list> </analyzed> </analyzed_list> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="O1" value="60.7"/> <measurement group_id="O2" value="67.9"/> <measurement group_id="O3" value="85.2"/> <measurement group_id="O4" value="33.3"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <analysis_list> <analysis> <group_id_list> <group_id>O1</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.042</p_value> <method>Chi-squared</method> <param_type>Risk Difference (RD)</param_type> <param_value>27.4</param_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>2.0</ci_lower_limit> <ci_upper_limit>52.7</ci_upper_limit> </analysis> <analysis> <group_id_list> <group_id>O2</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.01</p_value> <method>Chi-squared</method> <param_type>Risk Difference (RD)</param_type> <param_value>34.5</param_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>9.7</ci_lower_limit> <ci_upper_limit>59.3</ci_upper_limit> </analysis> <analysis> <group_id_list> <group_id>O3</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value><0.001</p_value> <method>Chi-squared</method> <param_type>Risk Difference (RD)</param_type> <param_value>51.9</param_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>29.6</ci_lower_limit> <ci_upper_limit>74.1</ci_upper_limit> </analysis> </analysis_list> </outcome> <outcome> <type>Secondary</type> <title>Rescue Medication Use</title> <description>Percentage of subjects using rescue medication from 0-24 hours</description> <time_frame>24 hours after first dose</time_frame> <population>Rescue Medication Used within 24h</population> <group_list> <group group_id="O1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="O4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <measure> <title>Rescue Medication Use</title> <description>Percentage of subjects using rescue medication from 0-24 hours</description> <population>Rescue Medication Used within 24h</population> <units>percentage of participants</units> <param>Number</param> <analyzed_list> <analyzed> <units>Participants</units> <scope>Measure</scope> <count_list> <count group_id="O1" value="28"/> <count group_id="O2" value="28"/> <count group_id="O3" value="27"/> <count group_id="O4" value="27"/> </count_list> </analyzed> </analyzed_list> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="O1" value="42.9"/> <measurement group_id="O2" value="57.1"/> <measurement group_id="O3" value="29.6"/> <measurement group_id="O4" value="74.1"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <analysis_list> <analysis> <group_id_list> <group_id>O1</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.019</p_value> <method>Chi-squared</method> <param_type>Risk Difference (RD)</param_type> <param_value>-31.2</param_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>-55.9</ci_lower_limit> <ci_upper_limit>-6.5</ci_upper_limit> </analysis> <analysis> <group_id_list> <group_id>O2</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.187</p_value> <method>Chi-squared</method> <param_type>Risk Difference (RD)</param_type> <param_value>-16.9</param_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>-41.6</ci_lower_limit> <ci_upper_limit>7.8</ci_upper_limit> </analysis> <analysis> <group_id_list> <group_id>O3</group_id> <group_id>O4</group_id> </group_id_list> <non_inferiority_type>Superiority</non_inferiority_type> <p_value>0.001</p_value> <method>Chi-squared</method> <param_type>Risk Difference (RD)</param_type> <param_value>-44.4</param_value> <ci_percent>95</ci_percent> <ci_n_sides>2-Sided</ci_n_sides> <ci_lower_limit>-68.3</ci_lower_limit> <ci_upper_limit>20.6</ci_upper_limit> </analysis> </analysis_list> </outcome> </outcome_list> <reported_events> <time_frame>Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.</time_frame> <desc>An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.</desc> <group_list> <group group_id="E1"> <title>MR-107A-02 1.25 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="E2"> <title>MR-107A-02 5 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="E3"> <title>MR-107A-02 15 mg Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet</description> </group> <group group_id="E4"> <title>Placebo Twice in a 24 Hour Period</title> <description>Oral tablet, one day of dosing Placebo: Placebo oral tablet</description> </group> </group_list> <serious_events> <category_list> <category> <title>Total</title> <event_list> <event> <sub_title>Total, all-cause mortality</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/> </event> <event> <sub_title>Total, serious adverse events</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/> </event> </event_list> </category> </category_list> </serious_events> <other_events> <frequency_threshold>5</frequency_threshold> <default_assessment>Systematic Assessment</default_assessment> <category_list> <category> <title>Total</title> <event_list> <event> <sub_title>Total, other adverse events</sub_title> <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="7" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="8" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="8" subjects_at_risk="27"/> </event> </event_list> </category> <category> <title>Gastrointestinal disorders</title> <event_list> <event> <sub_title>Nausea</sub_title> <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="5" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/> </event> <event> <sub_title>Vomitting</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/> </event> <event> <sub_title>Diarrhoea</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/> </event> </event_list> </category> <category> <title>Investigations</title> <event_list> <event> <sub_title>Blood bilirubin increased</sub_title> <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/> </event> </event_list> </category> <category> <title>Nervous system disorders</title> <event_list> <event> <sub_title>Headache</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/> </event> <event> <sub_title>Dizziness</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/> <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/> <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/> <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/> </event> </event_list> </category> </category_list> </other_events> </reported_events> <certain_agreements> <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee> <restrictive_agreement>Subject to a multi-site coordination for publication, Institution and Investigator may publish its results by providing a copy of any presentation/publication derived from the Study for review and comment at least 30 days in advance of any disclosure, presentation, or submission for publication in order for the removal of anything that Sponsor identifies as trade secrets, proprietary information or Confidential Information.</restrictive_agreement> </certain_agreements> <point_of_contact> <name_or_title>Susanne Vogt</name_or_title> <organization>Viatris</organization> <phone>004906172 ext 88801</phone> <email>susanne.vogt@viatris.com</email> </point_of_contact> </clinical_results> </clinical_study>

MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery. Inclusion Criteria: 1. Males and females ≥18 years of age. 2. Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which involves partial or complete mandibular bony impaction. 3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery in the eligibility assessment as well as in the baseline assessment immediately pre-dosing. 4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery. Exclusion Criteria: 1. Previously dosed with MR-107A-02. 2. Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs). 3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may affect coagulation. 4. Moderate or severe hypertension, prior stroke or transient ischemic attack. 5. Use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer. 6. Use of medications with the potential to interact with MR-107A-02. 7. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator.

NCT0531xxxx/NCT05317325.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/NCT05317325</url> </required_header> <id_info> <org_study_id>HXDB-2203</org_study_id> <nct_id>NCT05317325</nct_id> </id_info> <brief_title>A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC</brief_title> <official_title>A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma</official_title> <sponsors> <lead_sponsor> <agency>Sichuan University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Sichuan 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 single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">April 1, 2024</completion_date> <primary_completion_date type="Anticipated">December 30, 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> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>The number of treatment-related adverse events</measure> <time_frame>From the first administration of vaccine to 3 months after the last administration</time_frame> <description>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description> </primary_outcome> <secondary_outcome> <measure>Disease-free Survival</measure> <time_frame>from the study start to 1 year after the study completion</time_frame> <description>Number of participants with Disease-free Survival as assessed by RECIST1.1</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Esophageal Squamous Cell Carcinoma</condition> <arm_group> <arm_group_label>Experimental Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Autologous DCs pulsed with HOCl-oxidized autologous tumor lysate (OCDC) vaccine is administered in prime phase and personal neoantigen-sensitized DC(NeoDC) vaccine is administered in boost phase.</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>OCDC vaccine; NeoDC vaccine</intervention_name> <description>OCDC vaccine and NeoDC vaccine are administered in a prime-boost regimen by subcutaneous injection.</description> <arm_group_label>Experimental Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Pathologically confirmed diagnosis of esophageal squamous cell carcinoma  - no preoperative adjuvant therapy  - Karnofsky performance status 0-2;  - The postoperative pathological stage is pT2-4 and / or N + M0 according to AJCC 8th  - Function of the main organs is normal;  - Edition Patient's written informed consent  Exclusion Criteria:  - Tumor emergencies;  - Abnormal coagulation function;  - Contagious diseases, such as HIV, HBV, HCV infection;  - Mental disorders;  - Concomitant tumors;  - Immunological co-morbidities </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>Zhen-Yu Ding, Prof</last_name> <role>Principal Investigator</role> <affiliation>Sichuan University</affiliation> </overall_official> <overall_contact> <last_name>Zhen-Yu Ding, Prof</last_name> <phone>0086288542357</phone> <email>dingzhenyu@scu.edu.cn</email> </overall_contact> <location> <facility> <name>West China Hospital</name> <address> <city>Chengdu</city> <state>Sichuan</state> <zip>610000</zip> <country>China</country> </address> </facility> <contact> <last_name>Zhen-Yu Ding, Prof</last_name> <phone>0086288542357</phone> <email>dignzhenyu@scu.edu.cn</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Sichuan University</investigator_affiliation> <investigator_full_name>Zhen-Yu Ding</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>esophageal cancer</keyword> <keyword>tumour cell lysate</keyword> <keyword>neoantigen</keyword> <keyword>prime-boost</keyword> <keyword>dendritic cell vaccine</keyword> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Carcinoma, Squamous Cell</mesh_term> <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Vaccines</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> </patient_data>  </clinical_study>

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC Inclusion Criteria: - Pathologically confirmed diagnosis of esophageal squamous cell carcinoma - no preoperative adjuvant therapy - Karnofsky performance status 0-2; - The postoperative pathological stage is pT2-4 and / or N + M0 according to AJCC 8th - Function of the main organs is normal; - Edition Patient's written informed consent Exclusion Criteria: - Tumor emergencies; - Abnormal coagulation function; - Contagious diseases, such as HIV, HBV, HCV infection; - Mental disorders; - Concomitant tumors; - Immunological co-morbidities

NCT0531xxxx/NCT05317338.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/NCT05317338</url> </required_header> <id_info> <org_study_id>2019-0119</org_study_id> <nct_id>NCT05317338</nct_id> </id_info> <brief_title>Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly</brief_title> <official_title>Effects of a Multicomponent Exercise Program on the Functional Performance and Cognitive Ability of Hospitalized Older People: A Randomized Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>Hospital de Clinicas de Porto Alegre</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Federal University of Rio Grande do Sul</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Hospital de Clinicas de Porto Alegre</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> Older patients spend most of their time in situations of muscle disuse during acute hospitalization. Physical inactivity is a key factor for the development of adverse events caused by hospitalization, known as iatrogenic nosocomial disability. Adopting a multicomponent training program during acute hospitalization can be an efficient strategy to reduce adverse effects and promote improvements in older health. This study is a randomized clinical trial with acutely hospitalized older individuals. Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. The control group will receive only the usual care and rehabilitation. </textblock> </brief_summary> <detailed_description> <textblock> This study is a randomized controlled trial with acutely hospitalized older individuals. The first aim is to evaluate the effects of a multicomponent training intervention on functionality, cognitive ability and inflammatory profile in older patients during acute hospitalization.  The population studied will be older patients (≥ 70 years), admitted to the Internal Medicine sector of the Hospital de Clinicas de Porto Alegre. The number of older people obtained through sample calculation is 30 individuals per group, totaling 60 participants in the study.  Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. Exercises aimed at the lower and upper limbs will be performed, such as sitting and standing up from a chair, leg press, bilateral knee extension and bench press with elastic tape. Balance and gait exercises will also be performed. The training session will be considered complete if patients are able to perform 90% or more of the scheduled exercises, the frequency and possible adverse events will be documented in daily records. The control group will not receive multicomponent physical training, only the usual care provided by the hospital. Both groups will be evaluated before and after 5-7 days of intervention. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 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>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Changes in functional independence scores</measure> <time_frame>Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.</time_frame> <description>By using the Barthel Index. This tool indicates an individual's ability to perform basic activities of daily living. Scores range from 0 (severe functional dependence) to 100 (functional independence).</description> </primary_outcome> <primary_outcome> <measure>Changes in lower limbs functional capacity</measure> <time_frame>Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.</time_frame> <description>By using the Short Physical Performance Battery (SPPB) the mobility of the lower limbs will be evaluated through static balance tests while standing, walking speed and muscle strength</description> </primary_outcome> <secondary_outcome> <measure>Handgrip strength</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>Assessed using a handgrip dynamometer</description> </secondary_outcome> <secondary_outcome> <measure>Maximum dynamic muscle strength of lower limbs</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>Maximum strength assessed through the one repetition maximum test in the leg press and knee extension exercises.</description> </secondary_outcome> <secondary_outcome> <measure>Lower limb muscle power</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>Muscle power will be assessed in leg press and knee extension exercises, with intensities of 30% and 60% using an encoder device.</description> </secondary_outcome> <secondary_outcome> <measure>Walking ability</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>6 meter walking ability</description> </secondary_outcome> <secondary_outcome> <measure>Inflammatory markers</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>The following markers will be collected: C-reactive protein, leptin, tumor necrosis factor, interleukin, interferon, insulin like growth factor, transforming growth factor</description> </secondary_outcome> <secondary_outcome> <measure>Changes in cognitive state</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>The Mini Mental State Assessment instrument will be used. Questionnaire with a scale of 0 to 30 points, with 0 being the worst and 30 the best.</description> </secondary_outcome> <secondary_outcome> <measure>Changes in quality of life scores</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>Quality of life will be assessed using the EuroQol-5 Dimension questionnaire. Questionnaire that encompasses 5 health domains (mobility, personal care, usual activities, pain/discomfort and anxiety/depression) whose variation from 0 to 100 corresponds, respectively, to the worst and best health status.</description> </secondary_outcome> <secondary_outcome> <measure>Mortality</measure> <time_frame>Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.</time_frame> <description>Days alive since admission to hospital</description> </secondary_outcome> <secondary_outcome> <measure>Clinical condition</measure> <time_frame>Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.</time_frame> <description>Information will be collected about clinical conditions (number of days of hospitalization and readmission).</description> </secondary_outcome> <secondary_outcome> <measure>Muscle thickness</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>The quadriceps muscle thickness will be evaluated by ultrasonography</description> </secondary_outcome> <secondary_outcome> <measure>Muscle quality</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>The muscle quality of the quadriceps will be evaluated through echo intensity using an ultrasound device</description> </secondary_outcome> <secondary_outcome> <measure>Changes in executive function</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>To assess executive function, the Trail Making Test will be performed</description> </secondary_outcome> <secondary_outcome> <measure>Level of agitation, sedation and delirium</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>The Confusion Assessment Method will be used</description> </secondary_outcome> <secondary_outcome> <measure>Changes in the depressive symptoms scale</measure> <time_frame>Baseline and after the intervention period (after 7 days)</time_frame> <description>The Geriatric Depression Symptoms (GDS) tool will be used. Score from 0 to 15, if greater than 5, the patient is suspected of having depression.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">60</enrollment> <condition>Old Age; Debility</condition> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants randomized to this group will be enrolled to a multicomponent training for 5-7 consecutive days and will continue to receive usual hospital care. The training program consists of strength, balance and gait exercises performed within the hospital.</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Participants randomized to the control group will receive only the usual hospital care and rehabilitation, without performing multicomponent exercises.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Group-based exercise training during hospitalization</intervention_name> <description>Multicomponent exercises for 5-7 days with acutely hospitalized older.</description> <arm_group_label>Intervention group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age 70 years and older;  - Able to tolerate exercise;  - Barthel Index ≥60;  - Be able to walk alone or with the aid of a cane, crutch or walkers;  - Be able to communicate and inform consent to participate in the research.  Exclusion Criteria:  - Length of stay <5 days;  - Inability to participate in the testing procedures and/or the multi-component training program, as determined by the physician;  - Present one or more factors:  1. Terminal illness;  2. Myocardial infarction in the last 3 months;  3. Unstable cardiovascular disease;  4. Any type of fracture in the last 3 months, which makes it impossible to carry out the movements;  5. Severe dementia. </textblock> </criteria> <gender>All</gender> <minimum_age>70 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Emílio H Moriguchi, PhD</last_name> <role>Principal Investigator</role> <affiliation>Hospital de Clínicas de Porto Alegre</affiliation> </overall_official> <overall_contact> <last_name>Juliana L Teodoro, M.Sc</last_name> <phone>+55 51 985923129</phone> <email>julopesteodoro@hotmail.com</email> </overall_contact> <location> <facility> <name>Hospital de Clínicas de Porto Alegre</name> <address> <city>Porto Alegre</city> <state>Rio Grande Do Sul</state> <country>Brazil</country> </address> </facility> <contact> <last_name>Juliana L Teodoro, MSc</last_name> <phone>+55 51 985923129</phone> <email>julopesteodoro@hotmail.com</email> </contact> <investigator> <last_name>Emílio H Moriguchi, PhD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Eduardo L Cadore, PhD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Brazil</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>December 8, 2021</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Frailty</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Older patients spend most of their time in situations of muscle disuse during acute hospitalization. Physical inactivity is a key factor for the development of adverse events caused by hospitalization, known as iatrogenic nosocomial disability. Adopting a multicomponent training program during acute hospitalization can be an efficient strategy to reduce adverse effects and promote improvements in older health. This study is a randomized clinical trial with acutely hospitalized older individuals. Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. The control group will receive only the usual care and rehabilitation. This study is a randomized controlled trial with acutely hospitalized older individuals. The first aim is to evaluate the effects of a multicomponent training intervention on functionality, cognitive ability and inflammatory profile in older patients during acute hospitalization. The population studied will be older patients (≥ 70 years), admitted to the Internal Medicine sector of the Hospital de Clinicas de Porto Alegre. The number of older people obtained through sample calculation is 30 individuals per group, totaling 60 participants in the study. Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. Exercises aimed at the lower and upper limbs will be performed, such as sitting and standing up from a chair, leg press, bilateral knee extension and bench press with elastic tape. Balance and gait exercises will also be performed. The training session will be considered complete if patients are able to perform 90% or more of the scheduled exercises, the frequency and possible adverse events will be documented in daily records. The control group will not receive multicomponent physical training, only the usual care provided by the hospital. Both groups will be evaluated before and after 5-7 days of intervention. Inclusion Criteria: - Age 70 years and older; - Able to tolerate exercise; - Barthel Index ≥60; - Be able to walk alone or with the aid of a cane, crutch or walkers; - Be able to communicate and inform consent to participate in the research. Exclusion Criteria: - Length of stay <5 days; - Inability to participate in the testing procedures and/or the multi-component training program, as determined by the physician; - Present one or more factors: 1. Terminal illness; 2. Myocardial infarction in the last 3 months; 3. Unstable cardiovascular disease; 4. Any type of fracture in the last 3 months, which makes it impossible to carry out the movements; 5. Severe dementia.

NCT0531xxxx/NCT05317351.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/NCT05317351</url> </required_header> <id_info> <org_study_id>G-EYE15080</org_study_id> <nct_id>NCT05317351</nct_id> </id_info> <brief_title>A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®</brief_title> <official_title>A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy</official_title> <sponsors> <lead_sponsor> <agency>Smart Medical Systems Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Smart Medical Systems Ltd.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:  (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy </textblock> </brief_summary> <detailed_description> <textblock> This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:  (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 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>Parallel Assignment</intervention_model> <intervention_model_description>This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy, (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™), and (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy</intervention_model_description> <primary_purpose>Screening</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Adenoma Per Colonoscopy (APC) (AI compared with AG)</measure> <time_frame>Upon histology results (up to 30 days)</time_frame> <description>Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.</description> </primary_outcome> <secondary_outcome> <measure>Adenoma Per Colonoscopy (APC) (SC compared with AG)</measure> <time_frame>Upon histology results (up to 30 days)</time_frame> <description>Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG</description> </secondary_outcome> <secondary_outcome> <measure>Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)</measure> <time_frame>Upon histology results (up to 30 days)</time_frame> <description>Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">2160</enrollment> <condition>Colorectal (Colon or Rectal) Cancer</condition> <condition>Adenoma</condition> <arm_group> <arm_group_label>Standard Colonoscopy ("SC")</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.</description> </arm_group> <arm_group> <arm_group_label>Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)</description> </arm_group> <arm_group> <arm_group_label>Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Standard Colonoscopy</intervention_name> <description>Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope</description> <arm_group_label>Standard Colonoscopy ("SC")</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Artificial Intelligence Aided Colonoscopy (GI Genius™)</intervention_name> <description>Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)</description> <arm_group_label>Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy</intervention_name> <description>Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).</description> <arm_group_label>Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patients of age ≥ 45 years old  2. Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)  3. The patient must understand and provide written consent for the procedure.  Exclusion Criteria:  1. Subjects with inflammatory bowel disease  2. Subjects with a personal history of polyposis syndrome  3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy  4. Subjects with diverticulitis or toxic megacolon  5. Subjects with a history of radiation therapy to abdomen or pelvis  6. Pregnant or lactating female subjects  7. Subjects who are currently enrolled in another clinical investigation.  8. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.  9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)  10. Any patient condition deemed too risky for the study by the investigator  11. Previous colonic surgery (except for appendectomy) </textblock> </criteria> <gender>All</gender> <minimum_age>45 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Douglad K Rex, MD</last_name> <role>Principal Investigator</role> <affiliation>Indina University</affiliation> </overall_official> <overall_contact> <last_name>Douglas K Rex, MD</last_name> <phone>317-777-9676</phone> <email>drex@iu.edu</email> </overall_contact> <location> <facility> <name>Indiana University</name> <address> <city>Indianapolis</city> <state>Indiana</state> <zip>46202</zip> <country>United States</country> </address> </facility> <contact> <last_name>Douglas K Rex, MD</last_name> <phone>317-777-9676</phone> <email>drex@iu.edu</email> </contact> </location> <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> <contact> <last_name>Seth A Gross, MD</last_name> <phone>212-263-3095</phone> <email>Seth.Gross@nyulangone.org</email> </contact> </location> <location_countries> <country>United States</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 7, 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 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Adenoma</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms. Inclusion Criteria: 1. Patients of age ≥ 45 years old 2. Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection) 3. The patient must understand and provide written consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease 2. Subjects with a personal history of polyposis syndrome 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy 4. Subjects with diverticulitis or toxic megacolon 5. Subjects with a history of radiation therapy to abdomen or pelvis 6. Pregnant or lactating female subjects 7. Subjects who are currently enrolled in another clinical investigation. 8. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 10. Any patient condition deemed too risky for the study by the investigator 11. Previous colonic surgery (except for appendectomy)

NCT0531xxxx/NCT05317364.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/NCT05317364</url> </required_header> <id_info> <org_study_id>300008970</org_study_id> <nct_id>NCT05317364</nct_id> </id_info> <brief_title>Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery</brief_title> <official_title>Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery: a Randomized Clinical Trial</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>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency results in changes in the vaginal epithelium and poor tissue quality which results in poor wound healing. For postmenopausal women with vaginal atrophy undergoing surgery for pelvic organ prolapse, early administration of topical vaginal E2 therapy resulted in improved markers of tissue quality. Currently, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. In this proposed randomized, placebo-controlled trial, women who sustain OASIS will be recruited and randomized to begin intravaginal estrogen therapy or placebo at their 2-week follow-up visit after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact. The primary outcome of this study will be sexual dysfunction symptom severity measured by the female sexual function index (FSFI) at 6 months postpartum. Secondary outcomes will be urinary and anal incontinence distress and impact measured by St. Mark's score and the fecal incontinence quality of life (FIQOL) questionnaire for anal incontinence and urogenital distress inventory (UDI-6) for urinary incontinence. The objective of this study is to determine if intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after OASIS. </textblock> </brief_summary> <detailed_description> <textblock> Obstetric anal sphincter injuries (OASIS) are known to cause significant morbidity and are known risk factors for sexual dysfunction, urinary and anal incontinence. Recent studies have reported that women with OASIS experience more problems with sexual dysfunction compared to their age and parity matched counterparts who do not have these tears. Despite this, little attention is paid to its prevalence or treatment in this population. These women are also at a 4-fold higher risk of anal incontinence. Additionally, significantly more women with OASIS report urinary incontinence 10 weeks after delivery and have significantly worse quality of life scores. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency results in changes in the vaginal epithelium and poor tissue quality which results in poor wound healing. For postmenopausal women with vaginal atrophy undergoing surgery for pelvic organ prolapse, early administration of topical vaginal E2 therapy resulted in improved markers of tissue quality.  Due to the significant morbidity associated with OASIS, it is critical to further explore treatment options to ultimately improve wound healing and outcomes in women who sustain OASIS tears in their postpartum recovery. Training in identification of OASIS and close follow up in specialized OASIS clinics have improved outcomes for these women. However, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. Intra-vaginal estrogen therapy has proven to be safe and feasible in this population as demonstrated by no difference in the serum estrogen concentration in those women treated with intra-vaginal estrogen therapy for treatment of granulation tissue. Although evidence is limited, anecdotally, vaginal estrogen cream has been used to treat postpartum women with OASIS to treat vaginal atrophy and improve wound healing. This proposed research is critical to ultimately improving the postpartum recovery for women who sustain OASIS. This information will add to the growing literature aiming to optimize quality of life and improve care for these women.  In this proposed randomized, placebo-controlled trial, women who sustain OASIS will be recruited and randomized to begin intravaginal estrogen therapy or placebo at their 2-week follow-up visit, (upon establishing care at postpartum perineal clinic), after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact at the 2-week postpartum visit (baseline). Participants will follow up at designated intervals (12-weeks and 6 months) and complete questionnaires with plan for total of 6-months intravaginal estrogen or placebo therapy. The primary outcome will be sexual dysfunction symptom severity measured by the female sexual function index (FSFI) at 6 months postpartum. Secondary outcomes will be urinary and anal incontinence distress and impact measured by St. Mark's and the fecal incontinence quality of life (FIQOL) scores for anal incontinence and urogenital distress inventory (UDI-6) for urinary incontinence. The objective of this study is to determine if intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after OASIS. We hypothesize that topical vaginal estrogen cream therapy postpartum will improve sexual function scores thereby improving functional status and related quality of life. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 14, 2022</start_date> <completion_date type="Anticipated">July 1, 2024</completion_date> <primary_completion_date type="Anticipated">January 1, 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> <intervention_model_description>Participants are assigned to receive either topical vaginal estrogen or placebo cream and will continue this therapy for duration of study.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> <masking_description>Double blind</masking_description> </study_design_info> <primary_outcome> <measure>sexual dysfunction symptom severity</measure> <time_frame>6 months postpartum</time_frame> <description>measured by the female sexual function index (FSFI). Minimum score 1, maximum score 36. Higher scores indicate a higher level of sexual function.</description> </primary_outcome> <secondary_outcome> <measure>Urinary incontinence</measure> <time_frame>6 months postpartum</time_frame> <description>measured by urogenital distress inventory (UDI-6). Minimum score is 0, maximum score 75. Higher scores indicate a higher level of distress and impact on quality of life caused by urinary incontinence.</description> </secondary_outcome> <secondary_outcome> <measure>Anal incontinence</measure> <time_frame>6 months postpartum</time_frame> <description>measured by St. Mark's and the fecal incontinence quality of life (FIQOL) scores. For St. Marks, minimum score 0, maximum 24. A higher score indicates a higher degree of incontinence and impact on lifestyle. For FIQOL, minimum score is 4, maximum score is 20. A lower score indicates a lower functional status and related quality of life.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">50</enrollment> <condition>Obstetric; Injury Pelvic Floor</condition> <condition>Sexual Dysfunction</condition> <condition>Anal Incontinence</condition> <condition>Urinary Incontinence</condition> <arm_group> <arm_group_label>Topical vaginal estrogen group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Estradiol vaginal cream 0.01% 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g estradiol vaginal cream 0.01% will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy</description> </arm_group> <arm_group> <arm_group_label>Placebo group</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Placebo cream, 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g of placebo cream will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Estradiol 0.01% Vag Cream</intervention_name> <description>1g estradiol vaginal cream 0.01% or placebo will be administered nightly for 2 weeks then twice weekly to complete 6 months therapy</description> <arm_group_label>Topical vaginal estrogen group</arm_group_label> <other_name>Estrace cream</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo vaginal cream</intervention_name> <description>Placebo cream</description> <arm_group_label>Placebo group</arm_group_label> <other_name>Versabase vaginal cream</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - women who sustained 3rd or 4th degree lacerations  - aged 18 years or older  - must be able to self apply vaginal cream  Exclusion Criteria:  - Contraindications to intra-vaginal estrogen therapy (spontaneous DVT, stroke, hormone responsive breast cancer)  - tobacco use  - allergy to estradiol vaginal cream 0.01% or its constitutions  - perineal wound breakdown or infection at 2-week Postpartum visit. </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>Hannah L Chapman, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Alabama at Birmingham</affiliation> </overall_official> <overall_contact> <last_name>Hannah L Chapman, MD</last_name> <phone>3072626398</phone> <email>hlchapman@uabmc.edu</email> </overall_contact> <location> <facility> <name>University of Alabama at Birmingham</name> <address> <city>Birmingham</city> <state>Alabama</state> <zip>35249</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Hannah L Chapman, MD</last_name> </contact> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Sayed Ahmed WA, Kishk EA, Farhan RI, Khamees RE. Female sexual function following different degrees of perineal tears. Int Urogynecol J. 2017 Jun;28(6):917-921. doi: 10.1007/s00192-016-3210-6. Epub 2016 Dec 6.</citation> <PMID>27924373</PMID> </reference> <reference> <citation>Andrews V, Thakar R, Sultan AH, Jones PW. Evaluation of postpartum perineal pain and dyspareunia--a prospective study. Eur J Obstet Gynecol Reprod Biol. 2008 Apr;137(2):152-6. doi: 10.1016/j.ejogrb.2007.06.005. Epub 2007 Aug 2.</citation> <PMID>17681663</PMID> </reference> <reference> <citation>Soerensen MM, Buntzen S, Bek KM, Laurberg S. Complete obstetric anal sphincter tear and risk of long-term fecal incontinence: a cohort study. Dis Colon Rectum. 2013 Aug;56(8):992-1001. doi: 10.1097/DCR.0b013e318299c209.</citation> <PMID>23838869</PMID> </reference> <reference> <citation>Stedenfeldt M, Pirhonen J, Blix E, Wilsgaard T, Vonen B, Oian P. Anal incontinence, urinary incontinence and sexual problems in primiparous women - a comparison between women with episiotomy only and women with episiotomy and obstetric anal sphincter injury. BMC Womens Health. 2014 Dec 16;14:157. doi: 10.1186/s12905-014-0157-y.</citation> <PMID>25511413</PMID> </reference> <reference> <citation>Scheer I, Andrews V, Thakar R, Sultan AH. Urinary incontinence after obstetric anal sphincter injuries (OASIS)--is there a relationship? Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):179-83. doi: 10.1007/s00192-007-0431-8. Epub 2007 Aug 2.</citation> <PMID>17671753</PMID> </reference> <reference> <citation>Woodward AP, Matthews CA. Outcomes of revision perineoplasty for persistent postpartum dyspareunia. Female Pelvic Med Reconstr Surg. 2010 Mar;16(2):135-9. doi: 10.1097/SPV.0b013e3181cc8702.</citation> <PMID>22453161</PMID> </reference> <reference> <citation>Karp DR, Jean-Michel M, Johnston Y, Suciu G, Aguilar VC, Davila GW. A randomized clinical trial of the impact of local estrogen on postoperative tissue quality after vaginal reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):211-5. doi: 10.1097/SPV.0b013e31825e6401.</citation> <PMID>22777369</PMID> </reference> <reference> <citation>Ripperda CM, Maldonado PA, Acevedo JF, Keller PW, Akgul Y, Shelton JM, Word RA. Vaginal estrogen: a dual-edged sword in postoperative healing of the vaginal wall. Menopause. 2017 Jul;24(7):838-849. doi: 10.1097/GME.0000000000000840.</citation> <PMID>28169915</PMID> </reference> <reference> <citation>Bochenska K, Kujawa S, Zhao H, Kenton K, Bulun SE, Lewicky-Gaupp C. Molecular Effects of Topical Estrogen on Vaginal Granulation Tissue in Postpartum Women. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):521-526. doi: 10.1097/SPV.0000000000001076.</citation> <PMID>34261104</PMID> </reference> <reference> <citation>Brown O, Heliker BD, Geynisman-Tan J, Tavathia M, Mueller MG, Collins S, Kenton K, Lewicky-Gaupp C. Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):659-666. doi: 10.1097/SPV.0000000000001037.</citation> <PMID>34608032</PMID> </reference> <verification_date>July 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 11, 2023</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>Hannah Chapman</investigator_full_name> <investigator_title>Clinical instructor, fellow</investigator_title> </responsible_party> <keyword>Obstetric anal sphincter injury</keyword> <keyword>sexual dysfunction</keyword> <keyword>anal incontinence</keyword> <keyword>urinary incontinence</keyword> <condition_browse>  <mesh_term>Fecal Incontinence</mesh_term> <mesh_term>Urinary Incontinence</mesh_term> <mesh_term>Enuresis</mesh_term> <mesh_term>Wounds and Injuries</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Estradiol</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency results in changes in the vaginal epithelium and poor tissue quality which results in poor wound healing. For postmenopausal women with vaginal atrophy undergoing surgery for pelvic organ prolapse, early administration of topical vaginal E2 therapy resulted in improved markers of tissue quality. Currently, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. In this proposed randomized, placebo-controlled trial, women who sustain OASIS will be recruited and randomized to begin intravaginal estrogen therapy or placebo at their 2-week follow-up visit after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact. The primary outcome of this study will be sexual dysfunction symptom severity measured by the female sexual function index (FSFI) at 6 months postpartum. Secondary outcomes will be urinary and anal incontinence distress and impact measured by St. Mark's score and the fecal incontinence quality of life (FIQOL) questionnaire for anal incontinence and urogenital distress inventory (UDI-6) for urinary incontinence. The objective of this study is to determine if intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after OASIS. Obstetric anal sphincter injuries (OASIS) are known to cause significant morbidity and are known risk factors for sexual dysfunction, urinary and anal incontinence. Recent studies have reported that women with OASIS experience more problems with sexual dysfunction compared to their age and parity matched counterparts who do not have these tears. Despite this, little attention is paid to its prevalence or treatment in this population. These women are also at a 4-fold higher risk of anal incontinence. Additionally, significantly more women with OASIS report urinary incontinence 10 weeks after delivery and have significantly worse quality of life scores. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency results in changes in the vaginal epithelium and poor tissue quality which results in poor wound healing. For postmenopausal women with vaginal atrophy undergoing surgery for pelvic organ prolapse, early administration of topical vaginal E2 therapy resulted in improved markers of tissue quality. Due to the significant morbidity associated with OASIS, it is critical to further explore treatment options to ultimately improve wound healing and outcomes in women who sustain OASIS tears in their postpartum recovery. Training in identification of OASIS and close follow up in specialized OASIS clinics have improved outcomes for these women. However, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. Intra-vaginal estrogen therapy has proven to be safe and feasible in this population as demonstrated by no difference in the serum estrogen concentration in those women treated with intra-vaginal estrogen therapy for treatment of granulation tissue. Although evidence is limited, anecdotally, vaginal estrogen cream has been used to treat postpartum women with OASIS to treat vaginal atrophy and improve wound healing. This proposed research is critical to ultimately improving the postpartum recovery for women who sustain OASIS. This information will add to the growing literature aiming to optimize quality of life and improve care for these women. In this proposed randomized, placebo-controlled trial, women who sustain OASIS will be recruited and randomized to begin intravaginal estrogen therapy or placebo at their 2-week follow-up visit, (upon establishing care at postpartum perineal clinic), after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact at the 2-week postpartum visit (baseline). Participants will follow up at designated intervals (12-weeks and 6 months) and complete questionnaires with plan for total of 6-months intravaginal estrogen or placebo therapy. The primary outcome will be sexual dysfunction symptom severity measured by the female sexual function index (FSFI) at 6 months postpartum. Secondary outcomes will be urinary and anal incontinence distress and impact measured by St. Mark's and the fecal incontinence quality of life (FIQOL) scores for anal incontinence and urogenital distress inventory (UDI-6) for urinary incontinence. The objective of this study is to determine if intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after OASIS. We hypothesize that topical vaginal estrogen cream therapy postpartum will improve sexual function scores thereby improving functional status and related quality of life. Inclusion Criteria: - women who sustained 3rd or 4th degree lacerations - aged 18 years or older - must be able to self apply vaginal cream Exclusion Criteria: - Contraindications to intra-vaginal estrogen therapy (spontaneous DVT, stroke, hormone responsive breast cancer) - tobacco use - allergy to estradiol vaginal cream 0.01% or its constitutions - perineal wound breakdown or infection at 2-week Postpartum visit.

