Datasets:

hackint0sh

/

pardata

like 0

## Protocol Section ### Identification Module **NCT ID:** NCT06418932 **Brief Title:** Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure **Official Title:** Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion #### Organization Study ID Info **ID:** COMPRESSION-HF #### Organization **Class:** OTHER **Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fundación para la Investigación del Hospital Clínico de Valencia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Randomized 1:1 multicenter double-blind clinical investigation evaluating the efficacy and safety of compression therapy of the lower limbs plus parenteral administration of diuretics vs. administration of parenteral diuretics alone (standard treatment) in patients with decompensated HF and predominantly systemic tissue congestion and absence of intravascular systemic congestion. Patients will be assigned to standard treatment (parenteral administration of furosemide) versus parenteral administration of furosemide plus lower limb compression therapy for up to 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible healthcare professional. ### Conditions Module **Conditions:** - Heart Failure ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients will be assigned to standard treatment (parenteral administration of furosemide) versus parenteral administration of furosemide plus lower limb compression therapy for a maximum of 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible health professional. ##### Masking Info **Masking:** DOUBLE **Masking Description:** Sham procedure. Blinded to treatment allocation. The investigator and the patients will be blinded to treatment assignments. For this purpose, a restraint system will be used which will be applied to the lower limbs and will mask the assignment. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 106 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Compressive therapy of the lower limbs plus parenteral administration of diuretics **Intervention Names:** - Device: UrgoK2 / UrgoK2 Lite **Label:** Compressive **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Parenteral diuretics alone **Intervention Names:** - Other: Controll **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Compressive **Description:** Multicomponent compressive bandage system consisting of an internal bandage of short traction and an external cohesive bandage of long traction, with pressure indicators on both bandages, which provides a sustained ankle pressure of \~20/40mmHg. **Name:** UrgoK2 / UrgoK2 Lite **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control **Description:** Administration of parenteral diuretics only **Name:** Controll **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Percentage of patients in whom tolerance of the compressive bandage is achieved at 24 and 72 hours **Measure:** Tolerance **Time Frame:** 72 hours **Description:** Estimated glomerular filtration rate (eGFR) at 72 hours **Measure:** eGFR **Time Frame:** 72 hours **Description:** Electrolyte disturbances at 72 hours (hyponatremia: \<135 mmo/l, hypernatremia\>150 mmo/l, hypokalemia\<3.5 mmo/l and hyperkalemia\>5 mmo/l) **Measure:** Electrolyte disturbances **Time Frame:** 72 hours **Description:** Clinical adverse events at 30 days total and cardiovascular, with special emphasis on cardiovascular death and HF decompensation **Measure:** Clinical adverse events **Time Frame:** 30 days #### Primary Outcomes **Description:** Changes in natriuresis at 24 hours after randomization. **Measure:** Natriuresis **Time Frame:** 24 hours **Description:** Changes in weight at 24 hours after randomization **Measure:** Weight **Time Frame:** 24 hours #### Secondary Outcomes **Description:** Changes in the diameter of the lower limbs (at 5 and 10 cm from the ankles) at 24 and 72 hours after randomization. **Measure:** Diameter of the lower limbs **Time Frame:** 72 hours **Description:** Changes in clinical congestion score at 24 and 72 hours **Measure:** Congestion score **Time Frame:** 72 hours **Description:** Changes in inferior vena cava diameter at 3, 24 and 72 hours **Measure:** Inferior vena cava diameter **Time Frame:** 72 hours **Description:** Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours. **Measure:** NT-proBNP **Time Frame:** 72 hours **Description:** Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days **Measure:** CA125 **Time Frame:** 15±3 days **Description:** Doses of furosemide equivalents used in the first 72 hours after randomization **Measure:** Doses of furosemide **Time Frame:** 72 hours **Description:** Time to switch from diuretics to oral administration **Measure:** Time to oral administration. **Time Frame:** 72 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 18 years or older. * Patient with clinical judgment of acute decompensated heart failure in the first 96 hours from the start of parenteral diuretic treatment. * Patient treated with furosemide at least 40 mg in the last 24 hours. * NT-proBNP levels\>1000 pg/ml at least 1 time since the onset of decompensation. * Presence of tibio-malleolar edema at least grade II/IV at the time of inclusion. * Inferior vena cava (IVC) diameter on ultrasonography ≤21 mm at the time of the "screening" visit. Exclusion Criteria: * Being admitted to the Intensive Care Unit. * Renal transplant, chronic renal failure stage 5 (eGFR \<15 ml/min/1.73m2) or being included in dialysis program (peritoneal/hemodialysis) or in need of ultrafiltration. * Absence of peripheral pulses. * Ankle brachial index (ABI) \<0.9. * History of severe peripheral artery disease. * Previous intolerance to compressive bandaging. * HF secondary to acute myocardial infarction. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Email:** yulnunez@gmail.com - **Name:** Julio JN Nuñez - **Phone:** 652856689 - **Phone Ext:** +34 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Clínico Universitario de Valencia **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418919 **Brief Title:** A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease. **Official Title:** A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease. #### Organization Study ID Info **ID:** UW 22-504 #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2020-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Investigator Affiliation:** The University of Hong Kong **Investigator Full Name:** Dr. Lang Hung Hin, Brian **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** There have been previous reports of using High-intensity focused ultrasound (HIFU) as a feasible thermal ablative treatment for relapsed Graves' disease. In recent years, radiofrequency ablation (RFA) has become another promising alternative for thermal ablation of benign thyroid nodules. RFA has the advantage of avoiding a surgical scar, organ preservation and being an ambulatory procedure. It utilizes a small caliber radiofrequency electrode, which is inserted into the thyroid gland percutaneously. The active tip of the RF electrode would induce frictional heat in the surrounding tissue, causing a thermal ablative effect. The direct application of energy of RFA to tissue is different from that in HIFU, in which energy is transmitted through the skin of the participants from the transducer. Studies of follow-up after RFA of Graves' disease have not been published. Given the previous successful experience with HIFU, the investigators would like to explore the feasibility, safety and efficacy of RFA as an alternative thermal ablation option for relapsed Graves' disease. Thus, the purpose of this prospective study is to assess the efficacy and safety of US-guided RFA for the treatment of relapsed Graves' disease. ### Conditions Module **Conditions:** - Relapsed Graves' Disease - Thyroid; Functional Disturbance - Radiofrequency Ablation Treatment ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Radiofrequency ablation treatment **Label:** RFA treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RFA treatment **Description:** RFA is used to ablate the entire thyroid gland **Name:** Radiofrequency ablation treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Graves' disease remission rate after a single course of RFA **Measure:** Short term disease remission rate after a single course of RFA **Time Frame:** 12 months **Description:** Graves' disease remission after a single course of RFA **Measure:** Mid term remission rate after a single course of RFA **Time Frame:** 24 months and 36 months **Description:** To measure the complication rates after RFA **Measure:** Complication rates **Time Frame:** 1 month **Description:** To examine the change in qualitfy of life with SF-12 scores in post-treatment from baseline to 24 months and 36 months **Measure:** Change in Quality of life **Time Frame:** 24 months, 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (a) age older than 18 years, * (b) relapsed Graves' disease despite an adequate ATD treatment for 18 months or more and * (c) absence of vocal cord immobility. Exclusion Criteria: * (a) patients who prefer or indicated for surgery, * (b) head and/or neck disease preventing hyperextension of the neck, * (c) history of thyroid cancer or other malignant tumors in the neck region, * (d) history of neck irradiation, * (e) moderate to severe Graves' ophthalmopatty, * (f) large compressive goiter * (g) pregnancy or lactation, and * (h) any contraindication related to intravenous moderate sedation. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Queen Mary Hospital #### Overall Officials **Official 1:** **Affiliation:** The University of Hong Kong **Name:** Matrix, Man Him Fung, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Cooper DS. Antithyroid drugs. N Engl J Med. 2005 Mar 3;352(9):905-17. doi: 10.1056/NEJMra042972. No abstract available. **PMID:** 15745981 **Citation:** Watanabe N, Narimatsu H, Noh JY, Yamaguchi T, Kobayashi K, Kami M, Kunii Y, Mukasa K, Ito K, Ito K. Antithyroid drug-induced hematopoietic damage: a retrospective cohort study of agranulocytosis and pancytopenia involving 50,385 patients with Graves' disease. J Clin Endocrinol Metab. 2012 Jan;97(1):E49-53. doi: 10.1210/jc.2011-2221. Epub 2011 Nov 2. **PMID:** 22049174 **Citation:** Yip J, Lang BH, Lo CY. Changing trend in surgical indication and management for Graves' disease. Am J Surg. 2012 Feb;203(2):162-7. doi: 10.1016/j.amjsurg.2011.01.029. Epub 2011 Jun 17. **PMID:** 21683939 **Citation:** Lang BH, Woo YC, Chiu KW. Two-year outcomes of single-session high-intensity focused ultrasound (HIFU) treatment in persistent or relapsed Graves' disease. Eur Radiol. 2019 Dec;29(12):6690-6698. doi: 10.1007/s00330-019-06303-8. Epub 2019 Jun 17. **PMID:** 31209622 **Citation:** Lang BH, Woo YC, Wong IY, Chiu KW. Single-Session High-Intensity Focused Ultrasound Treatment for Persistent or Relapsed Graves Disease: Preliminary Experience in a Prospective Study. Radiology. 2017 Dec;285(3):1011-1022. doi: 10.1148/radiol.2017162776. Epub 2017 Jul 20. **PMID:** 28727542 **Citation:** Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14. **PMID:** 29962870 **Citation:** Kuo JH, Lee JA. The Adoption of Ultrasound-guided Radiofrequency Ablation of Thyroid Nodules in the United States. Ann Surg. 2021 Jan 1;273(1):e10-e12. doi: 10.1097/SLA.0000000000003930. No abstract available. **PMID:** 33064390 **Citation:** Papini E, Pacella CM, Solbiati LA, Achille G, Barbaro D, Bernardi S, Cantisani V, Cesareo R, Chiti A, Cozzaglio L, Crescenzi A, De Cobelli F, Deandrea M, Fugazzola L, Gambelunghe G, Garberoglio R, Giugliano G, Luzi L, Negro R, Persani L, Raggiunti B, Sardanelli F, Seregni E, Sollini M, Spiezia S, Stacul F, Van Doorne D, Sconfienza LM, Mauri G. Minimally-invasive treatments for benign thyroid nodules: a Delphi-based consensus statement from the Italian minimally-invasive treatments of the thyroid (MITT) group. Int J Hyperthermia. 2019;36(1):376-382. doi: 10.1080/02656736.2019.1575482. Epub 2019 Mar 26. **PMID:** 30909759 #### See Also Links **Label:** Ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules **URL:** http://www.nice.org.uk/guidance/ipg562 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005094 - Term: Exophthalmos - ID: D000009916 - Term: Orbital Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000006042 - Term: Goiter - ID: D000013959 - Term: Thyroid Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006980 - Term: Hyperthyroidism - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: LOW - As Found: Unknown - ID: M9214 - Name: Graves Disease - Relevance: HIGH - As Found: Graves' Disease - ID: M8237 - Name: Exophthalmos - Relevance: LOW - As Found: Unknown - ID: M12845 - Name: Orbital Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M9147 - Name: Goiter - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M10031 - Name: Hyperthyroidism - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006111 - Term: Graves Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418906 **Brief Title:** The Relationships Between Equanimity, Mindfulness, and Self-Compassion, and Mental Health Outcomes **Official Title:** The Relationships Between Equanimity, Mindfulness, and Self-Compassion, and Mental Health Outcomes #### Organization Study ID Info **ID:** NoID #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is an academic research study aiming to explore the relationships between equanimity, mindfulness, self-compassion, and mental health outcomes, and to examine the reliability and validity of the new measures in Hong Kong. **Detailed Description:** The current research aims to validate two new measures, the Equanimity Scale (ES-16) and the Sussex-Oxford Compassion for the Self Scale (SOCS-S) in Hong Kong. Standard procedures of forward-backward translation of the ES-16 and SOCS-S were employed. Adults aged 18 or above will be recruited in the community to fill out a set of questionnaires two times on equanimity, mindfulness, self-compassion, and mental health outcomes (i.e., depression, anxiety, stress, wellbeing). Relationships between these variables will be explored. To assess test-retest reliability, participants will be invited to fill out the same set of questionnaires on a total of two time points: baseline and two-week post-baseline. ### Conditions Module **Conditions:** - Mindfulness - Mental Health Outcomes - Self-Compassion ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is a single-arm study with no intervention involved. Adults aged 18 or above from the community will be invited to fill out the same set of questionnaires on a total of two time points: baseline and two-week post-baseline. **Intervention Names:** - Other: Self-reported questionnaires **Label:** Community adults aged 18 or above ### Interventions #### Intervention 1 **Arm Group Labels:** - Community adults aged 18 or above **Description:** After participants agree to participate in this study, they will first fill out the set of questionnaires once. After two weeks, the research team will send them reminders to fill out the same set of questionnaires again. **Name:** Self-reported questionnaires **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The 20-item Five Facet Mindfulness Questionnaire - 20 (FFMQ-20) will be used to measure mindfulness. Possible score range is 20 to 100, where higher scores indicate higher mindfulness. **Measure:** Mindfulness (Five Facet Mindfulness Questionnaire - 20) **Time Frame:** 2-week **Description:** The 16-item Equanimity Scale (ES-16) will be used to measure equanimity. Possible score range is 16 to 80, where higher scores indicate higher equanimity. **Measure:** Equanimity (Equanimity Scale) **Time Frame:** 2-week **Description:** The 20-item Sussex-Oxford Compassion for the Self Scale (SOCS-S) will be used to measure self-compassion. Possible score range is 20 to 100, where higher scores indicate higher self-compassion. **Measure:** Self-compassion (Sussex-Oxford Compassion for the Self Scale) **Time Frame:** 2-week **Description:** The nine-item Patient Health Questionnaire - 9 (PHQ-9) will be used to measure depression. Possible score range is 0 to 27, where higher scores mean more severe depression. **Measure:** Depression (Patient Health Questionnaire - 9) **Time Frame:** 2-week **Description:** The seven-item Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Possible score range is 0 to 21, where higher scores indicate more severe anxiety. **Measure:** Anxiety (Generalized Anxiety Disorder - 7) **Time Frame:** 2-week **Description:** The 10-item Perceived Stress Scale - 10 (PSS) will be used to measure stress. Possible score range is 0 to 40, where higher scores indicate higher perceived stress. **Measure:** Stress (Perceived Stress Scale - 10) **Time Frame:** 2-week **Description:** The seven-item Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) will be used to measure wellbeing. Possible score range is 0 to 35, where higher scores mean higher mental wellbeing. **Measure:** Wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale) **Time Frame:** 2-week **Description:** The Two-Factor Equanimity Scale (EQUA-S) will be used to measure equanimity, for assessing convergent validity of the ES-16. Possible score range is 14 to 70, where higher scores indicate higher equanimity. **Measure:** Equanimity (Two-Factor Equanimity Scale) **Time Frame:** 2-week **Description:** The 12-item Self-Compassion Scale - Short Form (SCS-SF) will be used to measure self-compassion, for assess convergent validity of the SOCS-S. Possible score range is 12 to 60, where higher scores indicate higher self-compassion. **Measure:** Self-compassion (Self-Compassion Scale - Short Form) **Time Frame:** 2-week #### Secondary Outcomes **Description:** Six single-item exploratory weekly measures respectively measuring equanimity, mindfulness, self-compassion, depression, anxiety, stress. Possible score range for single-item measures on equanimity, mindfulness, self-compassion are 1 to 7, where higher scores indicate higher equanimity, mindfulness, self-compassion respectively. Possible score range for single-item measures on depression, anxiety are 0 to 3, where higher scores indicate more severe depression, anxiety respectively. Possible score range for single-item measure on stress is 0 to 4, where higher scores indicate higher perceived stress. **Measure:** single-item measures on equanimity, mindfulness, self-compassion, depression, anxiety, stress (i.e., six items in total) **Time Frame:** 2-week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * aged 18 or above * can read and type Chinese * have means to access online surveys No Exclusion Criteria **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Community participants aged 18 or above ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hclok@connect.hku.hk **Name:** Hoi Chun Lok **Phone:** +852 3917-5889 **Role:** CONTACT **Contact 2:** **Email:** aksc@hku.hk **Name:** Amanda Kingsze Cheung **Phone:** +852 3917-5889 **Role:** CONTACT #### Locations **Location 1:** **City:** Hong Kong **Contacts:** ***Contact 1:*** - **Email:** hclok@connect.hku.hk - **Name:** Hoi Chun Lok - **Phone:** +852 3917-5889 - **Role:** CONTACT ***Contact 2:*** - **Email:** aksc@hku.hk - **Name:** Amanda Kingsze Cheung - **Phone:** +852 3917-5889 - **Role:** CONTACT **Country:** Hong Kong **Facility:** Department of Psychology, The University of Hong Kong #### Overall Officials **Official 1:** **Affiliation:** The University of Hong Kong **Name:** Hoi Chun Lok **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418893 **Brief Title:** Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients. **Official Title:** Effect of Isoflurane and Target Control Infusion (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients: A Randomized Controlled Trial. #### Organization Study ID Info **ID:** IEC/2023/100/MA05 #### Organization **Class:** OTHER **Full Name:** Institute of Liver and Biliary Sciences, India ### Status Module #### Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-17 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Institute of Liver and Biliary Sciences #### Lead Sponsor **Class:** OTHER **Name:** Institute of Liver and Biliary Sciences, India #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Both isoflurane and propofol are being used to give anaesthesia for living donor liver transplant in our institute. Propofol when compared to isoflurane has advantages like early awakening from anaesthesia, reduced nausea, vomiting in the postoperative period. Propofol also has antioxidant properties. Because of its antioxidant properties propofol may have a protective effect against oxidative stress and ischemia reperfusion injury in major organs during liver transplant surgery. However, there are no studies showing the effect of isoflurane and propofol on Intraoperative hemodynamics and postoperative liver and kidney functions.Thus, we are conducting this study to know the effect of these agents on intraoperative hemodynamics and postoperative liver and kidney function. ### Conditions Module **Conditions:** - Liver Transplant Recipients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomised, controlled, double blind ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Drug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period **Intervention Names:** - Drug: Inhalational isoflurane **Label:** Isoflurane **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Drug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period **Intervention Names:** - Drug: Target control infusion propofol **Label:** Propofol **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Propofol **Description:** target control infusion of propofol for target plasma concentration 2.5mcg/ml and BIS 40-60 **Name:** Target control infusion propofol **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Isoflurane **Description:** Inhalational Isoflurane at concentration 1-2% **Name:** Inhalational isoflurane **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** TCI propofol will provide more stable hemodynamics **Measure:** Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively. **Time Frame:** INTRAOPERATIVELY #### Secondary Outcomes **Measure:** To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes **Time Frame:** INTRAOPERATIVELY AT 15 MINUTES INTERVAL **Measure:** To compare between the two groups mean systemic vascular resistance during different phases of liver transplant recorded every 15 minutes **Time Frame:** INTRAOPERATIVELY AT 15 MINUTES INTERVAL **Measure:** To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes **Time Frame:** INTRAOPERATIVELY AT 15 MINUTES INTERVAL **Measure:** Total vasopressor requirement during reperfusion **Time Frame:** Intraoperative **Measure:** Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively **Time Frame:** Intraoperatively **Measure:** QTc interval between the two groups during different phases of liver transplant measured every 15 minutes **Time Frame:** Intraoperatively every 15 mins **Measure:** Peak lactate levels intraoperatively **Time Frame:** Intraoperatively **Measure:** Postoperative Liver function tests ie Bilirubin and albumin **Time Frame:** at 12, 24, 72 hours and day 7 postoperatively **Measure:** Postoperative Liver function tests ie AST and ALT **Time Frame:** at 12, 24, 72 hours and day 7 postoperatively **Measure:** Postoperative Liver function tests ie GGT **Time Frame:** at 12, 24, 72 hours and day 7 postoperatively **Measure:** Postoperative Liver function tests ie platelet count **Time Frame:** at 12, 24, 72 hours and day 7 postoperatively **Measure:** Postoperative coagulation profile **Time Frame:** at 12, 24, 72 hours and day 7 postoperatively **Measure:** Postoperative Renal function tests i.e. Blood urea and S.creatinine levels **Time Frame:** at12, 24, 72 hours and day7 postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:-Above 18 years of age who will undergo living donor liver transplant - Exclusion Criteria: Refusal to consent * Acute liver failure, Acute on chronic liver failure * Allergic to propofol or any component of propofol * Patients with pre existing cardiac dysfunction and cardiomyopathy * Patients with pre existing renal dysfunction/ deranged RFTs preoperatively **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** abhi27sh@gmail.com **Name:** Abhinav Sharma, MD **Phone:** 8860790151 **Phone Ext:** 91 **Role:** CONTACT #### Locations **Location 1:** **City:** Delhi **Contacts:** ***Contact 1:*** - **Email:** abhi27sh@gmail.com - **Name:** Abhinav Sharma, MD - **Phone:** 8860790151 - **Phone Ext:** 91 - **Role:** CONTACT **Country:** India **Facility:** Institute of liver and biliary sciences **Status:** RECRUITING **Zip:** 110070 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000018685 - Term: Anesthetics, Inhalation ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: VaCoAg - Name: Vasoconstrictor Agents ### Intervention Browse Module - Browse Leaves - ID: M18307 - Name: Propofol - Relevance: HIGH - As Found: Symptoms - ID: M10562 - Name: Isoflurane - Relevance: HIGH - As Found: Bismuth - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M20765 - Name: Anesthetics, Inhalation - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000015742 - Term: Propofol - ID: D000007530 - Term: Isoflurane ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418880 **Acronym:** AIDING **Brief Title:** Automated Insulin Delivery for Inpatients With Dysglycemia **Official Title:** Automated Insulin Delivery for Inpatients With Dysglycemia (AIDING) Randomized Controlled Trial #### Organization Study ID Info **ID:** STUDY00007081 #### Organization **Class:** OTHER **Full Name:** Emory University #### Secondary ID Infos **ID:** 1R01DK138366-01 **Link:** https://reporter.nih.gov/quickSearch/1R01DK138366-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Investigator Affiliation:** Emory University **Investigator Full Name:** Francisco Pasquel **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This randomized controlled trial will test the efficacy and safety of automated insulin delivery (AID) in hospitalized patients with diabetes (type 1 or type 2) requiring insulin therapy who are admitted to general medical/surgical floors. The main objectives of this study are: * To test the efficacy and safety of AID versus multiple daily insulin injections (MDI) + CGM in the inpatient setting * To determine differences in CGM-derived metrics between AID and MDI plus CGM in the hospital and explore differences in treatment effect according to individual characteristics. Participants will be: * Randomized to AID + remote CGM (intervention) or multiple daily insulin injections (MDI) + CGM (control group) * Followed for a total of 10 days or until hospital discharge (if less than 10 days). **Detailed Description:** Annually, over 8 million people in the United States are hospitalized due to diabetes. Among these patients, those with uncontrolled diabetes are at a significantly heightened risk for poor hospital outcomes. However, achieving glycemic targets within hospital settings proves challenging, as doing so often increases the risk of iatrogenic hypoglycemia. This is exacerbated by the variable insulin therapy requirements that arise during acute illnesses, such as unpredictable nutrition intake, illness severity, and the effects of various medications. These fluctuations pose a substantial challenge for healthcare providers tasked with caring for patients with diabetes. The usage of diabetes technology may offer an opportunity to improve inpatient diabetes care, but best practices are not yet defined. The COVID-19 pandemic has highlighted how accelerated use of technologies (e.g., telemedicine, e-consults, and remote monitoring) helps healthcare systems adapt care delivery while minimizing exposure risk. Following the non-objection by the US Food and Drug Administration (FDA) to the use of CGM in the hospital, the investigators and others implemented the usage of remote real-time CGM to treat patients with COVID-19. Initial clinical trials using remote real-time CGM have shown modest improvements in hypoglycemia detection and prevention and minimal or no increases in time spent in the target range (TIR) in non-ICU patients. The use of AID with remote insulin delivery and remote glucose monitoring is novel for the inpatient setting. The use of AID allows for 288 automated insulin dosing alterations per day, which is infeasible for hospital staff and could help proactively compensate for the multitude of factors affecting insulin requirements in the hospital. Preliminary data from AID trials with a single European AID system (using an insulin pump with tubing) have shown improvements in glycemic control in diverse populations without increasing the risk of hypoglycemia. However, these trials have limited involvement of patient care teams and the feasibility of hospital implementation and adoption is unknown. Using single-use insulin patch-pumps (without tubing) may offer a unique opportunity for hospital use of AID; however, no randomized controlled data on the use of AID in the hospital is available in the US. Results from our recently completed pilot study show that using AID with remote CGM is feasible in the hospital and appears to be associated with good glycemic control. In addition to improving glycemic control, this approach will: * Offer a unique treatment option for patients typically excluded from inpatient clinical trials, including patients with type 1 diabetes, steroids, medical nutrition therapy, or those under isolation precautions. * Use superficial wearable medical devices to alleviate inconveniences and discomforts to patients associated with current standard-of-care insulin therapy. The combination of a CGM and a patch-based insulin pump can greatly reduce the need for recurrent "sticks" and "pricks." They may thereby improve the quality of experience for patients admitted to the hospital. * Introduce remote insulin delivery and remote glucose monitoring, offering an unprecedented opportunity for effective diabetes care for people with highly contagious diseases or while interacting with patients during emergency conditions. * Set the stage for subsequent inpatient diabetes technology implementation efforts. The investigator's approach has multiple layers of safety to ensure improved glycemic control without increasing the risk of hypoglycemia, including a) nursing staff training for rapid response, b) EHR documentation and validation of sensor glucose values to confirm accuracy, c) remote monitoring with alarms (telemetry and inpatient treatment team). ### Conditions Module **Conditions:** - Type 1 Diabetes - Type 2 Diabetes **Keywords:** - continuous glucose monitoring - automated insulin delivery - Insulin Therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group will follow the hospital's usual practice for subcutaneous insulin for glucose control. It will be managed by the admitting team with the assistance of an inpatient endocrine team. Participants will wear a real-time CGM for 10 days or until hospital discharge (if \<10 days) **Intervention Names:** - Combination Product: Standard of Care Insulin Therapy + CGM **Label:** Control **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants in the intervention arm will be assigned to the Omnipod 5 AID system with integrated Dexcom CGM. These devices will communicate with a patient-specific smartphone secured within the patient room and remotely monitored by the nursing station. Nursing staff on medical-surgical units will provide insulin therapy using the investigational device for participants randomized to the intervention arm, including delivering insulin boluses, monitoring CGM values and trends, validating CGM accuracy against POC glucose, and performing routine device exchanges (Pod or CGM) when indicated AID therapy will continue for 10 days or until hospital discharge (if \<10 days) **Intervention Names:** - Device: AID system with Remote Real-Time CGM **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** The Omnipod 5 AID System is comprised of two components: * Omnipod 5 Pod (insulin infusion pump with SmartAdjust technology) * Omnipod 5 App (installed on the Controller or smart phone) The Omnipod 5 AID pod is a lightweight, self-adhesive device that the user fills with U-100 rapid-acting insulin and wears directly on their body. The Pod delivers insulin into the user's body through a small flexible tube, called a cannula, based on the commands from the compatible Controller. In the Omnipod 5 AID System, the Pod itself houses the MPC algorithm and communicates directly with the CGM and the Omnipod 5 App. Based on predicted glucose values, the algorithm commands the Pod's insulin delivery through micro-boluses. **Name:** AID system with Remote Real-Time CGM **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control **Description:** This includes the usage of subcutaneous insulin for glucose control. Participants will wear a real-time Continuous Monitoring (CGM) for 10 days or until hospital discharge (if \<10 days). Treatment decisions will be based on POC testing with consideration of daily evaluation of CGM patterns. **Name:** Standard of Care Insulin Therapy + CGM **Other Names:** - Multiple Daily Injections +CGM **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Other Outcomes **Description:** Percentage of time spent above the glucose levels of 180 mg/dl **Measure:** Time spent above 180 mg/dl **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** Percentage of time spent between the range of 70-99 mg/dl **Measure:** Time spent between 70-99 mg/dl **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** Number of Glycemic events above 300 mg/dl will be captured **Measure:** Glycemic events above 300 mg/dl **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** Number of Glycemic events below 54 mg/dl will be captured **Measure:** Glycemic events below 54 mg/dl **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** defined as an event that required assistance of another person due to altered consciousness to actively administer parenteral carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that the participant was unable to drink or eat oral carbs (e.g. juice, crackers), was incoherent, disoriented, and/or combative, or experienced seizure or coma. **Measure:** Number of hypoglycemic episodes (Glucose <40 mg/dl) **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** The number of Diabetes-related ketoacidosis (DKA) events across all participants. **Measure:** Number of Diabetes-related Ketoacidosis Events **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** The number of hyperosmolar hyperglycemic syndrome (HHS) events across all participants. **Measure:** Number of hyperosmolar hyperglycemic syndrome (HHS) events **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) #### Primary Outcomes **Description:** This will be captured by the percentage of time spent in glucose target range (TIR 70-180 mg/dl); **Measure:** Efficacy: Time spent in glucose target range **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** This will be captured by the percentage of time spent below glucose range (TBR \<54 mg/dl). **Measure:** Safety: Time spent below the target glucose range **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) #### Secondary Outcomes **Description:** Percentage of time spent above 250 mg/dl **Measure:** TAR >250mg/dl **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** Percentage of time spent below range (TBR \<70 mg/dl) **Measure:** TBR <70 mg/dl **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) **Description:** This will be calculated as the mean of total glucose levels during the hospital stay. **Measure:** Mean hospitalization glucose **Time Frame:** Up to 10 days (or hospital discharge if before 10 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients admitted to ICU * Patients anticipated to require less than 48 hours of admission. * Current evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state) * Severe anemia with hemoglobin \<7 g/dL * Evidence of hemodynamic instability * Hypoxia (SpO2 \<92% on supplemental oxygen) * Pre-admission or inpatient total-daily insulin dose \>150 units daily * T2D patients on sliding scale insulin therapy alone (no scheduled basal or bolus insulin) and with glucose levels below 180 mg/dl * Patients without diabetes with stress hyperglycemia (not related to steroids or medical nutrition therapy) and with HbA1c \<6.5% * Patients on AID as an outpatient * Patients who previously participated in AIDING feasibility trial or this RCT * Patients with a condition impeding the ability to consent or answer questionnaires * Patients who are pregnant or breastfeeding at the time of enrollment * Patients who are unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, or Novolog) during the study * Use of hydroxyurea, high dose of acetaminophen (\>4 grams/day), or high dose ascorbic acid Exclusion Criteria: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners * Cognitively impaired or Individuals with Impaired Decision-Making Capacity * Individuals who are not able to clearly understand English or Spanish will be excluded due to limited resources and practical limitations related to surveys and interviews that will be conducted in a parallel study including participants from the AIDING RCT. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fpasque@emory.edu **Name:** Francisco Pasquel, M.D., M.P.H **Phone:** 4047781695 **Role:** CONTACT #### Locations **Location 1:** **City:** Stanford **Country:** United States **Facility:** Stanford University School of Medicine **State:** California **Zip:** 94305 **Location 2:** **City:** Atlanta **Country:** United States **Facility:** Grady Health System (non-CRN) **State:** Georgia **Zip:** 30322 **Location 3:** **City:** Charlottesville **Country:** United States **Facility:** University of Virginia School of Medicine **State:** Virginia **Zip:** 22903 #### Overall Officials **Official 1:** **Affiliation:** Emory University **Name:** Francisco Pasquel, M.D., M.P.H **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: LOW - As Found: Unknown - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M29800 - Name: Insulin, Short-Acting - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418867 **Acronym:** Mindfulness **Brief Title:** The Effect of Mindfulness Intervention Program on Adolescents' Internet Addiction **Official Title:** The Effect of Mindfulness Intervention Program on Adolescents' Internet Addiction: Quasi-Experimental Study #### Organization Study ID Info **ID:** NearEastU2 #### Organization **Class:** OTHER **Full Name:** Near East University, Turkey ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kemal Elyeli #### Responsible Party **Investigator Affiliation:** Near East University, Turkey **Investigator Full Name:** Kemal Elyeli **Investigator Title:** Research Asistant, PhD (c) **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The Internet shows its presence in areas where human beings are actively involved, from education to health, from entertainment to the investment sector. The integration of the Internet into many areas of human life leads to its intensive use. According to the Global Digital Report, the number of individuals with access to the Internet worldwide at the beginning of 2024 is stated as 5.35 billion, and this number constitutes more than 66% of the total world population. One of the pioneering studies on internet addiction was conducted by Young. In this study, five subtypes of internet addiction were identified. These are cyber sex addiction (obsessive use of adult sites such as cyber sex, cyber porn), cyber relationship addiction (excessive involvement in online relationships), net compulsions (online gambling, shopping and trading), information overload (on websites). and constantly surfing databases) and computer addiction (playing computer games). Considering the sub-dimensions of internet addiction, it is seen that it affects many areas of life, from family life to interpersonal relationships, from social life to economic life. Conscious awareness is the awareness of one's internal state and environment. Mindfulness can help people avoid destructive or automatic habits and reactions by learning to observe their thoughts, feelings, and other momentary experiences without judging or reacting. Acting based on awareness is a much different way of life than the autopilot approach in which the individual carries out his daily routines and activities. In studies, mindfulness is examined not only to prevent the recurrence of addiction, but also as a long-term, ongoing health behavior that supports the recovery of addiction. Determining the effect of a mindfulness-based intervention program applied to adolescent nursing students studying at a university on internet addiction and awareness. is intended. ### Conditions Module **Conditions:** - Mindfulness - Internet Addiction Disorder - Adolescent Behavior **Keywords:** - mindfulness - internet addiction disorder - adolescent behavior ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 605 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Mindfulness intervention group **Intervention Names:** - Behavioral: Mindfulness **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Mindfulness Practice including 6 sessions with 1 hour for each **Name:** Mindfulness **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The scale developed by Gunuç consists of 35 items. The scale consists of four sub-dimensions. These dimensions are "Deprivation", "Difficulty in Control", "Impairment in Functionality" and "Social Isolation". The minimum score to be obtained from the scale is 35 and the maximum score is 175. On the scale score, 35-91 points are considered as the non-addicted group, 92-119 as the threshold group, 120-147 as the risk group and 148-175 as the dependent group. The Cronbach alpha (a) internal consistency coefficient of this scale was found to be 0.94. The internal consistency coefficients for the sub-dimensions are; "Deprivation" is 0.89, "Control difficulty" is 0.90, "Impairment in functionality" is 0.92, and "Social Isolation" is 0.90. **Measure:** Internet Addiction Scale **Time Frame:** 3 months **Description:** The Mindful Awareness Scale was developed by Brown. This scale measures the tendency to be aware of immediate experiences in daily life. It is a one-dimensional scale with 15 items and a 6-point Likert type. As a result of the reliability analysis, the Cronbach's alpha internal consistency coefficient of the scale was calculated as 0.80 and the test-retest correlation was calculated as 0.8. A minimum of 15 and a maximum of 90 points can be obtained from the scale. As the total scale score increases, the level of conscious awareness increases. **Measure:** Mindful Awareness Scale **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Volunteering to participate in the study * Being in the adolescent age group (17-19 years old) * Studying in Turkish nursing department Exclusion Criteria: • Previous participation in a mindfulness intervention program for internet addiction **Healthy Volunteers:** True **Maximum Age:** 19 Years **Minimum Age:** 17 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kemal.elyeli@neu.edu.tr **Name:** Kemal Mr. Elyeli, PhD(c). **Phone:** 5488350090 **Phone Ext:** +90 **Role:** CONTACT #### Locations **Location 1:** **City:** Nicosia **Contacts:** ***Contact 1:*** - **Email:** kemal.elyeli@neu.edu.tr - **Name:** Kemal KE Elyeli, PhD(c) - **Phone:** 5488350090 - **Role:** CONTACT **Country:** Cyprus **Facility:** Near East University **State:** Lefkoşa **Status:** RECRUITING **Zip:** 1190 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003192 - Term: Compulsive Behavior - ID: D000007175 - Term: Impulsive Behavior - ID: D000088942 - Term: Technology Addiction ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19100 - Name: Behavior, Addictive - Relevance: HIGH - As Found: Addiction - ID: M2355 - Name: Internet Addiction Disorder - Relevance: HIGH - As Found: Internet Addiction - ID: M6418 - Name: Compulsive Behavior - Relevance: LOW - As Found: Unknown - ID: M10220 - Name: Impulsive Behavior - Relevance: LOW - As Found: Unknown - ID: M2684 - Name: Technology Addiction - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016739 - Term: Behavior, Addictive - ID: D000082424 - Term: Internet Addiction Disorder ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418854 **Brief Title:** Dengue Vaccine Hesitancy Among International Travelers **Official Title:** Dengue Vaccine Hesitancy Among International Travelers #### Organization Study ID Info **ID:** TMEC24-029 #### Organization **Class:** OTHER **Full Name:** Mahidol University ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mahidol University #### Responsible Party **Investigator Affiliation:** Mahidol University **Investigator Full Name:** Thundon Ngamprasertchai, MD **Investigator Title:** Assoc.Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this cross-sectional study is to study dengue vaccine hesitancy among 390 international travelers who visit the Hospital for Tropical Diseases, Bangkok, and three public sites which are the area near the Grand Palace, Khaosan Road, and the snake farm at Queen Saovabha Memorial Institute. The main question it aims to answer is what are the factors associated with the dengue vaccine hesitancy among non-endemic international travelers visiting Thailand. Participants will do the questionnaire consists of three parts 1. Questionnaire to estimate vaccine hesitancy on each 5 domains. 2. Knowledge about dengue infection and vaccination 3. Demographics data of the participants The study prioritizes ethical considerations, confidentiality, and data management to ensure participant welfare and data security. **Detailed Description:** Rationale: Dengue, a disease caused by the flavivirus and characterized by four distinct serotypes, stands as a substantial public health concern, with an estimated 390 million infections occurring worldwide annually. Clinical manifestations range from mild febrile illness to severe dengue, with secondary infections carrying a heightened risk due to antibody-dependent enhancement (ADE). The incidence of dengue among travelers to endemic areas is around one percent monthly, influenced by factors like exposure duration, seasonality, and traveler activities. Despite lacking a specific treatment, vaccination has emerged as a promising preventative measure. However, the initial vaccines licensed in the market have demonstrated limited efficacy. Vaccination in a naïve population has been associated with an increased likelihood of severe disease during the initial natural dengue infection. The recently licensed second dengue vaccine requires further information before comprehensive guidelines for usage in travelers can be established. The rise of vaccine hesitancy, marked by reluctance or refusal, poses a growing concern, potentially leading to low vaccine coverage and emerging outbreaks. The literature about dengue vaccine hesitancy is very scarce because, unlike measles or COVID-19(CoronaVirus Disease of 2019), the efficacy of the dengue vaccine does not prove itself as a highly recommended option to prevent the disease. However, the controversial incident with the first dengue vaccine seemed to embed significant hesitation in both dengue and other vaccinations as well. Furthermore, proactive preparation for the prospective integration of the dengue vaccine into the national immunization program or its designation as a recommended vaccine for travelers is also crucial. This research aims to determine dengue vaccine hesitancy and its associated factors among non-endemic international travelers visiting Thailand, providing valuable insights for future vaccine recommendations and discussions. Objectives: 1. To study the dengue vaccine hesitancy among non-endemic international travelers visiting Thailand. 2. To assess the factors associated with the dengue vaccine hesitancy among non-endemic international travelers visiting Thailand. Methodology: The cross-sectional study will recruit 390 international travelers who visit the Hospital for Tropical Diseases, Bangkok, and three public sites which are the area near the Grand Palace, Khaosan Road, and the snake farm at Queen Saovabha Memorial Institute. Data collection involves a one-time gathering of information, with eligible participants willing to provide informed consent. The questionnaire can be done both paper-based and online-based (JOTFORM), which takes time around 10-15 minutes. The questionnaire consists of 3 main parts including, a question assessing dengue vaccine hesitancy, knowledge about dengue vaccination, and demographic data. The questionnaire for estimating dengue vaccine hesitancy was derived from previous literature and validated with the pilot cohort of 20 participants. The study prioritizes ethical considerations, confidentiality, and data management to ensure participant welfare and data security. ### Conditions Module **Conditions:** - Vaccine Hesitancy **Keywords:** - Dengue vaccine hesitancy - International travelers - 5C(Confidence, Complacency, Constraints, Risk calculation, Collective responsibility) model ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 390 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Questionnaire **Label:** Non-endemic international travelers **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-endemic international travelers **Description:** Adapted design questionnaire to estimate the vaccine hesitancy specifically for dengue vaccine **Name:** Questionnaire **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Spectrum of the dengue vaccine hesitancy score will be assessed by the 15 items questionaire with 7 likert scales adapting from 5C determinants of the vaccine hesitancy. The score ranging from 3-45 for each 5 domains. Higher score will represent stronger impact for each determinants; the positive determinants are confidence and collective responsibility while negative determinants are constraints, complacency, and calculation. **Measure:** Dengue vaccine hesitancy score **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Male and female international travelers from dengue-non-endemic countries * Age ≥18 years old * Able to read and understand English questionnaire * Willing to participate in the study Endemic countries of dengue will be defined as all countries in the ASEAN(Association of Southeast Asian Nations) economic community countries, Central and South American countries except Chile, and ten countries in Eastern Mediterranean and Africa showing high frequency of dengue transmission according to WHO(World Health Organization) and ECDC(European Centre for Disease Prevention and Control) data(Yemen, Egypt, Sudan, Eritrea, Djibouti, Tanzania, Kenya, Ethiopia, Somalia, Burkina Faso). Non-endemic countries refer to all the other countries apart from endemic countries. Exclusion Criteria * Travelers who are visiting the hospital for dengue vaccination or dengue infection or dengue-like symptoms, which is defined as acute fever with one of the following; rash, myalgia, headache, nausea, vomiting, retro-orbital pain. * Participants who are expatriate workers or lived in Thailand or other Southeast Asia countries for more than 1 year. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000096724 - Term: Mosquito-Borne Diseases - ID: D000079426 - Term: Vector Borne Diseases - ID: D000007239 - Term: Infections - ID: D000001102 - Term: Arbovirus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018177 - Term: Flavivirus Infections - ID: D000018178 - Term: Flaviviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000006482 - Term: Hemorrhagic Fevers, Viral ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6913 - Name: Dengue - Relevance: HIGH - As Found: Dengue - ID: M3255 - Name: Mosquito-Borne Diseases - Relevance: LOW - As Found: Unknown - ID: M2054 - Name: Vector Borne Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4412 - Name: Arbovirus Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20323 - Name: Flavivirus Infections - Relevance: LOW - As Found: Unknown - ID: M20324 - Name: Flaviviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M9568 - Name: Hemorrhagic Fevers, Viral - Relevance: LOW - As Found: Unknown - ID: T1794 - Name: Dengue Fever - Relevance: LOW - As Found: Unknown - ID: T5864 - Name: Viral Hemorrhagic Fever - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003715 - Term: Dengue ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418841 **Brief Title:** A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture **Official Title:** A Prospective Observational Study Comparing Computer-Assisted Paramedian Approach Versus Conventional Midline Approach for Lumbar Puncture #### Organization Study ID Info **ID:** ChiCTR2300067936 #### Organization **Class:** OTHER **Full Name:** Fujian Medical University Union Hospital ### Status Module #### Completion Date **Date:** 2025-10-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-28 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fujian Medical University Union Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to compare the effects of CMPAT and MAT in patients undergoing LP. Participants will be randomly assigned to either the CMPAT treatment group (group A) or the MAT treatment group (group B). Researchers will compare CMPAT treatment group and the MAT treatment group to see if the number of needle insertion attempts required for a successful LP, the puncture success rate, pain assessment in the back, head, and legs, and the occurrence of complications have different. ### Conditions Module **Conditions:** - Spinal Puncture **Keywords:** - computer modified paramedian approach technique, lumbar puncture, midline approach technique, puncture attempts, pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The L3-4 inter-laminar space will be selected as the target for puncture, and in the longitudinal direction, 1.0-1.5cm will be opened beside the upper edge of the spinous process (tip) of the lower vertebra as the entry point. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle. The puncture path will be maintained completely perpendicular to the skin until the needle reached the PLTLF (posterior layer of the thoracolumbar fascia), where some resistance will be felt. The puncture direction is adjusted as needed. The tip of the needle will be tilted 20±10° in the sagittal direction and 15±5° inward such that the tip will point at the midpoint of the spinal canal. After the needle reaches the PLTLF, it will be further inserted 3-7 cm. **Intervention Names:** - Procedure: Computer-Assisted Paramedian Approach Technique **Label:** Computer-Assisted Paramedian Approac Technique **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Puncture will be performed on the posterior median line near the midpoint of the L3-4 Space of spinous process. The lumbar puncture needle will be inserted vertically along the axis of the anesthesia needle, or the tip of the needle will be tilted 15° in the sagittal direction toward the head, so that the needle path is parallel to the space of spinous process. **Intervention Names:** - Procedure: Conventional Midline Approach Technique **Label:** Conventional Midline Approach Technique **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Computer-Assisted Paramedian Approac Technique **Description:** Computer-Assisted Paramedian Approach Technique **Name:** Computer-Assisted Paramedian Approach Technique **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Conventional Midline Approach Technique **Description:** Conventional Midline Approach Technique **Name:** Conventional Midline Approach Technique **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** The time taken to locate and mark the patient, defined as the duration from the beginning of positioning till the insertion of the anaesthetic needle. **Measure:** Locating time **Time Frame:** 30 minutes following treatment **Description:** The time taken to perform the LP defined as the duration from the first insertion of the puncture needle till the beginning of the outflow of CSF from the puncture needle. **Measure:** Puncture time **Time Frame:** 30 minutes following treatment **Description:** The methods for assessing LP immediately after physician evaluation are categorised as follows: very good, good, average, bad and very bad. **Measure:** Evaluation from physician **Time Frame:** 30 minutes following treatment **Description:** Patient satisfaction, rated by patients immediately after LP, is classified as very good, good, average, bad or very bad. **Measure:** Evaluation from patient **Time Frame:** 30 minutes following treatment #### Primary Outcomes **Description:** A successful puncture was defined as the presence of CSF outflow from the puncture needle. The number of needle insertion attempts was determined by the number of times the puncture needle was inserted into the target area. **Measure:** Number of needle insertion attempts for successful LP **Time Frame:** 30 minutes following treatment #### Secondary Outcomes **Description:** The parameters will measure the success rate of puncture in one attempt, the success rate of puncture within three attempts and the success rate of puncture within six attempts. **Measure:** LP success rate **Time Frame:** 30 minutes following treatment **Description:** In the NRS, patients will be asked to indicate a number ranging from 0 to 10, which best reflects the intensity of their pain. A score of 0 indicates the absence of pain, while a score of 10 signifies the most excruciating pain imaginable. The NRS will be used to assess the severity of localised back pain, headaches, leg pain and numbness experienced by patients after LP. **Measure:** Assessment of back, head and leg pain using the NRS **Time Frame:** before treatment, during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment **Description:** This study will monitor all adverse events during and after trial interventions, followed by causality assessment. In addition to risk mitigation protocols, we will remain vigilant about rare potential complications including drug allergies during anaesthesia; adjacent organ/ tissue injury; nerve, vascular or organ damage; paralysis, shock; difficulties/failures in puncture; needle breakage; persistent pain; neurological impairment; infections; CSF leakage; wound healing issues; epidural haematoma, etc. Their likelihood is extremely low under specialised surgical expertise.Any undesirable medical condition will be documented and reported transparently per ethics guidelines. The data safety monitoring board may recommend modifying/stopping the trial if safety concerns emerge. We will ensure diligent surveillance and injury precautions to safeguard participants. **Measure:** Adverse events and other unintended effects **Time Frame:** during surgery and 30 minutes,6 hours,1 days,3 days,7 days,2 weeks,4 weeks following treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 18-99 years. Indication for lumber puncture (diagnostic lumbar puncture, analysis of cerebrospinal fluid composition, measurement of cerebrospinal fluid pressure, release of cerebrospinal fluid, lumbar cistern drain-age or intrathecal injection). Body mass index between 18.5 and 35 kg/m2. Exclusion Criteria: * Cerebral hernia or known high cerebrospinal fluid pressure prone to cerebral hernia. * Oral anticoagulant or antiplatelet therapy (≤3 days) or coagulation dysfunction, various factors lead to a higher risk of bleeding. * Active infection or prior infection at the surgical site. * Skin breakdown. * Previous spine fusion surgery. * Cauda equina syndrome. * Pregnancy or breast feeding. * Severe comorbid medical or psychiatric disorder. * Unwilling to adhere to any of the required procedures. * Cognitive impairment interfering with participant's ability to give full and - - informed consent or complete the baseline or follow-up assessments. * Survival expectation less than 1 month. * Moving abroad in 1 month. **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zyd2013@qq.com **Name:** Yuan-Dong Zhuang **Phone:** 15260866029 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Puncture ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418828 **Brief Title:** Patients With Type B Aortic Dissection Returning to Work After Discharge：a Cross-sectional Survey **Official Title:** Cross-sectional Survey and Prediction Model Construction of Patients With Type B Aortic Dissection Returning to Work After Discharge #### Organization Study ID Info **ID:** 2024KY049 #### Organization **Class:** OTHER **Full Name:** Fujian Medical University Union Hospital ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fujian Medical University Union Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study wants to understand the incidence of returning to work after discharge in patients with type B aortic dissection. **Detailed Description:** The incidence of aortic dissection in China is increasing year by year. According to the latest research report, the annual incidence of aortic dissection in China is 5 \~ 10 / 100,000, the average age of patients is 51.8 years old, and the age of disease is about 10 years younger than that of European and American countries. RTW after discharge is a measure of disease recovery and recovery to normal state. There are only reports on RTW after discharge in the fields of cancer, stroke, organ transplantation, maintenance peritoneal dialysis and so on. Most of the existing literature in the cardiovascular field at home and abroad focuses on assessing the status of RTW and RRTW after discharge. Up to now, there is still a lack of research on the promotion and hindrance factors of RTW in TBAD patients, the status survey of post-RTW work ability and the related nomogram prediction model. Therefore, based on the Meleis transformation theory, this study aims to investigate the current status of return to work of TBAD patients at 6 months after discharge through quantitative and qualitative research, and to explore its influencing factors in depth. Based on the previous results, the RTW visual prediction model of TBAD patients was constructed, which provided a theoretical basis for the formulation and implementation of early intervention by medical staff, and further improved the research in this field. ### Conditions Module **Conditions:** - Type B Aortic Dissection - Return to Work ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 178 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Asked whether the patient returned to work, if the patient returned to work, included in this group. **Intervention Names:** - Other: return to work **Label:** Return to work group #### Arm Group 2 **Description:** Ask whether the patient returned to work, if the patient did not return to work, included in this group. **Intervention Names:** - Other: return to work **Label:** Non-return to work group ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-return to work group - Return to work group **Description:** Ask patients if they are going back to work **Name:** return to work **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** the incidence of returning to work was calculated according to whether the included patients could return to work. **Measure:** Rate of return to work **Time Frame:** Six months after discharge, ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: ( 1 ) TBAD was diagnosed by computed tomography angiography ( CTA ) or magnetic resonance angiography ( MRA ) ; ( 2 ) 18 years ≤ age \< 60 years at diagnosis ; ( 3 ) having full-time or part-time job at the time of diagnosis ; ( 4 ) TBAD patients were discharged after successful treatment and the discharge time was ≥ 6 months ; Exclusion Criteria: ( 1 ) reaching the retirement age 6 months after discharge ; ( 2 ) those with disturbance of consciousness, mental illness, inability to complete the interview independently or under the guidance of the researcher ; ( 3 ) Participate in other related research ; ( 4 ) Clinical end-stage or receiving palliative treatment. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** This study selected patients with TBAD who were hospitalized in the Department of Cardiac Surgery, Union Hospital Affiliated to Fujian Medical University. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fjxhyjl@163.com **Name:** Yanjuan Lin, MD **Phone:** +86 591 8621 8336 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** fjxhyjl@163.com - **Name:** Yanjuan Lin, MD - **Phone:** +86 591 8621 8336 - **Role:** CONTACT **Country:** China **Facility:** Fujian Medical University Union Hospital **State:** Fujian **Status:** RECRUITING **Zip:** 350000 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000094683 - Term: Acute Aortic Syndrome - ID: D000001018 - Term: Aortic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4114 - Name: Aortic Dissection - Relevance: HIGH - As Found: Aortic Dissection - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3085 - Name: Acute Aortic Syndrome - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000784 - Term: Aortic Dissection ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418815 **Brief Title:** Concept Map on Toxic Stress in Newborns **Official Title:** Effect of Concept Map on Nursing Students' Ability to Assess Toxic Stress in Newborns: A Randomized Controlled Trial #### Organization Study ID Info **ID:** CKU12 #### Organization **Class:** OTHER **Full Name:** Çankırı Karatekin University ### Status Module #### Completion Date **Date:** 2024-06-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-13 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Çankırı Karatekin University #### Responsible Party **Investigator Affiliation:** Çankırı Karatekin University **Investigator Full Name:** Aylin PEKYİGİT **Investigator Title:** Research Assistant PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study will be conducted as a single-blind randomized control group intervention trial to examine the effect of using concept maps on the students' knowledge levels about toxic stress in newborns, which is explained to second-year nursing students. **Detailed Description:** The Newborn Toxic Stress Knowledge Test (1st Test) will be administered to intervention and control group students who agree to participate in the research, before the 4-hour High Risk Newborn theoretical lecture. Training on Toxic Stress in Newborns will be given to both groups, and then a post-training knowledge test (2nd Test) will be administered. The initiative group will be composed of students who apply concept maps and make in-class maintenance plans after theoretical training. The control group will consist of students who receive theoretical training and implement in-class care plans. After the concept map application, a knowledge test will be applied again (3rd Test). The data of the research will be collected with the Personal Information Form and Newborn Toxic Stress Information Test. The personal information form was prepared by the researchers. In shape; There are questions about the student's age, gender, secondary school graduation status, whether they choose the nursing profession willingly, whether they consider the nursing profession suitable for themselves, whether they have heard the term concept map and whether they have applied concept map. Newborn Toxic Stress Information Test was prepared by researchers. The test consists of 25 multiple choice questions. It consists of true, false and I don't know options. ### Conditions Module **Conditions:** - Nursing Education - Newborn **Keywords:** - Concept map - Nursing education - Toxic stress - Newborn ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group will create a concept map regarding neonatal toxic stress. **Intervention Names:** - Other: Concept map group **Label:** Concept Map Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** During the application process of the research, knowledge tests will be applied as pre-test and post-test **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Concept Map Group **Description:** The intervention group will create a concept map regarding neonatal toxic stress. **Name:** Concept map group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** First, second and thirth knowledge tests will be applied to measure the level of knowledge. The student can get a minimum of 0 and a maximum of 100 from the knowledge test. Higher scores mean better results. **Measure:** Differences of knowledge scores between groups **Time Frame:** The first knowledge test (pre-test) will be given before class in the first week. Two knowledge tests will be administered for the final test. Total duration is 4 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Enrolled in the course * Had not taken this course before * Accepted to participate in the research Exclusion Criteria: * Have any records of absence * Taken this course before * Graduate of health vocational high school **Healthy Volunteers:** True **Maximum Age:** 27 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT ### References Module #### References **Citation:** Sand-Jecklin K. The impact of active/cooperative instruction on beginning nursing student learning strategy preference. Nurse Educ Today. 2007 Jul;27(5):474-80. doi: 10.1016/j.nedt.2006.08.006. Epub 2006 Oct 9. **PMID:** 17030077 **Citation:** Gul RB, Boman JA. Concept mapping: A strategy for teaching and evaluation in nursing education. Nurse Educ Pract. 2006 Jul;6(4):199-206. doi: 10.1016/j.nepr.2006.01.001. Epub 2006 Feb 28. **PMID:** 19040878 **Citation:** Baliga SS, Walvekar PR, Mahantshetti GJ. Concept map as a teaching and learning tool for medical students. J Educ Health Promot. 2021 Jan 28;10:35. doi: 10.4103/jehp.jehp_146_20. eCollection 2021. **PMID:** 33688544 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418802 **Brief Title:** Study of the Effects of STN-DBS on Gait in Parkinson's Disease. **Official Title:** Clinical Series Study of the Effects of STN-DBS on Gait in Parkinson's Disease Based on Wearable Devices. #### Organization Study ID Info **ID:** 2023YF062-02 #### Organization **Class:** OTHER **Full Name:** Fujian Medical University Union Hospital ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fujian Medical University Union Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Objectives: Parkinson's disease (PD) is the second most common degenerative disease of the nervous system. Postural instability/gait disorder (PIGD) is one of the motor symptoms of Parkinson's disease, which affects the quality of life of patients with Parkinson's disease. At present, deep brain stimulation（DBS）can significantly improve tremor and bradykinesia, but whether deep brain stimulation is effective for gait disorders is still a controversial topic. In addition, the previous gait assessment mainly focused on scales or simple walking tests, and appropriate and effective evaluation methods are needed to evaluate the efficacy of intervention for gait disorders in PD patients. Therefore, in view of these problems, this study will use wearable devices and traditional scale evaluation to explore the effects of deep brain stimulation on gait in patients with Parkinson's disease. Methods: A total of 30 patients with Subthalamic nucleus DBS（STN-DBS）were expected to be enrolled. By adjusting the parameters of STN-DBS (voltage, frequency, pulse width), the effects of different parameters on PD gait were compared. Gait changes were mainly analyzed by wearable devices and MDS Unified Parkinson's Disease Rating Scale assessment（MDS-UPDRS）. The （Timed Up and Go）TUG test, narrow channel task, circle task and trajectory analysis were performed in the unmedicated state. The wearable device was used to collect the motion information of 10 different positions of the human body, including the wrist, thigh, ankle, foot tip, chest and waist nodes. (1)Experiment 1: Patients were divided into pre-operation group and post-operation group. A case-control study was conducted, and patients were followed up at 1 month,3 months,6 months and 1 year after operation. (2)Experiment 2: This study was a single-center, randomized, double-blind, crossover trial of deep brain stimulation with a short pulse width (30s) versus conventional pulse width (60 s) in PD patients with bilateral STN-DBS. Gait data and MDS-UPDRS were collected at baseline, after 4 weeks and 8 weeks. (3)Experiment 3: By adjusting the frequency parameters of STN-DBS (30,100, and 130HZ), gait data and MDS-UPDRS were collected after 10 minutes of the washout period, and the best DBS parameters for gait improvement were maintained for 4-8 weeks and then evaluated again. Expected results: By adjusting the parameters (voltage, frequency, and pulse width) of STN-DBS, the potential mechanisms for improving gait disorders in PD were explored, meaningful digital biomarkers for PD gait prognosis were explored, and long-term programming of STN-DBS was guided. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PD Patient's gait were followed up at 1 month,3 months,6 months, and 1 year after bilateral STN-DBS surgery. **Intervention Names:** - Procedure: STN-DBS surgery **Label:** Experiment 1: Experimental group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** PD patient's gait with optimal medical therapy before bilateral STN-DBS surgery. **Intervention Names:** - Procedure: STN-DBS surgery **Label:** Experiment 1: Comparator group 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** PD patient's gait with a short pulse width (30s) with bilateral STN-DBS. **Intervention Names:** - Device: pulse width **Label:** Experiment 2: Experimental group 2 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** PD patient's gait with the conventional pulse width (60 s) with bilateral STN-DBS. **Intervention Names:** - Device: pulse width **Label:** Experiment 2: Comparator group 2 **Type:** ACTIVE_COMPARATOR #### Arm Group 5 **Description:** PD patient's gait with frequency parameters(60,100, and 130HZ) with bilateral STN-DBS. **Intervention Names:** - Device: frequency **Label:** Experiment 3: Experimental group 3 **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** PD patient's gait with the conventional frequency parameters with bilateral STN-DBS. **Intervention Names:** - Device: frequency **Label:** Experiment 3: Comparator group 3 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experiment 1: Comparator group 1 - Experiment 1: Experimental group 1 **Description:** bilateral subthalamic nucleus deep brain stimulation surgery **Name:** STN-DBS surgery **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Experiment 2: Comparator group 2 - Experiment 2: Experimental group 2 **Description:** a short pulse width (30s) **Name:** pulse width **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Experiment 3: Comparator group 3 - Experiment 3: Experimental group 3 **Description:** frequency parameters of STN-DBS (60,100, and 130HZ) **Name:** frequency **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Gait changes were analyzed by wearable devices and MDS-UPDRS. **Measure:** Gait data **Time Frame:** Pre-operation（baseline)，1 month,3 months,6 months and 1 year after operation. **Description:** Gait changes were analyzed by wearable devices and MDS-UPDRS. **Measure:** Gait data **Time Frame:** Baseline, after 4 weeks and 8 weeks. **Description:** Gait changes were analyzed by wearable devices and MDS-UPDRS. **Measure:** Gait data **Time Frame:** Baseline, after 10 minutes of the washout period, after4-8 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (1) Age 40-75 years old; (2) Patients who meet the Chinese Parkinson's disease diagnostic criteria and confirmed by two high-level physicians (\>10 years); (3) Diagnosed by Parkinson's Specialty Clinic For Parkinson's disease for more than 1 year and have been effective after treatment; (4) Hearing, visual and cognitive abilities are normal; (5) The subjects were informed of the test purpose, the benefits of the test, the test process and possible unexpected situations before the test , and signed the trial informed consent form. Exclusion Criteria: * (1) A variety of secondary Parkinson's syndrome (including traumatic, drug-induced, tumor, vascular, toxic, hydrocephalus, etc.) and Parkinson's superimposed syndrome. (2) Other diseases that cause gait disorders, including spinal joint injuries, muscle spasm, stroke, peripheral neuropathy, muscle diseases, hydrocephalus, cognitive impairment, etc. (3) Accompanied by vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumors, unstable conditions and other serious medical diseases. (4) Those who have serious behavior problems or mental confusion. (5)Those who do not cooperate with the examination. **Maximum Age:** 75 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cgessmu@fjmu.edu.cn **Name:** Guoen Cai **Phone:** 0591-18120922978 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418789 **Acronym:** GERMAN **Brief Title:** High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors **Official Title:** High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors #### Organization Study ID Info **ID:** German2 #### Organization **Class:** OTHER **Full Name:** N.N. Petrov National Medical Research Center of Oncology ### Status Module #### Completion Date **Date:** 2029-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2029-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** N.N. Petrov National Medical Research Center of Oncology #### Responsible Party **Investigator Affiliation:** N.N. Petrov National Medical Research Center of Oncology **Investigator Full Name:** Anna Igorevna Semenova **Investigator Title:** clinical oncologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a prospective, single-center, non-randomized phase II study. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy as second-line drug therapy for patients with advanced germ cell tumors. **Detailed Description:** Germ cell tumors are curable diseases. Only a small proportion of patients fail to be cured: those who experience a primary resistance to chemotherapy and those who relapsed after first line conventional dose cisplatin-based chemotherapy. Nowadays, there is heterogeneity of practice in salvage approaches. This includes conventional chemotherapy high dose chemotherapy with autologous stem cell transplant. Best choice of the therapy strategy is an unmet clinical need now. This is why this single-center, non-randomized phase II study will be conducted at the N.N. Petrov National Medical Research Center of Oncology. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive two cycles of high-dose TI (Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest; leukapheresis will be performed starting on day 11 in case of CD45+CD34+ blood level above 20x10\^6/L is achieved), followed by three cycles of high dose CE (Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m\^2 IV daily days -4 to -2, autlologous stem cell transplantation at day 0, GCSF support from day 4.) The primary endpoint of the study is to evaluate the efficacy by measuring progression-free survival. The secondary endpoints of the trial are overall survival, response rate by RECIST, safety and prognostic factors analysis. ### Conditions Module **Conditions:** - Germ Cell Tumor **Keywords:** - Germ Cell Tumor - Teratoma - Choriocarcinoma - Germinoma - Childhood Teratoma - Extragonadal Seminoma - Seminoma - Non-seminomatous Germ Cell Tumor - Yolk Sac Tumor - Mixed Germ Cell Tumor - Malignant Germ Cell Neoplasm ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In arm patients receive a TI-CE regime based on paclitaxel and ifosfamide in cycles 1-2 and carboplatin and etoposide in cycles 3-5. **Intervention Names:** - Drug: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) **Label:** Group 1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 **Description:** TI: Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest. Leukapheresis will be performed starting on day 11 in case blood level of CD45+CD34+ above 20x10\^6/L is achieved. CE: Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m\^2 IV daily days -4 to -2, autlologous stemm cell transplantation \>=2\*10\^6/Kg at day 0, GCSF support from day 4 until the recovery of neutrophils above 1\*10\^9/L. Patients will receive two cycles of TI followed by 3 cycles of CE in case at least 6\*10\^6 CD34+ stem cells will be harvested. **Name:** High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Progression Free Survival 2-year **Measure:** Progression Free Survival (PFS) **Time Frame:** Up to 24 months post-treatment #### Secondary Outcomes **Description:** Overall survival (OS) 3-year **Measure:** Overall survival (OS) **Time Frame:** Up to 36 months post-treatment **Description:** All toxicities will be evaluated and recorded based on the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). **Measure:** Incidence of adverse events **Time Frame:** Up to 3 months post-therapy discontinuation **Description:** Evaluation of the efficacy of high-dose TI (2 cycles)-CE (3 cycles) chemotherapy in patients with germ cell tumors of gonadal and extragonadal localization who progressed after prior platinum-containing first-line chemotherapy and received high-dose TI (2 cycles)-CE (3 cycles) chemotherapy, depending on the prognosis group (IGCCCG classification (1997), IGCCCG Update Model (2021)). **Measure:** Validation of International Prognostic Factor Study Group stratification system **Time Frame:** Up to 3 years post-registration **Description:** European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. **Measure:** Assessment of patients' quality of life **Time Frame:** also during the 5-year follow-up period. **Description:** Evaluation of the impact of patient nutritional support and the relationship between patient nutrition and the incidence of non-hematologic complications (mucositis, colitis, infectious complications) **Measure:** Possibilities of rehabilitation **Time Frame:** also during the 5-year follow-up period. **Description:** In case of poor mobilization according to the criteria of the European Society of Bone Marrow Transplantation, the addition of Plerixafor at a dose of 24 mg to the mobilization is envisaged. An evaluation of the feasibility of improving mobilization rates with Plerixafor is planned. **Measure:** Assessment of the possibility of improving mobilization rates with the drug "Plerixafor" **Time Frame:** 2 months **Description:** Incidence of complete, partial response, stable and progressive disease by RECIST 1.1 system **Measure:** Response Rate **Time Frame:** Every 8 weeks up to 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patient is able to provide informed consent and sign approved consent forms to participate in the study. 2. Males ≥ 18 years of age at the time of signing the IC Form. 3. Histologically verified diagnosis of GO (seminomatous, non-seminomatous). 2. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO. 3. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP). 4. Required Initial Laboratory Values: * Hemoglobin ≥ 90 g/L; * neutrophils ≥ 1.5 x 109/L; * platelets ≥ 75 x 109/L; * creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL/min); * ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases); * bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol/L); * alkaline phosphatase ≥ 2.5 x IUH. 5. Absence of neurologic symptoms in the presence of CNS metastases (asymptomatic CNS metastases are acceptable). Exclusion Criteria: 1. Primary CS of the brain 2. Administration of ≥2 lines of prior drug therapy for disseminated GO. 3. Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days prior to study inclusion. 4. Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence). **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mirannia@yandex.ru **Name:** Anna Semenova, MD, PhD **Phone:** 8 (812) 439-95-05 **Role:** CONTACT #### Locations **Location 1:** **City:** Saint Petersburg **Contacts:** ***Contact 1:*** - **Name:** Anna I Semenova, MD, PhD - **Role:** CONTACT **Country:** Russian Federation **Facility:** National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia **Status:** RECRUITING **Zip:** 197758 #### Overall Officials **Official 1:** **Affiliation:** National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia **Name:** Aleksei M Belyaev, MD,DSc,Prof. **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia **Name:** Tatyana Yu Semiglazova, MD,DSc,Prof. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20386 - Name: Endodermal Sinus Tumor - Relevance: LOW - As Found: Unknown - ID: M16494 - Name: Teratoma - Relevance: LOW - As Found: Unknown - ID: M20383 - Name: Germinoma - Relevance: LOW - As Found: Unknown - ID: M20385 - Name: Seminoma - Relevance: LOW - As Found: Unknown - ID: M6062 - Name: Choriocarcinoma - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: HIGH - As Found: Germ cell tumor - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T2475 - Name: Germ Cells Tumors - Relevance: HIGH - As Found: Germ cell tumor - ID: T1031 - Name: Central Nervous System Germinoma - Relevance: LOW - As Found: Unknown - ID: T5604 - Name: Testicular Seminoma - Relevance: LOW - As Found: Unknown - ID: T4160 - Name: Nonseminomatous Germ Cell Tumor - Relevance: LOW - As Found: Unknown - ID: T3579 - Name: Malignant Germ Cell Tumor - Relevance: LOW - As Found: Unknown - ID: T1179 - Name: Choriocarcinoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M8191 - Name: Etoposide - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M10117 - Name: Ifosfamide - Relevance: LOW - As Found: Unknown - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown - ID: M230811 - Name: Isophosphamide mustard - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418776 **Brief Title:** IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML **Official Title:** A Prospective Multicenter Randomized Clinical Trial on the Treatment of Patients With Refractory or Early Relapses of Acute Myeloid Leukemia #### Organization Study ID Info **ID:** IMPACT-AML #### Organization **Class:** NETWORK **Full Name:** National Research Center for Hematology, Russia ### Status Module #### Completion Date **Date:** 2029-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** St. Petersburg State Pavlov Medical University **Class:** OTHER **Name:** Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health #### Lead Sponsor **Class:** NETWORK **Name:** National Research Center for Hematology, Russia #### Responsible Party **Investigator Affiliation:** National Research Center for Hematology, Russia **Investigator Full Name:** Elena N.Parovichnikova **Investigator Title:** General director of National Medical Research Center for Hematology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective is to evaluate the efficacy and toxicity of high versus low intensity therapy options in patients with refractory forms and early relapses of acute myeloid leukemia (R/R AML) who are scheduled for allogeneic hematopoietic stem cell transplantation (alloHSCT). ### Conditions Module **Conditions:** - Refractory Acute Myeloid Leukemia - Early Relapses of Acute Myeloid Leukemia **Keywords:** - Acute myeloid leukemia - Relapse of AML - Refractory AML - Allogeneic Stem Cell Transplantation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients who could potentially undergo courses of intensive chemotherapy ("fit") are randomisedrandomized into two arms: * Arm 1 - intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito) * Arm 2 - low intensity therapy (Aza/Dac/LDARA-C + Ven) Randomization determines the intensity of the program, but not the specific therapeutic regimen. The treatment regimen is selected by the investigators based on accepted clinical practice, the availability of appropriate drugs at the participating centers, etc., after randomization. If a patient has FLT3 gene mutations, one of the available kinase inhibitors must be added to therapy: midostaurin, gilteritinib, sorafenib. If remission of the AML has been achieved, patients in both groups undergo alloHSCT as soon as possible. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 198 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to intensive chemotherapy courses **Intervention Names:** - Other: Intensive therapy **Label:** Intensive arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to low intensity courses **Intervention Names:** - Other: Low intensity therapy **Label:** Low-intensive arm **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intensive arm **Description:** Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito) **Name:** Intensive therapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Low-intensive arm **Description:** Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven) **Name:** Low intensity therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Evaluation method: Kaplan-Meier curves and log-rank test, censored for transplantation **Measure:** Event-free survival of patients with R/R AML depending on the use of high or low intensity therapy exposure before alloHSCT **Time Frame:** 2 years #### Secondary Outcomes **Description:** Assessment method: Chi-square test **Measure:** Probability of achieving CR in patients with R/R AML, depending on the use of high or low intensity treatment regimens **Time Frame:** 3 months **Description:** Assessment method: Chi-square test **Measure:** Probability of achieving a response (CR, CR with incomplete hematological recovery, morphologic leukemia- free state, partial remission) in patients with R/R AML, depending on the use of high or low intensity treatment regimens **Time Frame:** 3 months **Description:** Evaluation method: cumulative frequency curves and Gray's test **Measure:** Cumulative incidence of alloHSCT in patients with R/R AML, depending on the use of high or low intensity treatment regimens **Time Frame:** 2 years **Description:** Evaluation method: Chi-square test, parametric/nonparametric tests for means Variables to be evaluated: 1. Maximum degree and duration of neutropenia and/or thrombocytopenia; 2. Development of uncontrolled/life-threatening infectious complications; 3. Development of life-threatening hemorrhagic complications; 4. Development of severe organ failure. **Measure:** Toxicity of high versus low intensity regimens **Time Frame:** 3 months **Description:** Evaluation method: Kaplan-Meier curves and log-rank test **Measure:** OS over the entire duration of the study, including follow-up after alloHSCT **Time Frame:** 2 years **Description:** Evaluation method: Kaplan-Meier curves and log-rank test **Measure:** RFS in patients with R/R AML when achieving remission before alloHSCT, depending on the use of high or low intensity treatment regimens **Time Frame:** 2 years **Description:** Evaluation method: cumulative frequency curves and Gray's test **Measure:** Relapse incidence in patients with R/R AML when achieving remission before performing alloHSCT, depending on the use of high or low intensity treatment regimens **Time Frame:** 2 years **Description:** Evaluation method: Farington-Manning test, not censored for transplantation **Measure:** EFS of patients with R/R AML depending on the use of high or low intensity regimens, regardless of alloHSCT **Time Frame:** 2 years **Description:** Assessment method: Chi-square test **Measure:** Statistics on discontinued participation in the protocol and premature withdrawal from the study **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years; * Primary refractory AML; * Early relapsed AML; * A signed informed consent to participate in the study. Exclusion Criteria: * Late relapsed AML; * Isolated extramedullary relapse; * MRD relapse without development of bone marrow relapse of AML; * Acute promyelocytic leukemia; * Previous refractoriness or loss of response during ongoing venetoclax therapy; * Previous alloHSCT; * Pregnancy and/or lactation period; * Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study; * Lack of signed informed consent to participate in the study; * Failure of the subject to follow the study protocol; * Participation in any other clinical trial; * Uncontrolled infectious complications; * ECOG ≥ 3; * History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years; * Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (according to the CKD-EPI Creatinine Equation); * Severe cardiac pathology: 1. uncontrolled arterial hypertension; 2. stable angina III-IV functional classes; 3. unstable angina and/or myocardial infarction less than 6 months before inclusion in the study; 4. heart failure stages IIb-III, NYHA functional classes III-IV 5. uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities. * Cirrhosis classes B-C according to the Child-Pugh classification * Increased liver function tests above the following values: 1. Total bilirubin \> 1,5 above the normal range; 2. AST, ALT \> 10 above the normal range. * Major surgical interventions underwent less than 14 days before inclusion in the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kashlakova.a.i@gmail.com **Name:** Anastasia Kashlakova, MD **Phone:** +79629087553 **Role:** CONTACT **Contact 2:** **Email:** parovichnikova.e@blood.ru **Name:** Elena Parovichnikova, MD **Phone:** +74956122123 **Role:** CONTACT #### Locations **Location 1:** **City:** Moscow **Contacts:** ***Contact 1:*** - **Email:** director@blood.ru - **Name:** Elena Parovichnikova, MD - **Phone:** +74956122361 - **Role:** CONTACT ***Contact 2:*** - **Email:** kashlakova.a@blood.ru - **Name:** Anastasia Kashlakova, MD - **Phone:** +74956124592 - **Role:** CONTACT **Country:** Russian Federation **Facility:** National Research Center for Hematology **Status:** RECRUITING **Zip:** 125167 ### IPD Sharing Statement Module **Description:** Each center participating in the study includes patients and fills CRF forms separately. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Relapse - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418763 **Acronym:** SEAPRO01 **Brief Title:** The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health **Official Title:** The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health: a Short-term Study in Healthy Subjects #### Organization Study ID Info **ID:** SEAPRO01 #### Organization **Class:** INDUSTRY **Full Name:** Aventure AB ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Lund University **Class:** INDUSTRY **Name:** Carbiotix AB #### Lead Sponsor **Class:** INDUSTRY **Name:** Aventure AB #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this randomised, controlled, cross-over study is to investigate whether the intake of fermented brown seaweed can lower postprandial blood glucose levels and influence the composition of the gut microbiota in 25 healthy volunteers. Well-being and gastrointestinal symptoms as well as sensory properties of the products will also be evaluated using questionnaires. At the screening visit, the subjects will be informed about the study procedures and inclusion/exclusion criteria will be checked. Informed consent will be signed by each subject before participating in the study. The participants will consume the active and control product, respectively, for 5 days with a 14-day wash-out period in between. Capillary blood samples will be drawn for glucose measurement at the first day of each 5-day intervention period. Faecal samples will be collected before and after each 5-day intervention period to analyse changes in gut microbial composition. **Detailed Description:** Fermented seaweed is a sustainable food with increasing interest as an ingredient of a plant-based diet. Plant-based diets are gaining popularity both because of their health benefits and low-carbon footprint. Seaweed is a rich source of minerals, polyphenols and dietary fibres like xylans, carrageenan, fucoidan, laminarin and alginate. These bioactive compounds have been shown to exert positive effects on metabolic parameters, such as blood glucose and insulin, blood lipid profile and inflammatory markers and could therefore help in the prevention of cardiovascular diseases. Besides possible health benefits, fermentation of seaweed can offer potential advantages such as improved food safety and shelf life of non-dried seaweed as well as improved sensory properties. The project aims to investigate the effects of fermented brown seaweed (Alaria Esculenta, also known as winged kelp) on glucose metabolism and its prebiotic potential in humans. A short-term pilot study (5-day intake period) will be conducted in young healthy subjects. Twenty-five healthy subjects will be recruited to this study. This study will be a randomised controlled cross-over study where all participants will consume the test product and the control product for 5 days. In between each 5-day intervention period, there will be a wash-out period of 2 weeks. At the first day of each 5-day intake period, the subjects have to come to the study centre in the morning in a fasting state. A test meal with the active product or control product containing each 50g of total carbohydrates will be served. Blood samples (finger-pricking) will be taken at fasting state (0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min. The participants will then consume the product daily for 5 days at a dose of 2x 15g baobab with or without (control) 15% of the fermented seaweed. The product will be available as a spread in packages of 15g. After a wash-out period of 2 weeks, the participants will take the other product (cross-over design). Faecal samples will be collected before and at the end of each 5-day intervention period. The questionnaire about well-being and gastrointestinal symptoms will be filled at home daily during each 5-day intervention. Also, a sensory questionnaire will be filled in at day 1 and 5 of intervention period. ### Conditions Module **Conditions:** - Healthy Subjects **Keywords:** - seaweed - blood glucose - gut microbiota ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 25 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Daily intake 2x 15g The product is available as a spread and will be consumed with bread **Intervention Names:** - Dietary Supplement: Baobab spread mixed with fermented brown seaweed **Label:** Baobab spread mixed with fermented seaweed **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Daily intake 2x 15g The product is available as a spread and will be consumed with bread **Intervention Names:** - Dietary Supplement: Baobab spread **Label:** Baobab spread **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Baobab spread mixed with fermented seaweed **Description:** 5-day intake period **Name:** Baobab spread mixed with fermented brown seaweed **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Baobab spread **Description:** 5-day intake period **Name:** Baobab spread **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** iAUC 0-180min **Measure:** Postprandial blood glucose **Time Frame:** 0-180min (after intake of the study product) #### Secondary Outcomes **Description:** Total and Lactobacillus specific bacterial communities will be measured in fecal samples **Measure:** Gut microbiota **Time Frame:** Before and immediately after each 5-day intake period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy males and females * Age 20-40 years, at the time of signing the informed consent * BMI 20-25 kg/m2 * Stable body weight (less than 5% difference during the last 3 months) * Willing and able to give written informed consent for participating the study * Willing to comply with all study procedures Exclusion Criteria: * Intake of antibiotics within 4 weeks prior to the start of the study * Regular intake of probiotics and/or prebiotics within 4 weeks prior to the start of the study * Tobacco use (smoking and/or snus) * High alcohol intake: \> 4 glasses daily * Pregnancy or lactating * Chronical disease (e.g., liver, kidney) * Diabetes * Gastrointestinal disease (ulcerative colitis, Crohn's disease, irritable bowel syndrome) * Heart disease (within the last 12 months) * Inflammatory disease (e.g. asthma, GI inflammatory diseases) and auto-immune disease * Treatment with corticosteroids of significant degree * Psychological disease of significant degree * Cancer of significant difference * Gastric-bypass operation * Operation planned during the study period * Known gluten intolerance and/or lactose intolerance * Having allergies to the food components of the study, mustard and seafoods * Known gluten intolerance, lactose intolerance, milk protein allergy or other food allergies * Irregular diet (i.e., not eating 3 main meals daily) or special diet (e.g. vegan, low-carb high-fat, 5-2) * Investigator considers the subject unlikely to comply with the study procedures, restrictions, and requirements **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lieselotte.cloetens@tbiokem.lth.se **Name:** Lieselotte Cloetens **Phone:** +46462223853 **Role:** CONTACT #### Locations **Location 1:** **City:** Lund **Contacts:** ***Contact 1:*** - **Email:** elin.ostman@aventureab.com - **Name:** Elin Östman - **Role:** CONTACT **Country:** Sweden **Facility:** Aventure Clinical Trial Unit **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Lund University **Name:** Lieselotte Cloetens **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418750 **Acronym:** DELICATESSE **Brief Title:** Evaluation of a Range of Dermo-cosmetic Products to Treat Skin and Nail Toxicity Linked to Bispecific Anti-GPRC5D Bispecific Antibodies in Multiple Myeloma Patients". Myeloma". Descriptive Pilot Study **Official Title:** Evaluation of a Range of Dermo-cosmetic Products to Treat Skin and Nail Toxicity Linked to Bispecific Anti-GPRC5D Bispecific Antibodies in Multiple Myeloma Patients". Myeloma. #### Organization Study ID Info **ID:** RC23_0530 #### Organization **Class:** OTHER **Full Name:** Nantes University Hospital ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Nantes University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to assess the efficacy of range of dermo-cosmetic products (hand/feet serum, nail strengthening solution nail strengthening solution, dissolving oil and gloves/slippers) based on natural products and designed for cancer patients)on bispecific Ac-induced skin and nail toxicity in MM patients treated with anti-CD3xGPRC5D bispecific antibodies. The effects of supportive care products will be studied as a preventive measure in patients starting treatment with bispecific Ac and as a curative measure in patients undergoing treatment. Patients will be able to apply the products directly at home according to the study schedule, and a skin and nail toxicity skin and nail toxicity will be performed each time the patient comes for administration of bispecific Ac. Follow-up will be for a total of 6 months (or less if progression occurs earlier), and patients will be asked to complete a quality-of-life questionnaire at protocol inclusion and after 1 month and 6 months of supportive care. ### Conditions Module **Conditions:** - Myeloma Multiple ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Two groups studied: preventive and curative. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: dermo-cosmetic product **Label:** group preventive **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Other: dermo-cosmetic product **Label:** group curative **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - group curative - group preventive **Description:** For patients in the preventive group, treatment with hand serum, gloves/slippers and fortifying solution/dissolving oil will be started on the day of the first administration of Ac bispecific. In the curative group, treatment will begin on inclusion in the study and will be adapted to the lesions present on D0. Treatment will be readjusted on a weekly basis according to the lesions present at the time of the follow-up visit. **Name:** dermo-cosmetic product **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the efficacy of a range of dermo-cosmetic products in preventing/limiting cutaneous and nail toxicity induced by anti-GPRC5D bispecific Ac in MM patients according to the NCI-CTCAE V5.0 scale. **Measure:** Cutaneous and nail toxicity (pain, pruritus, erythema, edema, xerosis, hyperkeratosis, desquamation and onychodystrophy) within one month of starting to use support products. **Time Frame:** 1 month #### Secondary Outcomes **Description:** To evaluate the efficacy of a range of dermo-cosmetic products in preventing/limiting cutaneous and nail toxicity induced by anti-GPRC5D bispecific Ac in MM patients according to the NCI-CTCAE V5.0 scale. **Measure:** Cutaneous and nail toxicity (pain, pruritus, erythema, edema, xerosis, hyperkeratosis, desquamation and onychodystrophy) occurring after 6 months (or earlier if progression) of use of support products. **Time Frame:** 6 month **Measure:** Total DLQI score after 1 month and 6 months (or earlier if progression) post use of support products. **Time Frame:** 1 month/6 month **Measure:** Pain score after 1 month and 6 months (or earlier if progression) post use of support products. **Time Frame:** 1 month/6 month **Measure:** Satisfaction at 6 months (or earlier if progression) assessed on a Likert scale by the doctor and patient, for each product in the range tested. **Time Frame:** 6 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. MM patient. 2. Patient starting anti-GPRC5D bispecific Ac therapy OR patient undergoing anti-GPRC5D bispecific Ac therapy with NCI-NCTCAE V5.0 grade ≥2 skin and nail toxicity. 3. Patient with written consent. Exclusion Criteria: 1. Patients treated or considering treatment with dermatological drugs (dermocorticoids) normally used for hand-foot syndrome OR dermo-cosmetic products (serum or reparative solutions) other than those tested. 2. Patients with atomic dermatitis (eczema) 3. Patients allergic to one or more components of the products tested. 4. Pregnant or breast-feeding women. 5. Patients who are minors or under legal protection (guardianship or safeguard of justice). 6. Patient not affiliated to a social security scheme. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cyrille.touzeau@chu-nantes.fr **Name:** Cyrille Touzeau **Phone:** 02 53 48 24 05 **Role:** CONTACT **Contact 2:** **Email:** nicolettalibera.lilli@chu-nantes.fr **Name:** Nicoletta Libera LILLI **Phone:** 02 76 64 37 83 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: HIGH - As Found: Myeloma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Myeloma ### Condition Browse Module - Meshes - ID: D000009101 - Term: Multiple Myeloma - ID: D000054219 - Term: Neoplasms, Plasma Cell ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M20194 - Name: Antibodies, Bispecific - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418737 **Brief Title:** Sleep Hygiene Training in Gymnasts: Sleep Behaviour, Quality and Sleepiness **Official Title:** Sleep Hygiene Training in Gymnasts: Quasi-Experimental Study on Sleep Behaviour, Quality and Sleepiness #### Organization Study ID Info **ID:** BAIBU-SBF-UK-01 #### Organization **Class:** OTHER **Full Name:** Abant Izzet Baysal University ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Abant Izzet Baysal University #### Responsible Party **Investigator Affiliation:** Abant Izzet Baysal University **Investigator Full Name:** Ümid Karlı **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Sleep is essential to human health and well-being. Lack of or poor sleep can negatively impact cognitive function, mood, and physical performance. Athletes, especially elite athletes, are at risk for sleep problems due to heavy training schedules and the stress of travel. Lack of or poor sleep can negatively impact athletes in many ways, including lack of sleep can lead to mood disorders such as irritability, anxiety, and depression. This may have a negative impact on athlete motivation and participation in training. Sleep deprivation can lead to decreased muscle strength, endurance, and coordination. This can affect an athlete's performance in training and competition phase. Sleep hygiene refers to a set of practices aimed at regulating the sleep environment and habits to improve sleep quality. Sleep hygiene education is an intervention designed to teach athletes about the importance of sleep hygiene to improve their sleep quality. As sleep quality improves, attention, concentration, memory, and decision-making skills also improve . This can help athletes to perform better during training and competition. As sleep quality improves, mood disorders such as irritability, anxiety, and depression decrease. This can increase athlete motivation and participation in training. As sleep quality improves, so does muscle strength, endurance, and coordination. **Detailed Description:** This study will be one of the first study conduct on human to examine the effectiveness of sleep hygiene education among gymnasts. Gymnasts, like other athletes, are prone to sleep problems for the reasons mentioned above. Therefore, it is of great significance to study the impact of sleep hygiene education on the sleep quality of gymnasts and indirectly on sports performance and sleep health as well as its underlying mechanisms. Additionally, this study has the potential to make a significant contribution to the field of exercise science by examining the effectiveness of sleep hygiene education, specifically among gymnasts. By examining effects on sleep quality, athletic performance, and sleep health, this study could provide valuable insights into developing targeted interventions to optimize sleep and health in gymnasts. The duration of the measurements will be in week 1 to see the acute effects of sleep, and as a minimum of 18-21 days is required for behavioural change, sleep measurements will be made in week 4. ### Conditions Module **Conditions:** - Sleep Hygiene - Habit, Good Sleep **Keywords:** - Sleep Quality - Sleep Hygiene - Sleep Habits - Athletes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Single masked, randomized trial (experimental and control group) ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants are masked **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Sleep Intervention: A 60-minute sleep hygiene education session will be delivered to the participants by an expert with experience in providing education in the areas of sports and sleep. Subsequently, interventions will be implemented to improve the sleep environments of the athletes who are staying at the facility **Intervention Names:** - Behavioral: Sleep HygieneTraining **Label:** Sleep Training Group: **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No training will be provided If offered by the control group participants, "sleep hygiene training" will be given after all the data collected from the Sleep Training Group **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Sleep Training Group: **Description:** Training Content * Importance of Sleep: The vital importance of sleep for physical and mental health. * Benefits of Adequate and Quality Sleep: The numerous benefits of sufficient and good quality sleep. * Sleep Stages: The different stages of sleep and their characteristics. * Sleep Hygiene: The concept of sleep hygiene and its importance for improving sleep quality. * What to Do? * What to Avoid for Better Sleep? **Name:** Sleep HygieneTraining **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Actigraphy is a less invasive method compared to other sleep measurement methods such as polysomnography **Measure:** Actigraphy **Time Frame:** Pre-test, following one week mid-test and following one month post-test **Description:** Athlete Sleep Behavior Questionnaire is a 17-item, Likert-type (1- Never, 5- Always) scale with 4 sub-factors (sports-related, sleep quality, habitual sleep efficiency, sleep disturbance) **Measure:** Athlete Sleep Behavior Questionnaire (ASBQ) **Time Frame:** Pre-test and 1 month after the pre-test **Description:** Pittsburgh Sleep Quality Index assesses various sleep-related factors, including sleep latency, sleep duration, sleep efficiency, and daytime sleepiness. It is a 19-item self-report questionnaire. Each item is scored from 0 to 3, and the total score ranges from 0 to 57. Higher scores indicate poorer sleep quality. **Measure:** Pittsburgh Sleep Quality Index (PSQI) **Time Frame:** Pre-test and 1 month after the pre-test **Description:** Cleveland Adolescent Sleepiness Questionnaire provides a valid and reliable subjective measure of daytime sleepiness in adolescents. This Questionnaire consists of 16 items that measure daytime sleepiness. Scores range from 16 to 80 on a 5-point Likert scale (never: 1; rarely: 2; sometimes: 3; usually: 4; almost every day: 5). Five of the statements are scored in the reverse direction. Daytime sleepiness is obtained by summing the scores of the 16 items, and the higher the score, the higher the daytime sleepiness. **Measure:** Cleveland Adolescent Sleepiness Questionnaire **Time Frame:** Pre-test and 1 month after the pre-test ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Voluntariness: Participants must be willing to participate in the study voluntarily and provide informed consent. * Elite Gymnasts: Participants must be elite gymnasts competing at the national level. * Being Healthy: Participants must be in good health and free of any significant medical conditions that could affect their sleep or participation in the study. * No Prior Sleep Hygiene Training: Participants must not have received any formal sleep education or intervention in the past. Exclusion Criteria: * Complications During the Intervention: Participants who experience any complications during the sleep hygiene education intervention will be excluded from the study. * Regular Use of Sleep-Affecting Medication **Gender Based:** True **Gender Description:** Male individuals will be included due to the fact that women's hormonal responses may cause heterogeneous findings and the difficulty in interpreting the findings due to their hormonal profile. **Healthy Volunteers:** True **Maximum Age:** 20 Years **Minimum Age:** 15 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** karli_u@ibu.edu.tr **Name:** Umid Karli, PhD **Phone:** +90 374 254 10 00 **Phone Ext:** 7501 **Role:** CONTACT **Contact 2:** **Email:** aydin_k@ibu.edu.tr **Name:** Kutlu Aydın, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Bolu **Contacts:** ***Contact 1:*** - **Email:** karli_u@ibu.edu.tr - **Name:** Umid Karli, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Umid Karli, Phd - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Semih Karaman, Ms - **Role:** SUB_INVESTIGATOR **Country:** Turkey **Facility:** Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, **Status:** RECRUITING **Zip:** 14030 #### Overall Officials **Official 1:** **Affiliation:** Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, Department of Coaching Education **Name:** Umid Karli, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M1717 - Name: Sleepiness - Relevance: HIGH - As Found: Sleepiness ### Condition Browse Module - Meshes - ID: D000077260 - Term: Sleepiness ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418724 **Acronym:** NEOPECS **Brief Title:** Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma **Official Title:** Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma #### Organization Study ID Info **ID:** 02.23 #### Organization **Class:** OTHER **Full Name:** Melanoma and Skin Cancer Trials Limited ### Status Module #### Completion Date **Date:** 2027-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-12 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Melanoma and Skin Cancer Trials Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia. **Detailed Description:** As cutaneous squamous cell carcinoma typically occurs on sun-exposed areas of the head and neck, surgical resection of advanced disease can have significant morbidity and disfigurement and strategies to downstage disease prior to surgery, improve chance of R0 resection and reduce the risk of post-surgical relapse remain an area of need. This study aims to determine the preliminary activity and tolerability of neo-adjuvant combination cemiplimab and cetuximab in unresectable locally advanced cutaneous squamous cell carcinoma by clinical downstaging rate to resectable status. ### Conditions Module **Conditions:** - Locally Advanced Cutaneous Squamous Cell Carcinoma **Keywords:** - immunotherapy - neoadjuvant therapy - PD-1 inhibitor - EGFR inhibitor - cetuximab - cemiplimab ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 27 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients will be administered the same treatment combination. Cemiplimab will be administered 350mg intravenously every 21 days. A maximum of 4 cycles will be given. Cetuximab will be administered 400mg/m2 loading dose on day 1 and 250mg/m2 on day 8 and day 15 for a 21 day cycle for first cycle. Cetuximab will be administered 250mg/m2 on day 1, 8 and 15 for a 21 day cycle for subsequent cycles for 4 cycles. **Intervention Names:** - Drug: Cetuximab - Drug: Cemiplimab **Label:** Cetuximab and Cemiplimab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cetuximab and Cemiplimab **Description:** Cetuximab is a monoclonal antibody against epidermal growth factor receptor (EGFR). EGFR is over-expressed in many human cancers, including colorectal cancers. **Name:** Cetuximab **Other Names:** - Erbitux **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cetuximab and Cemiplimab **Description:** Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and cytotoxic activity. Cemiplimab potentiates T cell responses, including antitumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. **Name:** Cemiplimab **Other Names:** - Libtayo **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** To explore the relationship between cancer-immune cell-stroma interactions using spatial transcriptomics and single cell RNA sequencing and outcome. **Measure:** To explore the relationship between cancer-immune cell-stroma interactions using spatial transcriptomics and single cell RNA sequencing and outcome. **Time Frame:** 3 months **Description:** The European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30) will be utilized to assess the quality of life of cancer patients measured from 0-4 (Not at all - Very Much). **Measure:** Patient reported outcomes as assessed by EORTC QLQ-C30 **Time Frame:** 36 months **Description:** The Fear-of-Progression Questionnaire - Short Form (FoP-Q-SF) will be utilized to assess fear of cancer progression measured from 1-5 (never - very often). **Measure:** Patient reported outcomes as assessed by FoP-Q-SF **Time Frame:** 36 months #### Primary Outcomes **Description:** The primary preliminary activity endpoint will be the achievement of clinical downstaging from borderline resectable status to either resectable status or surgery avoidance due to complete metabolic response with no residual pathological disease as deemed by Multi-Disciplinary Team (MDT) consensus evaluation following up to 4 cycles of neoadjuvant therapy. **Measure:** Preliminary activity **Time Frame:** 3 months #### Secondary Outcomes **Description:** Safety and feasibility by assessment of Common Terminology Criteria for Adverse Events (CTCAE) V5.0 with the incidence of ≥ Grade 3 adverse events, \< Grade 3 adverse events and SAEs and AEs leading to study treatment discontinuation. **Measure:** Treatment safety and feasibility as assessed by NCI CTCAE v5 **Time Frame:** 12 months **Description:** Safety and feasibility by assessment of change in rate of R0 resection. R0 resection is defined no residual tumour in surgically removed specimen of curative intent per local and central pathology review. **Measure:** Treatment safety and feasibility as assessed by rate of R0 resection **Time Frame:** 12 months **Description:** Preliminary efficacy by assessment of pathological response rate, including complete (0% residual tumour cells) and major (0-10% residual tumour cells) pathological responses, by blinded central pathology review. Complete pathological response (pCR) defined as absence of viable tumor cells in surgical specimen. Major pathological response (MPR) defined as 0-10% viable tumor cells in surgical specimen. **Measure:** Pathological response rate **Time Frame:** 12 months **Description:** Preliminary efficacy by assessment of overall response rate (ORR) as per Modifed Response Evaluation Criteria in Solid Tumors for immune based therapeutics (iRECIST) criteria or investigator caliper assessment where disease is un-measurable by CT or MRI modalities **Measure:** Overall response rate (ORR) **Time Frame:** 12 months **Description:** Preliminary efficacy by assessment of 12-month and median PFS using the Kaplan-Meier method. PFS is defined as the interval from date of registration to the date of first evidence of disease progression or death, whichever occurs first. **Measure:** Progression free survival (PFS) **Time Frame:** 12 months **Description:** Preliminary efficacy by assessment of 12-month and median EFS using the Kaplan-Meier method. EFS is defined as the interval from date of registration to progressive disease or adverse events precluding surgery, inability to undergo complete (R0) resection, disease recurrence or death from any cause. **Measure:** Event-free survival (EFS) **Time Frame:** 12 months **Description:** Preliminary efficacy by assessment of 12-month and median OS using the Kaplan-Meier method. OS is defined as the interval from date of registration to date of death from any cause, or the date of last known follow-up alive. **Measure:** Overall survival (OS) **Time Frame:** 12 months **Description:** Change in predicted difficulty of surgical resection and repair pre- and post-neoadjuvant therapy as measured with paired surgeon-rated scaling "scale for predicted operability of cutaneous SCC". Scale scores range from Inoperable disease (A) to Complete response (F) **Measure:** Change in predicted difficulty of surgical resection and repair **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female \> 18 years of age and able to comply with treatment, assessment and follow up 2. Documentation of a locally advanced cutaneous squamous cell carcinoma diagnosis as evidenced by histopathology with available archival tissue. Locally Advanced cutaneous Squamous Cell Carcinoma (LASCC) defined as borderline resectable for surgery due to multiple recurrences, prior radiotherapy, large extension, bone erosion and/or deep infiltration beyond the subcutaneous tissue into muscle/nerve or, where curative resection may lead to unacceptable complications, morbidity or deformity, and ineligible for curative radiotherapy 3. Measurable disease in accordance with iRECIST criteria OR clinically measurable disease \>1cm by caliper measurement. Patients with synchronous primary cutaneous squamous cell carcinoma (cSCC) tumours will be eligible. 4. Adequate bone marrow function with haemoglobin \>100g/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L). Blood transfusion is allowable. 5. Adequate hepatic function with total bilirubin levels \<1.5 upper limit normal range and Alanine aminotransferase (ALT) and AST levels \<2.5 level normal range. 6. Adequate renal function with eGFR estimated with Cockcroft Gault formula \>50mL/min. Serum potassium levels 3.5 - 5.5 mmoL/L, Serum magnesium levels 0.7 - 1.05 mmol/L, Serum corrected calcium levels 2.15 - 2.55 mmol/L 7. Adequate performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 as assessed by investigator 8. Life expectancy of \>6 months 9. Able to provide written informed consent obtained from patient and ability for patient to comply with the requirements of the trial. Exclusion Criteria: 1. Distant metastatic disease (M1) including visceral or distant nodal metastases 2. Prior receipt of checkpoint inhibitor therapy or anti-EGFR therapy for LASCC or any other malignancy 3. Uncontrolled medical/psychiatric co-morbidity as per investigator that may jeopardize the ability of the patient to undergo trial procedures with reasonable safety 4. Uncontrolled autoimmune disease requiring active immune-suppression within 1 year of enrolment 5. Corticosteroid use of \>10mg daily of oral prednisone within 2 weeks of Cycle 1 Day 1 (C1D1) 6. Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases. 7. Uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency 8. Transplant recipient 9. Hepatitis C virus (HCV) and hepatitis B virus (HBV) testing will be performed at screening 10. Controlled HIV infection (undetectable viral load (HIV RNA PCR) and Cluster of differentiation 4 (CD4) counts above 350 either spontaneously or on a stable antiviral regimen) is permitted. Monitoring will be performed per local standards. 11. Controlled hepatitis B antibody positive infection (HBsAg+) is permitted providing a serum hepatitis B virus DNA PCR that is below the limit of detection and patient is receiving anti-viral therapy for hepatitis B. Periodic monitoring of HBV DNA is required. Anti-viral therapy for at least 6 months post the last dose of investigational study drug is required. 12. Controlled hepatitis C virus antibody positive (HCV Ab+) is permitted (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy). 13. History of another malignancy within 5 years prior to trial registration. A past history of adequately treated carcinoma-in-situ, basal cell carcinoma of skin, or superficial transitional cell carcinoma of the bladder is permitted. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years after definitive primary treatment and low expected risk of recurrence. 14. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with trial protocol and follow-up schedule, including alcohol and drug abuse. 15. Pregnancy, lactation or inadequate contraception. Women must be post-menopausal, infertile or willing to use reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilized or willing to use double barrier contraception. 16. Sexually active men and women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 6 months after the last dose of investigational drug. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** neopecs@masc.org.au **Name:** Melanoma and Skin Cancer Trials Ltd Project Officer **Phone:** +61 3 9903 9022 **Role:** CONTACT **Contact 2:** **Email:** louise.gonzales@masc.org.au **Name:** Louise Gonzales **Phone:** +61433880222 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Kinghorn Cancer Centre/St Vincent's Hospital **Name:** Jia (Jenny) Liu, MD, PhD, FRACP **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M315 - Name: Cetuximab - Relevance: HIGH - As Found: Solid - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M302522 - Name: Cemiplimab - Relevance: HIGH - As Found: Oral suspension - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10122 - Name: Immunoglobulin G - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068818 - Term: Cetuximab - ID: C000627974 - Term: Cemiplimab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418711 **Acronym:** ICoN-1 **Brief Title:** ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension **Official Title:** ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Clofazamine Inhalation Suspension When Added to Guideline-Based Therapy in Participants With Nontuberculous Mycobacterial Infection #### Organization Study ID Info **ID:** MKC-CI-002 #### Organization **Class:** INDUSTRY **Full Name:** Mannkind Corporation ### Status Module #### Completion Date **Date:** 2028-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Mannkind Corporation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to Guideline-based therapy (GBT). **Detailed Description:** Randomized, Double-Blind, Placebo-Controlled Study (Part A) designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to Guideline-based therapy (GBT). The primary objective of this study will be to compare the efficacy of Clofazimine Inhalation Suspension versus placebo as assessed by the co-primary endpoints, sputum culture conversion and change in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS). An Open Label Extension Study (Part B) will be offered to qualified participants for treatment with Clofazamine Inhalation Suspension. ### Conditions Module **Conditions:** - MAC Lung Disease - Treatment Refractory MAC Lung Disease - Mycobacterium Infections, Nontuberculous **Keywords:** - Bronchiectasis - NTM (Nontuberculous mycobacteria) - MAC (Mycobacterium avium complex) - MABSC (Mycobacterium abscessus complex) - Pulmonary Nontuberculous Mycobacteria - Respiratory Infection - antimycobacterial activity - antimycobacterial therapy - MAC infections - MAC Lung disease - MAC pulmonary infection - Mycobacteria - mycobacterium - Mycobacterium Avium Complex Infections - Mycobacterium avium complex lung disease - mycobacterium Infections - Nontuberculous - Non-tuberculous mycobacterial (NTM) infections - Nontuberculous mycobacterial lung disease - Non-tuberculous mycobacterial pulmonary disease - NTM infection - NTM lung disease - NTM Pulmonary Disease - NTM lung infection - Pulmonary MAC disease - Pulmonary Mycobacterium Avium Complex disease - Treatment refractory MAC lung disease - Treatment refractory mycobacterial lung disease - Treatment refractory NTM lung infection - Treatment refractory NTM pulmonary disease - Respiratory Tract diseases - Actinomycetales Infections - Gram-Positive Bacterial Infections - Bacterial Infections - Bacterial Infections and Mycoses - Infections - Mycobacterium Infections, Nontuberculous - Mycobacterium avium-intracellulare Infection - Lung diseases - Anti-Bacterial Agents - Anti-infective Agents - Antitubercular Agents - Azithromycin - Amikacin - Ethambutol - Clofazimine - Lamprene ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** At least 234 eligible participants will be randomized in a 2:1 ratio of 1 of 2 possible treatment assignments in order to ensure that a minimum of 180 participants are evaluable for efficacy: Clofazimine Inhalation Suspension (N=120) and Placebo (n=60). Randomization will be stratified by type of Nontuberculous mycobacteria (NTM) infection (Mycobacterium avium complex \[MAC\] infection only vs MAC co-infection with mycobacterium abscessus complex \[MABSC\] or other NTM species) based on historical samples used to establish eligibility during screening. Enrollment of participants with MAC coinfection with MABSC or other NTM species will be capped at 20% of all participants to limit heterogeneity in the participant population. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** During Part A of the study, the identity of the treatments will be concealed by the use of a placebo, and treatment unblinding will only occur in the case of participant emergencies or if requested by the Data and Safety Monitoring Board (DSMB). Sputum Test Results: Results of post-baseline testing for the presence of NTM in sputum will remain concealed until the participant has completed Part A of the study and the participant's result for the sample taken at the end of Month 6 becomes available. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 234 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** MNKD-101 (Clofazimine Inhalation Suspension) is a micronized suspension with a concentration of 20 mg/mL. Study drug will be inhaled using the PARI breath-enhanced jet nebulizer system daily for 28 days in Cycle 1. Cycle 2 will commence after 56 days off treatment and resume daily for 28 days. Dose: 80 mg **Intervention Names:** - Drug: Clofazimine Inhalation Suspension **Label:** Clofazimine Inhalation Suspension **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The placebo is comprised of isotonic saline (0.9% weight/volume sodium chloride). Study drug will be inhaled using the PARI breath-enhanced jet nebulizer system daily for 28 days in Cycle 1. Cycle 2 will commence after 56 days off treatment and resume daily for 28 days. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Clofazimine Inhalation Suspension **Description:** Eligible participants will be randomized in a 2:1 ratio to 1 of 2 possible treatment assignments, Clofazimine Inhalation Suspension or Placebo. **Name:** Clofazimine Inhalation Suspension **Other Names:** - MNKD-101 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Eligible participants will be randomized in a 2:1 ratio to 1 of 2 possible treatment assignments, Clofazimine Inhalation Suspension or Placebo. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** (Part A) Sputum NTM density in CFU/mL at the end of Month 6 **Measure:** (Part A) Sputum NTM density in CFU/mL at the end of Month 6 **Time Frame:** End of Month 6 **Description:** (Part A) Sputum NTM resistance patterns at the end of Month 6, measured using sputum microbiological lab assessments **Measure:** (Part A) Sputum NTM resistance patterns at the end of Month 6, measured using sputum microbiological lab assessments **Time Frame:** End of Month 6 **Description:** (Part A) Time to first negative NTM sputum culture in participants who achieve culture conversion by Month 6 **Measure:** (Part A) Time to first negative NTM sputum culture in participants who achieve culture conversion by Month 6 **Time Frame:** End of Month 6 **Description:** (Part A) Time to sputum culture conversion in participants who achieve culture conversion by Month 6 **Measure:** (Part A) Time to sputum culture conversion in participants who achieve culture conversion by Month 6 **Time Frame:** End of Month 6 **Description:** (Part A) Rate of sputum culture conversion (negative to positive) in the subgroup of study participants whose baseline sputum culture is negative for NTM **Measure:** (Part A) Rate of sputum culture conversion (negative to positive) in the subgroup of study participants whose baseline sputum culture is negative for NTM **Time Frame:** Baseline to end of study **Description:** (Part A) Time-to-positivity (TTP) in broth cultures for NTM in sputum at the end of Months 1,2,3,4,5, and 6 **Measure:** (Part A) Time-to-positivity (TTP) in broth cultures for NTM in sputum at the end of Months 1,2,3,4,5, and 6 **Time Frame:** End of Months 1,2,3,4,5, and 6 **Description:** (Part A) Changes in inflammatory markers (specific tests to be determined) from baseline to the end of Month 6 **Measure:** (Part A) Changes in inflammatory markers (specific tests to be determined) from baseline to the end of Month 6 **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Rate of pulmonary exacerbations, as diagnosed and defined by the investigator based upon a participant's need for a limited course of antibiotic medication to treat an acute worsening of symptoms, in Months 1,2,3,4,5, and 6 **Measure:** (Part A) Rate of pulmonary exacerbations, as diagnosed and defined by the investigator based upon a participant's need for a limited course of antibiotic medication to treat an acute worsening of symptoms, in Months 1,2,3,4,5, and 6 **Time Frame:** End of Months 1,2,3,4,5, and 6 **Description:** (Part A) Rate of respiratory-related (as defined by the investigator) hospitalization **Measure:** (Part A) Rate of respiratory-related (as defined by the investigator) hospitalization **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) All-cause mortality **Measure:** (Part A) All-cause mortality **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Respiratory-related (as determined by the investigator) mortality **Measure:** (Part A) Respiratory-related (as determined by the investigator) mortality **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Use of rescue medication (i.e., initiation of anti-mycobacterial medication that is recommended by the investigator due to a perception of lack of efficacy of study drug) for pulmonary NTM infection **Measure:** (Part A) Use of rescue medication (i.e., initiation of anti-mycobacterial medication that is recommended by the investigator due to a perception of lack of efficacy of study drug) for pulmonary NTM infection **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Difference in days of absenteeism from work **Measure:** (Part A) Difference in days of absenteeism from work **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Difference in hospitalization days **Measure:** (Part A) Difference in hospitalization days **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Difference in number of emergency room visits **Measure:** (Part A) Difference in number of emergency room visits **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Difference in number of urgent care visits **Measure:** (Part A) Difference in number of urgent care visits **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Difference in number of unscheduled doctor visits **Measure:** (Part A) Difference in number of unscheduled doctor visits **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Change in BMI from baseline to the end of Month 6 **Measure:** (Part A) Change in BMI from baseline to the end of Month 6 **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Slope of the change from baseline to end of Month 6 in log10 CFU/mL **Measure:** (Part A) Slope of the change from baseline to end of Month 6 in log10 CFU/mL **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Changes in other QoL-B questionnaire domain (Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden) scores from baseline to the end of Month 6 **Measure:** (Part A) Changes in other QoL-B questionnaire domain (Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden) scores from baseline to the end of Month 6 **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Changes in shortness of breath when sitting or at rest and when exercising from baseline to the end of Month 6, measured using stand-alone shortness of breath questionnaire **Measure:** (Part A) Changes in shortness of breath when sitting or at rest and when exercising from baseline to the end of Month 6, measured using stand-alone shortness of breath questionnaire **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Change in most severe symptom at baseline from baseline to the end of Month 6, measured using stand-alone shortness of breath questionnaire **Measure:** (Part A) Change in most severe symptom at baseline from baseline to the end of Month 6, measured using stand-alone shortness of breath questionnaire **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Concentration of clofazimine in serum **Measure:** (Part A) Concentration of clofazimine in serum **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Change in forced expiratory volume in 1 second (FEV1) from baseline to the end of Month 6 **Measure:** (Part A) Change in forced expiratory volume in 1 second (FEV1) from baseline to the end of Month 6 **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Rate of study drug discontinuations **Measure:** (Part A) Rate of study drug discontinuations **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Rate of study drug dose reductions **Measure:** (Part A) Rate of study drug dose reductions **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Rate of treatment-emergent adverse events (TEAEs) **Measure:** (Part A) Rate of treatment-emergent adverse events (TEAEs) **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Rate of serious adverse events (SAEs) **Measure:** (Part A) Rate of serious adverse events (SAEs) **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Rate of laboratory abnormalities **Measure:** (Part A) Rate of laboratory abnormalities **Time Frame:** Baseline to end of Month 6 **Description:** (Part A) Rate of electrocardiogram (ECG) abnormalities **Measure:** (Part A) Rate of electrocardiogram (ECG) abnormalities **Time Frame:** Baseline to end of Month 6 **Description:** (Part B) Adverse Events (AEs) related to inhalation intolerability **Measure:** (Part B) Adverse Events (AEs) related to inhalation intolerability **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) AEs due to skin discoloration **Measure:** (Part B) AEs due to skin discoloration **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) AEs due to QTc changes **Measure:** (Part B) AEs due to QTc changes **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Sputum culture conversion (i.e., 3 consecutive- monthly sputum cultures negative for NTM **Measure:** (Part B) Sputum culture conversion (i.e., 3 consecutive- monthly sputum cultures negative for NTM **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Rate of sputum culture conversion (negative to positive) in the subgroup of study participants whose baseline sputum culture is negative **Measure:** (Part B) Rate of sputum culture conversion (negative to positive) in the subgroup of study participants whose baseline sputum culture is negative **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Rate of persistency of negative sputum culture **Measure:** (Part B) Rate of persistency of negative sputum culture **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Change in QoL-B RSS from baseline **Measure:** (Part B) Change in QoL-B RSS from baseline **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Difference in days of absenteeism from work **Measure:** (Part B) Difference in days of absenteeism from work **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Difference in hospitalization days **Measure:** (Part B) Difference in hospitalization days **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Difference in number of emergency room visits **Measure:** (Part B) Difference in number of emergency room visits **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Difference in number of urgent care visits **Measure:** (Part B) Difference in number of urgent care visits **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Difference in number of unscheduled doctor visits **Measure:** (Part B) Difference in number of unscheduled doctor visits **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Sustainability of response to Clofazimine Inhalation Suspension, evaluated quarterly while on treatment following initial conversion, for participants who convert. Culture conversion with sustainability is defined as achieving culture conversion and then having no more than 2 consecutive broth or Agar positive sputum cultures and no Agar positive culture observed once initial conversion is achieved. **Measure:** (Part B) Sustainability of response to Clofazimine Inhalation Suspension, evaluated quarterly while on treatment following initial conversion, for participants who convert **Time Frame:** Study Month 7 through Study Month 22 **Description:** (Part B) Durability of response to Clofazimine Inhalation Suspension, evaluated quarterly following active treatment, for participants who remain converters at the end of active treatment. Culture conversion with durability is defined as achieving culture conversion and remaining a converter at the end of active treatment and then having no broth or Agar positive sputum culture following active treatment **Measure:** (Part B) Durability of response to Clofazimine Inhalation Suspension, evaluated quarterly following active treatment, for participants who remain converters at the end of active treatment **Time Frame:** Study Month 7 through Study Month 22 #### Primary Outcomes **Description:** (Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for NTM) by the end of Month 6 (Part A) **Measure:** (Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for NTM) by the end of Month 6 **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Change in QoL-B RSS from baseline to end of Month 6 (Part A) **Measure:** (Part A) Change in QoL-B RSS from baseline to end of Month 6 (Part A) **Time Frame:** Baseline to end of Month 6 #### Secondary Outcomes **Description:** (Part A) Time to a composite endpoint of pulmonary exacerbation, defined as the occurrence of any of the following clinical events: all-cause mortality, respiratory-related (as determined by the investigator) hospitalization, or the requirement for parenteral (inhaled or IV) antibiotic use for NTM or other pneumonia treatment (Part A) **Measure:** (Part A) Time to a composite endpoint of pulmonary exacerbation, as defined by: all-cause mortality, respiratory-related hospitalization, or the requirement for parenteral (inhaled or IV) antibiotic use for NTM or other pneumonia treatment (Part A) **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Change in 6-minute walk distance (6MWD) from baseline to the end of Month 6 **Measure:** (Part A) Change in 6-minute walk distance (6MWD) from baseline to the end of Month 6 **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Change in participant identified Most Bothersome Symptom (MBS) from baseline to the end of Month 6 **Measure:** (Part A) Change in participant identified Most Bothersome Symptom (MBS) from baseline to the end of Month 6 **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Change in response to the Patient Global Impression of Severity (PGI-S) questionnaire from baseline to the end of Month 6 **Measure:** (Part A) Change in response to the Patient Global Impression of Severity (PGI-S) questionnaire from baseline to the end of Month 6 **Time Frame:** Baseline to the end of Month 6 **Description:** (Part A) Response to the Patient Global Impression of Change (PGI-C) questionnaire at the end of Month 6 **Measure:** (Part A) Response to the Patient Global Impression of Change (PGI-C) questionnaire at the end of Month 6 **Time Frame:** Baseline to the end of Month 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Evidence of signed and dated informed consent document(s) indicating the participant has been informed of all pertinent aspects of the trial. 2. Age ≥18 years or legal age for the participating country (e.g., the legal age in South Korea is 19 years) and ≤85 years. 3. Evidence of underlying nodular bronchiectasis and/or fibrocavitary disease on a chest radiograph or chest computed tomography, as determined by the investigator, within the last 12 months. 4. MAC-positive culture results from at least two separates (at least 1 week apart) expectorated sputum samples, one taken within 12 months, and another taken within 3 months prior to the date of informed consent. Note: A sputum culture will be obtained at baseline, but the participant may be randomized prior to availability of the results. 5. Be able to produce at least 3 mL of sputum or be willing to undergo an induction that produces at least 3 mL of sputum for mycobacteriology. 6. FEV1 ≥40% of predicted during screening, as calculated by the local spirometry laboratory standards. 7. Currently receiving a multi-drug regimen of GBT for pulmonary NTM infection in line with the 2020 ATS/ERS/ESCMID/IDSA guideline for the treatment of NTM pulmonary disease for at least 6 months prior to consenting in this study, with no changes in this regimen within 2 months of screening. 8. For female participants of childbearing potential, a negative serum pregnancy test and agreement to use a protocol-recommended method of contraception during heterosexual intercourse from the start of the screening period until ≥12 months after the final dose of study therapy. Note: A female participant is considered to be of childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 9. For male participants who can father a child and are having intercourse with females of childbearing potential, agreement to use a protocol-recommended method of contraception from the start of the study therapy until ≥12 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy. Note: A male participant is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. 10. Willingness and ability to comply with scheduled visits, drug inhalation plan, study procedures, laboratory tests, and study restrictions. Exclusion Criteria: 1. Cystic fibrosis. 2. Active tuberculosis. Note: Participants with a history of treated latent or active tuberculosis may be eligible as long as their sputum cultures in the last year are negative for tuberculosis and they are deemed by the investigator as not having current active tuberculosis. 3. Disseminated MAC or MABSC infection or participants with isolated MABSC infection. 4. Recent (i.e., within the last 3 months from date of screening) ICU admission with or without mechanical ventilation. 5. Inability to inhale with a nebulizer, in the opinion of the investigator. 6. Participants with known hypersensitivity to any of the ingredients or excipients of clofazimine. 7. Prior therapy with clofazimine in the previous 4 months from date of screening. 8. Participants with known resistance to clofazimine as treatment for MAC (i.e., MIC \>8 ug/mL for MAC). 9. Prior therapy with amikacin by any route of administration (e.g., inhaled or IV) in the previous 2 months from date of screening. 10. Ongoing participation in any other interventional drug or device clinical trial, or exposure to another investigational drug within 28 days prior to start of study treatment. Note: For investigational therapies that have a prolonged half-life, a case-by-case assessment will be made regarding the required washout period prior to being eligible for this study. 11. Current (or planned during the study) pregnancy or breastfeeding. 12. QT prolongation during screening (450 ms or longer), and/or uncontrolled sinus rhythm (\>110/minute). 13. Increased risk of proarrhythmia (e.g., recent \[within 6 months\] myocardial infarction, stroke, heart failure decompensation or left ventricular ejection of \<45%, ventricular arrhythmias, torsade de pointes, unstable angina, or high-degree atrioventricular block). 14. A family history of sudden cardiac death, unexplained death, long-QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation. 15. Recent (within 6 months) initiation of or change in the dosing regimen of any concomitant medication that is known to prolong the QT interval. Note: Participants who are on a stable regimen, in the opinion of the investigator, of the concomitant medication during screening are eligible. 16. Chronic and clinically meaningful, in the opinion of the investigator, abnormalities in potassium, magnesium, or calcium levels. 17. Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 3 years before screening or anticipated during the study period. 18. Current alcohol, medication, or illicit drug abuse. 19. Prior or ongoing social or medical condition (e.g., concomitant illness, psychiatric condition, behavioral disorder), medical history, physical findings, ECG findings or laboratory abnormality that, in the opinion of the investigator, could adversely affect the safety of the participant, makes it unlikely that the course treatment or follow-up would be completed, or could impair the assessment of study results. 20. Any prior use of bedaquiline within 1 year of screening. 21. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 times upper limit of normal (ULN) or total bilirubin \>1.5 times ULN during screening. 22. Absolute neutrophil count \<500/µL during screening. 23. Use of prednisone ≥10mg/day within 3 months prior to screening, or other significant immunosuppression as deemed by the investigator. 24. Estimated glomerular filtration rate \<30mL/minute/1.73 m2 (according to the CKD-EPI 2021 creatine equation) during screening. 25. Advanced liver disease (Child-Pugh Class A, B, or C). **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ICoN1research@mannkindcorp.com **Name:** Kelley Snodgres **Phone:** 8186615000 **Role:** CONTACT #### Locations **Location 1:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** chorne@lcids.com - **Name:** Christine Horne - **Phone:** 843-856-3784 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kent Stock, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Low Country Infectious Diseases **State:** South Carolina **Zip:** 29414 #### Overall Officials **Official 1:** **Affiliation:** Mannkind Corporation **Name:** Wassim Fares, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000000193 - Term: Actinomycetales Infections - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Lung Disease - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M12119 - Name: Mycobacterium Infections - Relevance: HIGH - As Found: Mycobacterium Infections - ID: M12120 - Name: Mycobacterium Infections, Nontuberculous - Relevance: HIGH - As Found: Mycobacterium Infections, Nontuberculous - ID: M5263 - Name: Bronchiectasis - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M17970 - Name: Mycobacterium avium-intracellulare Infection - Relevance: LOW - As Found: Unknown - ID: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T3976 - Name: Mycobacterium Abscessus - Relevance: LOW - As Found: Unknown - ID: T3977 - Name: Mycobacterium Avium Complex Infections - Relevance: LOW - As Found: Unknown - ID: T4163 - Name: Nontuberculous Mycobacterial Lung Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000009164 - Term: Mycobacterium Infections - ID: D000009165 - Term: Mycobacterium Infections, Nontuberculous - ID: D000008171 - Term: Lung Diseases ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000007917 - Term: Leprostatic Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M3924 - Name: Amikacin - Relevance: LOW - As Found: Unknown - ID: M6224 - Name: Clofazimine - Relevance: HIGH - As Found: PDE - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M20132 - Name: Azithromycin - Relevance: LOW - As Found: Unknown - ID: M8125 - Name: Ethambutol - Relevance: LOW - As Found: Unknown - ID: M4311 - Name: Antitubercular Agents - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002991 - Term: Clofazimine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418698 **Acronym:** CAIS-MT **Brief Title:** The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy **Official Title:** The Prediction of Intracranial Artery Calcification on Adverse Outcomes of Large Vessel Occlusive, Acute Ischemic Stroke Patients After Mechanical Thrombectomy: A Prospective Cohort, Observational Study #### Organization Study ID Info **ID:** LC2024ZD026 #### Organization **Class:** OTHER **Full Name:** Zhujiang Hospital ### Status Module #### Completion Date **Date:** 2029-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-28 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-06 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhujiang Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** CAIS-MT is a single-center, prospective cohort study, to evaluate the correlation between outcomes of endovascular treatment(EVT) and intracranial artery calcification(IAC) in patients with acute ischemic stroke due to large or medium vessel occlusion. **Detailed Description:** This study have to objective to evaluate the predictive value of IAC Agatston score in patients with acute ischemic stroke due to large or medium vessel occlusion on worse angiographic and functional outcomes after EVT. The result of this study will provide a upfront basis for risk stratification of adverse outcomes of EVT by using quantitative IAC, so as to get a reference for an individualized and precise plan of EVT. ### Conditions Module **Conditions:** - Stroke, Acute - Ischemic Stroke - Vascular Diseases - Central Nervous System Diseases - Nervous System Diseases - Stroke - Brain Diseases - Cerebrovascular Disorders - Intracranial Arterial Calcification **Keywords:** - Acute ischemic stroke - Large vessel occlusion - Mechanical thrombectomy - Endovascular treatment - Agatston score - Prospective cohort study - Intracranial atherosclerotic disease ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 434 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with acute ischemic stroke due to large or medium vessel occlusion meeting inclusion criteria, must accept mechanical thrombectomy and have CT images which can get the IAC Agatston score. **Label:** Patients with acute ischemic stroke due to large or medium vessel occlusion ### Outcomes Module #### Primary Outcomes **Description:** Modified Rankin Scale(mRS) score \> 2 **Measure:** Proportion of patients with a adverse functional outcome at 3 months **Time Frame:** 90(±7) days #### Secondary Outcomes **Description:** mRS score 0-1 **Measure:** Proportion of patients without disability at 3 months **Time Frame:** 90(±7) days **Description:** mRS score 0-2 **Measure:** Proportion of patients with functional independence at 3 months **Time Frame:** 90(±7) days **Description:** mRS score 0-3 **Measure:** Proportion of patients ambulatory or bodily needs-capable or better at 3 months **Time Frame:** 90(±7) days **Description:** Change of the NIHSS score at 24 hours from baseline **Measure:** Change of the NIHSS score at 24 hours from baseline **Time Frame:** 24 hours **Description:** Change of the NIHSS score at 6 days or discharge if earlier from baseline **Measure:** Change of the NIHSS score at 6 days or discharge if earlier from baseline **Time Frame:** 6(±1) days **Description:** Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) **Measure:** Health-related quality of life at 3 months **Time Frame:** 90(±7) days **Description:** Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion) **Measure:** Proportion of substantial reperfusion at final angiogram **Time Frame:** 0 day **Description:** Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion) **Measure:** Proportion of substantial reperfusion at final angiogram without any rescue methods **Time Frame:** 0 day **Description:** Substantial reperfusion is defined as a expanded Treatment in Cerebral Infarction score of 2b50 (50 to 67% reperfusion), 2b67 (67 to 89% reperfusion), 2c(90 to 99% reperfusion) or 3 (complete reperfusion) **Measure:** Proportion of substantial reperfusion at first angiogram **Time Frame:** 0 day **Description:** ICH will be evaluated according to the Heidelberg Bleeding Classification. sICH is diagnosed if the new observed ICH is associated with any of the following conditions: 1) NIHSS score increased more than 4 points than that immediately before worsening; 2) NIHSS score increased more than 2 points in one category; 3) Deterioration led to intubation, hemicraniectomy, external ventricular drain placement or any other major interventions. Additionally, the symptom deteriorations could not be explained by causes other than the observed ICH. **Measure:** Proportion of patients with Symptomatic intracranial hemorrhage(sICH) within 48 hours **Time Frame:** Within 48 hours **Description:** ICH will be evaluated according to the Heidelberg Bleeding Classification. **Measure:** Proportion of patients with any ICH within 48 hours **Time Frame:** Within 48 hours **Description:** Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period. **Measure:** Mortality at 3 months **Time Frame:** 90(±7) days **Description:** Including but not limited to acute respiratory failure, severe or malignant cerebral artery infarction, acute heart failure, debridement decompression, and other major medical events that can result in death, immediately life-threatening, hospitalization or prolongation of this hospitalization, terminally or severely disabling/incapacitating, the loss of a significant ability to maintain normal life functioning, or medical intervention to avoid the above outcomes. **Measure:** Incidence of serious adverse events **Time Frame:** Within 3 years **Description:** such as arterial perforation, iatrogenic arterial dissection, embolization in previously uninvolved vascular territory, arterial access site hematoma, and retroperitoneal hematoma. Arterial perforation will be defined at angiography by the operator and associated with subarachnoid hemorrhage. Iatrogenic arterial dissection will be defined at angiography by the operator. Arterial access site hematoma will be assessed as a complication of arterial access puncture and defined by clinical examination and anatomic imaging. Retroperitoneal hematoma will be assessed as a complication of groin puncture and defined by imaging (ultrasound or CT or MR angiography). The definition of embolization in previously uninvolved vascular territory is noted after recanalization of the primary occlusion site, any vessel occlusions distal from the primary occlusion site are considered emboli due to periprocedural thrombus fragmentation. **Measure:** Procedure-related complications **Time Frame:** Up to 24 hours **Description:** New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion. **Measure:** Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 1 year **Time Frame:** 365(±30) days **Description:** New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion. **Measure:** Proportion of patients with new cerebrovascular events related with previous vessel occlusion at 3 years **Time Frame:** 1095(±30) days **Description:** New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion. **Measure:** Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 1 year **Time Frame:** 365(±30) days **Description:** New cerebrovascular events are defined as progression of ischemic lesion or newly hemorrhagic lesion. **Measure:** Proportion of patients with new cerebrovascular events irrelated with previous vessel occlusion at 3 years **Time Frame:** 1095(±30) days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or non-pregnant women with acute stroke symptoms aged over 18 years. * Occlusion of the intracranial internal carotid artery, the middle cerebral artery, the anterior cerebral artery, the posterior cerebral artery, basilar artery and intracranial vertebral artery confirmed by CT, MR angiography, or digital subtraction angiography. * No absolute contraindication to iodinated contrast media. * Planned treatment with EVT by clinical care team. * Informed consent obtained from patients or their legal representatives. * Willing to be followed up as required by the clinical study protocol. Exclusion Criteria: * Acute ischemic stroke occurs over 24 hours of time last known well. * Neurologic deficits caused by diagnoses other than ischemic stroke, such as intracerebral hemorrhage, subarachnoid hemorrhage, or intracranial tumors. * With other underlying factors leading to IAC, such as hyperthyroidism, end-stage renal disease, long-term oral intake of vitamin K antagonist(Warfarin), chronic vitamin D deficiency or overdose, persistent hypomagnesemia, persistent hypercalcemia, persistent hyperphosphatemia and high oral calcium intake. * Lack of non-contract CT images on admission and significant artifacts in CT images preventing IAC measurement. * Severe renal insufficiency (estimated glomerular filtration rate \< 30ml/min or serum creatinine \> 220μmol/L (2.5mg/dl)). * Previous cerebrovascular intervention treatment or craniotomy. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with a diagnosis of acute ischemic stroke due to large or medium vessel occlusion, who are enrolled at Zhujiang Hospital and meet the indication for EVT. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 13681134001@163.com **Name:** Feng Xin, MD **Phone:** +8613681134001 **Role:** CONTACT **Contact 2:** **Email:** 810107327@qq.com **Name:** Wen Zhuohua, MD **Phone:** +8615622311746 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** 13681134001@163.com - **Name:** Feng Xin, MD - **Phone:** +8613681134001 - **Role:** CONTACT ***Contact 2:*** - **Email:** 810107327@qq.com - **Name:** Wen Zhuohua, MD - **Phone:** +8615622311746 - **Role:** CONTACT **Country:** China **Facility:** Zhujiang Hospital, Southern Medical University **State:** Guangdong **Status:** RECRUITING **Zip:** 528400 #### Overall Officials **Official 1:** **Affiliation:** Zhujiang Hospital **Name:** Duan Chuanzhi, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000002128 - Term: Calcium Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Ischemic Stroke - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M17400 - Name: Vascular Diseases - Relevance: HIGH - As Found: Vascular Disease - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: HIGH - As Found: Cerebrovascular Disorders - ID: M5204 - Name: Brain Diseases - Relevance: HIGH - As Found: Brain Diseases - ID: M5742 - Name: Central Nervous System Diseases - Relevance: HIGH - As Found: Central Nervous System Diseases - ID: M5377 - Name: Calcinosis - Relevance: HIGH - As Found: Calcification - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M5391 - Name: Calcium Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000009422 - Term: Nervous System Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002114 - Term: Calcinosis - ID: D000007511 - Term: Ischemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418685 **Acronym:** RWS-VC **Brief Title:** Real-World Clinical Study on the Efficacy of Vibrating Capsule (Vibrabot Capsule) for Chronic Functional Constipation **Official Title:** The First Affiliated Hospital of Naval Medical University #### Organization Study ID Info **ID:** ANKONYX2023006 #### Organization **Class:** OTHER **Full Name:** Changhai Hospital ### Status Module #### Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-01-30 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Ruijin Hospital **Class:** OTHER **Name:** Shanghai Tongji Hospital, Tongji University School of Medicine **Class:** OTHER **Name:** Shanghai 10th People's Hospital **Class:** OTHER **Name:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine **Class:** OTHER **Name:** Shanghai 6th People's Hospital **Class:** OTHER **Name:** Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University **Class:** OTHER **Name:** Shanghai Pudong New Area Gongli Hospital #### Lead Sponsor **Class:** OTHER **Name:** Changhai Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is a multi-center prospective cohort study, which plans to include 300 patients with chronic functional constipation to treat with Vibrabot capsules, and at the same time, include ≥300 patients receiving constipation treatment during the same period. During the study, it is necessary to collect the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication. During the treatment phase, patients follow the doctor's advice to receive Vibrabot capsule treatment and maintain stable dietary intake and exercise according to the constipation diagnosis and treatment guidelines. During the study, patients need to scan the two-dimensional code or search for the electronic questionnaire "Vibrabot Health" Official Account on WeChat, and fill in the relevant information during the treatment in the electronic questionnaire in a timely and truthful manner. The treatment effect of the patients is evaluated by assessing the number of occurrences of spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM). **Detailed Description:** Constipation is characterized by a decrease in bowel movements, dry and hard stools, and difficulty in defecation. With changes in diet, faster pace of life, and social psychological factors, the prevalence of chronic constipation is on the rise. The global incidence of chronic constipation is 14%, while the prevalence of chronic constipation in adults in China is 4.0% to 10.0%. The prevalence of functional constipation in China is 6%. The high-risk groups for constipation include the elderly, women, diabetics, those taking opiates, antipsychotic drugs, or bedridden patients. Occupation, lifestyle, dietary habits, mental health, family history of constipation, and BMI are factors related to constipation. Constipation affects patients' quality of life, and some patients abuse laxatives or repeatedly seek medical treatment, increasing medical costs. The main treatments for constipation are adjusting lifestyle, medication, psychotherapy, biofeedback, and surgery. However, these methods often have side effects, and patient satisfaction is still relatively low. A new approach needs to be explored to address this clinical problem. The Disposable Gastrointestinal Vibrating Capsule System (Vibrabot capsule) (NMPA Device Approval No. 20223090282) is the world's first approved and marketed product for treating constipation through purely physical means. It can provide intermittent comfortable massages to the digestive tract, activate the intestinal neural network, awaken intestinal motility, and help alleviate constipation issues. Clinical study results show that the product is safe to use and can increase the frequency of bowel movements in patients with chronic functional constipation. This study focuses on post-marketing clinical study for patients with functional constipation of varying severity, further evaluating the efficacy of the product in a large sample population. Through this real-world study, to analyze the response of functional constipation patients with different severity, treatment status, capsule dosage, and combined medication to Vibrabot capsule, as well as the duration of efficacy maintenance during the follow-up period; to compare the efficacy with patients treated with drugs or other therapies during the same period, explore the possibility of curing functional constipation patients, further improve the treatment satisfaction of constipation patients, and promote the establishment and application of consensus or guidelines for the use of Vibrabot capsule in treating functional constipation. Each patient will undergo a series of study visits, including screening, treatment visit, and follow-up visit. The visit process is briefly described as follows: Visit 1 (0 \~ 1 day) - Baseline/Screening Period: This visit includes: The patient will sign an informed consent form; Set the inclusion/exclusion criteria; Guide patients to fill out the questionnaire using the Official Account and complete the Baseline Period Questionnaire in the Official Account. Prescription Vibrabot capsule treatment or other treatment options. Visit 2 (Week 2 ±3 days) - Treatment Period 1: This visit includes: Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks. Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 3 (Week 4±3 days) - Treatment Period 2 This visit includes: Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks. Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 4 (Week 6 ±3 days) - Treatment Period 3 This visit includes: Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks. Record adverse events and concomitant treatments. Visit 5 (Week 10±3 days) - Follow-up Period: This visit includes: Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks; Record adverse events and concomitant treatments. ### Conditions Module **Conditions:** - Clinical Study - Chronic Functional Constipation **Keywords:** - Real-World Clinical Study - Vibrating Capsule - Chronic Functional Constipation - Response Rate - Complete Spontaneous Bowel Movement ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Treatment with Vibrabot Capsule **Intervention Names:** - Device: Treatment with Vibrating Capsule **Label:** VC group #### Arm Group 2 **Description:** Selecting Alternative Treatment Methods through Assessment **Label:** Other treatment group ### Interventions #### Intervention 1 **Arm Group Labels:** - VC group **Description:** Main parameters of Vibrabot capsule: nominal diameter: 11.8±1mm; nominal length: 26.7±1mm; nominal weight: 4.5±1g. After the patient swallows the Vibrabot capsule, the capsule runs through the stomach → duodenum → jejunum and ileum → colon. According to the clinical data and configuration settings, the capsule will reach the colon and vibrate 8 hours after activation for ≥ 180 minutes in a cycle at low, medium, and high frequencies sequentially. The capsule relieves and treats constipation by massaging the colon wall through motor vibration to relieve colon muscle spasms and promote colonic peristalsis. The VC well be taken between 21:00 and 22:00 every day, and the frequency of administration is determined based on the patient's individual situation. **Name:** Treatment with Vibrating Capsule **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Collect relevant data through baseline questionnaire. **Measure:** Proportion of constipated patients (including different constipation types, occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment. **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through baseline questionnaire. **Measure:** occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment. **Time Frame:** at the end of the 4-week follow-up period. #### Primary Outcomes **Description:** The definition of the responder is a patient with an average weekly increase of ≥1 complete spontaneous bowel movement (CSBM) compared to the baseline. **Measure:** After treatment, whether the response rate of patients using the Vibrabot vibrating capsules alone reaches 50%. **Time Frame:** At the end of the sixth week of treatment #### Secondary Outcomes **Description:** Collect relevant data through daily defecation questionnaires. **Measure:** Proportion of constipated patients who use/do not use other constipation treatment methods **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through daily defecation questionnaires. **Measure:** Proportion of constipated patients who use/do not use other constipation treatment methods **Time Frame:** at the end of the 4-week follow-up **Description:** Collect relevant data through daily defecation questionnaires,CSBM refers to spontaneous defecation without anal obstruction and without taking laxatives within 24 hours before defecation. **Measure:** Proportion of patients with an average increase of ≥1 CSBMs per week compared to the baseline period **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through daily defecation questionnaires, SBM refers to spontaneous defecation without taking laxatives within 24 hours before defecation. **Measure:** Proportion of respondents with an average of ≥3 SBMs per week during the treatment period **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through daily defecation questionnaires, SBM refers to spontaneous defecation without taking laxatives within 24 hours before defecation.CSBM refers to spontaneous defecation without anal obstruction and without taking laxatives within 24 hours before defecation. **Measure:** Proportion of subjects with ≥3 SBMs per week and an increase of ≥1 CSBMs during at least 4 weeks of treatment compared to baseline **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through daily defecation questionnaires. **Measure:** Proportion of patients with an average increase of ≥1 CSBMs per week during the follow-up phase compared to the baseline period; **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through daily defecation questionnaires. **Measure:** Proportion of patients with an average of ≥3 SBMs per week during the follow-up phase **Time Frame:** at the end of the 4-week follow-up **Description:** Collect relevant data through daily defecation questionnaires. Patient Assessment of Constipation Quality of Life questionnaire，The PAC-QoL questionnaire consists of 28 items, each with a score of 0 to 4, measuring anxiety, physical discomfort, psychosocial discomfort, and treatment satisfaction, respectively The higher the score, the worse the quality of life. **Measure:** Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Quality of Life questionnaire(PAC-QOL) scores after treatment compared to the baseline period **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through daily defecation questionnaires.The PAC-SYM questionnaire consists of 12 items, each with a score of 0 to 4, quantifying stool symptoms, rectal symptoms, and abdominal symptoms. The higher the score, the more constipation symptoms will be serious. **Measure:** Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Symptom (PAC-SYM) scores after treatment compared to the baseline period **Time Frame:** At the end of the sixth week of treatment **Description:** Collect relevant data through daily defecation questionnaires. **Measure:** Time of first use of laxative or enema after a course of vibrating capsule treatment (6 weeks) **Time Frame:** After the end of the sixth week of treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients who can be diagnosed with functional constipation according to the Rome IV criteria. 2. Patients who consent to participate in this trial and voluntarily sign the informed consent form (ICF). Exclusion Criteria: 1. People who are not eligible for surgery or refuse to undergo any abdominal surgery; 2. People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula. 3. People allergic to polymeric materials; 4. People implanted with cardiac pacemakers and using gastrointestinal pacemakers; 5. People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies. 6. People with dysphagia; 7. Pregnant women; 8. People with severe depression and anxiety and severe acute gastrointestinal lesions. 9. People with other conditions, so the investigator considers them not eligible for this study. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This study is a multi-center clinical trial. Patients are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria. This study plans to include 300 patients with chronic functional constipation to treat with Vibrabot capsules for at least 6 weeks, and ≥300 patients with constipation receiving other treatments concurrently. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drfionachien@163.com **Name:** Yangyang Qian, MD **Phone:** +86 13818040017 **Role:** CONTACT **Contact 2:** **Email:** jiahuizhu2685@126.com **Name:** Jiahui Zhu, MD **Phone:** +86 18301952685 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** liaozhuan@smmu.edu.cn - **Name:** Zhuan Liao, MD - **Phone:** 86-21-31161004 - **Role:** CONTACT **Country:** China **Facility:** Changhai hospital #### Overall Officials **Official 1:** **Affiliation:** Changhai Hospital **Name:** Zhuan Liao, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Scott SM, Simren M, Farmer AD, Dinning PG, Carrington EV, Benninga MA, Burgell RE, Dimidi E, Fikree A, Ford AC, Fox M, Hoad CL, Knowles CH, Krogh K, Nugent K, Remes-Troche JM, Whelan K, Corsetti M. Chronic constipation in adults: Contemporary perspectives and clinical challenges. 1: Epidemiology, diagnosis, clinical associations, pathophysiology and investigation. Neurogastroenterol Motil. 2021 Jun;33(6):e14050. doi: 10.1111/nmo.14050. Epub 2020 Dec 2. **PMID:** 33263938 **Citation:** Zhu JH, Qian YY, Pan J, He C, Lan Y, Chen WN, Wang BM, Zhao W, Li JN, Li XQ, Lv B, Fan YH, Zuo XL, Li Z, Zou DW, Li ZS, Liao Z. Efficacy and safety of vibrating capsule for functional constipation (VICONS): A randomised, double-blind, placebo-controlled, multicenter trial. EClinicalMedicine. 2022 Apr 25;47:101407. doi: 10.1016/j.eclinm.2022.101407. eCollection 2022 May. **PMID:** 35518121 **Citation:** Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670. **PMID:** 18509121 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-07-18 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 6781938 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-15T12:54 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6472 - Name: Constipation - Relevance: HIGH - As Found: Constipation - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003248 - Term: Constipation ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418672 **Acronym:** GSSG **Brief Title:** Go Sun Smart Georgia Evaluation **Official Title:** Go Sun Smart Georgia Evaluation #### Organization Study ID Info **ID:** STUDY00007062 #### Organization **Class:** OTHER **Full Name:** Emory University #### Secondary ID Infos **ID:** 3U48DP006377-03S4 **Link:** https://reporter.nih.gov/quickSearch/3U48DP006377-03S4 **Type:** NIH ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-01 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Centers for Disease Control and Prevention **Class:** INDUSTRY **Name:** Klein Buendel, Inc. #### Lead Sponsor **Class:** OTHER **Name:** Emory University #### Responsible Party **Investigator Affiliation:** Emory University **Investigator Full Name:** Alexandra Morshed **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the dissemination of the Go Sun Smart Georgia (GSSG) program with Georgia worksites and learn whether the intervention changes the employees' sun protection behavior in outdoor workers in Southwest Georgia. The primary aim is to assess program effectiveness by comparing employee sun protection practices between the employers assigned to the GSSG intervention and the employers assigned to the wait-list control group (delayed intervention). The hypothesis that will be tested is that compared to the delayed intervention group, employees at intervention worksites will practice more sun protection during the post-test. Worksites will be asked to complete internal coach training and participate in technical assistance around sun safety. Study participants will fill out surveys and participate in interviews **Detailed Description:** This project builds on the original Go Sun Smart at Work (GSSW) program-a sun safety educational program delivered to worksite leaders, managers, and workers-that was previously shown to be effective for employers adopting sun safety policies and implementing sun safety education and actions, and improved employees' sun protection behavior (e.g., use of protective clothing). To successfully implement and scale up GSSW with outdoor workers in Southwest Georgia-predominantly African American and Hispanic-this intervention must be systematically adapted to ensure program fit to the population and setting while maintaining core program elements. A well-adapted and tailored occupational sun safety program with high dissemination potential will greatly impact this overlooked employee population, reduce health care costs, improve quality of life, and save lives. The adaptation process took place in 2022-2024, and the adapted Go Sun Smart Georgia (GSSG) program will be evaluated in 2024. Go Sun Smart Georgia (GSSG) is an educational, train-the-trainer, and technical assistance program for Georgia worksites that employ outdoor workers. It will be implemented with worksites assigned to the intervention group in May-Aug 2024 and with worksites assigned to the comparison (delayed intervention) group in Aug - Dec. 2024. The study team will provide worksites with training for internal worksite coaches (the coach(es) will be employee(s) chosen by the worksite to serve as a champion for the program, not part of the study staff and paid by the worksite), training for other internal educators, technical assistance for conducting the program, and employee educational sessions, as needed. ### Conditions Module **Conditions:** - Sun Safety **Keywords:** - Sun Protection Behavior - Sun Safety Education ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 312 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 6 worksites will be enrolled. GSSG implementation in May-August 2024 **Intervention Names:** - Behavioral: Go Sun Smart Georgia (GSSG) **Label:** Early Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 6 worksites will be enrolled. GSSG implementation in August- December 2024. **Intervention Names:** - Behavioral: Go Sun Smart Georgia (GSSG) **Label:** Delayed Intervention **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Delayed Intervention - Early Intervention **Description:** Go Sun Smart Georgia (GSSG) is an educational, train-the-trainer, and technical assistance program for Georgia worksites that employ outdoor workers. GSSG is delivered through personal contacts with senior worksite managers, employee training, and distribution of educational materials. In meetings with managers, trained coaches work to increase perceived need for workplace sun safety, cite advice from national authorities (e.g., CDC and NIOSH), plan for policy implementation, alter policies/education and/or workplace to improve fit, clarify changes to other managers/ employees, and bundle sun safety with worksite safety. The intervention period will last 12-16 weeks in each of the groups. **Name:** Go Sun Smart Georgia (GSSG) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Will be captured through outdoor worker survey (posttest). To evaluate the impact of GSSG on sun safety behaviors (primary outcome), employees will report a) frequency of sun protection at work (i.e., sunscreen with SPF 30+, long-sleeved shirts, long pants, hat with wide-brim, sunglasses, shade use, limit midday sun exposure, and have sunscreen, hat and eye protection at all times \[1=never, 5=always\]) and b) sunburn in past 3 months on the job (yes/no; number). Surveys will include questions about amount of times respondent works outdoors; the respondent's sun and heat protection behaviors; perceptions of their sun exposure risk and history of sunburn; presence and perception of workplace policies, procedures, standards, resources, and training for sun safety and heat at the organization; experience with the Go Sun Smart Georgia program; and respondent demographics. **Measure:** Change in outdoor worker sun safety behaviors **Time Frame:** 16 weeks #### Secondary Outcomes **Description:** Will be captured through manager survey, outdoor worker survey **Measure:** Change in worksite policy adoption **Time Frame:** Baseline, After 16 weeks **Description:** Will be captured through manager survey, outdoor worker survey **Measure:** Worksite sun safety education **Time Frame:** Baseline, After 16 weeks **Description:** Will be captured through manager survey **Measure:** Change in worksite sun safety actions **Time Frame:** Baseline, After 16 weeks **Description:** Will be captured through manager survey, outdoor worker survey, semi-structured interviews **Measure:** Appropriateness of program **Time Frame:** At 16 weeks **Description:** Will be captured through manager survey, outdoor worker survey, semi-structured interviews **Measure:** Feasibility of program **Time Frame:** At 16 weeks **Description:** Will be captured through manager survey, outdoor worker survey, semi-structured interviews **Measure:** Acceptability of program **Time Frame:** At 16 weeks **Description:** Will be captured through program logs. **Measure:** Fidelity of implementation **Time Frame:** 16 weeks **Description:** Will be captured through outdoor worker survey **Measure:** Representativeness of participants **Time Frame:** At 16 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Outdoor workers * Employed at participating worksite * Works at least 5 hours outdoors per week * Can read and/or clearly understand English Managers * Employed at participating worksite in supervisory position * Responsible for worksite safety/health policy or training * Can read and/or clearly understand English Semi-structured interviews * Employed by participating worksite * Closely involved with GSSG implementation * Can read and/or clearly understand English Exclusion Criteria: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners * Cognitively impaired or Individuals with Impaired Decision-Making Capacity * Individuals who are not able to clearly understand English **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** alexandra.morshed@emory.edu **Name:** Alexandra Morshed, PhD **Phone:** 404-727-1077 **Role:** CONTACT **Contact 2:** **Email:** Radhika.agarwal2@emory.edu **Name:** Radhika Agarwal **Role:** CONTACT #### Locations **Location 1:** **City:** Atlanta **Country:** United States **Facility:** Rollins School of Public Health **State:** Georgia **Zip:** 30322 #### Overall Officials **Official 1:** **Affiliation:** Rollins School of Public Health **Name:** Alexandra Morshed, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Scientific data will be preserved and shared using the Emory Dataverse Repository, sco.library.emory.edu/dataverse, where they will be publicly available to those interested in using them. **Description:** To enable interoperability of datasets and resources, we will provide a data codebook/dictionary for all variables included per dataset and documentation with the following elements: information about how the data were collected, sampling details, data cleaning details, related publications, and grant information. The team will make available platform-independent, character-based formats of datasets (e.g., CSV) that retain full detail and precision **Info Types:** - SAP - CSR **IPD Sharing:** YES **Time Frame:** Data will be made available no later than the time of an associated publication or the end of the performance period of the SIP award that funds this project. Data will be made available for at least 5 years. ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418659 **Brief Title:** A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients **Official Title:** A Clinical Trial Assessing the Safety and Efficacy of Intravenous CD-801 for the Treatment of Patients With Advanced Hepatocellular Carcinoma #### Organization Study ID Info **ID:** CZXH-HCC-2024-IIT #### Organization **Class:** OTHER **Full Name:** Shanghai Changzheng Hospital ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Changzheng Hospital #### Responsible Party **Investigator Affiliation:** Shanghai Changzheng Hospital **Investigator Full Name:** Wei-Fen Xie **Investigator Title:** Director, Department of Gastroenterology, Changzheng Hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this investigator-initiated, a single-arm, open-label, pilot study is to investigate the safety, tolerability, and efficacy of Intravenous CD-801 treatment in subjects with advanced hepatocellular carcinoma(HCC). Condition of disease: advanced hepatocellular carcinoma. Intervention： CD-801 will be administered intravenously for the treatment of HCC. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. The trial is structured in two phases: dose escalation and dose expansion. Dose Escalation Phase: The study employs a i3+3 design to assess escalating CD-801 dosages: 25 μg, 50 μg, and 100 μg. Post-initial dose, a 14-day DLT observation will evaluate tolerability and safety, guiding dose adjustments or selection of the Recommended Dose (RD) for the expansion phase. Cohorts may include up to 9 participants, adjusted for safety. Dose Expansion Phase: The expansion phase will use the safe dosage and regimen from the escalation phase, with treatments starting 14 ± 3 days after the initial dose, then every 28 ± 7 days, adjusted as needed. It ends upon complete response, disease progression, toxicity, withdrawal, loss to follow-up, new oncological treatments, or investigator termination, with a final assessment 14 days post-last dose. The phase plans to enroll about 10 participants to further assess CD-801's safety, tolerability, and antitumor effects using mRECIST. Drug: CD-801, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α. **Detailed Description:** Hepatocellular carcinoma (HCC) is the most common form of liver cancer. Recent advancements in understanding tumor biology and the tumor microenvironment, along with the approval of systemic therapeutic agents, including immunotherapy and vascular endothelial growth factor (VEGF)-targeted agents, have dramatically transformed the treatment landscape for advanced stage HCC. However, the survival for advanced HCC patients still remains unsatisfactory. Differentiation therapy in oncology is defined as a therapeutic strategy that reactivates endogenous differentiation programs and reverts malignant phenotypes. Its hallmark success is the treatment of acute promyelocytic leukemia (APL) by the combination of all-trans retinoic acid (ATRA) and arsenic. Unfortunately, this approach has achieved limited success in solid tumors. Hepatocyte nuclear factor 4α (HNF4α) is a transcription factor (TF) belonging to the nuclear receptor family. HNF4α is highly enriched in mature hepatocytes and serves as a master regulator of hepatocyte differentiation and hepatic metabolism. Previous studies, including our own and others, have demonstrated that the reduced expression of HNF4α plays a critical role in hepatocarcinogenesis. Restoring HNF4α expression induces the differentiation of HCC cells into mature hepatocytes and has shown significant therapeutic effects in various animal models of HCC. In this study, we developed CD-801, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α, for the treatment of HCC patients. Preclinical studies have shown that CD-801 effectively inhibits the growth of subcutaneous and orthotopic liver tumors in mice. Acute toxicity tests in Sprague-Dawley rats have demonstrated that a single intravenous injection of CD-801 injection at a dose of 150 μg/animal is well-tolerated, with no significant toxicity, indicating good safety profiles. This trial, structured in two phases: dose escalation and dose expansion, is a single-arm, open-label, exploratory clinical study aimed at evaluating the efficacy, safety, and tolerability of CD-801 administered intravenously through a peripheral vein in the treatment of advanced-stage HCC. The treatment schedule is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. ### Conditions Module **Conditions:** - Advanced Hepatocellular Carcinoma **Keywords:** - Hepatocellular carcinoma - Hepatocyte nuclear factor 4α ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The subjects with advanced HCC will be treated by CD-801 intravenously via a peripheral vein. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 37 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The subjects with advanced HCC will be treated by CD-801 intravenously via a peripheral vein. **Intervention Names:** - Drug: CD-801 **Label:** CD-801 treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CD-801 treatment **Description:** CD-801 will be administered intravenously for the treatment of HCC. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. **Name:** CD-801 **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** To evaluate the impact of CD-801 treatment on Health Related Quality of Life for subjects treated using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. **Measure:** Health Related Quality of Life based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). **Time Frame:** Through study completion, an average of 2 years **Description:** To evaluate the impact of CD-801 treatment on Health Related Quality of Life for subjects treated using HCC-specific EORTC QLQ-HCC18 questionnaire. **Measure:** Health Related Quality of Life based on HCC-specific EORTC QLQ-HCC18 questionnaire. **Time Frame:** Through study completion, an average of 2 years **Description:** To evaluate the impact of CD-801 treatment on Health Related Quality of Life for subjects treated using European Quality of Life questionnaire. **Measure:** Health Related Quality of Life based on European Quality of Life questionnaire. **Time Frame:** Through study completion, an average of 2 years **Description:** To investigate the changes in serum tumor biomarkers among subjects with advanced HCC following CD-801 treatment. **Measure:** The impact of CD-801 treatment on tumor biomarkers in serum. **Time Frame:** Through study completion, an average of 2 years **Description:** To investigate the changes in serum cytokines among subjects with advanced HCC following CD-801 treatment. **Measure:** The impact of CD-801 treatment on cytokines in serum. **Time Frame:** Through study completion, an average of 2 years **Description:** To investigate the changes of immune cell profiling in serum among subjects with advanced HCC following CD-801 treatment. **Measure:** The impact of CD-801 treatment on immune cell profiling in serum. **Time Frame:** Through study completion, an average of 2 years **Description:** To investigate the changes of histopathology in tumor tissue among subjects with advanced HCC following CD-801 treatment. **Measure:** The impact of CD-801 treatment on tumor histopathology. **Time Frame:** Through study completion, an average of 2 years **Description:** To investigate the changes of tumor metabolism through metabolomic analysis of liver cancer tissue among subjects with advanced HCC following CD-801 treatment. **Measure:** The impact of CD-801 treatment on tumor metabolism. **Time Frame:** Through study completion, an average of 2 years **Description:** To investigate the changes of tumor gene expression profiles through next-generation sequencing and single-cell sequencing analysis of liver cancer tissue among subjects with advanced HCC following CD-801 treatment. **Measure:** The impact of CD-801 treatment on gene expression profiles within tumors. **Time Frame:** Through study completion, an average of 2 years #### Primary Outcomes **Description:** Safety and tolerability are assessed based on the incidence of Dose-Limiting Toxicities (DLTs) within 14 days post-initial drug administration, along with the frequency and severity of adverse events (AEs), serious adverse events (SAEs), and events leading to treatment discontinuation throughout the treatment period, all evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. **Measure:** (Escalation part) To evaluate the tolerability and safety for intravenous CD-801 in subjects with hepatocellular carcinoma (HCC) **Time Frame:** Through study completion, an average of 2 years **Description:** To assess the proportion of subjects who have best overall response of complete response or partial response at the time of data cutoff based on mRECIST. **Measure:** (Expansion part) To assess the objective response rate (ORR) by modified Response Evaluation Criteria in Solid Tumours (mRECIST). **Time Frame:** From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months #### Secondary Outcomes **Description:** To assess the proportion of subjects who have best overall response of complete response or partial response at the time of data cutoff based on mRECIST and RECIST v1.1. **Measure:** (Escalation part) To assess the objective response rate (ORR) by mRECIST and RECIST v1.1. **Time Frame:** From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months. **Description:** To assess the frequency and severity of AEs, SAEs, and events leading to treatment discontinuation throughout the treatment period, all evaluated using CTCAE 5.0. **Measure:** (Expansion part) To evaluate the tolerability and safety for intravenous CD-801 in subjects with HCC **Time Frame:** Through study completion, an average of 2 years **Description:** To assess the proportion of subjects who have best overall response of complete response or partial response at the time of data cutoff based on RECIST v1.1 **Measure:** (Expansion part) The objective response rate based on RECIST v1.1 **Time Frame:** From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months **Description:** To assess the time from the first documentation of complete response or partial response to the date of first documentation of disease progression or death (whichever occurs first) based on mRECIST and RECIST v1.1 **Measure:** Duration of response based on mRECIST and RECIST v1.1 **Time Frame:** up to 24 months **Description:** To assess the time from the first study dose date to the date of first documentation of disease progression or death(whichever occurs first) based on mRECIST and RECIST v1.1 **Measure:** Progression-free survival based on mRECIST and RECIST v1.1 **Time Frame:** up to 24 months **Description:** To assess the time from the first study dose date to the date of first documentation of disease progression based on mRECIST and RECIST v1.1 **Measure:** Time to progression based on mRECIST and RECIST v1.1 **Time Frame:** up to 24 months **Description:** To assess the time from the date of first study dose to the date of first documentation of complete response or partial response based on mRECIST and RECIST v1.1 **Measure:** Time to response based on mRECIST and RECIST v1.1 **Time Frame:** up to 24 months **Description:** To assess the proportion of subjects who have best overall response of complete response or partial response or stable disease (minimum duration from the initial treatment to stable disease ≥5 weeks) based on mRECIST and RECIST v1.1 **Measure:** Disease control rate based on mRECIST and RECIST v1.1 **Time Frame:** up to 24 months **Description:** To assess the proportion of subjects who have best overall response of complete response or partial response or durable stable disease (duration of stable disease ≥ 23 weeks) based on mRECIST and RECIST v1.1 **Measure:** Clinical benefit rate based on mRECIST and RECIST v1.1 **Time Frame:** up to 24 months **Description:** To assess the time from the first study dose date until date of death from any cause . Subjects who are lost to follow-up and the subjects who are alive at the date of data cutoff will be censored at the date the subject was last known alive or the cut-off date, whichever comes earlier. **Measure:** Overall Survival **Time Frame:** Throughout the entire course of treatment until the end of the follow-up period, an average of 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Males or females, aged 18 years or older. 2. Subjects must have confirmed diagnosis of HCC with any of the following criteria according to the American Association for the Study of Liver Diseases criteria. 3. Unresectable HCC. 4. Subjects were not eligible for locoregional or systemic therapies, or had disease progression, or would not benefit after at least one of the conventional therapies. 5. According to mRECIST, subjects should be with at least 1 measurable target lesion. 6. Life expectancy of 12 weeks or more. 7. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2. 8. Males with fertility and females of childbearing potential are willing to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation. Females of childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment. 9. Subjects who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol. Exclusion Criteria: 1. Inadequate liver function：Albumin (ALB) \< 26 g/L, or total bilirubin \>5.0 mg/dL, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \>5 × the upper limit of normal (ULN). 2. Inadequate renal function defined as creatinine \>1.5 × ULN or calculated creatinine clearance \< 40 mL/min. 3. Absolute neutrophil count (ANC) \< 1.0×109/L, or Platelets \< 30×109/L, or Hemoglobin \< 8.5 g/dL. 4. International Normalized Ratio (INR) \> 2.3. 5. Subjects with a history of liver transplantation. 6. Subjects with poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction. 7. Subjects with extrahepatic metastasis who had not received first-line systemic therapies (excluding those who are not eligible for systemic therapies) or who were receiving effective systemic therapy currently. 8. Subjects who had prior anticancer treatment with any locoregional therapies, antiangiogenic targeted therapies, immune checkpoint inhibitors or chemotherapy (within 4 weeks, or within 2 weeks in case of sorafenib), radiotherapy (within 3 weeks), or active traditional Chinese medicine (within 2 weeks) before the first dose of study treatment, except for the treatments after which the disease still progressed according to mRECIST. 