NCT0531xxxx/NCT05317377.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/NCT05317377</url> </required_header> <id_info> <org_study_id>LeapGeriatric2021</org_study_id> <nct_id>NCT05317377</nct_id> </id_info> <brief_title>Leap Motion In Geriatric Rehabilitation</brief_title> <official_title>Leap Motion Controller Based Exergame Therapy in Geriatric Individuals</official_title> <sponsors> <lead_sponsor> <agency>Istanbul Medipol University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Istanbul Medipol 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> Little is Known about the effects of leap motion based exergame therapy on different functions of elderly adults. The purpose of this study was to evaluate the effect of leap motion based exergame therapy on hand function, cognitive function and quality of life in older adults </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">July 5, 2021</start_date> <completion_date type="Actual">March 10, 2022</completion_date> <primary_completion_date type="Actual">February 15, 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 (Participant)</masking> <masking_description>participants will be included in the study and randomly divided into two groups using block randomization in Microsoft Excel 'RAND(WS)' function.</masking_description> </study_design_info> <primary_outcome> <measure>Grip Strength Test</measure> <time_frame>changes after 8 weeks</time_frame> <description>A hand dynamometer (pinch meter gauge; Jamar® Hand Dynamometer - Hydraulic - 200 lb Capacity. Patterson Medical Illinois, USA) will be used to determine the grip strength of the participants. While taking the measurements, the patients will be seated with the shoulder adducted and neutrally rotated, elbow flexed at 90°, forearm and wrist in neutral position. Each grip test will be repeated three times and the highest score for the affected extremity will be used for further analysis.</description> </primary_outcome> <secondary_outcome> <measure>Pittsburgh Rehabilitation Participation Scale</measure> <time_frame>changes after 8 weeks</time_frame> <description>It is a clinician-evaluated outcome scale that examines the patient's participation in therapy and motivation. While the test period lasts 5 minutes, it consists of 6 different scores (1-none/6-excellent). Higher scores mean better performance.</description> </secondary_outcome> <secondary_outcome> <measure>World Health Organization Quality of Life Instrument-Older Adults Module</measure> <time_frame>changes after 8 weeks</time_frame> <description>It is a versatile scale that helps to evaluate the quality of life in elderly individuals. WHOQOL-OLD consists of 6 sections: sensory skills, autonomy, past-present-future activities, social participation, death and relationships, and includes 4 items in each section, consisting of a total of 24 questions.</description> </secondary_outcome> <secondary_outcome> <measure>Digit Span Test</measure> <time_frame>changes after 8 weeks</time_frame> <description>It consists of two sub-categories, forward and backward number range, and evaluates attention . During the test, the participant is asked to repeat the numbers from 1 to 9 in mixed order, starting from 4 and increasing to 8. At this time, it is important to note that each number is said in one second, slowing down may develop different strategies. The forward range consists of 5 to 7 numbers, while the reverse range consists of 3 to 7 numbers. The participant is asked to count forward or backward from the number said. As many points as they can say are noted as a score.</description> </secondary_outcome> <secondary_outcome> <measure>Duruöz Hand Index</measure> <time_frame>changes after 8 weeks</time_frame> <description>It is an 18-item, self-answered scale that evaluates hand activity limitations and its effect on activities of daily living. In the scale where scores between 0-90 can be obtained, high scores indicate low function.</description> </secondary_outcome> <secondary_outcome> <measure>Stroop Test</measure> <time_frame>changes after 8 weeks</time_frame> <description>The Stroop Test measures the processing speed, the ability to suppress habitual behavior, focused attention, the ability to do unusual behavior, the ability to change the perceptual setup according to changing demands, and under a disturbing effect. The tests proved to be reliable (with test/retest reliabilities ranging from acceptable (r=0.63) to high (r=0.88) and sensitive to detect small differences in subjects from different age categories.</description> </secondary_outcome> <secondary_outcome> <measure>Purdue Pegboard Test</measure> <time_frame>changes after 8 weeks</time_frame> <description>The Purdue Pegboard consists of a board with holes into which metal pegs are inserted by the patient. It also comes with washers and collars to be placed on the pins. The test measures movements, coordination and speed of hand and finger dexterity. In the test procedures, the patient is first asked to use the right hand to properly insert as many pins as possible in the holes. Then, the same procedure is repeated for the left hand. In the final stage the patient is given 60 sec to place the pins, washers and collars using both hands.</description> </secondary_outcome> <secondary_outcome> <measure>Box and Block Test</measure> <time_frame>changes after 8 weeks</time_frame> <description>It examines unilateral gross motor skills. A stopwatch, a wooden box with a middle section, and 150 wooden cubes are the required materials. The total duration of the test is 2-5 minutes. The test can be applied between the ages of 6 and 65. Within 60 seconds, which is kept by the stopwatch, it is requested to pass the cubes one by one from one compartment to the other and the number of cubes is noted. This test is applied separately for both extremities.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Elderly</condition> <arm_group> <arm_group_label>Structured Exercise</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Structured hand exercises will be applied in 45-minute sessions (16 sessions total), 2 days a week, over 8 weeks in addition to participants' routine physical activities.</description> </arm_group> <arm_group> <arm_group_label>Leap Motion Based Exergame (LMBE)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>"ErgoActive" and "HandROM" exercise apps focusing on hand exercises and fine motor skills will be applied in 45-minute session (16 sessions total), 2 days a week, over 8 weeks in addition to participants' routine physical activities.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Exercise Therapy</intervention_name> <description>Structured exercises focused on hand functionality</description> <arm_group_label>Structured Exercise</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Leap Motion Based Exergame</intervention_name> <description>Appropriate games from Leap Motion Based Exergame system focused on hand functionality</description> <arm_group_label>Leap Motion Based Exergame (LMBE)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 50 years old and over,  - having adequate hand function,  - ability to follow commands,  - 24< points in MMSE  Exclusion Criteria:  - presence of exercise contraindications  - 14 or more points on the Geriatric Depression Scale  - diagnosis of dementia  - recent (acute) hand or arm injury </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Istanbul Medipol University</name> <address> <city>Istanbul</city> <zip>34815</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2022</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 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation> <investigator_full_name>Farzin Hajebrahimi, PhD</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>The data that support the findings of this study will be available on reasonable request from the principle investigator. The data are not publicly available due to ethical issues.</ipd_description> </patient_data>  </clinical_study>

Little is Known about the effects of leap motion based exergame therapy on different functions of elderly adults. The purpose of this study was to evaluate the effect of leap motion based exergame therapy on hand function, cognitive function and quality of life in older adults Inclusion Criteria: - 50 years old and over, - having adequate hand function, - ability to follow commands, - 24< points in MMSE Exclusion Criteria: - presence of exercise contraindications - 14 or more points on the Geriatric Depression Scale - diagnosis of dementia - recent (acute) hand or arm injury

NCT0531xxxx/NCT05317390.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/NCT05317390</url> </required_header> <id_info> <org_study_id>2020P004129</org_study_id> <nct_id>NCT05317390</nct_id> </id_info> <brief_title>Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia</brief_title> <official_title>Clinical Validation of DystoniaNet Deep Learning Platform for Diagnosis of Isolated Dystonia</official_title> <sponsors> <lead_sponsor> <agency>Massachusetts Eye and Ear Infirmary</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Massachusetts Eye and Ear Infirmary</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 involves retrospective and prospective studies for clinical validation of a DystoniaNet deep learning platform for the diagnosis of isolated dystonia. </textblock> </brief_summary> <detailed_description> <textblock> Isolated dystonia is a movement disorder of unknown pathophysiology, which causes involuntary muscle contractions leading to abnormal, typically patterned, twisting movements and postures. A significant challenge in the clinical management of dystonia is due to the absence of a biomarker and associated 'gold' standard diagnostic test. Currently, the diagnosis of dystonia is guided by clinical evaluations of its symptoms, which lead to a low agreement between clinicians and a high rate of diagnostic inaccuracies. It is estimated that only 5% of patients receive an accurate diagnosis at symptom onset, and the average diagnostic delay extends up to 10.1 years. This study will conduct retrospective and prospective studies to clinically validate the performance of DystoniaNet, a biomarker-based deep learning platform for the diagnosis of isolated dystonia.  The retrospective studies will clinically validate the diagnostic performance of the DystoniaNet algorithm (1) in patients compared to healthy subjects (normative test), and (2) between patients with dystonia and other neurological and non-neurological conditions (differential test).  The prospective randomized study will validate the performance of DystoniaNet algorithm for accurate, objective, and fast diagnosis of dystonia in the actual clinical setting.  This research is expected to advance the DystoniaNet algorithm for dystonia diagnosis into its clinical use for increased accuracy of dystonia diagnosis. Early detection and diagnosis of dystonia will enable its early therapy and improved prognosis, having an overall positive impact on healthcare and patients' quality of life. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">April 30, 2027</completion_date> <primary_completion_date type="Anticipated">April 30, 2027</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>Double (Participant, Care Provider)</masking> </study_design_info> <primary_outcome> <measure>Correctness of clinical diagnosis of dystonia using the DystoniaNet algorithm</measure> <time_frame>4 years</time_frame> <description>Correctness of dystonia diagnosis (yes dystonia/no dystonia) will be established using the DystoniaNet machine-learning algorithm</description> </primary_outcome> <primary_outcome> <measure>Time of clinical diagnosis of dystonia using the DystoniaNet algorithm</measure> <time_frame>4 years</time_frame> <description>The length of time (in months) from symptom onset to clinical diagnosis will be established using the DystoniaNet machine-learning algorithm</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">1000</enrollment> <condition>Dystonia</condition> <condition>Drug Induced Dystonia</condition> <condition>Parkinson Disease</condition> <condition>Essential Tremor</condition> <condition>Dyskinesias</condition> <condition>Myoclonus</condition> <condition>Tic Disorders</condition> <condition>Torticollis</condition> <condition>Ulnar Nerve Entrapment</condition> <condition>Temporomandibular Joint Disorders</condition> <condition>Dysphonia</condition> <arm_group> <arm_group_label>Retrospective clinical validation of DystoniaNet</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Retrospective studies will (1) clinically validate the diagnostic performance of DystoniaNet compared to a normal neurological state (normative test), and (2) develop and test DystoniaNet extensions in comparison with other neurological and non-neurological conditions (differential test).</description> </arm_group> <arm_group> <arm_group_label>Prospective clinical validation of DystoniaNet</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Prospective randomized studies will validate DystoniaNet performance for accurate, objective, and fast diagnosis of dystonia in the actual clinical setting.</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>DystoniaNet-based diagnosis of isolated dystonia</intervention_name> <description>DystoniaNet will be used for the diagnosis of dystonia and its differential diagnosis from other neurological and non-neurological disorders mimicking symptoms of dystonia</description> <arm_group_label>Prospective clinical validation of DystoniaNet</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion criteria:  1. Males and females of diverse racial and ethnic backgrounds, with age across the lifespan;  2. Patients will have at least one of the forms of dystonia, including focal dystonia (e.g., laryngeal, cervical, oromandibular, blepharospasm, focal hand, musicians), segmental dystonia, or generalized dystonia;  3. Patients will have other movement disorders (Parkinson's disease, essential tremor, dyskinesia, myoclonus) and other non-neurological conditions (tic disorders, torticollis, ulnar nerve entrapments, temporomandibular disorders, dysphonia) that mimic dystonic symptoms.  Exclusion criteria:  1. Patients who are incapable of giving informed consent;  2. Patients who are unable to undergo brain MRI due to the presence of certain tattoos and ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve) that cannot be removed or due to pregnancy or breastfeeding at the time of the 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> <overall_official> <last_name>Kristina Simonyan, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Massachusetts Eye and Ear</affiliation> </overall_official> <overall_contact> <last_name>Kristina Simonyan, MD, PhD</last_name> <phone>617-573-6016</phone> <email>simonyan_lab@meei.harvard.edu</email> </overall_contact> <location> <facility> <name>Massachusetts Eye and Ear Infirmary</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02114</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kristina Simonyan, MD, PhD</last_name> <phone>617-573-6016</phone> <email>simonyan_lab@meei.harvard.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>November 28, 2021</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>August 10, 2022</last_update_submitted> <last_update_submitted_qc>August 10, 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>Massachusetts Eye and Ear Infirmary</investigator_affiliation> <investigator_full_name>Kristina Simonyan</investigator_full_name> <investigator_title>Associate Professor of Otolaryngology - Head and Neck Surgery</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Temporomandibular Joint Disorders</mesh_term> <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term> <mesh_term>Dysphonia</mesh_term> <mesh_term>Parkinson Disease</mesh_term> <mesh_term>Dystonia</mesh_term> <mesh_term>Dystonic Disorders</mesh_term> <mesh_term>Dyskinesias</mesh_term> <mesh_term>Essential Tremor</mesh_term> <mesh_term>Tic Disorders</mesh_term> <mesh_term>Myoclonus</mesh_term> <mesh_term>Nerve Compression Syndromes</mesh_term> <mesh_term>Ulnar Nerve Compression Syndromes</mesh_term> <mesh_term>Torticollis</mesh_term> </condition_browse>  </clinical_study>

This research involves retrospective and prospective studies for clinical validation of a DystoniaNet deep learning platform for the diagnosis of isolated dystonia. Isolated dystonia is a movement disorder of unknown pathophysiology, which causes involuntary muscle contractions leading to abnormal, typically patterned, twisting movements and postures. A significant challenge in the clinical management of dystonia is due to the absence of a biomarker and associated 'gold' standard diagnostic test. Currently, the diagnosis of dystonia is guided by clinical evaluations of its symptoms, which lead to a low agreement between clinicians and a high rate of diagnostic inaccuracies. It is estimated that only 5% of patients receive an accurate diagnosis at symptom onset, and the average diagnostic delay extends up to 10.1 years. This study will conduct retrospective and prospective studies to clinically validate the performance of DystoniaNet, a biomarker-based deep learning platform for the diagnosis of isolated dystonia. The retrospective studies will clinically validate the diagnostic performance of the DystoniaNet algorithm (1) in patients compared to healthy subjects (normative test), and (2) between patients with dystonia and other neurological and non-neurological conditions (differential test). The prospective randomized study will validate the performance of DystoniaNet algorithm for accurate, objective, and fast diagnosis of dystonia in the actual clinical setting. This research is expected to advance the DystoniaNet algorithm for dystonia diagnosis into its clinical use for increased accuracy of dystonia diagnosis. Early detection and diagnosis of dystonia will enable its early therapy and improved prognosis, having an overall positive impact on healthcare and patients' quality of life. Inclusion criteria: 1. Males and females of diverse racial and ethnic backgrounds, with age across the lifespan; 2. Patients will have at least one of the forms of dystonia, including focal dystonia (e.g., laryngeal, cervical, oromandibular, blepharospasm, focal hand, musicians), segmental dystonia, or generalized dystonia; 3. Patients will have other movement disorders (Parkinson's disease, essential tremor, dyskinesia, myoclonus) and other non-neurological conditions (tic disorders, torticollis, ulnar nerve entrapments, temporomandibular disorders, dysphonia) that mimic dystonic symptoms. Exclusion criteria: 1. Patients who are incapable of giving informed consent; 2. Patients who are unable to undergo brain MRI due to the presence of certain tattoos and ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve) that cannot be removed or due to pregnancy or breastfeeding at the time of the study.

NCT0531xxxx/NCT05317403.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/NCT05317403</url> </required_header> <id_info> <org_study_id>Venetoclax Epigenetic</org_study_id> <nct_id>NCT05317403</nct_id> </id_info> <brief_title>Venetoclax to Augment Epigenetic Modification and Chemotherapy</brief_title> <official_title>A Phase I Study of Venetoclax to Augment Epigenetic Modification and Chemotherapy in Pediatric and Young Adult Patients With Relapsed and Refractory Acute Myeloid Leukemia</official_title> <sponsors> <lead_sponsor> <agency>Medical College of Wisconsin</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Medical College of Wisconsin</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> The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients. </textblock> </brief_summary> <detailed_description> <textblock> The investigators are testing if the addition of venetoclax to epigenetic therapy will not only enhance the treatment response for patients with epigenetic lesions but improve the poor response we have observed in those patients without epigenetic lesions. The addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy will be investigated. This regimen may be tolerable and increase LSC targeting resulting in deeper, more durable responses in children, adolescents, and young adults with relapsed or refractory AML  The study will enroll patients in two strata - a primary stratum of eligible patients without Down syndrome, and a secondary stratum of eligible patients with Down syndrome (DS-AML). Subjects will receive two 35 day cycles of therapy. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 31, 2023</start_date> <completion_date type="Anticipated">January 2027</completion_date> <primary_completion_date type="Anticipated">November 2026</primary_completion_date> <phase>Phase 1</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>Venetoclax Dose-Limiting Toxicity</measure> <time_frame>42 months</time_frame> <description>The primary endpoint, for dose escalation of venetoclax, is the occurrence of a dose-limiting toxicity (DLT) observed during the first course of therapy.</description> </primary_outcome> <secondary_outcome> <measure>Response Rates</measure> <time_frame>42 months</time_frame> <description>Response rates as measured by morphologic response (CR)</description> </secondary_outcome> <secondary_outcome> <measure>Response Rates</measure> <time_frame>42 months</time_frame> <description>Response rates as measured by morphologic response (PD)</description> </secondary_outcome> <secondary_outcome> <measure>Response Rates</measure> <time_frame>42 months</time_frame> <description>Response rates as measured by morphologic response (SD)</description> </secondary_outcome> <secondary_outcome> <measure>Response Rates</measure> <time_frame>42 months</time_frame> <description>Response rates as measured by morphologic response (CRi)</description> </secondary_outcome> <secondary_outcome> <measure>Response Rates</measure> <time_frame>42 months</time_frame> <description>Response rates as measured by morphologic response (PR)</description> </secondary_outcome> <secondary_outcome> <measure>MRD</measure> <time_frame>42 months</time_frame> <description>minimal residual disease (MRD) via multiparameter flow cytometry</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Acute Myeloid Leukemia, in Relapse</condition> <condition>Acute Myeloid Leukemia Refractory</condition> <arm_group> <arm_group_label>AML without Down Syndrome</arm_group_label> <arm_group_type>Other</arm_group_type> <description>The subject receives 2 courses of therapy approximately 35 days each. Venetoclax: Days 1-14 Azacitidine and Vorinostat: Days 1-5 Filgrastim Days: 5 start and continue until post-nadir ANC > 500 cells/mm3 Fludarabine and Cytarabine Days 6 - 10 IT Cytarabine Day 0 or 1, optional between day 35 and 42</description> </arm_group> <arm_group> <arm_group_label>AML with Down Syndrome</arm_group_label> <arm_group_type>Other</arm_group_type> <description>The subject receives 2 courses of therapy approximately 35 days each. Venetoclax: Days 1-14 Azacitidine and Vorinostat: Days 1-5 Filgrastim Days: 5 start and continue until post-nadir ANC > 500 cells/mm3 Fludarabine and Cytarabine Days 6 - 10 IT Cytarabine Day 0 or 1, optional between day 35 and 42</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Venetoclax</intervention_name> <description>Dose Level 0: Day 1 60 mg/m2 PO x1, Days 2-14 120 mg/m2/dose PO once daily (Max: 200 mg/day) Dose level 1: Day 1 120 mg/m2 PO x1, Days 2-14 240 mg/m2/dose PO once daily (Max: 400 mg/day) Dose level 2: Day 1 180 mg/m2 PO x1, Days 2-14 360 mg/m2/dose PO once daily (Max: 600 mg/day)</description> <arm_group_label>AML with Down Syndrome</arm_group_label> <arm_group_label>AML without Down Syndrome</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Azacitadine</intervention_name> <description>75 mg/m2/dose IV once daily over 15 minutes</description> <arm_group_label>AML with Down Syndrome</arm_group_label> <arm_group_label>AML without Down Syndrome</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Vorinostat</intervention_name> <description>1 year to 17.99 years old: 180 mg/m2/dose PO once daily ≥18 years old 200 mg PO BID. Doses should be separated by 12 hr (±4 hr)</description> <arm_group_label>AML with Down Syndrome</arm_group_label> <arm_group_label>AML without Down Syndrome</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Cytarabine</intervention_name> <description>2000 mg/m2/dose IV once daily over 3 hours IT Cytarabine: - 1.99 years old: 30 mg - 2.99 years old: 50 mg 3 years old: 70 mg</description> <arm_group_label>AML with Down Syndrome</arm_group_label> <arm_group_label>AML without Down Syndrome</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Fludarabine</intervention_name> <description>30 mg/m2/dose IV once daily over 30 minutes</description> <arm_group_label>AML with Down Syndrome</arm_group_label> <arm_group_label>AML without Down Syndrome</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Filgrastim</intervention_name> <description>5 microgram/kg/dose subcutaneous (or IV over 15-30 min) once daily</description> <arm_group_label>AML with Down Syndrome</arm_group_label> <arm_group_label>AML without Down Syndrome</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria  - Diagnosis  1. Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow.  - 1st or greater relapse, OR  - Failed to go into remission after 1st or greater relapse, OR  - Failed to go into remission from original diagnosis after 2 or more induction attempts  2. Patients may have CNS or other sites of extramedullary disease. No cranial irradiation is allowed during the protocol therapy.  3. Patients with treatment related AML (tAML) are eligible. A relapse of tAML is not necessary to enroll on this study thus newly diagnosed tAML are eligible.  4. Patients with immunophenotypic AML evolving as lineage switch from ALL or acute leukemia NOS, may be eligible if they have relapsed/refractory disease  5. Patients with Down syndrome are eligible  - Performance Level- Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for patients ≤ 16 years of age. (See Appendix II for Performance Scales)  - Prior Therapy- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.  1. Myelosuppressive chemotherapy  2. Cytoreduction with hydroxyurea Hydroxyurea can be initiated and continued for up to 24 hours prior to the start of Venetoclax. It is recommended to use hydroxyurea in patients with significant leukocytosis (WBC > 50,000/L) to control blast count before initiation of systemic protocol therapy.  3. Patients who relapsed while they are receiving cytotoxic therapy At least 7 days must have elapsed since the completion of the cytotoxic therapy, except Intrathecal chemotherapy.  4. Hematopoietic stem cell transplant: Patients who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD), and are at least 90 days post-transplant at the time of enrollment, no longer receiving GVHD therapy.  5. Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).  6. Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair. This includes flotetuzumab.  7. Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after the last dose of monoclonal antibody. (i.e. Gemtuzumab = 36 days)  8. Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines or CAR-T cells.  9. XRT: Craniospinal XRT is prohibited during protocol therapy. No waiting period is necessary for radiation given to non-CNS chloromas; ≥ 90 days must have elapsed if prior TBI or craniospinal XRT.  10. Infection Prevention: Patients must be able to tolerate and receive anti-fungal prophylaxis with echinocandins or amphotericin therapy for the duration of their treatment course and neutrophil recovery (post-nadir ANC is > 750/μL).  11. Inhibitors and Inducers ofCYP3A4  - Patients taking strong CYP3A4 inhibitors should have their venetoclax dose reduced by 75%  - Patients taking moderate CYP3A4 inhibitors should have their venetoclax dose reduced by 50%  - Inhibitors of P-glycoprotein (P-gp): Patients taking p-glycoprotein inhibitors should have their venetoclax doses reduced by 50%.  - Renal and hepatic function- Patients must have adequate renal and hepatic functions as indicated by the following laboratory values:  1. Adequate renal function defined as: Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2 OR a normal serum creatinine  2. Adequate Liver Function Defined as: Direct bilirubin < 1.5 x upper limit of normal (ULN) for age or normal, AND alanine transaminase (ALT) < 5 x ULN for age. The hepatic requirements are waived for patients with known or suspected liver involvement by leukemia. This must be reviewed by and approved by the study chair or vice chair.  - Adequate Cardiac Function Defined as: Shortening fraction of ≥ 27% OR ejection fraction of ≥ 50%.  - Reproductive Function  1. Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.  2. Female patients with infants must agree not to breastfeed their infants while on this study.  3. Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.  - Informed Consent- Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks, and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent. Age-appropriate assent will be obtained per institutional guidelines. To allow non-English speaking patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible.  - Protocol Approval- All institutional, FDA, and OHRP requirements for human studies must be met.  Exclusion Criteria  •.Patients will be excluded if they have a known allergy to any of the drugs used in the study.  - Patients will be excluded if they have a systemic fungal, bacterial, viral, or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.  - Patients will be excluded if they have had any positive fungal culture within 30 days prior to enrollment or evidence of disseminated fungal disease.  - Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.  - Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder, or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.  - Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded. </textblock> </criteria> <gender>All</gender> <minimum_age>1 Year</minimum_age> <maximum_age>25 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Michael Burke, MD</last_name> <role>Study Chair</role> <affiliation>Medical College of Wisconsin</affiliation> </overall_official> <overall_contact> <last_name>Amberley Kemic, RN</last_name> <phone>414-266-2038</phone> <email>akemic@chw.org</email> </overall_contact> <location> <facility> <name>Children's Wisconsin</name> <address> <city>Milwaukee</city> <state>Wisconsin</state> <zip>53226</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Amberley Kemic, RN</last_name> <phone>414-266-2038</phone> <phone_ext>2038</phone_ext> <email>akemic@childrenswi.org</email> </contact> <contact_backup> <email>MACCcto@mcw.edu</email> </contact_backup> <investigator> <last_name>Michael Burke, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Zachary T. Graff, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 8, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>April 28, 2023</last_update_submitted> <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 1, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation> <investigator_full_name>Michael Burke</investigator_full_name> <investigator_title>Associate Professor, Department of Pediatrics, Division of Hematology/Oncology/BMT</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Leukemia</mesh_term> <mesh_term>Leukemia, Myeloid</mesh_term> <mesh_term>Leukemia, Myeloid, Acute</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Cytarabine</mesh_term> <mesh_term>Fludarabine</mesh_term> <mesh_term>Venetoclax</mesh_term> <mesh_term>Vorinostat</mesh_term> </intervention_browse>  </clinical_study>

The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients. The investigators are testing if the addition of venetoclax to epigenetic therapy will not only enhance the treatment response for patients with epigenetic lesions but improve the poor response we have observed in those patients without epigenetic lesions. The addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy will be investigated. This regimen may be tolerable and increase LSC targeting resulting in deeper, more durable responses in children, adolescents, and young adults with relapsed or refractory AML The study will enroll patients in two strata - a primary stratum of eligible patients without Down syndrome, and a secondary stratum of eligible patients with Down syndrome (DS-AML). Subjects will receive two 35 day cycles of therapy. Inclusion Criteria - Diagnosis 1. Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow. - 1st or greater relapse, OR - Failed to go into remission after 1st or greater relapse, OR - Failed to go into remission from original diagnosis after 2 or more induction attempts 2. Patients may have CNS or other sites of extramedullary disease. No cranial irradiation is allowed during the protocol therapy. 3. Patients with treatment related AML (tAML) are eligible. A relapse of tAML is not necessary to enroll on this study thus newly diagnosed tAML are eligible. 4. Patients with immunophenotypic AML evolving as lineage switch from ALL or acute leukemia NOS, may be eligible if they have relapsed/refractory disease 5. Patients with Down syndrome are eligible - Performance Level- Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for patients ≤ 16 years of age. (See Appendix II for Performance Scales) - Prior Therapy- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. 1. Myelosuppressive chemotherapy 2. Cytoreduction with hydroxyurea Hydroxyurea can be initiated and continued for up to 24 hours prior to the start of Venetoclax. It is recommended to use hydroxyurea in patients with significant leukocytosis (WBC > 50,000/L) to control blast count before initiation of systemic protocol therapy. 3. Patients who relapsed while they are receiving cytotoxic therapy At least 7 days must have elapsed since the completion of the cytotoxic therapy, except Intrathecal chemotherapy. 4. Hematopoietic stem cell transplant: Patients who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD), and are at least 90 days post-transplant at the time of enrollment, no longer receiving GVHD therapy. 5. Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®). 6. Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair. This includes flotetuzumab. 7. Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after the last dose of monoclonal antibody. (i.e. Gemtuzumab = 36 days) 8. Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines or CAR-T cells. 9. XRT: Craniospinal XRT is prohibited during protocol therapy. No waiting period is necessary for radiation given to non-CNS chloromas; ≥ 90 days must have elapsed if prior TBI or craniospinal XRT. 10. Infection Prevention: Patients must be able to tolerate and receive anti-fungal prophylaxis with echinocandins or amphotericin therapy for the duration of their treatment course and neutrophil recovery (post-nadir ANC is > 750/μL). 11. Inhibitors and Inducers ofCYP3A4 - Patients taking strong CYP3A4 inhibitors should have their venetoclax dose reduced by 75% - Patients taking moderate CYP3A4 inhibitors should have their venetoclax dose reduced by 50% - Inhibitors of P-glycoprotein (P-gp): Patients taking p-glycoprotein inhibitors should have their venetoclax doses reduced by 50%. - Renal and hepatic function- Patients must have adequate renal and hepatic functions as indicated by the following laboratory values: 1. Adequate renal function defined as: Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2 OR a normal serum creatinine 2. Adequate Liver Function Defined as: Direct bilirubin < 1.5 x upper limit of normal (ULN) for age or normal, AND alanine transaminase (ALT) < 5 x ULN for age. The hepatic requirements are waived for patients with known or suspected liver involvement by leukemia. This must be reviewed by and approved by the study chair or vice chair. - Adequate Cardiac Function Defined as: Shortening fraction of ≥ 27% OR ejection fraction of ≥ 50%. - Reproductive Function 1. Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment. 2. Female patients with infants must agree not to breastfeed their infants while on this study. 3. Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment. - Informed Consent- Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks, and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent. Age-appropriate assent will be obtained per institutional guidelines. To allow non-English speaking patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible. - Protocol Approval- All institutional, FDA, and OHRP requirements for human studies must be met. Exclusion Criteria •.Patients will be excluded if they have a known allergy to any of the drugs used in the study. - Patients will be excluded if they have a systemic fungal, bacterial, viral, or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours. - Patients will be excluded if they have had any positive fungal culture within 30 days prior to enrollment or evidence of disseminated fungal disease. - Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period. - Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder, or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results. - Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.

NCT0531xxxx/NCT05317416.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/NCT05317416</url> </required_header> <id_info> <org_study_id>C1071007</org_study_id> <secondary_id>2021-006052-14</secondary_id> <secondary_id>MagnetisMM-7</secondary_id> <nct_id>NCT05317416</nct_id> </id_info> <brief_title>Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant</brief_title> <acronym>MagnetisMM-7</acronym> <official_title>A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION</official_title> <sponsors> <lead_sponsor> <agency>Pfizer</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Pfizer</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> The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years </textblock> </brief_summary> <detailed_description> <textblock> Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 25, 2022</start_date> <completion_date type="Anticipated">October 31, 2029</completion_date> <primary_completion_date type="Anticipated">August 4, 2027</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>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Progression Free Survival</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria</description> </primary_outcome> <secondary_outcome> <measure>Overall Survival</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Defined as the time from randomization until death due to any cause</description> </secondary_outcome> <secondary_outcome> <measure>Minimal Residual Disease negativity rate</measure> <time_frame>12 months after randomization</time_frame> <description>Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing</description> </secondary_outcome> <secondary_outcome> <measure>Sustained MRD negativity rate</measure> <time_frame>24 months after randomization</time_frame> <description>Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing</description> </secondary_outcome> <secondary_outcome> <measure>Progression Free Survival</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Progression Free Survival by investigator per IMWG response criteria</description> </secondary_outcome> <secondary_outcome> <measure>Overall minimal residual disease negativity rate</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Minimal residual disease negativity rate per IMWG criteria</description> </secondary_outcome> <secondary_outcome> <measure>Duration of minimal residual disease negativity</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Minimal residual disease negativity per IMWG criteria</description> </secondary_outcome> <secondary_outcome> <measure>Sustained minimal residual disease negativity rate</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months</description> </secondary_outcome> <secondary_outcome> <measure>Complete response rate</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Complete response rate by blinded independent central review and by investigator per IMWG criteria</description> </secondary_outcome> <secondary_outcome> <measure>Duration of complete response</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Duration of complete response by blinded independent central review and by investigator per IMWG criteria</description> </secondary_outcome> <secondary_outcome> <measure>Frequency of adverse events</measure> <time_frame>Up to 90 days after last dose</time_frame> <description>Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention</description> </secondary_outcome> <secondary_outcome> <measure>Frequency of laboratory abnormalities</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>Pre-dose concentrations of elranatamab</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Pharmacokinetics of elranatamab (trough concentrations of elranatamab)</description> </secondary_outcome> <secondary_outcome> <measure>Post-dose concentrations of elranatamab</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"</description> </secondary_outcome> <secondary_outcome> <measure>Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Immunogenicity of elranatamab</description> </secondary_outcome> <secondary_outcome> <measure>Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms</description> </secondary_outcome> <secondary_outcome> <measure>Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms</description> </secondary_outcome> <secondary_outcome> <measure>Progression Free Survival 2</measure> <time_frame>Assessed for up to approximately 5 years</time_frame> <description>Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">760</enrollment> <condition>Multiple Myeloma</condition> <arm_group> <arm_group_label>Arm A - Part 1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Elranatamab</description> </arm_group> <arm_group> <arm_group_label>Arm B - Part 1</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Lenalidomide</description> </arm_group> <arm_group> <arm_group_label>Arm B - Part 2</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Lenalidomide</description> </arm_group> <arm_group> <arm_group_label>Arm C - Part 2</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Elranatamab</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Elranatamab</intervention_name> <description>BCMA-CD3 bispecific antibody</description> <arm_group_label>Arm A - Part 1</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Lenalidomide</intervention_name> <description>Immunomodulatory drug</description> <arm_group_label>Arm B - Part 1</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Lenalidomide</intervention_name> <description>Immunomodulatory drug</description> <arm_group_label>Arm B - Part 2</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Elranatamab</intervention_name> <description>BCMA-CD3 bispecific antibody</description> <arm_group_label>Arm C - Part 2</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis  - Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive  - History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.  - Partial Response or better according to IMWG criteria at the time of randomization  - Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.  - ECOG performance status ≤1  - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1  - Not pregnant and willing to use contraception  Exclusion Criteria:  - Plasma cell leukemia  - Amyloidosis, Waldenström's macroglobulinemia  - POEMS syndrome  - Known active CNS involvement or clinical signs of myelomatous meningeal involvement  - Previous MM maintenance treatment  - Prior treatment with BCMA targeted therapy  - Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ  - Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness  - Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer) </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>Pfizer CT.gov Call Center</last_name> <role>Study Director</role> <affiliation>Pfizer</affiliation> </overall_official> <overall_contact> <last_name>Pfizer CT.gov Call Center</last_name> <phone>1-800-718-1021</phone> <email>ClinicalTrials.gov_Inquiries@pfizer.com</email> </overall_contact> <location> <facility> <name>Ronald Reagan UCLA Medical Center</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90095</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90095</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>OhioHealth Arthur G.H. Bing, MD, Cancer Center</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43214</zip> <country>United States</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>OhioHealth Research Institute</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43214</zip> <country>United States</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>OhioHealth Riverside Methodist Hospital</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43214</zip> <country>United States</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Pindara Private Hospital</name> <address> <city>Benowa</city> <state>Queensland</state> <zip>4217</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>QScan Radiology Clinics</name> <address> <city>Clayfield</city> <state>Queensland</state> <zip>4011</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Princess Alexandra Hospital</name> <address> <city>Woolloongabba</city> <state>Queensland</state> <zip>4102</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Epworth Healthcare</name> <address> <city>East Melbourne</city> <state>Victoria</state> <zip>3002</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Precision Haematology</name> <address> <city>East Melbourne</city> <state>Victoria</state> <zip>3002</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>St Vincent's Hospital (Melbourne)</name> <address> <city>Fitzroy</city> <state>Victoria</state> <zip>3065</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Slade Pharmacy</name> <address> <city>Richmond</city> <zip>3121</zip> <country>Australia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universitaetsklinikum Allgemeines Krankenhaus Wien</name> <address> <city>Vienna</city> <state>Wien</state> <zip>1090</zip> <country>Austria</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hanusch-Krankenhaus</name> <address> <city>Vienna</city> <zip>1140</zip> <country>Austria</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Medizinische Universität Wien</name> <address> <city>Wien</city> <zip>1090</zip> <country>Austria</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Grand Hôpital de Charleroi</name> <address> <city>Charleroi</city> <state>Hainaut</state> <zip>6000</zip> <country>Belgium</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site God</name> <address> <city>Yvoir</city> <state>Namur</state> <zip>5530</zip> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>ZNA Middelheim</name> <address> <city>Antwerpen</city> <zip>2020</zip> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>ZNA Stuivenberg</name> <address> <city>Antwerpen</city> <zip>2060</zip> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>UZ Brussel</name> <address> <city>Brussel</city> <zip>1090</zip> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador</name> <address> <city>Salvador,</city> <state>Bahia</state> <zip>41253-190</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa</name> <address> <city>Porto Alegre</city> <state>RIO Grande DO SUL</state> <zip>90110-270</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Mae de Deus</name> <address> <city>Porto Alegre</city> <state>RIO Grande DO SUL</state> <zip>90880-480</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Ambulatório de QT Convênio</name> <address> <city>Jaú</city> <state>SÃO Paulo</state> <zip>17210-120</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Amaral Carvalho</name> <address> <city>Jaú</city> <state>SÃO Paulo</state> <zip>17210-120</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (US</name> <address> <city>Ribeirão Preto</city> <state>SÃO Paulo</state> <zip>14051-140</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>BP - A Beneficencia Portuguesa de São Paulo</name> <address> <city>Sao Paulo</city> <state>SÃO Paulo</state> <zip>01321-001</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fundação Doutor Amaral Carvalho</name> <address> <city>Jaú</city> <zip>17210-080</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Américas Medical City</name> <address> <city>Rio de Janeiro</city> <zip>22775-001</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Instituto de Educação, Pesquisa e Gestão em Saúde</name> <address> <city>Rio de Janeiro</city> <zip>22775001</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis</name> <address> <city>São Paulo</city> <zip>01232-010</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>HU UNIFESP / SPDM - Hospital São Paulo</name> <address> <city>São Paulo</city> <zip>04024-002</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universidade Federal de Sao Paulo</name> <address> <city>São Paulo</city> <zip>04024-002</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Japonês Santa Cruz</name> <address> <city>São Paulo</city> <zip>04122-000</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Clínica Médica São Germano S/S Ltda</name> <address> <city>São Paulo</city> <zip>04537-080</zip> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tom Baker Cancer Center</name> <address> <city>Calgary</city> <state>Alberta</state> <zip>T2N4N2</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Dr. Everett Chalmers Regional Hospital</name> <address> <city>Fredericton</city> <state>New Brunswick</state> <zip>E3B 5N5</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Saint John Regional Hospital</name> <address> <city>Saint John</city> <state>New Brunswick</state> <zip>E2L 4L2</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hamilton Health Sciences Corporation</name> <address> <city>Hamilton</city> <state>Ontario</state> <zip>L8L 8E7</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Princess Margaret Cancer Centre</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M5G 2M9</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H1T 2M4</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>McGill University Health Centre</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H4A 3J1</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUS</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H4J 1C5</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy</name> <address> <city>Wuhan</city> <state>Hubei</state> <zip>430030</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Institute of hematology&blood disease hospital</name> <address> <city>Tianjin</city> <state>Tianjin</state> <zip>300020</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>The First Affiliated Hospital of Wenzhou Medical University</name> <address> <city>Wenzhou</city> <state>Zhejiang</state> <zip>325000</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Shanghai Fourth People's Hospital</name> <address> <city>Shanghai</city> <zip>200434</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Fakultní nemocnice Brno Bohunice</name> <address> <city>Brno</city> <state>Brno-město</state> <zip>625 00</zip> <country>Czechia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fakultni nemocnice Hradec Kralove</name> <address> <city>Hradec Kralove</city> <state>Hradec Králové</state> <zip>500 05</zip> <country>Czechia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fakultni nemocnice Ostrava</name> <address> <city>Ostrava-Poruba</city> <state>Moravskoslezský KRAJ</state> <zip>708 52</zip> <country>Czechia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fakultni nemocnice Olomouc</name> <address> <city>Olomouc</city> <zip>779 00</zip> <country>Czechia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Vseobecna fakultni nemocnice v Praze</name> <address> <city>Praha 2</city> <zip>12808</zip> <country>Czechia</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Oulun yliopistollinen sairaala</name> <address> <city>Oulu</city> <state>Pohjois-pohjanmaa</state> <zip>90220</zip> <country>Finland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)</name> <address> <city>Helsinki</city> <state>Uusimaa</state> <zip>00029</zip> <country>Finland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Turku University Hospital</name> <address> <city>Turku</city> <state>Varsinais-suomi</state> <zip>20520</zip> <country>Finland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE</name> <address> <city>Toulouse</city> <state>Haute-garonne</state> <zip>31100</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hopital Claude Huriez - CHU de Lille</name> <address> <city>Lille</city> <state>Nord</state> <zip>59000</zip> <country>France</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Centre Hospitalier Universitaire de Poitiers</name> <address> <city>Poitiers</city> <state>Vienne</state> <zip>86021</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hopital Claude Huriez - CHU de Lille</name> <address> <city>Lille</city> <zip>59037</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hôpital Saint Antoine</name> <address> <city>Paris Cedex 12</city> <zip>75571</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hopital Lyon Sud</name> <address> <city>Pierre Benite</city> <zip>69495</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau</name> <address> <city>Tours</city> <zip>37032</zip> <country>France</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Hôpital Saint Antoine</name> <address> <city>Paris</city> <state>Île-de-france</state> <zip>75571</zip> <country>France</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Universitätsklinikum Würzburg</name> <address> <city>Würzburg</city> <state>Bayern</state> <zip>97080</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universitaetsklinikum Koeln</name> <address> <city>Köln</city> <state>Nordrhein-westfalen</state> <zip>50937</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universitaetsklinikum Schleswig-Holstein Campus Kiel</name> <address> <city>Kiel</city> <state>Schleswig-holstein</state> <zip>24105</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Charite Universitätsmedizin Berlin Campus Benjamin Franklin</name> <address> <city>Berlin</city> <zip>12200</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Charite Universitätsmedizin Berlin Campus Benjamin Franklin</name> <address> <city>Berlin</city> <zip>12203</zip> <country>Germany</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Klinikum Chemnitz gGMbH</name> <address> <city>Chemnitz</city> <zip>09116</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universitätsklinikum Essen</name> <address> <city>Essen</city> <zip>45147</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Klinikum rechts der Isar der Technischen Universität München</name> <address> <city>München</city> <zip>81675</zip> <country>Germany</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Evangelismos General Hospital of Athens</name> <address> <city>Athens</city> <state>Attikí</state> <zip>106 76</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Alexandra General Hospital of Athens</name> <address> <city>Athens</city> <state>Attikí</state> <zip>115 28</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Theageneio Cancer Hospital of Thessaloniki</name> <address> <city>Thessaloniki</city> <state>Kentrikí Makedonía</state> <zip>546 39</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Evangelismos Hospital</name> <address> <city>Athens</city> <zip>10676</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University Hospital of Ioannina</name> <address> <city>Ioannina</city> <state>Ípeiros</state> <zip>455 00</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Somogy Megyei Kaposi Mór Oktató Kórház</name> <address> <city>Kaposvár</city> <state>Somogy</state> <zip>7400</zip> <country>Hungary</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Semmelweis Egyetem</name> <address> <city>Budapest</city> <zip>1088</zip> <country>Hungary</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Dél-Pesti Centrumkórház</name> <address> <city>Budapest</city> <zip>1097</zip> <country>Hungary</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Debreceni Egyetem Klinikai Kozpont</name> <address> <city>Debrecen</city> <zip>4032</zip> <country>Hungary</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórhá</name> <address> <city>Nyíregyháza</city> <zip>4400</zip> <country>Hungary</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Artemis hospital</name> <address> <city>Gurugram</city> <state>Haryana</state> <zip>122001</zip> <country>India</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Medanta-The Medicity</name> <address> <city>Gurugram</city> <state>Haryana</state> <zip>122001</zip> <country>India</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fortis Memorial Research Institute</name> <address> <city>Gurugram</city> <state>Haryana</state> <zip>122002</zip> <country>India</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Christian Medical College Vellore</name> <address> <city>Ranipet</city> <state>Tamil NADU</state> <zip>632517</zip> <country>India</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Himalayan Institute Hospital Trust University</name> <address> <city>Dehradun</city> <state>Uttarakhand</state> <zip>248140</zip> <country>India</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tata Medical Center</name> <address> <city>Kolkata</city> <state>WEST Bengal</state> <zip>700160</zip> <country>India</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Rajiv Gandhi Cancer Institute And Research Centre</name> <address> <city>Delhi</city> <zip>110085</zip> <country>India</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Soroka Medical Center</name> <address> <city>Be'er Sheva</city> <state>Hadarom</state> <zip>8410101</zip> <country>Israel</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Sheba Medical Center</name> <address> <city>Ramat Gan</city> <state>Hamerkaz</state> <zip>5262100</zip> <country>Israel</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Rambam Health Care Campus</name> <address> <city>Haifa</city> <state>Hatsafon</state> <zip>3109601</zip> <country>Israel</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital</name> <address> <city>Tel Aviv</city> <state>Tell Abīb</state> <zip>6423906</zip> <country>Israel</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hadassah Medical Center</name> <address> <city>Jerusalem</city> <state>Yerushalayim</state> <zip>9112001</zip> <country>Israel</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hadassah Mount Scopus Medical Center</name> <address> <city>Jerusalem</city> <state>Yerushalayim</state> <zip>9124001</zip> <country>Israel</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Shaare Zedek Medical Center</name> <address> <city>Jerusalem</city> <zip>9103102</zip> <country>Israel</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"</name> <address> <city>Meldola</city> <state>Emilia-romagna</state> <zip>47014</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fondazione Policlinico Universitario Agostino Gemelli</name> <address> <city>Roma</city> <state>Lazio</state> <zip>00168</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico</name> <address> <city>Milano</city> <state>Lombardia</state> <zip>20122</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Policlinico "G. Rodolico"</name> <address> <city>Catania</city> <state>Sicilia</state> <zip>95123</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Azienda Ospedaliero Universitaria Senese</name> <address> <city>Siena</city> <state>Toscana</state> <zip>53100</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte</name> <address> <city>Siena</city> <state>Toscana</state> <zip>53100</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi</name> <address> <city>Ancona</city> <zip>60126</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>IRCCS - AOU di Bologna</name> <address> <city>Bologna</city> <zip>40138</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>AOU Policlinico Umberto I</name> <address> <city>Roma</city> <zip>00161</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nagoya City University Hospital</name> <address> <city>Nagoya</city> <state>Aichi</state> <zip>467-8602</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Gunma University Hospital</name> <address> <city>Maebashi</city> <state>Gunma</state> <zip>371-8511</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Iwate Medical University Hospital</name> <address> <city>Yahaba-cho, Shiwa-gun</city> <state>Iwate</state> <zip>028-3695</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University Hospital,Kyoto Prefectural University of Medicine</name> <address> <city>Kyoto-shi</city> <state>Kyoto</state> <zip>602-8566</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tohoku University Hospital</name> <address> <city>Sendai</city> <state>Miyagi</state> <zip>980-8574</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hamamatsu University Hospital</name> <address> <city>Hamamatsu-shi</city> <state>Shizuoka</state> <zip>431-3192</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Shizuoka Cancer Center</name> <address> <city>Sunto-gun</city> <state>Shizuoka</state> <zip>411-8777</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>National Hospital Organization Kumamoto Medical Center</name> <address> <city>Kumamoto</city> <zip>860-0008</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University Hospital,Kyoto Prefectural University of Medicine</name> <address> <city>Kyoto</city> <zip>602-8566</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>National Hospital Organization Okayama Medical Center</name> <address> <city>Okayama</city> <zip>701-1192</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Osaka Metropolitan University Hospital</name> <address> <city>Osaka</city> <zip>545-8586</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Japanese Red Cross Medical Center</name> <address> <city>Tokyo</city> <zip>150-8935</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Yamagata University Hospital</name> <address> <city>Yamagata</city> <zip>990-9585</zip> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Gachon University Gil Medical Center</name> <address> <city>Namdong-gu</city> <state>Incheon-gwangyeoksi [incheon]</state> <zip>21565</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Chonnam National University Hwasun Hospital</name> <address> <city>Hwasun Gun</city> <state>Jeonranamdo</state> <zip>58128</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Seoul National University Bundang Hospital</name> <address> <city>Seongnam</city> <state>Kyǒnggi-do</state> <zip>13620</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Pusan National University Hospital</name> <address> <city>Busan</city> <state>Pusan-kwangyǒkshi</state> <zip>49241</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Seoul National University Hospital</name> <address> <city>Seoul</city> <state>Seoul-teukbyeolsi [seoul]</state> <zip>03080</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Samsung Medical Center</name> <address> <city>Seoul</city> <state>Seoul-teukbyeolsi [seoul]</state> <zip>06351</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)</name> <address> <city>Seoul</city> <state>Seoul-teukbyeolsi [seoul]</state> <zip>06591</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>The Catholic Univ. of Korea Seoul St. Mary's Hospital</name> <address> <city>Seoul</city> <state>Seoul-teukbyeolsi [seoul]</state> <zip>06591</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kyungpook National University</name> <address> <city>Daegu</city> <state>Taegu-kwangyǒkshi</state> <zip>41944</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kyungpook National University Hospital</name> <address> <city>Jung-gu</city> <state>Taegu-kwangyǒkshi</state> <zip>41944</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>HagaZiekenhuis</name> <address> <city>Den Haag</city> <state>Zuid-holland</state> <zip>2545 AA</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Maastricht Universitair Medisch Centrum</name> <address> <city>Maastricht</city> <zip>6229 HX</zip> <country>Netherlands</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Isala</name> <address> <city>Zwolle</city> <zip>8025 AB</zip> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Haukeland Universitetssjukehus</name> <address> <city>Bergen</city> <state>Hordaland</state> <zip>5021</zip> <country>Norway</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Oslo Universitetssykehus Ullevål</name> <address> <city>Oslo</city> <zip>0450</zip> <country>Norway</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Stavanger Universitetssykehus</name> <address> <city>Stavanger</city> <zip>4011</zip> <country>Norway</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centrum Medyczne Pratia Poznań</name> <address> <city>Skorzewo</city> <state>Wielkopolskie</state> <zip>60-185</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Uniwersyteckie Centrum Kliniczne,</name> <address> <city>Gdansk</city> <zip>80-214</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Uniwersytecki Szpital Kliniczny w Poznaniu</name> <address> <city>Poznan</city> <zip>60-569</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny</name> <address> <city>Warszawa</city> <zip>02-097</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy</name> <address> <city>Warszawa</city> <zip>02-781</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku</name> <address> <city>Wroclaw</city> <zip>50-367</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Pratia Onkologia Katowice</name> <address> <city>Katowice</city> <state>Śląskie</state> <zip>40-519</zip> <country>Poland</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Complejo Hospitalario Universitario de Santiago</name> <address> <city>Santiago de Compostela</city> <state>A Coruna</state> <zip>15706</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitari Vall d'Hebron</name> <address> <city>Barcelona</city> <state>Barcelona [barcelona]</state> <zip>08035</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Institut Català d'Oncologia - L'Hospitalet</name> <address> <city>L'Hospitalet Del Llobregat</city> <state>Barcelona [barcelona]</state> <zip>08908</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitari Mutua Terrassa</name> <address> <city>Terrassa</city> <state>Barcelona [barcelona]</state> <zip>08221</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Institut Catala d' Oncologia. Hospital Germans Trias i Pujol</name> <address> <city>Badalona</city> <state>Barcelona</state> <zip>08916</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitari Mutua Terrassa</name> <address> <city>Terrassa</city> <state>Barcelona</state> <zip>08221</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitario de Salamanca</name> <address> <city>Salamanca</city> <state>Castilla Y LEÓN</state> <zip>37007</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Clínic de Barcelona</name> <address> <city>Barcelona</city> <state>Catalunya [cataluña]</state> <zip>08036</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Clinica Universidad de Navarra</name> <address> <city>Madrid</city> <state>Madrid, Comunidad DE</state> <zip>28027</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitario Quironsalud Madrid</name> <address> <city>Pozuelo de Alarcon</city> <state>Madrid</state> <zip>28223</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Clinica Universidad de Navarra</name> <address> <city>Pamplona</city> <state>Navarra</state> <zip>31008</zip> <country>Spain</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta</name> <address> <city>Gerona</city> <zip>17007</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital La Princesa</name> <address> <city>Madrid</city> <zip>28006</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital General Universitario Gregorio Marañon</name> <address> <city>Madrid</city> <zip>28007</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitario 12 de Octubre</name> <address> <city>Madrid</city> <zip>28041</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitario HM Sanchinarro</name> <address> <city>Madrid</city> <zip>28050</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca</name> <address> <city>Salamanca</city> <zip>37007</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitari i Politecnic La Fe</name> <address> <city>València</city> <zip>46026</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Helsingborgs Lasarett</name> <address> <city>Helsingborg</city> <state>Skåne LÄN [se-12]</state> <zip>251 87</zip> <country>Sweden</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Karolinska Universitetssjukhuset Huddinge</name> <address> <city>Stockholm</city> <state>Stockholms LÄN [se-01]</state> <zip>141 86</zip> <country>Sweden</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Södra Älvsborgs Sjukhus Borås</name> <address> <city>Borås</city> <state>Västra Götalands LÄN [se-14]</state> <zip>501 82</zip> <country>Sweden</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Falu Lasarett</name> <address> <city>Falun</city> <zip>791 31</zip> <country>Sweden</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universitetssjukhuset Örebro</name> <address> <city>Örebro</city> <state>Örebro LÄN [se-18]</state> <zip>701 85</zip> <country>Sweden</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Universitetssjukhuset i Linköping</name> <address> <city>Linköping</city> <state>Östergötlands LÄN [se-05]</state> <zip>581 85</zip> <country>Sweden</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>China Medical University Hospital</name> <address> <city>Taichung</city> <zip>40447</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Taichung Veterans General Hospital</name> <address> <city>Taichung</city> <zip>407</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>National Taiwan University Hospital</name> <address> <city>Taipei</city> <zip>10002</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Taipei Veterans General Hospital</name> <address> <city>Taipei</city> <zip>11217</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Chang Gung Medical Foundation-Linkou Branch</name> <address> <city>Taoyuan</city> <zip>333</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Medipol Mega Universite Hastanesi</name> <address> <city>İstanbul</city> <state>İ̇stanbul</state> <zip>34214</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Sisli Florence Nightingale Hastanesi</name> <address> <city>İstanbul</city> <state>İ̇stanbul</state> <zip>34381</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Ege Universitesi Hastanesi</name> <address> <city>Izmir</city> <state>İ̇zmir</state> <zip>35100</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Dokuz Eylul Universitesi Hastanesi</name> <address> <city>İzmir</city> <state>İ̇zmir</state> <zip>35340</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Ankara Universitesi Tip Fakultesi Hastanesi</name> <address> <city>Ankara</city> <zip>06100</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi</name> <address> <city>Ankara</city> <zip>06200</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Gazi Universitesi</name> <address> <city>Ankara</city> <zip>06560</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Akdeniz Universitesi Hastanesi</name> <address> <city>Antalya</city> <zip>07070</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Aydın Adnan Menderes Universitesi Hastanesi</name> <address> <city>Aydin</city> <zip>09100</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Erciyes Universitesi Tıp Fakultesi Hastaneleri</name> <address> <city>Kayseri</city> <zip>38030</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Özel Anadolu Sağlık Merkezi</name> <address> <city>Kocaeli</city> <zip>41400</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Australia</country> <country>Austria</country> <country>Belgium</country> <country>Brazil</country> <country>Canada</country> <country>China</country> <country>Czechia</country> <country>Finland</country> <country>France</country> <country>Germany</country> <country>Greece</country> <country>Hungary</country> <country>India</country> <country>Israel</country> <country>Italy</country> <country>Japan</country> <country>Korea, Republic of</country> <country>Netherlands</country> <country>Norway</country> <country>Poland</country> <country>Spain</country> <country>Sweden</country> <country>Taiwan</country> <country>Turkey</country> <country>United States</country> </location_countries> <link> <url>https://pmiform.com/clinical-trial-info-request?StudyID=C1071007</url> <description>To obtain contact information for a study center near you, click here.</description> </link> <verification_date>September 2023</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>September 13, 2023</last_update_submitted> <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>BCMA</keyword> <keyword>Multiple Myeloma</keyword> <keyword>Newly diagnosed</keyword> <keyword>Elranatamab</keyword> <keyword>Targeted T-cell</keyword> <keyword>MagnetisMM</keyword> <keyword>MM7</keyword> <keyword>Phase 3</keyword> <keyword>B-cell Maturation Antigen</keyword> <keyword>monoclonal antibody</keyword> <keyword>Stem cell transplant</keyword> <keyword>Autologous stem cell transplant (ASCT)</keyword> <keyword>Hematologic disease</keyword> <keyword>Minimum residual disease</keyword> <keyword>Lenalidomide</keyword> <condition_browse>  <mesh_term>Multiple Myeloma</mesh_term> <mesh_term>Neoplasms, Plasma Cell</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Lenalidomide</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description> <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url> </patient_data>  </clinical_study>

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. Inclusion Criteria: - Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis - Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive - History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT. - Partial Response or better according to IMWG criteria at the time of randomization - Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant. - ECOG performance status ≤1 - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1 - Not pregnant and willing to use contraception Exclusion Criteria: - Plasma cell leukemia - Amyloidosis, Waldenström's macroglobulinemia - POEMS syndrome - Known active CNS involvement or clinical signs of myelomatous meningeal involvement - Previous MM maintenance treatment - Prior treatment with BCMA targeted therapy - Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ - Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness - Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

NCT0531xxxx/NCT05317429.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/NCT05317429</url> </required_header> <id_info> <org_study_id>QIB07/2020</org_study_id> <nct_id>NCT05317429</nct_id> </id_info> <brief_title>Glycaemic Responses to Carbohydrate-rich Meals (GlyCarb)</brief_title> <acronym>GlyCarb</acronym> <official_title>Measuring Postprandial Glycaemic Responses to Carbohydrate-rich Meals Using a Standardised Remote Monitoring Protocol</official_title> <sponsors> <lead_sponsor> <agency>Quadram Institute Bioscience</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Norfolk and Norwich University Hospitals NHS Foundation Trust</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Quadram Institute Bioscience</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> Carbohydrate-rich foods such as potatoes, bread, rice, pasta, breakfast cereals, biscuits and other snacks are a major component of the human diet. The effect of different carbohydrate-rich foods on blood sugar (glucose) levels after a meal varies between foods. This is relevant to health because studies have shown that regular intake of carbohydrate foods that cause large increases in blood glucose levels after ingestion can be detrimental to metabolic health.  The aim of the GlyCarb study is to investigate how food structure influences postprandial glycaemic responses to carbohydrate foods.  This will be achieved through a series of acute postprandial studies (up to 5 studies), wherein healthy participants within each postprandial study consume a pair of carbohydrate-rich test meals while wearing a continuous glucose monitoring system (CGM).  Each postprandial study will use the same GlyCarb Remote standard protocol, where a randomised cross-over design is used to measure the glycaemic response to two carbohydrate-rich test meals, one "test" and one "control". Both meals will be matched by carbohydrate content, contain similar ingredients and have a similar physical appearance, but will differ in one key food property (e.g., altered food structure) to test its effect on postprandial glycaemia.  In each postprandial study, habitual dietary intake and body composition will be captured at baseline as part of the participant characterisation. Participants will consume two different carbohydrate-rich test meals twice, on separate occasions, in a randomly allocated order over a 10 to 14-day period of continuous glucose monitoring. Data from the continuous glucose monitors will be used to assess the postprandial glycaemic response to each carbohydrate food. The participants will be required to complete brief questionnaires designed to evaluate differences in palatability (taste, texture, portion size) and satiety amongst test meals. Study participant feedback will be requested at the end of the study and used to assess and improve future study procedures.  The GlyCarb study will enable new understanding of how food properties influence glycaemic responses to different types of carbohydrate foods. Ultimately, the findings will inform the rational design or reformulation of food products and diets to support a healthy glucose metabolism. </textblock> </brief_summary> <detailed_description> <textblock> The overarching aim of this project is to investigate a wide range of carbohydrate rich test meals (from 'off the shelf' commercially available products, through to enriched, restructured and re-formulated food products) on postprandial glycaemic response in normo-glycaemic individuals.  The 'remote' study protocol has been designed to maintain social distancing and thereby reduce risk of COVID19 transmission between participants and researchers during the ongoing outbreak. It also makes excellent use of continuous glucose monitoring devices, which enable continuous recording of participant body sugar levels in 'free-living' conditions. At no point will the participant be required to attend a clinical research facility. Support from the study team to participants will be provided through virtual appointments.  The study population will be healthy participants. Participants will also need to have access to a smart phone to be used in conjunction with the CGM as well as for virtual study appointments (video call) and to complete online forms.  The precise test meals will vary from study to study, and will always need to meet a set standard with regard to microbiological safety, traceability and nutrient composition. As an extra precaution, participants with ANY food allergy will not be able to take part in the study. The meals will be well characterised and details of nutrient composition, ingredients, allergens etc. will be provided to participants prior to consent.  Informed consent - to ensure participants can make an informed decision as to whether or not they wish to take part on the trial they will be provided with a study specific PIS and invited to participate in an informal discussion about the study. Consent will be obtained by a member of staff who is GCP trained and experienced in conducting human intervention trials. In line with the 'remote' nature of the study, participants and study team members will be video and audio recorded during the consent procedure, with their permission. Hard copies of the consent form will also be initialled and signed by the participant and countersigned by the study team as written informed consent.  Risks/Burdens - (i) At the eligibility assessment a small blood sample is collected. Participants may feel a little discomfort on initial insertion of the needle or bruising at the site of venepuncture. Similarly, there may be some discomfort during finger prick testing. (ii) The CGM sensor may be secured by an adhesive 'plaster' which could cause irritation. Should this occur the CGM could be secured in place with an elastic support bandage such as tubigrip or similar.  iii) This study involves periods of fasting. Participants will be advised to drink water during the fasting period. All study sessions will be scheduled for the morning time to reduce the length of fast.  (iv) As part of the eligibility assessment it is possible that some test results are returned as abnormal. Abnormal blood and urine test results are reviewed by our medical doctor who advises whether inclusion, re-screen or exclusion is appropriate. In addition, copies of all test results (whether abnormal or not) will be sent to the participants GP.  Participants will complete a Food Frequency Questionnaire to capture the habitual diet as a baseline characteristic as well as measure fat and muscle mass using a smart scale.  Data protection and confidentiality - Participants will be assigned a unique code and a Quadram Institute Bioscience (QIB)-based email which will be used on all samples/data arising from a study. Paper documents containing identifiable information (e.g. consent forms) and coded information will be kept in locked cabinets at the QIB. The file linking the code with the participant will be kept separately. All documents will only be accessible to the members of the study team. All electronic data will be stored on a password protected shared file at the QIB and access will be limited to members of the study team. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">February 14, 2022</start_date> <completion_date type="Anticipated">June 1, 2026</completion_date> <primary_completion_date type="Anticipated">June 1, 2026</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>Randomised crossover study</intervention_model_description> <primary_purpose>Basic Science</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> <masking_description>Blinding will be conducted by a member of staff who is independent of the study team. For all studies, an effort will be made to blind the research team and study participants to the test and reference meals. Whilst we recognize that this approach is 'gold standard' it may not be possible in all circumstances, for example due to the different appearance of some food products.</masking_description> </study_design_info> <primary_outcome> <measure>Fasting and postprandial glucose levels measured in interstitial fluid</measure> <time_frame>0-4 hours after the test meal</time_frame> <description>Maximum rise in glucose concentration from fasted levels (iCmax)</description> </primary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>2 to 4 hours after the test meal</time_frame> <description>Incremental area under the curve (iAUC) for the first peak</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>2 to 4 hours after the test meal</time_frame> <description>Incremental area under the curve (iAUC) between 0-120 min</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>2 to 4 hours after the test meal</time_frame> <description>Minimum glucose concentration (Cmin)</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>2 to 4 hours after the test meal</time_frame> <description>Time to reach glucose peak concentration (Tmax), time to reach minimum concentration (Tmin)</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>2 to 4 hours after the test meal</time_frame> <description>Time to reach minimum glucose concentration (Tmin)</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>Over 14 days</time_frame> <description>Coefficient of variation (CV)</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>Over 14 days</time_frame> <description>Time in Range (TIR)</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>Over 14 days</time_frame> <description>Mean Amplitude Glucose Excursion (MAGE)</description> </secondary_outcome> <secondary_outcome> <measure>Glycaemic response indicators</measure> <time_frame>Over 14 days</time_frame> <description>Mean of daily differences (MODD)</description> </secondary_outcome> <secondary_outcome> <measure>Satiety</measure> <time_frame>Time 0 (before meal), 30 (after meal), 60, 120, 180 and 240 minutes after each test meal.</time_frame> <description>Online survey responses from participants.</description> </secondary_outcome> <secondary_outcome> <measure>Palatability</measure> <time_frame>Once per day on intervention days, four times per study</time_frame> <description>Online survey responses from participants. Palatability scores (recorded once after each test meal), from 'Dislike Very Much' to 'Like Very Much'.</description> </secondary_outcome> <other_outcome> <measure>BMI</measure> <time_frame>Baseline</time_frame> <description>weight and height will be combined to report BMI in kg/m^2</description> </other_outcome> <other_outcome> <measure>Body composition</measure> <time_frame>Baseline</time_frame> <description>Percentage of fat mass</description> </other_outcome> <other_outcome> <measure>Body composition</measure> <time_frame>Baseline</time_frame> <description>Percentage of muscle mass</description> </other_outcome> <other_outcome> <measure>Habitual dietary Intake</measure> <time_frame>Baseline</time_frame> <description>Food Frequency Questionnaire</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">25</enrollment> <condition>Glycaemia</condition> <arm_group> <arm_group_label>Treatment</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Carbohydrate-rich meal</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Carbohydrate-rich meal</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>A meal delivering 75 g of carbohydrate</intervention_name> <description>The nature of the test meal will depend upon the research question being addressed and it is anticipated that the test meals may include (but are not limited to) the following: (i) Re-structured, enriched, and/or reformulated or non-conventionally processed food products (ii) Model food matrices with different structures or types of carbohydrate e.g. soups with different viscosity.</description> <arm_group_label>Control</arm_group_label> <arm_group_label>Treatment</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Men and women ≥ 18 years of age  - Have access to/own a smartphone or tablet or computer and are willing to use this with apps needed for the study  - BMI between 18 and 30 kg/m2 (calculated from self-reported height and weight)  - Fasted HbA1C < 42 mmol/mol (6.0%)  - Willing to consume study foods (study foods and ingredients are discussed during the study talk)  Exclusion Criteria:  - Smokers of tobacco-based cigarettes or electronic cigarettes (or stopped smoking less than 6 months ago)  - Gastro-intestinal disease/disorders e.g., Crohn's disease/ulcerative colitis  - Other medical conditions that are judged to affect the study outcome or which may compromise the well-being of the participant e.g., active cancer, haemophilia. This will be assessed on a case-by-case basis.  - Type 1 diabetes or insulin-dependent or non-insulin-dependent type 2 diabetes  - Active infection with COVID-19, unless they are willing to postpone the screening until after the end of the self-isolation period (10 days from test or symptoms).  - Prescribed and non-prescribed medications that may affect the study outcome or which may compromise the well-being of the participant e.g., warfarin, proton-pump inhibitors. This will be assessed on a case by-case-basis.  - Dietary supplements that are judged to affect the study outcome unless the participant is willing to discontinue them for 4 weeks preceding the start of the study and for the duration of the study. This will be assessed on a case-by-case basis and includes protein supplements (shakes) or supplements that are not taken on a regular basis (on and off), particularly those containing ascorbic acid which may affect glucose readings.  - Any known allergy, intolerance, or sensitivity to any food products oradhesives (for CGM application).  - Those following a restrictive diet that may affect the study outcome (e.g., 5:2 diet) unless they are willing to suspend the diet for the duration of the study.  - Women who are, or have been pregnant, within the last 12 months or who are breast-feeding  - Parallel participation in another research project that involves dietary intervention.  - Any person related to or living with any member of the study team.  - Those who are part of the line manager/supervisory team of the Chief Investigator  - Lack of capacity to provide written informed consent.  - Clinical eligibility test results deemed by the CRF medical advisor to be indicative of a health problem which may compromise the well-being of the participant or which could affect the study outcome. </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>Cathrina Edwards, PhD</last_name> <role>Study Chair</role> <affiliation>Quadram Institute Bioscience</affiliation> </overall_official> <overall_official> <last_name>Marina Corrado, PhD</last_name> <role>Principal Investigator</role> <affiliation>Quadram Institute Bioscience</affiliation> </overall_official> <location> <facility> <name>Quadram Institute</name> <address> <city>Norwich</city> <state>Norfolk</state> <zip>NR4 7UQ</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>February 16, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Carbohydrates</keyword> <keyword>Starch</keyword> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>De-identified individual participant data for primary and secondary outcome measures will be made available</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>Data will be available after publication in scientific journal within 18 months of study completion</ipd_time_frame> <ipd_access_criteria>Data access will be reviewed by the study team</ipd_access_criteria> </patient_data>  </clinical_study>

Carbohydrate-rich foods such as potatoes, bread, rice, pasta, breakfast cereals, biscuits and other snacks are a major component of the human diet. The effect of different carbohydrate-rich foods on blood sugar (glucose) levels after a meal varies between foods. This is relevant to health because studies have shown that regular intake of carbohydrate foods that cause large increases in blood glucose levels after ingestion can be detrimental to metabolic health. The aim of the GlyCarb study is to investigate how food structure influences postprandial glycaemic responses to carbohydrate foods. This will be achieved through a series of acute postprandial studies (up to 5 studies), wherein healthy participants within each postprandial study consume a pair of carbohydrate-rich test meals while wearing a continuous glucose monitoring system (CGM). Each postprandial study will use the same GlyCarb Remote standard protocol, where a randomised cross-over design is used to measure the glycaemic response to two carbohydrate-rich test meals, one "test" and one "control". Both meals will be matched by carbohydrate content, contain similar ingredients and have a similar physical appearance, but will differ in one key food property (e.g., altered food structure) to test its effect on postprandial glycaemia. In each postprandial study, habitual dietary intake and body composition will be captured at baseline as part of the participant characterisation. Participants will consume two different carbohydrate-rich test meals twice, on separate occasions, in a randomly allocated order over a 10 to 14-day period of continuous glucose monitoring. Data from the continuous glucose monitors will be used to assess the postprandial glycaemic response to each carbohydrate food. The participants will be required to complete brief questionnaires designed to evaluate differences in palatability (taste, texture, portion size) and satiety amongst test meals. Study participant feedback will be requested at the end of the study and used to assess and improve future study procedures. The GlyCarb study will enable new understanding of how food properties influence glycaemic responses to different types of carbohydrate foods. Ultimately, the findings will inform the rational design or reformulation of food products and diets to support a healthy glucose metabolism. The overarching aim of this project is to investigate a wide range of carbohydrate rich test meals (from 'off the shelf' commercially available products, through to enriched, restructured and re-formulated food products) on postprandial glycaemic response in normo-glycaemic individuals. The 'remote' study protocol has been designed to maintain social distancing and thereby reduce risk of COVID19 transmission between participants and researchers during the ongoing outbreak. It also makes excellent use of continuous glucose monitoring devices, which enable continuous recording of participant body sugar levels in 'free-living' conditions. At no point will the participant be required to attend a clinical research facility. Support from the study team to participants will be provided through virtual appointments. The study population will be healthy participants. Participants will also need to have access to a smart phone to be used in conjunction with the CGM as well as for virtual study appointments (video call) and to complete online forms. The precise test meals will vary from study to study, and will always need to meet a set standard with regard to microbiological safety, traceability and nutrient composition. As an extra precaution, participants with ANY food allergy will not be able to take part in the study. The meals will be well characterised and details of nutrient composition, ingredients, allergens etc. will be provided to participants prior to consent. Informed consent - to ensure participants can make an informed decision as to whether or not they wish to take part on the trial they will be provided with a study specific PIS and invited to participate in an informal discussion about the study. Consent will be obtained by a member of staff who is GCP trained and experienced in conducting human intervention trials. In line with the 'remote' nature of the study, participants and study team members will be video and audio recorded during the consent procedure, with their permission. Hard copies of the consent form will also be initialled and signed by the participant and countersigned by the study team as written informed consent. Risks/Burdens - (i) At the eligibility assessment a small blood sample is collected. Participants may feel a little discomfort on initial insertion of the needle or bruising at the site of venepuncture. Similarly, there may be some discomfort during finger prick testing. (ii) The CGM sensor may be secured by an adhesive 'plaster' which could cause irritation. Should this occur the CGM could be secured in place with an elastic support bandage such as tubigrip or similar. iii) This study involves periods of fasting. Participants will be advised to drink water during the fasting period. All study sessions will be scheduled for the morning time to reduce the length of fast. (iv) As part of the eligibility assessment it is possible that some test results are returned as abnormal. Abnormal blood and urine test results are reviewed by our medical doctor who advises whether inclusion, re-screen or exclusion is appropriate. In addition, copies of all test results (whether abnormal or not) will be sent to the participants GP. Participants will complete a Food Frequency Questionnaire to capture the habitual diet as a baseline characteristic as well as measure fat and muscle mass using a smart scale. Data protection and confidentiality - Participants will be assigned a unique code and a Quadram Institute Bioscience (QIB)-based email which will be used on all samples/data arising from a study. Paper documents containing identifiable information (e.g. consent forms) and coded information will be kept in locked cabinets at the QIB. The file linking the code with the participant will be kept separately. All documents will only be accessible to the members of the study team. All electronic data will be stored on a password protected shared file at the QIB and access will be limited to members of the study team. Inclusion Criteria: - Men and women ≥ 18 years of age - Have access to/own a smartphone or tablet or computer and are willing to use this with apps needed for the study - BMI between 18 and 30 kg/m2 (calculated from self-reported height and weight) - Fasted HbA1C < 42 mmol/mol (6.0%) - Willing to consume study foods (study foods and ingredients are discussed during the study talk) Exclusion Criteria: - Smokers of tobacco-based cigarettes or electronic cigarettes (or stopped smoking less than 6 months ago) - Gastro-intestinal disease/disorders e.g., Crohn's disease/ulcerative colitis - Other medical conditions that are judged to affect the study outcome or which may compromise the well-being of the participant e.g., active cancer, haemophilia. This will be assessed on a case-by-case basis. - Type 1 diabetes or insulin-dependent or non-insulin-dependent type 2 diabetes - Active infection with COVID-19, unless they are willing to postpone the screening until after the end of the self-isolation period (10 days from test or symptoms). - Prescribed and non-prescribed medications that may affect the study outcome or which may compromise the well-being of the participant e.g., warfarin, proton-pump inhibitors. This will be assessed on a case by-case-basis. - Dietary supplements that are judged to affect the study outcome unless the participant is willing to discontinue them for 4 weeks preceding the start of the study and for the duration of the study. This will be assessed on a case-by-case basis and includes protein supplements (shakes) or supplements that are not taken on a regular basis (on and off), particularly those containing ascorbic acid which may affect glucose readings. - Any known allergy, intolerance, or sensitivity to any food products oradhesives (for CGM application). - Those following a restrictive diet that may affect the study outcome (e.g., 5:2 diet) unless they are willing to suspend the diet for the duration of the study. - Women who are, or have been pregnant, within the last 12 months or who are breast-feeding - Parallel participation in another research project that involves dietary intervention. - Any person related to or living with any member of the study team. - Those who are part of the line manager/supervisory team of the Chief Investigator - Lack of capacity to provide written informed consent. - Clinical eligibility test results deemed by the CRF medical advisor to be indicative of a health problem which may compromise the well-being of the participant or which could affect the study outcome.

NCT0531xxxx/NCT05317442.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/NCT05317442</url> </required_header> <id_info> <org_study_id>ON101CLAS05</org_study_id> <nct_id>NCT05317442</nct_id> </id_info> <brief_title>Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound</brief_title> <official_title>Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound</official_title> <sponsors> <lead_sponsor> <agency>Taipei Medical University WanFang Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Oneness Biotech Co., Ltd.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Taipei Medical University WanFang Hospital</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> Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound </textblock> </brief_summary> <detailed_description> <textblock> This study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of Fespixon Cream for the treatment of pressure injury in sacrum wound. The duration of this study is: run in/ screen phase (2 weeks); treatment phase (16 weeks); follow-up phase (4 weeks), and visits are conducted every 2 weeks for a total of 12 visits. During the treatment phase, the Fespixon cream will be applied to the target ulcer once a day for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 4 weeks. During the follow-up phase, standard of care will be used for subjects who have unhealed or with recurrent wounds.  At each visit, the size and changes of the target pressure ulcer are recorded by photographing. The target pressure ulcer area in the photo is calculated using Image Pro® PLUS software. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 6, 2022</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date> <phase>Phase 4</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>Uncontrolled Open-label Randomized: N/A Single Arm Duration of treatment: up to 16 weeks Titration: no Multi-center(Taiwan)</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Incidence of treatment-related Adverse Events associated with Fespixon cream</measure> <time_frame>16 weeks</time_frame> <description>Note: Assessment of Safety: Safety will be assessed based on the incidence of adverse events, including overall AEs, Fespixon-related AEs, target pressure ulcer-related AEs, and SAEs. During the trial, in addition to self-reported AEs, physicians will check physical examination, vital signs, and laboratory reports to determine the presence of AEs.</description> </primary_outcome> <secondary_outcome> <measure>Incidence of complete wound closure of the target ulcer area</measure> <time_frame>16 weeks</time_frame> <description>According to "Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment" issued by the US FDA in June 2006, complete wound closure of target ulcer area is defined as "skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart" Time to complete wound closure of the target ulcer area was defined as "time to first visit of complete wound closure of the target ulcer area."</description> </secondary_outcome> <secondary_outcome> <measure>Time to complete wound closure of the target ulcer area</measure> <time_frame>16 weeks</time_frame> <description>According to "Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment" issued by the US FDA in June 2006, complete wound closure of target ulcer area is defined as "skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart" Time to complete wound closure of the target ulcer area was defined as "time to first visit of complete wound closure of the target ulcer area."</description> </secondary_outcome> <secondary_outcome> <measure>Percentage of target ulcer wound area reduction at visit 9/ EOT (changed from V1 baseline)</measure> <time_frame>16 weeks</time_frame> <description>Take a photo of the target ulcer and use Image-Pro® Plus software to calculate the size of the target ulcer after taking photographs.The target ulcer wound area at the Visit 9/EOT will be compared to the area of the target ulcer at the baseline visit (Visit 1) and expressed in percentage.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">12</enrollment> <condition>Pressure Injury Stage 2</condition> <arm_group> <arm_group_label>Pressure Injury in Sacrum Wound</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Name: Fespixon Cream Dosage form: Topical cream, 15 g ointment per tube Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply once a day Duration: up to 16 weeks</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Fespixon Cream</intervention_name> <description>Name: Fespixon Cream Dosage form: Topical cream, 15 g ointment per tube Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply once a day Duration: up to 16 weeks</description> <arm_group_label>Pressure Injury in Sacrum Wound</arm_group_label> <other_name>ON101 Cream</other_name> </intervention> <eligibility> <criteria> <textblock> 1. Main inclusion criteria:  1. At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter  2. NPUAP is classified as stage 2  3. No active infection, i.e., IDSA level 1  4. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment)  5. If an artificial ostomy is not performed, the distance between the target ulcer and the anus must be greater than 5 cm to prevent contamination  2. Main exclusion criteria:  1. Those who have an allergic reaction to the ingredients of this product, including those who have been allergic to sulfa drugs, Plectranthus amboinicus, Centella asiatica or excipients  2. Acute infection caused by wound ( WBC > 12×10³/uL； or C-Reactive protein (CRP) > 30 mg/dL)  3. Liver and kidney dysfunction ( defined as [AST or ALT] > 3× the upper limit of normal; serum creatinine > 3× the upper limit of normal)  4. Pregnant or lactating women  5. Infected with human immunodeficiency virus  6. Body mass index (BMI) less than 18.5 kg/m²  7. Unable to cooperate with changing of subject's position  8. Patients with anemia (Hgb < 7.0 g/dL).  9. Unable to prevent contaminations such as feces or urinary incontinence  10. Malnutrition (Albumin< 2.5 g/dL)  11. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer  12. In the opinion of the investigator, entering this trial may pose a threat to subject compliance. </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>99 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Hsian-Jenn Wang</last_name> <role>Principal Investigator</role> <affiliation>Taipei Medical University WanFang Hospital</affiliation> </overall_official> <overall_official> <last_name>Shu-Hung Huang</last_name> <role>Principal Investigator</role> <affiliation>Kaohsiung Medical University Chung-Ho Memorial Hospital</affiliation> </overall_official> <overall_contact> <last_name>Wei-Ju Lin</last_name> <phone>+886-2-930-7930</phone> <phone_ext>7772</phone_ext> <email>linda52091@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Yun-Chien Hung</last_name> <phone>+886-7-312-1101</phone> <phone_ext>7094</phone_ext> <email>orihaya2218@gmail.com</email> </overall_contact_backup> <location> <facility> <name>Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）</name> <address> <city>Kaohsiung City</city> <zip>801</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yun-Chien Hung</last_name> <phone>+886-7-312-1101</phone> <phone_ext>7094</phone_ext> <email>orihaya2218@gmail.com</email> </contact> <investigator> <last_name>Shu-Hung Huang</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Ya-Wei Lai</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name> <address> <city>Kaohsiung City</city> <zip>80756</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yun-Chien Hung</last_name> <phone>+886-7-312-1101</phone> <phone_ext>7094</phone_ext> <email>orihaya2218@gmail.com</email> </contact> <investigator> <last_name>Shu-Hung Huang</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Ya-Wei Lai</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>Taipei Medical University WanFang Hospital</name> <address> <city>Taipei City</city> <zip>10675</zip> <country>Taiwan</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Wei-Ju Lin</last_name> <phone>+886-2-930-7930</phone> <phone_ext>7772</phone_ext> <email>linda52091@gmail.com</email> </contact> <investigator> <last_name>Hsian-Jenn Wang</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Wen-Kuan Chiu</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>Taiwan</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>March 16, 2023</last_update_submitted> <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Taipei Medical University WanFang Hospital</investigator_affiliation> <investigator_full_name>Hsian-Jenn Wang</investigator_full_name> <investigator_title>Consultant, Department of Surgery</investigator_title> </responsible_party> <keyword>Fespixon</keyword> <keyword>Pressure Injury</keyword> <keyword>Wound</keyword> <keyword>NPIAP Stage 2</keyword> <condition_browse>  <mesh_term>Wounds and Injuries</mesh_term> <mesh_term>Crush Injuries</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>IIT study</ipd_description> </patient_data>  </clinical_study>

Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound This study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of Fespixon Cream for the treatment of pressure injury in sacrum wound. The duration of this study is: run in/ screen phase (2 weeks); treatment phase (16 weeks); follow-up phase (4 weeks), and visits are conducted every 2 weeks for a total of 12 visits. During the treatment phase, the Fespixon cream will be applied to the target ulcer once a day for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 4 weeks. During the follow-up phase, standard of care will be used for subjects who have unhealed or with recurrent wounds. At each visit, the size and changes of the target pressure ulcer are recorded by photographing. The target pressure ulcer area in the photo is calculated using Image Pro® PLUS software. 1. Main inclusion criteria: 1. At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter 2. NPUAP is classified as stage 2 3. No active infection, i.e., IDSA level 1 4. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment) 5. If an artificial ostomy is not performed, the distance between the target ulcer and the anus must be greater than 5 cm to prevent contamination 2. Main exclusion criteria: 1. Those who have an allergic reaction to the ingredients of this product, including those who have been allergic to sulfa drugs, Plectranthus amboinicus, Centella asiatica or excipients 2. Acute infection caused by wound ( WBC > 12×10³/uL； or C-Reactive protein (CRP) > 30 mg/dL) 3. Liver and kidney dysfunction ( defined as [AST or ALT] > 3× the upper limit of normal; serum creatinine > 3× the upper limit of normal) 4. Pregnant or lactating women 5. Infected with human immunodeficiency virus 6. Body mass index (BMI) less than 18.5 kg/m² 7. Unable to cooperate with changing of subject's position 8. Patients with anemia (Hgb < 7.0 g/dL). 9. Unable to prevent contaminations such as feces or urinary incontinence 10. Malnutrition (Albumin< 2.5 g/dL) 11. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer 12. In the opinion of the investigator, entering this trial may pose a threat to subject compliance.