9. All toxicities related to prior locoregional or systemic anti-tumor treatments are still grade 2 or more (except for hair loss and other events that have been judged tolerable by researchers). 10. Subjects with complication histories of liver cirrhosis or HCC such as gastrointestinal hemorrhage, overt hepatic encephalopathy, or refractory ascites within 2 weeks prior to the first dose of study treatment. 11. Uncontrolled active infection (eg, lung infections, or abdominal infections). 12. History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate \> 90%), such as adequately treated early gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer. 13. HBV DNA greater than 500 copies/mL, or HCV RNA greater than 15 U/mL. 14. Subject is positive for Human Immunodeficiency Virus (HIV). 15. Any subject who is allergic to MRI contrast agents. 16. Pregnant/lactating women, or women who have the possibility of pregnancy. 17. Participation in other investigational drug trials within 4 weeks prior to initiation of this study treatment. 18. Any medical or other condition which, in the opinion of the investigator, would preclude participation in this clinical trial. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ilse1225@163.com **Name:** CHUAN YIN, M.D. **Phone:** +8613482705212 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Shanghai Changzheng Hospital **Name:** Wei-Fen Xie, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Hepatocellular Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000006528 - Term: Carcinoma, Hepatocellular ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418646 **Brief Title:** Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany **Official Title:** Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany #### Organization Study ID Info **ID:** ALSpsychosoz #### Organization **Class:** OTHER **Full Name:** Technische Universität Dresden ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** ALS Association **Class:** UNKNOWN **Name:** German Society of Muscle Diseases #### Lead Sponsor **Class:** OTHER **Name:** Technische Universität Dresden #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The progressive loss of physical functioning resulting from ALS leads also to high psychosocial burden for those affected, and organizational challenges related to medical care and aids. A multidimensional and -professional care is advised in order to meet the complex requirements of this disease. In Germany, medical care structures may not fulfil these high requirements, since non-medical services such as psychological support or social counselling are not regularly included in care procedures for ALS patients. Specialised palliative care is not a standard and still commonly restricted to the last weeks of life. Additionally, it is well known that caregivers of ALS patients are highly burdened, but there is a lack of support services for them. By means of a cross-sectional, multicentre survey, we aim to investigate patients' and caregivers' perception of medical care for ALS, provided in Germany - with particular regard to psychosocial and palliative aspects. The extent to which physical, psychological, social, spiritual, practical and informational needs are subjectively met will be assessed and correlations with mental wellbeing, subjective quality of life, attitudes towards life-sustaining measures and physician-assisted suicide, as well as caregiver burden will be examined. Currently, study planning (questionnaires and ethical approval) is already completed and recruitment was started. The study aims to recruit 500 participants from nationwide ALS-centres. Cooperating ALS-centres will be recruited via the German Network for Motoneuron Diseases (MND-Net), of which our centre is a member. It is intended to provide data-based starting points on how care of ALS patients and their caregivers can be improved in Germany, in line with their needs. ### Conditions Module **Conditions:** - Amyotrophic Lateral Sclerosis **Keywords:** - palliative care - caregiver burden - multidimensional care ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** patients' satisfaction with professional care for potential symptoms in the six domains physical, psychological, social, spiritual, practical and informational **Measure:** patients' satisfaction with professional care **Time Frame:** baseline #### Secondary Outcomes **Description:** McGill QoL **Measure:** subjective quality of life **Time Frame:** baseline **Description:** HADS **Measure:** mental wellbeing **Time Frame:** baseline **Description:** CBI **Measure:** caregiver burden **Time Frame:** baseline **Measure:** attitudes towards life-sustaining measures and assisted suicide **Time Frame:** baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with at least "possible ALS" according to El-Escorial-criteria * at least 18 years old * no impairments of behaviour or mental performance relevant to everyday life that limits the ability to make judgments or give consent (e.g. as part of a comorbid FTD) Exclusion Criteria: * impairments of behaviour or mental performance relevant to everyday life that limits the ability to make judgments or give consent (e.g. as part of a comorbid FTD) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients with Amyotrophic Lateral Sclerosis and their caregivers ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** katharina.linse@ukdd.de **Name:** Katharina Linse, Dr. **Phone:** 004935145819792 **Role:** CONTACT **Contact 2:** **Email:** rene.guenther@ukdd.de **Name:** René Günther, PD Dr. **Phone:** 00493514582532 **Role:** CONTACT #### Locations **Location 1:** **City:** Dresden **Contacts:** ***Contact 1:*** - **Email:** katharina.linse@ukdd.de - **Name:** Katharina Linse, Dr. - **Phone:** 004935145819792 - **Role:** CONTACT ***Contact 2:*** - **Email:** rene.guenther@ukdd.de - **Name:** René Günther, PD Dr. - **Phone:** 03514582532 - **Role:** CONTACT **Country:** Germany **Facility:** University Hospital Carl Gustav Carus at Technische Universität Dresden **State:** Saxony **Status:** RECRUITING **Zip:** 01307 #### Overall Officials **Official 1:** **Affiliation:** University Hospital Carl Gustav Carus at Technische Universität Dresden **Name:** René Günther, PD Dr. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Upon reasonable request including a methodologically sound proposal for the usage of data approved by the responsible review committee, data may be shared. **IPD Sharing:** UNDECIDED ### References Module #### See Also Links **Label:** Related Info **URL:** http://mnd-net.de ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000057177 - Term: TDP-43 Proteinopathies - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M2480 - Name: Caregiver Burden - Relevance: LOW - As Found: Unknown - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M18879 - Name: Motor Neuron Disease - Relevance: HIGH - As Found: Lateral Sclerosis - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M28759 - Name: TDP-43 Proteinopathies - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis - ID: T4699 - Name: Primary Lateral Sclerosis - Relevance: HIGH - As Found: Lateral Sclerosis ### Condition Browse Module - Meshes - ID: D000016472 - Term: Motor Neuron Disease - ID: D000000690 - Term: Amyotrophic Lateral Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418633 **Acronym:** FAST&THROMBIN **Brief Title:** Variations in the Hemostatic System Induced by a Standardized Walking Test **Official Title:** Variations in the Hemostatic System Induced by a Standardized Walking Test: Controls vs. Cases With a History of Non-anticoagulated Venous Thromboembolic Disease #### Organization Study ID Info **ID:** NIMAO 2023 1 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Nīmes ### Status Module #### Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-28 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Nīmes #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests. **Detailed Description:** Induced venous thromboembolism is a situation in which venous thromboembolic disease is triggered by an acute event that activates hemostasis: surgery, trauma, infectious or inflammatory outbreak, etc., a situation in which the risk of spontaneous recurrence, in the absence of a new provoking circumstance, is low, leading to the suggestion, not of long-term thromboprophylaxis, but simply the transient prevention of an event when there is a new clinical event likely to activate hemostasis. One such event is acute physical exertion. Indeed, cohort studies seem to show that regular physical activity is associated with a low incidence of venous thromboembolism. Trained individuals have an endogenous thrombotic potential, assessed by the thrombin TGT test, lower than that of sedentary controls. A 3-month regimen of daily endurance exercise reduces thrombin generation controls and optimizes the fibrinolytic system. Repetitive exercise is accompanied by a depletion of exercise-induced platelet activation. However, several cases of venous thromboembolism have been reported in high-level athletes without usual risk factors and acute high-intensity rowing induces an acute increase in thrombin generation immediately after exercise, which disappears within 16 to 24 hours. The relationship between the level of physical activity and the risk of VTE could be a U-shaped relation, with an increasing risk of event in intense acute practice. However, no data exists on the hemostatic impact of an acute session of physical activity in patients with a history of venous thromboembolism. Thus, the hypothesis is that exercise-induced response of hemostasis differ in patients with an history of provoked VTE compared to subjects without a history of venous thromboembolism. This is a proof-of-concept, pathophysiological, single-center, cross-sectional, prospective comparison study of a group of patients with a personal history of induced Venous thromboembolism to a group of sex- and age- and sex-matched controls (+/- 5 years). - Type of clinical study: Stress test-induced variations in parameters describing the results of the thrombin generation test (Thromboscreen®) in a group of Patients (Cases) will be compared with those obtained in a group of Control subjects (Controls) with a ratio 1:1. The Patients group comprises 47 patients with a personal history of induced venous thromboembolism, the last event dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.The Control group comprises 47 patients with no personal history of venous thromboembolism and no family history of venous thromboembolism in first-degree relatives. The study intervention consists of an hour-long walking test and two blood tests in both groups for all participants (Controls and Patients). - Intra-individual reproducibility will be analyzed in 20 subjects (10 patients and 10 controls) who will take the walking test twice on two separate days. Patients will be selected during a venous thromboembolism follow-up consultation by a physician from either department (Vascular Medicine Consultation or Biological Hematology and Consultations).Inclusion and non-inclusion criteria will be checked, and the study will be explained to participants (patients and controls).Patients and controls will be systematically asked to take part in the variability analysis on a voluntary basis, until 10 subjects per group have agreed to carry out the second test. The walking test is performed in the morning, 2 hours after a standard breakfast, on a treadmill. It will be preceded by a clinical examination, a resting 12-lead electrocardiogram and a brachial pressure measurement. After a 3-minute warm-up and "habituation" period (walking speed 2.5 km per hour with no incline), the speed and incline will be gradually increased until a target heart rate close to the theoretical ventilatory threshold, and of the order of 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), so as to maintain aerobic exercise conditions of moderate intensity, enabling prolonged effort to be maintained. Blood samples will be taken from each participant whilst at rest, before undergoing the 60-minute walking test, in a sitting position, and just after the exercise test. ### Conditions Module **Conditions:** - Venous Thromboembolism **Keywords:** - Physical exercise ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a single-center, prospective, cross-sectional, proof-of-concept study, ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 94 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives. **Intervention Names:** - Other: 60-minute walking test - Diagnostic Test: Static blood test - Diagnostic Test: Post-effort blood test - Other: Electrocardiogram - Other: Blood pressure monitoring **Label:** Control group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients with a personal history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis **Intervention Names:** - Other: 60-minute walking test - Diagnostic Test: Static blood test - Diagnostic Test: Post-effort blood test - Other: Electrocardiogram - Other: Blood pressure monitoring **Label:** Patients **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** 10 subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives who have accepted to re-do the test one week later. **Intervention Names:** - Other: 60-minute walking test - Diagnostic Test: Static blood test - Diagnostic Test: Post-effort blood test - Other: Electrocardiogram - Other: Blood pressure monitoring **Label:** Individual reproducibility" subgroup: controls **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** 10 patients with a history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis, who have accepted to re-do the test one week later. **Intervention Names:** - Other: 60-minute walking test - Diagnostic Test: Static blood test - Diagnostic Test: Post-effort blood test - Other: Electrocardiogram - Other: Blood pressure monitoring **Label:** Individual reproducibility" subgroup: patients **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group - Individual reproducibility" subgroup: controls - Individual reproducibility" subgroup: patients - Patients **Description:** Treadmill walking test in the morning, 2 hours after breakfast, following a clinical examination, resting 12-lead electrocardiogram and blood pressure measurement. After a 3-minute warm-up and walking of speed 2.5 km per hour, no incline, the speed and incline are gradually increased to reach a target heart rate close to the theoretical ventilatory threshold, around 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), i.e. aerobic conditions of moderate intensity so that prolonged effort can be maintained. Test performed in presence of a physician trained in stress testing. Emergency cart and defibrillator available in the department. Intra-hospital vital emergency protocol in place, with resuscitation teams on standby. The cardiology department, in the same building, can be contacted in the event of a cardiological abnormality during the test or recovery. The test takes 60 minutes, including a 3-minute initial warm-up. **Name:** 60-minute walking test **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control group - Individual reproducibility" subgroup: controls - Individual reproducibility" subgroup: patients - Patients **Description:** 33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test **Name:** Static blood test **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Control group - Individual reproducibility" subgroup: controls - Individual reproducibility" subgroup: patients - Patients **Description:** 33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test. **Name:** Post-effort blood test **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Control group - Individual reproducibility" subgroup: controls - Individual reproducibility" subgroup: patients - Patients **Description:** An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery. **Name:** Electrocardiogram **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Control group - Individual reproducibility" subgroup: controls - Individual reproducibility" subgroup: patients - Patients **Description:** Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery. **Name:** Blood pressure monitoring **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Ages will be recorded in years **Measure:** Age in Controls **Time Frame:** Day 0 **Description:** Sex will be recorded as Male/Female/Non-binary **Measure:** Sex in Controls **Time Frame:** Day 0 **Description:** Body mass index of controls will be recorded in units of kg/m² **Measure:** Body mass index in Controls **Time Frame:** Day 0 **Description:** Ages will be recorded in years **Measure:** Age in Patients **Time Frame:** Day 0 **Description:** Sex will be recorded as Male/Female/Non-binary **Measure:** Sex in Patients **Time Frame:** Day 0 **Description:** Body mass index of controls will be recorded in units of kg/m² **Measure:** Body Mass Index in Patients **Time Frame:** Day 0 #### Primary Outcomes **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM) **Measure:** Thrombin generation dosage before effort in controls **Time Frame:** Day 0 **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM) **Measure:** Thrombin generation dosage before effort in patients **Time Frame:** Day 0 **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1 **Measure:** Thrombin generation dosage after effort in controls **Time Frame:** Day 0 **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1 **Measure:** Thrombin generation dosage after effort in patients **Time Frame:** Day 0 **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM) **Measure:** Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls **Time Frame:** Day 7 **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM) **Measure:** Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients **Time Frame:** Day 7 **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1 **Measure:** Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls **Time Frame:** Day 7 **Description:** The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1 **Measure:** Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: patients **Time Frame:** Day 7 #### Secondary Outcomes **Description:** Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Control group **Measure:** Distribution in the Control group **Time Frame:** Day 0 **Description:** Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Patient group **Measure:** Distribution in the Patient group **Time Frame:** Day 0 **Description:** Latency time in the absence of thrombomodulin will be measured in seconds in Controls. **Measure:** Thromboscreen test in Controls in the absence of thrombomodulin : Latency time **Time Frame:** Day 0 **Description:** Thrombin peak intensity in the absence of thrombomodulin will be measured in Controls. **Measure:** Thromboscreen test in Controls in the absence of thrombomodulin : Thrombin peak intensity **Time Frame:** Day 0 **Description:** Time-to-peak thrombin in the absence of thrombomodulin will be measured in Controls. **Measure:** Thromboscreen test in Controls in the absence of thrombomodulin : Time-to-peak thrombin **Time Frame:** Day 0 **Description:** Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Controls. **Measure:** Thromboscreen test in Controls in the absence of thrombomodulin : Initial thrombin generation velocity **Time Frame:** Day 0 **Description:** Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Controls. **Measure:** Thromboscreen test in Controls in the absence of thrombomodulin : Time to return to baseline **Time Frame:** Day 0 **Description:** Latency time in the presence of thrombomodulin will be measured in seconds in Controls. **Measure:** Thromboscreen test in Controls in the presence of thrombomodulin : Latency time **Time Frame:** Day 0 **Description:** Thrombin peak intensity in the presence of thrombomodulin will be measured in Controls. **Measure:** Thromboscreen test in Controls in the presence of thrombomodulin : Thrombin peak intensity **Time Frame:** Day 0 **Description:** Time-to-peak thrombin in the presence of thrombomodulin will be measured in Controls. **Measure:** Thromboscreen test in Controls in the presence of thrombomodulin : Time-to-peak thrombin **Time Frame:** Day 0 **Description:** Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Controls. **Measure:** Thromboscreen test in Controls in the presence of thrombomodulin : Initial thrombin generation velocity **Time Frame:** Day 0 **Description:** Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Controls. **Measure:** Thromboscreen test in Controls in the presence of thrombomodulin : Time to return to baseline **Time Frame:** Day 0 **Description:** Latency time in the absence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the absence of thrombomodulin : Latency time **Time Frame:** Day 0 **Description:** Thrombin peak intensity in the absence of thrombomodulin will be measured in Patients. **Measure:** Thromboscreen test in Patients in the absence of thrombomodulin : Thrombin peak intensity **Time Frame:** Day 0 **Description:** Time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline for the thrombin generation test performed in the absence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the absence of thrombomodulin : Time-to-peak thrombin **Time Frame:** Day 0 **Description:** Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the absence of thrombomodulin : Initial thrombin generation velocity **Time Frame:** Day 0 **Description:** Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the absence of thrombomodulin : Time to return to baseline **Time Frame:** Day 0 **Description:** Latency time in the presence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the presence of thrombomodulin : Latency time **Time Frame:** Day 0 **Description:** Thrombin peak intensity in the presence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the presence of thrombomodulin : Thrombin peak intensity **Time Frame:** Day 0 **Description:** Time-to-peak thrombin in the presence of thrombomodulin be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the presence of thrombomodulin : Time-to-peak thrombin **Time Frame:** Day 0 **Description:** Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the presence of thrombomodulin : Initial thrombin generation velocity **Time Frame:** Day 0 **Description:** Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Patients. **Measure:** Thromboscreen test in Patients in the presence of thrombomodulin : Time to return to baseline **Time Frame:** Day 0 **Description:** The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Controls **Measure:** Distribution of other parameters of the Thromboscreen test in Controls **Time Frame:** Day 0 **Description:** The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Patients **Measure:** Distribution of other parameters of the Thromboscreen test in Patients **Time Frame:** Day 0 **Description:** nM.min **Measure:** Endogenous Thrombotic Potential in the presence of thrombomodulin in Controls **Time Frame:** Day 0 **Description:** nM.min **Measure:** Endogenous Thrombotic Potential in the absence of thrombomodulin in Controls **Time Frame:** Day 0 **Description:** nM.min **Measure:** Endogenous Thrombotic Potential in the presence of thrombomodulin in Patients **Time Frame:** Day 0 **Description:** nM.min **Measure:** Endogenous Thrombotic Potential in the absence of thrombomodulin in Patients **Time Frame:** Day 0 **Description:** Statistical analysis, Cochrane's Q test **Measure:** Heterogeneity of Endogenous Thrombotic Potential in Controls **Time Frame:** Day 0 **Description:** Statistical analysis, Cochrane's Q test **Measure:** Heterogeneity of Endogenous Thrombotic Potential in Patients **Time Frame:** Day 0 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: White blood cells **Time Frame:** Day 0 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: White blood cells **Time Frame:** Day 7 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: White blood cells **Time Frame:** Day 0 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: White blood cells **Time Frame:** Day 7 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: White blood cells **Time Frame:** Day 0 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: White blood cells **Time Frame:** Day 7 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: White blood cells **Time Frame:** Day 0 **Description:** White blood cells will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: White blood cells **Time Frame:** Day 7 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Controls before the walking test: Red blood cells **Time Frame:** Day 0 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Controls before the walking test: Red blood cells **Time Frame:** Day 7 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Patients before the walking test: Red blood cells **Time Frame:** Day 0 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Patients before the walking test: Red blood cells **Time Frame:** Day 7 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Controls after the walking test: Red blood cells **Time Frame:** Day 0 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Controls after the walking test: Red blood cells **Time Frame:** Day 7 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Patients after the walking test: Red blood cells **Time Frame:** Day 0 **Description:** Red blood cells will be measured in millions per cubic millimeter **Measure:** Complete Blood Count in Patients after the walking test: Red blood cells **Time Frame:** Day 7 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Controls before the walking test:Hemaglobin **Time Frame:** Day 0 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Controls before the walking test:Hemaglobin **Time Frame:** Day 7 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Patients before the walking test:Hemaglobin **Time Frame:** Day 0 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Patients before the walking test:Hemaglobin **Time Frame:** Day 7 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Controls after the walking test: Hemaglobin **Time Frame:** Day 0 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Controls after the walking test: Hemaglobin **Time Frame:** Day 7 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Patients after the walking test: Hemaglobin **Time Frame:** Day 0 **Description:** Hemaglobin will be measured in g/L **Measure:** Complete Blood Count in Patients after the walking test: Hemaglobin **Time Frame:** Day 7 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Controls before the walking test: Hematocrite **Time Frame:** Day 0 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Controls before the walking test: Hematocrite **Time Frame:** Day 7 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Patients before the walking test: Hematocrite **Time Frame:** Day 0 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Patients before the walking test: Hematocrite **Time Frame:** Day 7 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Controls after the walking test: Hematocrite **Time Frame:** Day 0 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Controls after the walking test: Hematocrite **Time Frame:** Day 7 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Patients after the walking test: Hematocrite **Time Frame:** Day 0 **Description:** Hematrocrite will be measured in L/L **Measure:** Complete Blood Count in Patients after the walking test: Hematocrite **Time Frame:** Day 7 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Controls before the walking test: mean corpuscular volume **Time Frame:** Day 0 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Controls before the walking test: mean corpuscular volume **Time Frame:** Day 7 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Patients before the walking test: mean corpuscular volume **Time Frame:** Day 0 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Patients before the walking test: mean corpuscular volume **Time Frame:** Day 7 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Controls after the walking test: mean corpuscular volume **Time Frame:** Day 0 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Controls after the walking test: mean corpuscular volume **Time Frame:** Day 7 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Patients after the walking test: mean corpuscular volume **Time Frame:** Day 0 **Description:** Mean corpuscular volume will be measured in fL **Measure:** Complete Blood Count in Patients after the walking test: mean corpuscular volume **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin will be measured in pg **Measure:** Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 7 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 0 **Description:** Mean Corpuscular Hemoglobin Concentration will be measured in g/L **Measure:** Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration **Time Frame:** Day 7 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Controls before the walking test: red cell distribution width **Time Frame:** Day 0 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Controls before the walking test: red cell distribution width **Time Frame:** Day 7 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Patients before the walking test: red cell distribution width **Time Frame:** Day 0 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Patients before the walking test: red cell distribution width **Time Frame:** Day 7 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Controls after the walking test: red cell distribution width **Time Frame:** Day 0 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Controls after the walking test: red cell distribution width **Time Frame:** Day 7 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Patients after the walking test: red cell distribution width **Time Frame:** Day 0 **Description:** Red cell distribution width will be measured as % **Measure:** Complete Blood Count in Patients after the walking test: red cell distribution width **Time Frame:** Day 7 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Platelets **Time Frame:** Day 0 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Platelets **Time Frame:** Day 7 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Platelets **Time Frame:** Day 0 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Platelets **Time Frame:** Day 7 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Platelets **Time Frame:** Day 0 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Platelets **Time Frame:** Day 7 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Platelets **Time Frame:** Day 0 **Description:** Platelets will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Platelets **Time Frame:** Day 7 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Neutrophils **Time Frame:** Day 0 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Neutrophils **Time Frame:** Day 7 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Neutrophils **Time Frame:** Day 0 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Neutrophils **Time Frame:** Day 7 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Neutrophils **Time Frame:** Day 0 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Neutrophils **Time Frame:** Day 7 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Neutrophils **Time Frame:** Day 0 **Description:** Neutrophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Neutrophils **Time Frame:** Day 7 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Lymphocytes **Time Frame:** Day 0 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Lymphocytes **Time Frame:** Day 7 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Lymphocytes **Time Frame:** Day 0 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Lymphocytes **Time Frame:** Day 7 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Lymphocytes **Time Frame:** Day 0 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Lymphocytes **Time Frame:** Day 7 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Lymphocytes **Time Frame:** Day 0 **Description:** Lymphocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Lymphocytes **Time Frame:** Day 7 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Monocytes **Time Frame:** Day 0 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Monocytes **Time Frame:** Day 7 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Monocytes **Time Frame:** Day 0 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Monocytes **Time Frame:** Day 7 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Monocytes **Time Frame:** Day 0 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Monocytes **Time Frame:** Day 7 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Monocytes **Time Frame:** Day 0 **Description:** Monocytes will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Monocytes **Time Frame:** Day 7 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Controls before the walking test: Eosinophils **Time Frame:** Day 0 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Controls before the walking test: Eosinophils **Time Frame:** Day 7 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Patients before the walking test: Eosinophils **Time Frame:** Day 0 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Patients before the walking test: Eosinophils **Time Frame:** Day 7 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Controls after the walking test: Eosinophils **Time Frame:** Day 0 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Controls after the walking test: Eosinophils **Time Frame:** Day 7 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Patients after the walking test: Eosinophils **Time Frame:** Day 0 **Description:** Eosinophils will be measured in hundreds/µL **Measure:** Complete Blood Count in Patients after the walking test: Eosinophils **Time Frame:** Day 7 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Basophils **Time Frame:** Day 0 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls before the walking test: Basophils **Time Frame:** Day 7 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Basophils **Time Frame:** Day 0 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients before the walking test: Basophils **Time Frame:** Day 7 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Basophils **Time Frame:** Day 0 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Controls after the walking test: Basophils **Time Frame:** Day 7 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Basophils **Time Frame:** Day 0 **Description:** Basophils will be measured in thousands/µL **Measure:** Complete Blood Count in Patients after the walking test: Basophils **Time Frame:** Day 7 **Description:** Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls before the walking test **Time Frame:** Day 0 **Description:** Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls after the walking test **Time Frame:** Day 0 **Description:** Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat **Measure:** NETosis markers in Patients before the walking test **Time Frame:** Day 7 **Description:** Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat **Measure:** NETosis markers in Patients after the walking test **Time Frame:** Day 7 **Description:** The percentage of reacting monocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls before the walking test: reacting monocytes **Time Frame:** Day 0 **Description:** The percentage of reacting monocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls after the walking test: reacting monocytes **Time Frame:** Day 0 **Description:** The percentage of reacting monocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls before the walking test: reacting monocytes **Time Frame:** Day 7 **Description:** The percentage of reacting monocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls after the walking test: reacting monocytes **Time Frame:** Day 7 **Description:** The percentage of reacting lymphocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls before the walking test: reacting lymphocytes **Time Frame:** Day 0 **Description:** The percentage of reacting lymphocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls after the walking test: reacting lymphocytes **Time Frame:** Day 0 **Description:** The percentage of reacting lymphocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Patients before the walking test: reacting lymphocytes **Time Frame:** Day 7 **Description:** The percentage of reacting lymphocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Patients after the walking test: reacting lymphocytes **Time Frame:** Day 7 **Description:** The percentage of reacting lymphocytes will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls before the walking test: **Time Frame:** Day 0 **Description:** The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat **Measure:** NETosis markers in Controls after the walking test: circulating citrulinated histone H3 **Time Frame:** Day 0 **Description:** The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat **Measure:** NETosis markers in Patients before the walking test: circulating citrulinated histone H3 **Time Frame:** Day 7 **Description:** The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat **Measure:** NETosis markers in Patients after the walking test: circulating citrulinated histone H3 **Time Frame:** Day 7 **Description:** Fibrinogen will be measured in g/L **Measure:** Coagulation factors in Controls before the walking test: fibrinogen **Time Frame:** Day 0 **Description:** Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units **Measure:** Coagulation factors in Controls before the walking test **Time Frame:** Day 0 **Description:** Fibrinogen will be measured in g/L **Measure:** Coagulation factors in Controls after the walking test: fibrinogen **Time Frame:** Day 0 **Description:** Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units **Measure:** Coagulation factors in Controls after the walking test **Time Frame:** Day 0 **Description:** Fibrinogen will be measured in g/L **Measure:** Coagulation factors in Patients before the walking test: fibrinogen **Time Frame:** Day 7 **Description:** Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units **Measure:** Coagulation factors in Patients before the walking test **Time Frame:** Day 7 **Description:** Fibrinogen will be measured in g/L **Measure:** Coagulation factors in Patients after the walking test: fibrinogen **Time Frame:** Day 7 **Description:** Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units **Measure:** Coagulation factors in Patients after the walking test **Time Frame:** Day 7 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers **Time Frame:** Day 0 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers **Time Frame:** Day 0 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers **Time Frame:** Day 7 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers **Time Frame:** Day 7 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers **Time Frame:** Day 0 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers **Time Frame:** Day 0 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers **Time Frame:** Day 7 **Description:** Circulating fibrin monomers will be measured in fibrinogen equivalent units **Measure:** Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers **Time Frame:** Day 7 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Controls before the walking test: D-dimers **Time Frame:** Day 0 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Controls after the walking test: D-dimers **Time Frame:** Day 0 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Patients before the walking test: D-dimers **Time Frame:** Day 0 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Patients after the walking test: D-dimers **Time Frame:** Day 0 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Controls before the walking test: D-dimers **Time Frame:** Day 7 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Controls after the walking test: D-dimers **Time Frame:** Day 7 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Patients before the walking test: D-dimers **Time Frame:** Day 7 **Description:** D-dimers will be measured in DDUs **Measure:** Indicators of fibrinoformation in Patients after the walking test: D-dimers **Time Frame:** Day 7 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time **Time Frame:** Day 0 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time **Time Frame:** Day 0 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time **Time Frame:** Day 0 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time **Time Frame:** Day 0 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time **Time Frame:** Day 7 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time **Time Frame:** Day 7 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time **Time Frame:** Day 7 **Description:** Euglobulin lysis time will be measured in hours **Measure:** Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time **Time Frame:** Day 7 **Description:** Willebrand factor will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: Willebrand factor **Time Frame:** Day 0 **Description:** Willebrand factor will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: Willebrand factor **Time Frame:** Day 0 **Description:** Willebrand factor will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: Willebrand factor **Time Frame:** Day 0 **Description:** Willebrand factor will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: Willebrand factor **Time Frame:** Day 0 **Description:** Willebrand factor will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: Willebrand factor **Time Frame:** Day 7 **Description:** Willebrand factor will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: Willebrand factor **Time Frame:** Day 7 **Description:** Willebrand factor will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: Willebrand factor **Time Frame:** Day 7 **Description:** Willebrand factor will be measured as a% **Measure:** Markers of Endothelial function in Patients after the walking test: Willebrand factor **Time Frame:** Day 7 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: ristocetin cofactor **Time Frame:** Day 0 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: ristocetin cofactor **Time Frame:** Day 0 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: ristocetin cofactor **Time Frame:** Day 0 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: ristocetin cofactor **Time Frame:** Day 0 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: ristocetin cofactor **Time Frame:** Day 7 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: ristocetin cofactor **Time Frame:** Day 7 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: ristocetin cofactor **Time Frame:** Day 7 **Description:** Ristocetin cofactor will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: ristocetin cofactor **Time Frame:** Day 7 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity **Time Frame:** Day 0 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity **Time Frame:** Day 0 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity **Time Frame:** Day 0 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity **Time Frame:** Day 0 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity **Time Frame:** Day 7 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity **Time Frame:** Day 7 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity **Time Frame:** Day 7 **Description:** ADAMTS-13 activity will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity **Time Frame:** Day 7 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin **Time Frame:** Day 0 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin **Time Frame:** Day 0 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin **Time Frame:** Day 0 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin **Time Frame:** Day 0 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin **Time Frame:** Day 7 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin **Time Frame:** Day 7 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin **Time Frame:** Day 7 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin **Time Frame:** Day 7 **Description:** Soluble endothelial protein C receptor will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor **Time Frame:** Day 0 **Description:** Soluble endothelial protein C receptor will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor **Time Frame:** Day 0 **Description:** Soluble endothelial protein C receptor will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor **Time Frame:** Day 0 **Description:** Soluble endothelial protein C receptor will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor **Time Frame:** Day 0 **Description:** Soluble endothelial protein C receptor will be measured as a % **Measure:** Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor **Time Frame:** Day 7 **Description:** Soluble endothelial protein C receptor will be measured as a % **Measure:** Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor **Time Frame:** Day 7 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor **Time Frame:** Day 7 **Description:** Soluble thrombomodulin will be measured as a % **Measure:** Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor **Time Frame:** Day 7 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Inclusion criteria common to both groups : * Patients who have given written informed consent. * Patients who are affiliated to or beneficiaries of a social security scheme. Inclusion criteria specific to the Patient Group: * Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis. Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are : * First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch. * Hormonal stimulation for oocyte retrieval * Pregnancy and 6 weeks post-partum * Surgery * Trauma * Immobilisation in plaster or splint * Outbreak of acute infectious disease * Acute flare-up of inflammatory disease * Prolonged air travel lasting at least 4 hours * Prolonged strict bed rest lasting at least 3 consecutive days. Inclusion criteria specific to the Control Group: * Subjects with no personal history of venous thromboembolism * Subjects with no family history of venous thromboembolism in first-degree relatives * Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case. Exclusion Criteria: * Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure \> 200/110 mmHg, recent stroke or transient ischemic attack). * Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month. * Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension. * Last surgery dating back to less than 3 months. * Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months. * For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month * Pregnancy within the last year. * Difficult venous access. * Regular practice of an intensive sporting/physical activity, such as running, tennis, cycling etc. of more than 3 hours per week. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** antonia.perez.martin@chu-nimes.fr **Name:** Antonia PEREZ MARTIN, Prof. **Phone:** +334 66 68 33 13 **Role:** CONTACT **Contact 2:** **Email:** drc@chu-nimes.fr **Name:** Anissa MEGZARI **Phone:** +33466684236 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Nîmes University Hospital **Name:** Antonia PEREZ MARTIN, Prof. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Nîmes University Hospital **Name:** Stéphane FAURE **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Gris JC, Guillotin F, Dos Santos TP, Chea M, Loubet P, Laureillard D, Sotto A, Muller L, Barbar SD, Roger C, Lefrant JY, Jung B, Klouche K, Mura T, Quere I, Perez-Martin A. Prognostic value of an automated thrombin generation assay in COVID-19 patients entering hospital: A multicentric, prospective observational study. Thromb Res. 2023 Feb;222:85-95. doi: 10.1016/j.thromres.2022.12.019. Epub 2023 Jan 2. **PMID:** 36608393 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16682 - Name: Thromboembolism - Relevance: HIGH - As Found: Thromboembolism - ID: M27780 - Name: Venous Thromboembolism - Relevance: HIGH - As Found: Venous Thromboembolism - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M7784 - Name: Embolism - Relevance: LOW - As Found: Unknown - ID: M19128 - Name: Embolism and Thrombosis - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013923 - Term: Thromboembolism - ID: D000054556 - Term: Venous Thromboembolism ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418620 **Brief Title:** A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants **Official Title:** Phase 1, Open Label, Randomized, 3-sequence, 3-period, Single Dose Study Assessing the Effect of Food on the Bioavailability of Venglustat Tablet and Comparing the Relative Bioavailability of Venglustat Tablet Chewed Versus Tablet Swallowed Whole #### Organization Study ID Info **ID:** PKM16157 #### Organization **Class:** INDUSTRY **Full Name:** Sanofi #### Secondary ID Infos **Domain:** ICTRP **ID:** U1111-1228-9121 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2020-08-07 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-08-07 **Type:** ACTUAL #### Start Date **Date:** 2020-06-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sanofi #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the effect of food on the bioavailability of venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole with water versus a tablet chewed and then swallowed without water. Also, to evaluate the safety and tolerability of a single dose tablet of venglustat under fed (swallowed whole) and fasted (swallowed whole or chewed) conditions in healthy adult participants. The maximum duration for participants from screening is up to 63 days. **Detailed Description:** Total study duration for participants is up to 63 days including screening up to 27 days, 1 day of treatment in period 1 of 7 days, washout of 3 days, 1 day of treatment in period 2 of 7 days, washout of 3 days, 1 day of treatment in period 3 of 7 days, followed by a final observation over 7 days (+/- 2 days). ### Conditions Module **Conditions:** - Healthy Volunteers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 9 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Fasted, venglustat tablet swallowed with water **Intervention Names:** - Drug: Venglustat **Label:** Treatment A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Fasted, venglustat tablet chewed and swallowed without water **Intervention Names:** - Drug: Venglustat **Label:** Treatment B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Fed, venglustat tablet swallowed with water **Intervention Names:** - Drug: Venglustat **Label:** Treatment C **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment A - Treatment B - Treatment C **Description:** Pharmaceutical form:Tablet-Route of administration:Oral **Name:** Venglustat **Other Names:** - GZ/SAR402671 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Maximum plasma concentration observed (Cmax) of venglustat **Time Frame:** Multiple time points up to day 27 **Measure:** Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat **Time Frame:** Multiple time points up to day 27 **Measure:** Area under the plasma concentration versus time curve (AUC) of venglustat **Time Frame:** Multiple time points up to day 27 #### Secondary Outcomes **Measure:** Number of participants with Adverse Events (AEs) **Time Frame:** Multiple time points up to day 63 **Measure:** Time to reach Cmax (tmax) of venglustat **Time Frame:** Multiple time points up to day 27 **Measure:** Interval between administration time and the sampling time preceding the first concentration above the limit of quantification (tlag) of venglustat **Time Frame:** Multiple time points up to day 27 **Measure:** Terminal half-life associated with the terminal slope (λz) (t1/2z) of venglustat **Time Frame:** Multiple time points up to day 27 **Measure:** Apparent total body clearance of a drug from the plasma (CL/F) of venglustat **Time Frame:** Multiple time points up to day 27 **Measure:** Apparent volume of distribution at steady state (Vss/F) of venglustat **Time Frame:** Multiple time points up to day 27 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -Male and/or female participant, between 18 and 45 years of age, inclusive. * Body mass index between 18.0 and 30.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * Vital signs after 10 minutes resting in supine position within the following ranges: * 95 mmHg \< systolic blood pressure (SBP) \<140 mmHg * 50 mmHg \< diastolic blood pressure (DBP) \<90 mmHg * 50 bpm \< heart rate (HR) \<100 bpm * Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms \< PR \<220 ms, QRS \<120 ms, QTc ≤450 ms (Fridericia algorithm recommended), 50 bpm \< HR \<100 bpm and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant. * Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participant. * Having given written informed consent prior to undertaking any study-related procedure. * Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research. * Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Men or women of childbearing potential (WOCBP as defined by the protocol) are required to either practice true abstinence consistent with their preferred and usual lifestyle, or use double contraceptive methods for the entire duration of the treatment until 6 weeks after the last treatment with venglustat for women and until 90 days for men. "Double-contraceptive methods" means: * A barrier method such as a condom or occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository, and, * An established non-barrier method, such as oral, injected, or implanted hormonal methods, an intrauterine device, or an intrauterine system. * In addition, male participants must refrain from donating sperm from the inclusion up to 3 months after the last dosing. * Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile vaginal intercourse or use a male condom during each episode of penile penetration from the inclusion up to 3 months after the last dosing. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). * Blood donation, any volume, within 2 months before inclusion. * Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). Note that 12 fluid ounces of regular beer, 5 fluid ounces of wine, and 1.5 fluid ounces of distilled spirits each contain approximately 14 g of alcohol. * Smoking regularly more than approximately 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). * If female, pregnancy (defined as positive β-HCG test) or breast-feeding. * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any drug which could impact by any mechanism of action, the pharmacokinetics of the investigational medicinal product, including moderate and strong CYP3A4 inhibitors or inducers. * Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. * Any participant enrolled or having participated, in any other clinical study involving an investigational medicinal product or in any other type of medical research, and is still in the exclusion period according to applicable regulations. * Any participant who cannot be contacted in case of emergency. * Any participant who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study, or any person dependent (employees or immediate family members) on the study site, the Investigator or the Sponsor. * Prisoners or participant who are legally institutionalized. * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV-1 and anti HIV-2 Ab). * Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). * Positive alcohol test. * Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5 days before inclusion. * Any participant who cannot comply with the following study restrictions: refraining from drinking alcohol, tea, coffee, chocolate, quinine, or caffeine-containing beverages from 1 day before institutionalization and throughout the study duration; not smoking or using tobacco from 1 day prior to institutionalization throughout the study duration until the end-of-study visit; following a stable lifestyle with no intensive physical activity from 1 day prior to institutionalization throughout the study duration until the end-of-study visit. * Lack of sufficiently healthy dentition for chewing a hard tablet. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Saint Paul **Country:** United States **Facility:** Prism Research Site Number : 8400001 **State:** Minnesota **Zip:** 55114 ### IPD Sharing Statement Module **Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org **IPD Sharing:** YES ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M349697 - Name: Venglustat - Relevance: HIGH - As Found: Intelligibility - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000608118 - Term: Venglustat ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418607 **Brief Title:** A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants **Official Title:** Phase 1, Open Label, Randomized, Single-center, 2-sequence, 2-period, 2 Treatment Single Dose Crossover Bioequivalence Study Comparing Venglustat Tablet Formulation (Test) to Hard Capsule Formulation (Reference) #### Organization Study ID Info **ID:** BEQ15920 #### Organization **Class:** INDUSTRY **Full Name:** Sanofi #### Secondary ID Infos **Domain:** ICTRP **ID:** U1111-1239-0220 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2020-07-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-07-13 **Type:** ACTUAL #### Start Date **Date:** 2020-06-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sanofi #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions. Also, to evaluate the safety and tolerability of a single dose tablet and hard capsule of venglustat (swallowed whole) under fasting conditions in healthy adult participants. The maximum duration for participants from screening is up to 47 days. **Detailed Description:** Total study duration for participants is up to 47 days including screening up to 20 days, 1 day of treatment in period 1 of 8-10 days, 1 day of treatment in period 2 of 8 days and followed by a final observation over 7 days (+/- 2 days). ### Conditions Module **Conditions:** - Healthy Volunteers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Venglustat hard capsule administered in period 1 followed by tablet administered in period 2. **Intervention Names:** - Drug: Venglustat **Label:** Sequence 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Venglustat tablet administered in period 1 followed by hard capsule administered in period 2. **Intervention Names:** - Drug: Venglustat **Label:** Sequence 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Sequence 1 - Sequence 2 **Description:** Pharmaceutical form:Tablet-Route of administration:Oral **Name:** Venglustat **Other Names:** - GZ/SAR402671 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Sequence 1 - Sequence 2 **Description:** Pharmaceutical form:Hard Capsule-Route of administration:Oral **Name:** Venglustat **Other Names:** - GZ/SAR402671 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Maximum plasma concentration observed (Cmax) of venglustat **Time Frame:** Multiple time points up to day 16 **Measure:** Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat **Time Frame:** Multiple time points up to day 16 **Measure:** Area under the plasma concentration versus time curve (AUC) of venglustat **Time Frame:** Multiple time points up to day 16 #### Secondary Outcomes **Measure:** Number of participants with adverse events **Time Frame:** Multiple time points up to day 47 **Measure:** Time to reach Cmax (tmax) of venglustat **Time Frame:** Multiple time points up to day 16 **Measure:** Interval between administration time and the sampling time preceding the first concentration above the limit of quantification (tlag) of venglustat **Time Frame:** Multiple time points up to day 16 **Measure:** Terminal half-life associated with the terminal slope (λz) (t1/2z) of venglustat **Time Frame:** Multiple time points up to day 16 **Measure:** Apparent total body clearance of a drug from the plasma (CL/F) of venglustat **Time Frame:** Multiple time points up to day 16 **Measure:** Apparent volume of distribution at steady state (Vss/F) of venglustat **Time Frame:** Multiple time points up to day 16 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -Body mass index between 18.0 and 30.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * Vital signs after 10 minutes resting in supine position within the following ranges: * 95 mmHg \< systolic blood pressure (SBP) \<140 mmHg, * 50 mmHg \< diastolic blood pressure (DBP) \<90 mmHg, * 45 bpm \< heart rate (HR) \<100 bpm. * Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms \< PR \<220 ms, QRS \<120 ms, QTc ≤450 ms (Fridericia algorithm recommended), 45bpm \< HR \<100 bpm and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant. * Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participant. Serum creatinine, hepatic transaminases (aspartate aminotransferase, alanine aminotransferase), and alkaline phosphatase should not exceed 1.25X the upper laboratory norm. Total biluribin out of normal range can be acceptable if total bilirubin does not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the participant has documented Gilbert syndrome). * Having given written informed consent prior to undertaking any study-related procedure. * Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research. * Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Required to either practice true abstinence consistent with their preferred and usual lifestyle, or use double contraceptive methods for the entire duration of the treatment until 6 weeks after the last treatment with venglustat for women and until 90 days for men Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). * Blood donation, any volume, within 2 months before inclusion. * Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). Note that 12 fluid ounces of regular beer, 5 fluid ounces of wine, and 1.5 fluid ounces of distilled spirits each contain approximately 14 g of alcohol. * Smoking regularly more than approximately 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). * If female, pregnancy (defined as positive β-HCG test) or breast-feeding. * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any drug which could impact by any mechanism of action, the pharmacokinetics of the investigational medicinal product, including moderate and strong CYP3A4 inhibitors or inducers. * Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. * Any participant enrolled or having participated, in any other clinical study involving an investigational medicinal product or in any other type of medical research, and is still in the exclusion period according to applicable regulations. * Any participant who cannot be contacted in case of emergency. * Any participant who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study, or any person dependent (employees or immediate family members) on the study site, the investigator or the sponsor. * Prisoners or participant who are legally institutionalized. * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV-1 and anti HIV-2 Ab). * Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). * Positive alcohol test. * Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5 days before inclusion). * Any participant who cannot comply with the following study restrictions: refraining from drinking alcohol, tea, coffee, chocolate, quinine, or caffeine-containing beverages from 1 day before institutionalization and throughout the study duration; not smoking or using tobacco from 1 day prior to institutionalization throughout the study duration until the end of-study visit; following a stable lifestyle with no intensive physical activity from 1 day prior to institutionalization throughout the study duration until the end-of-study visit. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Miami **Country:** United States **Facility:** Clinical Pharmacology of Miami Site Number : 8400001 **State:** Florida **Zip:** 33014 **Location 2:** **City:** Saint Paul **Country:** United States **Facility:** Prism Research Site Number : 8400002 **State:** Minnesota **Zip:** 55144 ### IPD Sharing Statement Module **Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org **IPD Sharing:** YES ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M349697 - Name: Venglustat - Relevance: HIGH - As Found: Intelligibility - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000608118 - Term: Venglustat ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418594 **Brief Title:** Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis **Official Title:** Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis: A Phase II Study #### Organization Study ID Info **ID:** MA-BC-II-070 #### Organization **Class:** OTHER **Full Name:** Beijing 302 Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing 302 Hospital #### Responsible Party **Investigator Affiliation:** Beijing 302 Hospital **Investigator Full Name:** Wang Tao **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Some studies have shown that approximately 15% of patients with advanced hormone receptor (HR) positive breast cancer and 1/3 of triple negative breast cancer will develop brain metastasis. At present, there is no unified drug treatment standard for HER2-negative breast cancer brain metastasis (BCBM). The evidence of single traditional chemotherapy drug as the main treatment of brain metastasis is not sufficient. Some exploratory studies on HER2-negative BCBM have shown that the central nervous system objective response rate (CNS-ORR) of anti-angiogenic drugs combined with chemotherapy is around 55%-80%。 Adebrelimab (a humanized PD-L1 monoclonal antibody) specifically blocks the binding of PD-1 and PD-L1, terminates the immunosuppressive signal produced by T cells, and makes T cells re-recognize tumor cells and kill them, thereby inhibiting tumor growth. In China, Adebelizumab has been approved for using in combination with chemotherapy as a first-line treatment for extensive stage small cell lung cancer. Apatinib (a small molecule VEGFR tyrosine kinase inhibitor) mainly plays an anti-angiogenic effect in the treatment of malignant tumors by inhibiting VEGFR. Apatinib has been approved monotherapy for advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has progressed or relapsed after at least two systematic chemotherapies, advanced liver cancer that has failed or is intolerable after at least first-line systematic treatment, and first-line treatment in patients with unresectable or metastatic hepatocellular carcinoma combined with camrelizumab. Due to the lack of effective drug therapy for HER2-negative BCBM, a variety of treatment combinations are still being explored. We hypothesized that adebrelimab plus apatinib and etoposide is an explorable and effective treatment for HER2- negative BCBM. ### Conditions Module **Conditions:** - HER2-negative Breast Cancer Brain Metastases ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This study adopts a single-arm, open-label design, planning to enroll 30 patients with HER2-negative breast cancer brain metastasis. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adebrelimab: 1200mg， ivgtt，administered on the first day of each cycle, with a cycle of 21 days. Apatinib: 250 mg, oral, once daily, continuous use, with a cycle of 21 days. Etoposide: 50mg/day, oral, administered on days 1-14 of each cycle, with a cycle of 21 days. **Intervention Names:** - Drug: Adebrelimab - Drug: Apatinib - Drug: Etoposide **Label:** Adebrelimab+Apatinib+Etoposide **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Adebrelimab+Apatinib+Etoposide **Description:** Adebrelimab: 1200mg, ivgtt, administered on the first day of each cycle, with a cycle of 21 days **Name:** Adebrelimab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Adebrelimab+Apatinib+Etoposide **Description:** Apatinib: 250 mg, oral, once daily, continuous use, with a cycle of 21 days **Name:** Apatinib **Other Names:** - Apatinib Mesylate Tablets **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Adebrelimab+Apatinib+Etoposide **Description:** Etoposide: 50mg/day, oral, administered on days 1-14 of each cycle, with a cycle of 21 days **Name:** Etoposide **Other Names:** - VP-16 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Central nervous system objective response rate (CNS-ORR), as assessed according to the RANO-BM criteria **Measure:** CNS-ORR **Time Frame:** 2 months #### Secondary Outcomes **Description:** CNS progression-free survival **Measure:** CNS-PFS **Time Frame:** 1 Year **Description:** According to recist1.1 standard, the proportion of patients whose extracranial best remission was CR or PR accounted for the total number of evaluable patients **Measure:** Extracranial objective response rate **Time Frame:** 2 Years **Description:** The time to the date of first documented progression or date of death from any cause, whichever came first **Measure:** Extracranial progression-free survival **Time Frame:** 2 Years **Description:** The time from the beginning of treatment to the time of death caused by any cause **Measure:** OS **Time Frame:** 3 Years **Description:** Clinical benefit rate: CR+PR+SD≥6 months **Measure:** CBR **Time Frame:** 2 Years **Description:** The time from the beginning of CR or PR to the time when the tumor was first evaluated as PD or any cause of death. **Measure:** DoR **Time Frame:** 2 Years **Description:** Adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE), in accordance with the NCI-CTC AE version 5.0 criteria. AE recorded from infromed consent to 28 days after treatment completion. **Measure:** Safety **Time Frame:** AE recorded from infromed consent to 28 days after treatment completion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female, aged ≥18 years * Expected survival time ≥3 months. * Histologically or cytologically confirmed HER2-negative (IHC 0 or 1+; or IHC 2+ ISH negative) locally recurrent or metastatic disease * New brain metastasis or brain metastasis progression after treatment * HR+ advanced breast cancer with prior CDK4/6 inhibitor treatment failure or the investigator deems unsuitable for CDK4/6 inhibitors * At least one intracranial measurable lesion as defined by RECIST V1.1 criteria； * ECOG PS 0-2； * Patients must have the ability to swallow oral medication； * Prior WBRT, stereotactic radiosurgery, and surgical resection are allowed； * Organ function levels are basically normal, and the investigator believes that the study drug can be applied： * Voluntarily join this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up Exclusion Criteria: * Urgent need for local treatment of brain metastasis * Immunohistochemistry HER2 positive (IHC 3 or IHC 2 ISH amplification) * Previously treated with Apatinib, Avelumab, or VP-16； * Severe dysfunction of important organs such as the heart, liver, or kidneys； * Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug administration and absorption； * Participants diagnosed with any other malignant tumor within 5 years before this study, excluding non-melanoma skin cancer that has undergone radical treatment. Basal cell or squamous cell skin cancer or cervical carcinoma in situ and thyroid papillary carcinoma。 * Patients who allergy to any component of the drugs in this protocol; patients with history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation * History of any cardiac disease, including: (1) arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be unsuitable for participation in this trial, etc. * Pregnant or lactation female patients; females of childbearing age with a positive baseline pregnancy test or unwilling to take effective contraceptive measures during the entire trial period； * According to the investigator's judgment, there are severe accompanying diseases that endanger the patient's safety or affect the completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.). **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jinzhu2714@sina.com **Name:** Jinmei Zhou, Doctor **Phone:** +86-010-66947250 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** The Fifth Medical Center of PLA General Hospital **State:** Beijing **Zip:** 100071 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000009385 - Term: Neoplastic Processes - ID: D000010335 - Term: Pathologic Processes - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M5209 - Name: Brain Neoplasms - Relevance: HIGH - As Found: Brain Metastases - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000001932 - Term: Brain Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000047428 - Term: Protein Kinase Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8191 - Name: Etoposide - Relevance: HIGH - As Found: Tolerability - ID: M288166 - Name: Apatinib - Relevance: HIGH - As Found: Immunogenicity - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005047 - Term: Etoposide - ID: C000553458 - Term: Apatinib ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418581 **Brief Title:** Investigation on Burnout of Physicians **Official Title:** Investigation on Burnout of Physicians #### Organization Study ID Info **ID:** 2024-0139 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-19 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study proposes to analyze the burnout, emotional states, and sleep conditions of internal medicine doctors at the Second Affiliated Hospital of Zhejiang University School of Medicine through a questionnaire survey. The findings aim to provide reference for implementing measures to address burnout among medical staff, improve their physical and mental health, and enhance the quality of healthcare. **Detailed Description:** Burnout, proposed by American psychologist Herbert Freudenberger in 1974, is defined as a syndrome resulting from chronic exposure to workplace stressors and the inability to successfully manage them. Subsequently, Maslach et al. considered burnout as the state of emotional exhaustion, depersonalization, and reduced personal accomplishment resulting from prolonged exposure to work-related stressors. In January 2022, the World Health Organization (WHO) included "burn-out" in the 11th Revision of the International Classification of Diseases (ICD-11) for the first time, officially recognizing it as a disease. Burnout is considered a syndrome resulting from chronic workplace stress that has not been successfully managed. Compared to other professions, doctors are at a higher risk of experiencing burnout. Burnout among medical professionals is closely related to job quality, doctor-patient relationships, and overall health. In 2022, 47% of 13,000 physicians in the United States reported experiencing burnout. Investigating whether burnout affects physical and mental health, thereby impacting the quality of healthcare, is essential. ### Conditions Module **Conditions:** - Burnout ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** article **Measure:** Investigation and analysis of occupational burnout and psychological status of physicians **Time Frame:** 2024.10.1-2025.10.1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Currently employed or non-employed internists, including those in gastroenterology, cardiology, pulmonology, hematology, rheumatology, endocrinology, general medicine, infectious diseases, oncology, neurology, psychiatry, nutrition, and other related specialties. 2. Ability to complete the questionnaire. 3. No history of mental illness. Exclusion Criteria: 1. Individuals who are not part of the internal medicine system, such as those in surgery, medical technology departments, or administrative roles. 2. Inability to effectively complete all sections of the questionnaire. **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The study will involve doctors from the internal medicine department of the Second Affiliated Hospital of Zhejiang University who will fill out the survey questionnaire using internet-based methods after providing informed consent. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wangcaihua@zju.edu.cn **Name:** Caihua Wang, Doctor **Phone:** 13857134782 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** wangcaihua@zju.edu.cn - **Name:** Caihua Wang, Doctor - **Phone:** 13857134782 - **Role:** CONTACT **Country:** China **Facility:** SAHZhejiangU **State:** Zhejiang **Status:** RECRUITING **Zip:** 310000 #### Overall Officials **Official 1:** **Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University **Name:** Caihua Wang, Doctor **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Dewa CS, Loong D, Bonato S, Trojanowski L. The relationship between physician burnout and quality of healthcare in terms of safety and acceptability: a systematic review. BMJ Open. 2017 Jun 21;7(6):e015141. doi: 10.1136/bmjopen-2016-015141. **PMID:** 28637730 **Citation:** Farr E, Lee S, Maltser S, Verduzco-Gutierrez M, Shapiro LT. A rapid response for burnout among inpatient physiatrists: A survey of leaders of inpatient rehabilitation facilities. PM R. 2022 Sep;14(9):1080-1085. doi: 10.1002/pmrj.12870. Epub 2022 Aug 9. **PMID:** 35789206 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M1658 - Name: Burnout, Psychological - Relevance: HIGH - As Found: Burnout - ID: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000077062 - Term: Burnout, Psychological ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418568 **Brief Title:** Efficacy and Safety Trial of Using Ultra-Pulsed Shockwaves to Deliver Tranexamic Acid for the Treatment of Melasma **Official Title:** Efficacy and Safety Trial of Using Ultra-Pulsed Shockwaves to Deliver Tranexamic Acid for the Treatment of Melasma #### Organization Study ID Info **ID:** 2023-1174 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Melasma is a prevalent chronic facial pigmentation condition affecting Asian women of childbearing age, attributed to genetic predisposition, sunlight exposure, and hormonal changes. Treatment methods include phototherapy and medication, notably tranexamic acid, which inhibits melanin production. Ultra-pulsed shockwave therapy is a non-invasive approach that boosts skin cell vitality and collagen synthesis. Currently, there is a lack of comprehensive research on the effectiveness and safety of using ultra-pulsed shockwaves to deliver tranexamic acid for melasma treatment. This study will involve a non-randomized, self-half-face, pre-post controlled prospective clinical trial. This design aims to evaluate the depigmenting effects and safety profile of tranexamic acid delivered via ultra-pulsed shockwaves. **Detailed Description:** Melasma is a common, chronic, acquired facial pigmentation disorder, also known as chloasma. Clinically, it presents as symmetrical, unevenly pigmented light to dark brown patches on the cheeks, forehead, and jawline with indistinct borders. The prevalence among Asian women of childbearing age can be as high as 30%, and it tends to recur and is difficult to cure. The pathogenesis of melasma is not fully understood, but genetic susceptibility, sunlight exposure, and hormonal changes are considered the three major contributing factors. Increased melanin synthesis, vascular proliferation at skin lesions, inflammation, and impaired skin barrier all play roles in the development of melasma. Melasma is clinically staged as active or stable phase. Clinical subtypes of melasma are categorized based on vascular involvement into 2 types: pure pigment type (M-type) and pigment combined with vascular type (M + V type). This classification guides the selection of treatment drugs and methods. According to the location of pigmentation, it is classified into 2 types: epidermal type (increased epidermal pigmentation) and mixed type (increased epidermal pigmentation + dermal superficial melanocytes). This classification is useful for determining treatment efficacy. In the Expert Consensus on Phototherapy and Repair of Melasma (2020 edition), it is suggested that systemic medication is not the first choice for treating melasma and is mostly used off-label. Intravenous administration is effective, and oral administration is generally less effective. Common regimens include vitamin C, glutathione combined with vitamin C, and intravenous tranexamic acid. Oral tranexamic acid has some efficacy. The Expert Consensus on the Diagnosis and Treatment of Melasma in China (2021 edition) states that single or repeated phototherapy can lead to pigment deposition, pigment reduction/loss, and recurrence, thus phototherapy is not recommended as a long-term clinical maintenance approach. The number of consecutive phototherapy treatments should not exceed 15 times, and repeat treatments can be considered after a 1-year interval. Topical medication is the preferred treatment: 1. Photoprotective agents, routinely combined with antioxidants; 2. Hydroquinone and its combination therapy are the most thoroughly researched topical medications. Adverse reactions include skin irritation, allergic contact dermatitis, and rarely, ochronosis; 3. Non-hydroquinone topical medications: retinoic acid, tranexamic acid, kojic acid, mequinol, arbutin, licorice extract, niacinamide, etc., most of which are also tyrosinase inhibitors. Tranexamic acid, also known as aminomethylbenzoic acid, is clinically used primarily for various bleeding disorders caused by acute or chronic, localized, or systemic primary fibrinolysis. Tranexamic acid is a protease inhibitor, with a molecular structure very close to tyrosine. When high concentrations of tranexamic acid enter skin tissues, it competitively binds with tyrosinase, inhibiting its activity and thereby reducing melanin formation. Therefore, tranexamic acid has been widely used clinically in dermatology for the treatment of melasma both domestically and abroad. Tranexamic acid's main indication in clinical practice is hemostasis. Oral tranexamic acid for treating melasma is considered off-label, and long-term oral administration carries risks such as thrombosis (cerebral thrombosis, myocardial infarction, venous thrombosis, etc.), necessitating long-term monitoring of patients' coagulation function and blood viscosity. Therefore, topical application of tranexamic acid directly to the affected skin area can enhance local drug efficacy and significantly reduce systemic adverse reactions due to its effect on the skin barrier; however, the local effective absorption rate of topically applied tranexamic acid is the main limitation for achieving therapeutic effects. Ultra-pulsed shockwave therapy is a non-invasive anti-aging treatment that can be applied to facial rejuvenation. It uses the principle of high-speed vibration to compress the medium intensely and focus to generate mechanical sound waves. Mechanical sound waves produce physical effects on the skin, including mechanical effects, shockwave technical effects, and cavitation effects, to activate biological effects, among which a 36mm treatment handle acts on superficial tissues, improving local cell membrane permeability and can be used for drug-related delivery, enhancing cellular vitality and metabolic capacity, stimulating collagen regeneration. Tranexamic acid delivery therapy is a common treatment method for melasma, while utilizing ultra-pulsed shockwaves to deliver tranexamic acid is a novel treatment approach. Currently, there is no comparative research on the efficacy and safety of tranexamic acid (aminomethylbenzoic acid) delivered via ultra-pulsed shockwave therapy for treating melasma domestically and internationally. This study designs a non-randomized, self-half-face, and pre-post controlled prospective clinical trial, intending to use ultra-pulsed shockwaves to deliver tranexamic acid to increase local tranexamic acid concentration in the skin spots and achieve depigmenting effects safely. This will provide clinical evidence for dermatologists and patients to formulate individualized treatment plans. ### Conditions Module **Conditions:** - Chloasma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention involves treating melasma using tranexamic acid (aminomethylbenzoic acid) delivered through ultra-pulsed shockwave therapy on one side of the face, while the other side receives topical application of tranexamic acid at the same concentration. **Intervention Names:** - Device: Ultra-pulsed Shockwave Therapy Device by Shenzhen Lifotronic Technology Co., Ltd. **Label:** Patients with chloasma **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with chloasma **Description:** The intervention involves treating melasma using tranexamic acid (aminomethylbenzoic acid) delivered through ultra-pulsed shockwave therapy on one side of the face, while the other side receives topical application of tranexamic acid at the same concentration. The shockwave therapy parameters are tailored based on patient tolerance. Each patient undergoes 3 treatment sessions spaced 3 weeks apart, followed by a 4-week follow-up period. Facial skin is assessed using the VISIA system before each treatment and at the 4-week follow-up, evaluating the Melasma Area Severity Index (MASI). Patient and researcher satisfaction levels are rated on a scale of 1 to 5. Adverse reactions, including short-term effects like pain and swelling, and potential long-term effects such as allergic reactions and hyperpigmentation, are monitored after each treatment session. **Name:** Ultra-pulsed Shockwave Therapy Device by Shenzhen Lifotronic Technology Co., Ltd. **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The Melasma Area Severity Index (MASI) is a clinical scoring system used to assess the severity of melasma based on the extent and darkness of pigmented areas on the face. It takes into account four different facial regions: the forehead, cheeks (right and left), and chin. The MASI score is calculated using the following formula: MASI=0.3×(DF+DB)×AF+0.3×(RF+RB)×AF+0.3×(CF+CB)×AF+0.1×(LF+LB)×AF The MASI score ranges from 0 to approximately 48, with higher scores indicating more severe melasma. It is used to quantify and monitor changes in melasma severity over time in response to treatment interventions. **Measure:** Melasma area severity index(MASI) **Time Frame:** 3 months #### Secondary Outcomes **Description:** Physician's Global Assessment (PGA) Overall Evaluation by Physicians: Based on the residual condition of pigmentation after treatment, scores range from 0 to 6 points: 0 points indicate complete clearance (100%) or minimal residual pigmentation, 1. point indicates essentially cleared (≥ 90%), 2. points indicate marked improvement (75% \~ 89%), 3. points indicate moderate improvement (50% \~ 74%), 4. points indicate slight improvement (25% \~ 49%), 5. points indicate no improvement (\< 25%), 6. points indicate worsening compared to before treatment. **Measure:** Physician's Global Assessment (PGA) **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years, any gender; 2. Diagnosis of melasma; 3. Able to comprehend and voluntarily sign a written informed consent form, and able to complete the treatment and follow-up as required. Exclusion Criteria: 1. History of other pigmentary disorders such as lentigines, Ota nevus, freckles, etc.; 2. History of oral retinoid or tetracycline-class photosensitizing drugs within the past 6 months prior to treatment; 3. History of facial injections, fillers, chemical peels, laser or radiofrequency treatments, or other treatments targeting pigmentation within the past 6 months prior to treatment; 4. Abnormal coagulation function; 5. History of oral glucocorticoids or immunosuppressive agents within the past 3 months prior to treatment; 6. Patients with malignant tumors; 7. Pregnant or lactating women; 8. Patients with active herpes simplex or herpes zoster on the face. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 2465598440@qq.com **Name:** SuiQing Cai, PHD **Phone:** 13957107910 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** 2465598440@qq.com - **Name:** SuiQing Cai, PHD - **Phone:** 13957107910 - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital Zhejiang University School of Medicine **State:** Zhejiang **Status:** RECRUITING **Zip:** 310009 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017495 - Term: Hyperpigmentation - ID: D000010859 - Term: Pigmentation Disorders - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11531 - Name: Melanosis - Relevance: HIGH - As Found: Chloasma - ID: M19760 - Name: Hyperpigmentation - Relevance: LOW - As Found: Unknown - ID: M13754 - Name: Pigmentation Disorders - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008548 - Term: Melanosis ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418555 **Brief Title:** Construction and Application Research of Home Cardiac Rehabilitation Plan for Patients Undergoing Transcatheter Aortic Valve Replacement Based on Mobile Healthcare **Official Title:** The Effectiveness of a Digital Home Rehabilitation Program for TAVR Patients Based on Instant Information Intervention: a Randomized Controlled Trial #### Organization Study ID Info **ID:** 2023-0921 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Cardiac rehabilitation is a long-term process, but patients have poor compliance with cardiac rehabilitation. The theory of behavior change rotation aims to comprehensively intervene from three aspects: ability, opportunity, and motivation, promoting individual behavior change by selecting the best intervention function and maximizing the use of available resources. To improve the compliance of TAVR patients with digital home cardiac rehabilitation, this study is based on the needs of TAVR patients and their caregivers for digital home cardiac rehabilitation. Based on the best evidence summary of TAVR patients' home cardiac rehabilitation, a home cardiac rehabilitation plan for TAVR patients is constructed using the theory of behavior change wheels. The Delphi method is used to revise the plan, develop a TAVR patient home cardiac rehabilitation management system, and conduct clinical application research on the plan to explore the intervention effect of TAVR patients' home cardiac rehabilitation based on real-time information intervention. ### Conditions Module **Conditions:** - Transcatheter Aortic Valve Replacement Surgery **Keywords:** - Transcatheter Aortic Valve Replacement - Cardiac Rehabilitation - Extended Care - instant message intervention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adding an immediate information-based intervention to the routine home care intervention with a home cardiac rehabilitation program intervention for TAVR patients. **Intervention Names:** - Behavioral: A home rehabilitation program centered on exercise **Label:** Home Rehabilitation Team **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Routine care **Intervention Names:** - Behavioral: A home rehabilitation program centered on exercise **Label:** Routine care group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Home Rehabilitation Team - Routine care group **Description:** Establish a multidisciplinary team, with team members combining clinical experience, summarizing the best evidence as the basis, and using the theory of behavior change wheels as the framework, to preliminarily construct a home-based cardiac rehabilitation plan suitable for TAVR patients in China's national conditions. Conduct expert consultation using the Delphi method to form the final version of the home cardiac rehabilitation plan for TAVR patients. **Name:** A home rehabilitation program centered on exercise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** Six minute walking distance **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** Home-based cardiac rehabilitation exercise adherence **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge #### Secondary Outcomes **Description:** Katz activities of daily living，Katz-ADL **Measure:** KATZ **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** Barthel index **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** Grip(kg) **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** KCCQ **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** death **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** Postoperative related complications **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge **Description:** Measured at the time of the patient's follow-up visit to the clinic **Measure:** readmission rate **Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Postoperative TAVR patients are classified as Grade I-III by the New York Heart Association (NYHA); Patients are able to use mobile devices such as smartphones; Patients who have obtained admission qualifications after undergoing digital home cardiac rehabilitation risk assessment by the rehabilitation team. The patient and their family members voluntarily participate in this study and are willing to provide an informed consent form; Able to use remote rehabilitation diagnosis and treatment systems. Exclusion Criteria: * Malignant tumors or those with serious complications; Patients with hearing and visual impairments; Patients with limited physical activity due to other diseases; Patients with obvious cognitive or mental disorders; Patients without Internet connection after returning home from hospital; Patients who have participated in or participated in other trials or rehabilitation plans within the past three months. **Healthy Volunteers:** True **Maximum Age:** 100 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zrxwk1@zju.edu.cn **Name:** jianping song **Phone:** 13757119617 **Role:** CONTACT **Contact 2:** **Email:** 22218917@zju.edu.cn **Name:** Yingying Jia **Phone:** 18298437245 **Role:** CONTACT #### Locations **Location 1:** **City:** Zhejiang **Contacts:** ***Contact 1:*** - **Email:** zrxwk1@zju.edu.cn - **Name:** jianping song - **Phone:** 13757119617 - **Role:** CONTACT **Country:** China **Facility:** Yingying Jia **State:** Zhe Jiang **Status:** RECRUITING **Zip:** 310000 #### Overall Officials **Official 1:** **Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University **Name:** Yingying Jia **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418542 **Brief Title:** Contrast Nephropathy Associated FFA **Official Title:** Assessment of the Frequency of Fundus Fluorescein Angiography Relationship With Contrast Nephropathy and Associated Factors #### Organization Study ID Info **ID:** E-48865165 #### Organization **Class:** OTHER **Full Name:** Saglik Bilimleri Universitesi ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Saglik Bilimleri Universitesi #### Responsible Party **Investigator Affiliation:** Saglik Bilimleri Universitesi **Investigator Full Name:** NUR SENA ÇOBAN **Investigator Title:** Assistant Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** After the use of iodinated contrast agents, there is a risk of developing contrast nephropathy. Limited data in the literature are available on the incidence of contrast nephropathy after fluorescein angiography (FFA), which is an iodine-free organic contrast. Additionally, factors associated with contrast nephropathy after FFA are not clearly understood. Our study aims to evaluate these points. **Detailed Description:** It is known that patients are at risk of developing contrast nephropathy after FFA with iodinated contrast media. However, although it is known that contrast nephropathy may develop after FFA with fluorescein, a non-iodinated organic contrast agent, there is very limited data in the literature. In this study, we aimed to determine the incidence of contrast nephropathy after FFA for retinopathy evaluation and to evaluate the associated factors (age, gender, diabetes mellitus, hypertension, chronic kidney disease, baseline renal function, medications, etc.). Our study was planned prospectively. Patients over the age of 18 years who applied to Prof. Dr. Cemil Taşcıoğlu City Hospital Eye Clinic as outpatients and who did not meet the exclusion criteria and agreed to participate in the study will be included in our study. Age, gender, demographic, clinical and laboratory data of these patients will be recorded from the patient file and hospital data processing system. The definition of contrast nephropathy is defined as an increase in serum creatinine (SCr) ≥0.5 mg/dL or more than 25% of the baseline value in the study titled "Contrast-induced Kidney Injury:Focus on Modifiable Risk Factorsand Prophylactic Strategies", "Risk of nephropathy after intravenous administration of contrast material: a critical literature analysis. In this study, an increase of 0.3 mg/dL in serum creatinine within 48 hours after contrast was accepted. The definition of contrast nephropathy will be evaluated separately as both an increase of 0.5 mg/dl or 25% increase in creatinine value compared to baseline and an increase of 0.3 mg/dl compared to baseline. In this way, there are studies in which the frequency of contrast nephropathy was evaluated separately according to both criteria in the same study. ### Conditions Module **Conditions:** - Contrast-induced Nephropathy - Acute Kidney Injury ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients who have chronic renal disease **Intervention Names:** - Device: use of florescein **Label:** END **Type:** OTHER #### Arm Group 2 **Description:** patients who don't have chronic renal disease **Intervention Names:** - Device: use of florescein **Label:** END free **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - END - END free **Description:** Fluorescein, an organic contrast agent, is used in FFA to detect retinal pathologies. **Name:** use of florescein **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Urea and creatinine values will be measured 48-72 hours after FFA . The renal function of these patients one month before FFA will be compared with the renal function 48-72 hours after FFA and the development of contrast nephropathy will be determined based on KDIGO and AKIN criteria. **Measure:** Contrast Nephropathy associated FFA **Time Frame:** 48-72 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Over 18 years old. Patients with an indication for FFA. Those who agreed to participate in the study. Exclusion Criteria: * Patients with nephrotoxic drug exposure in the last two weeks * Patients who underwent imaging management requiring the use of other contrast agents in the last month (such as coronary angiography, CT angiography) * Patients with unstable hemodynamics * Patients with obstructive uropathy * Patients with end-stage renal failure with eGFR\<15 * Patients on a routine hemodialysis program **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Saglik Bilimleri University **Zip:** 34000 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051437 - Term: Renal Insufficiency - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Nephropathy - ID: M28998 - Name: Acute Kidney Injury - Relevance: HIGH - As Found: Acute Kidney Injury - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000058186 - Term: Acute Kidney Injury - ID: D000007674 - Term: Kidney Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418529 **Brief Title:** A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis **Official Title:** Comparative Effectiveness of New Initiators of Tofacitinib and Other Biologic/Targeted Synthetic DMARDs in Patients With Rheumatoid Arthritis #### Organization Study ID Info **ID:** A3921445 #### Organization **Class:** INDUSTRY **Full Name:** Pfizer ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pfizer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of this study is to learn how different types of medicines may improve disease activity in people with rheumatoid arthritis (RA). RA is a kind of joint disease that causes pain and swelling. The study will look at data from a large, US-based group of RA patients who have taken the below medicines: * Tofacitinib * Abatacept * Tocilizumab or sarilumab The study will compare clinical disease activity scores of patients on the different medicines taken. The study will also decide whether some patient traits or disease factors play a role in how medicines may improve disease activity. ### Conditions Module **Conditions:** - Rheumatoid Arthritis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 20000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients diagnosed with rheumatoid arthritis **Intervention Names:** - Drug: tofacitinib - Drug: tumor necrosis factor inhibitors (TNFi) - Drug: abatacept - Drug: tocilizumab or sarilumab **Label:** rheumatoid arthritis ### Interventions #### Intervention 1 **Arm Group Labels:** - rheumatoid arthritis **Description:** New index treatment of tofacitinib **Name:** tofacitinib **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - rheumatoid arthritis **Description:** New index treatment of TNFi **Name:** tumor necrosis factor inhibitors (TNFi) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - rheumatoid arthritis **Description:** New index treatment of abatacept **Name:** abatacept **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - rheumatoid arthritis **Description:** New index treatment of tocilizumab or sarilumab **Name:** tocilizumab or sarilumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10.0 **Time Frame:** Months 6, 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years on the cohort entry date. 2. Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date: 1. At least two RA diagnosis codes at least 30 days apart, each coming from an encounter with a rheumatologist; 2. At least one inpatient visit with a RA diagnosis code; 3. At least two outpatient records with a RA diagnosis code at least 30 days apart and within a year, regardless of physician specialty; or 4. At least one outpatient record with an RA diagnosis and a prescription or fill for a disease modifying anti-rheumatic drug (DMARD) from a specified list and does not have any of the non-RA conditions for which those drugs may also be prescribed. 3. Initiation of specified biologic or targeted synthetic molecule DMARDs of interest for treatment of RA (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, tocilizumab, or sarilumab). 4. At least 180 days of baseline data available prior to and including the cohort entry date. 5. At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline). Exclusion Criteria: 1. Patients diagnosed with concomitant indications for tofacitinib \[psoriatic arthritis (PsA), UC, and polyarticular course juvenile idiopathic arthritis (pcJIA)\] at any time prior to cohort entry date, determined by at least two (2) diagnosis codes at least 30 days apart and prior to baseline. 2. Patients with \>1 b/tsDMARD (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept tocilizumab, or sarilumab) prescribed on index date. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A retrospective design will be used to explore the comparative effectiveness of tofacitinib among a cohort of patients with rheumatoid arthritis (RA) in the U.S. using the OM1 PremiOM™ RA dataset (OM1, Inc., Boston, MA). This dataset of over 244,000 patients with RA is derived from deterministically linked, de-identified, individual-level healthcare claims and electronic medical record (EMR) data. EMR data are derived from several healthcare systems and rheumatologist's EMR provider systems geographically representative of the U.S. population. For this analysis, the OM1 PremiOM™ RA dataset will include the time period from 01 January 2013 through 31 December 2023. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ClinicalTrials.gov_Inquiries@pfizer.com **Name:** Pfizer CT.gov Call Center **Phone:** 1-800-718-1021 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Pfizer **Name:** Pfizer CT.gov Call Center **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **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 Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: HIGH - As Found: Rheumatoid Arthritis - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000001172 - Term: Arthritis, Rheumatoid ### Intervention Browse Module - Ancestors - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000075242 - Term: Janus Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000893 - Term: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M2052 - Name: Tumor Necrosis Factor Inhibitors - Relevance: HIGH - As Found: Celiac artery - ID: M483 - Name: Abatacept - Relevance: HIGH - As Found: Oxygenation - ID: M258018 - Name: Tofacitinib - Relevance: HIGH - As Found: Burn - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M1474 - Name: Janus Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000079424 - Term: Tumor Necrosis Factor Inhibitors - ID: D000069594 - Term: Abatacept - ID: C000479163 - Term: Tofacitinib ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418516 **Acronym:** ANGELA **Brief Title:** Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device **Official Title:** Early Detection of Esophageal Squamous Cell Carcinoma With the Capsule Sponge Device Coupled With Molecular Biomarkers and Machine Learning #### Organization Study ID Info **ID:** 439/2023 #### Organization **Class:** OTHER **Full Name:** Centre of Postgraduate Medical Education ### Status Module #### Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Maria Sklodowska-Curie National Research Institute of Oncology #### Lead Sponsor **Class:** OTHER **Name:** Centre of Postgraduate Medical Education #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Esophageal squamous cell carcinoma accounts for \~90% of the nearly half-million annual incident cases of esophageal cancer worldwide. The high costs and invasiveness of upper endoscopy constitute a limitation in providing adequate surveillance for at-risk individuals, including those with previous head and neck cancer. The ANGELA study is a prospective evaluation of the minimally-invasive capsule-sponge device, coupled with tissue biomarkers (p53-immunohistochemistry), to detect squamous neoplasia in high-risk individuals. **Detailed Description:** Esophageal squamous cell carcinoma (ESCC) is the most common type of esophageal cancer worldwide, accounting for nearly 90% of the 456,000 incident cases of esophageal cancer each year. Overall, it is the seventh most common malignancy and the sixth most common cause of cancer-related mortality, with a high incidence rate in eastern to central Asia and eastern and southern Africa. This cancer is more common in men (\~70%), and the main risk factors include cigarette smoking, alcohol consumption, poor oral hygiene, the ingestion of caustic agents, and nutritional deficiencies. Additionally, an increased risk of ESCC following curative treatment of head and neck cancer (HNC) has been well-documented in the literature, with a lifetime incidence ranging between 3.8% and 14.9% in prospective observational studies. The carcinogenesis of ESCC is sequential and preceded by several precancerous stages, including low-grade intraepithelial neoplasia (LG-IEN) and, subsequently, high-grade intraepithelial neoplasia (HG-IEN). Although the prognosis of ESCC is extremely poor, with 5-year survival below 20%, it dramatically improves if the disease is detected at an early stage. Consequently, mass screening in high-incidence regions is being widely debated. However, population-wide screening presents a large challenge in terms of cost-effectiveness and manpower, as currently, a potential screening regime for ESCC would rely on endoscopic examination with biopsies, which remains the gold standard for ESCC diagnosis. Furthermore, since around 80% of all ESCCs occur in economically less-developed regions, newer, cheaper, and less invasive diagnostic tools are highly warranted. The capsule-sponge is a novel, minimally-invasive device that collects cells from the esophagus to produce a pseudo-biopsy suitable for routine laboratory analysis. In addition, tissue biomarkers such as p53 immunohistochemistry (p53-IHC) and molecular testing, including copy number assays to detect aneuploidy, can be applied. There is extensive data on the use of this technology for early diagnosis of Barrett's esophagus (precursor to adenocarcinoma), which has now reached wide clinical implementation in the UK National Health Service. Building on the promising pilot data, the current study aims to expand further our previously developed clinical assay for early detection of esophageal squamous neoplasia using the capsule-sponge device coupled with biomarkers and machine learning technologies. In this prospective trial, we plan to recruit patients within three risk groups for ESCC: 1. healthy controls; 2. high-risk individuals (previous head-and-neck cancer/ESCC); and 3. patients with known early ESCC. Each patient will undergo a high-definition endoscopy and a capsule-sponge examination. The biomarker assay, including p53-IHC and shallow whole genome sequencing, will be tested within the capsule-sponge samples and compared with the final endoscopic diagnosis. Machine learning algorithms will be applied to digitalized cytology to detect atypical cells and regions of p53-IHC overexpression. Lastly, we will extract microbial DNA from capsule-sponge samples to assess any taxonomic diversity within the three risk groups for ESCC. We hope to develop a novel, effective, and affordable diagnostic assay that, coupled with a minimally-invasive capsule-sponge device, could be implemented in a clinical setting, improving the early detection of ESCC and, eventually, patient outcomes. ### Conditions Module **Conditions:** - Esophageal Cancer - Head and Neck Cancer - Squamous Cell Carcinoma **Keywords:** - Prevention - Screening - Esophageal Cancer - Capsule Sponge ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single Group Assignment A prospective cohort study ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 340 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This part of the study will have an active prospective recruitment of patients. Recruitment will involve three patient populations: 1. Patients with ESCC 2. Patients at high risk for ESCC 3. Healthy controls Following inclusion in the study, subjects will be asked to complete a behavior questionnaire, have blood collected, and undergo a capsule-sponge procedure followed by diagnostic gastroscopy using advanced imaging with biopsies. During gastroscopy, additional tissue samples will be collected for research purposes. These samples, along with cytological specimens from the capsule-sponge, will be analyzed to assess the diagnostic accuracy of biomarkers in the diagnosis of esophageal squamous neoplasia. **Intervention Names:** - Device: Capsule-sponge **Label:** Capsule-sponge **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Capsule-sponge **Description:** The capsule-sponge is a minimally-invasive sampling device consisting of a polyurethane sponge compressed in a cellophane capsule attached to a string. When swallowed, the capsule dissolves in the stomach, releasing the cell collection sponge that expands to 3 cm in diameter. Next, a nurse or qualified medical technician retrieves the sponge by pulling back on the string and retracting it through the mouth. During extraction, the rough texture on the surface of the sponge collects epithelial cells in the cardia and along the entire length of the esophagus. **Name:** Capsule-sponge **Other Names:** - Upper endoscopy with biopsies - Blood collection - throat swab **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Sensitivity (%) and Specificity (%) of the capsule-sponge device in identifying patients with early squamous neoplasia (LG-IEN, HG-IEN, ESCC) as compared to the upper endoscopy with biopsies (gold standard) **Measure:** Feasibility and diagnostic yield of capsule-sponge coupled with cellular atypia and p53-IHC analysis for detecting ESCC and its precursor lesions compared with endoscopy (gold standard) **Time Frame:** 3 years #### Secondary Outcomes **Description:** % of Participants that have scored the Cytosponge experience of at least 6 points on a 0 to 10 Visual Analogue Scale (VAS) acceptability scale whereby 0 denotes "worst experience in life" and 10 denotes "best experience in life". **Measure:** Acceptability of the capsule-sponge device in patients with ESCC and high-risk for ESCC **Time Frame:** 3 years **Description:** Within this outcome, we will clarify the optimal depth of sequencing, and we will then perform shallow whole genome sequencing (sWGS) on the samples collected in the training phase to input the copy-number variation (CNV) into the classification algorithm and evaluate the output as compared with the diagnosis of the patient. This will enable us to refine the classifications with the ultimate aim of using them predictively in a testing phase. **Measure:** Study on accuracy and feasibility of adding copy number profiling for aneuploidy assessment to the capsule-sponge samples **Time Frame:** 3 years **Description:** To assess the utility of machine learning-based approaches to assist pathological assessment of the capsule-sponge samples for the applicability of the technology at scale. We will test the feasibility of applying the artificial intelligence (AI)-based technology onto digitalized capsule-sponge samples. The assessment will comprise of AI training phase and a validation period. **Measure:** Application of artificial intelligence on Cytosponge digitalized samples **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with esophageal squamous cell cancer (ESCC): * Patients ≥18 years of with adequate performance status for endoscopy * Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth/Chth) * Patients currently undergoing oncological treatment (Rth/Chth) * Consent to provide tissue samples for the study * Dysphagia grade ≤2 (able to swallow mixed foods and tablets) 2. Patients at high risk for ESCC: * Patients ≥18 years of age with adequate performance status for endoscopy * Prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both Rth, Chth, and combination treatment) * Prior definitive endoscopic treatment for early ESCC in the past (at least 6 months since completion) * Consent to provide tissue samples for the study * Dysphagia grade ≤2 3. Healthy controls - Patients ≥18 years old undergoing endoscopic evaluation for typical GI symptoms other than dysphagia (e.g., GERD, dyspepsia, etc.) without significant risk factors for ESCC Exclusion Criteria (for all patients): * Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification * Dysphagia grade ≥3 (able to swallow only liquid foods) * History of myocardial infarction or other cardiovascular event within 6 months of enrolment * Neurological diseases associated with impaired swallowing * Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability). **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wjanuszewicz@cmkp.edu.pl **Name:** Wladyslaw Januszewicz, M.D., PhD **Phone:** +48225462328 **Phone Ext:** +48 **Role:** CONTACT **Contact 2:** **Email:** jaroslaw.regula@coi.pl **Name:** Jaroslaw Regula, M.D., PhD **Phone:** +48225462328 **Phone Ext:** +48 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Centre of Postgraduate Medical Education, Warsaw, Poland **Name:** Wladyslaw Januszewicz, M.D., PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data obtained through this study may be provided to qualified researchers with academic interest in esophageal cancer. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophageal Cancer - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000004938 - Term: Esophageal Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418503 **Brief Title:** Effects of EMG-Biofeedback Balance Training on Hoffman's Reflex **Official Title:** Effects of EMG-Biofeedback Balance Training on Hoffman's Reflex and Their Longevity #### Organization Study ID Info **ID:** 17485 #### Organization **Class:** OTHER **Full Name:** McMaster University ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** McMaster University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to gain a further understanding of the effects of EMG-biofeedback balance training and we will be analyzing changes in spinal reflex excitability by responses from the calve muscles and data about your standing balance. The EMG-biofeedback balance training has the potential to improve balance of older adults and prevent future falls and in this study we will learn if it also creates changes in the nervous system. This study aims to 1) determine the effects of a one-month long EMG-biofeedback balance intervention on the H-reflex amplitude, 2) determine whether there is a related behavioural change in the control of balance and 3) determine whether changes in balance and H-reflex amplitude persist for up to two weeks following the end of the balance training intervention. **Detailed Description:** Injuries caused by falls are a major worldwide issue and the most serious injuries include hip fractures and trauma to the brain. In-depth analysis of the risk factors for falls have discovered that balance disorders and abnormal gait are the strongest contributors. It is not a surprise that neural control of posture is altered as a function of age. Falls among the elderly has become an increasing issue and are leading to an escalating number of medical conditions, mortality and utilization of health care services. In Canada, 32 to 42% of older adults who are 70 years or older fall each year. Balance is the key ability needed to avoid falls because maintaining upright balance is needed to complete individual daily activities. Quantitative assessments are needed when evaluating the postural balance of participants. The force plate is a piece of equipment that is a reliable balance assessment method which is used widely in both laboratory and clinical settings. Despite the many research studies over the last three decades analyzing the effects of age and postural control, the number of deaths caused by falling and fall-related injuries has continued to increase. More studies are needed to highlight how old age affects neural mechanisms of postural control. Specifically, we need to understand the mechanisms by which balance training can lead to improved postural control to decrease falls among older adults. A valuable neurophysiological measurement known as the Hoffman (H) reflex, has a high sensitivity to posture. Measuring the H-reflex amplitude can be used to detect whether changes in spinal excitability accompany balance training. It is a relatively simple technique which makes it an intriguing tool for research. The H-reflex has been used for decades in motor control studies which emphasize spinal mechanisms. It is commonly used as a tool for analyzing spinal excitability, or how effectively synaptic transmission occurs between motor neurons and 1a afferents. For balance training, electromyography (EMG) biofeedback can be implemented which would involve the participants controlling objects on a screen through the electrical signals of their muscles while standing. The sensors used for EMG are not painful or invasive and can be applied to target the impairment of specific muscles or muscle groups. The EMG-Biofeedback system creates a classifier that predicts the user's intended game control inputs through real-time EMG signals. This innovation would be achieved by placing the sensors on the upper leg and arms to collect data for the signals of the lower and upper extremities, so the motor performance and successful game execution can be focused on the balance of participants. Eighteen sessions (40 minutes each) of EMG-biofeedback training of the lower body (tibialis anterior muscle) over three weeks in participants suffering with chronic stroke was shown to improve motor control outcomes including balance and strength. To gain a further understanding of the neurophysiological effects of EMG-biofeedback, we will be analyzing changes in spinal reflex excitability by measuring H-reflex amplitudes, and balance board test results before and after 4 weeks of balance training in the aging population. While there have been published studies regarding this intervention improving balance, there have not been any studies exploring whether EMG-biofeedback training also changes spinal reflex excitability. This intervention has the potential to improve spinal reflexes and balance of older adults and prevent future falls. This intervention can possibly decrease major injuries across the healthy older adult population, and changes in H-reflex amplitudes can be associated with balance changes. Studies which have explored changes in H-reflex amplitude after one-month long balance training, have not done a follow-up assessment to confirm the longevity of improvements in balance and decreased amplitudes of the H-reflex. Methods: During the participants' first visit to the laboratory, they will complete 3 functional assessments, and one neurophysiological assessment. The functional assessments will measure balance in a standing position. These balance assessments will take approximately 10 min. to complete. The measurement of muscle activity will involve non-invasive stimulation behind the knee which will evoke a muscle twitch in the calve (soleus) muscle. This Hoffman Reflex assessment will be completed for each leg and reflects the activity of circuits within the spinal cord that are thought to contribute to balance. This procedure requires approximately 20 minutes for each leg. The participants will be randomly assigned to the balance training or biofeedback balance training group by the lead investigator of this study, and the participant will not be told which group they have been assigned to. Irrespective of which group the participant has been assigned to, they will have electrodes placed on upper and lower body muscles which will be attached to the EMG system using leads and you will be completing a computer game that requires your balance for 30 min. each of your training sessions. Assistive devices such as canes, walkers etc. will not be used during the balance training. The participants can take breaks and sit down occasionally during the balance training. This training will take place 4 times per week for a total of 16 times. Both groups will experience the computer game during standing balance training. The day after their last session, they will complete a follow-up assessment session which will also involve completion of the 3 functional balance tests and measurement of muscle activity for each leg, which will follow the same procedure as the first assessment session. The second follow-up assessment will take place 2 weeks after the final training session. All assessments from the first follow-up will be repeated. ### Conditions Module **Conditions:** - Spinal Reflex Excitability - Balance **Keywords:** - Hoffman's - Reflex - Biofeedback - EMG ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will be masked to which intervention they receive (balance training or EMG-biofeedback balance training). **Who Masked:** - PARTICIPANT **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 34 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Completing a Tetris (block stacking) computer game while attached to an EMG device by electrodes and leads. **Intervention Names:** - Other: Balance Training **Label:** Balance Training **Type:** SHAM_COMPARATOR #### Arm Group 2 **Description:** Completing an EMG-biofeedback block stacking game using the electrodes to detect muscle signals which are controlling the movements of the blocks. **Intervention Names:** - Other: EMG-Biofeedback Training **Label:** EMG-Biofeedback Training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Balance Training **Description:** Participants will complete 16 sessions of balance training (30 min. each) over one month. **Name:** Balance Training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - EMG-Biofeedback Training **Description:** Participants will complete 16 sessions of EMG-biofeedback balance training (30 min. each) over one month. **Name:** EMG-Biofeedback Training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measurements of maximal Hoffman reflex **Measure:** Change in Spinal Reflex Excitability **Time Frame:** Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up **Description:** Measurements of balance using balance board assessments **Measure:** Change in Balance **Time Frame:** Pre-intervention (before 1st training session), post-intervention (1-2 days after last training session), 2-week follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy older adults between 60-75 years old * able to stand free of assistive devices for at least 3 consecutive minutes * free of visual disorders that prevent meaningful interaction with the intervention interface. Exclusion Criteria: * Sustained a serious musculoskeletal injury in the past 6 months or have any diagnosis that could impact movement coordination or balance * significant cognitive or language barriers **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nelsonaj@mcmaster.ca **Name:** Aimee J Nelson, PhD **Phone:** 9055259140 **Phone Ext:** 28053 **Role:** CONTACT **Contact 2:** **Email:** bobinska@mcmaster.ca **Name:** Ava R Bobinski, BSc **Phone:** 9059334648 **Role:** CONTACT ### References Module #### References **Citation:** Chen B, Liu P, Xiao F, Liu Z, Wang Y. Review of the Upright Balance Assessment Based on the Force Plate. Int J Environ Res Public Health. 2021 Mar 8;18(5):2696. doi: 10.3390/ijerph18052696. **PMID:** 33800119 **Citation:** Bakker LBM, Lamoth CJC, Vetrovsky T, Gruber M, Caljouw SR, Nieboer W, Taube W, van Dieen JH, Granacher U, Hortobagyi T. Neural Correlates of Balance Skill Learning in Young and Older Individuals: A Systematic Review and Meta-analysis. Sports Med Open. 2024 Jan 7;10(1):3. doi: 10.1186/s40798-023-00668-3. **PMID:** 38185708 **Citation:** Tsaih PL, Chiu MJ, Luh JJ, Yang YR, Lin JJ, Hu MH. Practice Variability Combined with Task-Oriented Electromyographic Biofeedback Enhances Strength and Balance in People with Chronic Stroke. Behav Neurol. 2018 Nov 26;2018:7080218. doi: 10.1155/2018/7080218. eCollection 2018. **PMID:** 30598705 **Citation:** Theodosiadou A, Henry M, Duchateau J, Baudry S. Revisiting the use of Hoffmann reflex in motor control research on humans. Eur J Appl Physiol. 2023 Apr;123(4):695-710. doi: 10.1007/s00421-022-05119-7. Epub 2022 Dec 26. **PMID:** 36571622 **Citation:** Park C, Mishra RK, York MK, Enriquez A, Lindsay A, Barchard G, Vaziri A, Najafi B. Tele-Medicine Based and Self-Administered Interactive Exercise Program (Tele-Exergame) to Improve Cognition in Older Adults with Mild Cognitive Impairment or Dementia: A Feasibility, Acceptability, and Proof-of-Concept Study. Int J Environ Res Public Health. 2022 Dec 6;19(23):16361. doi: 10.3390/ijerph192316361. **PMID:** 36498431 **Citation:** Public Health Agency of Canada. (2022). Senior-falls-in-Canada-en.pdf. Surveillance Report on Falls Among Older Adults in Canada. https://www.canada.ca/content/dam/hc-sc/documents/reserch/surveillance/senior-falls-in-Canada-en.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14863 - Name: Reflex, Abnormal - Relevance: HIGH - As Found: Hoffman's Reflex - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012021 - Term: Reflex, Abnormal ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418490 **Acronym:** DIIBD **Brief Title:** The Application of Digital Intelligent Diagnostic and Therapeutic Technology in Biliary Dilation Diagnosis **Official Title:** Navigating the Biliary Maze：a Retrospective Cohort Study of Augmented Reality Improving Outcomes in Choledochal Dilation Resection #### Organization Study ID Info **ID:** 2024-KY-042 #### Organization **Class:** OTHER **Full Name:** Zhujiang Hospital ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhujiang Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This research discusses the clinical application value of augmented reality navigation technology combined with three-dimensional visualization technology in improving surgical safety and promoting the development of precision surgery. This technology can reduce intraoperative vascular and bile duct injuries, effectively avoid serious postoperative complications, and reduce residual cysts. **Detailed Description:** Choledochal cysts (CC) have traditionally been considered as cystic dilatations of the extrahepatic bile duct. Choledochal cysts are now referred to as choledochal dilatation, which also includes intrahepatic and extrahepatic cysts. Choledochal cysts are defined as cystic dilatations involving the bile duct tree of single or multiple segments of the intrahepatic and extrahepatic bile ducts. In 1959, Alonso-Lej et al. first divided CC into 3 types based on the location of bile duct dilatation. It was not until 1977 that Todani et al. revised the classification, adding 2 more types of CCs, which is the most commonly used classification by clinicians today; however, some experts dispute this, claiming that each type of CC has its own natural history, complications, and treatments. It is suggested to focus more on the pathogenesis rather than a simple anatomical classification of the bile duct tree. Choledochal cysts are a rare anomaly and are sometimes considered as a precancerous condition, which often leads to diagnostic challenges. The typical presentation of this condition is nonspecific. Medical teams must have a high clinical suspicion of choledochal cysts when investigating patients with jaundice, abdominal pain, and palpable abdominal masses. Due to the ambiguity of these symptoms and physical examination findings, appropriate imaging studies are crucial for diagnosis. Resection of choledochal dilatation has shown excellent results, with a complication-free rate of 89% and an overall 5-year survival rate exceeding 90%. Therefore, early diagnosis and appropriate management are essential to achieve optimal outcomes and a good prognosis. Clinical practice has confirmed that the modern digital imaging technology, such as three-dimensional visualization and augmented reality navigation technology, built for hepatobiliary surgery diagnosis and treatment platform plays a crucial guiding role in precise preoperative assessment, lesion localization, formulation of optimal surgical plans, and intraoperative navigation to avoid collateral damage. Professor Fang Chihua's team has conducted long-term research and breakthroughs in this field. A significant portion of the literature in the field of digital intelligent diagnosis and treatment technology retrieved from SinoMed - China Biomedical Literature Service System comes from Professor Fang Chihua's team. The team has published consecutive expert consensus in the Chinese Journal of Practical Surgery in the field of digital intelligence in hepatobiliary surgery, including the publication of "Expert Consensus on Precise Diagnosis and Treatment of Three-Dimensional Visualization of Hepatobiliary Stones (2019 Edition)," which affirms the significant impact of three-dimensional visualization technology in guiding the precise diagnosis and treatment of hepatobiliary stones. The "Consensus recommendations of three-dimensional visualization for diagnosis and management of liver disease" published in an international journal demonstrates that China's research level in this field is at the forefront globally. Sioh Huang Lim et al. utilized ICG intraoperative navigation technology to visualize the extrahepatic bile ducts without radiation, enabling quicker identification of bile ducts compared to cholangiography. Liu Yangsui et al. applied fluorescence imaging technology for real-time navigation of the extrahepatic bile ducts, achieving superior outcomes in terms of surgical time, intraoperative blood loss, and postoperative hospital stay compared to the traditional surgery group. In laparoscopic re-exploration of the bile duct, Tian Guangjin et al. used ICG fluorescence navigation technology as surgical assistance, with a conversion to open surgery rate of approximately 3.3% in the navigation group compared to 22.9% in the conventional surgery group, achieving higher rates of minimally invasive abdominal surgery in the navigation group. Takeshi Aoki et al. indicated in their literature the successful staining of subsegments or liver segments in 33 out of 35 cases (94.3%) using fluorescence imaging technology for liver resection navigation. Kunshan He et al. demonstrated that near-infrared (NIR) imaging method resulted in less blood loss and shorter hospital stay compared to traditional methods. ICG fluorescence imaging technology has shown promising prospects in partial liver resection surgery. In conclusion, three-dimensional visualization technology can achieve precise preoperative differentiation of vascular variations, formulate individualized surgical plans based on reconstructed three-dimensional models, and provide real-time navigation during surgery to ensure the success of the operation. Intraoperative real-time augmented reality technology navigation helps prevent intraoperative bile duct injuries, effectively reduce severe postoperative complications, and decrease residual cysts and associated complications. Therefore, the combined application of both technologies in the treatment of choledochal cysts surgery provides better medical technological support, enhances surgical safety and precision, promotes the development of minimally invasive surgery, and holds significant clinical value. ### Conditions Module **Conditions:** - Congenital Biliary Dilatation - Choledochal Cyst **Keywords:** - Congenital Biliary Dilatation - Choledochal Cyst - Augmented reality - Digital intelligent - Three-dimensional visualization ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Arms Interventions Module #### Arm Group 1 **Description:** After adequate general anesthesia, the non-3D group underwent conventional choledochal cyst excision surgery, while the 3D group underwent choledochal cyst excision surgery guided by three-dimensional visualization technology or enhanced reality navigation. **Intervention Names:** - Device: Three-dimensional visualization technology **Label:** 3D-group #### Arm Group 2 **Description:** After adequate general anesthesia, the non-3D group underwent conventional choledochal cyst excision surgery, while the 3D group underwent choledochal cyst excision surgery guided by three-dimensional visualization technology or enhanced reality navigation. **Label:** Non-3D Group ### Interventions #### Intervention 1 **Arm Group Labels:** - 3D-group **Description:** Three-dimensional reconstruction technology is a software that can collect CT and MRI data, perform image segmentation and three-dimensional reconstruction of the liver, gallbladder, dilated bile ducts, pancreas, venous, and arterial systems step by step. The software is called Abdominal Medical Image 3D Visualization Software (MI-3DVS, software copyright registration number: 2008SR18798).The AR-ANS (Software Copyright No.: 2018SR840555) is an intraoperative navigation system that integrates three-dimensional visualization technology.This modification provides visual guidance for surgeons when ligating or protecting critical vascular tissues during surgery. **Name:** Three-dimensional visualization technology **Other Names:** - Augmented Reality Navigation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Comprehensive Complication Index:integrating all recorded complications weighted by severity in a single formula. **Measure:** CCI **Time Frame:** Postoperative review lasted until 1 year **Description:** minutes **Measure:** operation time **Time Frame:** perioperative period **Description:** ml **Measure:** intraoperative blood loss **Time Frame:** perioperative period #### Secondary Outcomes **Description:** G/L **Measure:** Postoperative complete blood count **Time Frame:** perioperative period **Measure:** Repeat surgery rate **Time Frame:** perioperative period **Description:** μmol/L **Measure:** serum bilirubin levels **Time Frame:** perioperative period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Diagnosis of congenital biliary dilatation confirmed; The standard of Child-Pugh classification of preoperative liver function was; class A or B; Clinical data were complete; Exclusion Criteria: Patients with cardiopulmonary dysfunction who cannot tolerate surgery or anesthesia; Patients with malignant transformation; Lack of clinical data. **Maximum Age:** 75 Years **Minimum Age:** 16 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients who underwent choledochal dilation resection surgery from January 2010 to March 2023 in zhujiang hospital were included in this study and divided into the 3D group and non-3D group. ### Contacts Locations Module #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** chen_ning16@foxmail.com - **Name:** zeng ning, Doctor - **Phone:** +8613760694012 - **Phone Ext:** +86 - **Role:** CONTACT ***Contact 2:*** - **Email:** v689023@163.com - **Name:** cai peilin, master - **Phone:** +8615625854491 - **Phone Ext:** +86 - **Role:** CONTACT **Country:** China **Facility:** zhujiang Hospital **State:** Guangdong **Status:** RECRUITING **Zip:** 510280 ### IPD Sharing Statement Module **IPD Sharing:** YES **Time Frame:** after 2024.5.30 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000003560 - Term: Cysts - ID: D000009369 - Term: Neoplasms - ID: D000001649 - Term: Bile Duct Diseases - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000004065 - Term: Digestive System Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M18172 - Name: Choledochal Cyst - Relevance: HIGH - As Found: Choledochal Cyst - ID: M7292 - Name: Dilatation, Pathologic - Relevance: HIGH - As Found: Dilatation - ID: M6765 - Name: Cysts - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M4935 - Name: Bile Duct Diseases - Relevance: LOW - As Found: Unknown - ID: M4946 - Name: Biliary Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M7254 - Name: Digestive System Abnormalities - Relevance: LOW - As Found: Unknown - ID: T756 - Name: Bile Duct Cysts - Relevance: HIGH - As Found: Choledochal Cyst ### Condition Browse Module - Meshes - ID: D000015529 - Term: Choledochal Cyst - ID: D000004108 - Term: Dilatation, Pathologic ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M22554 - Name: Pancrelipase - Relevance: LOW - As Found: Unknown - ID: M13114 - Name: Pancreatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418477 **Brief Title:** Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients With MIDD **Official Title:** Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients With Monoclonal Immunoglobulin Deposition Disease #### Organization Study ID Info **ID:** 2024PHB134-001 #### Organization **Class:** OTHER **Full Name:** Peking University People's Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University People's Hospital #### Responsible Party **Investigator Affiliation:** Peking University People's Hospital **Investigator Full Name:** Jin Lu, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone. **Detailed Description:** The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. ### Conditions Module **Conditions:** - Monoclonal Gammopathy of Renal Significance **Keywords:** - Daratumumab - Bortezomib - Monoclonal Immunoglobulin Deposition Disease ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Daratumumab: Cyclophosphamide Bortezomib Dexamethasone **Intervention Names:** - Drug: Dara-CyBorD **Label:** Dara-CyBorD **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dara-CyBorD **Description:** Patient will receive Dara-CyBorD (Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone) for at least 6 cycles, and then Daratumumab maintainance. Drug: Daratumumab: 16mg/kg IV dose OR 1800 mg subcutaneously Drug: Cyclophosphamide: 300 mg/m\^2 as an oral or IV dose Drug: Bortezomib: 1.3 mg/m\^2 as an subcutaneous (SC) injection. Drug: Dexamethasone: 20-40mg Patients will receive the above drugs (Dara-CyBorD) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 1 years. Note: If patients achieve less than hematologic VGPR by cycle 3 or less than PR by cycle 2, treatment plan will be allowed to discontinued, according to treatment principle in systemic light chain amyloidosis. **Name:** Dara-CyBorD **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Hematologic complete response requires absence of monoclonal protein by immunofixation electrophoreses of both serum and urine as well as a normal FLC ratio (FLCr). CR is considered when FLCr was altered in favour of the non-amyloidogenic, uninvolved FLC (uFLC), even though the ratio may not have been normalised. **Measure:** Rate of Hematologic Complete Response at the completion of 6 cycles **Time Frame:** 6 months #### Secondary Outcomes **Measure:** Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels **Time Frame:** 6 months **Measure:** Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels **Time Frame:** 6 months **Description:** Renal response at 6 months **Measure:** Renal response at 6 months **Time Frame:** 6 months **Description:** Cardiac response (for patients with cardiac involvement) at 6 months **Measure:** Cardiac response at 6 months **Time Frame:** 6 months **Description:** Minimal residual disease status at 6 months **Measure:** MRD status at 6 months **Time Frame:** 6 months **Description:** Renal Survival in 2 years **Measure:** Renal Survival in 2 years **Time Frame:** 2 years **Description:** Overall Survival in 2 years **Measure:** Overall Survival in 2 years **Time Frame:** 2 years **Description:** Treatment-related adverse events up to 2 years **Measure:** TRAEs **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment 2. ECOG 0,1,2 3. Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L. 4. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; 5. Informed consent explained to, understood by and signed by the patient. Exclusion Criteria: 1. Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid) 2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma. 3. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 4. Severe or persistent infection that cannot be effectively controlled; 5. Presence of severe autoimmune diseases or immunodeficiency disease; 6. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); 7. Patients with HIV infection or syphilis infection; 8. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jin1lu@sina.com **Name:** Jin Lu **Phone:** 86-13311491805 **Role:** CONTACT **Contact 2:** **Email:** pkuphliuyang@bjmu.edu.cn **Name:** Yang Liu **Phone:** 86-13716926210 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** zhuangjunling@hotmail.com - **Name:** Junling Zhuang - **Role:** CONTACT ***Contact 2:*** - **Name:** Junling Zhuang, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking Union Medical College Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100005 **Location 2:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** pkuphliuyang@bjmu.edu.cn - **Name:** Yang Liu - **Phone:** +8613716926210 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jin Lu, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking University People's Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100044 **Location 3:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** 13719209240@163.com - **Name:** Juan Li - **Role:** CONTACT ***Contact 2:*** - **Name:** Juan Li, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** The First Affiliated Hospital, Sun Yat-sen University **State:** Guangdong **Status:** RECRUITING **Zip:** 510062 #### Overall Officials **Official 1:** **Affiliation:** Peking University People's Hospital **Name:** Jin Lu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000006942 - Term: Hypergammaglobulinemia - ID: D000054219 - Term: Neoplasms, Plasma Cell - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000686 - Term: Amyloidosis - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11962 - Name: Monoclonal Gammopathy of Undetermined Significance - Relevance: HIGH - As Found: Monoclonal Gammopathy - ID: M4021 - Name: Amyloidosis - Relevance: LOW - As Found: Unknown - ID: M1483 - Name: Immunoglobulin Light-chain Amyloidosis - Relevance: HIGH - As Found: Monoclonal Immunoglobulin Deposition Disease - ID: M13178 - Name: Paraproteinemias - Relevance: HIGH - As Found: Monoclonal Gammopathy - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M9993 - Name: Hypergammaglobulinemia - Relevance: LOW - As Found: Unknown - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: T3867 - Name: Monoclonal Gammopathy of Undetermined Significance - Relevance: HIGH - As Found: Monoclonal Gammopathy - ID: T254 - Name: AL Amyloidosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000075363 - Term: Immunoglobulin Light-chain Amyloidosis - ID: D000010265 - Term: Paraproteinemias - ID: D000008998 - Term: Monoclonal Gammopathy of Undetermined Significance ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M6727 - Name: Cyclophosphamide - Relevance: LOW - As Found: Unknown - ID: M376 - Name: Bortezomib - Relevance: LOW - As Found: Unknown - ID: M272211 - Name: Daratumumab - Relevance: LOW - As Found: Unknown - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M19117 - Name: Immunoglobulins, Intravenous - Relevance: LOW - As Found: Unknown - ID: M12147 - Name: Myeloma Proteins - Relevance: LOW - As Found: Unknown - ID: M13179 - Name: Paraproteins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418464 **Acronym:** ELITE **Brief Title:** Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy **Official Title:** Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy: Protocol of a Multi-center, Non-inferiority, Randomized Controlled Trial (ELITE Study) #### Organization Study ID Info **ID:** 2023YFE0204100 #### Organization **Class:** OTHER **Full Name:** Peking University People's Hospital ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Hebei Provincial People's Hospital **Class:** OTHER **Name:** Xingtai People's Hospital #### Lead Sponsor **Class:** OTHER **Name:** Peking University People's Hospital #### Responsible Party **Investigator Affiliation:** Peking University People's Hospital **Investigator Full Name:** Wei Liu **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is designed as a blinded, multi-center, non-inferiority randomized controlled clinical trial. It aims to enroll hospitalized T1D diabetes patients, ensuring an equal distribution with a 1:1 ratio between the intervention and control groups. The trial is set to take place across three locations in China: Peking University People's Hospital, Hebei Provincial People's Hospital, and Xingtai People's Hospital. Before participating, all subjects are required to provide their consent by signing a written informed consent form. Within the framework of the trial, the intervention group will receive insulin dosage recommendations from AP-A, subject to approval by a physician, whereas the control group will be treated with insulin dosages according to the current clinical guidelines established by their physicians. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 1 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System. **Intervention Names:** - Device: AP-A Dosage Decision Support System **Label:** AP-A Dosage Decision Support System **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The injection dose of the control group was determined by the doctor solely. **Intervention Names:** - Device: AP-A Dosage Decision Support System **Label:** Physician decision-making **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - AP-A Dosage Decision Support System - Physician decision-making **Description:** The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System. **Name:** AP-A Dosage Decision Support System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The proportion of time that the glucose levels, as recorded by CGM during the treatment period, are within the range of 3.9mmol/L to 10.0mmol/L. This metric can be directly obtained by the algorithm system through closed-loop reading of CGM data. **Measure:** Time in Range (TIR) **Time Frame:** At the end of the treatment period #### Secondary Outcomes **Description:** The proportion of time that the glucose levels, as recorded by CGM during the treatment adjustment period, are below 3.9mmol/L. **Measure:** Time Below Range (TBR) **Time Frame:** At the end of the treatment period **Description:** The proportion of glucose data stored by CGM during the treatment period that is in the range of 3.0-3.8mmol/L. **Measure:** Other Secondary Outcomes1 **Time Frame:** At the end of the treatment period **Description:** The proportion of glucose data stored by CGM during the treatment adjustment period that is below 3.0mmol/L. **Measure:** Other Secondary Outcomes2 **Time Frame:** At the end of the treatment period **Description:** The area under the curve (AUC) of glucose levels below 3.9mmol/L in the Ambulatory Glucose Profile (AGP) during the treatment adjustment period. **Measure:** Other Secondary Outcomes3 **Time Frame:** At the end of the treatment period **Description:** The proportion of glucose data stored by CGM during the treatment adjustment period that is above 10.0mmol/L. **Measure:** Other Secondary Outcomes4 **Time Frame:** At the end of the treatment period **Description:** The proportion of glucose data stored by CGM during the treatment adjustment period that is above 13.3mmol/L. **Measure:** Other Secondary Outcomes5 **Time Frame:** At the end of the treatment period **Description:** The area under the curve (AUC) of glucose levels below 10.0mmol/L in the AGP during the treatment adjustment period. **Measure:** Other Secondary Outcomes6 **Time Frame:** At the end of the treatment period **Description:** The mean of the glucose data stored by CGM during the treatment adjustment period (MEAN). **Measure:** Other Secondary Outcomes7 **Time Frame:** At the end of the treatment period **Description:** The standard deviation of the glucose data stored by CGM during the treatment adjustment period (SD). **Measure:** Other Secondary Outcomes8 **Time Frame:** At the end of the treatment period **Description:** The discrepancy between the physician-approved dosage and the AI-recommended dosage in the intervention group. **Measure:** Other Secondary Outcomes9 **Time Frame:** At the end of the treatment period **Description:** The number of times the physician-approved dosage differs from the AI-recommended dosage in the intervention group. **Measure:** Other Secondary Outcomes10 **Time Frame:** At the end of the treatment period **Description:** In the intervention group, the proportion of time that the glucose levels are within the range of 3.9mmol/L to 10.0mmol/L within 4 hours after insulin injection when there is a discrepancy between the physician-approved dosage and the algorithm-recommended dosage. **Measure:** Other Secondary Outcomes11 **Time Frame:** At the end of the treatment period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Voluntary signing of an informed consent form. 2. Age between 18 and 70 years, with a T1D diagnosis of at least one year. 3. A confirmed diagnosis of T1D diabetes by at least two endocrinologists and fulfillment of at least one of the following conditions: a) Fasting C-peptide level less than 0.3 ng/mL. b) Fasting C-peptide level between 0.3 ng/mL and 0.6 ng/mL with at least one positive diabetic autoantibody. 4. Receiving intensified treatment regimen with multiple daily subcutaneous insulin injections upon screening and during the whole study period. Exclusion Criteria: 1. Conditions such as diabetic ketoacidosis, diabetic ketosis, hyperglycemic hyperosmolar state, or other acute complications related to diabetes. 2. The presence of concurrent fever, severe infections, acute abdominal conditions, uncontrolled thyroid dysfunction, or the acute phase of any organ system disease. 3. A history within the last 3 months of serious cardiovascular issues including decompensated heart failure (NYHA Class III or IV), myocardial infarction, coronary artery bypass grafting, or coronary stent implantation, as well as uncontrolled severe arrhythmias or ischemic or hemorrhagic stroke. 4. Laboratory test abnormalities that exceed certain thresholds, such as alanine transaminase or aspartate transaminase levels greater than three times the upper limit of normal, total bilirubin levels more than twice the upper limit of normal, hemoglobin levels below 100 g/L, albumin levels below 30 g/L, or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m². 5. Individuals who are required to fast or are unable to eat normally due to special circumstances. 6. Pregnant or breastfeeding women. 7. Individuals suffering from psychiatric illnesses or other cognitive impairments that may affect their ability to participate in the study. 8. Participants who are unable to wear a CGM due to severe allergies, skin diseases, or conditions at the sensor site such as lesions, scarring, redness, infection, or edema, which could interfere with the sensor's adhesion or the accuracy of glucose measurements in the interstitial fluid. 9. The systemic use of corticosteroids within the last month, with the exception of inhaled or topical steroids. 10. Any other condition or reason that the researcher deems to make the participant unsuitable for inclusion in the study. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 1 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M22554 - Name: Pancrelipase - Relevance: LOW - As Found: Unknown - ID: M13114 - Name: Pancreatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418451 **Brief Title:** A Randomized Controlled Trial of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse **Official Title:** To Compare the Clinical Efficacy and Complications of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse #### Organization Study ID Info **ID:** K5788 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2027-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lan Zhu #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Lan Zhu **Investigator Title:** Director of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background: Pelvic organ prolapse is one of the most common benign gynecological disorders in middle-aged and elderly women, and it has a significant negative impact on women's social, physical, and psychological health. Sacrospinous ligament fixation (SSLF) is one of the main surgical procedures for reconstructing pelvic floor defects. In previous studies, the ischial spine fascia fixation (ISFF) technique developed by our team has been shown to be a safe and effective alternative to SSLF. However, both procedures have inadequate support for the anterior vaginal wall. Therefore, based on the traditional ISFF, we fix the anterior vaginal wall to the ipsilateral ischial spine fascia to enhance support for the anterior vaginal wall. This modified procedure is called modified ISFF. This trial aims to compare the subjective and objective therapeutic effects, recurrence rates, quality of life, perioperative parameters, and complications of modified ISFF and SSLF in the treatment of patients with pelvic organ prolapse of degrees II-IV. Methods: This trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite surgical success rate at one-year follow-up, defined as the absence of subjective vaginal bulge symptoms, no need for retreatment, and absence of POP-Q points at or beyond the hymen or vaginal introitus, i.e., Aa, Ba, C, Ap, Bp all \< 0 cm. The secondary outcomes include anatomical outcomes of each vaginal segment based on the POP-Q score, subjective improvement in quality of life evaluated by questionnaires (PFIQ-7, PFDI-20, PISQ-12, and PGI-I), perioperative parameters (operation time, blood loss, length of hospital stay, pain VAS score, hospital costs), and complications. Data analysis will be conducted according to the intention-to-treat principle. Based on a composite success rate of 88% and a non-inferiority margin of -10% (one-sided α = 0.025, β = 0.2), 370 patients will be recruited from 9 centers, including a 10% dropout rate. The purpose of this study is to investigate whether modified ISFF is non-inferior to SSLF in terms of clinical efficacy and complications. Discussion: This multicenter non-inferiority trial will evaluate the effectiveness and safety of modified ISFF compared to SSLF in symptomatic patients with degrees II-IV uterovaginal prolapse. If modified ISFF is proven to be non-inferior to SSLF, it would be a preferable alternative for patients with a shorter vaginal length and those who have difficulties with SSLF due to anatomical factors. ### Conditions Module **Conditions:** - Pelvic Organ Prolapse ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 370 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: sacrospinous ligament fixation (SLFF) **Label:** sacrospinous ligament fixation (SLFF) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Procedure: modified ischial spinous fascia fixation (modified ISFF) **Label:** modified ischial spinous fascia fixation (modified ISFF) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - sacrospinous ligament fixation (SLFF) **Description:** SSLF is a surgical procedure used to treat vaginal apex prolapse by fixing the vaginal apex to the right sacrospinous ligament. The procedure involves marking and incising the posterior vaginal wall, dissecting the vaginal rectal space, and placing sutures on the outer one-third of the ligament. These sutures connect the vaginal apex to the attachment point of the right uterosacral ligament. Anterior/posterior vaginal wall repair procedures can be performed if needed, without using implant materials. SSLF provides enhanced support for the vaginal apex. **Name:** sacrospinous ligament fixation (SLFF) **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - modified ischial spinous fascia fixation (modified ISFF) **Description:** The modified ISFF procedure involves making a midline incision along the posterior fornix of the vagina, exposing the ischial spine fascia. Two sutures are placed around the ischial spine and passed through the mucosa of the anterior and posterior vaginal walls, lifting the vaginal apex and anterior wall towards the spine. The procedure also allows for additional anterior/posterior vaginal wall repair if necessary, without using implant materials. **Name:** modified ischial spinous fascia fixation (modified ISFF) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** 1. No sensation of vaginal bulge or protrusion, indicated by a response of "no" or a score of 0 on question 3 of the PFDI-20 questionnaire, which asks, "Do you often see or feel a bulge or something falling out of your vagina?" 2. No further treatment (surgical or non-surgical) required for POP (Pelvic Organ Prolapse). 3. Absence of POP-Q points at the hymen or beyond the hymen, indicating that Aa, Ba, C, Ap, and Bp are all \< 0cm. **Measure:** The composite success rate **Time Frame:** At the one-year follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with symptomatic mid-pelvic organ prolapse (POP-Q stage ≥ II) who may concurrently have anterior and/or posterior pelvic organ prolapse. * Patients willing to undergo long-term follow-up for at least one year. * Patients willing to sign an informed consent form and participate in this study. Exclusion Criteria: * Patients who have undergone previous POP or urinary incontinence surgery with the use of implant materials. * Patients who require simultaneous anti-urinary incontinence surgery for the current procedure. * Contraindications for general anesthesia and surgical intervention, such as severe medical comorbidities that render the patient unable to tolerate surgery. * Patients who wish to preserve the uterus. * Patients in the active phase of genital, urinary, or systemic infections. * Patients who, for other reasons (such as having genital malignancies), choose not to undergo SSLF/modified ISFF surgical intervention at the moment. * Patients who are unable or unwilling to attend follow-up visits (excluding those who may be willing to participate in telephone follow-up). **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** shellypumch@163.com **Name:** Ying Zhou, MD **Phone:** +8613681253992 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Lan Zhu, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M28618 - Name: Pelvic Organ Prolapse - Relevance: HIGH - As Found: Pelvic Organ Prolapse - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011391 - Term: Prolapse - ID: D000056887 - Term: Pelvic Organ Prolapse ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418438 **Brief Title:** A Randomized Controlled Trail of Uterosacral Ligament Suspension in the Treatment of Pelvic Organ Prolapse **Official Title:** To Compare the Clinical Efficacy and Safety of Laparoscopic Uterosacral Ligament Suspension With or Without Hysterectomy in the Treatment of POP #### Organization Study ID Info **ID:** K5787 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2027-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lan Zhu #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Lan Zhu **Investigator Title:** Director of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Pelvic organ prolapse (POP) is one of the common benign gynecological disorders in middle-aged and elderly women, which severely affects patients' quality of life and increases the social burden. The lifetime risk of undergoing surgery for POP is 12.6%. Surgery is an important treatment modality for POP, and currently, there are various surgical procedures used in clinical practice, but there is still no clear consensus on which procedure is superior. Autologous tissue repair remains crucial in pelvic floor reconstruction surgery, and high uterosacral ligament suspension (HUSLS) via a vaginal approach is a classic corrective procedure for central pelvic defects. However, with the development of minimally invasive techniques, laparoscopic uterosacral ligament suspension (LUSLS) has been widely used in the field of pelvic floor reconstruction. Compared to the vaginal approach, LUSLS is easier to perform, has a shorter learning curve, provides better exposure of the ureters, and allows for higher-quality suture placement under safe conditions. The main controversial clinical issue in the industry regarding high uterosacral ligament suspension is whether to perform uterine preservation, with the core concern being the risk of postoperative recurrence. High uterosacral ligament suspension with uterine preservation achieves level I repair by fixing the lower segment or cervix to supporting structures. Its advantages include shorter operation time, less blood loss, and the preservation of the patient's fertility. Many women request uterine preservation for various reasons. Therefore, high-quality research is needed to guide the clinical decision-making regarding uterine preservation in high uterosacral ligament suspension. Previous studies have found that approximately 40% of patients with pelvic organ prolapse have concurrent cervical elongation. For patients with cervical elongation, symptoms in the central pelvic region are mainly caused by the protrusion of elongated cervical tissue into the vagina. Removing the elongated cervix significantly reduces the need for biological support in pelvic floor reconstruction, making autologous tissue repair strategies the preferred option for this patient population while providing a foundation for uterine preservation. Based on long-term observational studies, the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital has proposed combining laparoscopic uterosacral ligament suspension with cervical amputation for the treatment of pelvic organ prolapse with cervical elongation. This study aims to compare whether uterine preservation in laparoscopic uterosacral ligament suspension is non-inferior to uterine removal, providing more treatment options for future patients with pelvic organ prolapse and cervical elongation. ### Conditions Module **Conditions:** - Pelvic Organ Prolapse ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 314 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Laparoscopic uterosacral ligament suspension with hysterectomy **Label:** Laparoscopic uterosacral ligament suspension with hysterectomy **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Procedure: Laparoscopic uterosacral ligament suspension with cervical amputation **Label:** Laparoscopic uterosacral ligament suspension with cervical amputation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Laparoscopic uterosacral ligament suspension with hysterectomy **Description:** After anesthesia, bladder stone removal patients undergo laparoscopic hysterectomy. The adnexa are coagulated and cut, and the bladder peritoneal reflection is opened. The uterus is removed transvaginally. Next, laparoscopic uterosacral ligament suspension is performed. The right and left uterosacral ligaments are freed and sutured to lift the residual end. **Name:** Laparoscopic uterosacral ligament suspension with hysterectomy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Laparoscopic uterosacral ligament suspension with cervical amputation **Description:** After anesthesia, bladder stone removal patients undergo cervical amputation surgery. The cervix is exposed and elevated using Allis forceps. A dilator is used to expand the cervix, and an incision is made on the anterior vaginal wall. The cervix is excised and shaped using the Sturmdorf method. Afterward, laparoscopic uterosacral ligament suspension is performed. The right and left uterosacral ligaments are freed and sutured to lift the uterus. **Name:** Laparoscopic uterosacral ligament suspension with cervical amputation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** 1. No sensation of vaginal bulge or protrusion, indicated by a response of "no" or a score of 0 on question 3 of the PFDI-20 questionnaire, which asks, "Do you often see or feel a bulge or something falling out of your vagina?" 2. No further treatment (surgical or non-surgical) required for POP (Pelvic Organ Prolapse). 3. Absence of POP-Q points at the hymen or beyond the hymen, indicating that Aa, Ba, C, Ap, and Bp are all \< 0cm. **Measure:** The composite success rate at the one-year follow-up **Time Frame:** At the one-year follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years with symptomatic stage II or higher uterine prolapse (C ≥ +1cm) and gynecological ultrasonography confirming cervical length ≥ 4cm. Concurrent anterior and/or posterior vaginal wall prolapse may be present. * Preoperative pelvic ultrasound and cervical screening show no abnormalities. * The patient does not have a desire for future fertility. * Willingness and ability to adhere to the follow-up treatment plan. * Competence to provide informed consent. Exclusion Criteria: * Suspected untreated lower genital tract tumor, accompanied by other uterine, ovarian, and cervical lesions requiring surgical intervention, indicating contraindication for uterine preservation. * Patients with a history of total hysterectomy/subtotal hysterectomy. * Patients who have previously undergone pelvic organ prolapse surgery or other pelvic floor surgeries. * Patients with contraindications for laparoscopic surgery, such as intestinal obstruction. * Patients with intestinal hernia. * Patients with gynecological and urinary tract infections, anticoagulant therapy, coagulation disorders, previous pelvic radiotherapy, as well as neurological or medical conditions affecting bladder and bowel function (such as multiple sclerosis, spinal cord injury, or residual neurological dysfunction caused by stroke), and patients with underlying conditions such as chronic pelvic pain, who are at higher risk for surgery. * Simultaneous anti-urinary incontinence surgery is required for this procedure. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** shellypumch@163.com **Name:** Ying Zhou, MD **Phone:** +8613681253992 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Lan Zhu, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M28618 - Name: Pelvic Organ Prolapse - Relevance: HIGH - As Found: Pelvic Organ Prolapse - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011391 - Term: Prolapse - ID: D000056887 - Term: Pelvic Organ Prolapse ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418425 **Acronym:** EPPIC **Brief Title:** Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore **Official Title:** EPPIC Trial: Exercise Program and Protein Intake Counselling for Frailty Prevention in Singapore #### Organization Study ID Info **ID:** 2023/00860 #### Organization **Class:** OTHER_GOV **Full Name:** National Healthcare Group Polyclinics #### Secondary ID Infos **Domain:** NHG ENHANCED POPULATION HEALTH FUND (EPHF) **ID:** EPHF-C/2023/POV/S/4 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-04-18 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-18 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** National Healthcare Group, Singapore #### Lead Sponsor **Class:** OTHER_GOV **Name:** National Healthcare Group Polyclinics #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a randomized controlled trial that is designed to study the effectiveness of home-based exercise program and high dietary protein counselling in preventing frailty among elderly in Singapore primary care setting. **Detailed Description:** The investigators are studying the elderly population who have prefrailty (Fried Frailty). Participants include those who are: a) Aged 65 to 100 years old b) screened CFS 3-4 with prefrailty in Fried Frailty Criteria. Patients will be approached via phone call by care coordinators, as part of the routine care. As part of the routine care to our chronic patients, care coordinators identify eligible patients for annual screening to update personal particulars/ cancer screening and vaccination statuses as per the Healthier SG program before patient's chronic disease appointment. Also as part of the routine care, care coordinators will screen for CFS 3 and 4 patients over the phone. Patients who fulfil CFS 3 and 4 will be arranged to have a physical consultation with care coordinators on their day of prescheduled visit in the clinic. Patients meeting the eligibility criteria for the study, will be approached by the care coordinator to ask for research interest. If interested in participating, patients will be referred to the research team member for secondary screening after pre-screening informed consent is taken. Participants who fulfil prefrailty in Fried Frailty criteria will be recruited and consent will be taken. Participants will then be randomly assigned to "intervention" or "usual care" parallel arms. Randomisation of participants will be done on 1:1 allocation to intervention or usual care by a simple randomisation procedure. Participants randomly assigned to the usual care group will receive normal primary care, including dietitian and physiotherapy services if needed. Intervention participants will receive the described intervention on top of usual care. Intervention participants will be taught specific resistance and balance exercises and participants will receive a leaflet with pictorial guide on the home based exercise regime. The participants will be advised to consume adequate protein and participants will also receive another leaflet on protein consumption as part of a balanced diet. At the 3 month and 12 month mark, participants in the intervention group will see the care coordinator who will assess compliance and re-enforce the exercise regime and dietary protein intake counselling, and check for any difficulties faced. ### Conditions Module **Conditions:** - Frailty **Keywords:** - frailty - pre-frailty - primary care - exercise - high protein diet - nutrition ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants meeting the eligibility criteria, will be approached by the care coordinator. If interested in participating, they will be referred to the research team member for secondary screening. Those who fulfil prefrailty in Fried Frailty criteria will be recruited and consent will be taken. Participants will then be randomly assigned to "intervention" or "usual care" parallel arms. Randomisation of participants will be done on 1:1 allocation to intervention or usual care using a simple randomisation procedure. Allocation will be concealed using opaque envelopes. ##### Masking Info **Masking:** SINGLE **Masking Description:** Research coordinator who assesses the outcomes will be blinded. This clinical research coordinator is different from the one taking the informed consent and performing the randomisation. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants randomly assigned to the intervention group will be taught specific resistance, balance and aerobic exercises by the care co-ordinator and participants will receive a leaflet with pictorial guide on the home-based exercise regime. The participants will be given a monitoring log to record the date and frequency of exercise they do. The participants will be advised to consume adequate protein and they will also receive another leaflet on protein consumption as part of a balanced diet. **Intervention Names:** - Behavioral: counselling on home-based exercise program and dietary protein intake **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the control group will receive usual care at the polyclinic which does not include counselling on dietary protein intake and home-based exercise program. **Label:** Usual Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Participants in the intervention group will be on a home-based exercise program and go through counselling on dietary protein intake with the aim of achieving prevention of frailty status. Participants will be required to attend the 3 study visits throughout the study period. Research procedures include physical measurements (eg. Weight, height, waist and hip circumference, calf circumference, hand grip strength, blood pressure, short physical performance battery tests), administration of questionnaires on sociodemographics, physical activity, dietary habits, smoking, alcohol, health conditions, health-related quality of life, clinical frailty status and sarcopenia screening. At three months and twelve months, the intervention group participants will see the care coordinators who will check their compliance to the exercise programme and high protein diet, reinforce the interventions. **Name:** counselling on home-based exercise program and dietary protein intake **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Measured with Fried Frailty phenotype model which measures exhaustion, unintentional weight loss, gait speed, low energy and hand grip strength. Participants with 3 or more affected domains are frail, those with 1-2 affected domains are pre-frail, and those with no affected domains are robust. **Measure:** Frailty (Fried Frailty) **Time Frame:** Baseline, 3 months, 12 months #### Secondary Outcomes **Description:** The CFS is a scale that ranges from 1 to 9, with each number representing a different level of frailty, depending on the physical activity level, fatigue level and functional level of the participant. The care-coordinator will assign a CFS score after a brief assessment of the participant. Additionally, the participant will also completed a self-rated CFS questionnaire (CFS-self) that will rate their CFS level. CFS 1 is very fit, with progressive frailty status down the scale to maximum CFS 9 for terminally ill. **Measure:** Clinical Frailty Scale (CFS) **Time Frame:** Baseline, 3 months, 12 months **Description:** The SPPB (score range 0-12) consists of chair-stand, gait speed and standing balance. In the balance test, the participant will be made to stand in three different feet positions (side-by-side, semi-tandem, tandem) for 10 seconds each and will be scored for how long they are able to hold that position. The gait speed test will score the participants based on how long they take to walk three meters. Lastly, the chair rise test will score the participants on how long they take to complete five raises from a seated position in a chair. **Measure:** Short Physical Performance Battery (SPPB) **Time Frame:** Baseline, 3 months, 12 months **Description:** Measured by the EuroQoL 5 Dimensions - 5L (EQ5D-5L) and the EuroQoL 5 Visual Analogue Scale (EQ5D-VAS). The EQ5D-5L consists of two components, the first component is the healthstate Utility Index (UI). It measures five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression) on a five-point severity scale (no problems, slight problems, moderate problems, severe problems and extreme problems). The Singapore time trade-off values will be used to convert the information into UI scores, with -0.790 being the worst health state and 1.000 being the best health state. The second component of the EQ5D is the visual analogue scale (VAS) which consists of a scale from 0 to 100. It assesses self-perceived global levels of health, with 0 representing the worst imaginable health state and 100 the best imaginable health state. **Measure:** Health-related Quality of life **Time Frame:** Baseline, 3 months, 12 months **Description:** According to the Asian Work Group of Sarcopenia (AWGS) 2019 criteria, which is SARC-Calf more than or equal to 11 and poor handgrip strength (\<28kg for men and \<18kg for women). The SARC-Calf is a combination of assessments for the SARC-F questionnaire and calf-circumference. The SARC-F questionnaire has 5 items measuring self-reported strength, assistance in walking, difficulty rising from a chair, difficulty in climbing stairs, and falls in the past year. Each item requires a response of "None" or "Some" or "Great difficulty", except for the last item on falls which has responses of "None" or "1-3 falls" or "4 or more falls". The calf circumference measures the maximum value of both calves using a non-elastic tape, with a cut-off of \<34cm for men and \<33cm for women for sarcopenia case finding. Each item of the SARC-Calf is scored 0-2 and the items are summed together to give a total score. **Measure:** Sarcopenia **Time Frame:** Baseline, 3 months, 12 months **Description:** Measured by International physical activity questionnaire (IPAQ). 3.3 METs for low level, 4.0 METs for moderate level, and 8.0 METs high level of physical activity. **Measure:** Physical activity **Time Frame:** Baseline, 3 months, 12 months **Description:** Measured by 24-hour dietary recall and food frequency on protein sources. Participants will be asked to recall the food or drink they consumed the previous day in detail. The information collected will be analyzed to quantify daily protein intake in grams. Additionally, participants will be asked to complete a brief food frequency questionnaire on various protein sources. **Measure:** Dietary Protein Intake **Time Frame:** Baseline, 3 months, 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 65 - 100 years old * CFS score of 3 or 4 and Prefrail in Fried Frailty Criteria * Community dwelling * On chronic disease follow up with polyclinic * Ability to communicate in English or Mandarin * Able to understand the study and give consent Exclusion Criteria: * Individuals with existing dietitian/ physiotherapy intervention (Individuals who are already seeing dietitian for special delivery requirements, or seeing physiotherapist for musculoskeletal exercises for specific condition or injury) * Institutionalized individuals * Individuals with significant medical conditions limiting their physical activity or high protein diet, such as severe heart conditions, recent strokes, active malignancy, chronic kidney disease stage 3-5 etc. * Terminal illness with life expectancy \< 12 months * severe audiovisual impairment * Not able to communicate in English or Mandarin * Pregnant women ( as population involves participants beyond childbearing age, investigators do not expect to include pregnant women in this study) **Maximum Age:** 100 Years **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** pui_mun_liew@nhgp.com.sg **Name:** Liew Pui Mun Doctor, MBBS **Phone:** 63553000 **Role:** CONTACT #### Locations **Location 1:** **City:** Singapore **Contacts:** ***Contact 1:*** - **Name:** Pui Mun Liew, MBBS - **Role:** CONTACT **Country:** Singapore **Facility:** Ang Mo Kio Polyclinic **Status:** RECRUITING **Zip:** 569666 #### Overall Officials **Official 1:** **Affiliation:** National Healthcare Group Polyclinic **Name:** Liew Pui Mun Doctor, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Serra-Prat M, Sist X, Domenich R, Jurado L, Saiz A, Roces A, Palomera E, Tarradelles M, Papiol M. Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial. Age Ageing. 2017 May 1;46(3):401-407. doi: 10.1093/ageing/afw242. **PMID:** 28064172 **Citation:** Travers J, Romero-Ortuno R, Bailey J, Cooney MT. Delaying and reversing frailty: a systematic review of primary care interventions. Br J Gen Pract. 2019 Jan;69(678):e61-e69. doi: 10.3399/bjgp18X700241. Epub 2018 Dec 3. **PMID:** 30510094 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Frailty ### Condition Browse Module - Meshes - ID: D000073496 - Term: Frailty ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418412 **Brief Title:** A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC **Official Title:** A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated Non-small Cell Lung Cancer (NSCLC) #### Organization Study ID Info **ID:** ATORG006 #### Organization **Class:** OTHER **Full Name:** National Cancer Centre, Singapore ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Cancer Centre, Singapore #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** There are limited in depth studies on the epidemiology and clinical management of EGFR exon 20 insertion mutated NSCLC in Asia. In addition, there is preliminary data suggesting the exact location of the insertion and variant may influence the response and efficacy to novel EGFR targeted therapies. This study aims to fill this knowledge gap, by comprehensively characterising the epidemiology and clinical outcomes of Asian advanced EGFR exon 20 insertion mutated NSCLC patients. **Detailed Description:** This study will be a multi-center observational study and will enroll patients with advanced EGFR exon 20 insertion mutated NSCLC. The study will include patients recruited from countries across Asia, including sites in, but not limited to - Hong Kong, Korea, Singapore, Taiwan and Thailand. There will be approximately 20-30 sites recruiting for the study. In Singapore, sites may include National Cancer Centre Singapore (NCCS), National University Hospital (NUH) and Tan Tock Seng Hospital (TTSH). Approximately 600 patients will be enrolled retrospectively. ### Conditions Module **Conditions:** - Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer **Keywords:** - EGFR EXON20 insertion - NSCLC (Non small cell lung cancer) ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Time from diagnosis to death. **Measure:** Overall survival (OS) **Time Frame:** Up to 10 years. **Description:** Time from start of treatment regimen to end of treatment regimen. **Measure:** Duration of therapy (DOT) **Time Frame:** Up to 10 years. **Description:** Time from start of treatment regimen to disease progression or death. **Measure:** Real-world progression-free survival (PFS) **Time Frame:** Up to 10 years. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically confirmed advanced NSCLC 2. Positive testing result from any locally approved test (including but not limited to RT-PCR, Cobas and NGS) for EGFR exon 20 insertion mutation 3. Diagnosis date from 1 Jan 2013 to 31 Dec 2022 (to allow for minimum 12 months of follow-up clinical and treatment outcome data) 4. Male or female adults, age as defined by local regulations Exclusion Criteria: 1. Patients without an EGFR exon 20 insertion mutation **Maximum Age:** 99 Years **Minimum Age:** 21 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with advanced EGFR exon 20 insertion mutated NSCLC. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** justine.chu.j.h@nccs.com.sg **Name:** Justine Chu **Phone:** +65 64368000 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Name:** Dong-Wan Kim - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Seoul National University Hospital **Status:** RECRUITING **Location 2:** **City:** Singapore **Contacts:** ***Contact 1:*** - **Email:** aaron.tan@singhealth.com.sg - **Name:** Aaron C. Tan, MBBS, PhD - **Phone:** +65 6436 8000 - **Role:** CONTACT ***Contact 2:*** - **Email:** daniel.tan.s.w@singhealth.com.sg - **Name:** Daniel SW Tan, BSc, MBBS, PhD - **Phone:** +65 6436 8000 - **Role:** CONTACT **Country:** Singapore **Facility:** National Cancer Centre, Singapore **Status:** RECRUITING **Zip:** 168583 **Location 3:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Name:** Jin-Yuan Shih - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** National Cancer Centre, Singapore **Name:** Aaron C. Tan, MBBS, PhD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** National Cancer Centre, Singapore **Name:** Daniel SW Tan, BSc, MBBS, PhD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Seoul National University Hospital **Name:** Dong-Wan Kim, MD, MS, PhD **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** National Taiwan University Hospital **Name:** Jin-Yuan Shih, MD, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418399 **Brief Title:** The Role of Central Sensitization in Pain, Functionality, and Quality of Life in Cancer Patients **Official Title:** The Role of Central Sensitization in Pain, Functionality, and Quality of Life in Cancer Patients #### Organization Study ID Info **ID:** 22.04.2024.354 #### Organization **Class:** OTHER **Full Name:** Marmara University ### Status Module #### Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Marmara University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Pain is one of the most important and challenging symptoms in cancer patients. Depending on the stage of cancer, approximately 40% to 70% of patients complain of pain. With the increasing lifespan of cancer patients due to developing treatments, pain palliation has become even more crucial to improve their quality of life. Cancer-related pain can develop through multiple mechanisms such as the tumor itself, metastasis, or the methods used in treatment. The type of pain can be nociceptive, neuropathic, or mixed. Central sensitization refers to the increased response of central nervous system nociceptive neurons to normal or subthreshold stimuli. Recently, central sensitization (CS) has been recognized as a potential pathophysiological mechanism underlying a group of chronic pain diseases such as fibromyalgia, temporomandibular joint disorder, irritable bowel syndrome, interstitial cystitis, tension-type headache, and chronic low back pain. Since pain perception varies from person to person, physicians should assess the character of pain thoroughly and not rely solely on peripheral pain treatment in cases with a component of central sensitization. The lack of evaluation of the extent to which central sensitization affects patients and the failure to fully determine the factors influencing it appear to be clinical limitations for now. There are studies suggesting that central sensitization may be a significant factor in chronic refractory pain in cancer patients, indicating the need for consideration of alternative options to classical treatments. To the best of our knowledge, no study has been conducted in Turkey to investigate the frequency of central sensitization and its impact on treatment outcomes in chronic cancer pain patients visiting outpatient clinics. The aim of this study is to investigate the frequency of central sensitization and its effect on pain and quality of life in chronic cancer pain patients attending algology clinics in multiple centers in Turkey. ### Conditions Module **Conditions:** - Central Sensitization **Keywords:** - Central Sensitization - cancer patients ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included. **Name:** cancer patients **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Central sensitization is a common condition in cancer patients and has negative consequences on pain, functionality, and quality of life. **Measure:** The frequency of central sensitization in cancer patients can be determined. **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 18 and 80 years 1. Diagnosis of cancer confirmed pathologically 2. Experiencing cancer or cancer treatment-related pain complaints for more than 3 months Exclusion Criteria: * 1.Patients with chronic pain not related to cancer will be excluded from the study 2.Patients who do not provide consent to participate in the study 3.Patients with conditions such as dementia, traumatic brain injury, advanced psychiatric disorders (schizophrenia, etc.), chromosomal disorders (Down syndrome), genetic diseases (fragile X syndrome), and neurodegenerative diseases that may lead to mental disorders. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients aged between 18 and 80 years with cancer-related pain lasting for more than 3 months will be included. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** savas-44@hotmail.com **Name:** Savaş Şencan, Assoc. Prof. **Phone:** 5370665713 **Phone Ext:** +90 **Role:** CONTACT **Contact 2:** **Email:** ronaybozyel@gmail.com **Name:** Ronay Bozyel, M.D. **Phone:** 5392320689 **Phone Ext:** +90 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Marmara University Faculty of Medicine, Department of Pain Medicine **Name:** Savaş Şencan, Assoc. Prof. **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Marmara University Faculty of Medicine, Department of Pain Medicine **Name:** Serdar Kokar, Assoc. Prof. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** The study is planned as multicenter, and data transfer will be conducted with other centers. **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Bouhassira D, Luporsi E, Krakowski I. Prevalence and incidence of chronic pain with or without neuropathic characteristics in patients with cancer. Pain. 2017 Jun;158(6):1118-1125. doi: 10.1097/j.pain.0000000000000895. **PMID:** 28267066 **Citation:** Petersel DL, Dror V, Cheung R. Central amplification and fibromyalgia: disorder of pain processing. J Neurosci Res. 2011 Jan;89(1):29-34. doi: 10.1002/jnr.22512. **PMID:** 20936697 **Citation:** Smart KM, Blake C, Staines A, Thacker M, Doody C. Mechanisms-based classifications of musculoskeletal pain: part 1 of 3: symptoms and signs of central sensitisation in patients with low back (+/- leg) pain. Man Ther. 2012 Aug;17(4):336-44. doi: 10.1016/j.math.2012.03.013. Epub 2012 Apr 23. **PMID:** 22534654 **Citation:** Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18. **PMID:** 20961685 **Citation:** Nishigami T, Manfuku M, Lahousse A. Central Sensitization in Cancer Survivors and Its Clinical Implications: State of the Art. J Clin Med. 2023 Jul 11;12(14):4606. doi: 10.3390/jcm12144606. **PMID:** 37510721 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418386 **Brief Title:** Bacterial Reduction of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars **Official Title:** Clinical Assessment of Antimicrobial Effect of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars #### Organization Study ID Info **ID:** M18060722 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2024-05-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-15 **Type:** ACTUAL #### Start Date **Date:** 2022-09-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Investigator Affiliation:** Mansoura University **Investigator Full Name:** Menna Mahgoub **Investigator Title:** principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will evaluate and compare the microbial efficacy of rotary and manual filing system using Neem extract, NaOCL and saline . with hypotheses that neem can used alternative to sodium hypochlorite and there is no difference between rotary and manual filling in bacterial reduction. **Detailed Description:** The calculated sample size of the study will be 22 participants for each group at 5% level of significance and 80 % power 30 participants for each group (10 for The sample size will be increased tocompensate for incomplete data and to increase the study each subgroup) topower Grouping: 30 child will be selected from the Pediatric Clinic, Faculty of Dentistry, Mansoura University .the child should have 2 contralateral primary molars indicated for pulpectomy. The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file. Then the children will be randomly sub grouped according to irrigant that will be used: Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl . clinical procedures : 1. Psychological management of child 2. X-ray for inclusion criteria 3. The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution 4. . All carious tissue will be removed by sterilized round bur and root canal access will be done 5. On gaining the access, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. 6. A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). 7. In-group 1 will be prepared with manual files the irrigation with saline in IA, with neem in IB and irrigation with NaOCl in IC. 8. In group II will be prepared with rotary files the irrigation with saline in IIA, with neem in IIB, with NaOCl in IIC 9. The sterile paper point will be introduced into root cannel and will be left for 1 min, the paper point will be removed with sterilized tweezer and then transferred to a tube containing transport medium 19. 10. Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory. 11. Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown Laboratory procedures : 1. All samples will be incubated on blood agar aerobically and anaerobically at 37 for 48-72 hours and aspectically streak the plates 19,20. 2. Identification of bacteria by culture characteristics ,microscopic examination and biochemical reaction 21. 3. Number of colony forming unit will be counted (CFU/ml) ### Conditions Module **Conditions:** - Necrotic Pulp ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file. Then the children will be randomly sub grouped according to irrigant that will be used: Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** manual k files for pulpectomy and normal saline irrigation **Intervention Names:** - Procedure: manual saline IA **Label:** manual saline **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** manual k files and 100% neem extract **Intervention Names:** - Procedure: manual neem IB **Label:** manual neem extract **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** mannul k files and 1% sodium hypochlorite **Intervention Names:** - Procedure: manual sodium hypochlorite IC **Label:** manual sodium hypochlorite **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** AF baby files for pediatric( fanta ) and normal saline **Intervention Names:** - Procedure: rotary saline IIA **Label:** rotary saline **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** AF baby files for pediatric( fanta ) and 100% NEEM EXTRACT **Intervention Names:** - Procedure: rotary neem IIB **Label:** rotary neem **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** AF baby files for pediatric( fanta ) and 1% sodium hypochloride **Intervention Names:** - Procedure: rotary sodoium hypochlorite IIC **Label:** rotary sodium hypochloride **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - manual saline **Description:** * The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution, All carious tissue will be removed by hight speed handpiece, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min ,The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium),using manual k file starting with #15 and irrigation with normal saline * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown **Name:** manual saline IA **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - manual neem extract **Description:** * The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution * . All carious tissue will be removed by high speed hand piece , distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using manual file and irrigation with neem leaf extract 100% * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown **Name:** manual neem IB **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - manual sodium hypochlorite **Description:** * adjacent rubber dam will be disinfected with tincture of iodine solution * . All carious tissue will be removed by hight speed hand piece * distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using manual file and irrigation with 1% sodium hypochlorite * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown **Name:** manual sodium hypochlorite IC **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - rotary saline **Description:** * shaping and cleaning done with using AF baby fanta files open file:#17 taper 08,then #20 taper 04 ,yellow then #25 taper 04 red , then #30 taper 04 blue . the files activated with torque 2 and speed 350 . Irrigation with normal saline * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then restored with glass inomar and stainless steel crown **Name:** rotary saline IIA **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - rotary neem **Description:** * The procedural tooth is anesthetized and isolated with rubber dam as mentioned * All carious tissue will be removed by high speed hand piece ,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using AF baby fanta files SAME AS METION BEFORE ,and irrigation with 100%neem extract * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown **Name:** rotary neem IIB **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - rotary sodium hypochloride **Description:** * The procedural tooth is anesthetized and isolated with rubber dam as mentioned * All carious tissue will be removed by hight speed hand piece,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using AF baby fanta files SAME AS MENTION BEFORE , and irrigation with 1% sodium hypochlorite * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown **Name:** rotary sodoium hypochlorite IIC **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** number of of colony forming units less the better instrumentation technique and irritant **Measure:** number of of colony forming units **Time Frame:** 48 hours after culture ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age group 4 -8 years. * good health. * No recent history of antibiotic coverage for at least two weeks * necrotic teeth. * restorable tooth structure. Exclusion Criteria: * more than 2/3 resorption of root. * uncooperative patient. * detection perforation on radiograph. **Healthy Volunteers:** True **Maximum Age:** 8 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Mansoura **Country:** Egypt **Facility:** Mansoura University **Zip:** 35516 #### Overall Officials **Official 1:** **Affiliation:** Mansoura University **Name:** mansoura university **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Susila AV, Sai S, Sharma N, Balasubramaniam A, Veronica AK, Nivedhitha S. Can natural irrigants replace sodium hypochlorite? A systematic review. Clin Oral Investig. 2023 May;27(5):1831-1849. doi: 10.1007/s00784-023-04913-7. Epub 2023 Feb 18. **PMID:** 36808559 **Citation:** Sundaram D, Narayanan RK, Vadakkepurayil K. A Comparative Evaluation on Antimicrobial Effect of Honey, Neem Leaf Extract and Sodium Hypochlorite as Intracanal Irrigant: An Ex-Vivo Study. J Clin Diagn Res. 2016 Aug;10(8):ZC88-91. doi: 10.7860/JCDR/2016/19268.8311. Epub 2016 Aug 1. **PMID:** 27656571 **Citation:** Lakshmanan L, Jeevanandan G. Microbial Evaluation of Root Canals after Biomechanical Preparation with Manual K-files, Manual H-files, and Kedo-SG Blue Rotary Files: An In Vivo Study. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):687-690. doi: 10.5005/jp-journals-10005-2457. **PMID:** 36866149 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009336 - Term: Necrosis - ID: D000010335 - Term: Pathologic Processes - ID: D000003788 - Term: Dental Pulp Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6986 - Name: Dental Pulp Necrosis - Relevance: HIGH - As Found: Necrotic Pulp - ID: M6984 - Name: Dental Pulp Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003790 - Term: Dental Pulp Necrosis ### Intervention Browse Module - Ancestors - ID: D000004202 - Term: Disinfectants - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: Micro - Name: Micronutrients - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M15775 - Name: Sodium Hypochlorite - Relevance: HIGH - As Found: Cash - ID: M44557 - Name: Eusol - Relevance: HIGH - As Found: Cash - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown - ID: M229695 - Name: Cadexomer iodine - Relevance: LOW - As Found: Unknown - ID: M7383 - Name: Disinfectants - Relevance: LOW - As Found: Unknown - ID: T237 - Name: Neem - Relevance: HIGH - As Found: Tissue regeneration ### Intervention Browse Module - Meshes - ID: D000012973 - Term: Sodium Hypochlorite - ID: C000024611 - Term: Eusol ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418373 **Brief Title:** Development and Polit Study of Get Ready With my Heart Program **Official Title:** Development and Polit Study of an Intervention Program to Enhance the Transition Readiness of Adolescents With Congenital Heart Disease #### Organization Study ID Info **ID:** CHFudanU0505 #### Organization **Class:** OTHER **Full Name:** Children's Hospital of Fudan University ### Status Module #### Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Children's Hospital of Fudan University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if the Get Ready with my Heart Program developed based on SMART theory is applicable for AYAs with CHD to enhance their Transition Readiness. The main questions it aims to answer are: 1. Is the Get Ready with my Heart Program clinically feasible？ 2. Does the Get Ready with my Heart Program improve participants' Transition Readiness? Participants will: 1. The intervention group will receive interventions according to the Get Ready with my Heart Program, while the control group will receive standard interventions. 