NCT0531xxxx/NCT05317455.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/NCT05317455</url> </required_header> <id_info> <org_study_id>Pending</org_study_id> <nct_id>NCT05317455</nct_id> </id_info> <brief_title>Regulation of Brain Glucose Metabolism in Type 1 Diabetes</brief_title> <official_title>Regulation of Brain Glucose Metabolism in Type 1 Diabetes</official_title> <sponsors> <lead_sponsor> <agency>Yale University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Yale University</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 prospective randomized placebo-controlled double-blind crossover study determining the effect of dichloroacetate on brain glucose metabolism under clamped hypoglycemia in T1DM. </textblock> </brief_summary> <detailed_description> <textblock> This study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism under clamped hypoglycemia. The study population is comprised of intensively treated persons with T1D with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. The investigators will test the experimental compound DCA in a mechanistic study that determines whether brain metabolism is restored by this intervention, or whether the drug effect was primarily caused by changes in physiology outside of the brain. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 2023</start_date> <completion_date type="Anticipated">May 2024</completion_date> <primary_completion_date type="Anticipated">May 2024</primary_completion_date> <phase>Early Phase 1</phase> <study_type>Interventional</study_type> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>PDH flux in the frontal lobe</measure> <time_frame>1 day</time_frame> <description>Neuronal PDH flux in the frontal lobe measured by DMI of labeled glucose</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">16</enrollment> <condition>Diabetes Mellitus, Type 1</condition> <condition>Hypoglycemia Unawareness</condition> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>capsule with excipient only, no active drug.</description> </arm_group> <arm_group> <arm_group_label>Dichloroacetate</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>sodium salt of dichloroacetate, 1000mg</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Dichloroacetate</intervention_name> <description>Dichloroacetate has a long safety record of administration to humans with a rare metabolic disorder for over 40 years. It has been given orally to patients with T2DM for up to a week without any problems and other laboratory or significant clinical adverse effects were not noted. It activates mitochondrial PDH flux, a key regulator of glucose oxidation.</description> <arm_group_label>Dichloroacetate</arm_group_label> <arm_group_label>Placebo</arm_group_label> <other_name>DCA</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  T1DM subjects with:  - a history of severe hypoglycemia and/or hypoglycemia unawareness or  - a history of severe hypoglycemia with a blood glucose <54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or  - at least 2 values <54mg/dl during 2 weeks of CGMS testing during the week prior to study.  Exclusion Criteria:  - Age < 18 years or >55 years.  - Body weight >85 kg at screening visit  - BMI > 30 (female) and >30 (male) kg/m2.  - Untreated proliferative retinopathy  - carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Raimund Herzog, MD</last_name> <role>Principal Investigator</role> <affiliation>Yale School of Medicine</affiliation> </overall_official> <overall_contact> <last_name>Alice Hahn</last_name> <phone>4753210504</phone> <email>alice.hahn@yale.edu</email> </overall_contact> <verification_date>May 2023</verification_date> <study_first_submitted>March 30, 2022</study_first_submitted> <study_first_submitted_qc>March 30, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>May 10, 2023</last_update_submitted> <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Yale University</investigator_affiliation> <investigator_full_name>Raimund Herzog</investigator_full_name> <investigator_title>Associate Professor of Medicine</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Diabetes Mellitus</mesh_term> <mesh_term>Diabetes Mellitus, Type 1</mesh_term> <mesh_term>Hypoglycemia</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Grouped analysis will be made available after the completion of the study within one year after completion of enrollment at the most.</ipd_description> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>At the completion of the clinical study a summary of findings will be uploaded.</ipd_time_frame> <ipd_access_criteria>Written request needs to be submitted to the PI or his delegate.</ipd_access_criteria> </patient_data>  </clinical_study>

This is a prospective randomized placebo-controlled double-blind crossover study determining the effect of dichloroacetate on brain glucose metabolism under clamped hypoglycemia in T1DM. This study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism under clamped hypoglycemia. The study population is comprised of intensively treated persons with T1D with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. The investigators will test the experimental compound DCA in a mechanistic study that determines whether brain metabolism is restored by this intervention, or whether the drug effect was primarily caused by changes in physiology outside of the brain. Inclusion Criteria: T1DM subjects with: - a history of severe hypoglycemia and/or hypoglycemia unawareness or - a history of severe hypoglycemia with a blood glucose <54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or - at least 2 values <54mg/dl during 2 weeks of CGMS testing during the week prior to study. Exclusion Criteria: - Age < 18 years or >55 years. - Body weight >85 kg at screening visit - BMI > 30 (female) and >30 (male) kg/m2. - Untreated proliferative retinopathy - carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity

NCT0531xxxx/NCT05317468.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/NCT05317468</url> </required_header> <id_info> <org_study_id>202203067</org_study_id> <nct_id>NCT05317468</nct_id> </id_info> <brief_title>Assessing Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits</brief_title> <official_title>Pilot Randomized Controlled Trial to Assess Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits</official_title> <sponsors> <lead_sponsor> <agency>Washington University School of Medicine</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Society of Family Planning</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Washington University School 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> The Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model. </textblock> </brief_summary> <detailed_description> <textblock> The Contraceptive Choice Center (C3) will offer contraceptive counseling to patients via telehealth. Participants will be randomized to receive counseling via video or telephone. We will compare patient satisfaction with contraceptive counseling, receipt of desired contraceptive method, and identification of barriers with technology use. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2022</start_date> <completion_date type="Anticipated">August 31, 2023</completion_date> <primary_completion_date type="Anticipated">April 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Health Services Research</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Patient Satisfaction Assessed by IQFP</measure> <time_frame>Baseline</time_frame> <description>Interpersonal Quality in Family Planning (IQFP) scale Continuous score: 11-55, higher scores indicate higher patient satisfaction Dichotomous: highest score (55) versus lower scores, highest score indicates highest patient satisfaction</description> </primary_outcome> <secondary_outcome> <measure>% of Patients Receiving Desired Contraceptive Method Assessed by Medical Record Review</measure> <time_frame>30 Days Post Baseline</time_frame> </secondary_outcome> <secondary_outcome> <measure>% of Patients Reporting Barriers to Technology Use Assessed by Baseline Questionnaire</measure> <time_frame>Baseline</time_frame> <description>Percentage of patients reporting limited access to mobile telephone or computer with video capabilities, unreliable telephone or internet service, and environmental distractors (i.e. loud noises, lack of privacy)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">200</enrollment> <condition>Contraception</condition> <condition>Health Care Utilization</condition> <arm_group> <arm_group_label>Video</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients will complete contraceptive counseling using a video-based platform. Patients and counselors will have an audio and video connection.</description> </arm_group> <arm_group> <arm_group_label>Telephone</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients will complete contraceptive counseling on a telephone call. Patients and counselors will have an audio connection only.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Contraceptive Counseling</intervention_name> <description>Patients will receive contraceptive counseling to review all available contraceptive methods prior to their visit with a clinician.</description> <arm_group_label>Telephone</arm_group_label> <arm_group_label>Video</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Able to speak and read English  - Access to video-capable technology  Exclusion Criteria:  - Incarceration  - Unable to provide informed consent secondary to language barrier or cognitive limitation </textblock> </criteria> <gender>Female</gender> <minimum_age>14 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Tessa Madden, MD, MPH</last_name> <role>Principal Investigator</role> <affiliation>Washington University School of Medicine</affiliation> </overall_official> <overall_contact> <last_name>Rachel Paul, MPH</last_name> <phone>(314) 747-8176</phone> <email>paulr@wustl.edu</email> </overall_contact> <overall_contact_backup> <last_name>Megan Dorsey, MPH</last_name> <phone>(314) 273-2561</phone> <email>m.dorsey@wustl.edu</email> </overall_contact_backup> <location> <facility> <name>Washington University School fo 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>Tessa E Madden, MD, MPH</last_name> <phone>314-747-6495</phone> <email>maddent@wustl.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2022</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>June 15, 2022</last_update_submitted> <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc> <last_update_posted type="Actual">June 16, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <intervention_browse>  <mesh_term>Contraceptive Agents</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model. The Contraceptive Choice Center (C3) will offer contraceptive counseling to patients via telehealth. Participants will be randomized to receive counseling via video or telephone. We will compare patient satisfaction with contraceptive counseling, receipt of desired contraceptive method, and identification of barriers with technology use. Inclusion Criteria: - Able to speak and read English - Access to video-capable technology Exclusion Criteria: - Incarceration - Unable to provide informed consent secondary to language barrier or cognitive limitation

NCT0531xxxx/NCT05317481.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/NCT05317481</url> </required_header> <id_info> <org_study_id>2000032361</org_study_id> <secondary_id>STR-1-002-20</secondary_id> <nct_id>NCT05317481</nct_id> </id_info> <brief_title>Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms</brief_title> <official_title>Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms and Improve Brain Circuitry Functioning</official_title> <sponsors> <lead_sponsor> <agency>Yale University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>American Foundation for Suicide Prevention</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Yale 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> The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. The investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk. </textblock> </brief_summary> <detailed_description> <textblock> This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC). Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.  Objectives  1. Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases  2. Show pre-post BE-SMART-DR improvements in the functioning of a brain system that subserves emotional and other behavioral control (i.e., a hypothalamus-amygdala-ventral prefrontal cortex (vPFC), (HAV), system) </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 2, 2022</start_date> <completion_date type="Anticipated">March 31, 2025</completion_date> <primary_completion_date type="Anticipated">March 31, 2025</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>This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC).</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Change in the experimental group from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Beck Scale for Suicide Ideation (SSI)</measure> <time_frame>baseline, week 1, week 7, week 12 and month 6</time_frame> <description>Change in the experimental group from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using the interviewer assessed Beck Scale for Suicide Ideation (SSI), one of the most widely used measures to assess suicidal ideation. This is a 19 item scale with scores ranging from 0 to 38, with higher values indicating a greater risk of suicide.</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Concise Health Risk Tracking Scale (CHRT)</measure> <time_frame>baseline, week 1, week 7, week 12 and month 6</time_frame> <description>Change from baseline in Suicidal Ideation/Propensity (SI/P) using Concise Health Risk Tracking Scale (CHRT), a brief self report measure. The CHRT Propensity score (9 items) covers the domains of pessimism, helplessness, despair and perceived lack of social support. Items are scored on a five-point Likert scale with responses ranging from "strongly disagree" (zero) to "strongly agree" (four), thereby creating a total propensity score that ranges from 0-36, with higher scores showing higher levels of suicidal propensity and suicidal thoughts.</description> </primary_outcome> <primary_outcome> <measure>Change in the experimental group from baseline in BE-SMART-DRs Daily Rhythm (DR) using the Social Rhythm Metric (SRM)</measure> <time_frame>up to 6 months</time_frame> <description>Change in the experimental group from baseline in Daily Rhythms (DR) regularity using the Social Rhythm Metric (SRM). This is a five-item measure to assess the stability of social rhythms. Its interpretation can be qualitative and it can also be used as a therapy tool.</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Brief Social Rhythm Scale (BSRS)</measure> <time_frame>baseline, week 1, week 7, week 12 and month 6</time_frame> <description>Change from baseline in BE-SMART-DRs Daily Rhythms (DR) will be assessed using the Brief Social Rhythm Scale (BSRS). This is a measure of DR regularity for 10 activities that include social contexts. It uses a scale ranging from 1 (very regularly) to 6 (very irregularly), with high mean scores indicating high irregularity. Summary scores are the average across all 10 items with higher scores indicating higher irregularity.</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Pittsburgh Sleep Quality Index (PSQI)</measure> <time_frame>baseline, week 1, week 7, week 12 and month 6</time_frame> <description>Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Pittsburgh Sleep Quality Index (PSQI), a self-reported survey. The 10 items in the PSQI relate to usual sleep habits over the last month, including time it takes to fall asleep, usual bedtime, hours of sleep per night, as well as questions about the frequency of sleep issues (not during the past month, less than once per week, once or twice per week, or three or more times per week). Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">128</enrollment> <condition>Bipolar Disorder</condition> <condition>Major Depressive Disorder</condition> <condition>Mood Disorders</condition> <condition>Suicide</condition> <condition>Suicidal Ideation</condition> <arm_group> <arm_group_label>BE-SMART-DR</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.</description> </arm_group> <arm_group> <arm_group_label>control comparator condition</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>BE-SMART-DR</intervention_name> <description>Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk</description> <arm_group_label>BE-SMART-DR</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>psychoeducational control comparator condition (CC)</intervention_name> <description>Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being</description> <arm_group_label>control comparator condition</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - with Diagnostic and Statistical Manual 5 (DSM5) Bipolar Disorder (BD) I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD)  - have a history of 1 or more suicide attempts and/or a score of at least 3 on the SSI  Exclusion Criteria:  - Significant medical or neurologic illness (especially if related to cerebral tissue)  - MRI contraindication,  - pregnancy by urine test  - current moderate or severe alcohol/other substance use disorders except caffeine/nicotine  - positive urine screen for benzodiazepines, cocaine, amphetamines, phencyclidine, opiates, oxycodone; not cannabis as its use is common in this population and it can remain positive for a month  - current evidence-based individual psychotherapy (e.g. cognitive behavioral therapy, dialectical behavioral therapy,) or treatment directly targeting brain regions of interest e.g. transcranial magnetic stimulation or electro-convulsive therapy,  - current psychosis  - inability to provide informed consent, including IQ<70, Young Mania Rating Scale (YMRS) >25, or too symptomatic by PI's judgment  - active suicidal plan or intent or Columbia Suicide Severity Rating Scale (C-SSRS) stage "4" risk (some intent to carry out the plan; as indicated by multisite study assessing suicide risk in randomized clinical trials or if revealed on any rating scale or in judgment of any study clinician.  - homicidal ideation </textblock> </criteria> <gender>All</gender> <minimum_age>16 Years</minimum_age> <maximum_age>29 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Hilary Blumberg, MD</last_name> <role>Principal Investigator</role> <affiliation>Yale University</affiliation> </overall_official> <overall_contact> <last_name>Hilary Blumberg, MD</last_name> <phone>203-785-6180</phone> <email>hilary.blumberg@yale.edu</email> </overall_contact> <overall_contact_backup> <last_name>Susan Quatrano, BA</last_name> <phone>(203) 785-7875</phone> <email>susan.quatrano@yale.edu</email> </overall_contact_backup> <location> <facility> <name>Magnetic Resonance Research Center</name> <address> <city>New Haven</city> <state>Connecticut</state> <zip>06510</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Mood Disorders Research Program</name> <address> <city>New Haven</city> <state>Connecticut</state> <zip>06510</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>July 27, 2023</last_update_submitted> <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 1, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Depressive Disorder</mesh_term> <mesh_term>Depressive Disorder, Major</mesh_term> <mesh_term>Bipolar Disorder</mesh_term> <mesh_term>Suicide</mesh_term> <mesh_term>Mood Disorders</mesh_term> <mesh_term>Suicidal Ideation</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. The investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk. This is a randomized control trial (RCT) with subjects randomized 2:1 (using block randomization) to BE-SMART-DR or a psychoeducational control comparator condition (CC). Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up. Objectives 1. Show pre-post BE-SMART-DR suicidal ideation and propensity (SI/P) decreases associated with DR regularity and quality increases 2. Show pre-post BE-SMART-DR improvements in the functioning of a brain system that subserves emotional and other behavioral control (i.e., a hypothalamus-amygdala-ventral prefrontal cortex (vPFC), (HAV), system) Inclusion Criteria: - with Diagnostic and Statistical Manual 5 (DSM5) Bipolar Disorder (BD) I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD) - have a history of 1 or more suicide attempts and/or a score of at least 3 on the SSI Exclusion Criteria: - Significant medical or neurologic illness (especially if related to cerebral tissue) - MRI contraindication, - pregnancy by urine test - current moderate or severe alcohol/other substance use disorders except caffeine/nicotine - positive urine screen for benzodiazepines, cocaine, amphetamines, phencyclidine, opiates, oxycodone; not cannabis as its use is common in this population and it can remain positive for a month - current evidence-based individual psychotherapy (e.g. cognitive behavioral therapy, dialectical behavioral therapy,) or treatment directly targeting brain regions of interest e.g. transcranial magnetic stimulation or electro-convulsive therapy, - current psychosis - inability to provide informed consent, including IQ<70, Young Mania Rating Scale (YMRS) >25, or too symptomatic by PI's judgment - active suicidal plan or intent or Columbia Suicide Severity Rating Scale (C-SSRS) stage "4" risk (some intent to carry out the plan; as indicated by multisite study assessing suicide risk in randomized clinical trials or if revealed on any rating scale or in judgment of any study clinician. - homicidal ideation

NCT0531xxxx/NCT05317494.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/NCT05317494</url> </required_header> <id_info> <org_study_id>P22-535</org_study_id> <nct_id>NCT05317494</nct_id> </id_info> <brief_title>A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Greece</brief_title> <acronym>SURVIVE</acronym> <official_title>A Prospective Non-Interventional Study to Describe the Effectiveness and Safety of Venetoclax as a First-Line Treatment in Acute Myeloid Leukemia (AML) Patients Who Are Ineligible to Intensive Chemotherapy in Routine Clinical Practice in Greece</official_title> <sponsors> <lead_sponsor> <agency>AbbVie</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>AbbVie</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> Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece.  Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled.  Around 100 participants will be enrolled in the study in approximately 15 sites in Greece.  Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months.  There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 26, 2022</start_date> <completion_date type="Anticipated">December 31, 2026</completion_date> <primary_completion_date type="Anticipated">December 31, 2026</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>Percentage of Participants Achieving Overall Survival (OS)</measure> <time_frame>Up to 30 Months</time_frame> <description>OS is defined as the time from treatment initiation to death from any cause.</description> </primary_outcome> <secondary_outcome> <measure>Percentage of Participants Achieving Composite Complete Remission</measure> <time_frame>Up to 30 Months</time_frame> <description>Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).</description> </secondary_outcome> <secondary_outcome> <measure>Total Time of Treatment with Venetoclax Combination Therapy</measure> <time_frame>Up to 30 Months</time_frame> <description>The total time of treatment with venetoclax combination therapy.</description> </secondary_outcome> <secondary_outcome> <measure>Time to Transfusion Independence</measure> <time_frame>Up to 30 Months</time_frame> <description>Total duration of transfusion independence is defined as the period of at least 56 days with no Red Blood Cell (RBC) or platelet transfusion between the first dose of study drug and the last dose of study drug plus 30 days.</description> </secondary_outcome> <secondary_outcome> <measure>Post Baseline RBC and Platelet Transfusion Independence Rate</measure> <time_frame>Up to 30 Months</time_frame> <description>Post baseline RBC and platelet transfusion independence rate will be calculated as the proportion of participants who achieved RBC and platelet, respectively, transfusion independence post baseline.</description> </secondary_outcome> <secondary_outcome> <measure>Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important</measure> <time_frame>Up to 30 Months</time_frame> <description>The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.</description> </secondary_outcome> <secondary_outcome> <measure>Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs)</measure> <time_frame>Up to 30 Months</time_frame> <description>Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs (dosing with venetoclax and any modifications/interruptions/titrations, type and dosing of each HMA, frequency of response assessment, cycle length, dosing, concomitant medications, etc).</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Number of Transfusions (Red Blood Cell [RBC] or Platelets) Received during First-line Treatment in an Outpatient Setting</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the number of transfusions (red blood cell [RBC] or platelets) received during first-line treatment in an outpatient setting.</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the number of hospitalizations during first-line treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the number of intensive care unit (ICU) admissions during first-line treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the number of visits in a private healthcare practitioner.</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other)</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the name of relevant medication due to infections (antibiotics or other).</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other)</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the dosing scheme of relevant medication due to infections (antibiotics or other).</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Number of Laboratory Tests</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the number of laboratory tests.</description> </secondary_outcome> <secondary_outcome> <measure>Healthcare Resource Utilization as the Type of Laboratory Tests</measure> <time_frame>Up to 30 Months</time_frame> <description>Healthcare resource utilization as the type of laboratory tests.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">100</enrollment> <condition>Acute Myeloid Leukemia</condition> <arm_group> <arm_group_label>Venetoclax Participants</arm_group_label> <description>Participants treated with Venetoclax in accordance with approved local label.</description> </arm_group> <eligibility> <study_pop> <textblock> Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Greece. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.  - Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.  Exclusion Criteria:  - Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation. </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>ABBVIE INC.</last_name> <role>Study Director</role> <affiliation>AbbVie</affiliation> </overall_official> <overall_contact> <last_name>ABBVIE CALL CENTER</last_name> <phone>844-663-3742</phone> <email>abbvieclinicaltrials@abbvie.com</email> </overall_contact> <location> <facility> <name>General Hospital of Athens Gennimatas /ID# 245968</name> <address> <city>Athens</city> <state>Attiki</state> <zip>11527</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>General Hospital of Athens Laiko /ID# 244338</name> <address> <city>Athens</city> <state>Attiki</state> <zip>11527</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University General Hospital Attikon /ID# 248265</name> <address> <city>Athens</city> <state>Attiki</state> <zip>12462</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University General Hospital of Heraklion PA.G.N.I /ID# 244337</name> <address> <city>Heraklion</city> <state>Kriti</state> <zip>71500</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Papageorgiou General Hospital Thessaloniki /ID# 248266</name> <address> <city>Stavroupoli (Thessalonikis)</city> <state>Thessaloniki</state> <zip>55536</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>General University Hospital of Alexandroupolis /ID# 244235</name> <address> <city>Alexandroupolis</city> <zip>68100</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339</name> <address> <city>Athens</city> <zip>10676</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>General Anti-cancer Hospital Agios Savvas /ID# 244408</name> <address> <city>Athens</city> <zip>11522</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>General Hospital of Athens Laiko - Hematology Location /ID# 244234</name> <address> <city>Athens</city> <zip>11527</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University General Hospital of Ioannina /ID# 244336</name> <address> <city>Ioannina</city> <zip>45500</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University General Hospital of Patras /ID# 244335</name> <address> <city>RION Patras Achaia</city> <zip>26504</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>General Hospital of Thessaloniki George Papanikolaou /ID# 244237</name> <address> <city>Thessaloniki</city> <zip>57010</zip> <country>Greece</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Greece</country> </location_countries> <link> <url>https://www.rxabbvie.com/</url> <description>Related Info.</description> </link> <verification_date>August 2023</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 14, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Acute Myeloid Leukemia</keyword> <keyword>Venetoclax</keyword> <keyword>Venclexta</keyword> <keyword>Venclyxto</keyword> <keyword>ABT-199</keyword> <keyword>Cancer</keyword> <condition_browse>  <mesh_term>Leukemia</mesh_term> <mesh_term>Leukemia, Myeloid</mesh_term> <mesh_term>Leukemia, Myeloid, Acute</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled. Around 100 participants will be enrolled in the study in approximately 15 sites in Greece. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months. Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Greece. Inclusion Criteria: - Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label. - Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study. Exclusion Criteria: - Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

NCT0531xxxx/NCT05317507.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/NCT05317507</url> </required_header> <id_info> <org_study_id>710022US1313</org_study_id> <nct_id>NCT05317507</nct_id> </id_info> <brief_title>Safety of Co-Administered CHI-554 and Alcohol</brief_title> <official_title>Safety of Co-Administered CHI-554 and Alcohol</official_title> <sponsors> <lead_sponsor> <agency>Auburn University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Auburn University</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 is a Phase 1, randomized, double-blind study to assess the safety, tolerability, and effects of CHI-554 when co-administered with alcohol. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 9, 2022</start_date> <completion_date type="Anticipated">March 23, 2023</completion_date> <primary_completion_date type="Anticipated">March 23, 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>Crossover Assignment</intervention_model> <intervention_model_description>During the Experimental portion of the study, participants will be randomized to a dosing order of 3 different doses. During the at-home portion of the study all participants will receive the same dose for 4 weeks.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> <masking_description>The experimental portion of the study is double blind.</masking_description> </study_design_info> <primary_outcome> <measure>Adverse Events/Serious Adverse Events</measure> <time_frame>Day 0</time_frame> <description>Adverse Events/Serious Adverse Events</description> </primary_outcome> <primary_outcome> <measure>Adverse Events/Serious Adverse Events</measure> <time_frame>Day 3</time_frame> <description>Adverse Events/Serious Adverse Events</description> </primary_outcome> <primary_outcome> <measure>Adverse Events/Serious Adverse Events</measure> <time_frame>Day 6</time_frame> <description>Adverse Events/Serious Adverse Events</description> </primary_outcome> <primary_outcome> <measure>Adverse Events/Serious Adverse Events</measure> <time_frame>Day 34</time_frame> <description>Adverse Events/Serious Adverse Events</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in Alanine aminotransferase (ALT)</measure> <time_frame>Day 0</time_frame> <description>Alanine aminotransferase (ALT)</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in Alanine aminotransferase (ALT)</measure> <time_frame>Day 3</time_frame> <description>Alanine aminotransferase (ALT)</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in Alanine aminotransferase (ALT)</measure> <time_frame>Day 6</time_frame> <description>Alanine aminotransferase (ALT)</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in Alanine aminotransferase (ALT)</measure> <time_frame>Day 34</time_frame> <description>Alanine aminotransferase (ALT)</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in blood pressure</measure> <time_frame>Day 0</time_frame> <description>Blood pressure (systolic and diastolic)</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in blood pressure</measure> <time_frame>Day 3</time_frame> <description>Blood pressure (systolic and diastolic)</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in blood pressure</measure> <time_frame>Day 6</time_frame> <description>Blood pressure (systolic and diastolic)</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in blood pressure</measure> <time_frame>Day 34</time_frame> <description>Blood pressure (systolic and diastolic)</description> </primary_outcome> <secondary_outcome> <measure>Peak Blood Alcohol Level (BAL)</measure> <time_frame>Day 0</time_frame> <description>Peak BAL during experimental visits</description> </secondary_outcome> <secondary_outcome> <measure>Peak Blood Alcohol Level (BAL)</measure> <time_frame>Day 3</time_frame> <description>Peak BAL during experimental visits</description> </secondary_outcome> <secondary_outcome> <measure>Peak Blood Alcohol Level (BAL)</measure> <time_frame>Day 6</time_frame> <description>Peak BAL during experimental visits</description> </secondary_outcome> <number_of_arms>6</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Healthy Adults</condition> <arm_group> <arm_group_label>Randomization order 1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive placebo at visit 1, 50 mg CBD at visit 2, and 100 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.</description> </arm_group> <arm_group> <arm_group_label>Randomization order 2</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive placebo at visit 1, 100 mg CBD at visit 2, and 50 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.</description> </arm_group> <arm_group> <arm_group_label>Randomization order 3</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive 50 mg CBD at visit 1, placebo at visit 2, and 100 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.</description> </arm_group> <arm_group> <arm_group_label>Randomization order 4</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive 50 mg CBD at visit 1, 100 mg CBD at visit 2, and placebo at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.</description> </arm_group> <arm_group> <arm_group_label>Randomization order 5</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive 100 mg CBD at visit 1, 50 mg CBD at visit 2, and placebo at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.</description> </arm_group> <arm_group> <arm_group_label>Randomization order 6</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants receive 100 mg CBD at visit 1, placebo at visit 2, and 50 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>CBD oil</intervention_name> <description>50 mg</description> <arm_group_label>Randomization order 1</arm_group_label> <arm_group_label>Randomization order 2</arm_group_label> <arm_group_label>Randomization order 3</arm_group_label> <arm_group_label>Randomization order 4</arm_group_label> <arm_group_label>Randomization order 5</arm_group_label> <arm_group_label>Randomization order 6</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>CBD oil</intervention_name> <description>100 mg CBD</description> <arm_group_label>Randomization order 1</arm_group_label> <arm_group_label>Randomization order 2</arm_group_label> <arm_group_label>Randomization order 3</arm_group_label> <arm_group_label>Randomization order 4</arm_group_label> <arm_group_label>Randomization order 5</arm_group_label> <arm_group_label>Randomization order 6</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo</description> <arm_group_label>Randomization order 1</arm_group_label> <arm_group_label>Randomization order 2</arm_group_label> <arm_group_label>Randomization order 3</arm_group_label> <arm_group_label>Randomization order 4</arm_group_label> <arm_group_label>Randomization order 5</arm_group_label> <arm_group_label>Randomization order 6</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Is a healthy adult aged 21-65 years, inclusive, at the time of screening.  - Has a body mass index between 18 and 35 kg/m2 (inclusive).  - Reports at online screening (and confirmed at in-person screening) that has achieved a calculated blood alcohol concentration of at least .06% in the past month according to the Daily Drinking Questionnaire (Collins et al., 1985).  - Is judged by the Investigator to be in generally good health at screening based on participants' medical history, vital signs, and comprehensive metabolic panel test results. Laboratory results outside of the reference range but within acceptable limits must be documented as not clinically significant (NCS) at the discretion of the Investigator.  - Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.  - Able to read and write in English.  Exclusion Criteria:  - Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.  - Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication.  - Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.  - Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for 28 days prior to the Screening Visit.  - Current use of any known hepatotoxic medication.  - Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.  - Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).  - Has taken a medication with likely CBD-interactions, including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 28 days of the Screening Visit or during the study.  - Has taken grapefruit products and/or Seville oranges within the 7 days prior to the first Experimental Visit.  - Has used cannabis, synthetic cannabinoid or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., Spice, K2), or any CBD- or THC-containing product (e.g., Sativex, Epidiolex) within 28 days of the Screening Visit or during the study.  - Has a past or current severe Alcohol Use Disorder as assessed by the Structured Clinical Interview Diagnostic (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) at the Screening Visit.  - Has a past or current diagnosis of a significant psychiatric disorder, or current use of illicit drugs, as assessed by the SCID at the Screening Visit that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.  - Endorses current suicidal intent as assessed by the SCID at the Screening Visit.  - Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.  - Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.  - Has a positive result on an alcohol breath test or urine drug screen for benzodiazepines, PCP, barbiturates, antidepressants, cocaine, amphetamine, methamphetamine, THC, and opiates at the Screening Visit or at any Experimental Visit.  - Self-reports current use of nicotine-containing products or nicotine replacement products as assessed by the SCID at the Screening Visit.  - Anyone with a history of hypersensitivity to cannabidiol will not be enrolled in the study. - To avoid any potential drug-drug interactions, participants must not be taking any of the following at any time during study participation: CYP3A4 or CYP2C19 Inducers, CYP1A2, CYP2B6, CYP2C8, CYP2C9, and CYP2C19 Substrates (e.g.,, theophylline, or tizanidine), CYP2B6 substrates (e.g., bupropion, efavirenz), uridine 5'-diphospho-glucuronosyltransferase 1A9 (UGT1A9) substrates (e.g., diflunisal, propofol, fenofibrate), and UGT2B7 substrates (e.g., gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8 and CYP2C9 (e.g., phenytoin) substrates, drugs that are metabolized by (i.e., are substrates of) CYP2C19 (e.g., diazepam), stiripentol, everolimus, sirolimus, tacrolimus, digoxin, and Valproate. </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Sara Blaine, PhD</last_name> <phone>334-844-4412</phone> <email>sara.blaine@auburn.edu</email> </overall_contact> <location> <facility> <name>Auburn University</name> <address> <city>Auburn</city> <state>Alabama</state> <zip>36849</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ben Campbell</last_name> <email>aubielab@auburn.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 2022</study_first_posted> <last_update_submitted>January 12, 2023</last_update_submitted> <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 17, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Auburn University</investigator_affiliation> <investigator_full_name>Sara K Blaine</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party>  </clinical_study>

This is a Phase 1, randomized, double-blind study to assess the safety, tolerability, and effects of CHI-554 when co-administered with alcohol. Inclusion Criteria: - Is a healthy adult aged 21-65 years, inclusive, at the time of screening. - Has a body mass index between 18 and 35 kg/m2 (inclusive). - Reports at online screening (and confirmed at in-person screening) that has achieved a calculated blood alcohol concentration of at least .06% in the past month according to the Daily Drinking Questionnaire (Collins et al., 1985). - Is judged by the Investigator to be in generally good health at screening based on participants' medical history, vital signs, and comprehensive metabolic panel test results. Laboratory results outside of the reference range but within acceptable limits must be documented as not clinically significant (NCS) at the discretion of the Investigator. - Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening. - Able to read and write in English. Exclusion Criteria: - Women who are pregnant, lactating, breastfeeding, or planning a pregnancy. - Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication. - Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus. - Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for 28 days prior to the Screening Visit. - Current use of any known hepatotoxic medication. - Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP. - Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides). - Has taken a medication with likely CBD-interactions, including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 28 days of the Screening Visit or during the study. - Has taken grapefruit products and/or Seville oranges within the 7 days prior to the first Experimental Visit. - Has used cannabis, synthetic cannabinoid or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., Spice, K2), or any CBD- or THC-containing product (e.g., Sativex, Epidiolex) within 28 days of the Screening Visit or during the study. - Has a past or current severe Alcohol Use Disorder as assessed by the Structured Clinical Interview Diagnostic (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) at the Screening Visit. - Has a past or current diagnosis of a significant psychiatric disorder, or current use of illicit drugs, as assessed by the SCID at the Screening Visit that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements. - Endorses current suicidal intent as assessed by the SCID at the Screening Visit. - Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study. - Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol. - Has a positive result on an alcohol breath test or urine drug screen for benzodiazepines, PCP, barbiturates, antidepressants, cocaine, amphetamine, methamphetamine, THC, and opiates at the Screening Visit or at any Experimental Visit. - Self-reports current use of nicotine-containing products or nicotine replacement products as assessed by the SCID at the Screening Visit. - Anyone with a history of hypersensitivity to cannabidiol will not be enrolled in the study. - To avoid any potential drug-drug interactions, participants must not be taking any of the following at any time during study participation: CYP3A4 or CYP2C19 Inducers, CYP1A2, CYP2B6, CYP2C8, CYP2C9, and CYP2C19 Substrates (e.g.,, theophylline, or tizanidine), CYP2B6 substrates (e.g., bupropion, efavirenz), uridine 5'-diphospho-glucuronosyltransferase 1A9 (UGT1A9) substrates (e.g., diflunisal, propofol, fenofibrate), and UGT2B7 substrates (e.g., gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8 and CYP2C9 (e.g., phenytoin) substrates, drugs that are metabolized by (i.e., are substrates of) CYP2C19 (e.g., diazepam), stiripentol, everolimus, sirolimus, tacrolimus, digoxin, and Valproate.

NCT0531xxxx/NCT05317520.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/NCT05317520</url> </required_header> <id_info> <org_study_id>Mehmet Akif Ersoy University</org_study_id> <nct_id>NCT05317520</nct_id> </id_info> <brief_title>The Effect of Cold Vapor Application on Postoperative Sore Throat</brief_title> <official_title>The Effect of Cold Vapor Application on Sore Throat in The Patients Extubated After Surgery: A Randomized Control Trial</official_title> <sponsors> <lead_sponsor> <agency>Burdur Mehmet Akif Ersoy University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Burdur Mehmet Akif Ersoy 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> To determine the effect of cold vapor given in the post-extubation period on sore throat. </textblock> </brief_summary> <detailed_description> <textblock> General anesthesia increases the comfort of the patient by ensuring that the patient does not feel the surgical interventions and pain during the operation. The necessity of intubation is known in patients who have undergone surgery under general anesthesia. Intubation provides benefits such as keeping the airway open, controlling the airway and breathing, reducing respiratory effort and dead space volume, preventing aspiration, and facilitating resuscitation in case of any problem.  Although surgical interventions are an important treatment option for health problems, postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in patients receiving general anesthesia.  Although it is seen in the literature that pharmacological, non-pharmacological and herbal methods are applied to reduce postoperative sore throat, there are not enough studies examining the effect of cold steam application on sore throat. With this research, it is expected that the cold steam given in the postoperative period will contribute to the relief of sore throat. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">December 16, 2016</start_date> <completion_date type="Actual">May 17, 2018</completion_date> <primary_completion_date type="Actual">August 17, 2017</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>Patients were divided into intervention and control groups using a simple randomized control method.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Sore throat</measure> <time_frame>Within an hour after surgery</time_frame> <description>In our study, a horizontally prepared Numerical Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of their sore throat on a scale of 0 to 10. The scale begins with the absence of pain (0) and ends with excruciating pain (10). When the patient came to the recovery unit, the severity of sore throat was evaluated before and after the application of cold vapor at 0th hour.</description> </primary_outcome> <primary_outcome> <measure>Sore throat</measure> <time_frame>2nd hour after surgery</time_frame> <description>In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10). The severity of sore throat was evaluated before and after the application of cold vapor at 2nd hour postoperatively.</description> </primary_outcome> <primary_outcome> <measure>Sore throat</measure> <time_frame>6th hour after surgery</time_frame> <description>In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10). The severity of sore throat was evaluated before and after the application of cold vapor at 6th hour postoperatively.</description> </primary_outcome> <primary_outcome> <measure>Sore throat</measure> <time_frame>24th hour after surgery</time_frame> <description>In our study, a horizontally prepared Numeric Rating Scale was used to evaluate the severity of pain. Patients participating in the study were asked to rate the severity of sore throat between 0 and 10. The scale starts with the absence of pain (0) and ends with unbearable pain (10). Cold vapor was not applied to the patients at the 24th hour.. Only sore throat were evaluated.</description> </primary_outcome> <secondary_outcome> <measure>Hoarseness</measure> <time_frame>Within an hour after surgery</time_frame> <description>To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating.Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech). When the patient came to the recovery unit, the severity of hoarseness was evaluated before and after the application of cold vapor at the 0th hour.</description> </secondary_outcome> <secondary_outcome> <measure>Hoarseness</measure> <time_frame>2nd hour after surgery</time_frame> <description>To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech). The severity of hoarseness was evaluated before and after the application of cold vapor at the 2nd hour postoperatively.</description> </secondary_outcome> <secondary_outcome> <measure>Hoarseness</measure> <time_frame>6th hour after surgery</time_frame> <description>To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech). The severity of hoarseness was evaluated before and after the application of cold vapor at the 6th hour postoperatively.</description> </secondary_outcome> <secondary_outcome> <measure>Hoarseness</measure> <time_frame>24th hour after surgery</time_frame> <description>To assess hoarseness, patients were asked a single question, "Do you have any hoarseness in your voice now?" Participants were asked to evaluate this question with a 4-point Likert-type rating. Rating; 0 = no hoarseness, 1 = slow, hoarse voice, 2 = moderate hoarseness (clear during the interview), 3 = hoarseness (completely silent, no speech). Cold vapor was not applied to the patients at the 24th hour. Only hoarseness was evaluated.</description> </secondary_outcome> <secondary_outcome> <measure>Dry throat and swallowing difficulty</measure> <time_frame>Within an hour after surgery</time_frame> <description>The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable). When the patient came to the recovery unit, the severity of throat dryness and swallowing difficulty was evaluated before and after the application of cold vapor at the 0th hour.</description> </secondary_outcome> <secondary_outcome> <measure>Dry throat and swallowing difficulty</measure> <time_frame>2nd hour after surgery</time_frame> <description>The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable). At the 2nd hour postoperatively, the severity of throat dryness and swallowing difficulty were evaluated before and after the application of cold vapor.</description> </secondary_outcome> <secondary_outcome> <measure>Dry throat and swallowing difficulty</measure> <time_frame>6th hour after surgery</time_frame> <description>The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable). At the 6th hour postoperatively, the severity of throat dryness and swallowing difficulty were evaluated before and after the application of cold vapor.</description> </secondary_outcome> <secondary_outcome> <measure>Dry throat and swallowing difficulty</measure> <time_frame>24th hour after surgery</time_frame> <description>The patients were asked to rate the severity of dry throat and swallowing difficulty between 0 and 4 (0=None, 1=Mild, 2=Moderate, 3=Extreme, 4=Unbearable). Cold vapor was not applied to the patients at the 24th hour. Only dry throat and swallowing difficulty were evaluated.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">64</enrollment> <condition>Sore Throat</condition> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Cold vapor was applied 3 times in total at 0th,2nd and 6th hours.</description> </arm_group> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>No cold vapor was applied at 0th,2nd and 6th hours.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Cold vapor</intervention_name> <description>The Ramsey Sedation Scale was used to assess wakefulness after patients were extubated and arrived at the recovery unit at the 0th hour postoperatively. Sore throat, localization of pain, hoarseness, dry throat, and swallowing difficulty were evaluated in patients with a score of 2 according to this scale. Sore throat of the patients was evaluated with Numerical Rating Scale. Then, cold vapor was applied for 15 minutes with a vapor machine used as a standard in the hospital by the researcher. After the cold vapor application was finished, the patients' sore throat, localization of pain, hoarseness, swallowing difficulty and dry throat were re-evaluated with the same forms. Sore throat were evaluated before the application of cold vapor at the 2nd and 6th hours. Then cold vapor was applied for 15 minutes. After the cold vapor application was finished, sore throat were re-evaluated. At the 24th hour, cold vapor was not applied to the patients. Only sore throat were evaluated.</description> <arm_group_label>Intervention group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Those who accept the research  - Elective laparoscopic cholecystectomy surgery planned  - Patients in ASA I and II class  - 18 years and over  - Mallampati classification I and II  - Operation time more than 30 minutes  - Literate  - No hearing problem  - Patients without understanding difficulties  Exclusion Criteria:  - Overweight patients (Body Mass Index ≥ 40)  - Patients with sore throat and lower respiratory tract infection  - Patients with Chronic Obstructive Pulmonary Disease (COPD)  - Patients with a history of allergies  - Patients with hearing problems  - illiterate patients  - ASA classification III and above  - Mallampati classification III and IV patients  - Patients with an operation time of less than 30 minutes </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>Hatice Özsoy</last_name> <role>Principal Investigator</role> <affiliation>Burdur Mehmet Akif Ersoy University</affiliation> </overall_official> <location> <facility> <name>Hatice Özsoy</name> <address> <city>Merkez</city> <state>Burdur</state> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>July 27, 2021</study_first_submitted> <study_first_submitted_qc>April 6, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 7, 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 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Burdur Mehmet Akif Ersoy University</investigator_affiliation> <investigator_full_name>Hatice Özsoy</investigator_full_name> <investigator_title>Lecturer</investigator_title> </responsible_party> <keyword>Extubation</keyword> <keyword>Sore throat</keyword> <keyword>Cold vapor</keyword> <keyword>Nursing</keyword> <condition_browse>  <mesh_term>Pharyngitis</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.</ipd_description> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>6 months after publication</ipd_time_frame> <ipd_access_criteria>Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.</ipd_access_criteria> </patient_data>  </clinical_study>

To determine the effect of cold vapor given in the post-extubation period on sore throat. General anesthesia increases the comfort of the patient by ensuring that the patient does not feel the surgical interventions and pain during the operation. The necessity of intubation is known in patients who have undergone surgery under general anesthesia. Intubation provides benefits such as keeping the airway open, controlling the airway and breathing, reducing respiratory effort and dead space volume, preventing aspiration, and facilitating resuscitation in case of any problem. Although surgical interventions are an important treatment option for health problems, postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in patients receiving general anesthesia. Although it is seen in the literature that pharmacological, non-pharmacological and herbal methods are applied to reduce postoperative sore throat, there are not enough studies examining the effect of cold steam application on sore throat. With this research, it is expected that the cold steam given in the postoperative period will contribute to the relief of sore throat. Inclusion Criteria: - Those who accept the research - Elective laparoscopic cholecystectomy surgery planned - Patients in ASA I and II class - 18 years and over - Mallampati classification I and II - Operation time more than 30 minutes - Literate - No hearing problem - Patients without understanding difficulties Exclusion Criteria: - Overweight patients (Body Mass Index ≥ 40) - Patients with sore throat and lower respiratory tract infection - Patients with Chronic Obstructive Pulmonary Disease (COPD) - Patients with a history of allergies - Patients with hearing problems - illiterate patients - ASA classification III and above - Mallampati classification III and IV patients - Patients with an operation time of less than 30 minutes

NCT0531xxxx/NCT05317533.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/NCT05317533</url> </required_header> <id_info> <org_study_id>CLH20220312</org_study_id> <nct_id>NCT05317533</nct_id> </id_info> <brief_title>Prevalence of Distal Radial Artery Occlusion in Cardiovascular Catheterization Via Distal Radial Access</brief_title> <official_title>Prevalence of Distal Radial Artery Occlusion (DRAO) in Patients Undergoing Cardiovascular Catheterization Via Distal Radial Access (DRA)</official_title> <sponsors> <lead_sponsor> <agency>Wujin People's Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Wujin People's 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> Explore the prevalence of distal radial artery occlusion after cardiac catheterization via distal radial artery and the risk factors </textblock> </brief_summary> <detailed_description> <textblock> Cardiac catheterization via distal radial artery is prevalent worldwide, which can reduce the prevalence of radial artery occlusion. However, the distal radial artery occlusion has not been detected. This study is designed to explore the prevalence of distal radial artery occlusion in patients undergoing cardiac catheterization via distal radial access at 1 day and 3 months after the procedure, which is explored by ultrasound. In addition, the risk factors of distal radial artery occlusion are also analyzed. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 1, 2022</start_date> <completion_date type="Anticipated">March 31, 2024</completion_date> <primary_completion_date type="Anticipated">March 31, 2023</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>3 Months</target_duration> <primary_outcome> <measure>Prevalence of distal radial artery occlusion</measure> <time_frame>3 months after procedure</time_frame> <description>Prevalence of the distal radial artery occlusion is detected using ultrasound</description> </primary_outcome> <secondary_outcome> <measure>Prevalence of distal radial artery occlusion</measure> <time_frame>1 day after procedure</time_frame> <description>Prevalence of the distal radial artery occlusion is detected using ultrasound</description> </secondary_outcome> <secondary_outcome> <measure>Thickness of distal radial artery</measure> <time_frame>3 months after procedure</time_frame> <description>Comparison of the thickness of distal radial artery intima using ultrasound</description> </secondary_outcome> <enrollment type="Anticipated">500</enrollment> <condition>Catheterization</condition> <condition>Complications</condition> <condition>Distal Radial Artery</condition> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>cardiac catheterization via distal radial artery</intervention_name> <description>cardiac catheterization via distal radial artery</description> </intervention> <eligibility> <study_pop> <textblock> The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Age ≥ 18 years;  - Palpable distal radial artery  Exclusion Criteria:  - Age ≥ 90years;  - Height≥ 185cm;  - Cardiogenic shock;  - Refuse to sign the written informed consent. </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>Gaojun Cai, MD</last_name> <role>Study Chair</role> <affiliation>Cardiovascular department, Changzhou Wujin People's Hospital</affiliation> </overall_official> <overall_contact> <last_name>Feng Li, Ms</last_name> <phone>+86-0519-85579192</phone> <email>lifeng198boy@126.com</email> </overall_contact> <overall_contact_backup> <last_name>Gaojun Cai, MD</last_name> <phone>+86-0519-85579193</phone> <email>cgj982@126.com</email> </overall_contact_backup> <location> <facility> <name>Changzhou Wujin People's Hospital</name> <address> <city>Changzhou</city> <state>Jiangsu</state> <zip>213017</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Gaojun Cai, MD</last_name> <phone>+86-0519-85579193</phone> <email>cgj982@126.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <results_reference> <citation>Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.</citation> <PMID>33380922</PMID> </results_reference> <results_reference> <citation>Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.</citation> <PMID>30336816</PMID> </results_reference> <results_reference> <citation>Sattar Y, Talib U, Faisaluddin M, Song D, Lak HM, Laghari A, Khan MZ, Ullah W, Elgendy IY, Balla S, Daggubati R, Kawsara A, Jneid H, Alraies CM, Alam M. Meta-Analysis Comparing Distal Radial Versus Traditional Radial Percutaneous Coronary Intervention or Angiography. Am J Cardiol. 2022 May 1;170:31-39. doi: 10.1016/j.amjcard.2022.01.019. Epub 2022 Mar 2.</citation> <PMID>35248389</PMID> </results_reference> <results_reference> <citation>Prasad RM, Pandrangi P, Pandrangi G, Yoo H, Salazar AM, Ukponmwan E, Kehdi M, Abela G. Meta-Analysis Comparing Distal Radial Artery Approach Versus Traditional for Coronary Procedures. Am J Cardiol. 2022 Feb 1;164:52-56. doi: 10.1016/j.amjcard.2021.10.034. Epub 2021 Nov 20.</citation> <PMID>34815063</PMID> </results_reference> <results_reference> <citation>Pacchioni A, Mugnolo A, Sanz Sanchez J, Sgueglia GA, Pesarini G, Bellamoli M, Sacca S, Ribichini F, Reimers B, Gasparini GL. Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients. Catheter Cardiovasc Interv. 2022 Feb;99(3):827-835. doi: 10.1002/ccd.30005. Epub 2021 Nov 16.</citation> <PMID>34783423</PMID> </results_reference> <results_reference> <citation>Aminian A, Sgueglia GA, Wiemer M, Gasparini GL, Kefer J, Ruzsa Z, van Leeuwen MAH, Vandeloo B, Ungureanu C, Kedev S, Iglesias JF, Leibundgut G, Ratib K, Bernat I, Barriocanal I, Borovicanin V, Saito S. Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study. Am Heart J. 2022 Feb;244:19-30. doi: 10.1016/j.ahj.2021.10.180. Epub 2021 Oct 16.</citation> <PMID>34666014</PMID> </results_reference> <results_reference> <citation>Li F, Shi GW, Yu XL, Song RX, Xiao JQ, Huang HM, Li LM, Zhang LY, Gong C, Cai GJ. Safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial artery access in the anatomical snuffbox: a single-centre prospective cohort study using a propensity score method. BMC Cardiovasc Disord. 2022 Mar 2;22(1):74. doi: 10.1186/s12872-022-02518-8.</citation> <PMID>35236288</PMID> </results_reference> <results_reference> <citation>Shi G, Li F, Zhang L, Gong C, Xue S, Song Y, Cai G. Retrograde Recanalization of Occluded Radial Artery: A Single-Centre Experience and Literature Review. J Endovasc Ther. 2022 Oct;29(5):755-762. doi: 10.1177/15266028211067732. Epub 2022 Jan 10.</citation> <PMID>35001676</PMID> </results_reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 30, 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> <keyword>distal radial artery occlusion;cardiac catheterization</keyword> <condition_browse>  <mesh_term>Arterial Occlusive Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Explore the prevalence of distal radial artery occlusion after cardiac catheterization via distal radial artery and the risk factors Cardiac catheterization via distal radial artery is prevalent worldwide, which can reduce the prevalence of radial artery occlusion. However, the distal radial artery occlusion has not been detected. This study is designed to explore the prevalence of distal radial artery occlusion in patients undergoing cardiac catheterization via distal radial access at 1 day and 3 months after the procedure, which is explored by ultrasound. In addition, the risk factors of distal radial artery occlusion are also analyzed. The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time. Inclusion Criteria: - Age ≥ 18 years; - Palpable distal radial artery Exclusion Criteria: - Age ≥ 90years; - Height≥ 185cm; - Cardiogenic shock; - Refuse to sign the written informed consent.

NCT0531xxxx/NCT05317546.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/NCT05317546</url> </required_header> <id_info> <org_study_id>Pro00119770</org_study_id> <nct_id>NCT05317546</nct_id> </id_info> <brief_title>Cannabidiol in Youth Alcohol Use Disorder</brief_title> <official_title>Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder</official_title> <sponsors> <lead_sponsor> <agency>Medical University of South Carolina</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Medical University of South Carolina</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> The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 35 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 1, 2022</start_date> <completion_date type="Anticipated">July 2024</completion_date> <primary_completion_date type="Anticipated">July 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>Crossover Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Glutamate</measure> <time_frame>Changes 3 hours after administration of 600mg CBD vs. placebo</time_frame> <description>Glutamate level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy</description> </primary_outcome> <primary_outcome> <measure>GABA</measure> <time_frame>Changes 3 hours after administration of 600mg CBD vs. placebo</time_frame> <description>GABA level in the anterior cingulate cortex as measured by magnetic resonance spectroscopy</description> </primary_outcome> <primary_outcome> <measure>Alcohol cue reactivity neural activation</measure> <time_frame>Changes 3 hours after administration of 600mg CBD vs. placebo</time_frame> <description>Blood oxygen level dependent (BOLD) signal during alcohol cue reactivity in reward and salience brain regions</description> </primary_outcome> <primary_outcome> <measure>Alcohol cue reactivity (lab-based paradigm)</measure> <time_frame>Changes 3 hours after administration of 600mg CBD vs. placebo</time_frame> <description>In vivo response to olfactory alcohol cues measured via heart rate</description> </primary_outcome> <primary_outcome> <measure>Alcohol cue reactivity (lab-based paradigm)</measure> <time_frame>Changes 3 hours after administration of 600mg CBD vs. placebo</time_frame> <description>In vivo response to olfactory alcohol cues measured via salivation</description> </primary_outcome> <primary_outcome> <measure>Alcohol cue reactivity (lab-based paradigm)</measure> <time_frame>Changes 3 hours after administration of 600mg CBD vs. placebo</time_frame> <description>In vivo response to olfactory alcohol cues measured via subjective ratings</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">35</enrollment> <condition>Alcohol Use Disorder</condition> <arm_group> <arm_group_label>Cannabidiol, Then Placebo</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Placebo, Then Cannabidiol</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Cannabidiol</intervention_name> <description>In counterbalanced order, 35 youth (ages 16-22) will receive 600mg of cannabidiol or placebo three hours before a neuroimaging and behavioral assessment paradigm, separated by a 13-day washout period.</description> <arm_group_label>Cannabidiol, Then Placebo</arm_group_label> <arm_group_label>Placebo, Then Cannabidiol</arm_group_label> <other_name>Placebo</other_name> </intervention> <eligibility> <criteria> <textblock> Age 16 to 22. Does or does not drink alcohol. </textblock> </criteria> <gender>All</gender> <minimum_age>16 Years</minimum_age> <maximum_age>22 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Lindsay Squeglia, PhD</last_name> <phone>8437925451</phone> <email>squegli@musc.edu</email> </overall_contact> <overall_contact_backup> <last_name>Cori Herring, BS</last_name> <phone>843-792-8207</phone> <email>herrinco@musc.edu</email> </overall_contact_backup> <location> <facility> <name>Medical University of South Carolina</name> <address> <city>Charleston</city> <state>South Carolina</state> <zip>29425</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Lindsay M Squeglia, PhD</last_name> <phone>843-792-5451</phone> <email>squegli@musc.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>March 21, 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>November 10, 2022</last_update_submitted> <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 15, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Medical University of South Carolina</investigator_affiliation> <investigator_full_name>Lindsay Squeglia</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Alcoholism</mesh_term> <mesh_term>Alcohol Drinking</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Cannabidiol</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 35 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month. Age 16 to 22. Does or does not drink alcohol.

NCT0531xxxx/NCT05317559.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/NCT05317559</url> </required_header> <id_info> <org_study_id>STU00094737</org_study_id> <nct_id>NCT05317559</nct_id> </id_info> <brief_title>Cardiometabolic Outcomes With Light Exposure During Sleep</brief_title> <official_title>Cardiometabolic Outcomes With Light Exposure During Sleep</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>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function. </textblock> </brief_summary> <detailed_description> <textblock> This study tested the hypothesis that acute exposure to light during sleep adversely affects next morning glucose homeostasis and whether this effect occurs via reduced sleep quality, melatonin suppression, or sympathetic nervous system (SNS) activation during sleep. Twenty young adults participated in this parallel-group study design. The room light condition (n=10) included one night of sleep in dim light (< 3 lux) followed by one night of sleep with overhead room lighting (100 lux). The dim light condition (n=10) included two consecutive nights of sleep in dim light. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">February 2014</start_date> <completion_date type="Actual">July 2018</completion_date> <primary_completion_date type="Actual">January 2018</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>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Matsuda Index</measure> <time_frame>Day 2</time_frame> <description>OGTT</description> </primary_outcome> <primary_outcome> <measure>Matsuda Index</measure> <time_frame>Day 3</time_frame> <description>OGTT</description> </primary_outcome> <primary_outcome> <measure>HOMA-IR</measure> <time_frame>Day 2</time_frame> <description>Fasting</description> </primary_outcome> <primary_outcome> <measure>HOMA-IR</measure> <time_frame>Day 3</time_frame> <description>Fasting</description> </primary_outcome> <secondary_outcome> <measure>Sleep Stages</measure> <time_frame>Night 1</time_frame> <description>Stage N1, N2, N3</description> </secondary_outcome> <secondary_outcome> <measure>Sleep Stages</measure> <time_frame>Night 2</time_frame> <description>Stage N1, N2, N3</description> </secondary_outcome> <secondary_outcome> <measure>Sleep Stages</measure> <time_frame>Night 3</time_frame> <description>Stage N1, N2, N3</description> </secondary_outcome> <secondary_outcome> <measure>Heart Rate</measure> <time_frame>Night 2</time_frame> <description>beat to beat</description> </secondary_outcome> <secondary_outcome> <measure>Heart Rate</measure> <time_frame>Night 3</time_frame> <description>beat to beat</description> </secondary_outcome> <secondary_outcome> <measure>Blood pressure</measure> <time_frame>Day 2</time_frame> <description>diastolic/systolic</description> </secondary_outcome> <secondary_outcome> <measure>Blood pressure</measure> <time_frame>Day 3</time_frame> <description>diastolic/systolic</description> </secondary_outcome> <secondary_outcome> <measure>Slow Wave Activity</measure> <time_frame>Night 1</time_frame> <description>Spectral power in the Slow Wave Activity (0.5 to 4 Hz)</description> </secondary_outcome> <secondary_outcome> <measure>Slow Wave Activity</measure> <time_frame>Night 2</time_frame> <description>Spectral power in the Slow Wave Activity (0.5 to 4 Hz)</description> </secondary_outcome> <secondary_outcome> <measure>Slow Wave Activity</measure> <time_frame>Night 3</time_frame> <description>Spectral power in the Slow Wave Activity (0.5 to 4 Hz)</description> </secondary_outcome> <other_outcome> <measure>Melatonin</measure> <time_frame>Day 2</time_frame> <description>pg/ml</description> </other_outcome> <other_outcome> <measure>Melatonin</measure> <time_frame>Day 3</time_frame> <description>pg/ml</description> </other_outcome> <other_outcome> <measure>subjective sleepiness</measure> <time_frame>Day 2</time_frame> <description>sleepiness level</description> </other_outcome> <other_outcome> <measure>subjective sleepiness</measure> <time_frame>Day 3</time_frame> <description>sleepiness level</description> </other_outcome> <other_outcome> <measure>hunger</measure> <time_frame>Day 2</time_frame> <description>hunger level</description> </other_outcome> <other_outcome> <measure>hunger</measure> <time_frame>Day 3</time_frame> <description>hunger level</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">20</enrollment> <condition>Light</condition> <arm_group> <arm_group_label>room light</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The room light condition (n=10) included one night of sleep in dim light (< 3 lux) followed by one night of sleep with overhead room lighting (100 lux).</description> </arm_group> <arm_group> <arm_group_label>dim light</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The dim light condition (n=10) included two consecutive nights of sleep in dim light.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>room light</intervention_name> <description>The room light condition (n=10) included one night of sleep in dim light (< 3 lux) followed by one night of sleep with overhead room lighting (100 lux). The dim light condition (n=10) included two consecutive nights of sleep in dim light.</description> <arm_group_label>room light</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - healthy adults  - ages 18-40 years  - habitual sleep duration of 6.5-8.5 hours  - habitual sleep onset of 9:00 pm-1:00 am  Exclusion Criteria:  - any sleep disorder as assessed by history and screening questionnaires for obstructive sleep apnea (Berlin) and excessive daytime sleepiness (ESS >12), and by PSG to exclude sleep apnea (apnea hypopnea index ≥ 15), periodic leg movements (movement arousal index ≥ 15), or REM sleep behavior disorder;  - history of a cognitive or neurological disorder;  - history of a major psychiatric disorder, including but not limited to mood/anxiety, eating, and alcohol/substance abuse disorders;  - depressed mood (Beck Depression Inventory II score ≥ 20);  - diabetes or other endocrine disorders;  - any gastrointestinal disease requiring dietary adjustment;  - blindness or significant vision loss;  - any unstable or serious medical conditions;  - current or recent (within the past month) of psychoactive, hypnotic, stimulant or analgesic medications;  - shift work or other types of self-imposed irregular sleep schedules;  - obesity (body mass index > 30 kg/m2);  - history of habitual smoking (6 or more cigarettes per week) or drinking (7 or more alcoholic beverages per week) or caffeine consumption greater than 300 mg per day;  - current use of light therapy;  - use of any other legal or illicit substance that may affect sleep and/or appetite;  - allergy to heparin.  - Due to the metabolic stress associated with pregnancy and breastfeeding, patients who were pregnant or breastfeeding were also excluded. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <verification_date>March 2022</verification_date> <study_first_submitted>December 9, 2021</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>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 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>Northwestern University</investigator_affiliation> <investigator_full_name>Phyllis Zee</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>light</keyword> <keyword>sleep</keyword> <keyword>metabolism</keyword> <keyword>sympathetic nervous system</keyword> <keyword>insulin resistance</keyword> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>De-identified data to support the findings of the study are available in Arch, the open access Northwestern University Institutional Repository (https://doi.org/10.21985/n2-9zrx-ev05)</ipd_description> </patient_data>  </clinical_study>

This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function. This study tested the hypothesis that acute exposure to light during sleep adversely affects next morning glucose homeostasis and whether this effect occurs via reduced sleep quality, melatonin suppression, or sympathetic nervous system (SNS) activation during sleep. Twenty young adults participated in this parallel-group study design. The room light condition (n=10) included one night of sleep in dim light (< 3 lux) followed by one night of sleep with overhead room lighting (100 lux). The dim light condition (n=10) included two consecutive nights of sleep in dim light. Inclusion Criteria: - healthy adults - ages 18-40 years - habitual sleep duration of 6.5-8.5 hours - habitual sleep onset of 9:00 pm-1:00 am Exclusion Criteria: - any sleep disorder as assessed by history and screening questionnaires for obstructive sleep apnea (Berlin) and excessive daytime sleepiness (ESS >12), and by PSG to exclude sleep apnea (apnea hypopnea index ≥ 15), periodic leg movements (movement arousal index ≥ 15), or REM sleep behavior disorder; - history of a cognitive or neurological disorder; - history of a major psychiatric disorder, including but not limited to mood/anxiety, eating, and alcohol/substance abuse disorders; - depressed mood (Beck Depression Inventory II score ≥ 20); - diabetes or other endocrine disorders; - any gastrointestinal disease requiring dietary adjustment; - blindness or significant vision loss; - any unstable or serious medical conditions; - current or recent (within the past month) of psychoactive, hypnotic, stimulant or analgesic medications; - shift work or other types of self-imposed irregular sleep schedules; - obesity (body mass index > 30 kg/m2); - history of habitual smoking (6 or more cigarettes per week) or drinking (7 or more alcoholic beverages per week) or caffeine consumption greater than 300 mg per day; - current use of light therapy; - use of any other legal or illicit substance that may affect sleep and/or appetite; - allergy to heparin. - Due to the metabolic stress associated with pregnancy and breastfeeding, patients who were pregnant or breastfeeding were also excluded.

NCT0531xxxx/NCT05317572.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/NCT05317572</url> </required_header> <id_info> <org_study_id>CSITM2020</org_study_id> <nct_id>NCT05317572</nct_id> </id_info> <brief_title>Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section</brief_title> <official_title>Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section</official_title> <sponsors> <lead_sponsor> <agency>Ondokuz Mayıs University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Ondokuz Mayıs University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> In our study, It was aimed to determine the dose of morphine that provides the most effective analgesia with the least incidence of side effects in the postoperative period. </textblock> </brief_summary> <detailed_description> <textblock> Spinal anesthesia is a widely used method in cesarean section operations. It has become a popular practice to add opioids to local anesthetic agents to improve the quality and prolong the duration of intraoperative and postoperative analgesia. Morphine and fentanyl are commonly used opioids for this purpose. In cesarean sections, intrathecal morphine (ITM) is preferred for postoperative analgesia due to its slow onset and long-term analgesia, and intrathecal fentanyl is preferred for intraoperative analgesia due to its faster onset of action.  ITM can cause side effects such as nausea, vomiting, itching, sedation and respiratory depression. The quality of analgesia and the incidence of side effects may vary depending on the ITM dose used. There are studies indicating that reducing the dose of ITM results in good quality, long-term analgesia with a low incidence of side effects. However, the ideal dose of ITM providing optimal postoperative analgesia with the lowest incidence of side effects for cesarean section has not been determined yet in the literature. For this purpose, in this study it was compared the postoperative analgesia efficiency and incidence of side effects of three different ITM doses in order to contribute to the literature.  Patients were divided into three groups:  Group 1: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine was administered.  Group 2: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine was administered.  Group 3: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine was administered.  All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 1, 2017</start_date> <completion_date type="Actual">September 1, 2020</completion_date> <primary_completion_date type="Actual">January 1, 2019</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 patients were randomly divided into three groups of 50patients each. In the system where computer generated random numbers (SPSS v23.0, IBM,- Page 2 of 6 [DRAFT] -NewYork, USA) were used,</intervention_model_description> <primary_purpose>Supportive Care</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> <masking_description>The patients were randomly divided into three groups of 50patients each. In the system where computer generated random numbers (SPSS v23.0, IBM,- Page 2 of 6 [DRAFT] -NewYork, USA) were used, groups were determined at a ratio of 1:1:1 . Sealed and sequentially numbered envelopes were created. One hour before the operation, an experienced anesthesiologist, who was not involved in the intraoperative and postoperative follow-up of the patient and would only perform the spinal anesthesia procedure, opened a sealed opaque sealed envelope to learn the group that the patient would be included in. There were two different physicians who performed intraoperative and postoperative follow-up. Both of the follow-up physicians were blind to the patient group</masking_description> </study_design_info> <primary_outcome> <measure>Fentanyl consumption in the first 24 hours after surgery</measure> <time_frame>Postoperative Day 2</time_frame> <description>Fentanyl consumption in the first 24 hours was measured. Patients were able to request opioids via a PCA device when their VAS score is above 4 at rest and during activity (coughing and walking).</description> </primary_outcome> <secondary_outcome> <measure>Post-operative acute pain</measure> <time_frame>Postoperative Day 2</time_frame> <description>Pain status at rest and while activity (coughing and walking) was assessed by VAS scores at 0, 8, 24, 30, and 48 hours after surgery. The VAS is an 11-point numeric scale which ranges from 0 to 10 at rest and during activity.</description> </secondary_outcome> <secondary_outcome> <measure>The incidences of post-operative nausea and vomiting (PONV)</measure> <time_frame>Postoperative Day 2</time_frame> <description>The severity of postoperative nausea and vomiting (PONV) was assessed using a Numeric rating scale(NRS) at 0, 8, 24, 30, and 48 hours after surgery. If a score of 3 or more is recorded, ondansetron 0,1 mg/kg iv was administered.</description> </secondary_outcome> <secondary_outcome> <measure>The incidence of side effects related to opioid use</measure> <time_frame>Postoperative Day 2</time_frame> <description>Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression was recorded</description> </secondary_outcome> <secondary_outcome> <measure>Bromage Score Comparison</measure> <time_frame>Postoperative 2nd hour.</time_frame> <description>After spinal anesthesia was administered, motor block was evaluated according to the Bromage scale. Bromage score and motor block removal times were noted at the intraoperative 5th, 30th minutes, at the end of the operation, at the postoperative 30th minute and at the 2nd hour.</description> </secondary_outcome> <secondary_outcome> <measure>APGAR score</measure> <time_frame>The 5th minute APGAR score was recorded.</time_frame> <description>The 5th minute APGAR score was recorded.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">150</enrollment> <condition>Cesarean Section</condition> <condition>Spinal Anesthesia</condition> <condition>Postoperative Analgesia</condition> <arm_group> <arm_group_label>Group 1</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group 1: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine) + iv Fentanyl-PCA</description> </arm_group> <arm_group> <arm_group_label>Group 2</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group 2: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine) + iv Fentanyl-PCA</description> </arm_group> <arm_group> <arm_group_label>Group 3</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group 3: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine) + iv Fentanyl-PCA</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>80 mcg intrathecal morphine</intervention_name> <description>İntraoperative Management: Spinal anesthesia was administered to each patient in a sitting position, after aseptic conditions were achieved with a midline approach. A 25 gauge pencil point spinal needle was placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 10 mg of hyperbaric bupivacaine, 20 mcg of fentanyl and 80 micrograms of morphine were injected into the intrathecal space together with the determined morphine doses. Postoperative analgesia management: Diclofenac sodium 2 × 75 mg was administered intramuscularly to all patients. All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. For patients with pain VAS score of 5 or more, meperidine was administered at a rate of 25 mg each time and with a total daily dose of 200 mg.</description> <arm_group_label>Group 1</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>120 mcg intrathecal morphine</intervention_name> <description>İntraoperative Management: Spinal anesthesia was administered to each patient in a sitting position, after aseptic conditions were achieved with a midline approach. A 25 gauge pencil point spinal needle was placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 10 mg of hyperbaric bupivacaine, 20 mcg of fentanyl and 120 micrograms of morphine were injected into the intrathecal space together with the determined morphine doses. Postoperative analgesia management: Diclofenac sodium 2 × 75 mg was administered intramuscularly to all patients. All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. For patients with pain VAS score of 5 or more, meperidine was administered at a rate of 25 mg each time and with a total daily dose of 200 mg.</description> <arm_group_label>Group 2</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>160 mcg intrathecal morphine</intervention_name> <description>İntraoperative Management: Spinal anesthesia was administered to each patient in a sitting position, after aseptic conditions were achieved with a midline approach. A 25 gauge pencil point spinal needle was placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 10 mg of hyperbaric bupivacaine, 20 mcg of fentanyl and 160 mcg of morphine were injected into the intrathecal space together with the determined morphine doses. Postoperative analgesia management: Diclofenac sodium 2 × 75 mg was administered intramuscularly to all patients. All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. For patients with pain VAS score of 5 or more, meperidine was administered at a rate of 25 mg each time and with a total daily dose of 200 mg.</description> <arm_group_label>Group 3</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patient undergoing cesarean section  - Between the ages of 18-40,  - ASA II,  - Pregnant women with gestational week > 36  Exclusion Criteria:  - Not accepting regional anesthesia,  - İnfection at the injection site,  - Coagulopathy, bleeding diathesis,  - Severe hypovolemia,  - İncrease in intracranial pressure,  - Pregnant women with problems such as severe aortic stenosis, severe mitral stenosis for which spinal anesthesia is contraindicated,  - Patients with a history of allergy to any drug included in the study protocol </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>ilke tamdoğan</last_name> <role>Principal Investigator</role> <affiliation>Ondokuz Mayıs University Faculty of Medicine</affiliation> </overall_official> <location> <facility> <name>Ondokuz Mayıs University Faculty of Medicine</name> <address> <city>Samsun</city> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <results_reference> <citation>Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018. Erratum In: Anesthesiology 1999 Apr;90(4):1241.</citation> <PMID>9952150</PMID> </results_reference> <results_reference> <citation>Baraka A, Noueihid R, Hajj S. Intrathecal injection of morphine for obstetric analgesia. Anesthesiology. 1981 Feb;54(2):136-40. doi: 10.1097/00000542-198102000-00007.</citation> <PMID>7008655</PMID> </results_reference> <results_reference> <citation>Weigl W, Bierylo A, Wielgus M, Krzemien-Wiczynska S, Kolacz M, Dabrowski MJ. Perioperative analgesia after intrathecal fentanyl and morphine or morphine alone for cesarean section: A randomized controlled study. Medicine (Baltimore). 2017 Dec;96(48):e8892. doi: 10.1097/MD.0000000000008892.</citation> <PMID>29310376</PMID> </results_reference> <results_reference> <citation>Sarvela J, Halonen P, Soikkeli A, Korttila K. A double-blinded, randomized comparison of intrathecal and epidural morphine for elective cesarean delivery. Anesth Analg. 2002 Aug;95(2):436-40, table of contents. doi: 10.1097/00000539-200208000-00037.</citation> <PMID>12145067</PMID> </results_reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 4, 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 8, 2022</last_update_submitted> <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 15, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation> <investigator_full_name>Ilke Tamdogan</investigator_full_name> <investigator_title>Physician</investigator_title> </responsible_party> <keyword>Postoperative pain</keyword> <keyword>Intrathecal morphine</keyword> <condition_browse>  <mesh_term>Agnosia</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Morphine</mesh_term> </intervention_browse>  </clinical_study>

In our study, It was aimed to determine the dose of morphine that provides the most effective analgesia with the least incidence of side effects in the postoperative period. Spinal anesthesia is a widely used method in cesarean section operations. It has become a popular practice to add opioids to local anesthetic agents to improve the quality and prolong the duration of intraoperative and postoperative analgesia. Morphine and fentanyl are commonly used opioids for this purpose. In cesarean sections, intrathecal morphine (ITM) is preferred for postoperative analgesia due to its slow onset and long-term analgesia, and intrathecal fentanyl is preferred for intraoperative analgesia due to its faster onset of action. ITM can cause side effects such as nausea, vomiting, itching, sedation and respiratory depression. The quality of analgesia and the incidence of side effects may vary depending on the ITM dose used. There are studies indicating that reducing the dose of ITM results in good quality, long-term analgesia with a low incidence of side effects. However, the ideal dose of ITM providing optimal postoperative analgesia with the lowest incidence of side effects for cesarean section has not been determined yet in the literature. For this purpose, in this study it was compared the postoperative analgesia efficiency and incidence of side effects of three different ITM doses in order to contribute to the literature. Patients were divided into three groups: Group 1: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine was administered. Group 2: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine was administered. Group 3: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine was administered. All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively. Inclusion Criteria: - Patient undergoing cesarean section - Between the ages of 18-40, - ASA II, - Pregnant women with gestational week > 36 Exclusion Criteria: - Not accepting regional anesthesia, - İnfection at the injection site, - Coagulopathy, bleeding diathesis, - Severe hypovolemia, - İncrease in intracranial pressure, - Pregnant women with problems such as severe aortic stenosis, severe mitral stenosis for which spinal anesthesia is contraindicated, - Patients with a history of allergy to any drug included in the study protocol

NCT0531xxxx/NCT05317585.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/NCT05317585</url> </required_header> <id_info> <org_study_id>00000334</org_study_id> <nct_id>NCT05317585</nct_id> </id_info> <brief_title>Continuous Glucose Monitor Use in Pregnancy</brief_title> <official_title>Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>University of Massachusetts, Worcester</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Massachusetts, Worcester</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_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this study is to perform a randomized controlled trial among 162 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes. </textblock> </brief_summary> <detailed_description> <textblock> A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology.  The study team therefore propose to perform a randomized controlled trial among 162 pregnant women with T2DM comparing CGM use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">January 1, 2024</start_date> <completion_date type="Anticipated">July 1, 2027</completion_date> <primary_completion_date type="Anticipated">July 1, 2026</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>This is a prospective, single center, randomized study evaluating pregnancy glycemic monitoring strategies between women with continuous glucose monitors and standard of care fingerstick glucose monitoring.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Large for Gestational Age Infant</measure> <time_frame>Within 2 hours of birth</time_frame> <description>The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery.</description> </primary_outcome> <secondary_outcome> <measure>Third Trimester Hemoglobin A1c</measure> <time_frame>Between 28 weeks and delivery</time_frame> <description>Third Trimester Hemoglobin A1c</description> </secondary_outcome> <secondary_outcome> <measure>Mode of Delivery</measure> <time_frame>At delivery</time_frame> <description>Mode of delivery (vaginal versus cesarean)</description> </secondary_outcome> <secondary_outcome> <measure>Hypertensive Disorders of Pregnancy</measure> <time_frame>After 20 weeks of gestation until delivery</time_frame> <description>Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation</description> </secondary_outcome> <secondary_outcome> <measure>Preterm Birth</measure> <time_frame>At delivery</time_frame> <description>Preterm birth (delivery less than 37 weeks gestation)</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants with a shoulder dystocia</measure> <time_frame>At delivery</time_frame> <description>Number of participants with a shoulder dystocia</description> </secondary_outcome> <secondary_outcome> <measure>Neonatal Intensive Care Unit Admission (NICU)</measure> <time_frame>At delivery and within first 2 days of life</time_frame> <description>Neonatal Intensive Care Unit Admission (NICU)</description> </secondary_outcome> <secondary_outcome> <measure>Neonatal Respiratory Distress</measure> <time_frame>At delivery</time_frame> <description>Neonatal Respiratory Distress requiring respiratory support</description> </secondary_outcome> <secondary_outcome> <measure>APGAR less than 7 at 5 minutes of life</measure> <time_frame>5 Minutes after Delivery</time_frame> <description>APGAR score less than 7 at 5 minutes of life</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants with neonatal hypoglycemia</measure> <time_frame>Within 2 hours of birth</time_frame> <description>Number of participants with neonatal hypoglycemia as defined by first neonatal blood sugar obtained within 2 hours of birth</description> </secondary_outcome> <secondary_outcome> <measure>Gestational age at delivery</measure> <time_frame>At Delivery</time_frame> <description>Gestational age at delivery</description> </secondary_outcome> <secondary_outcome> <measure>Maternal Patient Satisfaction Survey with Glucose Monitoring</measure> <time_frame>postpartum day 1 after delivery</time_frame> <description>This will be assessed by the glucose monitoring satisfaction survey (GMSS) version 2. Participants will complete the survey, which contains 4 subscales and a total score. The subscales assess openness, emotional burden, behavioral burden, and worthwhileness. The higher the score the greater the satisfaction, with a total maximum score 75.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">162</enrollment> <condition>Type 2 Diabetes Treated With Insulin</condition> <condition>Pregnancy, High Risk</condition> <arm_group> <arm_group_label>Continuous Glucose Monitoring (CGM)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.</description> </arm_group> <arm_group> <arm_group_label>Fingerstick Glucose Monitoring</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Continuous Glucose Monitor</intervention_name> <description>Continuous Glucose Monitor</description> <arm_group_label>Continuous Glucose Monitoring (CGM)</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)</intervention_name> <description>Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)</description> <arm_group_label>Fingerstick Glucose Monitoring</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:  - 1) age greater than or equal to 18 years old  - 2) singleton gestation less than or equal to 14 weeks at initial obstetric visit  - 3) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL  - 4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC  - 5) able and willing to provide informed consent  Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:  - 1) known diagnosis of type 1 diabetes or gestational diabetes  - 2) plan to receive prenatal care or delivery outside of UMMHC  - 3) inability to provide informed consent  - 4) multifetal gestation </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>Gianna L Wilkie, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Massachusetts, Worcester</affiliation> </overall_official> <overall_contact> <last_name>Gianna L Wilkie, MD</last_name> <phone>7743642523</phone> <email>Gianna.Wilkie@umassmemorial.org</email> </overall_contact> <overall_contact_backup> <last_name>Heidi Leftwich, DO</last_name> <email>Heidi.Leftwich@umassmemorial.org</email> </overall_contact_backup> <location> <facility> <name>University of Massachusetts Memorial Medical Center</name> <address> <city>Worcester</city> <state>Massachusetts</state> <zip>01605</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15. Erratum In: Lancet. 2017 Nov 25;390(10110):2346.</citation> <PMID>28923465</PMID> </reference> <reference> <citation>Voormolen DN, DeVries JH, Sanson RME, Heringa MP, de Valk HW, Kok M, van Loon AJ, Hoogenberg K, Bekedam DJ, Brouwer TCB, Porath M, Erdtsieck RJ, NijBijvank B, Kip H, van der Heijden OWH, Elving LD, Hermsen BB, Potter van Loon BJ, Rijnders RJP, Jansen HJ, Langenveld J, Akerboom BMC, Kiewiet RM, Naaktgeboren CA, Mol BWJ, Franx A, Evers IM. Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled trial. Diabetes Obes Metab. 2018 Aug;20(8):1894-1902. doi: 10.1111/dom.13310. Epub 2018 May 8.</citation> <PMID>29603547</PMID> </reference> <reference> <citation>Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24.</citation> <PMID>23349548</PMID> </reference> <reference> <citation>Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.</citation> <PMID>18818254</PMID> </reference> <verification_date>May 2023</verification_date> <study_first_submitted>March 29, 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 2, 2023</last_update_submitted> <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 3, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation> <investigator_full_name>Gianna Wilkie</investigator_full_name> <investigator_title>Clinical Fellow in Maternal Fetal Medicine</investigator_title> </responsible_party> <keyword>Type 2 diabetes</keyword> <keyword>Pregnancy</keyword> <condition_browse>  <mesh_term>Diabetes Mellitus, Type 2</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to perform a randomized controlled trial among 162 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes. A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology. The study team therefore propose to perform a randomized controlled trial among 162 pregnant women with T2DM comparing CGM use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes. Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria: - 1) age greater than or equal to 18 years old - 2) singleton gestation less than or equal to 14 weeks at initial obstetric visit - 3) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL - 4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC - 5) able and willing to provide informed consent Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria: - 1) known diagnosis of type 1 diabetes or gestational diabetes - 2) plan to receive prenatal care or delivery outside of UMMHC - 3) inability to provide informed consent - 4) multifetal gestation

NCT0531xxxx/NCT05317598.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/NCT05317598</url> </required_header> <id_info> <org_study_id>KÜBGÜ</org_study_id> <nct_id>NCT05317598</nct_id> </id_info> <brief_title>The Key Model Of Courtesy And Integrıty</brief_title> <acronym>KMCI</acronym> <official_title>The Effect Of Posıtıve Psychotherapy-Based Courtesy And Honesty Psycoeducatıon On Effectıve Communıcatıon Skılls In Nursıng Students: The Key Model Of Courtesy And Integrıty</official_title> <sponsors> <lead_sponsor> <agency>Ondokuz Mayıs University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Ondokuz Mayıs 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> Backround: Positive psychotherapy (PPT) divides conflicts into three. One of these conflicts is the key conflicts that occur frequently in daily life and arise from the unbalanced use of courtesy and honesty. Avoiding key conflicts depends on the balanced use of courtesy and honesty. Nursing students' balance of courtesy and honesty while communicating will reduce key conflicts and increase the level of effective communication skills. This is important in terms of making a significant contribution to the quality of nursing care. Objectives: This research was conducted to determine the effect of PPT-based kindness and honesty psychoeducation on the level of effective communication skills of nursing students. Design: The study is a randomized controlled, pretest-posttest design, and a single-blind study. Settings and participants: This research will conduct with 64 undergraduate nursing students who took a psychiatric nursing course. Methods: Students will divid into intervention and control groups by simple randomization method. "Personal information form and effective communication skills scale" will apply to the intervention and control groups. After the pre-measurements will apply, the intervention group received courtesy and honesty key (KMCI) psychoeducation for 5 weeks, and no intervention will apply to the control group. Afterwards, a post-test will apply to both groups.  Key words: Positive psychotherapy, effective communication skills, nursing students, psychoeducation, courtesy and honesty. </textblock> </brief_summary> <detailed_description> <textblock> Positive psychotherapy (PPT) is a humanistic-based, universal type of therapy derived from the positive psychology movement and developed by Nossrat Pessechkian in Germany in the 1960s. Although positive psychotherapy is basically based on analytical psychotherapies, it includes therapy approaches such as gestalt therapy and existential therapy and exhibits an eclectic approach with its unique methods. Among the basic concepts of positive psychotherapy are the capacities to love and to know, which are thought to be the two basic abilities that every person is born with. Later, he argues that these two basic abilities turn into other sub-skills over time and that many conflicts in daily life arise from the development of these abilities more or less. Conflicts have an important place in positive psychotherapy. It divides it into three main conflicts: real, fundamental and key conflict. The conflicts that the individual has experienced in daily life are real conflicts; Conflicts between primary or secondary abilities are expressed as basic conflicts. In this study, the conflict of courtesy and honesty, which is one of the key conflicts, is discussed. In terms of positive psychotherapy, the concept of honesty means that individuals are open. When individuals believe that openness and honesty are more important than being respectful of others, they openly express their opinions in a very open and direct way. This means that they use their honesty skills at a high level. Treating others with respect and courtesy is defined as courtesy. Courtesy is also a concept that is considered in the communication process. At this point, courtesy; It means to communicate by considering the feelings of the other people . Overuse of courtesy leads to the inability of the person to express himself honestly and to the role of victim, while overuse of the ability of honesty causes him to turn into a rudeness devoid of courtesy and to play an oppressive role. Therefore, the balanced use of courtesy and honesty skills is important. A courtesy that lacks honesty or a courtesy that does not contain honesty appears as a conflict in communication and interpersonal relations. Key conflicts between people are likely to occur frequently in daily life. Skills studies are carried out in positive psychotherapy in order to ensure the balanced use of honesty and courtesy skills in individuals. E.g; Raising awareness about the use of kindness and honesty skills and developing effective communication skills are the working subjects of positive psychotherapy.  Being able to communicate effectively is closely related to the balanced use of courtesy and honesty skills. Because, among the conditions of effective communication, it is emphasized that people should not play the role of oppressor or victim while expressing themselves. The ability to communicate effectively has a critical importance for professional groups such as nursing, which is based on human-to-human relations. It is very important for nurses to establish healthy and effective communication with the patient they care for, and to use their honesty and courtesy skills in a balanced way while establishing this communication. In the researches, it is seen that the skills of conflict management, problem solving and effective communication in the basic steps of effective communication are not at the desired level. It has been determined that they have difficulties in communicating especially with patients and their familie. However, in order to provide quality and qualified care to sick or healthy individuals with different needs; It is expected that they will be able to communicate effectively with them, use their courtesy-honest skills in a measured way, or gain the skills to manage crisis/conflict situations in a healthy way. In this context, students should have a high level of developing positive behaviors in interpersonal relations, establishing a balance of kindness and honesty in communication, overcoming conflicts easily, and thus establishing effective communication skills. For this reason, it is thought that the psychoeducation program will be effective in facilitating effective communication skills. When the literature is examined, it is seen that psychoeducation is very beneficial for students. When the international or national literature on positive psychotherapy is examined, it is seen that researches mostly consist of subjects such as creating life goals, depression, motivation to quit smoking, and creating a life purpose. However, it is seen that the studies on the key conflict issue are quite limited in the literature. It is also known that PPT has only just begun to enter the nursing literature. Therefore, this research is important both in terms of contributing to the nursing literature and in terms of its originality.  The aim of this study is to determine the effect of kindness and honesty key psychoeducation based on positive psychotherapy on effective communication skills in nursing students </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">June 15, 2022</start_date> <completion_date type="Anticipated">August 15, 2022</completion_date> <primary_completion_date type="Anticipated">July 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> <intervention_model_description>This study is a randomized controlled trial with a single-blind, pre-test post-test design.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Double (Participant, Investigator)</masking> <masking_description>Participants in the pre-randomization study, two of the researchers, and the statistician will be blinded.</masking_description> </study_design_info> <primary_outcome> <measure>effective communication skills</measure> <time_frame>5 weeks</time_frame> <description>According to the initial level of nursing students, the increase in the level of effective communication skills within the 5-week psychoeducation process was evaluated using the effective communication skills scale.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">24</enrollment> <condition>Psychotherapy</condition> <condition>Communication</condition> <arm_group> <arm_group_label>Intervention group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Students in the intervention group will be given a 5-week positive psychotherapy-based kindness and honesty psychoeducation.</description> </arm_group> <arm_group> <arm_group_label>control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Students in the control group will not receive any intervention during the 5-week period.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Kindness and honesty psychoeducation based on positive psychotherapy: The Key Model Of Courtesy And Integrity (KMCI)</intervention_name> <description>It is an application that investigates the effect of kindness and honesty psychoeducation based on positive psychotherapy on effective communication skills of nursing students.</description> <arm_group_label>Intervention group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Being registered in the psychiatric nursing course and actively participating in the classes  - Being between the ages of 18-65  - Persons with computer/smartphone and internet access.  Exclusion Criteria:  - Students who did not meet the inclusion criteria,  - Did not complete the five-week pretest and posttest measurements,  - Did not actively continue the psychoeducation process,  - Did not have the necessary computer/smartphone and internet access to participate in the online psychoeducation program </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>Eda ALBAYRAK, MSc</last_name> <role>Study Chair</role> <affiliation>TC Erciyes University</affiliation> </overall_official> <overall_contact> <last_name>kübra GÜLIRMAK, MSc</last_name> <phone>05538501324</phone> <phone_ext>03623121919</phone_ext> <email>k_1058_g@hotmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Serap GÜLEÇ KESKİN, PhD</last_name> </overall_contact_backup> <location> <facility> <name>Kübra Gülırmak</name> <address> <city>Samsun</city> <state>Atakum</state> <zip>55000</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <results_reference> <citation>Rashid, T. (2015). Positive psychotherapy: A strength-based approach. The Journal of Positive Psychology, 10(1), 25-40.</citation> </results_reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 10, 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>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 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>Ondokuz Mayıs University</investigator_affiliation> <investigator_full_name>Kubra Gulırmak</investigator_full_name> <investigator_title>Research assistant in psychiatric nursing department</investigator_title> </responsible_party> <keyword>Efective communication skills</keyword> <keyword>positive psychotherapy</keyword> <keyword>nursing students</keyword> <keyword>psychoeducation</keyword> <keyword>kindness and honesty.</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Backround: Positive psychotherapy (PPT) divides conflicts into three. One of these conflicts is the key conflicts that occur frequently in daily life and arise from the unbalanced use of courtesy and honesty. Avoiding key conflicts depends on the balanced use of courtesy and honesty. Nursing students' balance of courtesy and honesty while communicating will reduce key conflicts and increase the level of effective communication skills. This is important in terms of making a significant contribution to the quality of nursing care. Objectives: This research was conducted to determine the effect of PPT-based kindness and honesty psychoeducation on the level of effective communication skills of nursing students. Design: The study is a randomized controlled, pretest-posttest design, and a single-blind study. Settings and participants: This research will conduct with 64 undergraduate nursing students who took a psychiatric nursing course. Methods: Students will divid into intervention and control groups by simple randomization method. "Personal information form and effective communication skills scale" will apply to the intervention and control groups. After the pre-measurements will apply, the intervention group received courtesy and honesty key (KMCI) psychoeducation for 5 weeks, and no intervention will apply to the control group. Afterwards, a post-test will apply to both groups. Key words: Positive psychotherapy, effective communication skills, nursing students, psychoeducation, courtesy and honesty. Positive psychotherapy (PPT) is a humanistic-based, universal type of therapy derived from the positive psychology movement and developed by Nossrat Pessechkian in Germany in the 1960s. Although positive psychotherapy is basically based on analytical psychotherapies, it includes therapy approaches such as gestalt therapy and existential therapy and exhibits an eclectic approach with its unique methods. Among the basic concepts of positive psychotherapy are the capacities to love and to know, which are thought to be the two basic abilities that every person is born with. Later, he argues that these two basic abilities turn into other sub-skills over time and that many conflicts in daily life arise from the development of these abilities more or less. Conflicts have an important place in positive psychotherapy. It divides it into three main conflicts: real, fundamental and key conflict. The conflicts that the individual has experienced in daily life are real conflicts; Conflicts between primary or secondary abilities are expressed as basic conflicts. In this study, the conflict of courtesy and honesty, which is one of the key conflicts, is discussed. In terms of positive psychotherapy, the concept of honesty means that individuals are open. When individuals believe that openness and honesty are more important than being respectful of others, they openly express their opinions in a very open and direct way. This means that they use their honesty skills at a high level. Treating others with respect and courtesy is defined as courtesy. Courtesy is also a concept that is considered in the communication process. At this point, courtesy; It means to communicate by considering the feelings of the other people . Overuse of courtesy leads to the inability of the person to express himself honestly and to the role of victim, while overuse of the ability of honesty causes him to turn into a rudeness devoid of courtesy and to play an oppressive role. Therefore, the balanced use of courtesy and honesty skills is important. A courtesy that lacks honesty or a courtesy that does not contain honesty appears as a conflict in communication and interpersonal relations. Key conflicts between people are likely to occur frequently in daily life. Skills studies are carried out in positive psychotherapy in order to ensure the balanced use of honesty and courtesy skills in individuals. E.g; Raising awareness about the use of kindness and honesty skills and developing effective communication skills are the working subjects of positive psychotherapy. Being able to communicate effectively is closely related to the balanced use of courtesy and honesty skills. Because, among the conditions of effective communication, it is emphasized that people should not play the role of oppressor or victim while expressing themselves. The ability to communicate effectively has a critical importance for professional groups such as nursing, which is based on human-to-human relations. It is very important for nurses to establish healthy and effective communication with the patient they care for, and to use their honesty and courtesy skills in a balanced way while establishing this communication. In the researches, it is seen that the skills of conflict management, problem solving and effective communication in the basic steps of effective communication are not at the desired level. It has been determined that they have difficulties in communicating especially with patients and their familie. However, in order to provide quality and qualified care to sick or healthy individuals with different needs; It is expected that they will be able to communicate effectively with them, use their courtesy-honest skills in a measured way, or gain the skills to manage crisis/conflict situations in a healthy way. In this context, students should have a high level of developing positive behaviors in interpersonal relations, establishing a balance of kindness and honesty in communication, overcoming conflicts easily, and thus establishing effective communication skills. For this reason, it is thought that the psychoeducation program will be effective in facilitating effective communication skills. When the literature is examined, it is seen that psychoeducation is very beneficial for students. When the international or national literature on positive psychotherapy is examined, it is seen that researches mostly consist of subjects such as creating life goals, depression, motivation to quit smoking, and creating a life purpose. However, it is seen that the studies on the key conflict issue are quite limited in the literature. It is also known that PPT has only just begun to enter the nursing literature. Therefore, this research is important both in terms of contributing to the nursing literature and in terms of its originality. The aim of this study is to determine the effect of kindness and honesty key psychoeducation based on positive psychotherapy on effective communication skills in nursing students Inclusion Criteria: - Being registered in the psychiatric nursing course and actively participating in the classes - Being between the ages of 18-65 - Persons with computer/smartphone and internet access. Exclusion Criteria: - Students who did not meet the inclusion criteria, - Did not complete the five-week pretest and posttest measurements, - Did not actively continue the psychoeducation process, - Did not have the necessary computer/smartphone and internet access to participate in the online psychoeducation program

NCT0531xxxx/NCT05317611.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/NCT05317611</url> </required_header> <id_info> <org_study_id>9286-23-2-2022</org_study_id> <nct_id>NCT05317611</nct_id> </id_info> <brief_title>Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries.</brief_title> <official_title>Intravenous Versus Intraperitoneal Instillation of Ondansetron for Decreasing Incidence of Nausea and Vomiting After Laparoscopic Gynecological Surgeries: A Randomized Controlled Study</official_title> <sponsors> <lead_sponsor> <agency>Zagazig University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Zagazig 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> Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries. </textblock> </brief_summary> <detailed_description> <textblock> Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting.  There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain).  Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">October 15, 2022</completion_date> <primary_completion_date type="Anticipated">October 1, 2022</primary_completion_date> <phase>Early Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic gynecological surgeries.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> <masking_description>Outcome assessor (anesthesiologist not sharing in the study) will assess outcome parameters</masking_description> </study_design_info> <primary_outcome> <measure>measure incidence and severity of postoperative nausea and vomiting</measure> <time_frame>24 hours postoperative</time_frame> <description>using Rohdes Index of Nausea, Vomiting, and Retching it is questionnaire of 8 items with minimum score =0 and maximum score =4 for each item.</description> </primary_outcome> <secondary_outcome> <measure>measure total numbers of rescue antiemetic</measure> <time_frame>all over 24 hours postoperative.</time_frame> <description>patients will receive 10 mg intravenous metoclopramide as rescue antiemetic immediately</description> </secondary_outcome> <secondary_outcome> <measure>Duration of hospital stay</measure> <time_frame>24 hours to 72 hours</time_frame> <description>time from PACU discharge till time to discharge home</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">63</enrollment> <condition>Prevention</condition> <arm_group> <arm_group_label>Intraperitoneal instillation of ondansetron and bupivacaine (group A)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % and (4 mg) 2 ml ondansetron through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.</description> </arm_group> <arm_group> <arm_group_label>Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patient will receive intravenous (4 mg) 2 ml ondansetron and intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.</description> </arm_group> <arm_group> <arm_group_label>Intraperitoneal instillation of bupivacaine (group C)</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>patient will receive intraperitoneal instillation of (100 mg) 20 ml of bupivacaine 0.5 % through abdominal ports by simple instillation technique before removal of trocars then clamping of abdominal drains for 1h to avoid drainage of LA.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Intraperitoneal instillation of ondansetron and bupivacaine</intervention_name> <description>The aim is to detect the effect of intraperitoneal instillation of ondansetron for prevention of postoperative nausea and vomiting</description> <arm_group_label>Intraperitoneal instillation of ondansetron and bupivacaine (group A)</arm_group_label> <other_name>Intraperitoneal instillation of zofran and marcaine</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Intravenous ondansetron and intraperitoneal instillation of bupivacaine</intervention_name> <description>The aim is to detect effect of intravenous ondansetron for prevention of postoperative nausea and vomiting</description> <arm_group_label>Intravenous ondansetron and intraperitoneal instillation of bupivacaine (group B)</arm_group_label> <other_name>Intravenous zofran and intraperitoneal instillation of marcaine</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Intraperitoneal instillation of bupivacaine</intervention_name> <description>The aim is to detect effect of intraperitoneal instillation of bupivacaine</description> <arm_group_label>Intraperitoneal instillation of bupivacaine (group C)</arm_group_label> <other_name>Intraperitoneal instillation of marcaine</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Written informed consent from the patient.  - Age: 21-45 years old.  - Both sex.  - Physical status: ASA 1& II.  - BMI = (25-35 kg/m2).  - Type of operation: elective laparoscopic gynecological surgeries.  Exclusion Criteria:  - Altered mental state.  - Patients with known history of allergy to the study drugs.  - Advanced hepatic, renal, cardiovascular, and respiratory diseases.  - Patients with chronic pain received NSAID or opioid during previous two weeks.  - Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery. </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <verification_date>April 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>Principal Investigator</responsible_party_type> <investigator_affiliation>Zagazig University</investigator_affiliation> <investigator_full_name>Dina Abdelhameed Elsadek Salem</investigator_full_name> <investigator_title>principle investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Vomiting</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Ondansetron</mesh_term> <mesh_term>Bupivacaine</mesh_term> </intervention_browse>  </clinical_study>

Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries. Laparoscopic surgeries have many advantages e.g., decreasing postoperative pain, better cosmetic, rapid recovery, and better recovery but also, it has side effects e.g., pain, postoperative nausea and vomiting. There are many risk factors that cause PONV either patient related factors or anesthesia related factors (opioids, inhalational anesthetics, Nitrous oxide and duration of anesthesia) and surgery related factors (intraabdominal, laparoscopic, postoperative pain). Intraperitoneal instillation of drugs can be used for instillation of LA, opoids, ketamine and antiemetics to provide analgesia and manage side effects of laparoscopic surgery. The mechanism of action of ondansetron is inhibition of presynaptic 5-HT3 receptors that located in the peripheral nervous. Study the effect of intraperitoneal instillation vs intravenous ondansetron on PONV added to intraperitoneal bupivacaine for enhanced recovery and to decrease incidence of PONV after laparoscopic surgeries. Inclusion Criteria: - Written informed consent from the patient. - Age: 21-45 years old. - Both sex. - Physical status: ASA 1& II. - BMI = (25-35 kg/m2). - Type of operation: elective laparoscopic gynecological surgeries. Exclusion Criteria: - Altered mental state. - Patients with known history of allergy to the study drugs. - Advanced hepatic, renal, cardiovascular, and respiratory diseases. - Patients with chronic pain received NSAID or opioid during previous two weeks. - Patients with history of PONV or motion sickness and patients received antiemetic therapy 24 h before the surgery.

NCT0531xxxx/NCT05317624.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/NCT05317624</url> </required_header> <id_info> <org_study_id>0201491</org_study_id> <nct_id>NCT05317624</nct_id> </id_info> <brief_title>Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief</brief_title> <acronym>PRP</acronym> <official_title>Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears</official_title> <sponsors> <lead_sponsor> <agency>Alexandria University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Alexandria University</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> Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears </textblock> </brief_summary> <detailed_description> <textblock> The effect of injection of platelet rich plasma will be compared with effects of steroids injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in both groups.  30 patient in each group will be included </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">August 10, 2021</start_date> <completion_date type="Actual">February 1, 2023</completion_date> <primary_completion_date type="Actual">November 1, 2022</primary_completion_date> <phase>Early Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>2 groups will be included</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Shoulder pain assesment</measure> <time_frame>4 months</time_frame> <description>The pain will be assessed using visual analogue scale( score range=0-10,less than 4,4-6 and more than 6 for mild, moderate and severe pain respectively)</description> </primary_outcome> <secondary_outcome> <measure>Assesment of rotator cuff tendon healing</measure> <time_frame>4 months</time_frame> <description>assesment healing process of tendon using ultrasound technique</description> </secondary_outcome> <secondary_outcome> <measure>Assesment the failure rate after shoulder joint injection</measure> <time_frame>4 months</time_frame> <description>failure of relief the symptoms after shoulder joint injection will be recorded</description> </secondary_outcome> <secondary_outcome> <measure>The reinjection rate recording</measure> <time_frame>4 months</time_frame> <description>the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded</description> </secondary_outcome> <secondary_outcome> <measure>Assesment the rate of tear recurrence after shoulder joint injection</measure> <time_frame>4 months</time_frame> <description>The rate of tear recurrence after 4 months of injection will be assessed using MRI or US</description> </secondary_outcome> <secondary_outcome> <measure>Simple shoulder assessment test</measure> <time_frame>4 months</time_frame> <description>Functional assessment of shoulder joint will be done using simple sholder assessment test 0= maximal disability 20% -40% = crippled 40% -60% = severe disability 60% -80% = moderate disability 100% = no disability</description> </secondary_outcome> <other_outcome> <measure>Measurement plasma C-Reactive Protein level</measure> <time_frame>4 months</time_frame> <description>The plasma C- Reactive Protein level will be measured prior to injection and 4 months later on after the procedure</description> </other_outcome> <other_outcome> <measure>Measurement the fasting blood glucose level</measure> <time_frame>one week</time_frame> <description>The fasting blood glucose level will be measure prior to and one week later after injection</description> </other_outcome> <other_outcome> <measure>Assesment the complications after shoulder joint injection</measure> <time_frame>4 months</time_frame> <description>Complications that might occur after shoulder joint injection such as infection, elevated blood sugar, allergy, nerve injury, nausea and vomiting will be recorded</description> </other_outcome> <other_outcome> <measure>Measurement the serum cortisol level</measure> <time_frame>one week</time_frame> <description>Early morning(8 am serum cortisol level) will be measured before the injection and one week later after injection</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">60</enrollment> <condition>Shoulder Pain</condition> <arm_group> <arm_group_label>Platelet rich plasma group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>participants will receive Ultrasound guided subacromial injection of 3 ml platelet rich plasma+0.5 ml of PRP activator (10% calcium gluconate)+ 1ml 0.5%bupivacaine.</description> </arm_group> <arm_group> <arm_group_label>Methylprednisolone group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.</description> </arm_group> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>Platelet rich plasma</intervention_name> <description>platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine</description> <arm_group_label>Platelet rich plasma group</arm_group_label> <other_name>PRP group</other_name> </intervention> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>Methylprednisolone</intervention_name> <description>1ml methyl prednisolone 40mg\ml mixed with normal saline and bupivacaine</description> <arm_group_label>Methylprednisolone group</arm_group_label> <other_name>steroids group</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patients with positive tests for rotator cuff pain  2. Patients with positive radiological (US or MRI) findings of partial rotator cuff tear  Exclusion Criteria:  1. Patient refusal  2. Age less than 20 years.  3. Infection at injection site.  4. Prior surgery on the shoulder joint area.  5. Presence of other associated pathology in the shoulder joint  6. Patients using antiplatelet drugs (aspirin).  7. Contraindications to the use of platelet concentrate  8. Contraindications to the steroids injection </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Dorreya Fikry</last_name> <role>Principal Investigator</role> <affiliation>AlexandriaUniversity</affiliation> </overall_official> <overall_official> <last_name>Tarek Sarhan</last_name> <role>Study Director</role> <affiliation>AlexandriaUniversity</affiliation> </overall_official> <location> <facility> <name>Facility of medicine</name> <address> <city>Alexandria</city> <zip>21519</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>July 19, 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>April 2, 2023</last_update_submitted> <last_update_submitted_qc>April 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 4, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Alexandria University</investigator_affiliation> <investigator_full_name>radwa saber</investigator_full_name> <investigator_title>Radwa saber</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Shoulder Pain</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Methylprednisolone</mesh_term> <mesh_term>Methylprednisolone Acetate</mesh_term> <mesh_term>Methylprednisolone Hemisuccinate</mesh_term> <mesh_term>Prednisolone</mesh_term> <mesh_term>Prednisolone acetate</mesh_term> <mesh_term>Prednisolone hemisuccinate</mesh_term> <mesh_term>Prednisolone phosphate</mesh_term> </intervention_browse>  </clinical_study>

Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears The effect of injection of platelet rich plasma will be compared with effects of steroids injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in both groups. 30 patient in each group will be included Inclusion Criteria: 1. Patients with positive tests for rotator cuff pain 2. Patients with positive radiological (US or MRI) findings of partial rotator cuff tear Exclusion Criteria: 1. Patient refusal 2. Age less than 20 years. 3. Infection at injection site. 4. Prior surgery on the shoulder joint area. 5. Presence of other associated pathology in the shoulder joint 6. Patients using antiplatelet drugs (aspirin). 7. Contraindications to the use of platelet concentrate 8. Contraindications to the steroids injection

NCT0531xxxx/NCT05317637.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/NCT05317637</url> </required_header> <id_info> <org_study_id>H49848</org_study_id> <nct_id>NCT05317637</nct_id> </id_info> <brief_title>Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708</brief_title> <official_title>Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708</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> Osteogenesis imperfecta (OI) is a group of congenital and heritable bone disorders that currently affects at least 50,000 people in the United States. OI varies in severity from perinatally lethal to mild forms. The majority of cases is caused by a dominant mutation in type I collagen genes (COL1α1 and COL1α2), altering the quantity or quality of type I collagen.  Although OI is typically characterized as a disease of the bone, it is perhaps more accurately described as a connective tissue disorder. Type I collagen is a major constituent of lung connective tissue. Respiratory insufficiency is the leading cause of death in patients with OI. Thus, it is important and necessary to understand the etiology of the restrictive pulmonary physiology in the OI population. </textblock> </brief_summary> <detailed_description> <textblock> This study is cross-sectional. At the participant's one study visit, data will be obtained at a single point in time and reflect the patients' current condition. Evaluations will include family and medical history, self-report questionnaires, physical evaluation, diagnostic studies, and radiographic studies. Eighteen participants will be enrolled, ideally within one year. Participants will be enrolled regardless of OI type since Bronchial Wall Thickening, a finding we are attempting to validate, was observed in all types of OI. Interested males with OI will be preferred over females to compensate for our highly female original cohort and determine if sexual dimorphism exists for cardiopulmonary outcomes in people with OI. Smokers will not be excluded. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">August 1, 2022</start_date> <completion_date type="Anticipated">September 1, 2026</completion_date> <primary_completion_date type="Anticipated">December 1, 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>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>proportion of restrictive lung physiology</measure> <time_frame>12 months</time_frame> <description>FEV1/FVC greater than or equal to 80%, which is obtained from PFT</description> </primary_outcome> <secondary_outcome> <measure>Presence and severity of Bronchial Wall Thickening</measure> <time_frame>12 months</time_frame> <description>measurement of percent of bronchial diameter subsumed by wall thickness</description> </secondary_outcome> <secondary_outcome> <measure>Vital lung capacity</measure> <time_frame>12 months</time_frame> <description>Vital capacity/total lung capacity/chest volume prediction based on 1) readings by trained chest CT readers and 2) 3-D lung imaging calculation</description> </secondary_outcome> <secondary_outcome> <measure>Presences of pulmonary fibrosis</measure> <time_frame>12 months</time_frame> <description>Presence of pulmonary fibrosis based on readings by trained chest CT readers</description> </secondary_outcome> <secondary_outcome> <measure>Change in lung tissue</measure> <time_frame>12 months</time_frame> <description>location of bronchiectasis, and presence of atelectasis based on readings by trained chest CT readers</description> </secondary_outcome> <other_outcome> <measure>Scoliosis</measure> <time_frame>12 months</time_frame> <description>Measurement of spinal scoliosis, kyphosis, lordosis and vertebral fractures including curve measurement based on standing plane films of thorax/abdomen exposed for bone imaging</description> </other_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">18</enrollment> <condition>Osteogenesis Imperfecta</condition> <arm_group> <arm_group_label>Adults with OI</arm_group_label> <description>18 participants will be enrolled through in this pilot study. Interested males with OI will be preferred over females to compensate for our highly female original cohort and determine if sexual dimorphism exists for cardiopulmonary outcomes in people with OI. This study is cross-sectional. At the participant's one study visit, data will be obtained at a single point in time and reflect the patients' current condition. All efforts will be made to complete all data collection and testing on the same day. However, procedures completed within ±12 months will be accepted. Evaluations will include family and medical history, self-report questionnaires, physical evaluation, diagnostic studies, and radiographic studies. Participants will be enrolled regardless of OI type since BWT, a finding we are attempting to validate, was observed in all types of OI. Smokers will not be excluded.</description> </arm_group> <eligibility> <study_pop> <textblock> Individuals with Osteogenesis Imperfecta </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Individuals who are able to give informed consent or have a legally authorized representative capable of giving consent on the subject's behalf  - Individuals ages 18 and older of all races and sexes  - Individuals who have been diagnosed with OI clinically and/or genetically  Exclusion Criteria:  - Individuals diagnosed with respiratory illness within 6 weeks of enrollment or undergoing diagnostic studies for an active illness.  - Individuals with other skeletal dysplasia or genetic diagnosis  - Individuals diagnosed with cardiopulmonary comorbidities that affect lung compliance </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_official> <last_name>Vernon Sutton, MD</last_name> <role>Principal Investigator</role> <affiliation>Baylor College of Medicine</affiliation> </overall_official> <overall_official> <last_name>Kathleen Raggio</last_name> <role>Study Chair</role> <affiliation>Hospital for Special Surgery, New York</affiliation> </overall_official> <overall_contact> <last_name>Holly Loturco</last_name> <phone>212.774.2355</phone> <email>loturcoh@HSS.EDU</email> </overall_contact> <location> <facility> <name>University of California Los Angeles</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90095</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sarah Gaunt</last_name> <email>UCLAOIstudies@mednet.ucla.edu</email> </contact> <investigator> <last_name>Deborah Krakow, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Kennedy Krieger Institute / Hugo W. Moser Research Institute</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21205</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Andrea De La Torre, RN, BSN</last_name> <phone>667-205-4244</phone> <email>researchtrials@kennedykrieger.org</email> </contact> <investigator> <last_name>Mahim Jain, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Hospital for Special Surgery</name> <address> <city>New York</city> <state>New York</state> <zip>10021</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Erin Carter</last_name> <phone>212-774-7332</phone> <email>CarterE@HSS.EDU</email> </contact> <investigator> <last_name>Cathleen Raggio, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>August 23, 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>May 18, 2023</last_update_submitted> <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 19, 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>Brendan Lee</investigator_full_name> <investigator_title>Consortium PI</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Osteogenesis Imperfecta</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Osteogenesis imperfecta (OI) is a group of congenital and heritable bone disorders that currently affects at least 50,000 people in the United States. OI varies in severity from perinatally lethal to mild forms. The majority of cases is caused by a dominant mutation in type I collagen genes (COL1α1 and COL1α2), altering the quantity or quality of type I collagen. Although OI is typically characterized as a disease of the bone, it is perhaps more accurately described as a connective tissue disorder. Type I collagen is a major constituent of lung connective tissue. Respiratory insufficiency is the leading cause of death in patients with OI. Thus, it is important and necessary to understand the etiology of the restrictive pulmonary physiology in the OI population. This study is cross-sectional. At the participant's one study visit, data will be obtained at a single point in time and reflect the patients' current condition. Evaluations will include family and medical history, self-report questionnaires, physical evaluation, diagnostic studies, and radiographic studies. Eighteen participants will be enrolled, ideally within one year. Participants will be enrolled regardless of OI type since Bronchial Wall Thickening, a finding we are attempting to validate, was observed in all types of OI. Interested males with OI will be preferred over females to compensate for our highly female original cohort and determine if sexual dimorphism exists for cardiopulmonary outcomes in people with OI. Smokers will not be excluded. Individuals with Osteogenesis Imperfecta Inclusion Criteria: - Individuals who are able to give informed consent or have a legally authorized representative capable of giving consent on the subject's behalf - Individuals ages 18 and older of all races and sexes - Individuals who have been diagnosed with OI clinically and/or genetically Exclusion Criteria: - Individuals diagnosed with respiratory illness within 6 weeks of enrollment or undergoing diagnostic studies for an active illness. - Individuals with other skeletal dysplasia or genetic diagnosis - Individuals diagnosed with cardiopulmonary comorbidities that affect lung compliance

NCT0531xxxx/NCT05317650.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/NCT05317650</url> </required_header> <id_info> <org_study_id>21/128</org_study_id> <nct_id>NCT05317650</nct_id> </id_info> <brief_title>Effects Multi-Gravitational Suspension-Based Therapy</brief_title> <official_title>Effects Multi-Gravitational Suspension-Based Therapy on Posture, Physical Fitness, Quality of Life, Depression, and Sleep Quality in Women Without Regular Exercise Habits</official_title> <sponsors> <lead_sponsor> <agency>Atlas University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Atlas 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> Background: Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy.  Aims: To examine the effects of M-Gravity exercise on posture, physical fitness, quality of life, depression, and sleep quality in women without regular exercise habits.  Methods: This study was designed as a non-randomized controlled trial. This study included 20 women without regular exercise habits, who participated in the exercise with M-Gravity and 20 women who did not participate in any exercise program, a total of 40 participants. In this study, the investigators planned to evaluate the effects of M-Gravity on women without regular exercise habits. The following outcomes were measured: posture with the New York Posture Assessment Method, the flexibility of the hamstring and pectoral muscles, time is taken to stay in the plank position, depression levels with the Beck Depression Inventory scale, sleep quality is performed with the Pittsburgh Sleep Quality Index, and the Nottingham Health Profile (NHP) questionnaire to measure the perceived health levels of the subjects. The measurement of the contraction force of the deep lumbar muscles is performed with the Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). Two evaluations were made before and after 4 weeks of exercise. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">September 1, 2021</start_date> <completion_date type="Actual">February 28, 2022</completion_date> <primary_completion_date type="Actual">January 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>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>New York Posture Assessment Method</measure> <time_frame>4 weeks</time_frame> <description>The posture of the subjects participating in the study was evaluated with the New York Posture Assessment Method (NYPDY). In this evaluation system, postural changes that may occur in 13 different parts of the body were monitored and scored. Accordingly, five (5) points were given if the person's posture was correct, three (3) points if moderately impaired, and one (1) point if severely impaired. The total score obtained as a result of the test is a maximum of 65 and a minimum of 13. Standard evaluation criteria developed for this test were defined as "very good" if the total score is >=45, "good" if the score is 40-44, "moderate" if the score is 30-39, "fair" if the score is 20-29, and "poor" if the score is <=19</description> </primary_outcome> <primary_outcome> <measure>Pittsburgh Sleep Quality Index</measure> <time_frame>4 weeks</time_frame> <description>The Pittsburgh Sleep Quality Index, includes 19 questions and consists of seven items evaluating subjective sleep quality, sleep delay, sleep duration, sleep efficiency, sleep disturbance, use of sleeping pills, and impairment in daytime work. The response of each is scored between 0-3 according to symptom frequency. Scoring; 0 if it has never happened during the past month, 1 if it is less than once a week, 2 if it is once or twice a week, and 3 if it is three or more times a week. The sleep quality assessment asked in the questionnaire is; It is scored as 0 very good, 1 fairly good, 2 very badly, and 3 very badly. The obtained global score ranges from 0 to 21, and high values indicate poor sleep quality and high level of sleep disturbance. A global score of 5 or above indicates that the quality of sleep is clinically significantly worse.</description> </primary_outcome> <primary_outcome> <measure>Nottingham Health Profile</measure> <time_frame>4 weeks</time_frame> <description>The 'Nottingham Health Profile is a general quality of life questionnaire that measures the perceived health problems of the person and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health.</description> </primary_outcome> <primary_outcome> <measure>Stabilizer Pressure Biofeedback</measure> <time_frame>4 weeks</time_frame> <description>The measurement of the contraction force of the deep lumbar muscles is performed with the "Stabilizer Pressure Biofeedback" (Chattanooga Stabilizer). Before the test, each patient is taught how to tighten the Transversus Abdominous with the corset method in the supine and quadrupedal position. Subjects will be placed face down on an inflated pillow attached to a manometer</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Exercise</condition> <arm_group> <arm_group_label>Control group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Control group, no exercise was performed, and the measurements were repeated at the end of 4 weeks.</description> </arm_group> <arm_group> <arm_group_label>M-Gravity group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Intervention group performed the exercise with the M-Gravity, 2 sessions per week, for 4 weeks, at the Outpatient Clinic of Department of Physical Therapy, Baskent University, one session for 60 minutes.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Multi-gravitational suspension-based therapy (M-Gravity)</intervention_name> <description>Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy.</description> <arm_group_label>M-Gravity group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Sedentary women  Exclusion Criteria:  - Individuals with a physical, cardiac, or neurological disease that may interfere with our practices and assessments  - Pregnancy and post-natal individuals  - Individuals with scoliosis of 20 degrees or more  - Glaucoma  - Recent surgery (3-6 months waiting period according to surgery)  - Hypertension, exercise in the head-down position can cause an increase in blood pressure and a hypertensive crisis  - Impaired cerebral circulation  - Botox treatment in the last 6 hours  - Spinal fractures  - Severe osteoporosis  - Sequestered disc herniation  - Spinal tumors  - Inflammatory conditions of the spine  - Head injuries  - Previous myocardial infarction  - Vertigo </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>50 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Aybüke Ersin</name> <address> <city>İ̇stanbul</city> <state>Kağıthane</state> <zip>34408</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 2, 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>Atlas University</investigator_affiliation> <investigator_full_name>Aybuke Ersin</investigator_full_name> <investigator_title>Head of Physiotherapy and Rehabilitation Department</investigator_title> </responsible_party> <keyword>woman</keyword> <keyword>exercise</keyword> <keyword>posture</keyword> <keyword>physical fitness</keyword> <keyword>quality of life</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Background: Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy. Aims: To examine the effects of M-Gravity exercise on posture, physical fitness, quality of life, depression, and sleep quality in women without regular exercise habits. Methods: This study was designed as a non-randomized controlled trial. This study included 20 women without regular exercise habits, who participated in the exercise with M-Gravity and 20 women who did not participate in any exercise program, a total of 40 participants. In this study, the investigators planned to evaluate the effects of M-Gravity on women without regular exercise habits. The following outcomes were measured: posture with the New York Posture Assessment Method, the flexibility of the hamstring and pectoral muscles, time is taken to stay in the plank position, depression levels with the Beck Depression Inventory scale, sleep quality is performed with the Pittsburgh Sleep Quality Index, and the Nottingham Health Profile (NHP) questionnaire to measure the perceived health levels of the subjects. The measurement of the contraction force of the deep lumbar muscles is performed with the Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). Two evaluations were made before and after 4 weeks of exercise. Inclusion Criteria: - Sedentary women Exclusion Criteria: - Individuals with a physical, cardiac, or neurological disease that may interfere with our practices and assessments - Pregnancy and post-natal individuals - Individuals with scoliosis of 20 degrees or more - Glaucoma - Recent surgery (3-6 months waiting period according to surgery) - Hypertension, exercise in the head-down position can cause an increase in blood pressure and a hypertensive crisis - Impaired cerebral circulation - Botox treatment in the last 6 hours - Spinal fractures - Severe osteoporosis - Sequestered disc herniation - Spinal tumors - Inflammatory conditions of the spine - Head injuries - Previous myocardial infarction - Vertigo

NCT0531xxxx/NCT05317663.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/NCT05317663</url> </required_header> <id_info> <org_study_id>20B16</org_study_id> <nct_id>NCT05317663</nct_id> </id_info> <brief_title>Developing and Testing Waterpipe-specific Health Warning Labels</brief_title> <official_title>Developing and Testing Waterpipe-specific Health Warning Labels Targeting Young People in Florida</official_title> <sponsors> <lead_sponsor> <agency>Florida International University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Florida International 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> Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Evidence suggests WP use leads to nicotine addiction, and increases the risk of lung cancer, heart and respiratory disease and exposure to secondhand smoke. The spread of WP use among youth has been fueled by a misperception of reduced-harm compared to cigarettes. Health Warning Labels (HWLs) represent one of the most successful tobacco control strategies to communicate smoking- related risks, and studies have consistently shown that HWLs are associated with a decrease in smoking rates and smoking-related morbidity and mortality. Therefore, communicating WP risks to young people through HWLs has been identified as a priority by major health bodies in the US including the FDA.  Using the Delphi method among international tobacco control experts, our team has developed a set of 12 WP HWLs corresponding to 4 health themes; health risks/addiction, harm to others, WP-specific harm, WP harm compared to cigarettes. Building on this work, and using a mixed- method approach incorporating qualitative and quantitative research, the investigators propose to:  Aim 1: Adapt the 12 HWLs to young WP smokers in Florida using exploratory focus groups.  Aim 2: Test in a clinical lab experiment the performance of the top 4 HWLs on the WP device compared to no-HWL/control on harm perception, intention to quit, and toxicant exposure (Carbon monoxide (CO), nicotine, oxidative stress).  Aim 3: Use the knowledge obtained to advocate for the adoption of WP-HWLs policies and disseminate information about WP harmful effects to young people in Florida and nationally.  Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in Florida. This pioneering work will inform the FDA and public health advocates on the potential of WP-HWLs policies and provide a model for other states to respond to the WP epidemic. </textblock> </brief_summary> <detailed_description> <textblock> Our Team developed 12 pictorial Health Warning Labels (HWLs) for the waterpipe (WP) corresponding to 4 themes; health risks/addiction, harm to others, specific harm, and harm compared to cigarettes. The investigators will build on this work to advance HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally through the following specific aims:  1. Adapt the HWLs to young adults in Florida using focus groups. The investigators will conduct mixed- gender focus groups combined with brief survey with regular WP smokers (6-8 groups; n ≈ 65; age 18-29 yrs) to 1- adapt the 12 HWLs to our target population, 2- explore their optimal placement and size, and 3- select the top 4 HWLs for testing (Aim 2).  2. Test the top 4 HWLs in a clinical lab experiment. Using the top 4 HWLs on the device, the investigators will recruit 2 groups of WP smokers (n= 248; age 18-29 yrs) based on their use frequency (beginners, established) for a within- (HWL vs no-HWL; pre- vs post- smoking) and between-subject (beginner vs. established; 4 HWLs) experiment. Participants will be randomly assigned to one of the 4 HWLs conditions and undergo 2 smoking sessions that differ by HWL (HWL vs. no-HWL), with pre-post smoking assessment of harm perception, intention to quit, and toxicant exposure. Participants will receive a follow-up phone call 3- month after exposure to assess longer-term changes in quit attitude and behavior. The investigators hypothesize that applying pictorial HWLs to the WP device will; 1- significantly increase harm perception and intention to quit, and reduce puffing behavior, satisfaction, and exposure to toxicants compared to no-HWL; 2- this effect will be more pronounced in beginner than established smokers.  3. Disseminate knowledge. The investigators will partner with Tobacco-Free Workgroup, and Truth Initiative to advocate for the adoption of HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally.  Impact: Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in the US. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 3, 2022</start_date> <completion_date type="Anticipated">May 2025</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>Crossover Assignment</intervention_model> <intervention_model_description>The investigators will conduct a 2x2x2x4 within-subject (2: HWL vs no-HWL x 2: pre- vs post- smoking) and between-subject (2: beginner vs established smokers x 4: HWLs) experimental study. Participant in each group (beginner, established smoker) will be randomly assigned to one of the 4 HWLs conditions, and undergo 2 WP smoking sessions that differ by HWL on the WP device (HWL vs. no-HWL), with pre-/post-smoking assessment of harm perception, intention to quit, puffing behavior, satisfaction, urge to smoke, and toxicant exposure. The investigators will use Latin Square crossover design balanced for carry-over effect (random order of 4 HWL condition), and to ensure equal distribution of study participants across gender.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Intention and motivation to quit</measure> <time_frame>pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.</time_frame> <description>Intention and motivation to quit will be measured by using 3 items; "Does the participant intend to reduce WP smoking?"; "Does the participant intend to quit WP smoking?", and "How motivated is the participant to quit WP smoking in the next month?" The scale will be scored on a 5-point scale ranging from 1 (not at all), to 5 (very much).</description> </primary_outcome> <secondary_outcome> <measure>Harm perception</measure> <time_frame>pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.</time_frame> <description>Harm perception will be measured by using 1 item "To what extent does the participant think about the serious health effects of WP smoking?". This scale will assess WP harm perception and measure perceptions of WP relative risk compared to cigarettes. The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful).</description> </secondary_outcome> <secondary_outcome> <measure>Exhaled Breath Condensate (EBC)</measure> <time_frame>It will be collected pre-post smoking session. Each session is approximately 45 minutes ad lib use period.</time_frame> <description>To test for markers of oxidative stress and DNA damage. The investigators will test for 6 biomarkers (8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxoguanosine, 8-isoprostane, formaldehyde, acetaldehyde and malondialdehyde). Samples will be collected during 15 min of tidal breathing through a single-use disposable Respiratory Tube Tympanic Membrane collector (Respiratory Research, Inc., Charlottesville, Va., USA). After sample collection, a plunger will be used to pool the condensed material within the tube into a single sample (about 1.0-2 ml). EBC samples will be divided in aliquots and stored at -80°C. EBC samples will be analyzed by our Forensic Chemistry Lab at Florida International University using Online Solid-Phase Extraction and Liquid Chromatography Triple Quadrupole Mass Spectrometry and Gas Chromatography Mass Spectrometry.</description> </secondary_outcome> <secondary_outcome> <measure>Social interaction</measure> <time_frame>at 3-month assessment</time_frame> <description>Social interaction will be measured by using 1 item "Since the participant started the study, how many times did the participant have a conversations with the family/friends about the HWLs?"</description> </secondary_outcome> <secondary_outcome> <measure>Change in WP smoking</measure> <time_frame>at 3-month assessment</time_frame> <description>Change in WP smoking will be measured by using 3 items; "Since the participant started the study, 1- did the participant stop smoking for 1 day or longer because the participant was trying to quit WP smoking?, 2- did the participant avoid smoking WP because the participant was thinking about the HWLs?, and 3- did the participant stop WP smoking completely because of the HWLs?"</description> </secondary_outcome> <secondary_outcome> <measure>Toxicant exposure: expired carbon monoxide</measure> <time_frame>initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the WP smoking session</time_frame> <description>expired carbon monoxide will be measured via expired carbon monoxide monitor.</description> </secondary_outcome> <secondary_outcome> <measure>Puff topography</measure> <time_frame>continuously during smoking. Puffing behavior is continuously measured during each WP smoking session (an approximately 45 minutes ad lib use period)</time_frame> <description>Measurement of puffing behavior.</description> </secondary_outcome> <secondary_outcome> <measure>Hear rate</measure> <time_frame>continuously during smoking. Each session is approximately 45 minutes ad lib use period.</time_frame> <description>Change in heart rate, measured in beats per minute.</description> </secondary_outcome> <secondary_outcome> <measure>Blood pressure</measure> <time_frame>continuously during smoking. Each session is approximately 45 minutes ad lib use period.</time_frame> <description>Change in blood pressure, measured in mm/hg.</description> </secondary_outcome> <secondary_outcome> <measure>Duke Sensory Questionnaire (DSQ)</measure> <time_frame>DSQ will be measured only after smoking. The session is approximately 45 minutes ad lib use period.</time_frame> <description>This scale will assess participants sensory experience of the inhaled product. The scale has nine items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).</description> </secondary_outcome> <secondary_outcome> <measure>The Cigarette/WP Evaluation Scale (WES)</measure> <time_frame>WES will be measured only after smoking. The session is approximately 45 minutes ad lib use period.</time_frame> <description>This scale assesses participants' perception of WP smoking. The scale has 11 items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).</description> </secondary_outcome> <secondary_outcome> <measure>Minnesota Nicotine Withdrawal Scale</measure> <time_frame>During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.</time_frame> <description>This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100. These items are presented as Visual Analog Scale with item (measure) centered above a horizontal line anchored on the left with not at all and on the right with extremely.</description> </secondary_outcome> <secondary_outcome> <measure>Questionnaire of Smoking Urges</measure> <time_frame>During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period</time_frame> <description>This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree).</description> </secondary_outcome> <secondary_outcome> <measure>Lung function tests (LFTs)</measure> <time_frame>During participants' 2 study visits. Lung function tests will be measured 2 times in each hookah smoking session: before and after an approximately 45 minutes ad lib use period</time_frame> <description>LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after hookah smoking. According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., % predicted value pred (FVC), FEV1 % pred FEV1/FVC, % pred); forced expiratory flow (FEF) and peak expiratory flow rate or (PEFR) will be performed. Diffusing capacity for carbon monoxide (DLCO) will be determined using a rapidly resolving gas analyzer (RGA) and the single-breath technique. Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">248</enrollment> <condition>Waterpipe Smoking</condition> <condition>Health Warning Label</condition> <condition>Harm Perception</condition> <condition>Puffing Behaviour</condition> <condition>Quitting Smoking</condition> <condition>Health Risk Behaviors</condition> <arm_group> <arm_group_label>Waterpipe with Health Warning Label (HWL)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>All participants will complete a lab visit where they will smoke waterpipe with HWL for up to 45 minutes.</description> </arm_group> <arm_group> <arm_group_label>Absence of Waterpipe without Health Warning Label (HWL)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>All participants will complete a lab visit where they will smoke waterpipe without HWL for up to 45 minutes.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Test Health Warning Label (HWL)</intervention_name> <description>Effect of Health Warning Label (HWL)</description> <arm_group_label>Waterpipe with Health Warning Label (HWL)</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Test without Health Warning Label (no-HWL)</intervention_name> <description>Effect of no Health Warning Label (no-HWL)</description> <arm_group_label>Absence of Waterpipe without Health Warning Label (HWL)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age of 21-35 years.  - Beginners WP smokers (defined as started WP smoking in the past 6 months, but smoke WP less than weekly); or established WP smokers (defined as smoked at least once a week in the past 6 months).  - Generally healthy individuals (determined by physical examination).  - Is willing to provide informed consent.  - Is willing to attend the lab as required by the study protocol.  - Have abstained from WP for 12 hours prior to each lab session.  Exclusion Criteria:  - Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).  - Individuals with self-reported history of chronic disease or psychiatric conditions.  - Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).  - Report tobacco product use regularly (> 5 times/month in the past year). </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>35 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Wasim Maziak, PhD, MD</last_name> <phone>3053484501</phone> <email>wmaziak@fiu.edu</email> </overall_contact> <location> <facility> <name>Florida International University</name> <address> <city>Miami</city> <state>Florida</state> <zip>33199</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Wasim Maziak, PhD, MD</last_name> <phone>305-348-4501</phone> <email>wmaziak@fiu.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>February 28, 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 22, 2023</last_update_submitted> <last_update_submitted_qc>June 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 26, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>waterpipe</keyword> <keyword>Health warning label</keyword> <keyword>Young people</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </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>November 13, 2020</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT05317663/Prot_SAP_000.pdf</document_url> </provided_document> <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>November 13, 2020</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT05317663/ICF_001.pdf</document_url> </provided_document> </provided_document_section>  </clinical_study>

Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Evidence suggests WP use leads to nicotine addiction, and increases the risk of lung cancer, heart and respiratory disease and exposure to secondhand smoke. The spread of WP use among youth has been fueled by a misperception of reduced-harm compared to cigarettes. Health Warning Labels (HWLs) represent one of the most successful tobacco control strategies to communicate smoking- related risks, and studies have consistently shown that HWLs are associated with a decrease in smoking rates and smoking-related morbidity and mortality. Therefore, communicating WP risks to young people through HWLs has been identified as a priority by major health bodies in the US including the FDA. Using the Delphi method among international tobacco control experts, our team has developed a set of 12 WP HWLs corresponding to 4 health themes; health risks/addiction, harm to others, WP-specific harm, WP harm compared to cigarettes. Building on this work, and using a mixed- method approach incorporating qualitative and quantitative research, the investigators propose to: Aim 1: Adapt the 12 HWLs to young WP smokers in Florida using exploratory focus groups. Aim 2: Test in a clinical lab experiment the performance of the top 4 HWLs on the WP device compared to no-HWL/control on harm perception, intention to quit, and toxicant exposure (Carbon monoxide (CO), nicotine, oxidative stress). Aim 3: Use the knowledge obtained to advocate for the adoption of WP-HWLs policies and disseminate information about WP harmful effects to young people in Florida and nationally. Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in Florida. This pioneering work will inform the FDA and public health advocates on the potential of WP-HWLs policies and provide a model for other states to respond to the WP epidemic. Our Team developed 12 pictorial Health Warning Labels (HWLs) for the waterpipe (WP) corresponding to 4 themes; health risks/addiction, harm to others, specific harm, and harm compared to cigarettes. The investigators will build on this work to advance HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally through the following specific aims: 1. Adapt the HWLs to young adults in Florida using focus groups. The investigators will conduct mixed- gender focus groups combined with brief survey with regular WP smokers (6-8 groups; n ≈ 65; age 18-29 yrs) to 1- adapt the 12 HWLs to our target population, 2- explore their optimal placement and size, and 3- select the top 4 HWLs for testing (Aim 2). 2. Test the top 4 HWLs in a clinical lab experiment. Using the top 4 HWLs on the device, the investigators will recruit 2 groups of WP smokers (n= 248; age 18-29 yrs) based on their use frequency (beginners, established) for a within- (HWL vs no-HWL; pre- vs post- smoking) and between-subject (beginner vs. established; 4 HWLs) experiment. Participants will be randomly assigned to one of the 4 HWLs conditions and undergo 2 smoking sessions that differ by HWL (HWL vs. no-HWL), with pre-post smoking assessment of harm perception, intention to quit, and toxicant exposure. Participants will receive a follow-up phone call 3- month after exposure to assess longer-term changes in quit attitude and behavior. The investigators hypothesize that applying pictorial HWLs to the WP device will; 1- significantly increase harm perception and intention to quit, and reduce puffing behavior, satisfaction, and exposure to toxicants compared to no-HWL; 2- this effect will be more pronounced in beginner than established smokers. 3. Disseminate knowledge. The investigators will partner with Tobacco-Free Workgroup, and Truth Initiative to advocate for the adoption of HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally. Impact: Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in the US. Inclusion Criteria: - Age of 21-35 years. - Beginners WP smokers (defined as started WP smoking in the past 6 months, but smoke WP less than weekly); or established WP smokers (defined as smoked at least once a week in the past 6 months). - Generally healthy individuals (determined by physical examination). - Is willing to provide informed consent. - Is willing to attend the lab as required by the study protocol. - Have abstained from WP for 12 hours prior to each lab session. Exclusion Criteria: - Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening). - Individuals with self-reported history of chronic disease or psychiatric conditions. - Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control). - Report tobacco product use regularly (> 5 times/month in the past year).

NCT0531xxxx/NCT05317676.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/NCT05317676</url> </required_header> <id_info> <org_study_id>2020-6007</org_study_id> <nct_id>NCT05317676</nct_id> </id_info> <brief_title>Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Below Knee Fracture Fixation</brief_title> <official_title>Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Postoperative Pain and Inflammation Following Below Knee Fracture Fixation: A Pilot Study.</official_title> <sponsors> <lead_sponsor> <agency>University of California, Irvine</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>GE Nutrients Inc. (Gencor)</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of California, Irvine</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> Palmitoylethanolamide (PEA), a non-psychoactive cannabis compound derived from peanuts, egg yolks, and soybeans, is an Endogenous FA Amide produced in the body as a biological response and a repair mechanism in chronic inflammation and chronic pain. In animal and clinical trials, PEA has also shown evidence of pain reduction, sleep improvement, and increased joint mobility and function with minimal side-effects. The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed. </textblock> </brief_summary> <detailed_description> <textblock> According to the National Center for Health Statistics, the United States sees approximately 492,000 tibial fractures per year. Of that population, there are greater than 70,000 hospitalizations, 800,000 office visits, and 500,000 hospital days attributed annually. This does not include the approximately 250,000 proximal femur fractures that occur in the US annually, which is expected to double by 2050. There are also over 5 million ankle injuries in the US per year at a rate of approximately 187 ankle fractures per 100,000 people. To repair these below knee fractures, patients with severe cases often have an open reduction and internal fixation (ORIF) surgery to stabilize and heal the broken bone.  On average, these patients are seen by physical therapy to determine their safety for going home and if they need any equipment like a walker or crutches. They are discharged with pain medications, such as analgesic opioids and stool softeners. These patients return to clinic in 2 weeks for follow up which involves an exam, suture removal, x-rays, and possibly weight bearing status update. They then return in 1 month for exam, x-rays, and weightbearing status. Finally they return at 3 months for exam, x-rays, and weightbearing status.  The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed </textblock> </detailed_description> <overall_status>Withdrawn</overall_status> <why_stopped> Sponsor suspending temporarily. </why_stopped> <start_date type="Anticipated">May 2023</start_date> <completion_date type="Anticipated">December 2025</completion_date> <primary_completion_date type="Anticipated">December 2024</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Investigator)</masking> </study_design_info> <primary_outcome> <measure>3 month post-surgical Opioid use Questionnaire</measure> <time_frame>3 months</time_frame> <description>Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with opioid prescription in chart</description> </primary_outcome> <primary_outcome> <measure>3 month post-surgical NSAID use Questionnaire</measure> <time_frame>3 months</time_frame> <description>Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with NSAID prescription in chart</description> </primary_outcome> <secondary_outcome> <measure>Pain Scores</measure> <time_frame>3 months</time_frame> <description>Pain scores using McGill Pain Questionnaire; minimum pain score: 0 (would not be seen in a person with true pain);maximum pain score: 78;The higher the pain score the greater the pain.</description> </secondary_outcome> <secondary_outcome> <measure>Pain Interference</measure> <time_frame>3 months</time_frame> <description>Pain interference using PROMIS Pain Interference Survey; Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 6-item form, the lowest possible raw score is 6; the highest possible raw score is 30.Locate the applicable score conversion table and use this table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10</description> </secondary_outcome> <secondary_outcome> <measure>Average Pain Scores</measure> <time_frame>3 months</time_frame> <description>Pain scores using Brief Pain Inventory; 0-10 numerical rating scale used to measure three pain severity items: "worst" in the past month, "average," and "now," where 0=no pain and 10=pain as bad as you can imagine.</description> </secondary_outcome> <secondary_outcome> <measure>Functional Status</measure> <time_frame>3 months</time_frame> <description>Functional status using PROMIS Physical Function Survey; The PF-10a is a 10-item questionnaire assessing current self-reported physical function. Raw scores range from 10 to 50 and can be translated into T-scores, with a mean of 50 and a standard deviation of 10, for comparison with the U.S. general population mean; for this study, all reported PF-10a scores are T-scores.</description> </secondary_outcome> <secondary_outcome> <measure>Post-Surgical Complications</measure> <time_frame>3 months</time_frame> <description>Any complications following surgery</description> </secondary_outcome> <secondary_outcome> <measure>Medication Adverse Events</measure> <time_frame>3 months</time_frame> <description>Any adverse events to study drug and post-surgical medications given at discharge</description> </secondary_outcome> <secondary_outcome> <measure>Average Pain Interference</measure> <time_frame>3 months</time_frame> <description>Pain interference using Brief Pain Inventory; 0-10 numerical rating scale used to measure three pain severity items: "worst" in the past month, "average," and "now," where 0=no pain and 10=pain as bad as you can imagine.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">0</enrollment> <condition>Tibial Fractures</condition> <condition>Fibula Fracture</condition> <condition>Knee Fracture</condition> <arm_group> <arm_group_label>Palmitoylethanolamide</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Palmitoylethanolamide</intervention_name> <description>2-month supply of PEA will be given upon discharge. 300mg will be taken twice a day in conjunction with discharge medications (opioid and NSAIDs).</description> <arm_group_label>Palmitoylethanolamide</arm_group_label> <other_name>PEA</other_name> <other_name>GenCor</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>2-month supply of placebo will be given upon discharge. Placebo will taken twice a day in conjunction with discharge medications (opioid and NSAIDs).</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 18 years of age or older  - Has an isolated below knee orthopaedic injury without any neurovascular injury involvement  - Has an isolated active orthopaedic injury  - Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test on Day 1 before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.  - If females are of non-child bearing potential, they must be post-menopausal defined as: age > 55 with no menses within the past 12 months or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.  Exclusion Criteria:  - Less than 18 years of age  - Pregnant or Breastfeeding  - Allergic to cannabis  - History of chronic opioid use  - History of substance abuse  - History of chronic use of cannabis products of any kind  - Has multiple active orthopaedic injuries  - Has neurovascular injury associated with your orthopaedic injury  - History of a syndrome that causes chronic pain (i.e. fibromuscular dysplasia, complex pain syndrome)  - History of peripheral neuropathy  - History of diagnosed psychiatric illness  - ASA score of greater than 3  - Clinically significant unstable medical condition, including but not limited to cardiovascular, neurologic, psychiatric, endocrine, hepatic, and renal disorders.  - Allergy to palmitoylethanolamide (PEA) or its derivatives such as soy or eggs  - AST/ALT ≥3x ULN and/or bilirubin ≥2x ULN at screening.  - Abnormal creatinine or renal function abnormalities.  - Have end stage organ failure (Cardiac, Renal, or Hepatic)  - Currently undergoing addiction/detoxification therapy </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>Ariana Nelson, MD</last_name> <role>Principal Investigator</role> <affiliation>Associate Clinical Professor</affiliation> </overall_official> <location> <facility> <name>UC Irvine Medical Center</name> <address> <city>Orange</city> <state>California</state> <zip>92868</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Artukoglu BB, Beyer C, Zuloff-Shani A, Brener E, Bloch MH. Efficacy of Palmitoylethanolamide for Pain: A Meta-Analysis. Pain Physician. 2017 Jul;20(5):353-362.</citation> <PMID>28727699</PMID> </reference> <reference> <citation>Grotenhermen F. Cannabinoids and the endocannabinoid system. Cannabinoids.2006;1:10-14.</citation> </reference> <reference> <citation>Martin-Sanchez E, Furukawa TA, Taylor J, Martin JL. Systematic review and meta-analysis of cannabis treatment for chronic pain. Pain Med. 2009 Nov;10(8):1353-68. doi: 10.1111/j.1526-4637.2009.00703.x. Epub 2009 Sep 1.</citation> <PMID>19732371</PMID> </reference> <reference> <citation>Cabral GA, Griffin-Thomas L. Emerging role of the cannabinoid receptor CB2 in immune regulation: therapeutic prospects for neuroinflammation. Expert Rev Mol Med. 2009 Jan 20;11:e3. doi: 10.1017/S1462399409000957.</citation> <PMID>19152719</PMID> </reference> <reference> <citation>Calignano A, La Rana G, Giuffrida A, Piomelli D. Control of pain initiation by endogenous cannabinoids. Nature. 1998 Jul 16;394(6690):277-81. doi: 10.1038/28393.</citation> <PMID>9685157</PMID> </reference> <reference> <citation>Calignano A, La Rana G, Piomelli D. Antinociceptive activity of the endogenous fatty acid amide, palmitylethanolamide. Eur J Pharmacol. 2001 May 11;419(2-3):191-8. doi: 10.1016/s0014-2999(01)00988-8.</citation> <PMID>11426841</PMID> </reference> <reference> <citation>Esposito E, Paterniti I, Mazzon E, Genovese T, Di Paola R, Galuppo M, Cuzzocrea S. Effects of palmitoylethanolamide on release of mast cell peptidases and neurotrophic factors after spinal cord injury. Brain Behav Immun. 2011 Aug;25(6):1099-112. doi: 10.1016/j.bbi.2011.02.006. Epub 2011 Feb 25.</citation> <PMID>21354467</PMID> </reference> <reference> <citation>Luongo L, Guida F, Boccella S, Bellini G, Gatta L, Rossi F, de Novellis V, Maione S. Palmitoylethanolamide reduces formalin-induced neuropathic-like behaviour through spinal glial/microglial phenotypical changes in mice. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):45-54. doi: 10.2174/1871527311312010009.</citation> <PMID>23394524</PMID> </reference> <reference> <citation>Scuderi C, Steardo L. Neuroglial roots of neurodegenerative diseases: therapeutic potential of palmitoylethanolamide in models of Alzheimer's disease. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):62-9. doi: 10.2174/1871527311312010011.</citation> <PMID>23394526</PMID> </reference> <reference> <citation>Nau R, Djukic M, Spreer A, Ribes S, Eiffert H. Bacterial meningitis: an update of new treatment options. Expert Rev Anti Infect Ther. 2015;13(11):1401-23. doi: 10.1586/14787210.2015.1077700. Epub 2015 Aug 18.</citation> <PMID>26293166</PMID> </reference> <reference> <citation>Gabrielsson L, Mattsson S, Fowler CJ. Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Br J Clin Pharmacol. 2016 Oct;82(4):932-42. doi: 10.1111/bcp.13020. Epub 2016 Jun 29.</citation> <PMID>27220803</PMID> </reference> <reference> <citation>COBURN AF, GRAHAM CE, HANINGER J. The effect of egg yolk in diets on anaphylactic arthritis (passive Arthus phenomenon) in the guinea pig. J Exp Med. 1954 Nov 1;100(5):425-35. doi: 10.1084/jem.100.5.425.</citation> <PMID>13211905</PMID> </reference> <reference> <citation>Hesselink JM. Evolution in pharmacologic thinking around the natural analgesic palmitoylethanolamide: from nonspecific resistance to PPAR-alpha agonist and effective nutraceutical. J Pain Res. 2013 Aug 8;6:625-34. doi: 10.2147/JPR.S48653. eCollection 2013.</citation> <PMID>23964161</PMID> </reference> <verification_date>May 2023</verification_date> <study_first_submitted>February 22, 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>May 5, 2023</last_update_submitted> <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of California, Irvine</investigator_affiliation> <investigator_full_name>Ariana M. Nelson</investigator_full_name> <investigator_title>Associate Clinical Professor</investigator_title> </responsible_party> <keyword>Palmitoylethanolamide</keyword> <keyword>Open reduction and internal fixation (ORIF) Surgery</keyword> <keyword>Postoperative Pain</keyword> <keyword>Inflammation</keyword> <keyword>Reduce Opioid Consumption</keyword> <condition_browse>  <mesh_term>Fractures, Bone</mesh_term> <mesh_term>Tibial Fractures</mesh_term> <mesh_term>Knee Fractures</mesh_term> <mesh_term>Fibula Fractures</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Palmidrol</mesh_term> </intervention_browse>  </clinical_study>

Palmitoylethanolamide (PEA), a non-psychoactive cannabis compound derived from peanuts, egg yolks, and soybeans, is an Endogenous FA Amide produced in the body as a biological response and a repair mechanism in chronic inflammation and chronic pain. In animal and clinical trials, PEA has also shown evidence of pain reduction, sleep improvement, and increased joint mobility and function with minimal side-effects. The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed. According to the National Center for Health Statistics, the United States sees approximately 492,000 tibial fractures per year. Of that population, there are greater than 70,000 hospitalizations, 800,000 office visits, and 500,000 hospital days attributed annually. This does not include the approximately 250,000 proximal femur fractures that occur in the US annually, which is expected to double by 2050. There are also over 5 million ankle injuries in the US per year at a rate of approximately 187 ankle fractures per 100,000 people. To repair these below knee fractures, patients with severe cases often have an open reduction and internal fixation (ORIF) surgery to stabilize and heal the broken bone. On average, these patients are seen by physical therapy to determine their safety for going home and if they need any equipment like a walker or crutches. They are discharged with pain medications, such as analgesic opioids and stool softeners. These patients return to clinic in 2 weeks for follow up which involves an exam, suture removal, x-rays, and possibly weight bearing status update. They then return in 1 month for exam, x-rays, and weightbearing status. Finally they return at 3 months for exam, x-rays, and weightbearing status. The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed Inclusion Criteria: - 18 years of age or older - Has an isolated below knee orthopaedic injury without any neurovascular injury involvement - Has an isolated active orthopaedic injury - Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test on Day 1 before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device. - If females are of non-child bearing potential, they must be post-menopausal defined as: age > 55 with no menses within the past 12 months or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation. Exclusion Criteria: - Less than 18 years of age - Pregnant or Breastfeeding - Allergic to cannabis - History of chronic opioid use - History of substance abuse - History of chronic use of cannabis products of any kind - Has multiple active orthopaedic injuries - Has neurovascular injury associated with your orthopaedic injury - History of a syndrome that causes chronic pain (i.e. fibromuscular dysplasia, complex pain syndrome) - History of peripheral neuropathy - History of diagnosed psychiatric illness - ASA score of greater than 3 - Clinically significant unstable medical condition, including but not limited to cardiovascular, neurologic, psychiatric, endocrine, hepatic, and renal disorders. - Allergy to palmitoylethanolamide (PEA) or its derivatives such as soy or eggs - AST/ALT ≥3x ULN and/or bilirubin ≥2x ULN at screening. - Abnormal creatinine or renal function abnormalities. - Have end stage organ failure (Cardiac, Renal, or Hepatic) - Currently undergoing addiction/detoxification therapy

NCT0531xxxx/NCT05317689.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/NCT05317689</url> </required_header> <id_info> <org_study_id>IRB#21-33765</org_study_id> <secondary_id>PR#202143H</secondary_id> <secondary_id>156917</secondary_id> <nct_id>NCT05317689</nct_id> </id_info> <brief_title>Comparing the Effects of Psilocin and Psilocybin in Healthy Adults</brief_title> <official_title>Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults</official_title> <sponsors> <lead_sponsor> <agency>University of California, San Francisco</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Filament Health</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of California, San Francisco</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 compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults. </textblock> </brief_summary> <detailed_description> <textblock> The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 26, 2022</start_date> <completion_date type="Anticipated">December 2024</completion_date> <primary_completion_date type="Anticipated">December 2024</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>Crossover Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Physiological Effects</measure> <time_frame>Baseline to 8 hours following drug delivery</time_frame> <description>blood pressure</description> </primary_outcome> <primary_outcome> <measure>Physiological Effects</measure> <time_frame>Baseline to 8 hours following drug delivery</time_frame> <description>heart rate</description> </primary_outcome> <primary_outcome> <measure>Psychological Effects</measure> <time_frame>Baseline to 4 weeks after drug delivery</time_frame> <description>- Peak psychedelic intensity ratings will be measured using Likert scale (0-10 rating scale, 0=not intense at all, 10=highest intensity imaginable)</description> </primary_outcome> <primary_outcome> <measure>Psychological Effects</measure> <time_frame>Baseline to 4 weeks after drug delivery</time_frame> <description>- Peak psychological effects will be measured by the Altered States of Consciousness (5D-ASC) questionnaire at the end of each dosing session</description> </primary_outcome> <primary_outcome> <measure>Psychological Effects</measure> <time_frame>Baseline to 4 weeks after drug delivery</time_frame> <description>- Peak psychological effects will be measured by the Challenging Experiences Questionnaire at the end of each dosing session</description> </primary_outcome> <primary_outcome> <measure>Psychological Effects</measure> <time_frame>Baseline to 4 weeks after drug delivery</time_frame> <description>- Persistent changes in attitude, mood, and behavior will be assessed using Persisting Effects Questionnaire, administered 4 weeks after each dosing session</description> </primary_outcome> <primary_outcome> <measure>Psychological Effects</measure> <time_frame>Baseline to 4 weeks after drug delivery</time_frame> <description>- Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session</description> </primary_outcome> <primary_outcome> <measure>Adverse Effects</measure> <time_frame>Baseline to 24 hours after dosing session</time_frame> <description>Acute hypertension, hypotension, tachycardia, or bradycardia will be detected through blood pressure and heart rate monitoring at 10 minutes prior to drug administration and measured frequently up to 360 minutes following administration Other dosing-related side effects including descriptive reports of nausea, headaches, dizziness, weakness, drowsiness, paresthesia, or blurred vision will be assessed during check-ins, after dosing effects have waned, and 24 hours following dosing</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Healthy</condition> <arm_group> <arm_group_label>Oral & Sublingual Psilocin, & Oral Psilocybin</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.</description> </arm_group> <arm_group> <arm_group_label>Sublingual Psilocin</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Psilocin</intervention_name> <description>17.5mg oral psilocin with psychological support and physiological monitoring</description> <arm_group_label>Oral & Sublingual Psilocin, & Oral Psilocybin</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Psilocybin</intervention_name> <description>25mg oral psilocybin with psychological support and physiological monitoring</description> <arm_group_label>Oral & Sublingual Psilocin, & Oral Psilocybin</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Sublingual Psilocin</intervention_name> <description>2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring</description> <arm_group_label>Oral & Sublingual Psilocin, & Oral Psilocybin</arm_group_label> <arm_group_label>Sublingual Psilocin</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age 25 to 50  - Comfortable speaking and writing in English  - Commit to attending all study visits and remote data collection tasks  - No planned surgeries during the study  - Had at least one prior experience with a psychedelic substance  - Generally mentally and physically healthy  - Agree to abstain from THC, CBD, or nicotine products during study  Exclusion Criteria:  - Participated in another clinical trial within 30 days of entry to this trial  - Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants  - A health condition that makes study unsafe or unfeasible, determined by study physicians </textblock> </criteria> <gender>All</gender> <minimum_age>25 Years</minimum_age> <maximum_age>50 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Joshua Woolley</last_name> <role>Principal Investigator</role> <affiliation>University of California, San Francisco</affiliation> </overall_official> <overall_official> <last_name>Jacob Aday</last_name> <role>Study Chair</role> <affiliation>University of California, San Francisco</affiliation> </overall_official> <overall_contact> <last_name>Jacob Aday</last_name> <phone>415-221-4810</phone> <phone_ext>24117</phone_ext> <email>psilocybinstudies@ucsf.edu</email> </overall_contact> <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>Jake Aday</last_name> <phone>415-942-0820</phone> </contact> <contact_backup> <last_name>Josh Woolley</last_name> <phone>415-221-4810</phone> <phone_ext>24117</phone_ext> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct.</citation> <PMID>33150319</PMID> </reference> <reference> <citation>Barrett FS, Bradstreet MP, Leoutsakos JS, Johnson MW, Griffiths RR. The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms. J Psychopharmacol. 2016 Dec;30(12):1279-1295. doi: 10.1177/0269881116678781. Epub 2016 Nov 17.</citation> <PMID>27856683</PMID> </reference> <reference> <citation>Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177/0269881115609019. Epub 2015 Oct 6.</citation> <PMID>26442957</PMID> </reference> <reference> <citation>Benet-Martinez V, John OP. Los Cinco Grandes across cultures and ethnic groups: multitrait multimethod analyses of the Big Five in Spanish and English. J Pers Soc Psychol. 1998 Sep;75(3):729-50. doi: 10.1037//0022-3514.75.3.729.</citation> <PMID>9781409</PMID> </reference> <reference> <citation>Bogenschutz MP, Johnson MW. Classic hallucinogens in the treatment of addictions. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:250-8. doi: 10.1016/j.pnpbp.2015.03.002. Epub 2015 Mar 14.</citation> <PMID>25784600</PMID> </reference> <reference> <citation>Bogenschutz MP, Ross S. Therapeutic Applications of Classic Hallucinogens. Curr Top Behav Neurosci. 2018;36:361-391. doi: 10.1007/7854_2016_464.</citation> <PMID>28512684</PMID> </reference> <reference> <citation>Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.</citation> <PMID>28353056</PMID> </reference> <verification_date>October 2022</verification_date> <study_first_submitted>March 7, 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>October 11, 2022</last_update_submitted> <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc> <last_update_posted type="Actual">October 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of California, San Francisco</investigator_affiliation> <investigator_full_name>Joshua Woolley, MD/PhD</investigator_full_name> <investigator_title>Associate Professor, Psychiatry</investigator_title> </responsible_party> <keyword>Psilocybin</keyword> <keyword>Psilocin</keyword> <keyword>Psilocybin Therapy</keyword> <keyword>Psychedelics</keyword> <keyword>Healthy</keyword> <keyword>San Francisco</keyword> <intervention_browse>  <mesh_term>Psilocybin</mesh_term> <mesh_term>Psilocin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults. The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant. Inclusion Criteria: - Age 25 to 50 - Comfortable speaking and writing in English - Commit to attending all study visits and remote data collection tasks - No planned surgeries during the study - Had at least one prior experience with a psychedelic substance - Generally mentally and physically healthy - Agree to abstain from THC, CBD, or nicotine products during study Exclusion Criteria: - Participated in another clinical trial within 30 days of entry to this trial - Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants - A health condition that makes study unsafe or unfeasible, determined by study physicians

NCT0531xxxx/NCT05317702.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/NCT05317702</url> </required_header> <id_info> <org_study_id>1</org_study_id> <nct_id>NCT05317702</nct_id> </id_info> <brief_title>The Duration of Effects of Massage in Healthy Participants</brief_title> <official_title>The Duration of Effects of Massage in Healthy Participants</official_title> <sponsors> <lead_sponsor> <agency>University of Central Florida</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Central Florida</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> Massage is a common rehabilitation treatment for musculoskeletal pain. Prior studies indicate massage applied with a deep pressure that induces a moderate amount of pain produces a lessening of pain sensitivity compared to light touch, pain free massage. The investigators now aim to investigate how long pain sensitivity changes last after 4 minutes of moderately painful massage and determine factors that help predict who displays a lessening of pain sensitivity. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">June 21, 2022</start_date> <completion_date type="Actual">July 12, 2022</completion_date> <primary_completion_date type="Actual">July 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>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 Pressure Pain Threshold</measure> <time_frame>PPT is applied between minutes 1, 2, 3, and 4 of massage. PPT is also applied at minutes 1,3,5,10,15 after massage. A higher PPT indicates a lessening of pain sensitivity.</time_frame> <description>A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold). Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.</description> </primary_outcome> <secondary_outcome> <measure>Temporal Summation</measure> <time_frame>Applied before massage</time_frame> <description>Mechanical temporal summation will be examined using a neuropen with neurotip. The neuropen with a neurotip has a semi-sharp point that exerts 40g of pressure. A series of ten pinpricks applied to the palmar surface of the hand opposite the trigger point identified at the beginning of the study visit (if the trigger point is on the left shoulder, the right palm will be used for this test.). Participants will rate the pain intensity of each pinprick using a numerical pain rating scale from 0-100 where 0=no pain and 100=worst pain imaginable. A higher pain rating indicates more pain.</description> </secondary_outcome> <secondary_outcome> <measure>Conditioned Pain Modulation</measure> <time_frame>Applied before massage</time_frame> <description>First, PPT will be measured on the foot opposite the trigger point. Second, the arm on the same of the participant's trigger point will be elevated for one minute. A blood pressure cuff will be inflated to 270 mmHg and the participant will return his or her arm to the horizontal position. The participant will repeatedly extend the wrist 20 times with a light weight. Third, PPT will be repeated on the top of the foot.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">20</enrollment> <condition>Healthy</condition> <condition>Pressure Pain Threshold</condition> <condition>Massage</condition> <arm_group> <arm_group_label>Moderately Painful Massage</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will be seated in a chair with his or her shirt on. Participants will receive 60 seconds of manual pressure applied to the myofascial trigger point identified in the participant's upper back. The researcher's thumb or index finger will apply a deep manual pressure such that the participant rates the pain = 50/100 on a 101-point numeric pain rating scale with 0 indicating no pain and 100 indicating the most severe pain imaginable. The participant will be asked to rate his or her pain during the massage so the pressure may be adjusted to maintain the 50/100 related pain. Massage will be applied for 60 seconds, 4 times for a total contact time of 240 seconds. During each 30 second break in which manual pressure is released, Pressure Pain Threshold (PPT) to the foot will be examined. PPT will be assessed 2 times immediately after each of the 4 massage applications.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Moderately Painful Massage</intervention_name> <description>Participants will be seated in a chair with his or her shirt on. Participants will receive 60 seconds of manual pressure applied to the myofascial trigger point identified in the participant's upper back. The researcher's thumb or index finger will apply a deep manual pressure such that the participant rates the pain = 50/100 on a 101-point numeric pain rating scale with 0 indicating no pain and 100 indicating the most severe pain imaginable. The participant will be asked to rate his or her pain during the massage so the pressure may be adjusted to maintain the 50/100 related pain. Massage will be applied for 60 seconds, 4 times for a total contact time of 240 seconds. During each 30 second break in which manual pressure is released, Pressure Pain Threshold (PPT) to the foot will be examined. PPT will be assessed 2 times immediately after each of the 4 massage applications.</description> <arm_group_label>Moderately Painful Massage</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  • pain-free  Exclusion Criteria:  - Non-English speaking  - Systemic medical condition known to affect sensation (i.e. uncontrolled diabetes)  - Regular use of prescription pain medication  - Current or history of chronic pain condition  - Currently taking a blood-thinning medication  - Any blood clotting disorder, such as hemophilia  - Contraindications to the application of a blood pressure cuff to the arm, such as: lymphedema or arterial/venous lines  - Contraindications to elevating the arm above the head or exercising the arm with a light weight, such as a recent surgery or fracture  - Investigator is unable to locate myofascial trigger point in the upper trapezius during testing session </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Abigail Wilson</last_name> <role>Principal Investigator</role> <affiliation>UCF</affiliation> </overall_official> <location> <facility> <name>University of Central Florida</name> <address> <city>Orlando</city> <state>Florida</state> <zip>32765</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 21, 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>July 12, 2022</last_update_submitted> <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Central Florida</investigator_affiliation> <investigator_full_name>Abigail Wilson</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Massage is a common rehabilitation treatment for musculoskeletal pain. Prior studies indicate massage applied with a deep pressure that induces a moderate amount of pain produces a lessening of pain sensitivity compared to light touch, pain free massage. The investigators now aim to investigate how long pain sensitivity changes last after 4 minutes of moderately painful massage and determine factors that help predict who displays a lessening of pain sensitivity. Inclusion Criteria: • pain-free Exclusion Criteria: - Non-English speaking - Systemic medical condition known to affect sensation (i.e. uncontrolled diabetes) - Regular use of prescription pain medication - Current or history of chronic pain condition - Currently taking a blood-thinning medication - Any blood clotting disorder, such as hemophilia - Contraindications to the application of a blood pressure cuff to the arm, such as: lymphedema or arterial/venous lines - Contraindications to elevating the arm above the head or exercising the arm with a light weight, such as a recent surgery or fracture - Investigator is unable to locate myofascial trigger point in the upper trapezius during testing session

NCT0531xxxx/NCT05317715.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/NCT05317715</url> </required_header> <id_info> <org_study_id>GHT-GHI LRM-20220118</org_study_id> <nct_id>NCT05317715</nct_id> </id_info> <brief_title>Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method</brief_title> <acronym>EPODIU</acronym> <official_title>"Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method"</official_title> <sponsors> <lead_sponsor> <agency>Raincy Montfermeil Hospital Group</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Raincy Montfermeil Hospital Group</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> Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns.  Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010.  In practice, in France, use of the IUD is still "reserved" for older women or those who have already had children, despite medical recommendations.  In this study the investigator will investigate whether clear information about the mode of action and insertion/withdrawal of IUDs would dispel these misconceptions of patients. </textblock> </brief_summary> <detailed_description> <textblock> Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns.  Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010.  In practice in France, the use of IUDs is still "reserved" for older women or those who have already had children, despite medical recommendations. Indeed, there is a certain feeling of mistrust towards the IUD as a contraceptive method. Sometimes the patient's reasons for refusal were unclear or misconceptions and prejudices prevailed.  Various research studies and theses have identified the various obstacles to the use of the IUD as a contraceptive. Today it would be interesting to evaluate whether a short presentation of the IUD during a consultation would lead to a better acceptance of women to use it as a possible contraceptive method.  In this study the investigators will investigate whether clear information about the mode of action and insertion/removal of IUDs would dispel these misconceptions of patients. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 14, 2022</start_date> <completion_date type="Anticipated">October 2022</completion_date> <primary_completion_date type="Anticipated">August 14, 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>Single-centre, prospective, randomised, open-label study comparing a group of patients who had information and demonstration about IUDs prior to completing a questionnaire and a group of patients who did not have information and demonstration about IUDs prior to completing the questionnaire</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Rate of acceptance of the IUD as a possible contraceptive method</measure> <time_frame>day 1</time_frame> <description>measuring the acceptance rate of the intrauterine device as a potential contraceptive method</description> </primary_outcome> <secondary_outcome> <measure>Basic knowledge of intrauterine devices</measure> <time_frame>day 1</time_frame> <description>verification of Basic knowledge of intrauterine devices</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">160</enrollment> <condition>Acceptance Processes</condition> <arm_group> <arm_group_label>without device information</arm_group_label> <arm_group_type>Other</arm_group_type> <description>this group of patients will complete a questionnaire before receiving information on contraceptive intrauterine devices (copper or hormonal)</description> </arm_group> <arm_group> <arm_group_label>with device information</arm_group_label> <arm_group_type>Other</arm_group_type> <description>This group of patients will receive information about contraceptive intrauterine devices (copper or hormonal) before completing a questionnaire</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Group A, who will complete a questionnaire before receiving information about intrauterine devices</intervention_name> <description>Group A will complete a questionnaire before receiving information about intrauterine devices and a demonstration of insertion/removal on a plastic dummy uterus.</description> <arm_group_label>without device information</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Group B who will answer a questionnaire after having the information about the intrauterine devices</intervention_name> <description>Group B will complete a questionnaire after receiving information about IUDs and a demonstration of insertion/removal on a plastic dummy uterus.</description> <arm_group_label>with device information</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Any woman aged 18 years and over who comes to a family planning centre  - Having expressed her free and informed written consent  - Affiliated to a social security scheme  Exclusion Criteria:  - Women under 18 years of age  - Woman with an IUD  - Woman who has had an IUD before  - Woman whose reason for consultation of the day is the insertion of an IUD  - Menopausal woman  - Woman who is infertile for any reason  - Illiterate woman or woman who does not read French  - Refusal to participate in the protocol  - Incapable of age.  - Pregnant or breastfeeding women  - Vulnerable persons and protected persons as provided for in the Public Health Code Public Health Code (articles L. 1121-5 to L.1121-8 and L.1122-1-2). </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>45 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Jean GUILLEMINOT, MD</last_name> <role>Principal Investigator</role> <affiliation>Le Raincy Montfermeil hospital</affiliation> </overall_official> <overall_contact> <last_name>Jean GUILLEMINOT, MD</last_name> <phone>01 41 70 81 19</phone> <phone_ext>+33</phone_ext> <email>jean.guilleminot@ght-gpne.fr</email> </overall_contact> <location> <facility> <name>Le Raincy Montfermeil hospital</name> <address> <city>Montfermeil</city> <zip>93370</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jean Guilleminot, MD</last_name> <phone>01 41 70 81 19</phone> <phone_ext>+33</phone_ext> <email>jean.guilleminot@ght-gpne.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <link> <url>https://dumas.ccsd.cnrs.fr/dumas-02883692/document</url> <description>The delivery of information by the health professional to the patient about contraception: a descriptive cross-sectional study</description> </link> <verification_date>March 2022</verification_date> <study_first_submitted>March 21, 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 29, 2022</last_update_submitted> <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">May 2, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Contraception</keyword> <keyword>Intrauterine devices</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns. Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010. In practice, in France, use of the IUD is still "reserved" for older women or those who have already had children, despite medical recommendations. In this study the investigator will investigate whether clear information about the mode of action and insertion/withdrawal of IUDs would dispel these misconceptions of patients. Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns. Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010. In practice in France, the use of IUDs is still "reserved" for older women or those who have already had children, despite medical recommendations. Indeed, there is a certain feeling of mistrust towards the IUD as a contraceptive method. Sometimes the patient's reasons for refusal were unclear or misconceptions and prejudices prevailed. Various research studies and theses have identified the various obstacles to the use of the IUD as a contraceptive. Today it would be interesting to evaluate whether a short presentation of the IUD during a consultation would lead to a better acceptance of women to use it as a possible contraceptive method. In this study the investigators will investigate whether clear information about the mode of action and insertion/removal of IUDs would dispel these misconceptions of patients. Inclusion Criteria: - Any woman aged 18 years and over who comes to a family planning centre - Having expressed her free and informed written consent - Affiliated to a social security scheme Exclusion Criteria: - Women under 18 years of age - Woman with an IUD - Woman who has had an IUD before - Woman whose reason for consultation of the day is the insertion of an IUD - Menopausal woman - Woman who is infertile for any reason - Illiterate woman or woman who does not read French - Refusal to participate in the protocol - Incapable of age. - Pregnant or breastfeeding women - Vulnerable persons and protected persons as provided for in the Public Health Code Public Health Code (articles L. 1121-5 to L.1121-8 and L.1122-1-2).

NCT0531xxxx/NCT05317728.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/NCT05317728</url> </required_header> <id_info> <org_study_id>ILR286-E002</org_study_id> <nct_id>NCT05317728</nct_id> </id_info> <brief_title>Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design</brief_title> <official_title>Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control</official_title> <sponsors> <lead_sponsor> <agency>Alcon Research</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Alcon Research</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL). </textblock> </brief_summary> <detailed_description> <textblock> Eligible subjects will be enrolled into one of two groups: BAL-FAIOL IOL or Monofocal IOL. Both eyes will receive cataract surgery with IOL implantation. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 31, 2023</start_date> <completion_date type="Anticipated">October 2024</completion_date> <primary_completion_date type="Anticipated">May 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>Device Feasibility</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)</measure> <time_frame>Month 6 post second eye implantation</time_frame> <description>Distance visual acuity will be measured with correction in place for each eye individually using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).</description> </primary_outcome> <primary_outcome> <measure>Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)</measure> <time_frame>Up to Year 1</time_frame> <description>The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for the BAL-FAIOL IOL only.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">120</enrollment> <condition>Cataract</condition> <arm_group> <arm_group_label>BAL-FAIOL</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)</description> </arm_group> <arm_group> <arm_group_label>Monofocal</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>BAL-FAIOL IOL</intervention_name> <description>Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject</description> <arm_group_label>BAL-FAIOL</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Monofocal IOL</intervention_name> <description>Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject</description> <arm_group_label>Monofocal</arm_group_label> <other_name>AcrySof IQ monofocal IOL (SN60WF)</other_name> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Cataract surgery</intervention_name> <description>Phacoemulsification with a clear cornea incision</description> <arm_group_label>BAL-FAIOL</arm_group_label> <arm_group_label>Monofocal</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Key Inclusion Criteria:  - Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;  - Willing and able to attend all scheduled study visits as required by the protocol;  - Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;  - Other protocol-specified inclusion criteria may apply.  Key Exclusion Criteria:  - Subjects taking medications that could increase risk or may affect accommodation;  - Clinically significant eye abnormalities as specified in the protocol;  - Previous eye surgery as specified in the protocol;  - Other protocol-specified exclusion criteria may apply. </textblock> </criteria> <gender>All</gender> <minimum_age>22 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Clinical Trial Lead, Surgical</last_name> <role>Study Director</role> <affiliation>Alcon Research, LLC</affiliation> </overall_official> <overall_contact> <last_name>Alcon Call Center</last_name> <phone>1-888-451-3937</phone> <email>alcon.medinfo@alcon.com</email> </overall_contact> <location> <facility> <name>Clinica 20/20</name> <address> <city>San José</city> <country>Costa Rica</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Laser Center SA</name> <address> <city>Santo Domingo</city> <zip>10124</zip> <country>Dominican Republic</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centro de Retina Medica y Quirurgica SC</name> <address> <city>Zapopan</city> <state>Jalisco</state> <zip>45116</zip> <country>Mexico</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Asociación Para Evitar la Ceguera en México</name> <address> <city>Mexico City</city> <zip>04030</zip> <country>Mexico</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Salauno Salud SAPI de CV</name> <address> <city>Mexico City</city> <zip>06600</zip> <country>Mexico</country> </address> </facility> <status>Not yet recruiting</status> </location> <location> <facility> <name>Panama Eye Center</name> <address> <city>Panama</city> <country>Panama</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Costa Rica</country> <country>Dominican Republic</country> <country>Mexico</country> <country>Panama</country> </location_countries> <verification_date>August 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>August 7, 2023</last_update_submitted> <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 8, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>IOL</keyword> <keyword>Intraocular lens</keyword> <condition_browse>  <mesh_term>Cataract</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL). Eligible subjects will be enrolled into one of two groups: BAL-FAIOL IOL or Monofocal IOL. Both eyes will receive cataract surgery with IOL implantation. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation. Key Inclusion Criteria: - Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form; - Willing and able to attend all scheduled study visits as required by the protocol; - Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision; - Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: - Subjects taking medications that could increase risk or may affect accommodation; - Clinically significant eye abnormalities as specified in the protocol; - Previous eye surgery as specified in the protocol; - Other protocol-specified exclusion criteria may apply.

NCT0531xxxx/NCT05317741.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/NCT05317741</url> </required_header> <id_info> <org_study_id>IA-14069_1a</org_study_id> <nct_id>NCT05317741</nct_id> </id_info> <brief_title>SAD Study of IA-14069</brief_title> <official_title>A Phase 1, First-in-human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics Following a Single Oral Dose of IA-14069 in Healthy Male Subjects</official_title> <sponsors> <lead_sponsor> <agency>ILAb Co., Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>ILAb Co., Ltd.</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> The purpose of this study is to assess the safety, tolerability, pharmacokinetics, food effect, and pharmacodynamics following a single oral dose of IA-14069 in healthy male subjects. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">August 23, 2021</start_date> <completion_date type="Actual">September 8, 2022</completion_date> <primary_completion_date type="Actual">September 8, 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> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Care Provider, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Incidence and severity of adverse events</measure> <time_frame>Up to Day 14</time_frame> </primary_outcome> <primary_outcome> <measure>Incidence and severity of clinical findings on physical examination</measure> <time_frame>Up to Day 8</time_frame> </primary_outcome> <primary_outcome> <measure>Change from baseline in vital signs: Blood pressure (Systolic/Diastolic)</measure> <time_frame>Up to Day 8</time_frame> </primary_outcome> <primary_outcome> <measure>Change from baseline in vital signs: Body temperature</measure> <time_frame>Up to Day 8</time_frame> </primary_outcome> <primary_outcome> <measure>Change from baseline in vital signs: Respiratory rate</measure> <time_frame>Up to Day 8</time_frame> </primary_outcome> <primary_outcome> <measure>Change from baseline in vital signs: Heart rate</measure> <time_frame>Up to Day 8</time_frame> </primary_outcome> <primary_outcome> <measure>Incidence and severity of clinical laboratory abnormalities</measure> <time_frame>Up to Day 8</time_frame> <description>Hematology, serum chemistry and urinalysis</description> </primary_outcome> <primary_outcome> <measure>Change from baseline in 12-lead ECG parameters</measure> <time_frame>Up to Day 8</time_frame> <description>PR, QRS, QT and QTc intervals</description> </primary_outcome> <secondary_outcome> <measure>Maximum observed concentration (Cmax) for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time to maximum concentration (Tmax) for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>Area under the concentration-time curve (AUC) for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>Terminal elimination half-life (t1/2) for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>Apparent clearance (CL/F) for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>Apparent volume of distribution (Vd/F) for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>Pharmacokinetic (PK) in Food effect measured by Cmax for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>PK in Food effect measured by Tmax for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>PK in Food effect measured by AUC for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <secondary_outcome> <measure>PK in Food effect measured by t1/2 for IA-14069</measure> <time_frame>Up to Day 8</time_frame> </secondary_outcome> <other_outcome> <measure>Change from baseline in concentration of Tumor necrosis factor in blood</measure> <time_frame>Up to Day 8</time_frame> </other_outcome> <number_of_arms>5</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Healthy</condition> <arm_group> <arm_group_label>A mg IA-14069 or Placebo</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>B mg IA-14069 or Placebo</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>C mg IA-14069 or Placebo</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Period 1: Fasted condition → Period 2: Fed condition</description> </arm_group> <arm_group> <arm_group_label>D mg IA-14069 or Placebo</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>E mg IA-14069 or Placebo</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>IA-14069</intervention_name> <description>Subjects received IA-14069 tablet orally on Day 1.</description> <arm_group_label>A mg IA-14069 or Placebo</arm_group_label> <arm_group_label>B mg IA-14069 or Placebo</arm_group_label> <arm_group_label>C mg IA-14069 or Placebo</arm_group_label> <arm_group_label>D mg IA-14069 or Placebo</arm_group_label> <arm_group_label>E mg IA-14069 or Placebo</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Subjects received matching placebo tablet orally on Day 1.</description> <arm_group_label>A mg IA-14069 or Placebo</arm_group_label> <arm_group_label>B mg IA-14069 or Placebo</arm_group_label> <arm_group_label>C mg IA-14069 or Placebo</arm_group_label> <arm_group_label>D mg IA-14069 or Placebo</arm_group_label> <arm_group_label>E mg IA-14069 or Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Signed the ICF.  2. Male subjects, ≥ 18 to ≤ 55 years of age at the time of signing the ICF.  3. Overtly healthy as determined by medical evaluation including medical history, physical examination and clinical laboratory tests.  4. Body mass index (BMI) within ≥ 18.0 to ≤ 32.0 kg/m2 and body weight not less than 50 kg.  5. Pulse rate between 40 and 100 beats per minutes (bpm)  6. A 12-lead ECG consistent with normal cardiac conduction and function, including:  - Sinus rhythm  - QTc interval of ≤ 450 milliseconds (QT interval corrected using Fridericia correction method [QTcF])  - QRS interval of ≤ 120 milliseconds  - PR interval ≤ 220 milliseconds  - Morphology consistent with healthy cardiac conduction and function  7. Non-smoker or ex-smoker for > 6 months.  8. Agree to use contraception (Appendix 1) during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.  Exclusion Criteria:  1. Resting BP systolic or diastolic > 140/90 mmHg or < 90/45 mmHg. Subjects BP may be re-checked per site SOPs.  2. Received any investigational drug or used any investigational device within 30 days or 5 half-lives whichever is longer prior to the first dosing of study drug.  3. Clinically significant history of any serious drug sensitivity or allergy, or food allergy as determined by the Investigator (i.e., requiring epinephrine or steroids to treat).  4. Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the Investigator, would unduly risk the subject's safety or may impact the conduct of the study.  5. Presence of any disorder that would interfere with the swallowing, absorption, distribution, metabolism and excretion of the investigational product as judged by the Investigator. Surgery for appendicitis is acceptable.  6. Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant /anti-anxiety medication).  7. Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject. Laboratory results may be re-checked once per Investigator's discretion.  8. Liver function test results of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 1.25 upper limit of normal (ULN); with an exception of subjects considered eligible to participate in the study per Investigator's discretion.  9. History of vaso-vagal syncope within 5 years.  10. History of any major surgery within 6 months.  11. History of any active infection within 30 days prior to the first dosing.  12. Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) Ab.  13. Subjects with a positive urine nicotine/cotinine test.  14. History of alcohol abuse as judged by the Investigator within approximately 1 year prior to admission. Average weekly alcohol intake > 14 units/week or are unwilling to stop alcohol consumption from 72 hr prior to dosing and outpatient visits and throughout the in-house periods until discharged from the clinical research unit and are unwilling to limit alcohol consumption during outpatient periods. Positive alcohol test at Screening or admission (One unit of alcohol equals about 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits).  15. History of illicit drug abuse, within approximately 1 year prior to admission or evidence of current use as judged by the Investigator. Positive drug test, including marijuana, at Screening or admission.  16. Donation or loss of > 500 mL of blood within 56 days prior to admission.  17. Chronic use of prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) prior to the first dosing per Investigator's discretion.  18. Unable to comply with the safety monitoring requirements of this clinical study or is considered by the Investigator to be an unsuitable candidate for the study. </textblock> </criteria> <gender>Male</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>ICON plc.</name> <address> <city>Lenexa</city> <state>Kansas</state> <zip>66219</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>October 27, 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>January 3, 2023</last_update_submitted> <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 4, 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>

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, food effect, and pharmacodynamics following a single oral dose of IA-14069 in healthy male subjects. Inclusion Criteria: 1. Signed the ICF. 2. Male subjects, ≥ 18 to ≤ 55 years of age at the time of signing the ICF. 3. Overtly healthy as determined by medical evaluation including medical history, physical examination and clinical laboratory tests. 4. Body mass index (BMI) within ≥ 18.0 to ≤ 32.0 kg/m2 and body weight not less than 50 kg. 5. Pulse rate between 40 and 100 beats per minutes (bpm) 6. A 12-lead ECG consistent with normal cardiac conduction and function, including: - Sinus rhythm - QTc interval of ≤ 450 milliseconds (QT interval corrected using Fridericia correction method [QTcF]) - QRS interval of ≤ 120 milliseconds - PR interval ≤ 220 milliseconds - Morphology consistent with healthy cardiac conduction and function 7. Non-smoker or ex-smoker for > 6 months. 8. Agree to use contraception (Appendix 1) during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. Exclusion Criteria: 1. Resting BP systolic or diastolic > 140/90 mmHg or < 90/45 mmHg. Subjects BP may be re-checked per site SOPs. 2. Received any investigational drug or used any investigational device within 30 days or 5 half-lives whichever is longer prior to the first dosing of study drug. 3. Clinically significant history of any serious drug sensitivity or allergy, or food allergy as determined by the Investigator (i.e., requiring epinephrine or steroids to treat). 4. Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the Investigator, would unduly risk the subject's safety or may impact the conduct of the study. 5. Presence of any disorder that would interfere with the swallowing, absorption, distribution, metabolism and excretion of the investigational product as judged by the Investigator. Surgery for appendicitis is acceptable. 6. Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant /anti-anxiety medication). 7. Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject. Laboratory results may be re-checked once per Investigator's discretion. 8. Liver function test results of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 1.25 upper limit of normal (ULN); with an exception of subjects considered eligible to participate in the study per Investigator's discretion. 9. History of vaso-vagal syncope within 5 years. 10. History of any major surgery within 6 months. 11. History of any active infection within 30 days prior to the first dosing. 12. Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) Ab. 13. Subjects with a positive urine nicotine/cotinine test. 14. History of alcohol abuse as judged by the Investigator within approximately 1 year prior to admission. Average weekly alcohol intake > 14 units/week or are unwilling to stop alcohol consumption from 72 hr prior to dosing and outpatient visits and throughout the in-house periods until discharged from the clinical research unit and are unwilling to limit alcohol consumption during outpatient periods. Positive alcohol test at Screening or admission (One unit of alcohol equals about 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits). 15. History of illicit drug abuse, within approximately 1 year prior to admission or evidence of current use as judged by the Investigator. Positive drug test, including marijuana, at Screening or admission. 16. Donation or loss of > 500 mL of blood within 56 days prior to admission. 17. Chronic use of prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) prior to the first dosing per Investigator's discretion. 18. Unable to comply with the safety monitoring requirements of this clinical study or is considered by the Investigator to be an unsuitable candidate for the study.

NCT0531xxxx/NCT05317754.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/NCT05317754</url> </required_header> <id_info> <org_study_id>PI22/110</org_study_id> <nct_id>NCT05317754</nct_id> </id_info> <brief_title>Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction</brief_title> <official_title>Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction: An Exploratory Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Hospital Miguel Servet</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Hospital Miguel Servet</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 efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. However, unlike these, there is a third group, known as deconstructive meditation practices, which has not been scientifically studied. Deconstructive practices aim to undo maladaptive cognitive patterns and generate knowledge about internal models of oneself, others and the world. Although there are theoretical and philosophical studies on the origin of addiction to the self or on the mechanisms of action associated with the deconstruction of the self, there are no randomized controlled trials evaluating these techniques in either a healthy population or clinical samples. This study aims to evaluate the effect of three deconstructive techniques by comparing them to the practice of mindfulness in the general population.  A randomized controlled clinical trial (RCT) will be conducted with about 240 participants allocated (1:1:1:1) to four groups: a) mindful breathing, b) prostrations, according to Tibetan Buddhist tradition; c) the Koan Mu, according to Zen Buddhist tradition; and d) the mirror exercise, according to Toltec tradition. The primary outcome will be the qualities of the non-dual experience and spiritual awakening, measured by the Nondual Embodiment Thematic Inventory, assessed at pre and post-treatment and at 3 and 6-month follow ups. Other outcomes will be mindfulness, happiness, compassion, affectivity and altered state of consciousness. Outcomes at each time point will be compared using mixed-effects linear regression models adjusted for baseline scores, sex and age.  This is the first RCT to apply deconstructive meditation techniques to evaluate their effect on the general population. The positive results of this project may have an important impact on the development of new interventions, not only to improve happiness and well-being in healthy populations but also potentially for the prevention and treatment of psychological and medical disorders, creating a new paradigm in the context of third-generation psychological interventions. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 11, 2023</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> <primary_purpose>Prevention</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mindful breathing group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <primary_outcome> <measure>The Nondual Embodiment Thematic Inventory (NETI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 20 to 100, is calculated by totalling the scores from all the items, with higher scores indicating higher levels of non-dual awareness</description> </primary_outcome> <secondary_outcome> <measure>Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group</description> </secondary_outcome> <secondary_outcome> <measure>Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>Sociodemographic data gender, age, nationality, current city of residence, marital status, education and for information regarding their experience with meditation.</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mindful breathing group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mindful breathing group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mindful breathing group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Nondual Awareness Dimensional Assessment (NADA)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mindful breathing group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>The Five Facet Mindfulness Questionnaire (FFMQ)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. A total score, ranging from 39 to 195, is calculated by totalling the scores from all the items, and higher total values indicate better full mindfulness</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mindful breathing group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>Sussex-Oxford Compassion Scales (SOCS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This scale is composed by two 20-item self-report scales measuring compassion. A total score, ranging from 20 to 100, is calculated for each scale, and higher total values indicate higher levels of compassion</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mindful breathing group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>The Pemberton Happiness Index (PHI)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. To calculate the overall PHI index, which included remembered and experienced well-being, individuals' scores of the 11 items related to remembered well-being plus the sum of scores on the experienced well-being were summed; the total sum is then divided by 12, so the resulting PHI total mean score also ranges from 0 to 10. Higher total values indicate higher levels of well-being</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mindful breathing group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Positive and Negative Affect Schedule (PANAS)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. This questionnaire comprises 20 items and two independent dimensions: positive affect and negative effect. Each scale has 10 items, and the score range for each is from 10 to 50. Higher total values indicate higher level of positive affect and negative effect respectively.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Baseline</time_frame> <description>In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mindful breathing group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the prostrations, according to Tibetan Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the Koan Mu, according to Zen Buddhist tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Post-treatment 60 days from baseline</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Three-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <secondary_outcome> <measure>Altered state of consciousness rating scale (OAV)</measure> <time_frame>Six-months follow-up</time_frame> <description>In the mirror exercise, according to Toltec tradition, group. The items are scored by measuring the millimeters from the low end of the scale to the subject's mark (integers from 0-100). Higher values indicate higher perception of an altered state of consciousness.</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">240</enrollment> <condition>Mental Health Wellness</condition> <arm_group> <arm_group_label>Mindful breathing</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Prostrations, according to Tibetan Buddhist tradition</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>The Koan Mu, according to Zen Buddhist tradition</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>The mirror exercise, according to Toltec tradition</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Mindful breathing</intervention_name> <description>Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night. There is no limit to the number of times informal practice can be performed during the day. Use of a diary is necessary to record the time and duration of all formal and informal practices. The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.</description> <arm_group_label>Mindful breathing</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Prostrations, according to Tibetan Buddhist tradition</intervention_name> <description>Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night. There is no limit to the number of times informal practice can be performed during the day. Use of a diary is necessary to record the time and duration of all formal and informal practices. The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.</description> <arm_group_label>Prostrations, according to Tibetan Buddhist tradition</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>The Koan Mu, according to Zen Buddhist tradition</intervention_name> <description>Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night. There is no limit to the number of times informal practice can be performed during the day. Use of a diary is necessary to record the time and duration of all formal and informal practices. The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.</description> <arm_group_label>The Koan Mu, according to Zen Buddhist tradition</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>The mirror exercise, according to Toltec tradition</intervention_name> <description>Formal practice should take 30-60 minutes/day. It can be divided into as many as 4 sessions/day at times of participants' choosing, but the recommended times are after waking up in the morning and before going to bed at night. There is no limit to the number of times informal practice can be performed during the day. Use of a diary is necessary to record the time and duration of all formal and informal practices. The intervention will have a duration of 60 days. During this period, participants are to take part only in the intervention to which they have been randomized and no other. After this period of time and during the follow-up, participants will be able to practise any kind of meditation and at times of their choosing, but this information must always be recorded in their diary.</description> <arm_group_label>The mirror exercise, according to Toltec tradition</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Older than 18 years of age  2. No psychiatric diagnosis (self-reported)  3. More than 1 year's experience of daily meditation practice  4. Having a computer and Internet connection at home  5. Being able to read and understand the Spanish language  6. Willingness to participate in the study and sign the written informed consent form  Exclusion Criteria:  1. Any diagnosis of a disease that may affect the central nervous system (pathological condition affecting the brain, traumatic brain injury, dementia) or other psychiatric diagnoses or acute psychiatric illnesses (severe range of depression, substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders), except for anxiety disorder  2. Any medical, infectious or degenerative disease that may affect mood; presence of delusional ideas; and hallucinations consistent or not with mood and suicide risk  3. Taking any psychiatric medication. </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>Department of Psychiatry. Miguel Servet University Hospital</name> <address> <city>Zaragoza</city> <zip>50009</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Javier García Campayo, pHd</last_name> <phone>976 50 65 78</phone> <email>investigaprimaria@gmail.com</email> </contact> </location> <location_countries> <country>Spain</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 27, 2023</last_update_submitted> <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 28, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Hospital Miguel Servet</investigator_affiliation> <investigator_full_name>Javier Garcia Campayo</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Deconstructive meditation practices</keyword> <keyword>Mindfulness</keyword> <keyword>Randomized controlled trial</keyword> <keyword>Wellbeing</keyword> <keyword>Self-deconstruction</keyword>  </clinical_study>

The efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. However, unlike these, there is a third group, known as deconstructive meditation practices, which has not been scientifically studied. Deconstructive practices aim to undo maladaptive cognitive patterns and generate knowledge about internal models of oneself, others and the world. Although there are theoretical and philosophical studies on the origin of addiction to the self or on the mechanisms of action associated with the deconstruction of the self, there are no randomized controlled trials evaluating these techniques in either a healthy population or clinical samples. This study aims to evaluate the effect of three deconstructive techniques by comparing them to the practice of mindfulness in the general population. A randomized controlled clinical trial (RCT) will be conducted with about 240 participants allocated (1:1:1:1) to four groups: a) mindful breathing, b) prostrations, according to Tibetan Buddhist tradition; c) the Koan Mu, according to Zen Buddhist tradition; and d) the mirror exercise, according to Toltec tradition. The primary outcome will be the qualities of the non-dual experience and spiritual awakening, measured by the Nondual Embodiment Thematic Inventory, assessed at pre and post-treatment and at 3 and 6-month follow ups. Other outcomes will be mindfulness, happiness, compassion, affectivity and altered state of consciousness. Outcomes at each time point will be compared using mixed-effects linear regression models adjusted for baseline scores, sex and age. This is the first RCT to apply deconstructive meditation techniques to evaluate their effect on the general population. The positive results of this project may have an important impact on the development of new interventions, not only to improve happiness and well-being in healthy populations but also potentially for the prevention and treatment of psychological and medical disorders, creating a new paradigm in the context of third-generation psychological interventions. Inclusion Criteria: 1. Older than 18 years of age 2. No psychiatric diagnosis (self-reported) 3. More than 1 year's experience of daily meditation practice 4. Having a computer and Internet connection at home 5. Being able to read and understand the Spanish language 6. Willingness to participate in the study and sign the written informed consent form Exclusion Criteria: 1. Any diagnosis of a disease that may affect the central nervous system (pathological condition affecting the brain, traumatic brain injury, dementia) or other psychiatric diagnoses or acute psychiatric illnesses (severe range of depression, substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders), except for anxiety disorder 2. Any medical, infectious or degenerative disease that may affect mood; presence of delusional ideas; and hallucinations consistent or not with mood and suicide risk 3. Taking any psychiatric medication.

NCT0531xxxx/NCT05317767.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/NCT05317767</url> </required_header> <id_info> <org_study_id>FLU-III-D-07/19</org_study_id> <nct_id>NCT05317767</nct_id> </id_info> <brief_title>The Objectives of This Study Are Comparative Assessment of the Tolerability, Safety and Immunogenicity of the Flu-M Vaccine vs. the Ultrix® Vaccine by Single Vaccination of Children Aged 6 to 17 Years.</brief_title> <official_title>Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Vaccine in Children Aged 6 to 17 Years (Inclusive)</official_title> <sponsors> <lead_sponsor> <agency>St. Petersburg Research Institute of Vaccines and Sera</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>St. Petersburg Research Institute of Vaccines and Sera</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> Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years. </textblock> </brief_summary> <detailed_description> <textblock> At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to include and randomize 300 children meeting the inclusion and non-inclusion criteria.  Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I, an "Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix® Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30 Days) will be prepared/  During Phase II , the trial for Phase I volunteers will continue in full in accordance with the Clinical Trial Regulations.  During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0 days - 11 years 11 months 30 days) will be further screened, of which it is planned to include and randomize 300 children meeting the inclusion criteria and not falling under the non-inclusion criteria. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">February 10, 2020</start_date> <completion_date type="Actual">September 14, 2020</completion_date> <primary_completion_date type="Actual">July 5, 2020</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>Diagnostic</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Change from Baseline Geometric mean antibodies titer (GMT) at 28 days</measure> <time_frame>Days 0-28</time_frame> </primary_outcome> <primary_outcome> <measure>Change from Baseline Seroconversion rate at 28 days</measure> <time_frame>Days 0-28</time_frame> <description>An increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise. Seroconversion level ≥ 40%.</description> </primary_outcome> <primary_outcome> <measure>Change from Baseline Seroprotection rate at 28 days</measure> <time_frame>Days 0-28</time_frame> <description>The percentage of subjects with a generated protective influenza haemagglutinin antibody titer (HA titer) (at least 1:40) vs. the baseline level. Seroprotection level ≥ 70%.</description> </primary_outcome> <primary_outcome> <measure>Change from Baseline Seroconversion factor at 28 days</measure> <time_frame>Days 0-28</time_frame> <description>The percentage of subjects who have a prevaccination titer of HA titer <1:10 and a post-vaccination HA titer >1:40 OR a prevaccination HA titer > 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline. Seroconversion factor ≥ 2.5.</description> </primary_outcome> <secondary_outcome> <measure>Immediate adverse events</measure> <time_frame>During 2 hours after vaccination</time_frame> <description>Allergic reactions that revaccination and are reported either by a volunteer / volunteer's parents to the clinical investigator</description> </secondary_outcome> <secondary_outcome> <measure>Adverse events</measure> <time_frame>During 7 days after vaccination</time_frame> <description>Local or systemic reactions that are reported either by a clinical investigator or by a volunteer / vaccinated volunteer's parents by phone</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of severe adverse events during the trial</measure> <time_frame>Measurements will be taken then up to 28 days post-vaccination</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">600</enrollment> <condition>Influenza</condition> <arm_group> <arm_group_label>Flu-M</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>300 children that will be vaccinated with a single dose of the Flu-M vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years)</description> </arm_group> <arm_group> <arm_group_label>Ultrix</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>300 children that will be vaccinated with a single dose of the Ultrix® vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years)</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Flu-M [Inactivated split influenza vaccine]</intervention_name> <description>solution for intramuscular injection, 0.5 ml</description> <arm_group_label>Flu-M</arm_group_label> </intervention> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Inactivated Split Influenza Vaccine</intervention_name> <description>solution for intramuscular injection, 0.5 ml</description> <arm_group_label>Ultrix</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  For volunteers aged 12 to 17 years:  - Healthy children1 of both sexes aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days);  - The written and dated informed consent of the volunteer (children aged 14-17 years) one of the parents for participation in the trial;  - If the volunteer has sexual relations, effective contraception methods must be used during the 30 days preceding vaccination and consent must be obtained to continue using these contraceptive methods during the trial and for two months after vaccination;  - The girls with mensis in the medical history shall have a negative pregnancy test result.  For volunteers aged 6 to 11 years:  - Healthy children of both sexes aged 6 to 11 years (6 years 0 months 0 days - 11 years 11 months 30 days);  - The written and dated informed consent of one of the parents for participation in the trial;  For all volunteers:  • Ability of a volunteer / volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer)  Exclusion Criteria:  History of influenza or previous influenza vaccination during 6 months before the trial;  - Vaccination with any vaccine less than 30 days before participating in the trial or scheduled vaccination with any vaccine within 30 days after vaccination with the trial vaccines;  - A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);  - Allergic reactions to vaccine components or any previous vaccination;  - History of allergic reaction to chicken protein;  - Encephalopathy that developed within 7 days of a previous vaccine administration;  - History of hematopoietic system, cancer;  - Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents;  - Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial;  - Long-term use (for more than 14 days) of any immunomodulating drugs (immunoregulating peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon)) less than 3 months prior to the commencement of the trial;  - Any confirmed or suspected immunosuppressive or immunodeficiency condition;  - History of chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, blood in the acute stage (recovery less than 4 weeks before vaccination) or in the decompensation stage;  - History of progressive neurological pathology, convulsive syndrome, afebrile convulsions;  - Acute infectious or non-infectious diseases less than 2 weeks before vaccination;  - Participation in another clinical trial less than 3 months before the start of the trial;  - Smoking (for children of older age group);  - Drug or alcohol abuse in the medical history (for children of older age group);  - Serious concurrent illnesses or pathological conditions not listed above which, in the opinion of the investigator, could complicate the assessment of the results of the trial including pathological deviations from age norms and norms of laboratory blood and urine parameters, which are clinically significant in the opinion of the investigator, or which may be a counter-indicative to participation in the trial in the opinion of the investigator;  - History of mental illness of the volunteer's parents </textblock> </criteria> <gender>All</gender> <minimum_age>6 Years</minimum_age> <maximum_age>17 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Perm State Medical University named after Academician E. A. Wagner</name> <address> <city>Perm</city> <country>Russian Federation</country> </address> </facility> </location> <location> <facility> <name>LLC "Meditsinskie Tehnologii"</name> <address> <city>Saint Petersburg</city> <country>Russian Federation</country> </address> </facility> </location> <location_countries> <country>Russian Federation</country> </location_countries> <verification_date>October 2021</verification_date> <study_first_submitted>October 26, 2021</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>March 30, 2022</last_update_submitted> <last_update_submitted_qc>March 30, 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>influenza</keyword> <keyword>flu</keyword> <keyword>vaccine</keyword> <keyword>Flu-M</keyword> <keyword>FluM</keyword> <keyword>Ultrix</keyword> <keyword>SPbSRIVS</keyword> <condition_browse>  <mesh_term>Influenza, Human</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Vaccines</mesh_term> </intervention_browse>  </clinical_study>

Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years. At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to include and randomize 300 children meeting the inclusion and non-inclusion criteria. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I, an "Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix® Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30 Days) will be prepared/ During Phase II , the trial for Phase I volunteers will continue in full in accordance with the Clinical Trial Regulations. During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0 days - 11 years 11 months 30 days) will be further screened, of which it is planned to include and randomize 300 children meeting the inclusion criteria and not falling under the non-inclusion criteria. Inclusion Criteria: For volunteers aged 12 to 17 years: - Healthy children1 of both sexes aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days); - The written and dated informed consent of the volunteer (children aged 14-17 years) one of the parents for participation in the trial; - If the volunteer has sexual relations, effective contraception methods must be used during the 30 days preceding vaccination and consent must be obtained to continue using these contraceptive methods during the trial and for two months after vaccination; - The girls with mensis in the medical history shall have a negative pregnancy test result. For volunteers aged 6 to 11 years: - Healthy children of both sexes aged 6 to 11 years (6 years 0 months 0 days - 11 years 11 months 30 days); - The written and dated informed consent of one of the parents for participation in the trial; For all volunteers: • Ability of a volunteer / volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer) Exclusion Criteria: History of influenza or previous influenza vaccination during 6 months before the trial; - Vaccination with any vaccine less than 30 days before participating in the trial or scheduled vaccination with any vaccine within 30 days after vaccination with the trial vaccines; - A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination); - Allergic reactions to vaccine components or any previous vaccination; - History of allergic reaction to chicken protein; - Encephalopathy that developed within 7 days of a previous vaccine administration; - History of hematopoietic system, cancer; - Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents; - Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial; - Long-term use (for more than 14 days) of any immunomodulating drugs (immunoregulating peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon)) less than 3 months prior to the commencement of the trial; - Any confirmed or suspected immunosuppressive or immunodeficiency condition; - History of chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, blood in the acute stage (recovery less than 4 weeks before vaccination) or in the decompensation stage; - History of progressive neurological pathology, convulsive syndrome, afebrile convulsions; - Acute infectious or non-infectious diseases less than 2 weeks before vaccination; - Participation in another clinical trial less than 3 months before the start of the trial; - Smoking (for children of older age group); - Drug or alcohol abuse in the medical history (for children of older age group); - Serious concurrent illnesses or pathological conditions not listed above which, in the opinion of the investigator, could complicate the assessment of the results of the trial including pathological deviations from age norms and norms of laboratory blood and urine parameters, which are clinically significant in the opinion of the investigator, or which may be a counter-indicative to participation in the trial in the opinion of the investigator; - History of mental illness of the volunteer's parents

NCT0531xxxx/NCT05317780.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/NCT05317780</url> </required_header> <id_info> <org_study_id>201601620</org_study_id> <nct_id>NCT05317780</nct_id> </id_info> <brief_title>Canavan-Single Patient IND</brief_title> <official_title>Expanded Access Trial of Systemic Delivery of Aspartoacylase ASPA (rAAV9-CB6-AspA) Gene Vector in a Single Patient With Canavan Disease</official_title> <sponsors> <lead_sponsor> <agency>University of Florida</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University of Miami</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Massachusetts, Worcester</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Florida</source> <brief_summary> <textblock> A recombinant virus vector constructed from adeno-associated virus (AAV) has been engineered to carry the human aspartoacylase (ASPA) gene expressed from a modified CMV-enhancer chicken β-actin (CB6) promoter. The construct has been shown to produce ASPA in animal models of Canavan disease, which closely match the proposed human study. The proposed clinical trial is an open label, expanded access study administering rAAV9-CB6-AspA gene vector by simultaneous systemic and intracerebroventricular routes to a single human subject (18-24 months of age) with Canavan disease. The subject will also receive immune modulation to transiently ablate B-cells (Rituximab) and modulate T-cell response (Sirolimus) prior to the initial exposure to AAV9. Given the null AspA mutations of the subject and current AAV seronegative status, this regimen will allow for later exposure to the therapeutic vector if needed and block any immuno-toxicity in the CNS. The goal of this study is to measure the safety and efficacy of AAV-mediated gene therapy as a treatment approach for neuronal pathology in Canavan disease. The subject will act as their own control and change from baseline will be assessed in regards to levels of brain NAA, brain water content and morphology, improved clinical status and peripheral levels of NAA. Safety parameters measured in this study will include: serum chemistries and hematology, urinalysis, physical assessments, whole blood assay for vector genomes, immunologic response to ASPA and AAV, as well as reported subject symptom history. </textblock> </brief_summary> <overall_status>No longer available</overall_status> <study_type>Expanded Access</study_type> <has_expanded_access>No</has_expanded_access> <expanded_access_info> <expanded_access_type_individual>Yes</expanded_access_type_individual> <expanded_access_type_treatment>Yes</expanded_access_type_treatment> </expanded_access_info> <condition>Canavan Disease</condition> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>rAAV9-CB6-AspA</intervention_name> <description>This study is an open label, expanded access trial of a simultaneous, single intravenous (IV) and intracerebroventricular (ICV) administration of rAAV9-CB6-AspA in a child with Canavan disease. The subject will also receive an immunosuppression protocol to prevent reaction to ASPA and vector capsids.</description> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Male  - 18-24 months of age at time of study enrollment  - Have a diagnosis of Canavan disease, as defined by biochemical criteria AND/OR genetic mutation analysis, AND demonstrate clinical findings such as macrocephaly, developmental delay, seizures or other positive findings  - Elevated brain NAA levels, which is correlated with NAA acidemia and aciduria  - Willing to discontinue aspirin, aspirin-containing products and other drugs that may alter platelet function 7 days prior to dosing, resuming 24 hours after the gene transfer agent has been administered  Exclusion Criteria:  - Have required acute (as distinguished from long-term, maintenance or chronic suppressive) oral or intravenous antibiotic therapy for a respiratory infection within 15 days prior to screening  - Have required oral or systemic corticosteroids within the last 15 days prior to baseline screening  - Have a platelet count less than 75,000/mm3  - Have history of platelet dysfunction, evidence of abnormal platelet function at screening, or history of recent use of drugs that may alter platelet function, which the subject is unable/unwilling to discontinue for study agent administration  - Have an INR greater than 1.3  - Have transaminases and alkaline phosphatase more than ten times the upper limit of normal at screening or Day-1; or an abnormal chemistry profile  - Have bilirubin and gamma-glutamyl transpeptidase greater than 2 times the upper limit of normal at screening or Day -1  - Be currently or within the past 30 days participating in any other research protocol involving investigational agents or therapies (Other than approved therapy)  - Have received gene transfer agents within the past 6 months  - Have any other concurrent condition that, in the opinion of the investigator, would make the subject unsuitable for the study. </textblock> </criteria> <gender>Male</gender> <gender_based>Yes</gender_based> <gender_description>This is a single patient IND, the patient was previously identified.</gender_description> <minimum_age>18 Months</minimum_age> <maximum_age>24 Months</maximum_age> </eligibility> <overall_official> <last_name>Barry J Byrne, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Florida</affiliation> </overall_official> <location> <facility> <name>University of Florida</name> <address> <city>Gainesville</city> <state>Florida</state> <zip>32610</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 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>August 21, 2023</last_update_submitted> <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Gene Therapy</keyword> <condition_browse>  <mesh_term>Canavan Disease</mesh_term> </condition_browse>  </clinical_study>

A recombinant virus vector constructed from adeno-associated virus (AAV) has been engineered to carry the human aspartoacylase (ASPA) gene expressed from a modified CMV-enhancer chicken β-actin (CB6) promoter. The construct has been shown to produce ASPA in animal models of Canavan disease, which closely match the proposed human study. The proposed clinical trial is an open label, expanded access study administering rAAV9-CB6-AspA gene vector by simultaneous systemic and intracerebroventricular routes to a single human subject (18-24 months of age) with Canavan disease. The subject will also receive immune modulation to transiently ablate B-cells (Rituximab) and modulate T-cell response (Sirolimus) prior to the initial exposure to AAV9. Given the null AspA mutations of the subject and current AAV seronegative status, this regimen will allow for later exposure to the therapeutic vector if needed and block any immuno-toxicity in the CNS. The goal of this study is to measure the safety and efficacy of AAV-mediated gene therapy as a treatment approach for neuronal pathology in Canavan disease. The subject will act as their own control and change from baseline will be assessed in regards to levels of brain NAA, brain water content and morphology, improved clinical status and peripheral levels of NAA. Safety parameters measured in this study will include: serum chemistries and hematology, urinalysis, physical assessments, whole blood assay for vector genomes, immunologic response to ASPA and AAV, as well as reported subject symptom history. Inclusion Criteria: - Male - 18-24 months of age at time of study enrollment - Have a diagnosis of Canavan disease, as defined by biochemical criteria AND/OR genetic mutation analysis, AND demonstrate clinical findings such as macrocephaly, developmental delay, seizures or other positive findings - Elevated brain NAA levels, which is correlated with NAA acidemia and aciduria - Willing to discontinue aspirin, aspirin-containing products and other drugs that may alter platelet function 7 days prior to dosing, resuming 24 hours after the gene transfer agent has been administered Exclusion Criteria: - Have required acute (as distinguished from long-term, maintenance or chronic suppressive) oral or intravenous antibiotic therapy for a respiratory infection within 15 days prior to screening - Have required oral or systemic corticosteroids within the last 15 days prior to baseline screening - Have a platelet count less than 75,000/mm3 - Have history of platelet dysfunction, evidence of abnormal platelet function at screening, or history of recent use of drugs that may alter platelet function, which the subject is unable/unwilling to discontinue for study agent administration - Have an INR greater than 1.3 - Have transaminases and alkaline phosphatase more than ten times the upper limit of normal at screening or Day-1; or an abnormal chemistry profile - Have bilirubin and gamma-glutamyl transpeptidase greater than 2 times the upper limit of normal at screening or Day -1 - Be currently or within the past 30 days participating in any other research protocol involving investigational agents or therapies (Other than approved therapy) - Have received gene transfer agents within the past 6 months - Have any other concurrent condition that, in the opinion of the investigator, would make the subject unsuitable for the study.