2. Outcome measures will be collected before the implementation of the program, and at 3 months and 6 months after the implementation. **Detailed Description:** China currently has the highest number of congenital heart disease (CHD) patients in the world, placing a heavy disease burden on the country. As the number of adolescent CHD patients continues to grow, the strain on pediatric healthcare systems increases significantly, which in turn imposes a serious disease burden on families and society. Over the past thirty years, the overall health of children and adolescents in China has greatly improved, but they are now facing new health issues and societal challenges. For example, unhealthy lifestyle behaviors are prevalent, and mental health issues are on the rise. Additionally, as treatment levels have improved, the focus of congenital heart disease care has shifted from simply improving survival rates to enhancing management throughout the entire lifecycle and overall prognosis. Effective transitional care management not only helps improve patients' self-management abilities and adherence to treatment but also reduces the socio-economic burden and enhances patients' quality of life. However, studies show that only a minority of adolescent CHD patients successfully complete this transition, highlighting the urgent need to strengthen transitional care management. The purpose of this clinical pilot trial is to verify the feasibility and effectiveness of a management program designed to improve the transition readiness of adolescents with congenital heart disease based on the SMART model. ### Conditions Module **Conditions:** - Transition to Adult Care - Congenital Heart Disease **Keywords:** - Transition to adult care - CHD - Adolescent ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Based on the current congenital heart disease care standards at Fudan University Children's Hospital, health education and medical management for adolescent CHD **Intervention Names:** - Behavioral: Conventional intervention **Label:** Conventional intervention group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients and their caregivers implement the "Get Ready with My Heart Program" **Intervention Names:** - Behavioral: Get Ready with My Heart Program - Behavioral: Conventional intervention **Label:** Intervention group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** In the intervention group, adolescent CHD patients undergo a comprehensive assessment by cardiology and cardiothoracic experts to determine their suitability for transitional care management. Based on the "Get Ready with My Heart Program," a personalized transition plan is developed, offering courses and resources that enhance self-management skills such as medication management, symptom monitoring, and health record maintenance. Throughout the transition period, regular support and follow-ups are provided to ensure that both patients and their families are adequately supported. The program includes regular assessments of transition readiness and quality of life changes to understand the intervention's impact and make necessary adjustments. Additionally, feedback is actively collected from patients and their families to continuously improve and refine the program. **Name:** Get Ready with My Heart Program **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Conventional intervention group - Intervention group **Description:** Adolescent CHD patients and their caregivers receive comprehensive health education and medical management. Upon admission, a detailed assessment of each patient's medical history and physical examination is conducted. A treatment and perioperative care plan is then tailored, including medication management with anticoagulants and antiarrhythmics, and surgery-related health guidance. Regular cardiac monitoring and follow-up assessments ensure treatment effectiveness and health status updates. Post-discharge, patients receive lifestyle management advice through remote consultations, focusing on diet and physical activity. Additionally, training on recognizing and managing emergencies is provided, equipping patients and caregivers to handle potential crises effectively. This holistic approach aims to improve both immediate and long-term health outcomes for adolescent CHD patients. **Name:** Conventional intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Evaluate the transition readiness levels of adolescent CHD patients using the Chinese version of Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) . The questionnaire includes a total of 13 items across three categories: self-management (5 items), disease knowledge (3 items), and patient-doctor communication (5 items). It uses a 5-point Likert scale ranging from "never" to "always" or "very difficult" to "very easy," with scores assigned from 1 to 5 respectively. The maximum score and minimal score for the questionnaire is 65 points and 13 points, , with higher scores indicating higher levels of self-management and transition readiness. The questionnaire is available in both parent-reported and self-reported versions, to be filled out by the adolescent CHD patients and their primary caregivers, with consistent assessment content and scoring methods. **Measure:** Self-Management and Transition to Adulthood with Rx = Treatment (STAR(x)) Questionnaire **Time Frame:** before，3 and 6 months after intervention #### Secondary Outcomes **Description:** Evaluated using the Chinese version of the Pediatric Quality of Life Inventory Cardiac Module (PedsQLTM 3.0 Cardiac Module)，The PedsQL 3.0 Cardiac Module consists of 22 items across five dimensions: heart problems and symptoms (5 items), perceived physical appearance (3 items), treatment anxiety (4 items), cognitive psychological issues (5 items), and communication issues (3 items). Additionally, a medication treatment issue section (5 items) is included for children who are currently undergoing medication treatment. It uses a 5-point Likert scale ranging from 0 (Never) to 4 (Almost always). Higher scores indicate a better quality of life. **Measure:** Health-related quality of life for adolescent CHD patients **Time Frame:** before and 6 months after intervention **Description:** Assessed using the General Self-Efficacy Scale (GSES) to evaluate patients' general self-efficacy and CHD disease knowledge. The Chinese version of the General Self-Efficacy Scale consists of 10 items, using a 4-point Likert scale ranging from 1 to 4. The scores of the 10 items are summed and then divided by 10 to calculate the overall scale score. A higher score indicates a higher sense of general self-efficacy. **Measure:** Transition skill levels for adolescent CHD patients-- General Self-Efficacy **Time Frame:** before and 6 months after intervention **Description:** Assessed using the Chinese version of the Leuven Knowledge Questionnaire for Congenital Heart Disease (LKQCHD) to evaluate patients' general CHD disease knowledge.The Chinese version of the LKQCHD consists of 27 items that assess the knowledge of children with congenital heart disease and their caregivers across four dimensions: (1) disease and treatment; (2) complications and prevention; (3) physical activity; (4) sexuality and genetics. The accuracy rate is calculated as the number of items correctly identified as "correct" divided by the total number of items, multiplied by 100%. **Measure:** Transition skill levels for adolescent CHD patients--Knowledge **Time Frame:** before and 6 months after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age between 12 and 21 years; 2. Diagnosed with congenital structural heart disease for at least 6 months; 3. Regularly receiving outpatient follow-up at Fudan University Children's Hospital; 4. Cognitive abilities corresponding to age, with adequate reading and comprehension skills; 5. Informed consent provided. Exclusion Criteria: 1. Patients with physical conditions that limit participation (e.g., severe heart failure); 2. Presence of other congenital malformations (e.g., various syndromes caused by chromosomal abnormalities); 3. Patients with psychiatric disorders such as schizophrenia, intellectual disabilities, visual impairments, or other conditions that preclude participation in the study. **Maximum Age:** 21 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Children's Hospital of Fudan University **Zip:** 201102 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Disease - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases - ID: D000006330 - Term: Heart Defects, Congenital ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnCoag - Name: Anticoagulants ### Intervention Browse Module - Browse Leaves - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418360 **Brief Title:** Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis **Official Title:** Evaluation of The Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis #### Organization Study ID Info **ID:** E2-23-3792 #### Organization **Class:** OTHER **Full Name:** Ankara City Hospital Bilkent ### Status Module #### Completion Date **Date:** 2023-11-23 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-23 **Type:** ACTUAL #### Start Date **Date:** 2023-03-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara City Hospital Bilkent #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings of patients. Methods: A total of 54 patients, aged between 40 and 75 years, were randomly divided into two groups. Both groups received CPT. Group 2 received TECAR therapy in addition to CPT, applied three times a week for two weeks, for a total of 6 sessions. All patient's knee joint range of motion (ROM) was measured goniometrically, isometric quadriceps muscle strength was measured, and pain levels were assessed using the Visual Analog Scale (VAS), and disability levels were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) before treatment, at the end of treatment, at 1 month, and at 3 months. ### Conditions Module **Conditions:** - Knee Osteoarthritis - Energy Transfer Capacitative and Resistive Therapy **Keywords:** - knee pain, osteoarthritis, capacitative and resistive energy transfer therap ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 54 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group 1 (HP, TENS, knee isometric and theraband exercise) to painful side knee area, two weeks, five times a week, 10 sessions. **Intervention Names:** - Device: conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack **Label:** conventional physical therapy (CPT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Group 2 (HP, TENS, knee isometric and theraband exercise) 10 sessions, two weeks, five times a week and in addition TECAR therapy, to painful side knee quadriceps and peripatellar area, three times a week for two weeks, for a total of 6 sessions. **Intervention Names:** - Device: TECAR **Label:** conventional physical therapy (CPT) and TECAR therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - conventional physical therapy (CPT) and TECAR therapy **Description:** Transfer Energy Capacitative and Resistive Therapy **Name:** TECAR **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - conventional physical therapy (CPT) **Description:** 10 sessions of HP and TENS for two weeks, five times a week. HP was applied to the painful knee area for 20 minutes using a heating pad for superficial heating purposes. TENS was applied to the painful knee area for 20 minutes at 80 Hz frequency **Name:** conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** 0 min , 10 is maximum pain score **Measure:** Visual Analog Scale (VAS) **Time Frame:** Before and the after treatment 0th day , 1th month, 3rd month **Description:** This 24-item index comprises three subscales: pain, stiffness, and physical function, each measured on a five-point Likert scale ranging from "none" to "extreme." **Measure:** Western Ontario and McMaster Universities Arthritis Index (WOMAC) **Time Frame:** Before and the after treatment 0th day, 1th month, 3rd month **Description:** Flexion and extension of the knee joint were measured using a universal goniometer relative to reference points. **Measure:** Range of Motion (ROM) **Time Frame:** Before and the after treatment 0th day, 1th month, 3rd month #### Secondary Outcomes **Description:** quadriceps muscle Isometric Strength Measure: Increased isometric muscle strength is an indicator of recovery. **Measure:** The Diers Myoline Isometric Muscle Strength Measurement System **Time Frame:** Before and the end of treatment 0th day, 1th month, 3rd month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 3 months of conservative treatment for unresponsive knee pain * Kellgren-Lawrence grade 2-3 on radiographic evaluation * Agreed to participate in the study. Exclusion Criteria: * History of physical therapy (electrotherapy/exercise) in the past 3 months * Intra-articular injection therapy in the past 3 months, * History of surgery or trauma to the affected knee * Inflammatory or neurological disease affecting the lower extremities * Active vasculitis or severe peripheral vascular disease * Pregnancy or lactation * Diagnosed restless legs syndrome * Neoplasia * Local sensory impairment, * Local or systemic acute infections * Severe osteoporosis * Pacemaker * Psychiatric disorder and cognitive impairment. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Özge TEZEN ### IPD Sharing Statement Module **Description:** participant data will not share **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418347 **Brief Title:** Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females **Official Title:** Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole #### Organization Study ID Info **ID:** ALA on PCOS #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-03-29 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This research study aims to investigate the effect of adding Alpha lipoic acid (ALA) supplement to letrozole treatment in infertile women with polycystic ovary syndrome (PCOS). The study will include 150 PCOS participants seeking fertility treatment. They will be randomly divided into two groups - control and intervention. Both groups will receive standard PCOS care including lifestyle counseling. The control group will be treated with letrozole only. The dose will start at (2.5 mg) for 5 days and can increase up to (7.5 mg) based on response. The intervention group will take ALA supplements along with letrozole treatment. ALA tablets (600mg) will be given three times daily starting from day 3 of the menstrual cycle till human chorionic gonadotropin (HCG) injection day. Letrozole dose for the intervention group will also follow the same incremental protocol as the control group. Patient monitoring will involve trans-vaginal ultrasound scans on certain cycle days to check follicle growth and the thickness of uterus lining. Once a follicle reaches 18mm in size, an intramuscular HCG injection will be given. Couples will be asked to have intercourse 36 hours after the injection. Pregnancy will be tested two weeks later if menstruation does not occur. Metabolic, hormonal, and ultrasound parameters will be recorded at baseline and follow-ups. All adverse effects of the treatment will be noted. The study period will be a maximum of 3 treatment cycles or untill pregnancy is achieved. Outcome measures include ovulation and pregnancy rates. The effect of ALA on metabolic parameters (fasting glucose, fasting insulin, BMI and HOMA-IR), hormone levels (mid-luteal progesterone and serum estradiol), and follicular growth will also be assessed. Proper sample size and randomization methods will be followed. A Statistical analysis of collected data will help determine if ALA has additional benefits when combined with letrozole for PCOS fertility treatment. Finally, the results will be statistically analyzed. Statistical analysis will be done using the SPSS statistical software package. **Detailed Description:** Eligible participants will be randomly allocated to the control group or the intervention group with a ratio of 1:1 after obtaining informed consent. The two study groups will be as follows: Control group: this group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines. Treatment with letrozole will begin after the baseline visit, and for three cycles, the administration will start after a spontaneous or progesterone-induced menstruation. In the first cycle, "2.5" mg letrozole will be taken for 5 days starting from day 3 to 7 of the menses, if no pregnancy was detected, letrozole dose will be increased to "5 mg" in the next cycle, and finally, "7.5 mg" letrozole will be administered during the third cycle if the patient is still unable to conceive. Interventional group: this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule as the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period, then daily until the day of human chorionic gonadotropin (HCG) injection. Baseline assessment: After enrollment, baseline data and demographics will be obtained from each participant including: * Age and body mass index will be calculated in Kg/m\^2. * Serum FSH, LH, TSH, prolactin, androgens, including free and total testosterone and SHBG. * Ultrasound measurements including antral-follicles count and detection of Polycystic ovaries "defined as either 12 or more follicles measuring 2 to 9 mm in diameter or an increased ovarian volume \>10 cm\^3.". * Menstrual cyclicity, presence of first degree relatives with diabetes mellitus , smoking status, comorbidities, medication history . * All subjects will be educated about their diet and physical activity, and they will be asked not to start any new medications during the study without informing the principal investigator. Patients monitoring and follow-up. All the participants included in the study after a spontaneous or progesterone-induced menstrual cycle will be randomly assigned to either Control group or Interventional group and will be monitored by trans-vaginal ultrasound to assess follicular diameter and endometrial thickness on the 10th day of the cycle, then on 12th , 14th and the 20th days of the cycle for assessment of dominant follicle ( ≥ 18 mm) on TVUS. The number of dominant follicles and the endometrial thickness will be documented for each menstrual cycle. * When at least one dominant follicle is detected, participants will receive an intramuscular injection of 10 000 IU human chorionic gonadotropin (HCG) (Choriomon, IBSA). * An HCG injection will be given when at least one follicle measuring at least 18 mm is observed. * Ovulation will also be confirmed by the evaluation of serum progesterone each cycle between cycle days 20-22 ( \> 5 ng/mL) and the test will be repeated 1 week later if the initial progesterone level is below the threshold to confirm ovulation. * Couples will be instructed to have timed intercourse 36 hours after the HCG injection. * Serum HCG will be determined 2 weeks after HCG injection in the absence of menstruation for the detection of pregnancy. * Pregnant women will be required to stop all medication. * Patients who do not have any dominant follicles, will start a new ovulation induction cycle in the following month. * Treatment of the next cycle will start if menses occurs either spontaneously or by induction. The first day of the menses is considered the first day of the cycle and this is repeated for up to a total of 3 treatment cycles. * For those who fail to achieve a dominant follicle, alpha lipoic acid will be stopped and restarted in the next cycle as before. ### Conditions Module **Conditions:** - Polycystic Ovary Syndrome - Infertility, Female **Keywords:** - PCOS - ALA - Letrozole - Infertility - Ovulation rate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines .Treatment with letrozole will begin after the baseline visit and for three cycles. **Intervention Names:** - Drug: Letrozole **Label:** Control **Type:** OTHER #### Arm Group 2 **Description:** this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule of the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period then daily until the day of human chorionic gonadotropin (HCG) injection **Intervention Names:** - Drug: Alpha lipoic acid - Drug: Letrozole **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Alpha-lipoic acid (ALA), also known as 1,2-dithiolane-3-pentanoic acid or thioctic acid, is found in the mitochondria. It acts as an enzymatic cofactor for various enzymes in the Kreb's cycle. ALA has many beneficial properties making it a potential candidate for various clinical disorders. It is considered the universal or "ideal" antioxidant as it is both water-soluble and fat-soluble facilitating its passage across membran. ALA has direct as well as indirect anti-inflammatory effects. Being a potent antioxidant leads to a reduction in oxidative stress which in turn reduces inflammation, meaning ALA indirectly has anti-inflammatory effects. To add to ALA's benefits, it has anti-inflammatory properties that are independent of its antioxidant effects. **Name:** Alpha lipoic acid **Other Names:** - ALA **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control - Intervention **Description:** Letrozole is an aromatase inhibitor that controls the conversion of androgen to estrogen and increases ovarian androgens. The administration of letrozole in the follicular phase removes the effect of negative estrogen feedback on the pituitary and hypothalamus, thus increasing the gonadotropins\]. When Letrozole blocks estrogen production, it encourages the body to produce more follicle-stimulating hormone (FSH).The additional FSH stimulates egg development and increases the likelihood of ovulation. Kar, S. Found that letrozole has excellent pregnancy rates compared to clomiphene citrate, Letrozole should be considered at par with clomiphene citrate as first-line drug for ovulation induction in infertile PCOS women. **Name:** Letrozole **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** which is defined as the proportion of cycles in which ovulation occurred in the whole follow-up period. **Measure:** The primary outcome is cumulative ovulation rate **Time Frame:** 1 year #### Secondary Outcomes **Description:** ultrasound visualization of one or more gestational sac with pulsating fetal pole **Measure:** The clinical pregnancy rate **Time Frame:** 1 year **Description:** weight in kilograms, height in meters will be combined to report BMI in kg/m\^2 **Measure:** BMI in kg/m^2 **Time Frame:** 1 year **Description:** fasting insulin in (microU/L), fasting glucose in (nmol/L) will be combined to report HOMA-IR **Measure:** HOMA-IR **Time Frame:** 1 year **Description:** Will be measure in (pg/ml) **Measure:** serum estradiol **Time Frame:** 1 year **Description:** Will be measured in (pg/ml) **Measure:** mid-luteal progesterone **Time Frame:** 1 year **Description:** Will be measured in (mm) **Measure:** size of follicles **Time Frame:** 1 year **Description:** Number of mature follicles in each ovary. **Measure:** number of dominant follicles (≥18 mm) **Time Frame:** 1 year **Description:** Will be measured in (mm) **Measure:** endometrial thickness **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female patient aged 18-35 * Willing to conceive * PCOS, diagnosed according to the revised 2003 Rotterdam consensus criteria. " Oligo- or anovulation secondary to PCOS and at least one of the remaining two criteria: hyperandrogenism or polycystic ovarian morphology on ultrasound . * Anovulation and/or infertility ≥ 1 year. * At least one patent fallopian tube * Normal uterine cavity * Male partner with sperm concentration of at least 14 million/mL in at least one ejaculate. Exclusion Criteria: * Other causes for the infertility (male factor, tubal factor). * Intake of hormonal or other drugs that can potentially influence the ovulation. * Causes of anovulation or hyperandrogenism other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia. * Contraindication to pregnancy * Myo-inositol use \&lt; 3 months prior to study enrollment * Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization. **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Moaaz.ahmed22@pharma.asu.edu.eg **Name:** Muoaz A. Sallam, Teaching assistance **Phone:** +0201102174081 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** deanoffice_2@pharma.asu.edu.eg - **Name:** Sara M. Zaki, Professor - **Phone:** +0201008742248 - **Role:** CONTACT ***Contact 2:*** - **Name:** Marwa A. Ahmed, Professor - **Phone:** +0201008742248 - **Role:** CONTACT ***Contact 3:*** - **Name:** Sara M. Zaki, Professor - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Ain shams university **Status:** RECRUITING **Zip:** 11566 **Location 2:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Name:** Sara M. Zaki, Professor - **Phone:** +0201006383120 - **Role:** CONTACT ***Contact 2:*** - **Name:** Marwa A. Ahmed, Professor - **Phone:** +0201006383120 - **Role:** CONTACT ***Contact 3:*** - **Name:** Sara M. Zaki, Professor - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Ain shams university **Status:** RECRUITING **Zip:** 11566 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Fruzzetti F, Benelli E, Fidecicchi T, Tonacchera M. Clinical and Metabolic Effects of Alpha-Lipoic Acid Associated with Two Different Doses of Myo-Inositol in Women with Polycystic Ovary Syndrome. Int J Endocrinol. 2020 Mar 19;2020:2901393. doi: 10.1155/2020/2901393. eCollection 2020. **PMID:** 32256570 **Citation:** Genazzani AD, Shefer K, Della Casa D, Prati A, Napolitano A, Manzo A, Despini G, Simoncini T. Modulatory effects of alpha-lipoic acid (ALA) administration on insulin sensitivity in obese PCOS patients. J Endocrinol Invest. 2018 May;41(5):583-590. doi: 10.1007/s40618-017-0782-z. Epub 2017 Oct 31. **PMID:** 29090431 **Citation:** Masharani U, Gjerde C, Evans JL, Youngren JF, Goldfine ID. Effects of controlled-release alpha lipoic acid in lean, nondiabetic patients with polycystic ovary syndrome. J Diabetes Sci Technol. 2010 Mar 1;4(2):359-64. doi: 10.1177/193229681000400218. **PMID:** 20307398 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000010048 - Term: Ovarian Cysts - ID: D000003560 - Term: Cysts - ID: D000009369 - Term: Neoplasms - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000006058 - Term: Gonadal Disorders - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Infertility - ID: M10291 - Name: Infertility, Female - Relevance: HIGH - As Found: Infertility, Female - ID: M13970 - Name: Polycystic Ovary Syndrome - Relevance: HIGH - As Found: Polycystic Ovary Syndrome - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6765 - Name: Cysts - Relevance: LOW - As Found: Unknown - ID: M12971 - Name: Ovarian Cysts - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011085 - Term: Polycystic Ovary Syndrome - ID: D000007246 - Term: Infertility - ID: D000007247 - Term: Infertility, Female - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047072 - Term: Aromatase Inhibitors - ID: D000065088 - Term: Steroid Synthesis Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000004965 - Term: Estrogen Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000975 - Term: Antioxidants - ID: D000020011 - Term: Protective Agents - ID: D000014803 - Term: Vitamin B Complex - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M4059 - Name: Androgens - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M1743 - Name: Letrozole - Relevance: HIGH - As Found: Visual - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M11063 - Name: Thioctic Acid - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M8759 - Name: Follicle Stimulating Hormone - Relevance: LOW - As Found: Unknown - ID: M21320 - Name: Citric Acid - Relevance: LOW - As Found: Unknown - ID: M1837 - Name: Sodium Citrate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M25769 - Name: Aromatase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M6228 - Name: Clomiphene - Relevance: LOW - As Found: Unknown - ID: M30361 - Name: Enclomiphene - Relevance: LOW - As Found: Unknown - ID: M30362 - Name: Zuclomiphene - Relevance: LOW - As Found: Unknown - ID: M9168 - Name: Chorionic Gonadotropin - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8114 - Name: Estrogen Antagonists - Relevance: LOW - As Found: Unknown - ID: M30483 - Name: Estrogen Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: T382 - Name: Citrate - Relevance: LOW - As Found: Unknown - ID: T359 - Name: Alpha-lipoic Acid - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008063 - Term: Thioctic Acid - ID: D000077289 - Term: Letrozole ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418334 **Brief Title:** Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis **Official Title:** Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Thoracal Hyperkyphosis #### Organization Study ID Info **ID:** 109 #### Organization **Class:** OTHER_GOV **Full Name:** Gaziosmanpasa Research and Education Hospital ### Status Module #### Completion Date **Date:** 2024-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-04 **Type:** ACTUAL #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-01-11 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Gaziosmanpasa Research and Education Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Spinal deformity is common in childhood and adolescence. Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. The investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities. **Detailed Description:** Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracal kyphosis deformity with various etiologies. Any spinal deformity, especially one that affects the thoracic spine, can affect lung function. If left untreated, the curves may distort over time as skeletal growth accelerates. In some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale. The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; Thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages. Based on this, the investigators aimed to measure the diaphragmatic thickness in adolescents with increased thoracal kyphosis (thoracal hyperkyphosis) deformities, to show whether there is any relationship between increased kyphosis deformity and diaphragmatic thickness, and to show whether there is any change in diaphragmatic thickness before or after the treatment for kyphosis. ### Conditions Module **Conditions:** - Hyperkyphosis - Spine Deformity - Diaphragm Issues **Keywords:** - Thoracal Hyperkyphosis - Diaphragma Thickness - Ultrasonographic Measurement ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Thoracal Hyperkyphosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity and applied to the scoliosis outpatient clinicwill be filled in detail. **Intervention Names:** - Diagnostic Test: Thoracal hyperkyphosis study form - Diagnostic Test: Scoliosis graphy - Diagnostic Test: Pulmonary function test - Diagnostic Test: Ultrasonographic Measurement **Label:** Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity **Description:** Thoracal hyperkyphosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with chest deformity will be filled in detail. **Name:** Thoracal hyperkyphosis study form **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity **Description:** Patients whose forward bending test and clinical evaluation results are compatible with hyperkyphosis and scoliosis radiographs are requested. Coronal, sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs. **Name:** Scoliosis graphy **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity **Description:** Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help participant healthcare provider diagnose and decide the treatment of certain lung disorders. The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken. **Name:** Pulmonary function test **Other Names:** - Spirometry Function Test **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Patients aged 10-18 years who were diagnosed with thoracal hyperkyphosis deformity **Description:** Diaphragm thickness will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter-cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken. **Name:** Ultrasonographic Measurement **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Thoracal hyperkyphosis study form consisting of clinical and radiological measurements of patients aged 8-18 years who applied to the outpatient clinic with chest deformity will be filled in detail. Coronal, sagittal balance; coronal and sagittal Cobb angles (degree) (degree between upper end vertebral line of thoracal 3 'T3' and lower end vertebral line of 'T12') will be measured from posterior-anterior (PA) and lateral scoliosis radiographs. **Measure:** Thoracal hyperkyphosis study form **Time Frame:** Within 1 month of applying to the outpatient clinic **Description:** The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second) (Liter-L), FEV1 (%predicted) (percentage), FVC (Forced Vital Capacity) (Liter-L), FVC (%predicted) (percentage), FEV1/FVC (%) and FEV1/FVC (%predicted) (percentage) will be evaluated. The arithmetic average of the results of these three measurements will be taken. **Measure:** Pulmonary function test **Time Frame:** Within 1 month of applying to the outpatient clinic **Description:** Diaphragm thickness (centimeter-cm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter-cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken. **Measure:** Ultrasonographic Measurement **Time Frame:** Within 1 month of applying to the outpatient clinic ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Increased thoracal kyphosis (thoracic hyperkyphosis) * Being between the ages of 10-18 Exclusion Criteria: * Congenital spinal, costal and diaphragmatic anomalies * Neuromuscular disease * Respiratory system diseases that affect lung functions * Patients who cannot cooperate with spirometry. * Having surgery to the chest wall or spine **Maximum Age:** 18 Years **Minimum Age:** 10 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** It will consist of participants with thoracal hyperkyphosis deformity who apply to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Gaziosmanpaşa Training and Research Hospital within the study date ranges, meet the inclusion and exclusion criteria and voluntarily agree to participate in the research. Healthy individuals identical in age and gender will be included in the study as a control group. Demographic information of all individuals involved in the recruitment will be collected. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dr_denizoke@hotmail.com **Name:** Deniz Oke, MD **Phone:** +90 532 430 69 50 **Role:** CONTACT **Contact 2:** **Email:** zeynel@uludag.edu.tr **Name:** Zeynel Karakullukcuoglu, MD **Phone:** +90 541 216 61 16 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** zeynel@uludag.edu.tr - **Name:** Zeynel Karakullukcuoglu, MD - **Phone:** +90 541 216 61 16 - **Role:** CONTACT ***Contact 2:*** - **Email:** drmeryemgunesergulec@gmail.com - **Name:** Meryem Guneser Gulec, MD - **Phone:** +90 530 567 88 32 - **Role:** CONTACT **Country:** Turkey **Facility:** Deniz Oke **State:** Gaziosmanpasa **Status:** RECRUITING **Zip:** 34255 #### Overall Officials **Official 1:** **Affiliation:** Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department **Name:** Meryem Guneser Gulec, MD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Medical Park Bahcelievler Hospital Physical Medicine and Rehabilitation Department **Name:** Cansu Ozkan, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants. **IPD Sharing:** NO ### References Module #### References **Citation:** Jagger F, Tsirikos AI, Blacklock S, Urquhart DS. Adaptation to reduced lung function in children and young people with spinal deformity. J Clin Orthop Trauma. 2020 Mar-Apr;11(2):191-195. doi: 10.1016/j.jcot.2019.12.013. Epub 2020 Jan 3. **PMID:** 32099278 **Citation:** Karaali E, Ciloglu O, Gorgulu FF, Ekiz T. Ultrasonographic measurement of diaphragm thickness in patients with severe thoracic scoliosis. J Ultrasound. 2021 Mar;24(1):75-79. doi: 10.1007/s40477-020-00536-w. Epub 2021 Feb 7. **PMID:** 33550575 **Citation:** Wang JS. Effect of joint mobilization and stretching on respiratory function and spinal movement in very severe COPD with thoracic kyphosis. J Phys Ther Sci. 2015 Oct;27(10):3329-31. doi: 10.1589/jpts.27.3329. Epub 2015 Oct 30. **PMID:** 26644703 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013121 - Term: Spinal Curvatures - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M10758 - Name: Kyphosis - Relevance: HIGH - As Found: Hyperkyphosis - ID: M15918 - Name: Spinal Curvatures - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007738 - Term: Kyphosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418321 **Brief Title:** Early Identification of Age-related Hearing Impairment **Official Title:** Early Identification of Age-related Hearing Impairment #### Organization Study ID Info **ID:** 535/2024 #### Organization **Class:** OTHER **Full Name:** Aalto University ### Status Module #### Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Business Finland **Class:** OTHER **Name:** Helsinki University Central Hospital #### Lead Sponsor **Class:** OTHER **Name:** Aalto University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The need for future hearing rehabilitation is enormous. World Health Organization (WHO 2021) has estimated that by 2050, 2.5 billion people will have some degree of hearing loss, and 1/4 of them will require hearing rehabilitation. Currently, healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment. This study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process. **Detailed Description:** The investigational device used in the study is part of the Otoscreen hearing screening system that is developed by Aalto University. The investigational device consists of the following parts: * Digital otoscope * User interface control unit. The investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires, digital otoscopy, and audiometry. The investigational device is used together with a CE-marked audiometer that is intended for hearing screening testing. ### Conditions Module **Conditions:** - Hearing Loss, Age-Related ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 230 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants are tested with the investigational device and the gold-standard device. **Intervention Names:** - Device: Investigational device - Other: Audiometer - Device: Otomicroscopy - Other: REM (Real Ear Measurements) **Label:** Participant group 1: HUS Helsinki University Hospital #### Arm Group 2 **Description:** Participants are tested with the investigational device. **Intervention Names:** - Device: Investigational device **Label:** Participant group 2: Aalto University ### Interventions #### Intervention 1 **Arm Group Labels:** - Participant group 1: HUS Helsinki University Hospital - Participant group 2: Aalto University **Description:** The participants' hearing status will be evaluated using the investigational device. **Name:** Investigational device **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Participant group 1: HUS Helsinki University Hospital **Description:** Participants' hearing thresholds are tested with an audiogram. **Name:** Audiometer **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Participant group 1: HUS Helsinki University Hospital **Description:** The status of the participants' ear canals and tympanic membranes are checked. **Name:** Otomicroscopy **Type:** DEVICE #### Intervention 4 **Arm Group Labels:** - Participant group 1: HUS Helsinki University Hospital **Description:** The acoustic properties of the participants' ears will be measured during the interventions. **Name:** REM (Real Ear Measurements) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The investigators compare scored views to the outer ear canal and tympanic membrane. **Measure:** Comparison between investigational device and gold-standard device (otomicroscope) findings. **Time Frame:** From digital otoscopy to the interpretation of pictures (up to six months). **Description:** The investigators compare pure tone averages. **Measure:** Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist. **Time Frame:** From hearing tests to the comparison (up to six months). #### Secondary Outcomes **Description:** The usability of the investigational device will be assessed using a usability testing protocol. It includes subjective feedback from participants through interviews, questionnaires, and observation of device use. The usability will be assessed using the AttrakDiff method, a standardized questionnaire designed to measure the user's perception of a product's attractiveness, pragmatism, and overall appeal. This method provides insights into both the pragmatic and hedonic aspects of usability. AttrakDiff consists of multiple items scored on a semantic differential scale that consists of seven-step items whose poles are opposite adjectives (e.g. "confusing - clear", "unusual - ordinary", "good - bad"). Each set of adjective items is ordered into a scale of intensity. Usability testing will be conducted iteratively with the first group of participants (N=20), followed by modifications based on feedback. This iterative process will continue until no negative feedback is received. **Measure:** Participant group 2: The usability of the investigational device. **Time Frame:** From study appointment to the analysis of the results (up to six months). **Description:** If there is a difference between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer, the investigators will look for the REM results if there is an explanation for the difference at the individual level. **Measure:** Participant group 1: REM measurements. **Time Frame:** From REM measurements to the analysis of the results (up to six months). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: • Must be able to understand Finnish or Swedish Exclusion Criteria: • Clinical diagnosis of hearing loss **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Healthy volunteers ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tanja.tervonen@aalto.fi **Name:** Tanja Tervonen **Phone:** +358400240800 **Role:** CONTACT #### Locations **Location 1:** **City:** Espoo **Contacts:** ***Contact 1:*** - **Email:** tanja.tervonen@aalto.fi - **Name:** Tanja Tervonen - **Phone:** +358400240800 - **Role:** CONTACT ***Contact 2:*** - **Name:** Wycliffe Raduma, M.Sc. - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Jouni Partanen, Prof. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Poonam Chawda - **Role:** SUB_INVESTIGATOR **Country:** Finland **Facility:** Aalto University **Status:** RECRUITING **Zip:** 02150 **Location 2:** **City:** Helsinki **Country:** Finland **Facility:** HUS Head and Neck Center **Status:** ENROLLING_BY_INVITATION **Zip:** 00130 #### Overall Officials **Official 1:** **Affiliation:** Aalto University **Name:** Jouni Partanen, Prof. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000006319 - Term: Hearing Loss, Sensorineural ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M24420 - Name: Hearing Loss - Relevance: HIGH - As Found: Hearing Impairment - ID: M6840 - Name: Deafness - Relevance: HIGH - As Found: Hearing Impairment - ID: M14178 - Name: Presbycusis - Relevance: HIGH - As Found: Hearing Loss, Age-Related - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M9407 - Name: Hearing Loss, Sensorineural - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000034381 - Term: Hearing Loss - ID: D000003638 - Term: Deafness - ID: D000011304 - Term: Presbycusis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418308 **Brief Title:** Intrathecal Dexmedetomidine vs Epinephrine **Official Title:** Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section #### Organization Study ID Info **ID:** STUDY-23-01613 #### Organization **Class:** OTHER **Full Name:** Icahn School of Medicine at Mount Sinai ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Icahn School of Medicine at Mount Sinai #### Responsible Party **Investigator Affiliation:** Icahn School of Medicine at Mount Sinai **Investigator Full Name:** Daniel Katz **Investigator Title:** Vice Chair of Education Department of Anesthesiology, Pain, & Perioperative Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section. ### Conditions Module **Conditions:** - Cesarean Section - Anesthesia, Spinal **Keywords:** - Cesarean Section - Spinal Anesthesia - Intrathecal adjuncts - Dexmedetomidine - Epinephrine ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients will be randomized to either receiving the addition of epinephrine or dexmedetomidine to the standard spinal medication mixture of 10.25 mg hyperbaric bupivacaine, 12.5 mcg fentanyl, and 0.125 mg morphine. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Patients will be assigned a group by picking from a stack of envelopes. The interventional drug which the envelope contains will be assigned by a random number generator. The interventional drug will be drawn up by an anesthesiologist not involved in the patient's care and the syringe given to the anesthesiologist performing the spinal anesthetic. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture. **Intervention Names:** - Drug: Dexmedetomidine - Drug: Standardized Spinal Mixture **Label:** Dexmedetomidine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture **Intervention Names:** - Drug: Epinephrine - Drug: Standardized Spinal Mixture **Label:** Epinephrine **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dexmedetomidine **Description:** 5 mcg of dexmedetomidine **Name:** Dexmedetomidine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Epinephrine **Description:** 200 mcg of epinephrine **Name:** Epinephrine **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Dexmedetomidine - Epinephrine **Description:** Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, 12.5 mcg fentanyl, and 0.125 mg morphine. **Name:** Standardized Spinal Mixture **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Time required for sensory recovery at T10 to investigate the efficacy of adjuvant agents in cesarean section. Once the sensory block has receded to a T10 level, the spinal is no longer as effective for surgical level anesthesia. This will be measured in minutes. **Measure:** Time required for sensory recovery at T10 **Time Frame:** 360 minutes #### Secondary Outcomes **Description:** Time to motor recovery determines how long the patient will be in the post anesthesia care unit. **Measure:** Time to motor and sensory recovery **Time Frame:** 480 minutes **Description:** The speed of sensory regression determines how long the spinal will be effective. **Measure:** Time to sensory recovery **Time Frame:** 480 minutes **Description:** The time to first postoperative analgesic gives information on how adequately pain is controlled postoperatively. **Measure:** Time to administration of postoperative analgesic **Time Frame:** 24 hours **Description:** The use of intravenous opioid agents such as fentanyl or morphine during the cesarean section can demonstrate that the spinal is not adequate for surgical anesthesia and analgesia. Any use of intravenous opioid administered during cesarean section is indicative of inadequate analgesia and the number of participants receiving this will be reported **Measure:** Number of participants receiving intravenous opioid **Time Frame:** 360 minutes **Description:** The onset time of the block can determine its feasibility in urgent situations where there is a time limit in which the surgeon must begin the operation. **Measure:** Time required to achieve T4 anesthetic level **Time Frame:** 60 minutes **Description:** Incidence of intraoperative hypotension, nausea, vomiting, shivering, and pruritis. Unfavorable side effects should be assessed as they affect patient experience. These are potential side effects from the spinal anesthesia itself and the normal mixture of bupivacaine, morphine, and fentanyl. **Measure:** Incidence of specific side effects **Time Frame:** 360 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant patients aged 18-55 years who are presenting for scheduled cesarean section and are candidates for single shot spinal anesthesia for cesarean section. Exclusion Criteria: * Patient refusal of spinal anesthetic * If patient is not a candidate for spinal anesthesia due to history of coagulopathy, elevated intracranial pressure, infection at site of injection, etc. * Emergency cesarean section * Preexisting motor or sensory deficit * Suspected pre-eclampsia * Patient receiving combined spinal-epidural as anesthetic technique **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** talia.scott@mountsinai.org **Name:** Talia Scott, MD **Phone:** 720-212-7448 **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** talia.scott@mountsinai.org - **Name:** Talia Scott, MD - **Phone:** 720-212-7448 - **Role:** CONTACT ***Contact 2:*** - **Name:** Daniel Katz - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mount Sinai Hospital **State:** New York **Zip:** 10029 #### Overall Officials **Official 1:** **Affiliation:** Icahn School of Medicine at Mount Sinai **Name:** Daniel Katz, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is no plan in place to share IPD. **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000058647 - Term: Adrenergic alpha-2 Receptor Agonists - ID: D000000316 - Term: Adrenergic alpha-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000318 - Term: Adrenergic beta-Agonists - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000009184 - Term: Mydriatics - ID: D000013566 - Term: Sympathomimetics - ID: D000014662 - Term: Vasoconstrictor Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M22662 - Name: Dexmedetomidine - Relevance: HIGH - As Found: Twice daily - ID: M11982 - Name: Morphine - Relevance: LOW - As Found: Unknown - ID: M7992 - Name: Epinephrine - Relevance: HIGH - As Found: Growth - ID: M30371 - Name: Racepinephrine - Relevance: LOW - As Found: Unknown - ID: M211043 - Name: Epinephryl borate - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3668 - Name: Adrenergic alpha-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-Agonists - Relevance: LOW - As Found: Unknown - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown - ID: M12139 - Name: Mydriatics - Relevance: LOW - As Found: Unknown - ID: M16345 - Name: Sympathomimetics - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004837 - Term: Epinephrine - ID: D000020927 - Term: Dexmedetomidine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418295 **Brief Title:** Cytokine Alterations and Chronic Post-Surgical Pain **Official Title:** Cytokine Alterations Associated With Persistent Post-surgical Pain and Their Regulation Through Epigenetic Changes - A Pilot Study #### Organization Study ID Info **ID:** CPSP Epigenetics #### Organization **Class:** OTHER **Full Name:** Lawson Health Research Institute ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-01-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lawson Health Research Institute #### Responsible Party **Investigator Affiliation:** Lawson Health Research Institute **Investigator Full Name:** Abhijit Biswas **Investigator Title:** Anesthesiologist, Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Chronic Post-Surgical Pain (CPSP) is a condition that involves experiencing pain and/or discomfort that lasts for more than 3 months following surgery without any explainable cause of this pain such chronic infection or pain caused from a condition preceding surgery. This condition negatively impacts health related quality of life and is associated with significant financial burden both for the patient and health care system. Patients undergoing common surgeries such as amputation, breast surgery, hernia repair, coronary artery bypass, and caesarean section can be prone to developing CPSP. CPSP may be caused by the release and expression of different cellular molecules called cytokines and chemokines that can cause a pain response when they are present in the body at certain levels. After surgical incision, tissue cells have been shown to release cytokines and chemokines, thus increasing the concentration of these molecules in the patient's blood. It is not entirely known what mechanisms cause the increased expression of chemokines and cytokines. One method that may play a role in in this expression is epigenetics which is the alteration of gene expression without permanently altering the structure of DNA. Unlike mutations, epigenetic changes are dynamic, possibly reversible, and are influenced by environmental and behavioral changes such as diet, exercise, disease, stress, toxin exposure etc. Epigenetic changes occur all throughout our life and have been associated with several disease processes such as cancer, diabetic complications, and chronic pain. At the molecular level, certain events take place that can regulate (increase or decrease) the expression of cytokines and chemokines, most notably DNA methylation of their promotor (which involves adding molecules to DNA that does not change its structure but changes it's activity). We are conducting this study to determine if the alteration of specific cytokines are associated with the occurrence of CPSP and whether these cytokines are regulated by DNA methylation at their promoter. This study will take place at London Health Sciences Centre and will recruit up to 50 patients who will be undergoing a thoracotomy procedure (surgery of the chest area). **Detailed Description:** Chronic Post-Surgical Pain (CPSP), defined by the International Association for the Study of Pain, is a clinical discomfort that lasts more than 3 months post-surgery without other causes of pain such as chronic infection or pain from a chronic condition preceding the surgery1. This condition negatively impacts health related quality of life and is associated with significant financial burden both for the patient and health care system. Patients undergoing a multitude of procedures, from amputation to hernia repair, are prone to develop CPSP with variable incidences2. CPSP may be a result of peripheral and central sensitization triggered by the release of cytokines and chemokines following surgery due to possible alterations in genetic expression. At the cellular level, after surgical incision, tissue cells from local areas have been implicated to drive synthesis of such cytokines/chemokines leading to alterations of their serum levels, including nerve growth factors (NGF) and interleukins (IL-1β)3. Specific regulatory mechanisms leading to augmented synthesis of these cytokines in the context of CPSP remain elusive. Several regulatory mechanisms may influence production of each cytokine. One method is via epigenetic mechanisms, which are defined as the alteration of gene expression without any structural genomic alterations4,5 that may regulate cytokine production at the transcriptional and post transcriptional levels6. Among these listed epigenetic mechanisms, DNA methylation has been well studied and plays a key role in translation4. In general, hypomethylation of the promoter region leads to increased gene expression and vice versa4. In this study we wish to investigate how these mechanisms could be implicated in the expression of cytokines and chemokines in CPSP. Patients undergoing unilateral thoracotomy for non-malignant lung resection will be included in this study. Their surgery and follow up care will proceed according to standard of care guidelines. Thoracic epidural analgesia, or patient controlled analgesia (PCA) pumps will be offered to each study participant as per standard of care. Patients' pain will be assessed preoperatively and postoperatively on days 1,2,3 and 3 months. Blood samples will also be taken during these times points and analyzed to determined the concentrations of the following cytokines, chemokines and growth factors: epidermal growth factor, eotaxin, fibroblast growth factor basic, G-CSF, GM-CSF, human growth factor, IFN-α, IFN-γ, IL-1ra, IL-1β, IL-2, IL-2r, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p40/p70), IL-13, IL-15, IL-17, IP-10, MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, and VEGF. The occurence of DNA methylation at the promotor region of these targets will be assessed via polymerase chain reaction (PCR) analysis. Results of these postoperative analyses will be compared to pre-operative molecular concentrations and pain scores to determine the association between epigenetic modifications (if any) and the development of CPSP and whether these modifications are driven by DNA promotor methylation. ### Conditions Module **Conditions:** - Chronic Post Operative Pain **Keywords:** - chronic pain - epigentics ### Design Module #### Bio Spec **Description:** Blood samples (5 mL) collected at the following time points: 1. Pre-operatively before surgery. 2. Post-operative day 1 following surgery 3. Post-operative day 2 following surgery 4. Post-operative day 3 following surgery, 5. 3 months following surgery **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Unilateral thoracotomy for non-malignant lung resection to proceed according to standard of care guidelines. **Intervention Names:** - Other: Unilateral thoracotomy for non-malignant lung resection **Label:** Unilateral thoracotomy for non-malignant lung resection ### Interventions #### Intervention 1 **Arm Group Labels:** - Unilateral thoracotomy for non-malignant lung resection **Description:** Unilateral thoracotomy for non-malignant lung resection to proceed as per standard of care guidelines. Thoracic epidural analgesia, or patient controlled analgesia (PCA) pumps will be offered to each study participant as per standard of care. Pre- and post-operative (post-operative days 1, 2, 3 and 3 months) pain scores and blood samples will be collected. Blood samples will be analyzed to determine the concentration of cytokines, chemokines, and growth factors that are potentially associated with CPSP (epidermal growth factor, eotaxin, fibroblast growth factor basic, G-CSF, GM-CSF, human growth factor, IFN-α, IFN-γ, IL-1ra, IL-1β, IL-2, IL-2r, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p40/p70), IL-13, IL-15, IL-17, IP-10, MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, and VEGF). DNA promotor methylation for these targets will also be investigated. **Name:** Unilateral thoracotomy for non-malignant lung resection **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Cellular assays will be performed on blood samples obtained pre-and postoperatively to determined the level of expression of certain chemokines, cytokines, and growth factors that have been shown to be potentially related to CPSP. Pre and postoperative results will be compared to determine the association that each may have on the development of CPSP. **Measure:** Identification of temporal alterations of cytokines in patients with CPSP. **Time Frame:** 3 months **Description:** Cellular assays will be performed on blood samples obtained pre-and postoperatively to determine if DNA promotor methylation is associated with changes in expression of the cytokines being investigated. Pre and postoperative results will be compared to determine the impact that this potential epigenetic change (DNA promotor methylation) may have on the development of CPSP. **Measure:** Identification of specific DNA promoter methylation regulating production of specific cytokines **Time Frame:** 3 months **Description:** As this is a pilot study, data will be analyzed to determine the sample size needed to power a larger, randomized controlled trial. **Measure:** Generate initial data to determine the sample size needed to adequately power a larger trial **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. 18 years of age or older 2. Undergoing unilateral thoracotomy for the first time on that side 3. Willing to provide informed consent for study participation. 4. Patient with lung cancer Exclusion Criteria: 1. Chronic pain prior to surgery 2. Pre-existing fibromyalgia 3. Long-term opioid use 4. Diabetes mellitus 5. Pre-existing neurological disease 6. Pre-existing nerve injury 7. Evidence of dementia, delirium or cognitive disorder that may interfere with study participation 8. Malignancy other than lung cancer 9. Autoimmune disorder 10. Pregnancy 11. Inability to communicate in the English language (required for completion of questionnaires and provision of pain scores **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients scheduled to undergo thoracotomy for non-malignant lung at Victoria Hospital, London Health Science Centre. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Abhijit.Biswas@lhsc.on.ca **Name:** Abhijit Biswas **Phone:** 5196858500 **Phone Ext:** 55956 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Western University **Name:** Abhijit Biswas **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Macrae WA, Davies HTO, Crombie IK, Linton S, Croft P, Von Korff M, LeResche L. Chronic postsurgical pain, Epidemiology of Pain, 1999, Seattle International Association for the Study of Pain (pg. 125-42) **Citation:** Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22. **PMID:** 18434337 **Citation:** Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238. **PMID:** 29738328 **Citation:** Aroke EN, Joseph PV, Roy A, Overstreet DS, Tollefsbol TO, Vance DE, Goodin BR. Could epigenetics help explain racial disparities in chronic pain? J Pain Res. 2019 Feb 18;12:701-710. doi: 10.2147/JPR.S191848. eCollection 2019. **PMID:** 30863142 **Citation:** Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e. **PMID:** 17426506 **Citation:** Odell DW. Epigenetics of pain mediators. Curr Opin Anaesthesiol. 2018 Aug;31(4):402-406. doi: 10.1097/ACO.0000000000000613. **PMID:** 29847367 **Citation:** Descalzi G, Ikegami D, Ushijima T, Nestler EJ, Zachariou V, Narita M. Epigenetic mechanisms of chronic pain. Trends Neurosci. 2015 Apr;38(4):237-46. doi: 10.1016/j.tins.2015.02.001. Epub 2015 Mar 9. Erratum In: Trends Neurosci. 2015 Sep;38(9):579. **PMID:** 25765319 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Chronic Post Operative Pain - ID: M29442 - Name: Chronic Pain - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown - ID: M27359 - Name: Interleukin 1 Receptor Antagonist Protein - Relevance: LOW - As Found: Unknown - ID: M19243 - Name: Interferon-alpha - Relevance: LOW - As Found: Unknown - ID: M20747 - Name: Interleukin-12 - Relevance: LOW - As Found: Unknown - ID: T312 - Name: Tea - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418282 **Acronym:** GRANDE **Brief Title:** Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema **Official Title:** An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema #### Organization Study ID Info **ID:** KCT 013 (GRANDE) #### Organization **Class:** INDUSTRY **Full Name:** Koya Medical, Inc. ### Status Module #### Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Koya Medical, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema **Detailed Description:** An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema ### Conditions Module **Conditions:** - Phlebolymphedema - Lymphedema - Chronic Venous Insufficiency ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner. **Intervention Names:** - Device: Dayspring **Label:** Dayspring, Non-Pneumatic Active Compression Device (NPCD) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dayspring, Non-Pneumatic Active Compression Device (NPCD) **Description:** NPCD **Name:** Dayspring **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 6 **Measure:** Lymphedema Overall Quality of Life and Patient Survey **Time Frame:** 6 months **Description:** Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events) **Measure:** Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events) **Time Frame:** 6 months **Description:** Mobility (daily steps using a pedometer) **Measure:** Mobility (daily steps using a pedometer) **Time Frame:** 6 months #### Secondary Outcomes **Description:** Lower extremity edema response (limb girth reduction) **Measure:** Lower extremity edema response (limb girth reduction) **Time Frame:** 6 months **Description:** LE Functional Index (LEFI) **Measure:** LE Functional Index (LEFI) **Time Frame:** 6 months **Description:** Venous Clinical Severity Score (VCSS) scored on severity from None (0), Mild (1), Moderate (2) to Severe (3). Higher score means a worse outcome **Measure:** Venous Clinical Severity Score (VCSS) **Time Frame:** 6 months **Description:** As assessed by reported adverse events **Measure:** Safety/Adverse Events **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males and females ≥ 18 years of age * Capable and willing to sign the informed consent and deemed capable of following the study protocol * Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency * Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux Exclusion Criteria: * Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy * Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device * Non-ambulatory individuals * Female: BMI \> 34 (5'4", 200 lbs.) * Male: BMI \> 34 (5'9", 230 lbs.) * (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm) * Diagnosis of lipedema * Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer) * Diagnosis of acute infection (in the last four weeks) * Diagnosis of active/open wound/ulcer * Diagnosis of acute thrombophlebitis (in last 2 months) * Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * Diagnosis of pulmonary edema * Diagnosis of congestive heart failure (uncontrolled/uncompensated) * Diagnosis of chronic kidney disease with acute renal failure * Diagnosis of epilepsy * Subjects with poorly controlled asthma * Any condition where increased venous and lymphatic return is undesirable * Women who are pregnant, planning a pregnancy or nursing at study entry * Participation in any clinical trial of an investigational substance or device during the past 30 days **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** clinical@koyamedical.com - **Name:** Glenn Jacobowitz, MD - **Phone:** 415-851-0337 - **Role:** CONTACT **Country:** United States **Facility:** Glenn Jacobowitz **State:** New York **Status:** RECRUITING **Zip:** 10016 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008206 - Term: Lymphatic Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17435 - Name: Venous Insufficiency - Relevance: HIGH - As Found: Venous Insufficiency - ID: M11206 - Name: Lymphedema - Relevance: HIGH - As Found: Lymphedema - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014689 - Term: Venous Insufficiency - ID: D000008209 - Term: Lymphedema ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418269 **Brief Title:** The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes **Official Title:** The Effect of Insulin Education Given to Children With Diabetes by Therapeutic Play Method on Anxiety and Fear Levels #### Organization Study ID Info **ID:** 53.2024fbu #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2025-08-18 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-18 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-18 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Fenerbahce University **Investigator Full Name:** Canan Genç **Investigator Title:** Research Assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study will be conducted using a randomized controlled method. Children with type 1 diabetes who are admitted to the Pediatric Endocrinology Service will be divided into two groups by randomization method. Following randomization, children in the experimental group will play a therapeutic game before their subcutaneous insulin treatment. In the subcutaneous insulin treatment of the children in the control group, the routine practice of the clinic will be applied. Anxiety and fear levels of all children in the experimental and control groups will be evaluated before and after subcutaneous insulin treatment. **Detailed Description:** Excessive stress and anxiety experienced by children can affect their physical and physiological health and hinder their ability to cope with medical interventions. Pain and negative emotions associated with blood sampling or insulin administration can negatively affect children's diabetes self-care skills and may lead to avoidance of injections. Play-based interventions allow the child to process potentially frightening events and correct misconceptions about an illness and its management. Overall, therapeutic play interventions have been effective in reducing the child's pain, anxiety and stress while encouraging cooperation. Since insulin treatment (subcutaneous) causes fear and anxiety in children, the aim of this study was to reduce fear and anxiety by dramatization method by storytelling the child's procedure and disease with the game of administering insulin treatment (subcutaneous) to a doll. In the Pediatric Endocrinology Service, children between the ages of 9 and 12 years who have just been diagnosed with Type 1 diabetes and who meet the sample selection criteria and their parents will be met and informed about the study and written and verbal consent will be obtained from the children and their parents who volunteer to participate in the study. Children will be asked to fill out the "Child Patient Identification Form", "State Anxiety Scale in Children" and "Child Fear Scale" 30 minutes before insulin treatment. Then, the children will be randomized by the researcher and assigned to two different groups as experimental and control groups. Before the insulin treatment procedure, the children in the experimental group will be made to take blood glucose and administer insulin on a doll with the therapeutic play method. The children in the control group will receive the routine treatment of the clinic. Within 10 minutes after subcutaneous insulin treatment, the child will be asked to fill out the "State Anxiety Scale in Children" and "Child Fear Scale". Therapeutic Play Content: The doll to be used in the study represents the sick children in the experimental group. The child will be told that the doll has been hospitalized with a diagnosis of Type 1 diabetes and will be expected to assume the role of a nurse in order to administer insulin to the doll. The materials to be used during insulin administration will be introduced to the child and the child will be made to recognize the materials more closely. Then, the steps of blood glucose measurement and insulin treatment (subcutaneous) will be explained to the child and the child will be asked to apply the insulin to the doll. ### Conditions Module **Conditions:** - Type1diabetes - Therapeutic Play - Fear State - Anxiety State **Keywords:** - Type1diabetes - Therapeutic play - Fear state - Anxiety State ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Therapeutic Play **Label:** Therapeutic Play Group **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Therapeutic Play Group **Description:** Children will be asked to fill in the "Child Patient Identification Form", "State Anxiety Scale in Children" and "Child Fear Scale" 30 minutes before insulin treatment. Before the insulin treatment, the children in the experimental group will have their blood glucose measured and insulin administered on a doll using the therapeutic play method. The child will be told that the doll is hospitalized with a diagnosis of Type 1 diabetes and will be expected to assume the role of a nurse to administer insulin to the doll. Then, the steps of blood glucose measurement and insulin treatment (subcutaneous) will be explained to the child and the child will be asked to administer insulin to the baby. Within 10 minutes after subcutaneous insulin treatment, the child will be asked to fill out the "State Anxiety Scale in Children" and "Child Fear Scale". **Name:** Therapeutic Play **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Anxiety states of children that may occur due to subcutaneous insulin treatment will be evaluated. The lowest score that can be obtained from the State Anxiety Scale is 20 and the highest score is 60. **Measure:** State-Trait Anxiety Inventory for Children **Time Frame:** 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment **Description:** Fear states of children that may occur due to subcutaneous insulin treatment will be evaluated. In this method, the child is shown a picture with five facial expressions rated between 0 and 4. 0 indicates no fear and anxiety, while 4 indicates the highest fear and anxiety. **Measure:** Child Fear Scale **Time Frame:** 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The child must be between the ages of 9 and 12 (since the State Anxiety Inventory for Children Scale is for this age range) * Diagnosed with type 1 diabetes * Absence of mental retardation * Receiving subcutaneous insulin treatment for the first time * Voluntariness of the child and parent to participate in the study Exclusion Criteria: * Visual, hearing or speech impairment * Illiteracy of the child * Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.) **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 9 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cananuzun5561@gmail.com **Name:** Canan Genç, MSc **Phone:** 5372828808 **Role:** CONTACT **Contact 2:** **Email:** nermin.guduloglu20@gmail.com **Name:** Nermin Eroğlu, PhD **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001523 - Term: Mental Disorders - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 - ID: D000001008 - Term: Anxiety Disorders ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418256 **Acronym:** SPLEENVIVO **Brief Title:** Physiology and Pathologies Linked to Human Splenic Function : Direct and Ex-vivo Perfusion Explorations **Official Title:** Physiology and Pathologies Linked to Human Splenic Function : Direct and Ex-vivo Perfusion Explorations #### Organization Study ID Info **ID:** NI17003 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **Domain:** IDRCB Number **ID:** 2024-A00654-43 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2031-10-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2031-10-16 **Type:** ESTIMATED #### Start Date **Date:** 2016-10-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Institut Pasteur #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options). **Detailed Description:** Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options). Participation to the study will be proposed to adult patients in whom a splenic intervention (spleno-pancreatectomy, or a total or partial splenectomy) is planned as part of their treatment. One or more tubes of venous blood collected for the care will be retrieved following the pre- or intra-operative assessment. These samples will serve as controls during analyzes of splenic filtration mechanisms and/or perfusion experiments with populations of altered or modified cells and/or immunological and/or genetic analyses. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Samples from different experimental conditions (for example red blood cell containing malaria parasite for a culture) may be introduced in the perfusion system pour kinetic analyses. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses by cytology, cytometry, histology, immunohistochemistry, electronic microscopy, biochemistry, molecular biology, single cell analyses, on any other method. Peripheral and splenic blood samples or cells, as well as spleen fragments will be stored in. a biobank for further use or experimental analyses. ### Conditions Module **Conditions:** - Splenectomy **Keywords:** - Spleen - Human splenic physiology - Splenic clearance - Splenic filtration mechanisms - Perfusion experiments - Role of the spleen in the adaptive immune response - Genetic spleen mechanisms - Blood - Erythrocytes - Leukocytes - Lymphocytes - Malaria - Sickle cell disease - Hereditary spherocytosis ### Design Module #### Bio Spec **Description:** Spleen fragments Peripheral blood cells Splenic blood cells, including red blood cells and Peripheral Blood Mononuclear Cells Plasma **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adult patients cared in one of the APHP hospital (Necker-Enfants Malades Hospital, Saint-Antoine Hospital, Pitié Salpêtrière Hospital and Beaujon Hospital) for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their treatment. **Intervention Names:** - Other: Spleen, blood and plasma collection **Label:** Patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients **Description:** Adult patients for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their care. One or more tubes of venous blood collected for the care will be recovered following the pre- or intra-operative assessment. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses. **Name:** Spleen, blood and plasma collection **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Ability of the isolated-perfused human spleen to filter altered cell populations. **Measure:** Refine the understanding of spleen role during infections and conditions of the red blood cell and other human blood cells **Time Frame:** Day 0 #### Secondary Outcomes **Description:** Explore splenic immunological mechanisms including the maintenance of long-term memory against Plasmodium sp antigens. and other infectious agents: Bartonella sp., Babesia sp., smallpox virus, measles, hepatitis. **Measure:** Exploring splenic immunological mechanisms **Time Frame:** Day 0 **Description:** Explore the spleen filter role during infections, illnesses or use of blood cells, including properties of cells retained in the spleen, possibily after modification in vitro. **Measure:** Kinetics of splenic clearance of altered or modified circulating elements **Time Frame:** Day 0 **Description:** Clearance mechanisms: tissue and cellular topography and concentration of deposition of normal or altered or modified cells in the spleen (Histology, Imaging, Electron Microscopy, etc.). **Measure:** Exploring splenic clearance mechanisms **Time Frame:** Day 0 **Description:** Genetic control of spleen function. **Measure:** Exploring the genetic control of spleen function **Time Frame:** Day 0 **Description:** Testing optimized freezing methods with evaluation of cell function in vitro and engraftment in a mouse model. **Measure:** Explore the impact of preservation processes on organ and cell functions, as well as engraftment **Time Frame:** Day 0 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients * Patient requiring left splenopancreectomy or planned splenectomy regardless of the method or indication Exclusion Criteria: - The patient notified his doctor of his refusal to recover his spleen and blood volume **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients with no age limit cared in one of the APHP hospital (Necker-Enfants Malades Hospital, Saint-Antoine Hospital, Pitié Salpêtrière Hospital and Beaujon Hospital) for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their treatment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** pierre.buffet@aphp.fr **Name:** Pierre Buffet, MD, PhD **Role:** CONTACT **Contact 2:** **Email:** helene.morel@aphp.fr **Name:** Hélène Morel **Phone:** 1 71 49 63 46 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Clichy **Contacts:** ***Contact 1:*** - **Email:** alain.sauvanet@aphp.fr - **Name:** Alain Sauvanet, MD, PhD - **Phone:** 1 40 87 55 84 - **Phone Ext:** + 33 - **Role:** CONTACT ***Contact 2:*** - **Email:** safi.dokmak@aphp.fr - **Name:** Safi Dokmak - **Phone:** 1 40 87 57 97 - **Phone Ext:** + 33 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Beaujon **Status:** RECRUITING **Zip:** 92110 **Location 2:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** françois.paye@aphp.fr - **Name:** François Paye, MD, PhD - **Phone:** 1 49 28 25 61 - **Phone Ext:** + 33 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Saint Antoine **Status:** RECRUITING **Zip:** 75012 **Location 3:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** christophe.tresallet@aphp.fr - **Name:** Christophe Trésallet, MD, PhD - **Phone:** 1 42 17 66 03 - **Phone Ext:** + 33 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Pitié Salpêtrière **Status:** RECRUITING **Zip:** 75013 **Location 4:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** pierre.buffet@aphp.fr - **Name:** Pierre Buffet, MD, PhD - **Role:** CONTACT **Country:** France **Facility:** Hôpital Necker-Enfants Malades **Status:** RECRUITING **Zip:** 75015 **Location 5:** **City:** Paris **Country:** France **Facility:** Institut Pasteur **Status:** ACTIVE_NOT_RECRUITING **Zip:** 75015 #### Overall Officials **Official 1:** **Affiliation:** Assistance Publique - Hôpitaux de Paris **Name:** Pierre Buffet, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4085 - Name: Anemia, Sickle Cell - Relevance: LOW - As Found: Unknown - ID: M11280 - Name: Malaria - Relevance: LOW - As Found: Unknown - ID: M15901 - Name: Spherocytosis, Hereditary - Relevance: LOW - As Found: Unknown - ID: T3571 - Name: Malaria - Relevance: LOW - As Found: Unknown - ID: T5229 - Name: Sickle Cell Anemia - Relevance: LOW - As Found: Unknown - ID: T2782 - Name: Hereditary Spherocytosis - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418243 **Acronym:** 3D-PEDSURG **Brief Title:** Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors **Official Title:** Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging #### Organization Study ID Info **ID:** APHP230680 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **Domain:** ID-RCB **ID:** 2023-A02070-45 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Imagine Institute #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study's purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index. It is implemented by making parents' patients, surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patient's tumor. **Detailed Description:** The investigator will inform the child and his parents during the pre-surgical consultation, and will collect their non-opposition to be included in the study at the latest on the day of the MRI examination or CT scan. Patients requiring emergency imaging will not be included. Pelvic tumors will benefit from MRI imaging and renal tumors from MRI and/or CT scan. A CT scan will be carried out for retroperitoneal tumors other than renal tumors (mainly neuroblastomas). All of the above examinations are carried out as part of the usual treatment, in the month preceding the surgery. Pre-operatively After the imaging has been carried out, the 2D images will be presented to the patient and his family before surgery as it is done routinely. The 3D image will be showed afterwards. The family will have the opportunity to ask questions which the surgeon will answer as usually done. The specific questionnaire will be completed by the patient and his family at the end of the consultation and given to the research team. Once the patient is included and the examinations have been carried out, the operating surgeons and their assistants (help No. 1 and 2) will look at the 2D images, followed by the 3D images secondly a few days before surgery. They will complete the specific questionnaire and give it to the research team. Once the patient is included and the imaging examinations have been carried out, surgeons external to the service will be contacted by the research team to organize a remote review session. The 2D images will be presented to them first, followed by the 3D images on the visualization software, via a remote communication system with screen sharing. They will complete the specific questionnaire independently and a copy of the questionnaires will then be sent to the research team by email and the originals sent by post. Intraoperatively: The 3D model of the patient will be displayed in the operating room, and/or integrated into the robot's display console (for robot-assisted surgeries) during the surgical procedure. At the end of the surgery, the operating surgeon and his assistants will complete (independently) a questionnaire on the consistency of the 2D and 3D images with the anatomy identified during the procedure and on the help or not provided by the 3D model. ### Conditions Module **Conditions:** - Pelvic Tumor - Retroperitoneal Tumor **Keywords:** - Surgery - 3D-Imaging - MRI - CT Scan - Paediatric surgery - Tumor ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention **Label:** Children planned to get an MRI or CT scan ### Outcomes Module #### Primary Outcomes **Description:** Comparison of the automatically segmented 3D model to the reference manual segmentation **Measure:** Segmentation comparison **Time Frame:** 1 month #### Secondary Outcomes **Description:** Distance comparison between the reference segmentation and the one obtained by the algorithm **Measure:** Distance comparison **Time Frame:** 1 month **Description:** Recognition of anatomical structures comparison from 2D imaging and 3D imaging by surgeons preoperatively **Measure:** Anatomical structure recognition comparison **Time Frame:** Day 0 **Description:** Contribution of 3D modeling comparison to 2D imaging in pre-operative planning **Measure:** Pre-operative planning contribution **Time Frame:** Day 0 **Description:** Added value evaluation of 3D modelling compared to 2D imaging for surgeons pre-operatively **Measure:** Added value evaluation **Time Frame:** Day 0 **Description:** Surgeons' support evaluation for integrating 3D modelling into routine pre-operative planning **Measure:** Surgeons' support evaluation in pre-operative routine **Time Frame:** Day 0 **Description:** Evaluation of the contribution of 2D imaging for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively **Measure:** 2D imaging evaluation contribution for families' understanding **Time Frame:** Day 0 **Description:** Evaluation of the contribution of 3D modelling for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively **Measure:** 3D modelling evaluation contribution for families' understanding **Time Frame:** Day 0 **Description:** Added value evaluation of 3D modelling compared to 2D imaging for families pre-operatively **Measure:** 3D modelling added value evaluation pre-operatively **Time Frame:** Day 0 **Description:** Contribution of 3D modelling evaluation compared to 2D imaging for surgeons during surgery **Measure:** 3D modelling added value evaluation during surgery **Time Frame:** 1 month **Description:** Consistency evaluation of the 3D imaging with anatomy observed intraoperatively **Measure:** Consistency evaluation between 3D modelling and anatomy **Time Frame:** 1 month **Description:** Surgeons' support evaluation for integrating 3D modeling into their current practice **Measure:** Surgeons' support evaluation in current practice **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Children: * Children between 3 months and less than 18 years old * Children with a pelvic tumor requiring an MRI for a possible surgical intervention * Children with a retroperitoneal tumor requiring a CT scan or MRI with a view to surgical intervention * Children with no contraindication for a CT scan and/or 3T MRI * Children whose parents do not object to their participation in the study Other participants: * Operating surgeon agreeing to participate in the study * Caregiver agreeing to participate in the study * External surgeon agreeing to participate in the study Exclusion Criteria: Children : * Contraindication to MRI: metallic ocular foreign body, pacemaker, mechanical heart valve, old vascular clips on cerebral aneurysm * Need for an MRI under general anaesthesia * Contraindication for a CT scan with injection: renal failure, allergy to iodinated contrast products * Patients having participated in a therapeutic clinical trial involving a new molecule within 30 days before inclusion * Emergency situation **Maximum Age:** 17 Years **Minimum Age:** 3 Months **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention coming at the hospital for a consultation as part of their standard care. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** thomas.blanc@aphp.fr **Name:** Thomas BLANC, MD **Phone:** +33 1 44 49 41 53 **Role:** CONTACT **Contact 2:** **Email:** gael.plastow@aphp.fr **Name:** Gael PLASTOW **Phone:** +33 1 44 38 18 57 **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** thomas.blanc@aphp.fr - **Name:** Thomas BLANC, MD - **Phone:** +33 1 44 49 41 53 - **Role:** CONTACT ***Contact 2:*** - **Email:** gael.plastow@aphp.fr - **Name:** Gael PLASTOW - **Phone:** +33 1 44 38 18 57 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Necker Enfants Malades **Zip:** 75015 #### Overall Officials **Official 1:** **Affiliation:** Assistance Publique - Hôpitaux de Paris **Name:** Sabine SARNACKI, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Wake N, Wysock JS, Bjurlin MA, Chandarana H, Huang WC. "Pin the Tumor on the Kidney:" An Evaluation of How Surgeons Translate CT and MRI Data to 3D Models. Urology. 2019 Sep;131:255-261. doi: 10.1016/j.urology.2019.06.016. Epub 2019 Jun 22. **PMID:** 31233814 **Citation:** Talanki VR, Peng Q, Shamir SB, Baete SH, Duong TQ, Wake N. Three-Dimensional Printed Anatomic Models Derived From Magnetic Resonance Imaging Data: Current State and Image Acquisition Recommendations for Appropriate Clinical Scenarios. J Magn Reson Imaging. 2022 Apr;55(4):1060-1081. doi: 10.1002/jmri.27744. Epub 2021 May 27. **PMID:** 34046959 **Citation:** Ibrahim I, Skoch A, Herynek V, Jiru F, Tintera J. Magnetic resonance tractography of the lumbosacral plexus: Step-by-step. Medicine (Baltimore). 2021 Feb 12;100(6):e24646. doi: 10.1097/MD.0000000000024646. **PMID:** 33578590 **Citation:** van der Zee JM, Fitski M, Simonis FFJ, van de Ven CP, Klijn AJ, Wijnen MHWA, van der Steeg AFW. Virtual Resection: A New Tool for Preparing for Nephron-Sparing Surgery in Wilms Tumor Patients. Curr Oncol. 2022 Feb 1;29(2):777-784. doi: 10.3390/curroncol29020066. **PMID:** 35200565 **Citation:** Bertrand MM, Macri F, Mazars R, Droupy S, Beregi JP, Prudhomme M. MRI-based 3D pelvic autonomous innervation: a first step towards image-guided pelvic surgery. Eur Radiol. 2014 Aug;24(8):1989-97. doi: 10.1007/s00330-014-3211-0. Epub 2014 May 17. **PMID:** 24838739 **Citation:** Simons DC, Buser MAD, Fitski M, van de Ven CP, Ten Haken B, Wijnen MHWA, Tan CO, van der Steeg AFW. Multi-modal 3-Dimensional Visualization of Pediatric Neuroblastoma: Aiding Surgical Planning Beyond Anatomical Information. J Pediatr Surg. 2024 Feb 24:S0022-3468(24)00107-6. doi: 10.1016/j.jpedsurg.2024.02.025. Online ahead of print. **PMID:** 38461108 **Citation:** Valls-Esteve A, Adell-Gomez N, Pasten A, Barber I, Munuera J, Krauel L. Exploring the Potential of Three-Dimensional Imaging, Printing, and Modeling in Pediatric Surgical Oncology: A New Era of Precision Surgery. Children (Basel). 2023 May 3;10(5):832. doi: 10.3390/children10050832. **PMID:** 37238380 **Citation:** Hampshire J, Dicken BJ, Uruththirakodeeswaran T, Punithakumar K, Noga M. Pediatric patient-specific three-dimensional virtual models for surgical decision making in resection of hepatic and retroperitoneal tumors. Int J Comput Assist Radiol Surg. 2023 Oct;18(10):1941-1949. doi: 10.1007/s11548-023-02852-y. Epub 2023 Mar 11. **PMID:** 36905500 **Citation:** Bernhard JC, Isotani S, Matsugasumi T, Duddalwar V, Hung AJ, Suer E, Baco E, Satkunasivam R, Djaladat H, Metcalfe C, Hu B, Wong K, Park D, Nguyen M, Hwang D, Bazargani ST, de Castro Abreu AL, Aron M, Ukimura O, Gill IS. Personalized 3D printed model of kidney and tumor anatomy: a useful tool for patient education. World J Urol. 2016 Mar;34(3):337-45. doi: 10.1007/s00345-015-1632-2. Epub 2015 Jul 11. **PMID:** 26162845 **Citation:** Youn JK, Park SJ, Choi YH, Han JW, Ko D, Byun J, Yang HB, Kim HY. Application of 3D printing technology for pre-operative evaluation, education and informed consent in pediatric retroperitoneal tumors. Sci Rep. 2023 Jan 30;13(1):1671. doi: 10.1038/s41598-023-28423-4. **PMID:** 36717595 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13297 - Name: Pelvic Neoplasms - Relevance: HIGH - As Found: Pelvic Tumors ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000010386 - Term: Pelvic Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418230 **Acronym:** EXOCARI **Brief Title:** EXOME SEQUENCING IN MEDULLARY SPONGE KIDNEY **Official Title:** EXOME SEQUENCING IN MEDULLARY SPONGE KIDNEY #### Organization Study ID Info **ID:** 69HCL23-5392 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Medullary sponge kidney is a rare, underdiagnosed renal pathology, characterized by precalyceal dilatation of the renal tubes associated with active and recurrent stone disease with nephrocalcinosis, hypercalciuria and tubular dysfunction with, for example, acidification and urinary concentration defects. The pathophysiology is poorly understood The prevalence and etiopathogenesis of the disease is not known Medullary sponge kidney is often characterized as a congenital pathology with delayed expression due to reported cases occurring in early childhood and associations with other congenital renal and extra-renal malformative pathologies, such as Wilms tumors, horseshoe kidney, contralateral renal hypoplasia, Beckwith-Wiedemann syndrome, Caroli disease, or congenital hepatic fibrosis, for example. However, no clear demonstration of the congenital nature has been established so far, and it is considered a sporadic disease. However familial cases have been reported with an autosomal dominant mode. The pathophysiology may involve disruptions in renal organogenesis, which depends on reciprocal inductive interactions necessary to coordinate nephrogenesis between the ureteric bud and the metanephric blastema during the 5th week of embryonic development. Some authors suggested that the GDNF and RET genes may be involved in the physiopathology of the disease. For instance 12% of heterozygous patients for rare GDNF variants were identified in an Italian cohort of 57 medullary sponge kidney patients. Other genes have been suggested to be involved in the pathophysiology based on reported cases, with no direct relationship demonstrated and their role remain putative Medullary sponge kidney disease is a debilitating condition, with the main symptoms being recurrent kidney stones and urinary infections. Additional data are needed to determine the involvement of genetic anomalies in the pathophysiology of the condition. The aim of the study is to describe the genetic variants identified with exome sequencing in medullary sponge kidney patients, in order to optimize management, especially for familial forms, and therapeutic interventions. ### Conditions Module **Conditions:** - Medulary Sponge Kidney **Keywords:** - exome - nephrolithiasis - medullary sponge kidney ### Design Module #### Bio Spec **Description:** 1 Urinary collection of the last 24 hours : Sodium, urea, creatinin, calcium, uric acid, oxalate, citrate, magnesium, albumin 1 Urine sample : CBEU, UB, cristallury, Ca/creat 1 Blood sample (20mL), including ionogram, albumin, creatinin, GFR (CKDEPI) (3mL) (3mL) ; PTH (4mL) ; 1-25 diOH Vit D (calcitriol) (4mL) ; 25OH Vit D (4mL) 1 blood sample (4mL) : exome analysis **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** medullary sponge kidney attending medical consultation **Label:** MEDULLARY SPONGE KIDNEY ### Outcomes Module #### Primary Outcomes **Measure:** Class 3, 4 and 5 variants detected at exome-sequencing **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * medullary sponge kidney attending medical consultation * consent signed * affiliated to social insurance scheme Exclusion Criteria: * legal protection measure (guardianship, curatorship) * Deprived of liberty by a judicial or administrative decision * subject participating in another research including an exclusion period still in progress at inclusion **Gender Based:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The patients will be selected from the hospital Edouard Herriot nephrology and urology departments and frome from the hospital de la Conception nephrology and urology departments Around 80 Medullary sponge kidney patients are followed at these nephrology and urology departments ### Contacts Locations Module #### Locations **Location 1:** **City:** Lyon **Country:** France **Facility:** Hôpital Edouard Herriot **Zip:** 69003 **Location 2:** **City:** Marseille **Country:** France **Facility:** Hôpital de la Conception **Zip:** 13005 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000052177 - Term: Kidney Diseases, Cystic - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000000015 - Term: Abnormalities, Multiple - ID: D000000013 - Term: Congenital Abnormalities - ID: D000072661 - Term: Ciliopathies - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10693 - Name: Kidney Calculi - Relevance: LOW - As Found: Unknown - ID: M27126 - Name: Nephrolithiasis - Relevance: LOW - As Found: Unknown - ID: M10713 - Name: Medullary Sponge Kidney - Relevance: HIGH - As Found: Sponge Kidney - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10712 - Name: Polycystic Kidney Diseases - Relevance: HIGH - As Found: Sponge Kidney - ID: M26983 - Name: Kidney Diseases, Cystic - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M14 - Name: Abnormalities, Multiple - Relevance: LOW - As Found: Unknown - ID: M1076 - Name: Ciliopathies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T3669 - Name: Medullary Sponge Kidney - Relevance: HIGH - As Found: Medullary Sponge Kidney ### Condition Browse Module - Meshes - ID: D000007691 - Term: Medullary Sponge Kidney - ID: D000007690 - Term: Polycystic Kidney Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418217 **Brief Title:** Exercise and Patient Education for Patients With Lateral Hip Pain **Official Title:** 3 Months Semi-supervised Exercise Intervention for Patients With Hip Abductor Tendon Pathology (HATP): A Prospective Clinical Cohort Study #### Organization Study ID Info **ID:** 1-16-02-180-24 #### Organization **Class:** OTHER **Full Name:** Horsens Hospital ### Status Module #### Completion Date **Date:** 2027-02-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Aarhus #### Lead Sponsor **Class:** OTHER **Name:** Jeppe Lange #### Responsible Party **Investigator Affiliation:** Horsens Hospital **Investigator Full Name:** Jeppe Lange **Investigator Title:** MD, PhD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This prospective cohort trial will investigate a progressive exercise protocol and patient education for patients with hip abductor tendon pathology. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), that will be conducted at baseline and at a 12 week follow-up. **Detailed Description:** This study protocol describes an interventional pragmatic prospective single-group cohort study, where the primary endpoint is change in hip pain measured with the revised HAGOS pain subscale following a 12 week intervention. Throughout the 12 weeks, eight physiotherapist-led exercise sessions will take place at Horsens Regional Hospital (HRH). Further, at the sessions at HRH patient education will be performed by the supervising physiotherapist. The first supervised sessions will be performed in continuation of the baseline assessment. The patients will be instructed to do the exercises daily at home in the time period between the physiotherapist-led sessions. The primary aim is to investigate changes in patient-reported hip pain based on the subscale "pain" from the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from baseline to 12 week follow-up. It is hypothesized that the revised HAGOS pain score will improve from baseline to 12 week follow-up. Secondarily explorative subgroup analyses regarding whether patients with different MRI findings, pain profiles, age, sex and body mass index (BMI) respond differently to the intervention, will be performed. All outcomes conducted will be published. That is, patient-reported outcomes, muscle strength, functional capacity and adherence to the exercise protocol. A full study protocol will be published and made available. ### Conditions Module **Conditions:** - Gluteal Tendinitis - Greater Trochanteric Pain Syndrome - Hip and Thigh Injury - Rupture of Hip Abductor Tendon (Disorder) **Keywords:** - Exercise - Patient education - Lateral Hip Pain - Rehabilitation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Physiotherapy-led exercise of patients with lateral hip pain **Intervention Names:** - Procedure: Exercise and Patient Education **Label:** Physiotherapist-led exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Physiotherapist-led exercise **Description:** Patients will undergo a 12-week physiotherapist-led exercise program consisting of 8 supervised sessions and home-based training in between. Patients will keep training diaries, where each session is tracked in regards of completed repetitions and pain before and after the sessions. Each session will consist of four exercises. **Name:** Exercise and Patient Education **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** The adherence will be calculated as the proportion of completed exercise sessions in relation to the planned exercise sessions. A high adherence will be defined as completion of 75% or more of the planned exercises sessions (both supervised and home-based), medium adherence with completion of 50-74%, and low adherence with completion of less than 50%. **Measure:** Adherence to the exercise program. **Time Frame:** From baseline to 3 months follow-up. #### Primary Outcomes **Description:** The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain. **Measure:** Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. #### Secondary Outcomes **Description:** The subscale "symptoms" on HAGOS measures the patients perception of hip and/or groin pain. It consist of seven items. A score from 0 to 100 is calculated, where a higher score is indicating lower symptoms. **Measure:** Changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** The subscale "ADL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher function. **Measure:** Changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** The subscale "sport/recreation" on HAGOS measures the patients perception of hip and/or groin pain. It consist of eight items. A score from 0 to 100 is calculated, where a higher score is indicating higher function. **Measure:** Changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** The subscale "PA" on HAGOS measures the patients perception of hip and/or groin pain. It consist of two items. A score from 0 to 100 is calculated, where a higher score is indicating higher ability to participate in physical activity. **Measure:** Changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** The subscale "QOL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher quality of life. **Measure:** Changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** Oxford Hip Score (OHS), which consists of 12items. OHS is developed and validated for patients undergoing total hip replacements to access pain and function. It is a composite score ranging from 0 (worst) to 48 (best). **Measure:** Changes in the patient-reported outcome measure Oxford Hip Score (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** European Questionnaire-5 Dimensions (EQ-5D-5L and EQ-VAS) consists of five items and a visual analogue score (VAS), a vertical line on which the patients score their perception of their overall health from 0 to 100 (worst to best) **Measure:** Changes in the patient-reported outcome measure EQ-5D-5L (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** GRoC consists of a 11-point scale, where the patient rates the perceived overall change of the hip condition from "very much better" to "very much worse" . Responses on GRoC will be considered successful if patients scored "moderately better" to "very much better". Global improvement will be measured as the percentage of successful reports. **Measure:** Global Rating of Change (GRoC) **Time Frame:** The outcome is conducted at 6-week and 3-months follow-up. **Description:** Participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable). Participants will rate their average pain for the past 7 days during rest, at the beginning of activity, during activity, 2 hours after activity and the worst lateral hip pain. **Measure:** Lateral hip pain on a numerical pain rating scale (NRS) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) is validated for patients with gluteal tendinopathy and measures the severity of disability related to the condition. VISA-G consist of eight items and appraise the pain in relation to gluteal tendinopathy by a score from 0-100, where a higher score will indicate lower pain and less disability. **Measure:** Changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** Maximal isometric hip abduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight. **Measure:** Changes of maximal isometric hip abduction muscle strength (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** Maximal isometric hip adduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight. **Measure:** Changes of maximal isometric hip adduction muscle strength (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** Maximal isometric hip flexion strength test measures the maximal voluntary isometric contraction in sitting position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight. **Measure:** Changes of maximal isometric hip flexion muscle strength (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** Maximal isometric hip extension strength test measures the maximal voluntary isometric contraction in prone position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight. **Measure:** Changes of maximal isometric hip extension muscle strength (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. **Description:** Number of repetitions (sits to stand) performed during 30 seconds on a chair with a seat height of 45 cm. **Measure:** Changes of the number of repetitions of a 30 second sit to stand test (continuous data) **Time Frame:** From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18-75 years * MRI verified HATP * Lateral hip pain duration \> 6 months * Ability to read and understand Danish. Exclusion Criteria: * Corticosteroid injection in the affected hip joint within the last six weeks prior to the intervention * Previous bone-related surgery to the affected hip, * Signs of bilateral HATP * X-ray verified hip osteoarthritis * Pregnancy **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mathhg@rm.dk **Name:** Mathias Høgsholt, PT,PhD.-st. **Phone:** +45 24205299 **Role:** CONTACT **Contact 2:** **Email:** jepplang@rm.dk **Name:** Jeppe Lange, MD, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Horsens **Contacts:** ***Contact 1:*** - **Email:** mathhg@rm.dk - **Name:** Mathias Høgsholt, PT,PhD.-st. - **Phone:** +45 24205299 - **Role:** CONTACT ***Contact 2:*** - **Email:** jepplang@rm.dk - **Name:** Jeppe Lange, MD,PhD. - **Role:** CONTACT **Country:** Denmark **Facility:** Horsens Regional Hospital **Status:** RECRUITING **Zip:** 8700 #### Overall Officials **Official 1:** **Affiliation:** Horsens Regional Hospital; Aarhus University **Name:** Mathias Høgsholt, PT, PhD.st. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Horsens Regional Hospital; Aarhus University **Name:** Jeppe Lange, MD, PhD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Horsens Regional Hospital **Name:** Signe Kierkegaard-Brøchner, PhD **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Copenhagen University Hospital, Hvidovre **Name:** Kristian Thorborg, PhD **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** Horsens Regional Hospital **Name:** Marie Bagger Bohn, MD, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** Proposals should be directed to mathhg@rm.dk. To gain access, data requestors will need to sign a data access agreement. **Description:** What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Immediately following publication and ending 5 years following primary article publication. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000013708 - Term: Tendon Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M15241 - Name: Rupture - Relevance: HIGH - As Found: Rupture - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M27013 - Name: Tendinopathy - Relevance: HIGH - As Found: Tendinitis - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000052256 - Term: Tendinopathy - ID: D000012421 - Term: Rupture ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418204 **Acronym:** COSMIC **Brief Title:** Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics **Official Title:** Complementary Options for Symptom Management In Cancer (COSMIC): Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics #### Organization Study ID Info **ID:** WF-2304 #### Organization **Class:** OTHER **Full Name:** Wake Forest University Health Sciences #### Secondary ID Infos **Domain:** NCI Trial Identifier **ID:** NCI-2024-03314 **Type:** OTHER **Domain:** Lead Organization Identifier **ID:** WF-2304 **Type:** OTHER **ID:** 5UG1CA189824 **Link:** https://reporter.nih.gov/quickSearch/5UG1CA189824 **Type:** NIH **ID:** 1U01CA286813 **Link:** https://reporter.nih.gov/quickSearch/1U01CA286813 **Type:** NIH ### Status Module #### Completion Date **Date:** 2028-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Wake Forest University Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs. **Detailed Description:** The objective of this study is to examine the association between cannabis and/or cannabinoid use and cancer-related symptoms assessed monthly for one year in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning or recently started to receive one or more systemic cancer directed therapies with chemotherapy and/or immune check point inhibitors (ICIs) PD-1, PD-L1 or CTLA-4. Participants complete surveys and have their medical records reviewed on study. ### Conditions Module **Conditions:** - Breast Carcinoma - Colorectal Carcinoma - Lung Non-Small Cell Carcinoma - Melanoma - Non-Hodgkin Lymphoma ### Design Module #### Bio Spec **Description:** About one tablespoon (15mL) of blood will be collected from a vein in the participant's arm at 3 different time points. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants complete surveys and have their medical records reviewed on study. **Intervention Names:** - Other: Non-interventional Study **Label:** Observational ### Interventions #### Intervention 1 **Arm Group Labels:** - Observational **Description:** Non-interventional study **Name:** Non-interventional Study **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Will use the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to measure cancer-related symptoms. Will examine the longitudinal relationship between cannabis and/or cannabinoid use and the likelihood of exhibiting individual symptoms using three-level GLMMs to account for the nested data. We will model continuous measures (e.g., symptom severity) using a linear generalized linear mixed-effects models (GLMM) and the prevalence of symptoms or moderate to severe symptoms using a logistic GLMM. Cannabis and/or cannabinoid use at each monthly assessment will be included as a time-varying covariate and an interaction with time will be included to assess its impact on symptoms over time. Analyses will consider dichotomous definitions of use (yes/no past month), frequency of use (# days in the past month) as well as mode of administration, dose/potency, and cannabinoid type. **Measure:** Cancer-related symptoms **Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment #### Secondary Outcomes **Description:** Cannabis and cannabinoid use will be measured monthly using items from the Cannabis Engagement Assessment (CEA). The CEA contains 30 questions that assess the quantity, frequency of use, and method of consumption for dried cannabis products (excluding edibles), cannabis concentrates, and edible products in the previous 30 days. Two additional sections assess other factors associated with cannabis use and history of use. Estimates of consumption can be calculated from responses, with a lower limit of 0 and no upper limit. Higher values represent higher consumption in that month. **Measure:** Cannabis and Cannabinoid Use from Cannabis Engagement Assessment **Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment **Description:** Cannabis and cannabinoid use will be measured monthly using items from the International Cannabis Policy Study (ICPS) survey. The ICPS surveys provide a comprehensive assessment of cannabis use, includes detailed patterns of consumption, purchasing, adverse outcomes, as well as attitudes and beliefs towards cannabis. Results from this survey will help quantify amount of cannabis use, if any. **Measure:** Cannabis and Cannabinoid Use from the International Cannabis Policy Study survey **Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment **Description:** The NCI Cannabis Core Measures survey will be used to ask cannabis and cannabinoid users each month whether they think cannabis or cannabinoid use worsened or improved their symptoms. Using the NCI Cannabis Core Measures survey, we will ask cannabis and cannabinoid users each month whether they think cannabis or cannabinoid use worsened or improved their symptoms. We will define this as a nominal outcome where 0=no change; 1=worsened quite a bit or somewhat worsened, and 2=somewhat improved or improved quite a bit. **Measure:** Cannabis and Cannabinoid Perceived Benefits and Harms **Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment **Description:** The Adverse Reactions Scale will be used to ask cannabis and cannabinoid users each month whether they have experienced a checklist of potential adverse reactions. We will participants using cannabis and/or cannabinoids each month whether they have experienced a checklist of potential adverse reactions. These are defined as presence or absence of the adverse effect. We will also consider the frequency of time they experience the effect (% of time they experience the effect when consuming cannabis or cannabinoids) and the severity of the effect (0 = Not at all distressing; 1 = Mildly distressing; 2 = Moderately distressing; 3 = Quite distressing 4 = Severely distressing) as continuous measures. **Measure:** Cannabis and Cannabinoid Adverse Effects **Time Frame:** Baseline and re-assessed monthly up to 12 months post-enrollment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patient * Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. * Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) with or without immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage patient before treatment starts, enrollment is allowed from diagnosis up to four weeks after the start of treatment but must be before cycle 2 treatment begins. * Patients must be able to comprehend English or Spanish (for survey completion). * Patients must be willing to complete surveys online. This can be completed at home, in the clinic or other location. * Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment. Patient Optional Substudy (available at select sites only): * Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU). * Must be receiving treatment at the WF CCC and VCU. * Must be diagnosed with non-small cell lung cancer. * Must be receiving paclitaxel as part of their chemotherapy in conjunction with ICIs PD-1, PDL1 or CTLA. * Must be enrolled before cycle 1 begins Exclusion Criteria: Patient \* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms. Patient Optional Substudy (available at select sites only): * Patients with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). * Patients with a history of HIV, hepatitis B or hepatitis C. * Patients with active infection who are receiving antibiotic, antifungal or antiviral treatment. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or immune checkpoint inhibitors (ICIs) ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** NCORP@wakehealth.edu **Name:** Karen Craver **Phone:** 336-716-0891 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Wake Forest University Health Sciences **Name:** Glenn Lesser, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** upon request to NCORP@wakehealth.edu **Description:** Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514. **IPD Sharing:** YES **Time Frame:** 6 months after publication for a 2 year duration **URL:** http://nctn-data-archive.nci.nih.gov/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000012871 - Term: Skin Diseases - ID: D000001941 - Term: Breast Diseases - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Lung Non-Small Cell Carcinoma - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Carcinoma - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M11528 - Name: Melanoma - Relevance: LOW - As Found: Unknown - ID: M5449 - Name: Marijuana Abuse - Relevance: LOW - As Found: Unknown - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000001943 - Term: Breast Neoplasms - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418191 **Brief Title:** Mobile Apps Enhancing Acupressure Therapy Compliance and Efficacy for Asthenopia **Official Title:** The Role Of Mobile Applications In Therapy Compliance And Efficacy Of Acupressure In Asthenopia #### Organization Study ID Info **ID:** 24-03-0424 #### Organization **Class:** OTHER **Full Name:** Indonesia University ### Status Module #### Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Indonesia University #### Responsible Party **Investigator Affiliation:** Indonesia University **Investigator Full Name:** Dion Rukmindar **Investigator Title:** Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if a mobile application works to improve adherence to acupressure therapy in asthenopia. It will also learn about the efficacy of acupressure as a therapy for asthenopia. The main questions it aims to answer are: -Does a mobile application have a role to improve therapy compliance and efficacy of self-guided acupressure in asthenopia? Researchers will compare users of a mobile app to non-users of a mobile app to see if a mobile app works to improve adherence to acupressure therapy in asthenopia Participants will: * Do acupressure 2 times every day for 4 weeks * Filling in the absence link has been after doing acupressure every day * Fill out the link regarding the condition of asthenopia once per week **Detailed Description:** This is a clinical trial study to evaluate the role of a mobile application in therapy compliance and acupressure efficacy in asthenopia sufferers. Participants are 60 males/females aged 18-64 years. They will be divided into 2 groups: (1) Acupressure mobile app users and (2) Non-acupressure mobile app users. Acupressure is scheduled 2 times every day for 4 weeks. Therapy compliance will be assessed from the absence link that participants fill out every day, while therapy efficacy will be assessed once per week for 4 weeks. ### Conditions Module **Conditions:** - Asthenopia ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Mobile application users will be notified twice per day to perform acupressure. Instructions for performing acupressure are in the mobile app **Intervention Names:** - Procedure: Acupressure **Label:** Mobile app users **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Non-users of the mobile application will be given an explanation of how to perform acupressure at the start of the study and will not be reminded to perform acupressure therapy. **Intervention Names:** - Procedure: Acupressure **Label:** Not a mobile app user **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Mobile app users - Not a mobile app user **Description:** Acupressure is a technique that involves applying pressure to specific points on the body. It is based on the same principles as acupuncture but uses pressure from fingers, palms, elbows, or specialized devices instead of needles. **Name:** Acupressure **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Daily acupressure reports are used to monitor participants' therapeutic compliance in performing acupressure every day **Measure:** Daily Report of Acupressure **Time Frame:** 2 times every day for 4 weeks **Description:** The Modified MMAS-8 questionnaire, also known as the Morisky Medication Adherence Scale-8, is a self-report measure designed to assess acupressure adherence. It consists of eight questions aimed at gauging patients' behaviors and attitudes towards their therapy. The questions focus on factors such as forgetfulness, carelessness, and intentional skipping of medications. A score of 8 indicates high adherence. Scores between 6 and 7 indicate medium adherence. Scores of 5 or lower indicate low adherence. **Measure:** Modified Morisky Medication Adherence Scale-8 Questionnaire **Time Frame:** Monitored every 2 weeks for 4 weeks #### Secondary Outcomes **Description:** The Computer Vision Syndrome Questionnaire (CVS-Q) is a tool used to assess symptoms related to prolonged computer use or other digital screens. It typically consists of a series of questions designed to evaluate various discomforts experienced by individuals who spend significant time in front of screens. These questions may inquire about symptoms such as eye strain, headaches, blurred vision, dry eyes, neck or shoulder pain, and general fatigue. A CVS-Q score ≥ 6 indicates asthenopia **Measure:** Computer Vision Syndrome Questionnaire (CVS-Q) **Time Frame:** Monitored once per week for 4 weeks **Description:** VAS is used to assess complaints of asthenopia intensity on a scale of 1-10 **Measure:** Visual Analog Scale (VAS) **Time Frame:** Monitored once per week for 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Using a smartphone with the Android platform. * Work or use digital gadgets for at least 4 hours a day. * Suffering from asthenopia as indicated by a CVS-Q score ≥ 6. * Can be contacted with the WhatsApp application. * Willing to take part in this research until completion and agree to informed consent. Exclusion Criteria: * There are tumors, wounds or skin infections in the eye area. **Healthy Volunteers:** True **Maximum Age:** 64 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dion.rukmindar@ui.ac.id **Name:** Dion Rukmindar, MD **Phone:** +6285217264132 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM **Name:** KEPK FKUI-RSCM **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4555 - Name: Asthenopia - Relevance: HIGH - As Found: Asthenopia - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001248 - Term: Asthenopia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418178 **Acronym:** DosOp **Brief Title:** Dose Optimization of MDMA-Assisted Therapy for PTSD **Official Title:** A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans #### Organization Study ID Info **ID:** 171633 #### Organization **Class:** FED **Full Name:** Bronx VA Medical Center ### Status Module #### Completion Date **Date:** 2029-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** Bronx VA Medical Center #### Responsible Party **Investigator Affiliation:** Bronx VA Medical Center **Investigator Full Name:** Rachel Yehuda **Investigator Title:** Mental Health Patient Care Center Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT. **Detailed Description:** This open label, within-subjects dose optimization study will determine the optimal number of treatment cycles of MDMA-AT (one cycle consists of one Experimental Session followed by three Integrative Sessions) for significant improvement in a sample of U.S. veterans with PTSD. All participants will receive three non-drug preparatory sessions and at least one cycle of MDMA-assisted therapy with a team of two therapists. Each cycle will consist of one approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions. After each cycle, participants will determine, in consultation with their therapy team, whether to continue with an additional cycle or to discontinue treatment. The decision will reflect the participant's perception of the potential for continued improvement (e.g., as based on current symptom burden, treatment response to date) weighed against the burden of an additional cycle (e.g., time required, any adverse events or emotional burden). Participants may complete up to a maximum of five cycles. The dose optimizing design allows for the identification of the optimal number of MDMA-AT cycles to achieve the best response and to assess tolerability of multiple cycles of MDMA-AT. Participants will also provide blood samples to be banked for future analysis of biological markers associated with treatment response. For each participant, the study will consist of: * Screening Period: initial screen, informed consent, eligibility assessment * Enrollment Period with Enrollment Confirmation: Enrollment and medication tapering period (if needed) followed by psychological assessment and Enrollment Confirmation, collection of biomarker blood samples. * Treatment Period: 3 Preparatory sessions; one to five Experimental Sessions, each followed by 3 non-drug Integrative Sessions and a follow-up visit with study therapists * Post-treatment Period and Study Termination: Psychological Evaluation, biomarker blood samples, study termination visit ### Conditions Module **Conditions:** - Posttraumatic Stress Disorder **Keywords:** - Posttraumatic Stress Disorder - MDMA-Assisted Therapy - Dose Optimization - Veterans ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Open label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions. **Intervention Names:** - Drug: Midomafetamine - Behavioral: Psychotherapy **Label:** Treatment Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment Arm **Description:** One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below) **Name:** Midomafetamine **Other Names:** - MDMA - 3,4-methylenedioxymethamphetamine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment Arm **Description:** Standardized psychotherapy performed by therapy team **Name:** Psychotherapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The PCL-5 is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms per DSM-5. Participants indicate how much distress they have experienced due to each symptom on a five-point Likert-type scale (1=Not at all to 5=Extremely). **Measure:** PTSD Checklist for DSM-5 (PCL-5) **Time Frame:** From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles) #### Secondary Outcomes **Description:** The last month CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure and past-month symptom severity to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. **Measure:** Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) **Time Frame:** From Pre-treatment Psychological Evaluation to Post-treatment Psychological Evaluation (up to ~28 weeks for participants who complete all five treatment cycles) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Are a U.S. military veteran at least 18 years old. 2. Are able to provide written, informed consent. 3. Are able to swallow pills. 4. Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions. 5. Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable. 6. If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods. 7. Must have a current PTSD diagnosis at screening and baseline. 8. Must not participate in any other interventional clinical trials for the duration of the study. 9. Must commit to medication dosing, therapy, and all study procedures. Exclusion Criteria: 1. Are not able to give adequate informed consent. 2. Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful. 3. Have uncontrolled hypertension. 4. Have evidence or history of significant medical or psychiatric disorders. 5. Have symptomatic liver disease. 6. Have history of hyponatremia or hyperthermia. 7. Weigh less than 48 kilograms (kg). 8. Unable or unwilling to safely taper off prohibited psychiatric medication. 9. Abusing illegal drugs or alcohol. 10. Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment. 11. Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Amy.Lehrner@va.gov **Name:** Amy Lehrner, PhD **Phone:** 718-584-9000 **Phone Ext:** 3205 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** James J. Peters VA Medical Center **Name:** Rachel Yehuda, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** James J. Peters VA Medical Center **Name:** Amy Lehrner, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Stress Disorder - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Posttraumatic Stress Disorder - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000013313 - Term: Stress Disorders, Post-Traumatic ### Intervention Browse Module - Ancestors - ID: D000006213 - Term: Hallucinogens - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018759 - Term: Adrenergic Uptake Inhibitors - ID: D000014179 - Term: Neurotransmitter Uptake Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000018663 - Term: Adrenergic Agents ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M20876 - Name: N-Methyl-3,4-methylenedioxyamphetamine - Relevance: HIGH - As Found: Crossover Trial - ID: M17835 - Name: 3,4-Methylenedioxyamphetamine - Relevance: LOW - As Found: Unknown - ID: M9305 - Name: Hallucinogens - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000018817 - Term: N-Methyl-3,4-methylenedioxyamphetamine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418165 **Acronym:** VIHOMPS **Brief Title:** Vienna Hypothermic Oxygenated Machine Perfusion Study **Official Title:** Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study #### Organization Study ID Info **ID:** 1610/2023 #### Organization **Class:** OTHER **Full Name:** Medical University of Vienna ### Status Module #### Completion Date **Date:** 2038-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2018-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical University of Vienna #### Responsible Party **Investigator Affiliation:** Medical University of Vienna **Investigator Full Name:** David Pereyra **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In this observational cohort study data on all patients undergoing liver transplantation after hypothermic oxygenated machine perfusion at Medical University of Vienna will be prospectively recorded. Investigation of short- and long-term outcome in this cohort will be conducted. ### Conditions Module **Conditions:** - End Stage Liver Disease - Hepatocellular Carcinoma **Keywords:** - Liver Transplantation - Hypothermic Oxygenated Machine Perfusion ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Non-anastomotic stenosis, post-transplant cholangiopathy **Measure:** Incidence of ischemic-type biliary lesions **Time Frame:** Within one year after liver transplantation #### Secondary Outcomes **Description:** Deviation of bilirubin, transaminases or international normalised ratio **Measure:** Rate of early allograft dysfunction **Time Frame:** Evaluated within the first 7 postoperative days **Measure:** Rate of primary non-function **Time Frame:** Evaluated in the immediate postoperative period, specifically within the first postoperative week **Measure:** Incidence of re-transplantation **Time Frame:** Evaluated in the immediate postoperative period, specifically within the first postoperative week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion * age ≥ 18 years Exclusion Criteria: * pregnancy * partial grafts * the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients listed for and undergoing liver transplantation using a liver graft which was subjected to hypothermic oxygenated machine perfusion ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** david.pereyra@muv.ac.at **Name:** David Pereyra, MD, PhD **Phone:** +4314040056210 **Role:** CONTACT **Contact 2:** **Email:** jule.dingfelder@muv.ac.at **Name:** Jule Dingfelder, MD **Phone:** +4314040056210 **Role:** CONTACT #### Locations **Location 1:** **City:** Vienna **Contacts:** ***Contact 1:*** - **Email:** david.pereyra@muv.ac.at - **Name:** David Pereyra, MD, PhD - **Phone:** +4314040056210 - **Role:** CONTACT ***Contact 2:*** - **Email:** jule.dingfelder@muv.ac.at - **Name:** Jule Dingfelder, MD - **Phone:** +4314040056210 - **Role:** CONTACT ***Contact 3:*** - **Name:** Gabriela A Berlakovich, Prof, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Georg Györi, MD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Thomas Soliman, Prof, MD - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Andreas Salat, Prof, MD - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Gerd Silberhumer, Prof, MD - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** Julia Jedamzik, MD - **Role:** SUB_INVESTIGATOR **Country:** Austria **Facility:** Medical University of Vienna **Status:** RECRUITING **Zip:** 1090 #### Overall Officials **Official 1:** **Affiliation:** Medical University of Vienna, Division of Transplantation **Name:** Gabriela A Berlakovich, Prof, MD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Medical University of Vienna, Division of Transplantation **Name:** Georg Györi, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** data available upon reasonable request and in accordance with appropriate data sharing agreements **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004066 - Term: Digestive System Diseases - ID: D000017093 - Term: Liver Failure - ID: D000048550 - Term: Hepatic Insufficiency - ID: D000001832 - Term: Body Temperature Changes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: LOW - As Found: Unknown - ID: M29168 - Name: End Stage Liver Disease - Relevance: HIGH - As Found: End Stage Liver Disease - ID: M11107 - Name: Liver Diseases - Relevance: HIGH - As Found: Liver Disease - ID: M10085 - Name: Hypothermia - Relevance: HIGH - As Found: Hypothermic - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M19415 - Name: Liver Failure - Relevance: LOW - As Found: Unknown - ID: M25970 - Name: Hepatic Insufficiency - Relevance: LOW - As Found: Unknown - ID: M5111 - Name: Body Temperature Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008107 - Term: Liver Diseases - ID: D000058625 - Term: End Stage Liver Disease - ID: D000007035 - Term: Hypothermia ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418152 **Acronym:** DART for DBS **Brief Title:** Dual-task Augmented Reality for PD DBS **Official Title:** Dual-task Augmented Reality Treatment (DART) for Parkinson's Disease and Deep Brain Stimulation #### Organization Study ID Info **ID:** 24-282 #### Organization **Class:** OTHER **Full Name:** The Cleveland Clinic ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jay Alberts #### Responsible Party **Investigator Affiliation:** The Cleveland Clinic **Investigator Full Name:** Jay Alberts **Investigator Title:** Center Director **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this project is to evaluate the safety and preliminary effectiveness of utilizing a digital therapeutic, Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD with a previously implanted deep brain stimulator (DBS). **Detailed Description:** Multi-Modal Training in PD patients: In order to treat dual-task impairment (difficulty performing two tasks at once), multi-modal treatment (MMT) was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. Briefly, MMT training consists of simultaneously training a motor and cognitive task. The motor aspect of MMT stresses high velocity, high amplitude training principles while the cognitive aspect stresses commonly impaired cognitive domains in PD such as attention and executive function. An example of an MMT task is marching while spelling words backwards. Delivery of a Digital Therapeutic via Augmented Reality for the Treatment of PIGD: The MMT intervention is well-suited for integration into an augmented reality (AR) platform as it consists of the patient performing a series of cognitive and motor tasks simultaneously while the patient receives knowledge of performance and results from a therapist. The Microsoft HoloLens is an untethered, AR headset used in applications as broad as teaching anatomy, displaying fine art and gaming. With AR, the user maintains contact with the physical world and the people in it. The HoloLens uses AR technology to place holograms, objects made entirely of projected light, into the user's physical environment; hence creating a first-person mixed reality environment. These holograms can be viewed from different angles and distances, can be two-dimensional or three-dimensional, can appear life-like, can move, be shaped, and change according to interaction with users' or the physical environment in which they are projected, depending on the programming. The MMT was previously developed for the Dual-task Augmented Reality Treatment (DART), which delivers MMT training on a head-mounted AR display. The DART platform was successfully piloted in 50 individuals with PD who did not have DBS (IRB # 20-207). The results of the project indicate that DART is an effective method of training for individuals with PD. The goal is to expand the impact of that project through the investigation of DART in individuals with PD who have previously undergone DBS surgery. ### Conditions Module **Conditions:** - Parkinson's Disease - Deep Brain Stimulation ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Up to 5 individuals with previously implanted deep brain stimulation and Parkinson's disease ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 5 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Up to five individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant **Intervention Names:** - Behavioral: Multi-modal treatment **Label:** Interventional Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Interventional Arm **Description:** Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task. **Name:** Multi-modal treatment **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Clinical assessment of PD motor symptoms **Measure:** MDS-UPDRS III **Time Frame:** Baseline and through study completion, average 8 weeks #### Secondary Outcomes **Description:** Distance traveled during a 2 minute period under single-and dual-task conditions **Measure:** Two Minute Walk Test **Time Frame:** Baseline and through study completion, average 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult with a diagnosis of idiopathic PD * History of deep brain stimulator placement for treatment of PD * Ability to ambulate \> 10 minutes continuously without an assistive device Exclusion Criteria: * Medical diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent -\>2 errors on the Short Portable Mental Status Questionnaire * Musculoskeletal or cardiopulmonary issue that limits one's ability to engage in exercise * Neurological disease other than Parkinson's disease that impacts motor or cognitive function **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jansena@ccf.org **Name:** Elizabeth Jansen, MPH **Phone:** 216-780-9160 **Role:** CONTACT #### Locations **Location 1:** **City:** Cleveland **Contacts:** ***Contact 1:*** - **Email:** jansena@ccf.org - **Name:** Elizabeth Jansen, MPH - **Phone:** 216-780-9160 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jay L. Alberts, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Cleveland Clinic Foundation **State:** Ohio **Status:** RECRUITING **Zip:** 44195 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418139 **Acronym:** PEMCLOCK **Brief Title:** Association of Pembrolizumab Infusion Time and Efficacy in Patients With Non-metastatic Triple-negative Breast Cancer (TNBC) Treated With Neoadjuvant Chemotherapy and Immunotherapy **Official Title:** Etude de l'Effet de l'Horaire de Perfusion de l'immunothérapie Sur la réponse et la toxicité Des Traitements Chez Les Patientes Atteintes de Cancer du Sein Triple négatif à Haut Risque traité Par chimiothérapie néoadjuvante et Pembrolizumab #### Organization Study ID Info **ID:** APHP240393 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Background: Triple negative breast cancer (TNBC) is characterized by an aggressive biological behaviour responsible for higher risk of recurrence and shorter median survival. Pembrolizumab, an immune checkpoint inhibitor (ICI) targeting programmed death (PD-1), in association to chemotherapy showed improvement of event-free survival in patients with previously untreated stage II or III TNBC and has been approved in Europe since March 2022 for this indication (KEYNOTE-522). Circadian timing system controls many various biological functions in humans including xenobiotic metabolism and elimination, immune functions, cell cycle event and apoptosis. Thus, chronotherapeutic approaches have shown improved efficacy and tolerability in the treatment of different types of cancer, notably in colorectal cancer. Pronounced circadian rhythms in immune functions are generated by cell-autonomous molecular clocks in T and B lymphocytes, macrophages, neutrophils, and dendritic cells. Recently, first evidence of the effect of timing infusion of immune checkpoint inhibitors on prognosis of patients with cancer has been reported in several retrospective trials. Landre et al.'s meta-analysis of 7 retrospective studies including 1019 patients who had metastatic cancer was presented at the American Society of Clinical Oncology (ASCO) meeting in 2023. An early time-of-day ICI infusions was associated with an increase overall survival (HR: 0.49, \[95% CI: 0.36-0.69\] p \< 0.0001). Objectives: The aim is to analyze immunotherapy infusion timing impact on histological response, toxicity and Event Free-Survival (EFS) in patients with TNBC treated with Neo-Adjuvant Chemotherapy (NAC) associated with pembroluzimab. Measure of histological response is the primary objective determined by Residual Cancer Burden (RCB). Secondary endpoints are Event free Survival (EFS), calculated from the date of diagnosis to invasive local, regional, or metastatic relapse, contralateral breast cancer, or death from any cause), toxicity which is assessed by recording adverse events (CT-CAE v5) occurring from start of treatment to last course. Methods: Data from patients with histologically proven early TNBC treated from July 2021 to May 2023 with the association of Pembrolizumab, Paclitaxel Carboplatine followed with Pembrolizumab Cyclophosphamide Epirubicine (according to KEYNOTE 522 study) will be collected. Dosing times of each Pembrolizumab and chemotherapy infusions given to consecutive patients as a neoadjuvant standard treatment, associated with chemotherapy, for early TNBC are retrieved from hospital records. Adjuvant Pembrolizumab timing intake will be also recorded as EFS is a secondary endpoint. Statistics: First, median clock hour of all infusions of Pembrolizumab will be determined. Then, patients will be dichotomized between "morning' and 'afternoon' groups using 2 cut-offs: 1/ median clock of all infusions of pembrolizumab ('morning group' will include the patients who receive the majority of Pembrolizumab infusions before this median clock hour and 'afternoon group', patients who receive the majority of Pembrolizumab infusions after this median clock hour) and 2/ cut-off optimizing differences of RCB between two groups. Patient's characteristics, toxicities, tumor response and EFS will be compared. ### Conditions Module **Conditions:** - Non-Metastatic Breast Carcinoma **Keywords:** - Non metastatic Triple-negative breast cancer - Triple-negative breast cancer - Chronotherapy - Immunotherapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 450 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: No intervention **Label:** Morning group #### Arm Group 2 **Intervention Names:** - Other: No intervention **Label:** Afternoon group ### Interventions #### Intervention 1 **Arm Group Labels:** - Afternoon group - Morning group **Description:** No intervention added by the study **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** RCB is studied after neoadjuvant treatment (Symmans et al. 2007) **Measure:** Residual cancer burden class (RCB) **Time Frame:** Up to 36 months #### Secondary Outcomes **Description:** Measurement of immune adverse events according to CTC-CAE Toxicity Grading Scale for Determining The Severity of Adverse Events version 5 **Measure:** Number of immune adverse events **Time Frame:** Up to 36 months **Description:** Complete response is defined as hCR or RCB 0 Invasive residual disease rate is defined as RCB 2-3 **Measure:** Histological Complete Response (hCR) rate versus invasive residual disease rate **Time Frame:** Up to 36 months **Description:** Association of RCB (class and continuous variable) with tumor-infiltrating lymphocyte (TIL) levels **Measure:** Tumor-infiltrating lymphocyte (TIL) levels **Time Frame:** Up to 36 months **Measure:** Progression-free survival **Time Frame:** At 2 years **Measure:** Number of Pembrolizumab infusions performed **Time Frame:** Up to 36 months **Description:** in % **Measure:** Tumor cellularity **Time Frame:** Up to 36 months **Description:** mm x mm **Measure:** Size of residual breast tumor **Time Frame:** Up to 36 months **Measure:** Number of invaded nodes **Time Frame:** Up to 36 months **Measure:** Diameter of largest lymph node metastasis if lymph node invaded **Time Frame:** Up to 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female sex * Age ≥ 18 years-old * Previously untreated histologically proven triple-negative breast cancer (RE \< 10%, RP \< 10%, Her-2 negative) * No metastatic * Having at least one injection of pembrolizumab associated with chemotherapy * Pembrolizumab injection schedule correctly reported by the nurse in charge of the patient Exclusion Criteria: • Metastatic disease **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Female with high-risk early triple-negative breast cancer treated with neoadjuvant chemotherapy combined with pembrolizumab ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sylvie.giacchetti@aphp.fr **Name:** Sylvie Giacchetti, Dr **Phone:** +33142499785 **Role:** CONTACT **Contact 2:** **Email:** jerome.lambert@u-paris.fr **Name:** Jérôme Lambert, Pr **Phone:** +33142499742 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Carcinoma - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000064726 - Term: Triple Negative Breast Neoplasms - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M349416 - Name: Pembrolizumab - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418126 **Acronym:** TNBC-RT2023 **Brief Title:** Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer **Official Title:** Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023 #### Organization Study ID Info **ID:** 2023-003 #### Organization **Class:** OTHER **Full Name:** Institut de cancérologie Strasbourg Europe ### Status Module #### Completion Date **Date:** 2027-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-11 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Centre de recherche du Centre hospitalier universitaire de Sherbrooke #### Lead Sponsor **Class:** OTHER **Name:** Institut de cancérologie Strasbourg Europe #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. TNBC patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment. At present, there are no biomarkers to differentiate these two groups. Some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. Gene expression profiling or protein signatures have not been able to define such biomarkers. The aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines IL-1β, IL-5 and IL-6 in plasma collected during radiotherapy can be used to predict TNBC patients at high risk of recurrence. ### Conditions Module **Conditions:** - Triple-negative Breast Cancer **Keywords:** - Radiotherapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session. They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred. **Intervention Names:** - Biological: blood sampling before radiotherapy - Biological: blood sampling after the fourth radiotherapy session - Other: collection of acute toxicity (radiodermatitis) - Other: collection of late toxicity - Other: collection of disease status - Radiation: Radiotherapy - Breast +/- lymph node areas - Radiation: Radiotherapy - Boost operating bed **Label:** Women with TNBC breast cancer **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Women with TNBC breast cancer **Description:** A blood sample (20 ml) will be taken prior to radiotherapy **Name:** blood sampling before radiotherapy **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Women with TNBC breast cancer **Description:** A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session. **Name:** blood sampling after the fourth radiotherapy session **Type:** BIOLOGICAL #### Intervention 3 **Arm Group Labels:** - Women with TNBC breast cancer **Description:** for the entire duration of radiotherapy **Name:** collection of acute toxicity (radiodermatitis) **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Women with TNBC breast cancer **Description:** every year for 5 years **Name:** collection of late toxicity **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Women with TNBC breast cancer **Description:** throughout the study **Name:** collection of disease status **Type:** OTHER #### Intervention 6 **Arm Group Labels:** - Women with TNBC breast cancer **Description:** 40.05 Gy in 15 fractions of 2.67 Gy, one fraction per week, 5 days per week Or 50 Gy in 25 fractions of 2 Gy, one fraction per week, 5 days per week **Name:** Radiotherapy - Breast +/- lymph node areas **Type:** RADIATION #### Intervention 7 **Arm Group Labels:** - Women with TNBC breast cancer **Description:** 10 Gy in 4 fractions of 2.5 Gy, one fraction per week, 5 days per week Or 16 Gy in 8 fractions of 2 Gy, one fraction per week, 5 days per week **Name:** Radiotherapy - Boost operating bed **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy. **Measure:** Predictive value of recurrence associated with the appearance of inflammatory cytokines **Time Frame:** up to 5 years #### Secondary Outcomes **Description:** TNBC cells will be incubated with plasma collected before or during radiotherapy. Boyden chambers will be used to determine the increase in cell invasion. **Measure:** To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence. **Time Frame:** up to 5 years **Description:** Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice. **Measure:** To determine whether the development of metastases in a mouse model injected with TNBC D2A1 cells pre-incubated with plasma collected during radiotherapy will be associated with recurrence. **Time Frame:** up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Women with TNBC breast cancer who meet the following criteria: * Women aged 18 and over; * Any tumor size (pT stage); * Regional lymph node pN0 to pN3; * Patient with pathologically confirmed TNBC (estrogen and progesterone receptor negative and HER2 negative); * Neo- or adjuvant chemotherapy followed by radiotherapy; * No evidence of distant metastasis at time of diagnosis; * Primary tumor removed by conservative surgery with negative margins; * Patient covered by the French social security system (for French patients). Exclusion Criteria: * Distant metastasis at the time of diagnosis; * Pregnant or breast-feeding women; * Woman deprived of liberty, under guardianship or trusteeship. * Patient unable to give consent * Patient unable to speak French * Patients unable to undergo regular long-term surveillance. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** v.sartori@icans.eu **Name:** Valérie SARTORI **Phone:** 0368767223 **Phone Ext:** 33 **Role:** CONTACT **Contact 2:** **Email:** promotion-rc@icans.eu **Name:** Manon VOEGELIN **Phone:** 0368767360 **Phone Ext:** 33 **Role:** CONTACT #### Locations **Location 1:** **City:** Strasbourg **Contacts:** ***Contact 1:*** - **Email:** v.sartori@icans.eu - **Name:** Valérie SARTORI - **Phone:** 0368767223 - **Phone Ext:** 33 - **Role:** CONTACT ***Contact 2:*** - **Email:** promotion-rc@icans.eu - **Name:** Manon VOEGELIN - **Phone:** 0368767360 - **Phone Ext:** 33 - **Role:** CONTACT ***Contact 3:*** - **Name:** Georges NOEL - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Institut de cancérologie Strasbourg europe **Status:** RECRUITING **Zip:** 67033 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000064726 - Term: Triple Negative Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418113 **Acronym:** GLINERA **Brief Title:** Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma **Official Title:** Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma #### Organization Study ID Info **ID:** 22/399 #### Organization **Class:** OTHER **Full Name:** Hospital San Carlos, Madrid ### Status Module #### Completion Date **Date:** 2027-03-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-11-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-03 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Asociación de Afectados Por Tumores Cerebrales en España (ASATE) #### Lead Sponsor **Class:** OTHER **Name:** Hospital San Carlos, Madrid #### Responsible Party **Investigator Affiliation:** Hospital San Carlos, Madrid **Investigator Full Name:** Juan Antonio Barcia Albacar **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). The main questions it aims to answer are: * What is the safety profile of neoadjuvant radiochemotherapy in terms of neurological deficit, radionecrosis, edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula? * What is the efficacy of neoadjuvant radiochemotherapy in terms of progression-free survival, overall survival, cognitive function, and quality of life? Participants will undergo the following tasks and treatments: * Stereotactic biopsy and diagnosis confirmation. * Conformal hypofractionated stereotactic radiotherapy with concurrent temozolomide. * Supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. * Maintenance temozolomide administration for 6 months. Researchers will compare the group receiving neoadjuvant radiochemotherapy to the control group following the standard Stupp protocol to assess safety and efficacy outcomes. **Detailed Description:** Objectives: To study the safety (primary) and efficacy (secondary) of neoadjuvant radiochemotherapy in the surgical resection of glioblastoma (GBM). Safety measures include: neurological deficit, radionecrosis (radiological and clinical), edema, headache, wound dehiscence, infection, and cerebrospinal fluid fistula. Efficacy measures include progression-free survival (PFS), overall survival (OS), cognitive function (MoCA Scale), and quality of life (EuroQol scales, EORTC QLQ-HN35, FACT-Br, and TWiST). Methods: Pilot safety and efficacy study in 6 patients compared to 6 controls. 2-year follow-up. A data safety monitoring committee will review the data one month after surgery for each of the first three patients to decide whether to stop or continue the study. Stereotactic biopsy will be performed, and if GBM is diagnosed, patients will undergo conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy and concurrent temozolomide (TMZ). 5 weeks later, patients will undergo supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. 7 days after surgery, maintenance TMZ will be administered for 6 months. The control group will follow standard treatment (Stupp protocol). Data analysis will be performed using non-parametric tests. Samples from successive surgeries will be studied with histology, molecular biology, and cell cultures. ### Conditions Module **Conditions:** - Glioblastoma - Glioblastoma Multiforme - Glioblastoma, IDH-wildtype - Radiotherapy; Complications - Cancer Brain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Stereotactic biopsy will be performed on patients in the experimental group, who will then be discharged. If the histopathological diagnosis is not wildtype IDH non-mutated glioblastoma, the patient will be withdrawn from the study and receive conventional treatment. If wildtype IDH non-mutated glioblastoma is diagnosed, ten days after the biopsy, patients will undergo conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg/m2/day for 7 days/week during the irradiation period (GEINO, 2016). Five weeks later, patients will undergo supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring. Starting from 4 weeks post-surgery, TMZ will be administered for 6 months according to the Stupp protocol. **Intervention Names:** - Radiation: hypofractionated stereotactic radiotherapy - Procedure: Stereotactic biopsy - Procedure: resection - Drug: Chemotherapy **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The Stupp protocol is a standard treatment regimen for glioblastoma, which involves a combination of radiotherapy and chemotherapy. **Intervention Names:** - Procedure: resection - Radiation: radiotherapy Stupp protocol - Drug: Chemotherapy Stupp Protocol **Label:** Stupp Protocol **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** conformal hypofractionated stereotactic radiotherapy to the FLAIR hyperintense signal, including the contrast-enhancing tumor on T1, with a total dose of 3990 cGy at the margin in 15 fractions of 266 cGy, one session per day, five days a week, and concurrent temozolomide (TMZ) at 75 mg/m2/day for 7 days/week during the irradiation period **Name:** hypofractionated stereotactic radiotherapy **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Experimental **Description:** Stereotactic biopsy **Name:** Stereotactic biopsy **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Experimental - Stupp Protocol **Description:** supramarginal resection guided by 5-ALA under intraoperative neurophysiological monitoring **Name:** resection **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Experimental **Description:** 4 weeks post-surgery, temozolomide (TMZ) will be administered for 6 months **Name:** Chemotherapy **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Stupp Protocol **Description:** radiotherapy + TMZ concurrently after 4 weeks of resection surgery, as per usual protocol: Three-dimensional radiotherapy planning to deliver a total dose of 60 Gy, with a fractionation of 2 Gy/day, 5 days/week, encompassing a 1-2 cm margin around the contrast-enhancing region defined on T1 imaging or the entire abnormal volume defined on T2 or FLAIR imaging (Li et al., 2016) + TMZ at 75 mg/m2/day for 7 days/week, for 6 weeks during radiotherapy. **Name:** radiotherapy Stupp protocol **Type:** RADIATION #### Intervention 6 **Arm Group Labels:** - Stupp Protocol **Description:** temozolomide (TMZ) will be administered for 6 months according to the Stupp protocol. **Name:** Chemotherapy Stupp Protocol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Information on adverse events will be reviewed through direct questioning of the patient. **Measure:** Emergent Adverse Events assessed by physical and neurological examination **Time Frame:** Clinical follow-up every month for 2 years **Description:** Information on adverse events will be reviewed through the results of examinations, complementary tests and analytical parameters. **Measure:** Emergent Adverse Events assessed by evaluation of the results of the analysis with hematology and biochemistry. **Time Frame:** Clinical follow-up every month for 2 years **Description:** brain RM image, for neuroradiological follow-up **Measure:** Emergent Adverse Events assessed by brain RM image **Time Frame:** every 3 months after surgery, for 2 years **Description:** AC_PET image, for neuroradiological follow-up **Measure:** Emergent Adverse Events assessed by AC_PET with 18-FdG **Time Frame:** every 6 months after surgery, for 2 years #### Secondary Outcomes **Description:** Progression-free survival (PFS), a measure of how long a patient receives treatment before the cancer begins to grow. **Measure:** Efficacy assessed by progression-free survival (PFS) **Time Frame:** through study completion, an average of 2 yeas. **Description:** Overall survival (OS), how long patients live after starting treatment. **Measure:** Efficacy assessed by overall survival (OS) **Time Frame:** through study completion, an average of 2 yeas. **Description:** A commonly used instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales. Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL **Measure:** Quality of life assessed by The Functional Assessment of Cancer Therapy-Brain (FACT-Br) **Time Frame:** every 3 months after surgery, for 2 years **Description:** It has been shown to be useful at detecting cognitive dysfunction in brain metastases. The test is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory recall (5 points), visuospatial abilities through clock-drawing (3 points) and cube copy (1 point), and orientation (6 points). Executive function is assessed through modified Trail Making Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points). A sustained-attention task (1 point), digit span (2 points), and serial calculation (3 points) test attention, concentration, and working memory. And lastly, language is assessed through naming low-familiarity animals (3 points), sentence repetition (2 points), and the fluency task **Measure:** Cognitive functionality assessed by MONTREAL COGNITIVE ASSESSMENT (MOCA) **Time Frame:** every 3 months after surgery, for 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 18 and 75 years. * Unifocal disease. * Unilobar tumor. * Clinical-radiological diagnosis of supratentorial unicentric high-grade glioma, eligible for macroscopically complete resection. Exclusion Criteria: * Multilobar tumor, interhemispheric or infratentorial extension, or multifocal disease. * Midline shift greater than 1 cm. * Intracranial hypertension symptoms requiring corticosteroid treatment. * Synchronous neoplasia. * Any contraindication for surgery, radiotherapy, or TMZ treatment. * Cognitive impairment. * Rejection of informed consent. * Inability to follow up for 2 years. * Women of childbearing potential according to the Clinical Trial Facilitation Group (CTFG) criteria. (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1.pdf) * Hypersensitivity to the active ingredient or any excipients of the investigational drug. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jabarcia@ucm.es **Name:** Juan Antonio Barcia **Phone:** +34 913303506 **Role:** CONTACT **Contact 2:** **Email:** rebeca.lliguin.leon@gmail.com **Name:** Mª Rebeca Lliguin León **Phone:** +34 622059861 **Role:** CONTACT #### Locations **Location 1:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Email:** jabarcia@ucm.es - **Name:** Juan Antonio Barcia - **Phone:** +34 913303506 - **Role:** CONTACT ***Contact 2:*** - **Email:** rebeca.lliguin.leon@gmail.com - **Name:** Mª Rebeca Lliguin León - **Phone:** 622059861 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Clínico San Carlos **Status:** RECRUITING **Zip:** 28040 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001254 - Term: Astrocytoma - ID: D000005910 - Term: Glioma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9019 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: M4561 - Name: Astrocytoma - Relevance: LOW - As Found: Unknown - ID: M9020 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2518 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: T2519 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005909 - Term: Glioblastoma ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M1692 - Name: Temozolomide - Relevance: LOW - As Found: Unknown - ID: M3960 - Name: Aminolevulinic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418100 **Brief Title:** Recto-intercostal Block for Coronary Artery Bypass Grafting **Official Title:** Recto-intercostal Fascial Plane Block for Postoperative Analgesia in Coronary Artery Bypass Grafting With Sternotomy: a Randomized, Double-blind, Controlled Study #### Organization Study ID Info **ID:** 272-2023 #### Organization **Class:** OTHER **Full Name:** Haseki Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-02-26 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Haseki Training and Research Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This interventional study aims to learn about the postoperative analgesic efficacy of a new fascial plane block, recto-intercostal fascial plane block, at coronary artery bypass grafting with sternotomy. There will be two groups, one of which will be the control group, and the other will be the study group randomly receiving postoperative recto-intercostal fascial plane block. The main questions it aims to answer are the effect of this new block on postoperative opioid consumption and pain scores. Also, postoperative outcomes related to respiratory ( postoperative oxygenation and atelectasis score), hemodynamic functions ( newly developed arrhythmias), total postanesthesia care unit stay, and hospital stay will be questioned. **Detailed Description:** All patients will receive standard general anaesthesia under standard monitoring along with the bispectral index (Medtronic). Intubation will be performed by administering intravenous (IV) 0,03 mg/kg midazolam, propofol (Lipuro, Braun, max. 2 mg/kg according to BIS), two mcg/kg fentanyl (Talinat, VEM), 1 mg /kg rocuronium (Esmeron, Alessandroorsini) followed by 1 MAC sevoflurane (Sevorane, Abbott) in an air-oxygen mixture for maintenance of anaesthesia. Following anaesthesia induction, all participants will receive superficial parasternal intercostal plane block (SPIP) bilaterally along with 8 mg dexamethasone before surgical incision as part of multimodal analgesia by a single experienced regional anaesthesiologist (B.C.) under ultrasound guidance (Esaote MyLab ™ Seven). SPIPB will be performed using a high-frequency probe to visualize the pectointercostal fascial area at the intercostal level of the intercostal 3-4 level, and 20 ml %0,25 bupivacaine was injected bilaterally. After applying SPIPB, the surgery is set to begin after at least 15 minutes of block procedure. The intraoperative analgesic need will be supplied by fentanyl bolus doses as 50 mcq if necessary, as heart rate or systolic blood pressure increases by more than %15. According to randomization, the intervention group will receive RIFPB with 20 ml %0,25 bupivacaine. From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NRS is over four or with the patient's request. The routine analgesia regimen was 1 gram IV paracetamol 6th hourly postoperatively at the PACU. All patients were followed up from the extubation time till hospital discharge to evaluate respiratory and hemodynamic changes, possible complications and total postoperative time. ### Conditions Module **Conditions:** - Coronary Artery Disease - Peripheral Nerve Blocks - Sternotomy **Keywords:** - coronary artery bypass grafting - Parasternal intercostal plane block - Recto-intercostal fascial plane block - Postoperative analgesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** prospective, randomized, triple-blind, controlled ##### Masking Info **Masking:** DOUBLE **Masking Description:** The participants under general anaesthesia and the cardiovascular surgeon responsible for the study were blinded to the study groups. This surgeon served as the sole evaluator of postoperative outcomes. Intraoperative results were recorded by the anaesthesia technician, who was present in the operating room and unaware of the block procedures performed. Moreover, the data analysis was conducted before the unblinding of the data. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants will have standardized anaesthesia management and receive postoperative rescue analgesia as morphine. **Label:** The Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The participants will receive postoperative recto intercostal fascial plane block, with 20 ml 0,25 bupivacaine bilaterally. **Intervention Names:** - Procedure: The recto intercostal fascial plane block **Label:** The rectointercostal fascial plane block **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - The rectointercostal fascial plane block **Description:** After ensuring aseptic conditions, the high-frequency linear ultrasound probe was used to detect the rectus abdominis muscle and the 6-7th costal cartilage as described by Tulgar et al. After rotating and shifting the transducer, 6-7th costal cartilages, the rectus abdominis muscle, and intercostal muscles between the cartilages were confirmed. The primary investigator (B.C.) directed the needle tip caudad in the cephalic direction in-plainly, and 20 ml 0,25% bupivacaine was injected bilaterally into the plane between the costal cartilage and the rectus abdominis muscle following negative aspiration. **Name:** The recto intercostal fascial plane block **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** up to discharge postoperative **Measure:** total hospital stay **Time Frame:** postoperative #### Primary Outcomes **Description:** . From the beginning of acclaimed arousal till the 24th hour, rescue analgesia as tramadol 100 mg (maximum daily dose 400 mg) is applied if NRS over 4 or with the patient's request. **Measure:** Total rescue analgesic **Time Frame:** postoperative 24 hour #### Secondary Outcomes **Description:** total amount of opioid use as fentanyl intraoperatively **Measure:** intraoperative opioid use **Time Frame:** intraoperative **Description:** systolic blood pressure **Measure:** intraoperative hemodynamic change **Time Frame:** at sternotomy **Description:** postoperative atelectasis score **Measure:** postoperative respiratory function **Time Frame:** postoperative 48 hour **Description:** postoperative arythmias especially atrial fibrillation **Measure:** postoperative arythmias **Time Frame:** postoperative 48 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients who will undergo CABG surgery with sternotomy * patients who have an American Society of Anesthesiologists (ASA) Physical Status classification of III to IV Exclusion Criteria: * refusal to participate * a history of neurological deficits or neuropathy affecting the thoracal innervation * infection at the site of block application * allergy to local anesthetics * epilepsy or treatment with antipsychotics * abuse of alcohol or drugs * previous surgery distorting the anatomy of the sternum, thorax or upper abdominal area * severe organ dysfunction ( kidney, liver and other); patients who fail at weaning after 12 hours of surgery. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** caliskan.b@gmail.com **Name:** Berna Caliskan, MD **Phone:** +905067108770 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** caliskan.b@gmail.com - **Name:** Berna Caliskan - **Phone:** +905067108770 - **Role:** CONTACT **Country:** Turkey **Facility:** Haseki Training and Research Hospital **State:** Sultangazi **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Haseki Training and Research Hospital Anesthesiology and Reanimation Department **Name:** Berna Caliskan **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available. **PMID:** 37295124 **Citation:** Chen Y, Li Q, Liao Y, Wang X, Zhan MY, Li YY, Liu GJ, Xiao L. Preemptive deep parasternal intercostal plane block for perioperative analgesia in coronary artery bypass grafting with sternotomy: a randomized, observer-blind, controlled study. Ann Med. 2023;55(2):2302983. doi: 10.1080/07853890.2024.2302983. Epub 2024 Feb 20. **PMID:** 38375661 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11982 - Name: Morphine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418087 **Acronym:** DUPLE **Brief Title:** Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC) **Official Title:** A Multicenter Phase II, Single Arm Study of Durvalumab (MEDI 4736) With Carboplatin Plus Etoposide for 4 Cycles Followed by Durvalumab Maintenance in Patients With Metastatic Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC) #### Organization Study ID Info **ID:** DUPLE- GOIRC- 05-2020 #### Organization **Class:** OTHER **Full Name:** Gruppo Oncologico Italiano di Ricerca Clinica ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-05-27 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2022-08-11 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gruppo Oncologico Italiano di Ricerca Clinica #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC) **Detailed Description:** This is a prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC). Enrolled subjects will receive a combination of intravenous carboplatin (AUC 5 on day 1), etoposide (100 mg/sqm on days 1-3), and durvalumab (1500 mg on day 1) administered every three weeks for a total of 4 courses (induction phase) or until progression of disease, unacceptable toxicity, patient refusal or loss of clinical benefit. Treatment with intravenous durvalumab (1500 mg on day 1) every 4 weeks (maintenance phase) will continue until completion of 24 courses (for a total of 28 courses, including the 4 courses of induction phase) or 2 years of treatment whichever occurs first, disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit. ### Conditions Module **Conditions:** - Pulmonary Large-cell Neuroendocrine Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 49 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All enrolled patients will receive intravenous infusion of durvalumab 1500 mg on day 1 (induction phase) with carboplatin (AUC 5 on day 1), etoposide (100 mg/sqm on days 1-3) every 3 weeks, and durvalumab (1500 mg on day 1) administered every three weeks for up to 4 cycles (induction phase) or until progression of disease, unacceptable toxicity, patient refusal or loss of clinical benefit (for durvalumab). Treatment with intravenous durvalumab (1500 mg on day 1) every 4 weeks ± 3 days (maintenance phase) will continue until completion of 24 courses (for a total of 28 courses, including the 4 courses of induction phase) or 2 years of treatment whichever occurs first, disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit. **Intervention Names:** - Drug: Durvalumab 50 MG/1 ML Intravenous Solution [IMFINZI] **Label:** Patient with Pulmonary Large-cell Neuroendocrine Carcinoma **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patient with Pulmonary Large-cell Neuroendocrine Carcinoma **Description:** Intravenous infusion of durvalumab 1500 mg on day 1 (induction phase) with carboplatin (AUC 5 on day 1), etoposide (100 mg/sqm on days 1-3) every 3 weeks, and durvalumab (1500 mg on day 1) administered every three weeks for up to 4 cycles (induction phase) or until progression of disease, unacceptable toxicity, patient refusal or loss of clinical benefit (for durvalumab). Treatment with intravenous durvalumab (1500 mg on day 1) every 4 weeks ± 3 days (maintenance phase) will continue until completion of 24 courses (for a total of 28 courses, including the 4 courses of induction phase) or 2 years of treatment whichever occurs first, disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit. **Name:** Durvalumab 50 MG/1 ML Intravenous Solution [IMFINZI] **Other Names:** - Carboplatino AHCL 10 mg/ml Concentrate for solution for infusion - Etoposide 20 mg/ml Concentrate for solution for infusion **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Efficacy of the combination of carboplatin + etoposide Overall Survival rate at 1 year **Measure:** Efficacy of the combination of carboplatin + etoposide + durvalumab in treatment-naïve patients, as first line treatment, with metastatic pulmonary LCNEC **Time Frame:** 1 year #### Secondary Outcomes **Description:** Activity of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC Median OS PFS ORR DCR and DoR at 1 year **Measure:** Activity of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC **Time Frame:** 1 year **Description:** Safety and tolerability profile of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC **Measure:** Number of Participants with treatment-related Adverse Events as assessed by CTCAE v. 5.0 - The safety and tolerability profile of the combination of carboplatin + etoposide + durvalumab as first-line treatment for patients with metastatic pulmonary LCNEC **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. * Age ≥18 years at the time of study entry * Histologically or cytologically (cell blocks only; smears are not acceptable) documented pulmonary large-cell neuroendocrine carcinoma (LCNEC) * Stage IV disease or unresectable stage IIIB, which cannot be safely encompassed in a single RT field (e.g. supraclavicular N3, T4 by infiltration of vertebral body), according to the AJCC 8th edition Cancer Staging Manual * Body weight \>30 kg * No prior chemotherapy or treatment with another systemic anti-cancer agent. Patients who have received prior chemoradiotherapy for locally advanced pulmonary LCNEC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months from last chemotherapy, radiotherapy or chemoradiotherapy cycle to disease relapse, progression, or diagnosis of metastatic LCNEC. In this case, all toxicity from previous treatments should be resolved and no cumulative toxicity of grade \>1 should be present (see also Section 4.2 "Exclusion criteria"). * No need for concomitant chest irradiation * ECOG performance status 0-1 * Life expectancy ≥ 12 weeks * At least one lesion measurable according to RECIST v 1.1 outside of the CNS, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements * Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1500/µL, hemoglobin ≥9 g/dL (5.58 mmol/L), and platelets ≥100,000/µL. * Adequate hepatic and renal functions: * Total bilirubin \< 1.5 times the upper limits of normal \[ULN\] * AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN * Serum creatinine ≤1.5 times the ULN or creatinine clearance, calculated according to the formula of Cockcroft and Gault \> 60 ml/min * The patient has adequate coagulation function as defined by International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) \< 1.5 x ULN.). Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤3.0. * Female patients must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments * Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation * For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception that results in a low failure rate (\< 1% per year) when used consistently and correctly, and to continue its use for 6 months after the last dose of chemotherapy or 90 days after the last dose of durvalumab, whichever occurs last. Such methods include: combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, and vasectomized partner (on the understanding that this is the only one partner during the whole study duration). * Male patients who are sexually active must be willing to use barrier contraceptives (i.e., by use of condoms) during sex with all partners during treatment with chemotherapy and for at least 6 months after the final dose of chemotherapy or 90 days after the last dose of durvalumab, whichever occurs last, to avoid exposing the embryo. Men must refrain from donating sperm during this same period * Ability to comply with the study protocol, in the investigator's judgment Exclusion Criteria: * Symptomatic brain metastases or spinal cord compression (CT or MRI of the head is required within 4 weeks prior to randomization) requiring immediate radiotherapy for palliation. Patients with asymptomatic CNS lesions are eligible, provided that all of the following criteria are met: * The patient has no history of intracranial hemorrhage, spinal cord hemorrhage or hemorrhagic intracranial lesions * At least 14 days between the end of stereotactic radiotherapy or whole brain radiotherapy and initiation of study treatment, or at least 28 days between neurosurgical resection and initiation of study treatment * The patient is on a dose of corticosteroids ≤ 10 mg of oral prednisone or equivalent; anticonvulsant therapy at a stable dose is permitted * Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla or spinal cord) * There is no evidence of interim progression between completion of CNS directed therapy (if administered) and initiation of study treatment * History of leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Patients with indwelling catheters (e.g., Pleura-Cath) are allowed. * Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected calcium \> ULN) * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C * Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. * Patients positive for hepatitis C (HCV) antibody are eligible if polymerase chain reaction is negative for HCV RNA. * Significant traumatic injury or radiotherapy involving an extensive field within the last 4 weeks prior to first dose of study treatment or anticipation of the need for major surgery during study treatment. Palliative radiotherapy to a limited field is allowed if concluded at least 2 weeks prior enrolment. * Other malignancies (previous or current), except for adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, localized prostate cancer surgically treated with curative intent or ductal carcinoma in situ treated surgically treated with curative intent or if previous malignancy was more than 5 years prior and there are no signs or symptoms of recurrence * Major surgery (including open biopsy) within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior to the first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial. * Prior allogeneic stem cell or solid organ transplantation. * Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e. patients with active serious infection, uncontrolled diabetes mellitus, pericardial effusion. * Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment other than those in the present study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. * Treatment with any other investigational agent within 30 days prior to starting study treatment, or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study * Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years may be included but only after consultation with the study physician * Patients with celiac disease controlled by diet alone * History or active autoimmune neurologic paraneoplastic syndrome (e.g. non-infectious encephalitis, Lambert-Eaton syndrome etc.) or any other immune-mediated paraneoplastic syndrome. * Patients with SIADH or ectopic ATCH production are allowed on trial * Patient has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP. * History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Prior therapy with any anti-PD-1, anti-PD-L1including durvalumab, or anti-PD-L2 agent and anti-CTL-A4 agent. * Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment. * Any condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. * History of allergies or hypersensitivity to any study drugs or study drug components or CHO derived products. * The patient is pregnant or breast-feeding * Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with carboplatin, etoposide or durvalumab may be included only after consultation with the Study Physician. * Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after last chemotherapy dose or 90 days after the last dose of durvalumab, whichever occurs last. Patients should refrain from donating sperm from the start of dosing until 4 months after discontinuing study treatment. * Patients should not donate blood whilst on this study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** goirc-duple@goirc.org **Name:** Davide Campana **Phone:** +390512142204 **Role:** CONTACT **Contact 2:** **Email:** goirc-duple@goirc.org **Name:** Michele Tognetto **Phone:** +390512142204 **Role:** CONTACT #### Locations **Location 1:** **City:** Bologna **Contacts:** ***Contact 1:*** - **Email:** davide.campana@unibo.it - **Name:** Davide Campana - **Phone:** +390512143067 - **Role:** CONTACT **Country:** Italy **Facility:** IRCCS AOU Policlinico Sant'Orsola Malpighi **State:** BO **Status:** RECRUITING **Zip:** 40138 **Location 2:** **City:** Viagrande **Contacts:** ***Contact 1:*** - **Email:** giuffridadario@alice.it - **Name:** Dario Giuffrida - **Role:** CONTACT **Country:** Italy **Facility:** Istituto Oncologico del Mediterraneo IOM - Viagrande Catania **State:** CT **Status:** NOT_YET_RECRUITING **Zip:** 95029 **Location 3:** **City:** Meldola **Contacts:** ***Contact 1:*** - **Email:** angelo.delmonte@irst.emr.it - **Name:** Angelo Delmonte - **Role:** CONTACT **Country:** Italy **Facility:** Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l. IRCCS **State:** FC **Status:** NOT_YET_RECRUITING **Zip:** 47014 **Location 4:** **City:** Firenze **Contacts:** ***Contact 1:*** - **Email:** antonuzzol@aou-careggi.toscana.it - **Name:** Lorenzo Antonuzzo - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Ospedaliera Universitaria Careggi **State:** FI **Status:** NOT_YET_RECRUITING **Zip:** 50134 **Location 5:** **City:** Rozzano **Contacts:** ***Contact 1:*** - **Email:** luca.toschi@cancercenter.humanitas.it - **Name:** Luca Toschi - **Role:** CONTACT **Country:** Italy **Facility:** Humanitas Research Hospital **State:** MI **Status:** NOT_YET_RECRUITING **Zip:** 20089 **Location 6:** **City:** Padova **Contacts:** ***Contact 1:*** - **Email:** giulia.pasello@iov.veneto.it - **Name:** Giulia Pasello - **Role:** CONTACT **Country:** Italy **Facility:** Istituto Oncologico Veneto IRCCS-IOV **State:** PD **Status:** NOT_YET_RECRUITING **Zip:** 35128 **Location 7:** **City:** Aviano **Contacts:** ***Contact 1:*** - **Email:** alessandro.delconte@cro.it - **Name:** Alessandro Del Conte - **Role:** CONTACT **Country:** Italy **Facility:** Centro di riferimento oncologico di Aviano **State:** PN **Status:** NOT_YET_RECRUITING **Zip:** 33081 **Location 8:** **City:** Roma **Contacts:** ***Contact 1:*** - **Email:** MMigliorino@scamilloforlanini.rm.it - **Name:** Rita Migliorino - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Ospedaliera San Camillo Forlanini-Ospedale San Camillo **State:** RM **Status:** NOT_YET_RECRUITING **Zip:** 00152 **Location 9:** **City:** Sassari **Contacts:** ***Contact 1:*** - **Email:** antonio.pazzola@aousassari.it - **Name:** Antonio Pazzola - **Role:** CONTACT **Country:** Italy **Facility:** AOU Sassari - Ospedale SS. Annunziata **State:** SS **Status:** NOT_YET_RECRUITING **Zip:** 07100 **Location 10:** **City:** Orbassano **Contacts:** ***Contact 1:*** - **Email:** paolo.bironzo@unito.it - **Name:** Paolo Bironzo - **Role:** CONTACT **Country:** Italy **Facility:** AOU Ospedale San Luigi Gonzaga **State:** TO **Status:** RECRUITING **Zip:** 10043 **Location 11:** **City:** Bari **Contacts:** ***Contact 1:*** - **Email:** mauro.cives@uniba.it - **Name:** Mauro Cives - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari **Status:** NOT_YET_RECRUITING **Zip:** 70120 **Location 12:** **City:** Lucca **Contacts:** ***Contact 1:*** - **Email:** editta.baldini@uslnordovest.toscana.it - **Name:** Editta Baldini - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Usl Toscana nord ovest Ospedale San Luca **Status:** NOT_YET_RECRUITING **Zip:** 55100 **Location 13:** **City:** Monza **Contacts:** ***Contact 1:*** - **Email:** d.cortinovis@asst-monza.it - **Name:** Diego Cortinovis - **Role:** CONTACT **Country:** Italy **Facility:** Ospedale San Gerardo Monza **Status:** RECRUITING **Zip:** 20900 **Location 14:** **City:** Napoli **Contacts:** ***Contact 1:*** - **Email:** nando.riccardi@gmail.com - **Name:** Ferdinando Riccardi - **Role:** CONTACT **Country:** Italy **Facility:** A.O.R.N. "A. Cardarelli" **Status:** NOT_YET_RECRUITING **Zip:** 80131 **Location 15:** **City:** Parma **Contacts:** ***Contact 1:*** - **Email:** pbordi@ao.pr.it - **Name:** Paola Bordi - **Role:** CONTACT **Country:** Italy **Facility:** Azienda Ospedaliera Universitaria di Parma **Status:** NOT_YET_RECRUITING **Zip:** 43126 #### Overall Officials **Official 1:** **Affiliation:** Gruppo Oncologico Italiano di Ricerca Clinica **Name:** Andrea Ardizzoni **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000000230 - Term: Adenocarcinoma - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M20423 - Name: Carcinoma, Neuroendocrine - Relevance: HIGH - As Found: Neuroendocrine Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000018278 - Term: Carcinoma, Neuroendocrine ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M8191 - Name: Etoposide - Relevance: HIGH - As Found: Tolerability - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: HIGH - As Found: Procedure - ID: M272500 - Name: Durvalumab - Relevance: HIGH - As Found: Electrical - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005047 - Term: Etoposide - ID: C000613593 - Term: Durvalumab - ID: D000019999 - Term: Pharmaceutical Solutions ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418074 **Acronym:** (KETO-HT) **Brief Title:** Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity **Official Title:** Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Patients With Essential Hypertension #### Organization Study ID Info **ID:** TZL-1-2024 #### Organization **Class:** OTHER **Full Name:** Gødstrup Hospital ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gødstrup Hospital #### Responsible Party **Investigator Affiliation:** Gødstrup Hospital **Investigator Full Name:** Trine Lyksholm **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a randomized, placebo-controlled, double-blinded crossover design. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2). **Detailed Description:** Background: Renewed interest in ketone bodies has emerged, partly driven by the recent success of selective sodium glucose co transporter 2 (SGLT-2) inhibition in preventing cardiovascular deaths in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Effects of ketosis are of importance in order to understand the beneficial effects of SGLT-2 inhibitors and to account for the full therapeutic potential of this treatment. Hypothesis: Ketosis decreases 24 hour systolic blood pressure and increases renal blood flow and glomerular filtration rate (GFR). Methods: It is a randomized, placebo-controlled double-blinded cross over study. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or for 5 days. After a wash out period of at least 14 days, the subjects are crossed over to receive the other treatment. After each treatment period effect variables will be measured including Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT) Perspectives: The study has the potential to provide information regarding the therapeutic potential of treatment with ketone bodies and understanding of conditions characterized by ketosis, such as SGLT2-inhibitor treatment. ### Conditions Module **Conditions:** - Ketosis - Essential Hypertension **Keywords:** - Natriuresis - Kidney circulation - Kidney physiology - Glomerular Filtration Rate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 19 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For five days each subject will receive beta-hydroxybutyrate (KE4), then crossed over to receive placebo drink for 5 days. **Intervention Names:** - Dietary Supplement: Beta-hydroxybutyrate - Other: Placebo **Label:** KE4, then Placebo drink **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** For five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate (KE4). **Intervention Names:** - Dietary Supplement: Beta-hydroxybutyrate - Other: Placebo **Label:** Placebo drink, then KE4 **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - KE4, then Placebo drink - Placebo drink, then KE4 **Description:** Each subject will receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined. **Name:** Beta-hydroxybutyrate **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - KE4, then Placebo drink - Placebo drink, then KE4 **Description:** Each subject will receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined. **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Change in systolic 24-hour blood pressure **Measure:** 24-hour systolic blood pressure **Time Frame:** Measured after each treatment period (each treatment period is 6 days) #### Secondary Outcomes **Description:** Change in RBF determined by water based PET/CT scans **Measure:** Renal Blood Flow (RBF) **Time Frame:** Measured after each treatment period (each treatment period is 6 days) **Description:** Change in GFR measured by Tc99m-DTPA clearance **Measure:** GFR **Time Frame:** Measured after each treatment period (each treatment period is 6 days) **Description:** Change in plasma levels of aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin **Measure:** Vasoactive hormones **Time Frame:** Measured after each treatment period (each treatment period is 6 days) **Description:** Change ind p-beta-hydroxybutyrate concentration **Measure:** P-Beta-hydroxybutyrate **Time Frame:** Measured after each treatment period (each treatment period is 6 days) **Description:** Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC) **Measure:** Plasma concentration of renal tubular transport proteins **Time Frame:** Measured after each treatment period (each treatment period is 6 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Essential hypertension (treatment with maximum 2 antihypertensive drugs) * eGFR \> 60ml/min * BMI \< 35 kg/m2 * Urine Albumin Creatinin Ratio (UACR) \< 300mg/g * Safe contraception if women in childbearing age Exclusion Criteria: * Diabetes type 1 or 2 * Heart Failure * Pregnancy or breast feeding * Liver disease * Malignant disease * Recent acute myocardial infarction (AMI), apoplexia/transient ischemic attack (TIA) (within 12 months of inclusion) * Daily use of prescription drugs (expect for contraceptives) * Alcohol or drug abuse * Periodic fasting * Routinely intake of ketogenic diet * Treatment with immunosuppressants or SGLT2-inhibitors **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** trizur@rm.dk **Name:** Trine Z Lykshom, MD **Phone:** 78432534 **Phone Ext:** 0045 **Role:** CONTACT **Contact 2:** **Name:** Jesper N Bech, MD, prof **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The University Clinic for Nephrology and Hypertenion, Regional Hospital Godstrup **Name:** Trine Z Lyksholm, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000000138 - Term: Acidosis - ID: D000000137 - Term: Acid-Base Imbalance - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M1470 - Name: Essential Hypertension - Relevance: HIGH - As Found: Essential Hypertension - ID: M10687 - Name: Ketosis - Relevance: HIGH - As Found: Ketosis - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M3499 - Name: Acidosis - Relevance: LOW - As Found: Unknown - ID: M3498 - Name: Acid-Base Imbalance - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000075222 - Term: Essential Hypertension - ID: D000007662 - Term: Ketosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418061 **Brief Title:** Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors **Official Title:** A Phase 1, Multicenter, Open-label Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors #### Organization Study ID Info **ID:** CIBI3005A101 #### Organization **Class:** INDUSTRY **Full Name:** Innovent Biologics (Suzhou) Co. Ltd. ### Status Module #### Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Innovent Biologics (Suzhou) Co. Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005. ### Conditions Module **Conditions:** - Solid Tumors ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 198 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: IBI3005 **Label:** IBI3005 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - IBI3005 **Description:** Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005) **Name:** IBI3005 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed **Measure:** Number of subjects with adverse events **Time Frame:** up to 3 years **Description:** Clinically significant abnormal physical examination findings reported by the investigator. **Measure:** Number of subjects with clinically significant changes in physical examination results **Time Frame:** up to 3 years **Description:** Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure **Measure:** Number of subjects with clinically significant changes in vital signs **Time Frame:** up to 3 years **Description:** Dose limiting toxicities (DLTs) to establish MTD and/or RP2D. **Measure:** Dose limiting toxicities (DLTs) **Time Frame:** Up to 4 weeks #### Secondary Outcomes **Description:** area under the curve (AUC) of single and multiple doses of IBI3005 **Measure:** area under the curve (AUC) **Time Frame:** up to 3 years **Description:** maximum concentration (Cmax) of single and multiple doses of IBI3005 **Measure:** maximum concentration (Cmax) **Time Frame:** up to 3 years **Description:** time to maximum concentration (Tmax) of single and multiple doses of IBI3005 **Measure:** time to maximum concentration (Tmax) **Time Frame:** up to 3 years **Description:** clearance (CL) of single and multiple doses of IBI3005 **Measure:** clearance (CL) **Time Frame:** up to 3 years **Description:** apparent volume of distribution (V) of single and multiple doses of IBI3005 **Measure:** apparent volume of distribution (V) **Time Frame:** up to 3 years **Description:** half-life (t1/2) of IBI3005 to the last administration of IBI3005 **Measure:** half-life (t1/2) **Time Frame:** up to 3 years **Description:** Incidence and characterization of anti-drug antibody (ADA). **Measure:** anti-drug antibody (ADA) **Time Frame:** up to 3 years **Description:** objective response rate (ORR) as evaluated per the RECIST v1.1 criteria. **Measure:** objective response rate (ORR) **Time Frame:** up to 3 years **Description:** duration of response (DoR) as evaluated per the RECIST v1.1 criteria. **Measure:** duration of response (DoR) **Time Frame:** up to 3 years **Description:** time to response (TTR) as evaluated per the RECIST v1.1 criteria. **Measure:** time to response (TTR) **Time Frame:** up to 3 years **Description:** as evaluated per the RECIST v1.1 criteria. **Measure:** progression free survival (PFS) **Time Frame:** up to 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Male or female subjects ≥ 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 4. Anticipated life expectancy of ≥ 12 weeks; 5. Adequate bone marrow and organ function. 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerant of standard treatment, or for which no standard treatment is available； Exclusion Criteria: 1. Enrolled in any other interventional clinical research unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study; 2. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigators' opinion) prior to first administration of the study drug； 3. Multiple concurrent malignant tumors within 5 years: except adequately resected non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured; 4. Allergic or hypersensitive to other monoclonal antibodies and/or exatecan or other camptothecin-derived agents (e.g., topotecan) based therapy, or any ingredients of IBI3005; 5. Not eligible to participate in this study at the discretion of the investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nedlands **Contacts:** ***Contact 1:*** - **Email:** azim.khan@oneclinicalresearch.com.au - **Name:** Azim Khan - **Phone:** 08 6279 9466 - **Role:** CONTACT **Country:** Australia **Facility:** One Clinical Research Pty Ltd **State:** Western Australia **Zip:** 6009 ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M5426 - Name: Camptothecin - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418048 **Acronym:** INDI-REBIO **Brief Title:** INfectious DIsease REgistry BIObank **Official Title:** Prospective Registry and Biobank of Patients With Infectious Diseases #### Organization Study ID Info **ID:** CET 138-2023 #### Organization **Class:** OTHER **Full Name:** IRCCS San Raffaele ### Status Module #### Completion Date **Date:** 2044-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2044-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-31 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IRCCS San Raffaele #### Responsible Party **Investigator Affiliation:** Ospedale San Raffaele **Investigator Full Name:** Castagna Antonella **Investigator Title:** Full Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Prospective observational study designed to describe the clinical, laboratory, imaging, microbiological characteristics and treatment of specific infectious diseases, with the addition of a dedicated biobank. **Detailed Description:** The registry would provide a comprehensive database including a vast population of patients with infectious diseases, favoring the analysis of clinical, laboratory and therapeutic data of specific infectious conditions. Specific infectious diseases of major interest include, among others: * Bloodstream infections (i.e.: infectious syndromes manifesting with bacteremia) * Endovascular infections (i.e.: infective endocarditis, cardiovascular implantable electronic device infections, vascular graft infections, etc.) * Central nervous system infections (i.e.: meningitis, encephalitis, cerebral abscess, ventricular shunts infections, etc.) * Bone and joint infections (i.e.: osteomyelitis, spondylodiscitis, prosthetic joint infections, etc.) * Sexually transmitted infections (i.e.: gonococcal and non-gonococcal urethritis, proctitis, epididymo-orchitis, syphilis, etc.) * HIV infection * Emerging and re-emerging infectious diseases. General objectives of the study for each specific infectious disease include: * description and evolution over time of clinical and laboratory characteristics of patients with specific infectious diseases; * description and evolution over time of microbial isolates, including antimicrobial susceptibility testing; * description and evolution over time of treatment employed in patients with specific infectious diseases; * evaluation of predictive factors for treatment success and mortality in patients with specific infectious diseases; * description, evaluation and prognostic impact of microbial, immunological and inflammatory biomarkers. The general study objectives, along with more specific objectives related to a specific infectious disease, will be evaluated in specific observational studies, nested within the Registry (i.e., using data and biosamples collected in the Registry with the potential addition of data obtained from investigations performed on available biological samples). To achieve these objectives, participants are asked to donate biological samples (blood, cerebrospinal fluid, urine, other relevant biological samples related to the specific infectious disease, collected according to good clinical practice and available guidelines) for studies to identify modifiers of a specific infectious disease and to establish and validate biological markers tracking the progressive course of the considered disease, along with drug efficacy and toxicity. The following clinical and laboratory data will be recorded at baseline and at follow-up visits: * Age, measured in years * Sex at birth (male, female) * Comorbidities, measured with Charlson score (minimum 0 - maximum 37; higher scores linked to worse outcome) * Source of infection, (central nervous system, respiratory tract, endovascular infection, intra-abdominal, urinary tract, skin and soft tissue, bone and joint, other). * Sequential Organ Failure Assessment (SOFA) score (minimum 0 - maximum 24; higher scores linked to worse outcome) * Pitt Score (minum 0 - maximum 14; higher scores linked to worse outcome) * Length of hospital stay (days) * Number of patients requiring Intensive care unit (ICU) admission, surgical interventions or other procedures * Nerological impairment (Rankin scale \[minimum 0 - maximum 6; higher scores linked to worse outcome\]) * Functional impairment (Karnofsky scale \[minum 0 - maximum 100; higher scores linked to better outcome\]) * Results of routine laboratory tests * Drug plasma concentrations * Results of microbiological investigations (identification of the causative organisms, antimicrobial susceptibility testing results, mechanism of resistance) * Results of imaging investigations * Treatment strategies (type, dose, administration of antimicrobials) * Development of drug toxicities * Mortality (all-cause and infection-attributable) Both data and biosamples will be collected starting from the baseline (BL) of the infectious disease after obtaining informed consent. Follow-up data and biosamples will be collected at the end of treatment (EOT) and at 6 months after the EOT for the specific condition or, in case of no therapeutic intervention, at 6 months after diagnosis. In patients with HIV infection follow-up data and biosamples will be collected yearly after baseline. Additional data and biosamples will be collected at other time-points according to the usual temporal evolution of specific diseases, and in case of relevant clinical events or therapeutic modification. All specimens will be collected according to good clinical practice and available national and international guidelines. Data analysis will be performed by the investigators on approved proposals. Statistical methods will be defined as part of the proposals. The variables of the study will be described using means or medians and 95% confidence intervals or interquartile ranges for continuous variables and proportions with their 95% confidence intervals for categorical variables. Comparisons between groups will be made using the chi-square test or Fisher's exact test (categorical variables) or using the non-parametric Mann-Whitney test (continuous variables). Significant variations in continuous variables over time may be assessed using t-tests for paired data o Wilcoxon ranks sign test (only two timepoints) o analysis of variance for repeated measures or linear mixed models (all timepoints available during follow-up). The presence of linear relationships between continuous variables can be tested by means of Pearson correlation coefficients (parametric) or Spearman correlation coefficients (non-parametric). Logistic regression models will be applied to determine the predictors of outcomes; the risks (odds ratios) and the corresponding 95% confidence intervals will be reported. Cox regression models will be applied to determine predictors of outcomes; risks (odds ratios) and corresponding 95% confidence intervals will be reported. ### Conditions Module **Conditions:** - Bloodstream Infections - Central Nervous System Infections - Bone and Joint Infections - Endovascular Infections - Infective Endocarditis - CIED-related Infections - Vertebral Osteomyelitis ### Design Module #### Bio Spec **Description:** * Blood * Cerebrospinal fluid (CSF) * Respiratory specimens * Synovial fluid * Urine * Stool * Seminal fluid * Tissue samples * Microbial isolates **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 20 Years ### Outcomes Module #### Primary Outcomes **Description:** Describe the clinical presentation of specific infectious diseases, by means of Sequential Organ Failure Assessment (SOFA) score (minimum 0 - maximum 24; higher scores linked to worse outcome). **Measure:** Clinical characteristics of specific infectious diseases **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the microbiological characteristics of specific infectious diseases. Specifically: * Identification of the causative organisms * Antimicrobial susceptibility testing results * Mechanism of resistance **Measure:** Microbiological characteristics of specific infectious diseases **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the antimicrobial treatment of specific infectious diseases **Measure:** Treatment of specific infectious diseases **Time Frame:** 6 months (with the exception of people living with HIV) #### Secondary Outcomes **Description:** Describe the predictive factors of microbiological cure, defined as negativization of cultures from the infected site **Measure:** Predictive factors of microbiological cure **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the predictive factors of clinical cure, defined as resolution of symptoms and signs attributable to the specific infectious disease **Measure:** Predictive factors of clinical cure **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the number of patients needing surgical intervention or other procedures **Measure:** Need for surgical intervention or other procedures **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the number of patients needing ICU transfer **Measure:** Need for ICU **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe mortality due to any cause **Measure:** Overall mortality **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe mortality due to the specific infectious disease **Measure:** Infection-attributable mortality **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the extent of neurological impairment (Rankin scale \[minimum 0 - maximum 6; higher scores linked to worse outcome\]) **Measure:** Neurological impairment **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the extent of functional impairment (Karnofsky scale \[minum 0 - maximum 100; higher scores linked to better outcome\]) **Measure:** Functional impairment **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the development of comorbidities (e.g. diabetes, cardiovascular diseases, etc.) **Measure:** Development of comorbidities **Time Frame:** 6 months (with the exception of people living with HIV) **Description:** Describe the development of drug toxicities. Specifically, but not limited to: * Nephrotoxicity, measured with serum creatinine levels (milligrams per deciliter) * Hepatotoxicity, measured with alanine aminotransferase and aspartate aminostrasferase (units per liter), bilirubin (milligrams per deciliter), prothrombin time (seconds) * Hematological Toxicity, measured with complete blood cell count (cells per microliter), hemoglobin (grams per deciliter), platelets (count per microliter) * Cardiotoxicity, evaluated with electrocardiogram monitoring for arrhythmias * Neurotoxicity, measured with Rankin scale (minimum 0 - maximum 6; higher scores linked to worse outcome) * Gastrointestinal Toxicity, measured with Bristol stool chart **Measure:** Development of drug toxicity **Time Frame:** 6 months (with the exception of people living with HIV) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with clinically suspected or microbiologically documented infectious diseases (bacterial, viral, fungal or parasitic); * At least 18 years of age or older; * Able to provide informed consent; * Participants who are unable to understand the study protocol or are unable to give informed consent, but have a legal representative Exclusion Criteria: - Participants who are unable to understand the study protocol or are unable to give informed consent, and have no legal representative. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with specific infectious diseases followed at the IRCCS San Raffaele Hospital (either as inpatients or outpatients). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** carini.elisabetta@hsr.it **Name:** Elisabetta Carini **Phone:** +390226437934 **Role:** CONTACT **Contact 2:** **Email:** bagaglio.sabrina@hsr.it **Name:** Sabrina Bagaglio **Phone:** +390226432276 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** carini.elisabetta@hsr.it - **Name:** Elisabetta Carini - **Phone:** +390226437934 - **Role:** CONTACT **Country:** Italy **Facility:** San Raffaele Scientific Institute **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** IRCCS San Raffaele Scientific Institute **Name:** Marco Ripa, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000001850 - Term: Bone Diseases, Infectious - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000053821 - Term: Cardiovascular Infections - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M7859 - Name: Endocarditis, Bacterial - Relevance: HIGH - As Found: Infective Endocarditis - ID: M7858 - Name: Endocarditis - Relevance: HIGH - As Found: Infective Endocarditis - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M20864 - Name: Sepsis - Relevance: HIGH - As Found: Bloodstream Infection - ID: M12942 - Name: Osteomyelitis - Relevance: HIGH - As Found: Osteomyelitis - ID: M5743 - Name: Central Nervous System Infections - Relevance: HIGH - As Found: Central Nervous System Infections - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5129 - Name: Bone Diseases, Infectious - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M27489 - Name: Cardiovascular Infections - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T3065 - Name: Infective Endocarditis - Relevance: HIGH - As Found: Infective Endocarditis - ID: T4321 - Name: Osteomyelitis - Relevance: HIGH - As Found: Osteomyelitis ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018805 - Term: Sepsis - ID: D000010019 - Term: Osteomyelitis - ID: D000004697 - Term: Endocarditis, Bacterial - ID: D000002494 - Term: Central Nervous System Infections - ID: D000004696 - Term: Endocarditis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418035 **Brief Title:** Acquisition of Daily Living Skills in Autistic Children: Comparison Between QR Code and a Human Operator **Official Title:** Acquisition of Daily Living Skills in Autistic Children: Comparison Between Video-modeling Mediated by iPad (QR Code) and Modeling With a Human Operator #### Organization Study ID Info **ID:** CNR-IRIB-PRO-2024-005 #### Organization **Class:** OTHER **Full Name:** Istituto per la Ricerca e l'Innovazione Biomedica ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Messina, Italy #### Lead Sponsor **Class:** OTHER **Name:** Istituto per la Ricerca e l'Innovazione Biomedica #### Responsible Party **Investigator Affiliation:** Istituto per la Ricerca e l'Innovazione Biomedica **Investigator Full Name:** Flavia Marino **Investigator Title:** Head of Unit **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Autism spectrum disorder (ASD), is a condition characterized by deficits in social communication and mutual interaction, as well as repetitive and restricted behaviors and interests. This condition manifests itself differently in each individual and can vary greatly in severity and impact on daily life. Autistic children may present various challenges and difficulties in developing daily living skills (DLS). These difficulties may relate to various areas, such as personal autonomy and domestic autonomy. For example, they may have difficulties in acquiring personal hygiene skills, such as dressing and tying their shoes independently. They may have difficulty performing household tasks, such as setting the table, preparing a simple meal, or folding a t-shirt. These difficulties may require specific support and training to help autistic children develop personal autonomy skills and achieve greater independence in different areas of their daily lives. Improving and developing DLS is an important goal in order to improve the quality of life and independence of children with autistic conditions. This protocol aims to acquire new useful DLS within the various settings of daily life. The hypothesis of the present study is the following: video modeling, through the use of the iPad (Qr code scanning), can be more effective in promoting autonomy in children with ASD, compared to a control group that receives a traditional training, without the use of technological instrumentation. **Detailed Description:** In this study, participants will be randomly assigned to an experimental or control group. Both groups will be subjected to applied behavior analysis (ABA) procedures: the behavioral procedure, called modeling, is a technique in which the participant observes and imitates a target behavior of a operator who serves as a "model." Such modeling can be in vivo or remotely (via video). Also included is the use of task analysis with the aim of identifying all the smaller teachable units of a complex behavior, the sub-targets, that make up a behavioral chain. The participant, after observing the entire target task performed by the model, in turn performs the behavioral chain. Based on the data collected at baseline, the operator will deliver a simultaneous response prompt to promote errorless learning only in the individual subtasks absent in the participant's repertoire. The mode in which prompts will be delivered will be of the "least to most" type, that is, from least to most intrusive help, according to the following hierarchy: P1. gestural prompt P2. verbal-vocal prompt P3. total physical prompt The operator will begin by delivering the least intrusive prompt, P1 (gestural). If the participant does not deliver the correct behavior within 5'', the operator will move to the next most intrusive prompt, P2 (verbal-vocal); if the participant does not deliver the correct behavior within 5'', the operator will move to the next most intrusive prompt, P3 (total physical). Both groups will be subjected to n° 5 personal autonomies, during every experimental sessions. The experimental group, inside the HomeLab, will scan the Qr code using iPad and view the video-modeling of the target activity to be performed; the control group will carry out the target activity, inside the HomeLab, in a traditional way, without technological instrumentation and will observe the operator who acts as a model live. This experimental study will be implemented for a total of 6 months with biweekly frequency lasting 45 minutes per session. At the end of each session, the percentage of independent correct answers will be calculated. The acquisition criterion for defining "acquired" target autonomy is the achievement of 90% independent responses for 3 consecutive sessions. Families of children with ASD will be recruited from the Institute for Biomedical Research and Innovation of the Italian National Research Council (IRIB-CNR) in Messina, Italy. Eligible participants who meet the inclusion criteria will receive written information about the procedure and will be asked to sign the informed consent form indicating their willingness to participate in the study. Only those individuals who have provided informed consent will be randomly assigned to the experimental or control group. ### Conditions Module **Conditions:** - Autism - Autism Spectrum Disorder **Keywords:** - autism - children - technology - daily living skills - video modeling - applied behavior analysis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention will be structured according to Applied Behavioral Analysis. The target activities to be performed are shown on the iPad through video-modeling. The child, using iPad, scans QR codes placed in various stations of the HomeLab, near the place where the target autonomy will be carried out. HomeLab is a room that simulates a real apartment with various domestic areas and allows the child to feel as comfortable as at home. **Intervention Names:** - Behavioral: Video modeling by scanning Qr code **Label:** Experimental group: treatment with technological tool **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The intervention will be structured according to Applied Behavioral Analysis. The target activities to be performed within HomeLab are shown, live, by an operator who acts as a model. **Intervention Names:** - Behavioral: Modeling traditional method **Label:** Control group: traditional treatment without technological tool **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group: treatment with technological tool **Description:** The protocol activity carried out by the experimental group will involve the use of the QR Code: in the operator's presence, the child scans the code through a technological device and watches the video of the activity to be played later in the HomeLab. **Name:** Video modeling by scanning Qr code **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control group: traditional treatment without technological tool **Description:** The control group will carry out the protocol activities in a traditional way, without technological tools. The child observes the operator who shows the live activity inside the HomeLab. **Name:** Modeling traditional method **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months. The WISC-IV scales are as follows: index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance. **Measure:** WISC-IV (Wechsler Intelligence Scale for Children-4° edition) **Time Frame:** The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete. **Description:** The Griffiths III are an instrument for assessing child development from birth to 6 years of age. The Griffiths III are based on an integrated model of development, conceived as consisting of various domains that interact and influence each other and determine the child's development. Scale A. Basics of learning, range scores (min 0 - max 20) Scale B. Language and communication, range scores (min 0 - max 20). Scale C. Oculo-manual coordination, range scores (min 0 - max 20) Scale D. Personal-social-emotional, range scores (min 0 - max 20) Scale E. Gross-motor, range scores (min 0 - max 20) For each sub-scale higher score corresponds to better performance. The Griffiths III enables information to be obtained about each area of development considered (each scale can also be used individually), to draw a developmental profile in terms of strengths and weaknesses, but also to have an indication of the child's overall level of development. **Measure:** Griffiths Mental Development Scales (GMDS-3rd) **Time Frame:** The evaluation session will be scheduled pre-intervention (T0). Test administration is individual and lasts about 90 minutes. **Description:** The Vineland-II, a revision of the Vineland Adaptive Behavior Scales, assess adaptive behavior (AB), i.e., the activities that the individual habitually performs to meet the expectations of personal autonomy and social responsibility characteristic of people of the same age and cultural background. Specifically, they aim to measure AB in the domains Communication, range scores (min 0 -max 160), Skills of Daily Living, range scores (min 0 - max 160) Socialization, range scores (min 0- max 160) (in individuals from 0 to 90 years of age) and Motor Skills, range scores (min 0 -max 160) (in individuals from 0 to 7 years of age and 56 to 90 years of age). For each sub-scale higher score corresponds to better performance. Assessment of AB is necessary for diagnosis of intellectual disability disorder and, in accordance with DSM-5, for assessment of the level of severity of the disorder. The Vineland-IIs consist of 4 scales divided into 11 subscales. They also provide an overall AB index. **Measure:** Vineland Adaptive Behavior Scales-II (Vineland-II) **Time Frame:** The tests will be scheduled pre intervention (T0) and at the study conclusion, at 6 months (T1).The T0 and T1 evaluations were conducted to determine whether the protocol carried out made a change. The test needs about 60 minutes. **Description:** The Assessment of Basic Language and Learning Skills- Revised (ABLLS-R) is tracking system based on the basic language and functional skills of an individual with autism and other developmental delays. It is used as a tool to help develop individualized curricula to teach language and other critical skills to children with autism or other developmental disabilities. The ABLLS-R focuses on 25 skills in the areas of language, social interaction, self-help, academic and motor skills. The evaluation of this tool helps to identify the skills necessary for the child to communicate effectively and to identify obstacles that prevent the child from acquiring new skills. For research purposes, the evaluation will focus on self-help skills, specifically: Dressing Skills (min 0 - max 30), Feeding-related autonomies ( min 0 - max 20) Personal care skills ( min 0 - max 14), Toileting Skills ( min 0 max 20). For each sub-scale higher score corresponds to better performance. **Measure:** The Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) **Time Frame:** The tests will be scheduled pre intervention (T0) and at the study conclusion, at 6 months (T1). The administration time is approximately 60 minutes. **Description:** PEP-3 assesses learning inhomogeneity, strengths and weaknesses, and related developmental disabilities in children with autism and pervasive developmental disorders and children with developmental difficulties that are difficult to test (age range 2 to 12 years). It is part of the TEACCH materials for individualized psychoeducational assessment and intervention for children with Autism Spectrum Disorder. The test consists of two main components: 1. The Performance section (10 subtests) 2. The questionnaire for parents (3 subtest). For the purpose of the research, only the parental questionnaire will be used. It investigates: problem behavior range scores (min 1 - max 20.) , personal autonomy range scores (min 1 - max 20.), adaptive behavior range scores (min 1 - max 20.). For each sub-scale higher score corresponds to better performance. **Measure:** Psychoeducational profile-3 (Pep-3) **Time Frame:** The questionnaire will be scheduled pre intervention (T0) and at the study conclusion, at 6 months (T1). The administration time of the questionnaire for parents is 45 minutes. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of autism spectrum disorder; * IQ below 80 assessed by means of WISC IV or Leiter-3; * Passing the ABLLS-R "imitation" and "visual performance" tests Exclusion Criteria: * Presence of other medical disorders; * Absence of imitative and visual-perceptual skills. **Maximum Age:** 12 Years **Minimum Age:** 5 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** flavia.marino@irib.cnr.it **Name:** Flavia Marino **Phone:** 393395798263 **Role:** CONTACT **Contact 2:** **Email:** mariavaleria.maiorana@irib.cnr.it **Name:** Maria valeria Maiorana **Phone:** +393285856656 **Role:** CONTACT #### Locations **Location 1:** **City:** Messina **Contacts:** ***Contact 1:*** - **Email:** flavia.marino@irib.cnr.it - **Name:** Flavia Marino - **Phone:** +393395798263 - **Role:** CONTACT ***Contact 2:*** - **Email:** mariavaleria.maiorana@irib.cnr.it - **Name:** Maria Valeria Maiorana - **Phone:** +393285856656 - **Role:** CONTACT ***Contact 3:*** - **Name:** Flavia Marino - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Roberta Minutoli - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Chiara Failla - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Noemi Vetrano - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Ileana Scarcella - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** Germana Doria - **Role:** SUB_INVESTIGATOR ***Contact 9:*** - **Name:** Paola Chilà - **Role:** SUB_INVESTIGATOR ***Contact 10:*** - **Name:** Giovanni Pioggia - **Role:** SUB_INVESTIGATOR **Country:** Italy **Facility:** Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) **Status:** RECRUITING **Zip:** 98164 #### Overall Officials **Official 1:** **Affiliation:** Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) **Name:** Flavia Marino **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Mclay, Laurie & Carnett, Amarie & van der Meer, Larah & Lang, Russell. (2015). Using a Video Modeling-Based Intervention Package to Toilet Train Two Children with Autism. Journal of Developmental and Physical Disabilities. 27. 10.1007/s10882-015-9426-4. **Citation:** Drysdale, Bradley & Lee, Clara & Anderson, Angelika & Moore, Dennis. (2014). Using Video Modeling Incorporating Animation to Teach Toileting to Two Children with Autism Spectrum Disorder. Journal of Developmental and Physical Disabilities. 27. 10.1007/s10882-014-9405-1. **Citation:** Popple B, Wall C, Flink L, Powell K, Discepolo K, Keck D, Mademtzi M, Volkmar F, Shic F. Brief Report: Remotely Delivered Video Modeling for Improving Oral Hygiene in Children with ASD: A Pilot Study. J Autism Dev Disord. 2016 Aug;46(8):2791-2796. doi: 10.1007/s10803-016-2795-4. **PMID:** 27106570 **Citation:** Lee, Clara & Anderson, Angelika & Moore, Dennis. (2014). Using Video Modeling to Toilet Train a Child with Autism. Journal of Developmental and Physical Disabilities. 26. 10.1007/s10882-013-9348-y. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: HIGH - As Found: Autism - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001321 - Term: Autistic Disorder - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418022 **Acronym:** TREND-US **Brief Title:** Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning **Official Title:** Evaluating Fluid Responsiveness in Intensive Care Unit Patients Using VTI and Trendelenburg Positioning. TREND-US Trial. #### Organization Study ID Info **ID:** 23-0441 #### Organization **Class:** OTHER **Full Name:** Lenox Hill Hospital ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lenox Hill Hospital #### Responsible Party **Investigator Affiliation:** Lenox Hill Hospital **Investigator Full Name:** Matthew Kheir **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Fluid administration is a commonly performed in the ICU for critically ill patients. However, it can lead to complications such as fluid overload, pulmonary edema, and increased mortality in some patients. Therefore, identifying patients who are likely to respond to fluid therapy is crucial for optimizing their management. Several methods have been used to assess fluid responsiveness, such as passive leg raising, stroke volume variation, and cardiac output monitoring. However, these methods have limitations and may not be feasible in all patients. In this study, the investigators aim to evaluate the use of velocity time integral (VTI) and Trendelenburg positioning in predicting fluid responsiveness in ICU patients. **Detailed Description:** The investigators will perform an echocardiogram both in the supine and Trendelenburg positions for research purposes prior to the ICU team assessing fluid responsiveness (see paragraph below). Critically ill patients in which fluid responsiveness is unclear typically admitted to the ICU routinely undergo a bedside echocardiogram in the supine position and then another echocardiogram still in the supine position after receiving IV fluids to assess the patient's fluid responsiveness (i.e., whether giving a small IV fluid bolus increases cardiac output). VTI is an echocardiographic surrogate for cardiac output and is routinely used in the ICU setting in addition to providing additional information on whether a patient is fluid responsive. This method is already standard practice in the medical and surgical ICU in our PCCM department. Unfortunately, administering IV fluids can potentially cause adverse events such as pulmonary edema, heart failure, interstitial edema, respiratory failure, and death. The use of a method, such as the passive leg raise maneuver (i.e., raising patient's legs by 30 degrees for 1 minute and then evaluating hemodynamic measurements), help predict whether a patient would benefit from IV fluids prior to giving them fluids in order to prevent these aforementioned adverse events since it is a reversible process. Literature and current practice support the use of the passive leg raise (PLR) maneuver in predicting fluid responsiveness, where an increase of at least 15% signifies a positive fluid response. Similar to IV fluids, the PLR maneuver can cause adverse events, is cumbersome, and not feasible in certain circumstances. There is recent research which suggests that Trendelenburg positioning (TP) can be used as an alternative approach that is potentially safer and less cumbersome. This study aims to evaluate a cutoff increase in VTI that would be accurate in predicting fluid responsiveness in patients undergoing TP. As stated above, in our study we will see if placing the patient in TP (i.e., tilt head of the bed 15 degrees downward) will predict if the patient is fluid responsive. The investigators want use ROC analysis to determine the cutoff VTI increase and the accuracy of using TP in predicting fluid responsiveness. The gold standard is to check VTI prior to and after administering an IV fluid bolus and the current literature demonstrates that a VTI increase by 15% is indicative of an appropriate fluid response. The patients in the study in the ICU will receive IV fluids regardless of our study based on the clinician's discretion (i.e., our study will not affect the decision of the clinician in any way). The bedside echocardiogram takes less than 2 minutes to perform and will not delay care. ### Conditions Module **Conditions:** - Shock - Fluid Overload - Cardiac Output, Low **Keywords:** - fluid - responsiveness - VTI - ICU - POCUS - ultrasound - Trendelenburg ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This is a single-center, minimal risk study that will include a total of 400 critically ill patients, aged 18 and older, that require fluid administration. In prior studies, fluid responsiveness has been shown after an IV fluid bolus with ≥15% increase in VTI or after a passive leg raise (PLR) with ≥ 15% increase in VTI. Similar to the other maneuvers such as the PLR maneuver, we hope to find an optimal cutoff in the increase in VTI after Trendelenburg positioning based on ROC analysis, with an increase of VTI \>15% in patients after receiving IV fluids as the gold standard. There will be no intervention arm and patients will serve as their own control. ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This study is evaluating the potential of Trendelenburg positioning (TP) in determining fluid responsiveness by using the change in velocity time integral (VTI), and echocardiographic parameter that can be used as a surrogate for stroke volume and cardiac output. There are essentially two arms, whereby the patients is being compared to themselves. The "control arm" is the patient receiving a fluid challenge (FC; IV fluid bolus of 500cc crystalloids- either 0.9% Normal Saline or Lactated Ringer's solution) that the clinician would have given regardless of the study; the change of VTI is collected after administration of IV fluids with comparison to the baseline supine position. The "intervention arm" is the same patient undergoing TP from the baseline supine position to determine the change in VTI after subjecting to TP. **Intervention Names:** - Device: Trendelenburg positioning VTI **Label:** Fluid challenge (control) **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Fluid challenge (control) **Description:** There are essentially two arms, whereby the patients is being compared to themselves. The "intervention arm" is the same patient undergoing TP from the baseline supine position to determine the change in VTI after subjecting to TP. We will be using a Sonosite PX ultrasound system, which is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body and, more specifically, for our echocardiographic measurements of velocity time integral (VTI; surrogate for stroke volume and cardiac output). The Sonosite PX is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals, for evaluation by ultrasound imaging or fluid flow analysis of the human body. This is an FDA-cleared (510K# K200964) commercial device legally marketed in the United States that is being used in accordance with labeling. **Name:** Trendelenburg positioning VTI **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The objective of this study is to determine the change in VTI cutoff with Trendelenburg positioning that would predict fluid responsiveness in medical and surgical intensive care unit patients. **Measure:** Change in VTI cutoff in TP that predicts fluid responsiveness **Time Frame:** ~1 year #### Secondary Outcomes **Description:** Evaluate other patient factors (e.g., demographics) to determine if they are independently associated with fluid responsiveness. **Measure:** Determine if patient factors are independently associated with fluid responsiveness **Time Frame:** ~1 year **Description:** Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of blood pressure (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC). **Measure:** Association of Trendelenburg positioning on the effect on hemodynamic parameters **Time Frame:** ~1 year **Description:** Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of heart rate (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC). **Measure:** Association of Trendelenburg positioning on the effect on hemodynamic parameters **Time Frame:** ~1 year **Description:** Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of pulse pressure (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC). **Measure:** Association of Trendelenburg positioning on the effect on hemodynamic parameters **Time Frame:** ~1 year **Description:** Evaluate the effect of Trendelenburg positioning (TP) and fluid challenge (FC) on hemodynamic parameter of central venous pressure (i.e., if there is a statistically significant change in the hemodynamic parameter after TP or FC). **Measure:** Association of Trendelenburg positioning on the effect on hemodynamic parameters **Time Frame:** ~1 year **Description:** Use receiver operating characteristic (ROC) curves to compare the predictive accuracy of the change in VTI compared to the change of certain hemodynamic parameters (e.g., pulse pressure, systolic blood pressure, diastolic blood pressure) with Trendelenburg positioning. **Measure:** Evaluate the predictive accuracy of the change in VTI versus other hemodynamic parameters **Time Frame:** ~1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (≥ 18 years old) admitted to the medical or surgical ICU. * Patients who require fluid administration for suspicion of hypovolemia or indicated for volume expansion due to any one of the following: hypotension (systolic blood pressure \< 90 mm Hg or mean arterial pressure \< 65 mm Hg), tachycardia (heart rate \> 100 beats per min), blood lactate \> 2.0 mmol/L, skin mottling, oliguria (urine output \< 30 ml/hr), or requiring vasopressor/inotrope support. * Patients who are able to tolerate the Trendelenburg position. Exclusion Criteria: * Pregnancy. * Prisoners and institutionalized patients. * Patients who are not able to tolerate the Trendelenburg position. This includes patients with increased intra-cranial hypertension, intra-abdominal hypertension and gastric retention which places a risk for stomach fluid aspiration. * Unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable VTI measurements at the left ventricular outflow tract \[LVOT\]). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mkheir1@northwell.edu **Name:** Matthew Kheir, MD **Phone:** 516-465-1910 **Role:** CONTACT **Contact 2:** **Name:** Sara Velichkovikj, BS **Phone:** 212-434-4087 **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** mkheir1@northwell.edu - **Name:** Matthew Kheir, MD - **Phone:** 212-434-4087 - **Role:** CONTACT **Country:** United States **Facility:** Lenox Hill Hospital- Northwell Health **State:** New York **Status:** RECRUITING **Zip:** 10075 #### Overall Officials **Official 1:** **Affiliation:** Lenox Hill Hospital- Northwell Health **Name:** Matthew Kheir, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M5559 - Name: Cardiac Output, Low - Relevance: HIGH - As Found: Cardiac Output, Low - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002303 - Term: Cardiac Output, Low ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06418009 **Brief Title:** Determination of the Effect of Cold Needle on Invasive Pain Cannulation **Official Title:** Determination of the Effect of Cold Needle Application on Invasive Pain Associated With Fistula Cannulation #### Organization Study ID Info **ID:** 2024/50 #### Organization **Class:** OTHER **Full Name:** Istanbul Demiroglu Bilim University ### Status Module #### Completion Date **Date:** 2024-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-05 **Type:** ACTUAL #### Start Date **Date:** 2024-04-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Demiroglu Bilim University #### Responsible Party **Investigator Affiliation:** Istanbul Demiroglu Bilim University **Investigator Full Name:** Nurten Ozen **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In studies evaluating the methods used to reduce invasive pain associated with cannulation, it is seen that pharmacological and non-pharmacological methods are used. Pharmacological treatment is considered risky as it may cause drug addiction in the patient and may cause side effects and complications. On the other hand, the use of non-pharmacological methods is preferred because they are cheaper and cause fewer side effects and complications. **Detailed Description:** Cold application, one of the non-pharmacological methods used, is effective in relieving pain by slowing down or blocking the conduction of peripheral nerves. Apart from this effect, it stimulates touch receptors by activating the Door-Control mechanism; It increases the release of endogenous opioids and stops pain by ensuring the nerve impulses caused by cold are transmitted to Delta fibers. Although studies conducted on hemodialysis patients have shown that cold application is effective in reducing pain; Due to the small number of sample groups and deficiencies in the methodology, it was suggested that further studies be conducted. In these studies, cold application; It was applied to the area one cm above the fistula or between the thumb and index finger of the opposite arm, using an ice pack and an ice-filled glove for 2-10 minutes. ### Conditions Module **Conditions:** - Hemodialysis Complication - Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Masking Description:** Pain assessment will be made by a nurse independent of the study **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 35 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Fistül girişimi için kullanılan iğne kendi torbasında durdurulur ve hastalığın takılacağı zaman Resmi tarafından deponun içinden çıkarılarak kullanılacaktır **Label:** Not cold needle application **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Before use, the needle will be removed from the refrigerator and kept on the nurse's table. When the temperature of the needle reaches 0-2 °C, the patient will be cannulated. **Intervention Names:** - Procedure: Cold needle application **Label:** Cold needle application **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cold needle application **Description:** Before use, the needle will be removed from the refrigerator and kept on the nurse's table. When the temperature of the needle reaches 0-2 °C, the patient will be cannulated. **Name:** Cold needle application **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** It will be assessed three times at the end of the dialysis session with Visual Analogue. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome **Measure:** Invasive pain **Time Frame:** Up to two weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients aged 18 years and older * had been treated with HD for at least 3 months, thrice a week, and for 4 hours per session * did not have a psychiatric disorder that would prevent communication * volunteered to participate in the study Exclusion Criteria: * Patients who were known to present difficulties when entering the fistula (requiring multiple cannulations) * had a history of hematoma or stenosis in the AVF * had an infection at the fistula site * took painkillers within 3 hours of treatment * did not want to participate in the study **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Demiroglu Bilim University **Zip:** 34384 #### Overall Officials **Official 1:** **Affiliation:** Istanbul Demiroglu Bilim University **Name:** Nurten Ozen, Assoc. Prof. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ozen N, Tosun B, Sayilan AA, Eyileten T, Ozen V, Ecder T, Tosun N. Effect of the arterial needle bevel position on puncture pain and postremoval bleeding time in hemodialysis patients: A self-controlled, single-blind study. Hemodial Int. 2022 Oct;26(4):503-508. doi: 10.1111/hdi.13044. Epub 2022 Sep 6. **PMID:** 36068183 **Citation:** Sadeghpour Marvi H, Baloochi Beydokhti T, Sajjadi M, Khaleghimanesh B. Comparing Effects of Rhythmic Breathing and Lidocaine Spray on Pain Intensity During Needle Insertion Into Arteriovenous Fistula in Hemodialysis Patients: A Randomized Controlled Trial. Anesth Pain Med. 2023 Apr 17;13(2):e126384. doi: 10.5812/aapm-126384. eCollection 2023 Apr. **PMID:** 37645007 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8532 - Name: Fistula - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417996 **Brief Title:** Biobeat Digital Home Monitoring Feasibility **Official Title:** Postoperative Digital Care Home Monitoring #### Organization Study ID Info **ID:** Digital Home Monitoring #### Organization **Class:** OTHER **Full Name:** Lawson Health Research Institute ### Status Module #### Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-02-21 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lawson Health Research Institute #### Responsible Party **Investigator Affiliation:** Lawson Health Research Institute **Investigator Full Name:** Richard Malthaner **Investigator Title:** Chair Chief Thoracic Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To assess the feasibility of evaluating postoperative home monitoring with Biobeat digital monitoring. The investigators hypothesize that the Biobeat digital home monitoring platform will lead to a decrease in unplanned visits to the ED (Emergency Department). In addition, patients' quality of life is postulated to be improved compared to patients receiving the current standard of care without home monitoring. **Detailed Description:** This trial will be a single centre, parallel arm, randomized controlled feasibility trial. The investigators will evaluate postoperative home monitoring with the Biobeat digital monitoring and two-way communication through the digital portal for 4 weeks post-operatively to the standard of care (no digital monitoring) in thoracic surgery patients undergoing elective thoracic surgical procedures. The investigators will assess whether conducting a larger randomized trial of digital home monitoring vs. standard of care is feasible in terms of recruitment, data collection and logistics. ### Conditions Module **Conditions:** - Thoracic Surgery - Home Monitoring ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group will not be monitored with continuity of care. **Label:** Control Group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** At the time of hospital discharge, the control group will be discharged without receipt of home monitoring, and the intervention group will receive a home monitoring kit with (NIBP (non-invasive blood pressure) and SPO2 (pulse oximetry) with instructions on how to use these devices. Patients in the intervention groups will receive digital communication for four weeks and have their NIBP, HR (heart rate), SPO2 and pain scores evaluated twice a day for two weeks. **Intervention Names:** - Other: Digital Group **Label:** Digital Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital Group **Description:** Once patients are ready for discharge, patients in the digital group will be sent home with the Biobeat digital monitoring kit with written \& oral instructions on how it will be used in maintaining continuity of care which will track ECG (electrocardiogram), HR, NIBP, SPO2, and pain scores. A continuous recording and two-lead ECG patch will be applied and activated at the time of discharge to identify any paroxysmal atrial fibrillation. **Name:** Digital Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The trial will be deemed feasible if \>/= 60% of eligible patients are recruited, \>/= 80% of data is collected, and \</= 20% of patients are lost to follow-up. **Measure:** To assess whether conducting a larger randomized trial of digital home monitoring vs. standard of care is feasible in terms of recruitment, data collection and logistics. **Time Frame:** 365 days #### Secondary Outcomes **Description:** Number of ED visits **Measure:** Number of ED Visits **Time Frame:** 30 days from discharge **Description:** Number of readmissions **Measure:** Readmission Rates **Time Frame:** 30 days from discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient willing to provide informed consent * Wi-fi or cellular connectivity at the patient's home * Patient undergoing elective lung cancer surgery * Patient familiar/comfortable with the use of technology such as online banking. Exclusion Criteria: - Patients who are not comfortable with the use of technology. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** deb.lewis@lhsc.on.ca **Name:** Deb Lewis **Phone:** 5196858500 **Phone Ext:** 75685 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417983 **Acronym:** NailFungus **Brief Title:** Topical Application of Essential Oils to Treat Onchomycosis **Official Title:** Use of Topical Essential Oil Compound to Treat Toe Nail Onychomycosis #### Organization Study ID Info **ID:** Onychomycosis Topical #### Organization **Class:** OTHER **Full Name:** Medical Life Care Planners, LLC ### Status Module #### Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical Life Care Planners, LLC #### Responsible Party **Investigator Affiliation:** Medical Life Care Planners, LLC **Investigator Full Name:** Gregory L Smith, MD, MPH **Investigator Title:** Principal Investigaor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients with documented onychomycosis of one or more toe nails will be treated with a daily application of a topical lacquer containing several essential oils. **Detailed Description:** The topical lacquer contains the following components: Active ingredients: Hydroxypropyl Chitosan OLEOZON(r) - natural, ozonized sunflower oil. Vitamin E Tea Tree Oil Cannabidiol Vehicle: Nanoparticle medium chain triglyceride oil ### Conditions Module **Conditions:** - Onychomycosis of Toenail - Fungal Infection - Toenail Infection ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Objective change in the thickness of the hyponychium of the most infected nailplate. The hyponycium will be measured with a micometer thickness guage in micrometer gradations at baseline, 2,5,9 and 12 weeks. **Measure:** Change in Thickness of the Hyponychium Fungal Infection **Time Frame:** 12 weeks **Description:** Subject's personal perception of improvement of all infected toenails using the OnyCOE-t questionnaire for patient reported outcomes for toenail onychomycosis at baseline, 2,5 ,9 and 12 weeks of treatment. **Measure:** Subject Perceived Improvement in overall toenail infection **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Clinician observation consistent with probable onychomycosis of one or more toenails. Positive polymerase chain reaction (PCR) for fungal infection or Positive Periodic Acid Schiff, Biopsy, KOH or Culture for fungal infection - Exclusion Criteria: Unwlling to discontinue current anti-fungal medication, oral or topical - **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All adult patients presenting to a community podiatry clinic who upon examination are noted to have podiatrist diagnosed onychomycosis of one or more toenails. Not currently using topical or oral anti-fungal treatment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** disabilityevaluators@gmail.com **Name:** Andronica Handie, DPM **Phone:** 9189944000 **Role:** CONTACT **Contact 2:** **Email:** DrSmith@NeX-Therapeutics.com **Name:** Gregory L Smith **Phone:** 4044514045 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Researcher with clear need to know **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** 6 months **URL:** http://nex-therapeutics.com ### References Module #### References **Citation:** Flores FC, Beck RC, da Silva Cde B. Essential Oils for Treatment for Onychomycosis: A Mini-Review. Mycopathologia. 2016 Feb;181(1-2):9-15. doi: 10.1007/s11046-015-9957-3. Epub 2015 Oct 19. **PMID:** 26481920 **Citation:** Halteh P, Scher RK, Lipner SR. Over-the-counter and natural remedies for onychomycosis: do they really work? Cutis. 2016 Nov;98(5):E16-E25. **PMID:** 28040821 **Citation:** Wang Y, Lipner SR. Retrospective analysis of adverse events with topical onychomycosis medications reported to the United States Food and Drug Administration. Arch Dermatol Res. 2020 Oct;312(8):581-586. doi: 10.1007/s00403-020-02044-7. Epub 2020 Feb 19. **PMID:** 32076805 **Citation:** Abd Rashed A, Rathi DG, Ahmad Nasir NAH, Abd Rahman AZ. Antifungal Properties of Essential Oils and Their Compounds for Application in Skin Fungal Infections: Conventional and Nonconventional Approaches. Molecules. 2021 Feb 19;26(4):1093. doi: 10.3390/molecules26041093. **PMID:** 33669627 **Citation:** Ghannoum MA, Long L, Isham N, Bulgheroni A, Setaro M, Caserini M, Palmieri R, Mailland F. Ability of hydroxypropyl chitosan nail lacquer to protect against dermatophyte nail infection. Antimicrob Agents Chemother. 2015 Apr;59(4):1844-8. doi: 10.1128/AAC.04842-14. Epub 2014 Dec 29. **PMID:** 25547349 **Citation:** Feldman M, Sionov RV, Mechoulam R, Steinberg D. Anti-Biofilm Activity of Cannabidiol against Candida albicans. Microorganisms. 2021 Feb 20;9(2):441. doi: 10.3390/microorganisms9020441. **PMID:** 33672633 **Citation:** Tong MM, Altman PM, Barnetson RS. Tea tree oil in the treatment of tinea pedis. Australas J Dermatol. 1992;33(3):145-9. doi: 10.1111/j.1440-0960.1992.tb00103.x. **PMID:** 1303075 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000014005 - Term: Tinea - ID: D000003881 - Term: Dermatomycoses - ID: D000012874 - Term: Skin Diseases, Infectious - ID: D000009260 - Term: Nail Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M12136 - Name: Mycoses - Relevance: HIGH - As Found: Fungal Infections - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M16766 - Name: Onychomycosis - Relevance: HIGH - As Found: Onychomycosis - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M16762 - Name: Tinea - Relevance: LOW - As Found: Unknown - ID: M7076 - Name: Dermatomycoses - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15677 - Name: Skin Diseases, Infectious - Relevance: LOW - As Found: Unknown - ID: M12211 - Name: Nail Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000009181 - Term: Mycoses - ID: D000014009 - Term: Onychomycosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417970 **Brief Title:** Proprioception, Touch and Psychometric Relationship in Volleyball Players **Official Title:** The Relationship Between Shoulder Proprioception, Palmar Touch Sensation and Psychometric Parameters in Volleyball Players #### Organization Study ID Info **ID:** Voleybolcu Omuz #### Organization **Class:** OTHER **Full Name:** Suleyman Demirel University ### Status Module #### Completion Date **Date:** 2024-05-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-17 **Type:** ACTUAL #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Suleyman Demirel University #### Responsible Party **Investigator Affiliation:** Suleyman Demirel University **Investigator Full Name:** Ramazan Kursat Erdas **Investigator Title:** Dr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Improvement of proprioception in athletes has been found to be effective in preventing fear of movement. The importance of these parameters has not been sufficiently emphasized in volleyball players. In addition, the relationship between upper extremity proprioception and the sense of touch, which is an important component of the somatosensory system, and common anxiety states in athletes has not been evaluated. Therefore, the aim of our study was to investigate the relationship between shoulder joint proprioception and psychometric parameters, kinesiophobia and palmar tactile sensation in volleyball players. **Detailed Description:** The study will not include any intervention program. Volleyball players who are volleyball players in their school team and volleyball players who apply to the Sports Medicine Polyclinic with a general health examination or lower extremity injury complaint will be invited to the study. Volleyball players between the ages of 18-30, who meet the inclusion criteria and consent to participate will be included in the study. At the beginning, the participants will be informed and if they volunteer, they will sign an informed consent form. The demographic data of the participants will be filled in on a form prepared by the researchers. The parameters to be evaluated during the study are glenohumeral joint proprioception measurements (internal rotation, external rotation), Athlete Psychological Strain Questionnaire, Tampa Kinesiophobia Questionnaire and palmar tactile sensation measurement with Semmes-Weinstein Monofilament. Glenohumeral joint proprioception measurements: Visual input is eliminated with a blindfold while the participant is in a seated position with the arm in 90° abduction and elbow in 90° flexion. The measurement reference angles are 30° and 60°. The upper extremity will be moved passively from the neutral position in the direction of internal and external rotation up to the reference angle. It will be held at the reference angle for 10 seconds and then passively moved back to the neutral position. The speed of the dynamometer will be set to 0.5°/s. The participant will then be instructed to repeat the position in which the upper limb was previously placed, taking into account the reference angle. After the learning trial, the average of the absolute error of the three test trials will be recorded as the position sense test result. Athlete Psychological Strain Questionnaire: This questionnaire will be used to measure sport-specific psychological tension. It consists of 10 items and each item is scored on a 5-point Likert scale (1=never to 5=always) and assesses self-regulation (e.g. "I felt less motivated"), performance (e.g. "I found training more stressful") and external coping (e.g. "I took unusual risks off the field"). The minimum score is 10, while the maximum score is 50. Higher scores indicate greater psychological strain. Tampa kinesiophobia questionnaire: This questionnaire measures fear of movement/reinjury. It consists of 17 items and the normal score range is between 17 and 68. A lower score indicates a better condition. Palmar tactile sensation: Palmar tactile sensation will be measured with the Semmes-Weinstein Monofilament. The tested hand will be placed on a towel and hidden behind a screen with the forearm supinated. Monofilaments will be placed in contact with the tip of the thumb (median nerve), the tip of the little finger (ulnar nerve) and between the index finger and thumb on the dorsal side of the hand (radial nerve). Patients will be asked to verbally answer "Yes" when they feel touched by the monofilaments. The monofilament will be applied perpendicular to the skin until it is slightly bent for 1.5 seconds. The measurement time (approach, pressure and withdrawal of the monofilament) will not exceed 3 seconds and the test will start with the thinnest monofilament (lowest pressure) and end when at least 1 positive response is collected from 3 trials. The power analysis of the study was performed with the program GPower 3.1.9.7 (Universitaet Kiel, Germany). In the study, the correlation value between the Y-Balance Test Inferolateral and Internal Rotation Active Joint Position Sensation measurements calculated in Mendez-Rebolledo et al. (2022), r=-0.57, was used. Accordingly, test family "Exact" and analysis type "Correlation: Bivariate normal model" were selected. The explanatory coefficient R2=0.33 and the alternative hypothesis effect size was calculated as 0.574. The sample size was determined as n=33 with a two-way table value, 95% power and 5% type-I margin of error. ### Conditions Module **Conditions:** - Proprioceptive Disorders - Sports Physical Therapy - Kinesiophobia - Somatosensory Disorders - Shoulder Injuries ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 33 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Shoulder Proprioception, Palmar Touch Sensation and Psychometric Parameters **Label:** Volleyball Players ### Interventions #### Intervention 1 **Arm Group Labels:** - Volleyball Players **Description:** Shoulder Proprioception: Proprioception will be measured with isokinetic device. The measurement reference angles are 30° and 60°. Palmar Touch Sensation: Palmar tactile sensation will be measured with the Semmes-Weinstein Monofilament. Psychometric Parameters: Athlete Psychological Strain Questionnaire, Tampa kinesiophobia questionnaire **Name:** Shoulder Proprioception, Palmar Touch Sensation and Psychometric Parameters **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Visual input is eliminated with a blindfold while the participant is in a seated position with the arm in 90° abduction and elbow in 90° flexion. The measurement reference angles are 30° and 60°. The upper extremity will be moved passively from the neutral position in the direction of internal and external rotation up to the reference angle. It will be held at the reference angle for 10 seconds and then passively moved back to the neutral position. The speed of the dynamometer will be set to 0.5°/s. The participant will then be instructed to repeat the position in which the upper limb was previously placed, taking into account the reference angle. After the learning trial, the average of the absolute error of the three test trials will be recorded as the position sense test result. **Measure:** Glenohumeral joint proprioception measurement **Time Frame:** Change from Baseline glenohumeral joint proprioception measurement at first day **Description:** This questionnaire will be used to measure sport-specific psychological tension. It consists of 10 items and each item is scored on a 5-point Likert scale (1=never to 5=always) and assesses self-regulation (e.g. "I felt less motivated"), performance (e.g. "I found training more stressful") and external coping (e.g. "I took unusual risks off the field"). The minimum score is 10, while the maximum score is 50. Higher scores indicate greater psychological strain. **Measure:** Athlete Psychological Strain Questionnaire **Time Frame:** Change from Baseline Athlete Psychological Strain Questionnaire at first day **Description:** This questionnaire measures fear of movement/reinjury. It consists of 17 items and the normal score range is between 17 and 68. A lower score indicates a better condition. **Measure:** Tampa kinesiophobia questionnaire **Time Frame:** Change from Baseline Tampa kinesiophobia questionnaire at first day **Description:** Palmar tactile sensation will be measured with the Semmes-Weinstein Monofilament. The tested hand will be placed on a towel and hidden behind a screen with the forearm supinated. Monofilaments will be placed in contact with the tip of the thumb (median nerve), the tip of the little finger (ulnar nerve) and between the index finger and thumb on the dorsal side of the hand (radial nerve). Patients will be asked to verbally answer "Yes" when they feel touched by the monofilaments. The monofilament will be applied perpendicular to the skin until it is slightly bent for 1.5 seconds. The measurement time (approach, pressure and withdrawal of the monofilament) will not exceed 3 seconds and the test will start with the thinnest monofilament (lowest pressure) and end when at least 1 positive response is collected from 3 trials. **Measure:** Palmar tactile sensation **Time Frame:** Change from Baseline palmar tactile sensation at first day #### Secondary Outcomes **Description:** Whether the athlete is healthy or not, age, gender, height, weight, history of upper extremity injuries, presence of chronic diseases, sport position, weekly training frequency, how long he/she has been playing volleyball, dominant side, shoulder range of motion will be recorded. **Measure:** Demographic data **Time Frame:** Change from Baseline demographic data at first day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being between 18-30 years old * Being a sub-elite level volleyball player (school team / student athlete) * Regular volleyball training (at least once a week) * No history of upper extremity injury in the last 1 year Exclusion Criteria: * Having undergone a surgery involving the upper extremity * Any orthopedic problems that may affect the assessments * Not giving consent to participate in the study **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Healthy volleyball athlete ### Contacts Locations Module #### Locations **Location 1:** **City:** Isparta **Country:** Turkey **Facility:** Süleyman Demirel University Faculty of Medicine, Clinic of Sports Medicine #### Overall Officials **Official 1:** **Affiliation:** Süleyman Demirel University **Name:** Ferdi Başkurt, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Süleyman Demirel University **Name:** Sabriye Ercan, PhD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Süleyman Demirel University **Name:** Elif Şahin, MSc **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Süleyman Demirel University **Name:** İsmet Tümtürk, MSc **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** Süleyman Demirel University **Name:** Ramazan Kürşat Erdaş, MD **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** Süleyman Demirel University **Name:** Fatih Uğur Taş, MD **Role:** STUDY_CHAIR **Official 7:** **Affiliation:** Süleyman Demirel University **Name:** Furkan Hasan Küçük, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010698 - Term: Phobic Disorders - ID: D000001008 - Term: Anxiety Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000014947 - Term: Wounds and Injuries - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M2922 - Name: Kinesiophobia - Relevance: HIGH - As Found: Kinesiophobia - ID: M22625 - Name: Somatosensory Disorders - Relevance: HIGH - As Found: Somatosensory Disorders - ID: M602 - Name: Shoulder Injuries - Relevance: HIGH - As Found: Shoulder Injuries - ID: M13603 - Name: Phobic Disorders - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020886 - Term: Somatosensory Disorders - ID: D000070599 - Term: Shoulder Injuries - ID: D000092442 - Term: Kinesiophobia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417957 **Brief Title:** Cultural Competence Education Given According to the Peer Education Model **Official Title:** The Effect of Cultural Competence Education Given According to the Peer Education Model on the Cultural Competence Levels of Student Nurses #### Organization Study ID Info **ID:** 1919B012203801 #### Organization **Class:** OTHER **Full Name:** Istanbul Aydın University ### Status Module #### Completion Date **Date:** 2024-03-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-01 **Type:** ACTUAL #### Start Date **Date:** 2023-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2023-01-30 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Scientific and Technological Research Council of Turkey #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Aydın University #### Responsible Party **Investigator Affiliation:** Istanbul Aydın University **Investigator Full Name:** Cennet Ciriş Yıldız **Investigator Title:** Asistant Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of the study is to determine the effect of cultural competence education given according to the peer education model on the cultural competence levels of student nurses. **Detailed Description:** Nursing students will be given cultural competence training (with peer education model) and then the effectiveness of this training will be evaluated. ### Conditions Module **Conditions:** - Culture Shock - Cultural Competence **Keywords:** - cultural knowledge, cultural practice, cultural sensitivity, cultural competence ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Group 1: Experimental group (Education group) Goup 2: Control group ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 153 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Experimental group (Education group) **Intervention Names:** - Other: cultural competence training **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** The peer students in the experimental group will be given a total of 16 hours of cultural competence training, two days a week, two lessons per day (60 min. + 60 min.) for four weeks. **Name:** cultural competence training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Cultural Qualıfıcatıon Assessment Scale (Special For Nursing Students). The level of cultural competence is determined by scoring the scale for four dimensions (cultural awareness, cultural knowledge, cultural sensitivity, cultural practice) with a specific score chart. cultural competence In determining the level, if one of the KYDS items is marked as "strongly agree" or "agree", the answer is considered correct and one (1) point is received; If "disagree" or "strongly disagree" is marked, the answer is considered incorrect and zero (0) points are received and the points are added up. The score that can be obtained from each dimension varies between 0-10. The maximum score that can be obtained from the total score of the four dimensions of the scale is forty (40). Scoring 40 points from the scale indicates that the individual is "culturally competent". **Measure:** Cultural Competence Assessment Tool **Time Frame:** Before training, immediately in the first and third months after training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Not receiving training on cultural competence, * Participated in Cultural Competence Peer Training for the experimental group, * Filled out the survey 3 times on the specified dates for the experimental and control groups, * Volunteer to participate in the research, * 3rd and 4th year nursing students. Exclusion criteria: * Receiving training on cultural competence, * Not participating in Cultural Competency Peer Training for the experimental group, * Failure to fill out the survey 3 times on the specified dates for the experimental and control groups, * Those who do not volunteer to participate in the research, * 1st and 2nd year nursing students, * Students who want to leave the study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul Aydın Üniversity **Zip:** 34 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417944 **Brief Title:** The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients **Official Title:** The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients #### Organization Study ID Info **ID:** 326 #### Organization **Class:** OTHER_GOV **Full Name:** Gaziosmanpasa Research and Education Hospital ### Status Module #### Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-28 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Gaziosmanpasa Research and Education Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions.Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness. **Detailed Description:** Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies. Any spinal deformity, especially one that affects the thoracic spine, can affect lung function. If left untreated, the curves may distort over time as skeletal growth accelerates. In some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale. The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; Thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages. In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness. ### Conditions Module **Conditions:** - Spine Deformity - Scoliosis - Scoliosis Idiopathic - Scoliosis; Adolescence - Diaphragm Issues **Keywords:** - Adolescent Idiopathic Scoliosis - Diaphragm Thickness - Three-dimensional Exercise (Schroth Exercise) - Ultrasonographic Measurement ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Months ### Arms Interventions Module #### Arm Group 1 **Description:** Patients aged 10-18 years who are diagnosed with scoliosis and given 10 sessions of schroth exercises, either outpatient or inpatient. Scoliosis study forms consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in in detail. **Intervention Names:** - Diagnostic Test: Scoliosis study form - Diagnostic Test: Scoliosis X-ray (orthorontgenogram) - Diagnostic Test: Pulmonary function test - Diagnostic Test: Ultrasonographic Measurement - Procedure: Three-dimensional Exercise (BSPTS Schroth Exercise) **Label:** Schroth group (Group 1) #### Arm Group 2 **Description:** Patients aged 10-18 years who are diagnosed with scoliosis and given home exercise Scoliosis study forms consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in in detail. **Intervention Names:** - Diagnostic Test: Scoliosis study form - Diagnostic Test: Scoliosis X-ray (orthorontgenogram) - Diagnostic Test: Pulmonary function test - Diagnostic Test: Ultrasonographic Measurement - Procedure: Home Exercise **Label:** Control group (Group 2) ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group (Group 2) - Schroth group (Group 1) **Description:** Scoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail. **Name:** Scoliosis study form **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Control group (Group 2) - Schroth group (Group 1) **Description:** Patients whose Adam's forward bending test and clinical evaluation results are compatible with scoliosis, scoliosis graphy are requested. (Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 5 degrees in those with BMI (Body Mass Index) above 85%. If it is below 85% and above 7 degrees, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis film will be requested.).Coronal, sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs. **Name:** Scoliosis X-ray (orthorontgenogram) **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Control group (Group 2) - Schroth group (Group 1) **Description:** Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken. **Name:** Pulmonary function test **Other Names:** - Spirometry Function Test **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Control group (Group 2) - Schroth group (Group 1) **Description:** Diaphragm thickness will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter- cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken. **Name:** Ultrasonographic Measurement **Type:** DIAGNOSTIC_TEST #### Intervention 5 **Arm Group Labels:** - Schroth group (Group 1) **Description:** It only provides outpatient treatment, but it has different practices, intensive or regular, depending on local and external patients. For local patients, it is applied once a week, accompanied by a therapist, and the treatment duration is determined according to the patient's condition. In patients coming from outside; It can be continued as 2 hours a day for 10 days, then as additional treatment for 1-2 weeks for 3-6 months depending on the patient's condition. I In regular treatment; 30 sessions of 90 minutes group treatment, the first 8 sessions are carried out under the supervision of a therapist for a shorter period of time. We will give 10 sessions of BSPTS Schroth exercises, either outpatient or inpatient. After 10 sessions of the Schroth exercise program, the home program will continue two months after outpatient/inpatient schroth exercise(Home program: 5 days/week, 45-60 minutes for all patients). **Name:** Three-dimensional Exercise (BSPTS Schroth Exercise) **Other Names:** - Physiotherapy Scoliosis Specific Exercises -PSSE (SOSORT Guidelines) **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Control group (Group 2) **Description:** In the home exercise program; daily living activities, neutral pelvis exercises, coronal balance exercises, rotational angular breathing exercises and axial elongation exercises were taught by the physiotherapist in one session. A total of 10-week home exercise program was planned, with exercises to be performed twice a week for the first two weeks, once every 15 days for 1 month (twice in one month), and then once a month. **Name:** Home Exercise **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Scoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail. **Measure:** Scoliosis study form **Time Frame:** Within 2 week of applying to the scoliosis outpatient clinic **Description:** We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second) (Liter-L), FEV1 (%predicted), FVC (Forced Vital Capacity) (Liter-L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken. **Measure:** Pulmonary function test **Time Frame:** Within 2 weeks after applying to the scoliosis clinic (pre-exercise) and 3 months after exercise **Description:** Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. Diaphragm thickness of End-expiratory (Forced residual capacity-FRC) (millimeter-mm), diaphragm thickness of end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken. **Measure:** Ultrasonographic Diaphragm Thickness Measurement **Time Frame:** Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise #### Secondary Outcomes **Description:** The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. Each item of the instrument is scored on a 5-point scale from 0- 4 for ages 8-18, (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem) ad 3-point scale for young child self reporting (ages 5- 7) as following (0 = not at all a problem, 2 = sometimes a problem, 4 = a lot of a problem) the large score means worst symptoms , scores are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) in which high score means better condition **Measure:** The Pediatric Quality of Life Inventory **Time Frame:** Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise **Description:** The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110 **Measure:** Scoliosis Research Society Score **Time Frame:** Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Having scoliosis affecting the thoracic region according to BSPTS (type 3C, type 4C and its subtypes) * Being between the ages of 10-18 * Being able to perform a respiratory function test * Having the mental capacity to answer surveys Exclusion Criteria: * Congenital spinal, costal and diaphragmatic anomalies * Neuromuscular disease * Respiratory system diseases that affect lung functions * Patients who cannot cooperate with spirometry. * Having surgery to the chest wall or spine **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 10 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Demographic information of all individuals included in the study will be collected. According to the Barcelona Scoliosis Physical Therapy School (BSPTS) Classification by Rigo and Weiss, the diaphragm thickness in patients diagnosed with scoliosis (type 3C and 4C) with thoracic curvature and in the control group was measured in the supine position with a 7-13 Mhz linear conventional ultrasound probe (brand) on the anterior axillary line. It will be measured at the end of inspiration and expiration from the intercostal space. Three measurements will be made on the right side and the arithmetic average will be evaluated. Follow-up measurement will be made by the same person, with the same device and with the same method in the 3rd month after the treatment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ofalp3456@gmail.com **Name:** Omer Faruk Alp, MD **Phone:** +90 541 785 10 26 **Role:** CONTACT **Contact 2:** **Email:** dr_denizoke@hotmail.com **Name:** Deniz Oke, MD **Phone:** +90 532 430 69 50 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** dr_denizoke@hotmail.com - **Name:** Deniz Oke, MD - **Phone:** +90 532 430 69 50 - **Role:** CONTACT ***Contact 2:*** - **Email:** ebru.yilmaz.yalcinkaya@gmail.com - **Name:** Ebru Yilmaz Yalcinkaya, MD,Professor - **Phone:** +90 505 451 85 73 - **Role:** CONTACT **Country:** Turkey **Facility:** Omer Faruk Alp **State:** Gaziosmanpasa **Status:** RECRUITING **Zip:** 34255 #### Overall Officials **Official 1:** **Affiliation:** Maltepe District, Askeri Firin Street, Inistanbul buildins F1 Block Flat: 82 Zeytinburnu /ISTANBUL **Name:** Aynur Metin Terzibasioglu, MD,Chief Assistant **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Gaziosmanpaşa Training and Research Hospital Physical Rehabilitation Department **Name:** Ebru Yilmaz Yalcinkaya, MD,Professor **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Jagger F, Tsirikos AI, Blacklock S, Urquhart DS. Adaptation to reduced lung function in children and young people with spinal deformity. J Clin Orthop Trauma. 2020 Mar-Apr;11(2):191-195. doi: 10.1016/j.jcot.2019.12.013. Epub 2020 Jan 3. **PMID:** 32099278 **Citation:** Karaali E, Ciloglu O, Gorgulu FF, Ekiz T. Ultrasonographic measurement of diaphragm thickness in patients with severe thoracic scoliosis. J Ultrasound. 2021 Mar;24(1):75-79. doi: 10.1007/s40477-020-00536-w. Epub 2021 Feb 7. **PMID:** 33550575 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013121 - Term: Spinal Curvatures - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M15417 - Name: Scoliosis - Relevance: HIGH - As Found: Scoliosis - ID: M15918 - Name: Spinal Curvatures - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012600 - Term: Scoliosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417931 **Brief Title:** Medication Adherence and Use of Inhaler Devices in Patients With Asthma or COPD **Official Title:** A Pharmacist-Led Intervention on Medication Adherence and Inhaler Usage on Clinical Outcomes Among Patients With Asthma and Chronic Obstructive Pulmonary Disease in Ibadan, Nigeria #### Organization Study ID Info **ID:** Medication adherence #### Organization **Class:** OTHER **Full Name:** University of Ibadan ### Status Module #### Completion Date **Date:** 2024-02-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-28 **Type:** ACTUAL #### Start Date **Date:** 2023-10-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Ibadan #### Responsible Party **Investigator Affiliation:** University of Ibadan **Investigator Full Name:** Uyiose Fortress Ufuah **Investigator Title:** Graduate Student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to evaluate the impact of a pharmacist-led intervention programme on medication adherence and use of inhaler devices on clinical outcomes of patients with asthma and COPD attending a tertiary health facility in Nigeria. **Detailed Description:** Medication non-adherence in asthma and COPD patients have been established to be very high, and along-side poor knowledge of proper use of inhaler devices, results in suboptimal disease control among these patients. Studies evaluating the impact of a comprehensive intervention on medication adherence and inhaler usage on disease control are scare in developing countries. This study was a prospective single-blind quasi-randomized-controlled study among asthma and COPD patients attending the chest out-patient clinic of the University College Hospital, Ibadan. The baseline questionnaire was administered to consenting patients to explore demographic and specific clinical characteristics, knowledge of the disease, current medications, medication adherence, knowledge of use of metered dose (MDIs) and diskus inhalers, and asthma/COPD control status using the asthma control test (ACT) and COPD assessment test (CAT) scales. Subsequently, patients were assigned into intervention or control groups using odd or even number assignation. Patients in the intervention group were followed up for two months via face to face interviews, short message services, and phone calls at one-weekly intervals, so as to provide education and counseling to resolve the identified gaps during the baseline interaction. Descriptive statistics were used to summarize the data, while chi-square, t-test, Fishers exact test and Wilcoxon-signed ranked tests were used as appropriate to test for associations at p \< 0.05. ### Conditions Module **Conditions:** - Asthma COPD ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Quasi-randomised control trial ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 130 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Patients in the intervention group received education and counselling tips about their disease condition and medications **Intervention Names:** - Behavioral: Patient education and counselling **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** The pharmacist intervention was aimed at identifying and addressing barriers to treatment adherence through tailored strategies **Name:** Patient education and counselling **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The difference between the intervention and control groups with respect to the changes in the medication adherence score from baseline to a 2-month follow-up. **Measure:** Medication adherence **Time Frame:** Two months **Description:** The difference between the intervention and control groups with respect to the changes in knowledge of the use of inhaler devices from baseline to a 2-month follow-up. **Measure:** Use of inhaler devices **Time Frame:** Two months #### Secondary Outcomes **Description:** The difference in asthma or Chronic obstructive pulmonary disease (COPD) control among patients in control and intervention groups from baseline to 2-months follow-up **Measure:** disease control **Time Frame:** Two months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients 18 years of age and older with a primary diagnosis of asthma or COPD by a physician who are willing to complete the study and have telephone access Exclusion Criteria: All non-consenting patients and patients who are not on any medications at any point in the study **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ibadan **Country:** Nigeria **Facility:** University College Hospital **State:** Oyo State **Zip:** 200212 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417918 **Acronym:** C0058 (4C) **Brief Title:** An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Pilot Randomized Controlled Trial **Official Title:** A Formative Study to Develop Culturally Valid Psychosocial Assessment Tools and Interventions to Promote Family Well-Being in Kenya - Part II #### Organization Study ID Info **ID:** 2017-0210 (4C) #### Organization **Class:** OTHER **Full Name:** Duke University ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Moi University #### Lead Sponsor **Class:** OTHER **Name:** Duke University #### Responsible Party **Investigator Affiliation:** Duke University **Investigator Full Name:** Eve Puffer **Investigator Title:** Director, Duke Center for Global Mental Health; Associate Professor, Psychology and Neuroscience and Global Health **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes highly distressed families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns; as such, particular emphasis is placed on adolescent-focused outcomes, including mental health and well-being. **Detailed Description:** The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili), using a single case series design. The intervention, delivered by lay counselors and through existing community social structures, focuses on improving family relationships and mental health with content derived from evidence-based practices; these include solution-focused family therapy and cognitive behavioral strategies. It is components based, with modules delivered based on need. The content and structure has been adapted in both content and implementation model based on formative research in this context. Primary hypotheses include achieving improvements in outcomes related to: 1. Family functioning, including elements such as communication, emotional closeness, structure and organization, and satisfaction for the overall family; this also includes indicators of functioning at dyadic levels (i.e., parent-child and couples functioning) 2. Mental health of both children and caregivers, including positive well-being, with a particular emphasis on outcomes for children and adolescents. The investigators also hypothesize feasibility and acceptability based on a previous evaluation of the program and are analyzing community-sourced practices used by lay counselors. Investigators hypothesize that they are integrating locally-grounded strategies that may influence the delivery or outcomes of the intervention. The study will follow a randomized controlled trial with a sample size of 80 families, including up to 2 caregivers per family (who hold primary responsibility for the child whether biological or non-biological) and a target child identified through caregiver-report of the child about whom they are most concerned. This design will allow for tracking changes in outcome variables over time and for linking clinical changes to session content and delivery strategies. ### Conditions Module **Conditions:** - Mental Health Issue - Family Relations - Family Conflict - Child Mental Disorder - Adolescent - Emotional Problem - Adolescent Problem Behavior - Child Behavior - Child Abuse - Marital Conflict - Domestic Violence - Parent-Child Relations - Parenting ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention, Tuko Pamoja, is delivered by lay counselors and through existing community social structures, focuses on improving family relationships and mental health with content derived from evidence-based practices; these include solution-focused family therapy and cognitive behavioral strategies. It is components based, with modules delivered based on need. The content and structure has been adapted in both content and implementation model based on formative research in this context. Tuko Pamoja includes a smart phone component to support psychoeducation components and data collection. **Intervention Names:** - Behavioral: Tuko Pamoja, "We are Together" in Kiswahili **Label:** Intervention: Tuko Pamoja **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention: Tuko Pamoja **Description:** Tuko Pamoja, "We are Together" in Kiswahili; This intervention, delivered by lay counselors and through existing community social structures, focuses on improving family relationships and mental health with content derived from evidence-based practices; these include solution-focused family therapy and cognitive behavioral strategies. It is components based, with modules delivered based on need. Tuko Pamoja includes a smart phone component to support psychoeducation components and data collection. The content and structure has been adapted in both content and implementation model based on formative research in this context. **Name:** Tuko Pamoja, "We are Together" in Kiswahili **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** 30 self-report items developed for the local context based on formative research (Family Togetherness Scale, FTS). Responses are endorsed on a 10-point scale and refer to the past month. One composite score is calculated; higher scores reflect better family functioning. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments. **Measure:** Family Functioning (Change over time) **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks **Description:** 20 self-report items from the Parent-Adolescent Communication Scale (PACS). Each include caregiver and child/adolescent report versions. Participants are asked to respond based on the past month. Children report on each caregiver separately. For primary analyses, one composite score will be calculated. For follow-up analyses, subsets of items may be analyzed, including those related specifically to harsh treatment/abuse. **Measure:** Parent-Child Communication (Change over time) **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks **Description:** 20 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Warmth Subscale. One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments. **Measure:** Parent-Child Relationship Quality (Change over time) **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks **Description:** 15 self-report items from the Parent Adolescent Relationship Questionnaire (PARQ) Hostility/Aggression Subscale. One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments. **Measure:** Harsh Parenting (Change over time) **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks **Description:** Locally-derived items and selected items adapted from standardized scales: Conflict Tactics Scale; Dyadic Adjustment Scale; additional locally-derived items. A total of 52 items are included, referring to both self and spouse behaviors. The majority of items are based on a frequency scale, referring to the past month; some items related to spousal maltreatment assess whether behaviors have ever occurred. One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments. **Measure:** Couples Relationship Quality (Change over time) **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks **Description:** Items locally developed and adapted from standardized measures, including the Brief Problem Monitor (BPM) and locally-developed items assessed local terms reflecting symptoms, hope, prosocial behavior, risk behavior, and sense of belongingness. The majority of items reported on a 3-point scale (Not/Never True, Somewhat/Sometimes True, Very/Often True). One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments. **Measure:** Child Mental Health (Change over time) **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks **Description:** Locally-developed items and items adapted from subscales of standardized measures, including: Patient Health Questionnaire, General Health Questionnaire. Caregivers self-report on 29 total items. One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments. **Measure:** Caregiver Mental Health (Change over time) **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks #### Secondary Outcomes **Description:** Four items from the Multiple Indicator Cluster Survey (MICS). Participants reported frequency of (a) beating with an object and (b) spanking/slapping/hitting in the past 2 months using a 4-point scale from "never" (0) to "many times" (3)." One composite score will be calculated, and potential follow-up analyses may examine subsets of items. A subset of these are administered repeatedly pre- and post-intervention as part of the single case series design multiple assessments. **Measure:** Physical Maltreatment **Time Frame:** Baseline and 1 month post-intervention; repeated measures pre, during, and post intervention up to 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Family with self-reported elevated distress (e.g., high levels of conflict) that also has a child/adolescent (ages 8-17) with caregiver-reported emotional or behavioral concerns Exclusion Criteria: * Families without reported distress and/or without reported adolescent distress. * Families with children older than 17 or younger than 8 years of age. * Families in which primary caregivers or children are living too far outside of the community to participate in treatment. **Healthy Volunteers:** True **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** eve.puffer@duke.edu **Name:** Eve S Puffer, PhD **Phone:** (919) 381-2494 **Role:** CONTACT #### Locations **Location 1:** **City:** Eldoret **Contacts:** ***Contact 1:*** - **Name:** Florence Jaguga, MBChB, MMed - **Role:** CONTACT **Country:** Kenya **Facility:** Moi University ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Mental Disorders - ID: M85 - Name: Problem Behavior - Relevance: HIGH - As Found: Problem Behavior - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: HIGH - As Found: Child Mental Disorder - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001523 - Term: Mental Disorders - ID: D000066553 - Term: Problem Behavior - ID: D000065886 - Term: Neurodevelopmental Disorders ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417905 **Brief Title:** Effect of Exercises on Dentists' Body Functions **Official Title:** Effects Of Exercise Training On Core Endurance, Scapular And Upper Exstremity Functions in Dentists #### Organization Study ID Info **ID:** supervisedvsvideovscontrol #### Organization **Class:** OTHER **Full Name:** Dokuz Eylul University ### Status Module #### Completion Date **Date:** 2024-01-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-29 **Type:** ACTUAL #### Start Date **Date:** 2023-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dokuz Eylul University #### Responsible Party **Investigator Affiliation:** Dokuz Eylul University **Investigator Full Name:** Emrullah ALKAN **Investigator Title:** Msc **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the study is to compare the effects of supervised exercises, video based exercises and control group on muscle strength, muscle endurance, pain and upper extremity function in dentists with musculoskeletal pain. Participants were randomly divided into 3 groups: Supervised exercise group (SEG), video based exercise group (VEG) and control group (CG). Both SEG and VEG were given same exercises but SEG did the exercises with a experienced physiotherapist while VEG did it through videos 3 days a week for 12 weeks. CG was only given postural education. ### Conditions Module **Conditions:** - Neck Pain **Keywords:** - muscle strength - muscle endurance - pain - neck pain - musculoskeletal problems ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Exercises were done 3 times a week for 12 weeks with a physiotherapist **Intervention Names:** - Other: Supervised exercises **Label:** Supervised Exercises **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Exercises were done 3 times a week for 12 weeks by subjects via videos **Intervention Names:** - Other: video based exercises **Label:** Video based Exercises **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Only postural education were given **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Supervised Exercises **Description:** strengthening deep neck flexors, serratus anterior middle and lower trapez stretchening upper trapezius, levator scapula **Name:** Supervised exercises **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Video based Exercises **Description:** strengthening deep neck flexors, serratus anterior middle and lower trapez stretchening upper trapezius, levator scapula **Name:** video based exercises **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** change in pain was assessed by using algometer **Measure:** Change in pain **Time Frame:** Before training and after 12 weeks of training #### Secondary Outcomes **Description:** change in cervical flexor and extensor muscle endurance was assessed by physiotherapist **Measure:** change in deep cervical flexor and extensor muscle endurance **Time Frame:** Before training and after 12 weeks of training **Description:** change in scapular muscle endurance was assessed by physiotherapist **Measure:** change in scapular muscle endurance **Time Frame:** Before training and after 12 weeks of training **Description:** change in core static and dynamic endurance was assessed by physiotherapist **Measure:** change in core static and dynamic endurance **Time Frame:** Before training and after 12 weeks of training **Description:** functional assessment was assessed using DASH Questtionnaire **Measure:** functional assessment **Time Frame:** Before training and after 12 weeks of training **Description:** neck disability was assessed using neck disability index **Measure:** neck disability **Time Frame:** Before training and after 12 weeks of training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * working as an active dentist for at least 3 years * Having nonspecific neck pain more than 3 months Exclusion Criteria: * any operation in neck area **Maximum Age:** 65 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** İzmir **Country:** Turkey **Facility:** Dokuz Eylul University ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M21485 - Name: Neck Pain - Relevance: HIGH - As Found: Neck Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019547 - Term: Neck Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417892 **Brief Title:** Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma **Official Title:** A Randomized Controlled Study of 2nd-line Treatment of Advanced G/GEJ Adenocarcinoma With Fruquintinib and Albumin-paclitaxel in Combination With or Without PD-1 Antibody in Patients Who Have Failed Treatment With PD-1 Antibody #### Organization Study ID Info **ID:** NCC4594 #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Status Module #### Completion Date **Date:** 2026-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Responsible Party **Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Investigator Full Name:** LIN YANG **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen **Detailed Description:** This is a single-center, prospective, open, randomized controlled study of patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma. The study population was pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma, which had undergone one systemic treatment; First-line exposure to immune drugs (including PD-1 drug exposure at the stage of neoadjuvant, adjuvant, and systemic therapy); For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment). After patients meeting the inclusion criteria signed informed consent, the study was observed from the start of treatment until death, withdrawal of informed consent, loss of follow-up, or the end of the study. Eligible subjects will be randomly assigned to either fruquintinib combined with albumin-paclitaxel or fruquintinib combined with albumin-paclitaxel combined with PD-1 monoclonal antibody in a 1:1 ratio. A total of 60 subjects are planned to enter the study treatment, 30 in each treatment group, and enter one of the following open treatment groups: Group A: Fruquintinib combined with albumin-paclitaxel regimen Group B: Fruquintinib, albumin-paclitaxel combined with PD-1 antibody regimen For enrolled patients, the treating physician conducted the first visit before treatment, and the follow-up visit and the last visit after treatment began. Visits were conducted in accordance with clinical norms and there was no fixed schedule for visits. Physicians collect demographic and disease-related baseline data from medical records or at the first visit prior to treatment. Treatment-related data, including adverse events and tumor status, were collected during follow-up visits. Survival follow-up was conducted every 3 months after the end of the study, either by phone, wechat or through other doctors. The last visit recorded patient death, withdrawal of informed consent, loss of visit, or end of study. ### Conditions Module **Conditions:** - Gastric Cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Fruquintinib combined with albumin paclitaxel **Label:** Fruquintinib + albumin paclitaxel #### Arm Group 2 **Description:** Fruquintinib, albumin paclitaxel combined with PD-1 antibody **Intervention Names:** - Drug: PD-1inhibitor **Label:** Fruquintinib + albumin paclitaxel + PD-1 antibody ### Interventions #### Intervention 1 **Arm Group Labels:** - Fruquintinib + albumin paclitaxel + PD-1 antibody **Description:** PD-1 antibody was selected according to first-line drug use **Name:** PD-1inhibitor **Other Names:** - PD-1 antibody **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Progression free survival **Measure:** PFS **Time Frame:** 2 years #### Secondary Outcomes **Description:** Objective Remission Rate **Measure:** ORR **Time Frame:** 2 years **Description:** Disease Control Rate **Measure:** DCR **Time Frame:** 2 years **Description:** Duration of Remission **Measure:** DoR **Time Frame:** 2 years **Description:** overall survival **Measure:** OS **Time Frame:** 2 years **Description:** Incidence of Treatment-Emergent Adverse Events **Measure:** Safety and Tolerability **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Age ≥18 years old; 3. Pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma with at least one systemic treatment; 4. Frontline experienced exposure to immune drugs (including exposure to PD-1 drugs in the neoadjuvant, adjuvant, and systemic treatment stages; For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment); 5. ECOG's physical condition was 0-1, and did not deteriorate within 7 days; 6. BMI≥18; 7. Expected survival ≥3 months; 8. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within the first 14 days of enrollment) a) Absolute neutrophil count ≥1.5×109/L, white blood cell ≥4.0×109/L; b) Platelet ≥100×109/L; c) Hemoglobin ≥90g/L; d) Total bilirubin TBIL≤1.5 times ULN; e)ALT and AST≤2.5 times ULN (up to 5 times in patients with liver metastasis); f) Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min); g) Left ventricular ejection fraction (LVEF) ≥50%; h)Fridericia's corrected QT interval (QTcF) \<470 ms. i) INR≤1.5 x ULN, APTT≤1.5 x ULN. 9. Women of childbearing age need to take effective contraceptive measures; 10. Good compliance, cooperate with follow-up; Exclusion Criteria: 1. Failure to comply with the study protocol or study procedure; 2. Previous treatment with VEGFR inhibitors; 3. Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the progression of the disease); 4. Known HER-2 positive patients; 5. Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period; 6. Had other malignancies within 5 years prior to enrollment, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 7. Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment; 8. Previously received allogeneic bone marrow transplantation or organ transplantation; 9. Subjects who are allergic to the investigational drug or any of its adjuncts; 10. Electrolyte abnormalities identified by the investigator as clinically significant; 11. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg; 12. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take the drug orally; 13. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment; 14. Patients with significant evidence or history of bleeding tendency (hemorrhage \>30 mL within 3 months, accompanied by hematemesis, stool, and blood in the stool), hemoptysis (\>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to enlistment; 15. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure New York Heart Association (NYHA) Grade \>2; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) \<50%; 16. Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection); 17. Known human immunodeficiency virus (HIV) infection. A known history of clinically significant liver disease, including viral hepatitis \[active HBV infection, i.e., positive HBV DNA (\>1×104 copies /mL or \>2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL); 18. Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity; 19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 20. Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 28 days before enrollment; 21. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk; 22. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \>1.0g; 23. The patients considered by the investigators to be unsuitable for inclusion in this study. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with advanced gastric/gastroesophageal junction adenocarcinoma who failed treatment with anti-PD-1 /PD-L1 regimen. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma ### Intervention Browse Module - Ancestors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: HIGH - As Found: Obstruction - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000082082 - Term: Immune Checkpoint Inhibitors ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417879 **Brief Title:** Attitude And Practice of Egyptian Dental Practitioners Regarding Restoration Repair **Official Title:** Attitude And Practice of Egyptian Dental Practitioners Regarding Restoration Repair: A Cross-Sectional Study #### Organization Study ID Info **ID:** 14422021484209 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Habiba Hassan Mostafa Hosni **Investigator Title:** Masters candidate at faculty of dentistry Cairo University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a cross-sectional study with an aim to evaluate the variations in self-reporting attitude and practice of restoration repair among Egyptian dental practitioners utilizing a survey questionnaire. It is undeniable that "Minimally invasive dentistry" nowadays offers solutions to prolong the longevity of resin composite restoration with adhesive technology. Due to the limited lifespan of dental restorations, defects are more prone to occur in the existing restorations and thus require dental treatment. it was stated in the literature that repairing could offer better advantages even though replacement of a restoration is a more common choice by many clinicians. Since the concept of preserving tooth structure nowadays plays a major part in dental practice, invistigators need to understand where Egyptian dental practitioners stand in understanding and applying the concept of restoration repair. Assessment of knowledge and the missing data regarding the concept of repair that dentists in Egypt have could help understand their awareness in applying conservatism in daily practice. There were some research about knowledge, attitude and practice of restoration repair in of dental practitioners in other countries, but little was known in Egypt. ### Conditions Module **Conditions:** - Practice - Attitude - Dental Restoration Repair ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 316 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Survey Questionnaire (Percentages) **Measure:** Practice of Egyptian dental practitioners toward repair restoration **Time Frame:** After data collection (4 months) **Description:** Survey Questionnaire (Percentages) **Measure:** Attitude of Egyptian dental practitioners toward repair restoration **Time Frame:** After data collection (4 months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the Egyptian Dental Syndicate. Exclusion Criteria: * Undergraduate dental students * Dental practitioners that are still in internship * Dental practitioners that don't have their practice license yet. * Dental practitioners that are not registered in the Egyptian Dental Syndicate. **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the Egyptian Dental Syndicate. ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417866 **Brief Title:** Informed Consent Using a Spinal Model **Official Title:** Enhancing Informed Consent Utilizing a Spinal Model for Lumbar Epidural Steroid Injection: A Prospective Randomized Controlled Study. #### Organization Study ID Info **ID:** 2023/719 #### Organization **Class:** OTHER **Full Name:** Ankara University ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara University #### Responsible Party **Investigator Affiliation:** Ankara University **Investigator Full Name:** Hanzade Aybuke Unal **Investigator Title:** Medical Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Informed consent is the first step in every medical procedure. It is important for the patient to clearly understand how the procedure will be performed, what to expect from the process, and the possible complications. Any of the specified processes disruption may alter procedure satisfaction and treatment outcomes. Studies have reported that providing insufficient information before interventional procedures increases anxiety and the severity of pain during the procedure. In this study, alongside the standard procedures for obtaining oral and written consent, it is envisaged to augment patient comprehension and engagement by visually demonstrating the treatment areas and needle insertion points using a spinal model. Within the study framework, patients will be presented with both verbal and written informed consent, supplemented by visual aids utilizing a spinal model. The study aims to assess and compare the efficacy of this enhanced consent process in terms of patient understanding, procedural acceptance, and subsequent satisfaction levels. **Detailed Description:** The informed consent process includes the processes of explanation, understanding, selection and approval of the volunteer. For informed consent to be valid, the patient must obtain sufficient information about the procedure, be in communication with the physician, be voluntary, and have the capacity to give consent. In our country, informed consent forms usually include a physician-patient interview, reading and signing of the written text. Although informed consent forms are written in a language that patients can understand, they can be complicated for patients. Studies have shown that video and other audio-visual materials significantly improve patients' understanding of the subject. It has been proven to facilitate follow-up and increase compliance with the treatment plan. Informed consent using multimedia tools is reported to be effective. Lumbar radiculopathy is a condition characterized by pain that can affect daily life and is one of the most common causes of low back pain. Epidural steroid injections can be applied to patients that do not benefit from conservative treatment. Lumbar epidural steroid injections are a minimally invasive procedure and their method of application in society is not clearly known. This procedure is performed with a needle and accompanied by imaging techniques, without any incision. There are a limited number of studies on informed consent forms before lumbar epidural applications. In a study, it was found that patients who did not understand the consent form or received insufficient information had lower post-procedure satisfaction. In another study it stated that in patients who were given a brochure explaining the procedure in addition to verbal and written consent, giving the brochure had no effect on pre-procedure anxiety and post-procedure pain severity. Verbal and written consent is routinely obtained from patients who are planned to receive lumbar epidural steroid injection in our clinic. In this study, in addition to the routine oral and written consent, it is planned to show the patients the areas to be treated and where the needle will be placed via a spinal model. Within the scope of the study, patients were provided with verbal and written informed consent and visual illustrations through a spine model in addition to verbal and written informed consent. The aim of the study is to compare the level of understanding of consent, acceptance of the procedure and its effect on patient satisfaction after the procedure. ### Conditions Module **Conditions:** - Anxiety - Depression - Pain **Keywords:** - pain - anxiety ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 168 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** standard verbal and written informed consent form **Intervention Names:** - Other: informed consent **Label:** standard informed consent #### Arm Group 2 **Description:** standard verbal and written informed consent form + visual spinal model **Intervention Names:** - Other: spine model **Label:** visual spinal model ### Interventions #### Intervention 1 **Arm Group Labels:** - standard informed consent **Description:** standard verbal and written informed consent **Name:** informed consent **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - visual spinal model **Description:** standard verbal and written informed consent + visual spine model **Name:** spine model **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The degree of understanding of the informed consent form evaluation with a 3-point Likert scale. **Measure:** Informed consent form comprehension assessment **Time Frame:** 1 day **Description:** The degree of patient satisfaction evaluation after the lumbar epidural steroid injection with a 5-point Likert scale. **Measure:** Patient satisfaction after the procedure **Time Frame:** 1st hour **Description:** anxiety and depression evaluation before the procedure with Hospital Anxiety and Depression Scale (HADS). A score of 0-7 in the survey indicates normal, 8-10 points indicates borderline, and 11 and above indicates anxiety/depression.The maximum score that can be obtained from the survey is 42, and higher scores are associated with worse outcome. **Measure:** anxiety and depression **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients scheduled for lumbar epidural steroid injection due to radicular pain * Patients who gave consent to participate in the study Exclusion Criteria: * Presence of psychiatric illness that is unstable/not controlled by medical treatment * Pregnant patients * Patients who have previously received epidural steroid injections * Patients who did not give consent to participate in the study * Patients with cognitive impairment * Patients with major coagulopathy * Patients with mental disabilities * Illiterate patients **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients between the ages of 18 and 65 who are scheduled to receive lumbar epidural steroid injection due to radicular pain will be included in the study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Ankara University **Zip:** 06230 #### Overall Officials **Official 1:** **Affiliation:** Ankara University **Name:** Hanzade A Unal, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ketelaars PJW, Buskes MHM, Bosgraaf RP, van Hamont D, Prins JB, Massuger LFAG, Melchers WJG, Bekkers RLM. The effect of video information on anxiety levels in women attending colposcopy: a randomized controlled trial. Acta Oncol. 2017 Dec;56(12):1728-1733. doi: 10.1080/0284186X.2017.1355108. Epub 2017 Aug 1. **PMID:** 28760058 **Citation:** Bahar Ozdemir Y, Sencan S, Ercalik T, Kokar S, Gunduz OH. Do informative leaflets affect pre-procedural anxiety and immediate pain after transforaminal epidural steroid injections? A prospective randomized controlled study. Agri. 2021 Jan;33(1):1-6. doi: 10.14744/agri.2020.27048. **PMID:** 34254651 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417853 **Acronym:** HD-MAP **Brief Title:** Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) **Official Title:** Phase I Clinical Study to Evaluate the Safety and Tolerability of a Monovalent Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) in Healthy Adults Aged 18 to 50 Years #### Organization Study ID Info **ID:** SP-1219-007 #### Organization **Class:** INDUSTRY **Full Name:** Vaxxas Pty Ltd ### Status Module #### Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Biomedical Advanced Research and Development Authority #### Lead Sponsor **Class:** INDUSTRY **Name:** Vaxxas Pty Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Study SP-1219-007 is a multi-centre, randomised, study designed to access the safety and tolerability of two doses of monovalent Influenza A (H7N9) vaccine delivered intradermally by a microarray patch delivery system in healthy adults aged 18 to 50 years. **Detailed Description:** 258 participants will be randomized to receive two doses (Day 1 and 22) of either VXS-1219, VXS-1219 with QS21 adjuvant (VXS-1219A), an intramuscular comparator (H7N9 vaccine or H7N9 + MF59® vaccine) or an uncoated, vaccine-free HD-MAP Delivery system (VXS-1219U). VXS-1219A is identical to VXS-1219 with the only difference being this investigational product will be formulated with QS21. VXS-1219U, the vaccine-free microarray patch delivery system comparator, includes a terminally sterilized polymer patch and does not include any vaccine coating formulation on the micro-projections, but is otherwise identical to VXS-1219 and VXS-1219A. The primary objective of the study is to evaluate the safety and tolerability of two doses of H7N9 Influenza A vaccine (12 to 25 mcg HA) with and without QS21 adjuvant (3.3 to 8 mcg), administered by the microarray patch delivery system, compared to IM H7N9 vaccine (7.5 mcg HA) with and without MF59® and uncoated, vaccine-free microarray patch delivery system, administered 21 days apart. The secondary objectives of the study are to evaluate the immune response to two doses H7N9 Influenza A vaccine (12 to 25 mcg HA) with and without QS21 adjuvant (3.3 to 8 mcg), administered by the microarray patch delivery system, compared to IM H7N9 vaccine (7.5 mcg HA) with and without MF59® and uncoated, vaccine-free microarray patch delivery system, administered 21 days apart. ### Conditions Module **Conditions:** - H7N9 Influenza **Keywords:** - Influenza A Monovalent Vaccine Microarray Delivery System ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** The study will be mixed and will contain open label and double-blinded groups; the active comparator groups (Group 1: H7N9 unadjuvanted IM and Group 4: H7N9 with MF59® IM) will be open-label whilst groups (Groups 2, 3 and 5 to 8: VXS-1219 and VXS-1219A) will be double-blinded. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 258 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 7.5 mcg HA unadjuvanted IM injection (n=30) **Intervention Names:** - Biological: Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection **Label:** Arm 1: Influenza A (H7N9) Vaccine Intramuscular Injection **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** VXS-1219 12 mcg HA (n=30) and VXS-1219U (n =3) **Intervention Names:** - Combination Product: Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA) - Device: Microarray Patch Delivery System **Label:** Arm 2: Unadjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** VXS-1219 25 mcg HA (n=30) and VXS-1219U (n =3) **Intervention Names:** - Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA) - Device: Microarray Patch Delivery System **Label:** Arm 3: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** 7.5 mcg HA with MF59® adjuvant 7.5 IM injection (n=30) **Intervention Names:** - Biological: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Injection **Label:** Arm 4: Adjuvanted Influenza A (H7N9) Vaccine Intramuscular Injection **Type:** ACTIVE_COMPARATOR #### Arm Group 5 **Description:** VXS-1219A 12 mcg HA + QS21 4 mcg (n=30) and VXS-1219U (n =3) **Intervention Names:** - Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, low dose adjuvant) - Device: Microarray Patch Delivery System **Label:** Arm 5: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** VXS-1219A 12 mcg HA + QS21 8 mcg (n=30) and VXS-1219 (n = 3) **Intervention Names:** - Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, high dose adjuvant) - Device: Microarray Patch Delivery System **Label:** Arm 6: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** VXS-1219A 20 mcg HA + QS21 3.3 mcg (n=30) and VXS-1219U (n=3) **Intervention Names:** - Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, low dose adjuvant) - Device: Microarray Patch Delivery System **Label:** Arm 7: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** VXS-1219A 20 mcg HA + QS21 6.7 mcg (n=30) and VXS 1219U (n=3) **Intervention Names:** - Combination Product: Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, high dose adjuvant) - Device: Microarray Patch Delivery System **Label:** Arm 8: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1: Influenza A (H7N9) Vaccine Intramuscular Injection **Description:** 7.5 mcg Influenza A (H7N9) Injection **Name:** Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Injection **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Arm 2: Unadjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Description:** 12 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219) **Name:** Unadjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA) **Type:** COMBINATION_PRODUCT #### Intervention 3 **Arm Group Labels:** - Arm 3: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Description:** 25 mcg Influenza A (H7N9) Microarray Patch Delivery System (VXS-1219) **Name:** Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA) **Type:** COMBINATION_PRODUCT #### Intervention 4 **Arm Group Labels:** - Arm 4: Adjuvanted Influenza A (H7N9) Vaccine Intramuscular Injection **Description:** 7.5 mcg Influenza A (H7N9) with MF59® Injection **Name:** Adjuvanted Influenza A (H7N9) Monovalent Vaccine Injection **Type:** BIOLOGICAL #### Intervention 5 **Arm Group Labels:** - Arm 5: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Description:** 12 mcg Influenza A (H7N9) with 4 mcg QS21 Microarray Patch Delivery System (VXS-1219A) **Name:** Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, low dose adjuvant) **Type:** COMBINATION_PRODUCT #### Intervention 6 **Arm Group Labels:** - Arm 6: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Description:** 12 mcg Influenza A (H7N9) with 8 mcg QS21 Microarray Patch Delivery System (VXS-1219A) **Name:** Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (low dose HA, high dose adjuvant) **Type:** COMBINATION_PRODUCT #### Intervention 7 **Arm Group Labels:** - Arm 7: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Description:** 20 mcg Influenza A (H7N9) with 3.3 mcg QS21 Microarray Patch Delivery System (VXS-1219A) **Name:** Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, low dose adjuvant) **Type:** COMBINATION_PRODUCT #### Intervention 8 **Arm Group Labels:** - Arm 8: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Description:** 20 mcg Influenza A (H7N9) with 6.7 mcg QS21 Microarray Patch Delivery System (VXS-1219A) **Name:** Adjuvanted Influenza A (H7N9) Monovalent Vaccine Microarray Patch Delivery System (high dose HA, high dose adjuvant) **Type:** COMBINATION_PRODUCT #### Intervention 9 **Arm Group Labels:** - Arm 2: Unadjuvanted Influenza A (H7N9) Vaccine Microarray Patch - Arm 3: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - Arm 5: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - Arm 6: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - Arm 7: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch - Arm 8: Adjuvanted Influenza A (H7N9) Vaccine Microarray Patch **Description:** Vaccine free Microarray Patch Delivery System (VXS-1219U) **Name:** Microarray Patch Delivery System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Incidence, severity and duration of solicited systemic adverse reactions including fever, headache, malaise, myalgia, arthralgia, fatigue, sweating and shivering from Day 1 through Day 8 (Dose 1) and Day 22 through Day 29 (Dose 2); **Time Frame:** 387 days **Measure:** Incidence, severity and duration of local adverse reactions including erythema, swelling, induration, ecchymosis, and vaccination site pain from Day 1 through Day 8 (Dose 1) and Day 22 through Day 29 (Dose 2); **Time Frame:** 387 days **Measure:** Incidence and severity of unsolicited (spontaneously reported) treatment-emergent adverse events (TEAEs) from Day 1 through Day 78; **Time Frame:** 78 days **Measure:** Incidence and severity of SAEs, MAAEs and PIMMCs from Day 1 through Day 387; **Time Frame:** 387 days **Measure:** Incidence and severity of Application Site Reactogenicity Adverse Events with onset after Day 78 from Day 79 through Day 387; **Time Frame:** 387 days **Description:** Clinical safety laboratory tests include Hematology, Biochemistry panel, Serology for Hepatitis B and C (HBsAg, HCV) and HIV (HIV-1 and HIV-2), Beta-human chorionic gonadotropin (HCG) serum pregnancy test for female participants of childbearing potential only. Females with natural amenorrhea for \<12 months and who ate not surgically sterile, and Urine pregnancy dipstick test will be performed onsite at pre-dose Day 1 and pre dose Day 22 for female participants of childbearing potential only. **Measure:** Number of Participants with Clinically Significant Changes in Laboratory Tests from Day 1 to Day 387; **Time Frame:** 387 days **Description:** A complete physical examination will include assessments of general appearance; skin and lymphatics; head; eyes; ears; nose; throat; cardiovascular system; respiratory system; abdomen/gastrointestinal system; musculoskeletal and neurological systems. Other body systems may also be examined as required, at the discretion of the Investigator. **Measure:** Number of Participants with Clinically Significant Changes in Physical Examination from Day 1 to Day 387 **Time Frame:** 387 days **Description:** Vital sign measurements will include tympanic body temperature (in degrees Celsius \[°C\]), systolic and diastolic blood pressure (in millimeters of mercury \[mmHg\]), heart rate (in beats per minute) and respiratory rate (number of breaths per minute). **Measure:** Number of Participants with Clinically Significant Changes in Vital Signs from Day 1 through Day 387; **Time Frame:** 387 days **Measure:** Local skin response, assessed by photo imaging and standardised scoring, measured at 10 minutes and 1 hour following application on Day 1 and Day 22, and at Days 4, 8, 29, and 78; **Time Frame:** 78 days **Measure:** Concomitant medication usage. **Time Frame:** 387 days #### Secondary Outcomes **Measure:** GMT of serum antibody response to H7N9 antigen, assessed by hemagglutination inhibition assay (HAI) at baseline and Days 8, 22, 29, 43, 78 and 387; **Time Frame:** 387 days **Measure:** GMT of the serum virus neutralising antibody titres to H7N9 antigen, assessed by microneutralisation (MN) assay at baseline and Days 8, 22, 29, 43, 78 and 387. **Time Frame:** 387 days **Measure:** GMT of serum antibody response to H7N9 antigen, seroconversion rate and % of subjects seropositive, assessed by hemagglutination inhibition assay (HAI) at baseline and Days 8, 22, 29, 43, 78 and 387. **Time Frame:** 387 days **Measure:** Seroconversion based on serum HAI antibody titres, defined as either a pre-vaccination HAI titre < 1:10 and a post-vaccination HAI titre ≥ 1:40, or a pre-vaccination HAI titre ≥ 1:10 and a minimum 4-fold increase in post-vaccination HAI titre. **Time Frame:** 387 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for this study: * Aged 18 to 50 years (inclusive) at the time of consent; * Body mass index (BMI) within the range 18.0 to 32.0 kg/m² (inclusive) at Screening; * Being in good health, as determined by satisfactory physical examination, vital signs, 12-lead ECG, laboratory evaluation, stable medical history and clinical judgment of the Investigator. Participants with stable, chronic underlying illnesses such as psychiatric/psychological disorders, hypertension, diabetes, ischemic heart disease or hypothyroidism (or other conditions as per investigator's discretion) may be enrolled at the discretion of the PI and provided their signs and symptoms are controlled. If on regular prescription medication, the medication dose must have been stable for at least three months prior to Screening; * Adequate venous access in left or right arm to allow collection of small-volume blood samples at different visits; * Participants of childbearing potential must return a negative pregnancy test at Screening (serum) and pre-dose on Day 1 (urine), and must agree to remain sexually abstinent, use medically effective contraception or have a partner who is sterile or same-sex, from Screening through to Day 78. The use of medically effective contraception or IUD must be stable for at least three months prior to Screening. Surgical sterilisation, e.g., tubal ligation, hysterectomy and bilateral oophorectomy in women, or vasectomy in men, is required at least six months prior to Screening. Post menopausal participants can be included, and are defined as those with at least 12 months since their last menstrual period; * Non-surgically sterilised, sexually active male participants with a female partner of child-bearing potential must agree to use condoms, together with medically effective contraception for their female partner through to Day 78; * Participant is able to communicate effectively with study personnel and is considered likely to be reliable, willing and cooperative in terms of compliance with the protocol requirements; * Participant is able and willing to provide written, personally signed, informed consent to participate in the study Exclusion Criteria: Participants meeting any of the following exclusion criteria will not be eligible for this study: * Participants who have received any registered vaccine within 30 days prior to Day 1; * Planned administration of any registered vaccine prior to the immunogenicity blood draw on Day 43; * Previous administration of any H7 vaccine, previous physician-confirmed H7 disease, previous known or potential exposure to avian influenza virus H7N9 HA antigen or any other avian influenza including H5N1, at any time in the past; * Participants with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) at the planned vaccination sites (2 adjacent sites overlying the deltoid muscle which are at least 3 cm apart) that could be expected to obscure the observation of treatment site reactions. If dosing on Day 22 is performed on different arm than Day 1, the same exclusion criteria shall apply; * Participant with known chronic spontaneous urticaria or dermographism; * Known predisposition to keloid-scar formation (participants who have developed a scar caused by BCG vaccine can be included in the study); * Known anaphylactic hypersensitivity to haemagglutinin or to any of the vaccine or adjuvant excipients (squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate, protein other than H7N9 including Madin Darby Canine Kidney (MDCK) cell protein, (residual), MDCK cell DNA, (residual), cetyltrimethylammonium bromide (residual), beta-propiolactone (residual), QS21 extract, or any other excipient contained in the study products; * Allergy to a previous vaccination at any time in the past; * Known history of demyelinating disease or Guillain-Barré syndrome; * History of granulomatous diseases, including sarcoidosis and granuloma annulare; * History of convulsions, epilepsy, other physician diagnosed central nervous system diseases, excluding febrile convulsions experienced as a child that are considered resolved; * History of clinically significant haematological, gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, that, at the discretion of the Investigator, precludes the participant from the study; * Presence of active viral or bacterial infection, with or without fever (tympanic temperature ≥38.0 °C), at Day 1 or within 72 hours prior to study vaccination, if determined by the Investigator to be of clinical significance. Participants with a minor illness such as mild diarrhoea or mild upper respiratory infection without fever may be enrolled at the discretion of the Investigator. Enrolment may be deferred for up to one week provided participant remains otherwise eligible and the total Screening period does not exceed 14 days; * History of any haematological malignancy or active neoplastic disease (Non-melanoma skin cancer that was successfully treated within the 5 year period can be included in the study). Active is defined as having received treatment within the five years prior to Screening; * Presence of an active medical condition, defined as a condition under current evaluation or treatment, that is considered clinically significant by the Investigator, or a recent illness that is considered clinically significant by the Investigator; * Any condition that, in the opinion of the Investigator, is considered clinically significant or might interfere with the evaluation of the study objectives; * Planned surgery requiring a general anaesthetic, or surgery requiring inpatient hospitalisation for at least 24 hours from Screening through to Day 78; * History of illness and/or infection with Hepatitis B, or Hepatitis C or Human Immunodeficiency Virus (HIV), or a positive test for Hepatitis B surface antigen, Hepatitis C or antibodies against HIV at Screening; * History of abnormal bleeding, and/or thrombophlebitis unrelated to venepuncture or intravenous cannulation; * History of autoimmune or autoinflammatory immune-mediated medical conditions; * Receiving chronic treatment with immunosuppressive therapy, including chronic use (more than 14 continuous days) of corticosteroids within 30 days prior to Day 1. * Participant who has received immunoglobulins and/or any blood or blood products within three months prior to Day 1 or plans to receive any blood or blood products at any time during the study; * Participant who has donated blood or plasma, or has had clinically significant blood loss, within 14 days prior to Day 1. Participants who plan to donate blood or plasma within 12 weeks of dose 2 should also be excluded; * Female participant who is pregnant or breast-feeding, or intends to become pregnant, from Screening through EoS; * A history of alcohol or drug abuse in the past 12 months, or current declared alcohol consumption \>4 standard drinks per day for 7 days per week (one standard drink is equivalent to 285 mL of full-strength beer, 100 mL of wine or 30 mL of spirits); * Use of any prescription medication (with the exception of contraceptives, hormone replacement therapy, or stable doses of medication required for the management of stable, chronic underlying illnesses) within seven days prior to Day 1; * Use of any investigational drug or device within 30 days, or five half-lives of the drug (whichever is longer) before Day 1, or planned use of another investigational drug or device at any time during the study; * An employee, or a first-degree family member of an employee, of the Sponsor, Contract Research Organization conducting this study, or study site involved in this study **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Morayfield **Contacts:** ***Contact 1:*** - **Email:** leelasena@usc.edu.au - **Name:** Indika Leelasena - **Phone:** +61 07 5456 - 3965 - **Role:** CONTACT **Country:** Australia **Facility:** University of Sunshine Coast Clinical Trials **State:** Queensland **Zip:** 4506 **Location 2:** **City:** Sippy Downs **Contacts:** ***Contact 1:*** - **Email:** swallac1@usc.edu.au - **Name:** Stephanie Wallace - **Phone:** +61 07 5456 - 3965 - **Role:** CONTACT **Country:** Australia **Facility:** University of Sunshine Coast Clinical Trials **State:** Queensland **Zip:** 4556 **Location 3:** **City:** South Brisbane **Contacts:** ***Contact 1:*** - **Email:** nsahai@usc.edu.au - **Name:** Nischal Sahai - **Phone:** +61 07 5409 - 8630 - **Role:** CONTACT **Country:** Australia **Facility:** University of Sunshine Coast Clinical Trials **State:** Queensland **Zip:** 4101 **Location 4:** **City:** East Melbourne **Contacts:** ***Contact 1:*** - **Email:** jmccarthy@dohertyclinicaltrials.com - **Name:** James McCarthy - **Phone:** +61 03 8344-0927 - **Role:** CONTACT **Country:** Australia **Facility:** Doherty Clinical Trials Ltd **State:** Victoria **Zip:** 3002 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000009976 - Term: Orthomyxoviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10295 - Name: Influenza, Human - Relevance: HIGH - As Found: Influenza - ID: M8707 - Name: Influenza in Birds - Relevance: HIGH - As Found: H7N9 - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M12902 - Name: Orthomyxoviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007251 - Term: Influenza, Human - ID: D000005585 - Term: Influenza in Birds ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: HIGH - As Found: Other - ID: M35911 - Name: MF59 oil emulsion - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014612 - Term: Vaccines ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417840 **Brief Title:** To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes **Official Title:** To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes: A Randomized, Double Blinded, Placebo-controlled Parallel Arm Trial #### Organization Study ID Info **ID:** 1.4/FCDOC/EC/HAO/2024-25 #### Organization **Class:** INDUSTRY **Full Name:** Brightseed ### Status Module #### Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-22 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Brightseed #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables. The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile. ### Conditions Module **Conditions:** - PreDiabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Dietary Supplement: Placebo Control **Label:** Placebo Control **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Intervention Names:** - Dietary Supplement: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) **Label:** N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) **Description:** N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (\>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, are manufactured under food GMPs and are of suitable quality for use in food, dietary supplements, and specialty nutrition products. **Name:** N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo Control **Description:** Placebo Control **Name:** Placebo Control **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Blood Glucose Concentration mg/dL **Measure:** Fasting Blood Glucose **Time Frame:** 0, and 28 days #### Secondary Outcomes **Description:** Blood Insulin Concentration mcIU/mL **Measure:** Fasting Blood Insulin **Time Frame:** 0, and 28 days **Description:** Percent (%) blood HbA1c level **Measure:** HbA1c **Time Frame:** 0, and 28 days **Description:** Continuous Blood Glucose Monitoring mg/dL **Measure:** Continuous Glucose Monitoring **Time Frame:** 0, and 28 days **Description:** Total blood cholesterol mg/dL **Measure:** Total Cholesterol **Time Frame:** 0, and 28 days **Description:** Blood Low-density lipoprotein (LDL) cholesterol mg/dL **Measure:** Low-density lipoprotein (LDL) cholesterol **Time Frame:** 0, and 28 days **Description:** Blood High-density lipoprotein (HDL) cholesterol mg/dL **Measure:** High-density lipoprotein (HDL) cholesterol **Time Frame:** 0, and 28 days **Description:** Blood Triglycerides mg/dL **Measure:** Triglycerides **Time Frame:** 0, and 28 days **Description:** kg of Body Weight **Measure:** Weight **Time Frame:** 0, and 28 days **Description:** Height in meters (m) **Measure:** Height **Time Frame:** 0, and 28 days **Description:** Body mass index (BMI) measured via weight in kilograms divided by the square of height in meters. **Measure:** Body Mass Index (BMI) **Time Frame:** 0, and 28 days **Description:** Waist Circumference in cm **Measure:** Waist Circumference **Time Frame:** 0, and 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Fasting Blood Glucose between 100-125 mg/dL; 2. and BMI range 25-30 kg/m2; 3. and waist circumference ≥80cm for women and ≥90cm for men; Exclusion Criteria: 1. Weight loss or gain ≥4.5 kg within 90 days of visit 1. 2. Use of weight loss medications within 90 days of visit 1. 3. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes. 4. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1. 5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator. 6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. 7. Current medical diagnosis of type 1 or type 2 diabetes mellitus. 8. HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1. 9. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable). 10. Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1. 11. Is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document. 12. Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk. 13. Excessive alcohol consumption (\> 2 Drinks, 60 ml of Whisky Per Day). **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Pre-diabetes - ID: M20295 - Name: Glucose Intolerance - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011236 - Term: Prediabetic State ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417827 **Brief Title:** Artificial Intelligence for Mental Health Diagnoses and Treatment Plans: A Protocol for Actors and Patients **Official Title:** Artificial Intelligence for Mental Health Diagnoses and Treatment Plans: A Protocol for Actors and Patients #### Organization Study ID Info **ID:** SHEBA-23-0356-MW-CTIL #### Organization **Class:** OTHER_GOV **Full Name:** Sheba Medical Center ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-12 **Type:** ACTUAL **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-10 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Sheba Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Artificial intelligence (AI) is becoming prevalent in modern medicine and psychiatry. AI is based on a wide variety of computer algorithms classified under machine learning (ML). The purpose of the present study is to evaluate the potential for mental health diagnosis using AI. In the first part of the study, the AI will conduct an interview with standardized patients \[SP\] (actors) presenting a psychiatric illness. The AI will present a differential diagnosis and treatment plan. Immediately afterward, the actors will be interviewed by a board-certified psychiatrist, who will also give a differential diagnosis and a treatment plan. The results of the AI and psychiatrist will be compared. In the second part of the study, AI will examine patients coming for consultation by a psychiatrist in the inpatient units, outpatient units, or in the emergency room (ER) at Sheba Medical center. The AI results will be compered to the psychiatrist diagnosis. **Detailed Description:** Procedure: In the firs part of the study, The AI will conduct an interview with standardized SP patients (actors) presenting a psychiatric illness. The actors will be trained in one of 5 scenarios: depression, anxiety, PTSD with cannabis abuse, psychosis, and control patients with no diagnosis. Each scenario will have 2 levels of severity. The actors will present demographic and medical backgrounds, symptoms and signs, including disorders of thought and affect. based on the interview, the AI will present a differential diagnosis and treatment plan. Immediately afterward, the actors will be interviewed by a board-certified psychiatrist, who will also give a differential diagnosis and a treatment plan. The results of the AI and psychiatrist will be compared. In the second part of the study, AI will examine patients patients treated in the Division of Psychiatry, patients who applied for treatment in the psychiatric clinic but are not yet treated there, and patients treated in the psychiatric emergency room (ER) in Sheba Medical center. In additional, a recruitment ad will be published in the media and on social networks, to include patients who will come in specifically to participate in the study. The patient will give informed consent and will be interviewed by AI. The interview will be done either digitally or will use voice-to-text and text-to-voice technology that will allow the patient to speak with the computer instead of typing questions into the computer. Future studies, not included in the current proposal, will use voice analysis, face recognition, and computerized emotion recognition as part of AI. Participants: * Actors SPs (n=10), each time employed by "MSR"- the Israeli Center for Medical Simulation, trained to simulate symptoms of psychiatric illnesses. * Board-certified Psychiatrists from the Drora and Pinchas Zachai Division of Psychiatry in the Sheba Medical Center. * Patients (n=150) examined in the psychiatric division and emergency room (ER) of Sheba. Or patient that recruited from the media. * Control group (n=50) Patients who came to the ER at the hospital due to physical problems, and no psychiatric history. They will be offered while waiting for the doctor to participate in the study and be examined by the AI and a psychiatrist. Outcome: The primary outcome of the study will be a comparison of the interviews, differential diagnoses, and recommendations for treatment assigned by the AI with those assigned by the board-certified psychiatrist. The rates of agreement will be the outcome of interest. ### Conditions Module **Conditions:** - Mental Health Diagnosis **Keywords:** - Artificial intelligence - Mental health diagnosis - Medical technology ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The actors (n=10) will be trained in one of 5 scenarios: depression, anxiety, PTSD with cannabis abuse, psychosis, and control patients with no diagnosis. Each scenario will have 2 levels of severity. The actors will present demographic and medical backgrounds, symptoms and signs, including disorders of thought and affect. based on the interview, the AI (LIV) will present a differential diagnosis and treatment plan. Immediately afterward, the actors will be interviewed by a board-certified psychiatrist, who will also give a differential diagnosis and a treatment plan. **Intervention Names:** - Diagnostic Test: SP patients-actors **Label:** SP patients-actors **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The patients (n=150) will be recruited for the study from patients who applied to the psychiatric clinic in Sheba, new patients, old patients and patients on the waiting list. In addition, patients from the various psychiatric departments and the psychiatric and general ER at the Sheba Medical Center - Tel Hashomer. In addition, a recruitment ad will be published on social networks. **Intervention Names:** - Diagnostic Test: Patients **Label:** Patients **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Control group (n=50) Patients who came to the ER at the hospital due to physical complaints, and no psychiatric history. They will be offered to participate in the study and be examined by the AI (LIV) and a psychiatrist while waiting for the ER physician. In addition, a recruitment ad will be published on social networks for patient with no psychiatric conditions. **Intervention Names:** - Diagnostic Test: Control group- patients **Label:** Control group- patients **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - SP patients-actors **Description:** SP Actors employed by MesserMSR, the Israeli Center for Medical Simulation, trained to simulate symptoms of psychiatric illnesses. **Name:** SP patients-actors **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Patients **Description:** Patients (n=150) examined in the psychiatric division and emergency room (ER) of Sheba Medical center. Or people who applied following an advertisement on social networks. **Name:** Patients **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Control group- patients **Description:** Control group (n=50) Patients who came to the ER at the hospital due to physical complaints, and no psychiatric history. **Name:** Control group- patients **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The accuracy of diagnosis of the AI and of the psychiatrist will be compared to the gold standard as defined by the training that the actors received. This will be quantified according to if the AI or psychiatrist diagnosis was categorized in the appropriate group: Anxiety disorders, Depressive disorders, Schizophrenia spectrum and other psychotic disorders and Trauma and stressor related disorders **Measure:** Percent agreement of the diagnosis that provide by the psychiatrist and the AI - SPs (actors) part **Time Frame:** 3 month **Description:** The psychiatrist and the AI will both interview the patient and will present a diagnosis. The psychiatrist will be considered as the gold standard, and the AI diagnosis will be compared to those given by the psychiatrist. This will be quantified according to if the AI defines the diagnosis in its appropriate group: Anxiety disorders, Depressive disorders, Schizophrenia spectrum and other psychotic disorders and Trauma and stressor related disorders. **Measure:** Percent agreement of the diagnosis that provide by the psychiatrist and the AI- Patients part **Time Frame:** 5 month #### Secondary Outcomes **Description:** 1. For biological treatment divided into groups: anti-depressive medication, Electroconvulsive therapy \[ECT\]/ketamine, anti-psychotics, mood stabilizers and anxiolytics. 2. Psychological treatments: Cognitive behavioral therapy \[CBT\], dynamic and supportive psychotherapy. The accuracy of the recommended course of treatment given by the AI and by the psychiatrist will be compared to the gold standard as defined by the training that the SPs received. **Measure:** Percent agreement of the recommendations provided by the AI and the psychiatrists- SPs (actors) part **Time Frame:** 3 month **Description:** 1. For biological treatment divided into groups: anti-depressive medication, ECT/ketamine, anti-psychotics, mood stabilizers and anxiolytics. 2. Psychological treatments: CBT, dynamic and supportive psychotherapy. The psychiatrist will be considered as the gold standard, and the AI recommendations of treatment will be compared to those given by the psychiatrist. **Measure:** Percent agreement of the recommendations provided by the AI and by the psychiatrists - Patients part **Time Frame:** 5 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: For the SPs part: * Actors SPs employed by "MSR"- the Israeli Center for Medical Simulation, trained to simulate symptoms of psychiatric illnesses. * Over the age of 18 * Sign an informed consent For the patient part: * Patients arriving for intake at the psychiatric clinic, the various psychiatric departments and the ER at the Sheba Medical Center. * Patients over the age of 18 * Sign an informed consent Exclusion Criteria: * Patients participating in another study * Patients under hospitalization order or court order **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Mark.Weiser@sheba.health.gov.il **Name:** Mark Weiser, M.D **Phone:** +972526666570 **Role:** CONTACT **Contact 2:** **Email:** Hadasa.Afgin@sheba.health.gov.il **Name:** Hadasa Afgin, B.A **Phone:** +972552709699 **Role:** CONTACT #### Locations **Location 1:** **City:** Ramat Gan **Contacts:** ***Contact 1:*** - **Email:** mweiser@netvision.net.il - **Name:** Mark Weiser, MD - **Phone:** +972-3-5303773 - **Role:** CONTACT ***Contact 2:*** - **Email:** Hadasa.Afgin@sheba.health.gov.il - **Name:** Hadasa Afgin, B.A - **Phone:** +972552709699 - **Role:** CONTACT ***Contact 3:*** - **Name:** Mark Weiser, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Israel **Facility:** Sheba Medical Center, Psychiatry Department **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Sheba Medical Center **Name:** Mark Weiser, M.D **Role:** PRINCIPAL_INVESTIGATOR ## Document Section ### Large Document Module #### Large Docs - Date: 2024-03-27 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 1061899 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-05T06:58 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Meshes - ID: D000004194 - Term: Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417814 **Acronym:** TROPION-Lung15 **Brief Title:** A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer **Official Title:** A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15) #### Organization Study ID Info **ID:** D516KC00001 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2028-02-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-12 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Daiichi Sankyo #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS). **Detailed Description:** This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in participants with epidermal growth factor receptor gene mutation (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on prior osimertinib treatment. Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups: 1. Dato-DXd + osimertinib combination therapy 2. Dato-DXd monotherapy 3. Platinum-based doublet chemotherapy Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator, unacceptable toxicity, or other discontinuation criterion is met. After study intervention discontinuation, all participants will undergo an end of treatment (EoT) visit within 35 days of discontinuation and will be followed up for safety assessments 28 (+ 7) days after their last dose of study intervention. ### Conditions Module **Conditions:** - Metastatic Non-small Cell Lung Cancer **Keywords:** - Epidermal growth factor receptor gene mutation - Standard of Care - Locally, advanced carcinoma - Metastatic carcinoma - Non-small cell lung cancer - Dato-dxd - Datopotamab deruxtecan - Osimertinib - Tagrisso - Pemetrexed - Carboplatin - Cisplatin ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 630 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive Dato-DXd 6 mg/kg as IV infusion Q3W on Day 1 of every 21-day cycle, and osimertinib 80 milligrams (mg) once daily (QD) orally, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met. **Intervention Names:** - Drug: Dato-DXd - Drug: Osimertinib **Label:** Group 1: Dato-DXd + Osimertinib Combination Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive Dato-DXd 6 milligrams per kilogram (mg/kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21-day cycle, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met. **Intervention Names:** - Drug: Dato-DXd **Label:** Group 2: Dato-DXd Monotherapy **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive pemetrexed 500 milligrams per meter square (mg/m2) in combination with carboplatin (AUC5) or cisplatin 75 mg/m2 as IV infusion Q3W for 4 cycles followed by pemetrexed maintenance 500 mg/m2 as IV infusion Q3W, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or another discontinuation criterion is met. **Intervention Names:** - Drug: Pemetrexed - Drug: Carboplatin - Drug: Cisplatin **Label:** Group 3: Platinum-based Doublet Chemotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1: Dato-DXd + Osimertinib Combination Therapy - Group 2: Dato-DXd Monotherapy **Description:** Dato-DXd will be administered as IV infusion. **Name:** Dato-DXd **Other Names:** - DS-1062a **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group 1: Dato-DXd + Osimertinib Combination Therapy **Description:** Osimertinib will be administered orally. **Name:** Osimertinib **Other Names:** - Tagrisso - AZD9291 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Group 3: Platinum-based Doublet Chemotherapy **Description:** Pemetrexed will be administered as IV infusion. **Name:** Pemetrexed **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Group 3: Platinum-based Doublet Chemotherapy **Description:** Carboplatin will be administered as IV infusion. **Name:** Carboplatin **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Group 3: Platinum-based Doublet Chemotherapy **Description:** Cisplatin will be administered as IV infusion. **Name:** Cisplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression. **Measure:** Progression free Survival (PFS) **Time Frame:** Up to 2.5 years #### Secondary Outcomes **Description:** OS is defined as time from randomization until the date of death due to any cause. **Measure:** Overall Survival (OS) **Time Frame:** Up to 3.5 years **Description:** CNS PFS is defined as the time from randomization to BICR confirmed progression in the CNS or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinically progresses prior to BICR confirmed CNS modified RECIST v1.1 progression. **Measure:** Central Nervous System Progression-free Survival (CNS PFS) **Time Frame:** Up to 2.5 years **Description:** ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by BICR per RECIST v1.1. **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to 2.5 years **Description:** DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, as assessed by BICR or death due to any cause. **Measure:** Duration of Response (DoR) **Time Frame:** Up to 2.5 years **Description:** PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial investigator assessed progression), after first subsequent therapy, or death. **Measure:** Progression-free Survival-2 (PFS-2) **Time Frame:** Up to 3.5 years **Description:** ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, using CNS modified RECIST v1.1. **Measure:** Objective Response Rate (ORR) Using CNS Modified RECIST v1.1 **Time Frame:** Up to 2.5 years **Description:** DoR is defined as the time from the date of first documented response until date of documented progression or death due to any cause using CNS modified RECIST v1.1. **Measure:** Duration of Response (DoR) Using CNS Modified RECIST v1.1 **Time Frame:** Up to 2.5 years **Description:** Time to deterioration (in pulmonary symptoms \[dyspnea, cough, and chest pain\]) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold. **Measure:** Time to Deterioration in Pulmonary Symptoms **Time Frame:** Up to 3.5 years **Description:** Time to deterioration in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 8c will be evaluated. Time to deterioration (in physical functionating) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold. **Measure:** Time to Deterioration in Physical Functioning **Time Frame:** Up to 3.5 years **Description:** Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172 will be reported. Time to deterioration (in GHS/QoL) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold. **Measure:** Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) **Time Frame:** Up to 3.5 years **Description:** Concentration of Dato-DXd, total anti-TROP2 antibody and DXd in plasma. **Measure:** Pharmacokinetics (PK) of Dato-DXd **Time Frame:** Up to 3.5 years **Description:** Presence of antidrug antibody (ADAs) for Dato-DXd (confirmatory results: positive or negative, titers). **Measure:** Immunogenicity of Dato-DXd **Time Frame:** Up to 3.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Histologically or cytologically confirmed non-squamous NSCLC. * Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M). * Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting. * Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI). * At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline. * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow reserve and organ function within 7 days before randomization. Exclusion Criteria: * Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention. * Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease. * Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage. * History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses. * Unstable spinal cord compression and/or unstable brain metastases. * Participants with symptomatic brain metastases (including leptomeningeal involvement). * Clinically significant corneal disease. * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. * Has known human immunodeficiency virus (HIV) infection that is not well controlled. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** information.center@astrazeneca.com **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure **URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000005493 - Term: Folic Acid Antagonists - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors - ID: D000092004 - Term: Tyrosine Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M145673 - Name: Osimertinib - Relevance: HIGH - As Found: Angioplasty - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: Strategies - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8619 - Name: Folic Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016190 - Term: Carboplatin - ID: D000068437 - Term: Pemetrexed - ID: C000596361 - Term: Osimertinib ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417801 **Acronym:** Pangeia-2 **Brief Title:** Prevalence of Emerging Treatment-induced Mutations in Metastatic ER-positive Breast Cancer. **Official Title:** PANGEIA-2: Prevalence of Emerging Treatment-induced Mutations in metastaticER Positive Breast Cancer. #### Organization Study ID Info **ID:** D3612L00003 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** Observational study on prevalence of emerging ESR1 mutations in liquid biopsy in two cohorts of patients with breast cancer (with and without prior therapies in metastatic setting) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling. **Detailed Description:** This is a prospective observational biomarker cohort study. Biomarkers: GS Focus Liquid Breast (liquid biopsy sequencing assay, covers mutations in ESR1, PIK3CA, AKT1, PTEN, ERBB2, BRCA1, BRCA2, PALB2) and parallel GS Focus Breast (tissue sequencing assay performed in baseline tissue biopsy from primary tumor or metastatic lesion not exposed to any systemic therapy, cover same gene panel). Biomarker assessment will be carried out by NGS methodology in both liquid biopsy and baseline tissue biopsy. Both strategies consider a custom panel covering PIK3CA, AKT1, PTEN, ESR1, BRCA1, BRCA2, PALB2, ERBB2 genes. NGS panels were internally validated and presented sensitivity, specificity and accuracy of 100,00% with a limit of detection of 0,5% VAF for liquid biopsy panel and sensitivity, specificity and accuracy of 100,00% with a limit of detection of 5% VAF for tissue panel. Basically, DNA is extracted from tissue samples (FFPE) and plasma using QIASymphony extractions kits. An input of 10 and 100 ng is required for liquid biopsy and tissue respectively. NGS libraries is prepared using QIAseq Targeted DNA Custom Panel (QIAGEN). Sequencing is performed in Illumina platform (NextSeq for liquid biopsy and MiSeq for tissue samples) in paired-end 2x 150 cycles. ### Conditions Module **Conditions:** - Metastatic Breast Cancer **Keywords:** - Breast Cancer; ER-positive; ESR-1 mutation ### Design Module #### Bio Spec **Description:** Tissue. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Locally-advanced/metastatic HR+/HER2- breast cancer, either treatment naive or previously exposed to adjuvant therapies, no prior palliative therapy, candidates to receive first-line hormone therapy, primary tumor tissue available. **Label:** Cohort 1 (N=30) #### Arm Group 2 **Description:** Locally-advanced/metastatic HR+/HER2- breast cancer, progression during hormone therapy plus CDK inhibitor; primary tumor tissue available. **Label:** Cohot 2 (N=40) ### Outcomes Module #### Primary Outcomes **Description:** To define the prevalence of emerging ESR1 mutations in liquid biopsy in two cohorts of BC patients (with and without prior therapies in metastatic setting) and compare with patient's baseline ESR1 mutation status as defined by tissue profiling. **Measure:** Prevalence of emerging ESR1 mutations **Time Frame:** Aug, 2024 #### Secondary Outcomes **Description:** To define the prevalence of PIK3CA, AKT1, PTEN, BRCA1, BRCA2, PALB2, ERBB2 mutations in liquid biopsy and compare with patient's baseline status. **Measure:** Define the prevalence of PIK3CA, AKT1, PTEN, BRCA1, BRCA2, PALB2, ERBB2 mutations. **Time Frame:** Aug, 2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Cohort 1: * BC patients, male and female, 18 years old and older, pre or post menopausal, with HR+ (ER and/or PR positive), Her-2 negative (confirmed centrally) locally advanced irresectable and/or metastatic disease * Confirmation of HR and Her-2 status may be performed in the primary tumor or in the metastatic lesion (patients with discordant results may be included) * Patients must be candidates to CDK4/6i therapy in combination with endocrine therapy in the first line setting (with or without ovarian suppression) * Patients may have received one previous line of chemotherapy in the metastatic setting, but no endocrine therapy in the metastatic setting is allowed * Patients may have received chemotherapy in the neo/adjuvant setting * Patients may have received endocrine therapy (with or without ovarian suppression) in the neo/adjuvant setting * Patients may have received a CDK4/6i in the adjuvant setting, provided they are still candidates for CDK4/6i therapy in the metastatic setting * Patients must be able to undergo a liquid biopsy procedure before starting their first line treatment * All patients must fill and sign an informed consent form. Cohort 2: * BC patients, male and felame, 18 years old and older, pre or post menopausal, with HR+ (ER and/or PR positive), Her-2 negative (confirmed centrally) locally advanced irresectable and/or metastatic disease who have progressed on a CDK4/6i in combination with endocrine therapy (with or without ovarian suppression) in the first or second line setting * All other non-conflicting inclusion criteria for cohort 1 apply. Exclusion Criteria: Patients with HR+ (ER and/or PR positive) and Her-2 negative disease NOT confirmed centrally * Patients with NO radiologic and/or pathologic confirmed locally irresectable and/or metastatic breast cancer * Patients who are NOT candidates for further systemic treatment after diagnosis of metastatic disease or disease progression * Patients who have already started a CDK4/6i in combination with endocrine therapy (with or without ovarian suppression) for metastatic disease in the first line setting (for cohort 1); and patients who have already started a new line of treatment for metastatic disease after disease progression on a CDK4/6i in combination with endocrine therapy (with or without ovarian suppression)(for cohort 2) * Patients who are NOT able to undergo a liquid biopsy procedure * Patients who are NOT able to provide informed consent. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Two parallel cohorts: 1. locally-advanced/metastatic HR+/HER2- breast cancer, either treatment naive or previously exposed to adjuvant therapies, no prior palliative therapy, candidates to receive first-line hormone therapy, primary tumor tissue available; 2. locally-advanced/metastatic HR+/HER2- breast cancer, progression during hormone therapy plus CDK inhibitor; primary tumor tissue available. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** information.center@astrazeneca.com **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** São Paulo **Country:** Brazil **Facility:** Oncoclínicas **Zip:** 04513-020 #### Overall Officials **Official 1:** **Affiliation:** Oncoclínicas **Name:** Rodrigo Dienstmann **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure **URL:** https://vivli.org/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417788 **Brief Title:** Dynamic Guided Implant Surgery VS Static Guided Surgery. **Official Title:** Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial. #### Organization Study ID Info **ID:** CIR-ECL-2018-09 #### Organization **Class:** OTHER **Full Name:** Universitat Internacional de Catalunya ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitat Internacional de Catalunya #### Responsible Party **Investigator Affiliation:** Universitat Internacional de Catalunya **Investigator Full Name:** Jordi Marquès Guasch **Investigator Title:** Jordi marques Guasch **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants. Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide. Participants will: * Receive implant treatment that will be placed by a dynamic or static pilot drill guided system. * Receive post-operative radiological exam for comparative (on the same appointment). ### Conditions Module **Conditions:** - Partially Edentulous Patients - Bone Crest of at Least 10 mm Length and 6 mm Width - Patients of at Least 18 Years Old ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients who need dental implants and fulfill the inclusion criteria will be randomly allocated to test group (dynamic guided system) or control group (static stereolithographic pilot drill guided system) ##### Masking Info **Masking:** SINGLE **Masking Description:** Due to the nature of the treatment, it is impossible to mask the treatment from the participant and the care provider. However, the data for analysis will be masked to the investigator responsible for assessing the accuracy of each implant placement system. **Who Masked:** - INVESTIGATOR **Primary Purpose:** DEVICE_FEASIBILITY #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** in this arm, the position and angulation of the implant in the patient's mouth will be guided by a dynamic guided system. **Intervention Names:** - Device: Dental implant placement **Label:** Test group or Dynamic guided group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In this arm, the position and angulation of the implant in the patient's mouth will be guided by a stereolitographic pilot drill guide. **Intervention Names:** - Procedure: Static guided implant placement **Label:** Control group or Static guided group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Test group or Dynamic guided group **Description:** Dental implant placement guided by Navident® (ClaroNav Inc., Toronto, Canada) **Name:** Dental implant placement **Other Names:** - dynamic guided implant placement **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control group or Static guided group **Description:** Dental implant placement guided by a stereolithographic pilot drill guide. **Name:** Static guided implant placement **Other Names:** - control group **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Implant placement accuracy compared with the implant planning. Expressed in mm. **Measure:** Implant placement accuracy at the implant platform level **Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes. **Description:** Implant placement accuracy compared with the implant planning. Expressed in mm. **Measure:** Implant placement accuracy at the implant apex level **Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes. **Description:** Implant placement accuracy compared with the implant planning. Expressed in degrees. **Measure:** Implant placement accuracy at an angular evel **Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes. **Description:** Implant placement accuracy compared with the implant planning. Expressed in mm. **Measure:** Implant placement accuracy at the vertical plane. **Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years or older, * ASA type 1 or 2, * Full mouth plaque scores up to 25% (O'LEARY TJ. The plaque control record 1972;43:38), -Partially edentulous with at least one missing tooth * Having a bone crest of at least 10mm in length and 6mm in width. Exclusion Criteria: * medical conditions contraindicating surgery, * untreated periodontal disease or caries * the need for bone augmentation * acute local infections * history of head/neck radiation. **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sant Cugat Del Vallès **Contacts:** ***Contact 1:*** - **Email:** jmarques@uic.es - **Name:** Marques Guasch - **Phone:** +447453802813 - **Role:** CONTACT ***Contact 2:*** - **Email:** jgargallo@uic.es - **Name:** Gargallo Albiol - **Phone:** +34637434270 - **Role:** CONTACT **Country:** Spain **Facility:** Universitat Internacional de Catalunya **State:** Barcelona **Status:** RECRUITING **Zip:** 08195 ### IPD Sharing Statement Module **Description:** Plan to publish the IPD. **Info Types:** - SAP - CSR **IPD Sharing:** YES **Time Frame:** when the data is available during the publication process ### References Module #### References **Citation:** Somogyi-Ganss E, Holmes HI, Jokstad A. Accuracy of a novel prototype dynamic computer-assisted surgery system. Clin Oral Implants Res. 2015 Aug;26(8):882-890. doi: 10.1111/clr.12414. Epub 2014 May 19. **PMID:** 24837492 **Citation:** Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x. **PMID:** 23062136 **Citation:** Hultin M, Svensson KG, Trulsson M. Clinical advantages of computer-guided implant placement: a systematic review. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:124-35. doi: 10.1111/j.1600-0501.2012.02545.x. **PMID:** 23062137 **Citation:** Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):92-99. doi: 10.11607/jomi.5004. Epub 2016 Sep 19. **PMID:** 27643585 **Citation:** D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175. **PMID:** 28000275 **Citation:** Sun TM, Lan TH, Pan CY, Lee HE. Dental implant navigation system guide the surgery future. Kaohsiung J Med Sci. 2018 Jan;34(1):56-64. doi: 10.1016/j.kjms.2017.08.011. Epub 2017 Dec 8. **PMID:** 29310817 **Citation:** Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30. **PMID:** 26452429 **Citation:** O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available. **PMID:** 4500182 **Citation:** Doyle DJ, Hendrix JM, Garmon EH. American Society of Anesthesiologists Classification. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/ **PMID:** 28722969 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000014076 - Term: Tooth Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12026 - Name: Mouth, Edentulous - Relevance: HIGH - As Found: Edentulous - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009066 - Term: Mouth, Edentulous ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417775 **Brief Title:** Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine **Official Title:** A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension #### Organization Study ID Info **ID:** M23-714 #### Organization **Class:** INDUSTRY **Full Name:** AbbVie ### Status Module #### Completion Date **Date:** 2027-09-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-09-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AbbVie #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed. Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico. Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. ### Conditions Module **Conditions:** - Migraine **Keywords:** - Migraine - Menstrual Migraine - Ubrogepant - UBRELVY ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 450 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive ubrogepant during the double-blind period. **Intervention Names:** - Drug: Ubrogepant **Label:** Double-Blind Period: Ubrogepant **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive placebo during the double-blind period. **Intervention Names:** - Drug: Placebo for Ubrogepant **Label:** Double-Blind Period: Placebo for Ubrogepant **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period. **Intervention Names:** - Drug: Ubrogepant **Label:** Open-Label Extension Period: Ubrogepant **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Double-Blind Period: Ubrogepant - Open-Label Extension Period: Ubrogepant **Description:** Oral Tablets **Name:** Ubrogepant **Other Names:** - UBRELVY **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Double-Blind Period: Placebo for Ubrogepant **Description:** Oral Tablets **Name:** Placebo for Ubrogepant **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary. **Measure:** Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Period (PMP) **Time Frame:** Up to approximately 16 Weeks **Description:** An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. **Measure:** Number of Participants With Adverse Events (AEs) **Time Frame:** Up to approximately 68 Weeks #### Secondary Outcomes **Description:** A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified. **Measure:** Change From Baseline in Number of Headache Days Occurring During Perimenstrual Period (PMP) **Time Frame:** Up to approximately 16 Weeks **Description:** A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified. **Measure:** Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Period (PMP) **Time Frame:** Up to approximately 16 Weeks **Description:** A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary. **Measure:** Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Period (PMP) **Time Frame:** Up to approximately 16 Weeks **Description:** Functional Disability Scale (FDS) is a single item used to measure the participant's level of functional disability. Participants will be asked to rate the performance of daily activities in the past 24 hours using 4 response options ranging from "No disability, able to function normally" to "Severely impaired, cannot do all or most things, bed rest may be necessary." **Measure:** Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days **Time Frame:** Up to approximately 16 Weeks **Description:** An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine. **Measure:** Change From Baseline in Acute Medication Use Days During the Perimenstrual Period (PMP) **Time Frame:** Up to approximately 16 Weeks **Description:** A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary. **Measure:** Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Period (PMP) **Time Frame:** Up to approximately 16 Weeks **Description:** Activity Level is a single-item used to assess overall limitations with performing daily activities over 24 hours with a 5-level response ranging from "Not at all limited" to "Unable to do daily activities." **Measure:** Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days **Time Frame:** Up to approximately 16 Weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * At least a 1-year history of migraine with or without aura. * Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period. * Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis. * Have regular menstrual cycles of between 21-35 days in length. * Less than 15 headache days per month. * At least 70% compliance completing screening period and at least 4 out of 5 days of ediary data in each of 3 screening PMP. Exclusion Criteria: * History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine. * Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion. * Clinically significant abnormalities in the physical examination as determined by the investigator. * Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion. * Acute headache medication overuse. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** abbvieclinicaltrials@abbvie.com **Name:** ABBVIE CALL CENTER **Phone:** 844-663-3742 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** AbbVie **Name:** ABBVIE INC. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ **Description:** AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/ **URL:** https://vivli.org/ourmember/abbvie/ ### References Module #### See Also Links **Label:** Related Info **URL:** https://www.abbvieclinicaltrials.com/study/?id=M23-714 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417762 **Brief Title:** Dime La VerDAD: Verify, Debunk, and Disseminate **Official Title:** Dime La VerDAD: Verify, Debunk, and Disseminate #### Organization Study ID Info **ID:** 202306135 #### Organization **Class:** OTHER **Full Name:** University of Iowa #### Secondary ID Infos **ID:** R01MD018730 **Link:** https://reporter.nih.gov/quickSearch/R01MD018730 **Type:** NIH ### Status Module #### Completion Date **Date:** 2028-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Chicago **Class:** OTHER **Name:** University of Michigan **Class:** OTHER **Name:** Rush University Medical Center **Class:** OTHER **Name:** Bedford Research Corporation, Inc. **Class:** UNKNOWN **Name:** Tanoma Consulting **Class:** NIH **Name:** National Institute on Minority Health and Health Disparities (NIMHD) #### Lead Sponsor **Class:** OTHER **Name:** Marina Del Rios #### Responsible Party **Investigator Affiliation:** University of Iowa **Investigator Full Name:** Marina Del Rios **Investigator Title:** MD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Dime La VerDAD is an innovative social media capacity-building program that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. The core of the implementation strategy consists of augmenting training and self-efficacy for natural community champions, "promotores de salud" from the Hispanic community as trusted messengers to debunk vaccination misinformation. Our study will leverage existing community relationships in Chicago and a first of its kind misinformation curriculum to debunk misinformation in communities served by participating promotores de salud. Dime La VerDAD (Verify, Debunk, and Disseminate) is an innovative social media capacity-building program based on theoretical frameworks related to health communication that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. This mixed methods study will use a rigorous stepped wedge design to 1) deliver a scalable program of science communicators using an adapted curriculum grounded in infodemiology, 2) evaluate how debunking misinformation is perceived on social media, and 3) discern how use of personal narratives to enhance science communication can lead to changes in opinions and behavior (vaccination rates) about COVID and influenza vaccines among Chicago's predominantly Hispanic communities. **Detailed Description:** Social media has accelerated the spread of vaccine misinformation leading to decreased immunization rates and increased preventable deaths in the US and globally. The health impact of misinformation is particularly critical to understand and address when considering the lives of minoritized racial and ethnic groups who are often the target of misinformation campaigns or who may not have easy access to culturally relevant and language-concordant reputable sources. Although access to vaccines remains a significant barrier, vaccine safety confidence is a significant predictor of influenza and COVID vaccination in Hispanic adults. Yet, little is known about how misinformation narratives emerge specifically in relation to Hispanic communities, how they are disseminated, and how they ultimately affect people's decision to get vaccinated. Social media posts that include personal narratives are more effective at communicating reliable health recommendations, especially those that come from a trusted peer. Therefore, communication strategies that leverage community and interpersonal relationships can prove extremely effective at debunking misinformation about vaccines. Promotores de salud are trusted community members who serve as links between health/social services and a community to improve access to health services and quality of service delivery. Promotores can diffuse and address misinformation in their communities and can be essential to debunk myths, increase trust, and improve health outcomes; they have been at the forefront of addressing disparities in COVID testing and vaccine uptake. Promotores de salud are uniquely positioned as trusted messengers to debunk vaccine misinformation through strategic use of social media and infodemiology principles. Dime La VerDAD (Verify, Debunk, and Disseminate) is an innovative social media capacity-building program based on theoretical frameworks related to health communication that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. To date, there has been no evaluation of whether training promotores de salud to identify and debunk misinformation on social media can improve uptake of accurate scientific information. Dime La VerDAD (Verify, Debunk, and Disseminate) will evaluate how debunking misinformation is perceived on social media, and discern how these can lead to changes in opinions and behavior. The proposed work will use a rigorous stepped wedge design to: 1. Identify and evaluate promotores' use of social media to disseminate vaccine information in the Hispanic community. We will conduct focus groups and key informant interviews with promotores de salud recruited through Illinois Unidos partnerships to verify their peers' information sources about vaccines, vaccine-related misbeliefs, perceptions of vaccine safety, and personal plans to get vaccinated. 2. Engage Promotores de Salud as community champions in an adapted science communication curriculum so they can learn to identify and debunk misinformation. Participants will learn how to make their own infographics to debunk misinformation as well as incorporate their personal narratives into posts. Promotores will also recruit members of their social media circles to participate as subjects to test the effectiveness of their posts. 3. Test effectiveness of personal-narrative posts versus resharing of standardized debunking content shared by promotores de salud to their social networks. Using a stepped-wedge approach, members of promotores' social media circles will be surveyed to measure the reach and effectiveness of various types of social media posts. We hypothesize that community champions will be viewed as trusted messengers within their social circles and that debunking posts with personal narrative using principles from the training program will be disseminated, viewed, and recalled more often as compared to a standard post without personal narrative and lead to increased COVID and influenza vaccination uptake. This work will test a model of community engagement and empowerment while providing greater knowledge of how credible scientific information can be shared and effect positive changes in opinions and behavior. ### Conditions Module **Conditions:** - Misinformation - Influenza - COVID-19 - Vaccine Hesitancy - Communication Research - Health Behavior ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Step wedge ##### Masking Info **Masking:** SINGLE **Masking Description:** De-identified information to data analysis.The list that links the study code to each participant's personal information will be kept completely separate from the de-identified database. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Initial baseline period before rollout of the intervention at six distinct predominantly Hispanic community areas in Chicago. **Label:** Control: One year baseline period **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Promotores de salud servicing two geographically adjacent community areas out of the six selected for participation in this study will receive a tailored curriculum on how to debunk misinformation and create infographics and media as well as incorporate their personal narratives into social media posts for their communities. The core of the implementation strategy consists of augmenting training and self-efficacy for natural community champions, "promotores de salud" from the Hispanic community as trusted messengers to debunk vaccination misinformation. **Intervention Names:** - Behavioral: Science Communication Curriculum Cohort 1 **Label:** Experimental: Cohort 1 participation in science communication curriculum **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Promotores de salud servicing two geographically adjacent community areas out of the six selected for participation in this study will receive a tailored curriculum on how to debunk misinformation and create infographics and media as well as incorporate their personal narratives into social media posts for their communities. The core of the implementation strategy consists of augmenting training and self-efficacy for natural community champions, "promotores de salud" from the Hispanic community as trusted messengers to debunk vaccination misinformation. **Intervention Names:** - Behavioral: Science communication curriculum Cohort 2 **Label:** Experimental: Cohort 2 participation in science communication curriculum **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Promotores de salud servicing two geographically adjacent community areas out of the six selected for participation in this study will receive a tailored curriculum on how to debunk misinformation and create infographics and media as well as incorporate their personal narratives into social media posts for their communities. The core of the implementation strategy consists of augmenting training and self-efficacy for natural community champions, "promotores de salud" from the Hispanic community as trusted messengers to debunk vaccination misinformation. **Intervention Names:** - Behavioral: Science communication curriculum Cohort 3 **Label:** Experimental: Cohort 3 participation in science communication curriculum **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: Cohort 1 participation in science communication curriculum **Description:** Promotores will receive a tailored curriculum on how to debunk misinformation and create infographics and media as well as incorporate their personal narratives into social media posts for their communities. Each session will be taught by a bilingual instructor and will be recorded for later consultation and viewing. Sessions will be 2 hours in length and will require an additional 1h of pre-work for each session. Together, each cohort will participate in 18 hours of training as follows: Session 1: What is Misinformation? How do you identify myths? Session 2: The Power of Storytelling, Present their myth. Session 3: Workshop: Review myths and storyboard for each person with feedback. Session 4: Infographics: Teaching creation of infographics on Canva (free to use). Session 5: Workshop: Present draft infographic and discuss preliminary social media strategy Session 6: Final Product: Share final infographic and final post / social media strategy **Name:** Science Communication Curriculum Cohort 1 **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Experimental: Cohort 2 participation in science communication curriculum **Description:** Promotores will receive a tailored curriculum on how to debunk misinformation and create infographics and media as well as incorporate their personal narratives into social media posts for their communities. Each session will be taught by a bilingual instructor and will be recorded for later consultation and viewing. Sessions will be 2 hours in length and will require an additional 1h of pre-work for each session. Together, each cohort will participate in 18 hours of training as follows: Session 1: What is Misinformation? How do you identify myths? Session 2: The Power of Storytelling, Present their myth. Session 3: Workshop: Review myths and storyboard for each person with feedback. Session 4: Infographics: Teaching creation of infographics on Canva (free to use). Session 5: Workshop: Present draft infographic and discuss preliminary social media strategy Session 6: Final Product: Share final infographic and final post / social media strategy **Name:** Science communication curriculum Cohort 2 **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Experimental: Cohort 3 participation in science communication curriculum **Description:** Promotores will receive a tailored curriculum on how to debunk misinformation and create infographics and media as well as incorporate their personal narratives into social media posts for their communities. Each session will be taught by a bilingual instructor and will be recorded for later consultation and viewing. Sessions will be 2 hours in length and will require an additional 1h of pre-work for each session. Together, each cohort will participate in 18 hours of training as follows: Session 1: What is Misinformation? How do you identify myths? Session 2: The Power of Storytelling, Present their myth. Session 3: Workshop: Review myths and storyboard for each person with feedback. Session 4: Infographics: Teaching creation of infographics on Canva (free to use). Session 5: Workshop: Present draft infographic and discuss preliminary social media strategy Session 6: Final Product: Share final infographic and final post / social media strategy **Name:** Science communication curriculum Cohort 3 **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Promotores' social media followers' intent to vaccinate against COVID and/or influenza. Members of promotores' social media circles will be surveyed to understand the reach and effectiveness of various types of social media posts. We will measure effectiveness by surveying the social circles of the Promotores six months after the implementation of the curriculum (see recruitment and retention plan), and after the completion of the campaign. Specific items will include which posts the social circle members remembered most and why. We will also ask whether this changed their thinking about COVID-19 and/or influenza vaccines and or the specific call to action that was put in the infographic. **Measure:** Vaccine uptake among promotores' social media followers **Time Frame:** Year 2 - Year 4 **Description:** Compare promotores confidence with addressing misinformation on social media before and after completing the Dime LaVerDAD science communication curriculum. 15-minute survey to assess their work-related social media communication self-efficacy. The baseline survey will also gather demographics, social determinants of health and baseline usage of Facebook and other social media (e.g., social media apps they use, the number of friends on each social media platform, the frequency of reading from and posting/sharing on each platform), and confidence and preparedness to address misinformation in their communities regarding vaccines (COVID-19 and influenza). **Measure:** Promotores' Social Media Self-Efficacy **Time Frame:** Year 1 - Year 3 #### Secondary Outcomes **Description:** Learner satisfaction will be measured through post evaluations using Likert items based on satisfaction with the course and willingness to recommend to others. **Measure:** Learner satisfaction **Time Frame:** Year 2 - Year 4 **Description:** Obtained through focus groups of promotores de salud. An interview guide will include questions aimed at verifying their use of social media as an information source about vaccines, vaccine-related misbeliefs, characteristics of information sources they trust, perceptions of vaccine safety, and personal plans to get vaccinated. Questions will be developed based on the Appreciative Inquiry (AI) model which is an asset-based approach to organizational and social engagement that utilizes questions and dialogue to help participants uncover existing strengths, advantages, or opportunities in their communities, organizations, or teams **Measure:** Verify vaccine-related beliefs in Hispanic communities in Chicago **Time Frame:** Year 1-2 **Description:** We will first use social media data analytics to measure and understand reach in cyberspace. We will ask for each promotor/a's consent and train them how to export their Facebook posts into JSON files that will be shared with the research team. If we need to add another emerging social media platform that does not support direct data export, we will explore different options to retrieve data, such as joining promotores' social circles or group chats, or instruct promotores to self-report data of their social media posts. We will quantify the volume of "impressions" (i.e., the number of users who will see the post) and "buzz" generated by promotores (e.g., numbers of likes, comments or shares). Then text analytics methods will be adopted to analyze more fine-grained reactions to these posts. **Measure:** Social media engagement **Time Frame:** Years 1- 5 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Inclusion criteria: 18 years or older; fluent in English or Spanish; provide services in at least one of the priority zip codes 60639, 60651, 60623, 60608, 60629, 60632 selected as priority areas in the Protect Chicago Plus program instituted in response to the COVID19 pandemic (see Johnson AK, Smith CS, Hunt B, Jacobs J, Roesch P. Chicago's Citywide COVID-19 Vaccine Equity Program: Protect Chicago Plus. Public Health Rep. 2023;138(2):218-222. doi:10.1177/00333549221143093); have a social media presence (personal or work-related) Exclusion Criteria: * Exclusion: Plans to stop working as a "promotor" before spring of 2027 (end of data collection planned). You can not participate if you are under the age of 18, or can not understand Spanish and English, or do not provide services in the included zip codes, or do not wish to participate in social media. **Healthy Volunteers:** True **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** karie-mobley@uiowa.edu **Name:** Karie Mobley, CCRC **Phone:** (319) 353-8791 **Role:** CONTACT **Contact 2:** **Email:** yajaira-bolanosflores@uiowa.edu **Name:** Yajaira Bolanos Flores, MPH **Phone:** (319) 353-8785 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Rush University **State:** Illinois **Status:** ACTIVE_NOT_RECRUITING **Zip:** 60612 **Location 2:** **City:** Chicago **Country:** United States **Facility:** University of Chicago **State:** Illinois **Status:** ACTIVE_NOT_RECRUITING **Zip:** 60637 **Location 3:** **City:** Iowa City **Contacts:** ***Contact 1:*** - **Email:** karie-mobley@uiowa.edu - **Name:** Karie Mobley, BS - **Phone:** 319-353-8791 - **Role:** CONTACT ***Contact 2:*** - **Email:** yajaira-bolanosflores@uiowa.edu - **Name:** Yajaira Bolanos Flores, MPH - **Phone:** (319) 353-8785 - **Role:** CONTACT ***Contact 3:*** - **Name:** Marina DelRios, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Iowa **State:** Iowa **Status:** RECRUITING **Zip:** 52242 **Location 4:** **City:** Ann Arbor **Country:** United States **Facility:** University of Michigan **State:** Michigan **Status:** ACTIVE_NOT_RECRUITING **Zip:** 48109 #### Overall Officials **Official 1:** **Affiliation:** University of Iowa Emergency Treatment Research Center **Name:** Marina DelRios, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: LOW - As Found: Unknown - ID: M10295 - Name: Influenza, Human - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417749 **Brief Title:** MIND Diet and Cognitive Function in Middle-aged and Older Adults **Official Title:** MIND Diet and Cognitive Function in Middle-aged and Older Adults #### Organization Study ID Info **ID:** LL20240353 #### Organization **Class:** OTHER **Full Name:** Zhejiang University ### Status Module #### Completion Date **Date:** 2025-10-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shandong University #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang University #### Responsible Party **Investigator Affiliation:** Zhejiang University **Investigator Full Name:** Changzheng Yuan **Investigator Title:** Research Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. **Detailed Description:** Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Middle-aged and Elderly People is a 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. The proposed MIND diet for this study is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field and Chinese Dietary Guidelines 2022. Specifically, the proposed MIND diet education will emphasize the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafood, beans and legumes, nuts, olive and seed oils, and green tea, and restrict red and processed meats, animal fat, fried foods, and sweets and pastries. The trial will employ a cluster randomization design comparing the effects on cognitive change of the MIND intervention diet education among 1200 adults aged 40-69 years. Secondary outcomes will include dietary behavior changes, health status changes, etc. The proposed study is sited at Taian, Shandong, China. ### Conditions Module **Conditions:** - Cognitive Function - Dementia **Keywords:** - Cognitive Function - Dietary Pattern ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is a two-arm parallel design, with one arm being the control arm and the other being the intervention arm (MIND diet education and food supply). ##### Masking Info **Masking:** SINGLE **Masking Description:** This is a single-blind design, where the outcome assessors will be masked from the assignment of the participants. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** General dietary advice **Intervention Names:** - Behavioral: Control arm **Label:** Control arm **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** MIND diet education **Intervention Names:** - Behavioral: Intervention arm **Label:** Intervention arm **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control arm **Description:** Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline. **Name:** Control arm **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Intervention arm **Description:** Participants will be given three MIND diet education videos on different topics at baseline and during follow-up. In addition, each participant will receive a MIND diet education brochure at baseline and some food supply during follow-up. **Name:** Intervention arm **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Cognitive function will be assessed using the MoCA at baseline and during follow-up. **Measure:** Change in 5-min Montreal Cognitive Assessment (MoCA) score **Time Frame:** 12 months #### Secondary Outcomes **Description:** The 5-level EQ-5D (EQ-5D-5L) will be used to assess life quality. Evaluations will be conducted at baseline and during follow-up. **Measure:** Change in EuroQol Five Dimensions (EQ-5D) scale **Time Frame:** 12 months **Description:** AD-8 will be used to assess cognitive function. Evaluations will be conducted at baseline and during follow-up. **Measure:** Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score **Time Frame:** 12 months **Description:** Dietary behavior will be assessed using food frequency questionnaire (FFQ). A 15-point MIND diet score will be calculated to reflect the MIND diet adherence among both groups of participants. Evaluations will be conducted at baseline and during follow-up. **Measure:** Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet score **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Normal chewing function, able to eat hard foods such as nuts. * Willing to participate and sign an informed consent form. * Able to understand research procedures and adhere to them throughout the entire study period. Exclusion Criteria: * Participation in or have participated in other clinical trial studies within the past year. * Medication to treat Alzheimer's or Parkinson's disease. * Diagnosis of severe chronic diseases, such as cancer. **Healthy Volunteers:** True **Maximum Age:** 69 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taian **Contacts:** ***Contact 1:*** - **Email:** chy478@zju.edu.cn - **Name:** Changzheng Yuan, ScD - **Phone:** (86)17326860291 - **Role:** CONTACT ***Contact 2:*** - **Name:** Changzheng Yuan, ScD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Tao Zhang, PhD - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Mutiple Counties **State:** Shandong **Zip:** 271000 ### IPD Sharing Statement Module **Description:** Interested collaborators may put in a request. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: HIGH - As Found: Dementia - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003704 - Term: Dementia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417736 **Brief Title:** Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women **Official Title:** Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women #### Organization Study ID Info **ID:** PRO2023-3614 #### Organization **Class:** OTHER **Full Name:** Women's Hospital School Of Medicine Zhejiang University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-01 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Women's Hospital School Of Medicine Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions：When taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? What medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? Efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt), and p53-abnormal(p53abn). Participants will: Take drug membrane-inhibiting formula plus oral progestins every day Visit the clinic once every 3 months for checkups, tests, and hysteroscopy Keep a diary of examination results and pathology ### Conditions Module **Conditions:** - Endometrial Cancer Stage I - Endometrial Hyperplasia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Megestrol acetate(160mg/day) and membrane-inhibiting formula, 24weeks **Intervention Names:** - Drug: Megestrol Acetate 40 MG **Label:** membrane-inhibiting formula combined with oral progestins **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - membrane-inhibiting formula combined with oral progestins **Description:** 160mg/one time/day **Name:** Megestrol Acetate 40 MG **Other Names:** - membrane-inhibiting formula **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn) **Measure:** CR in different molecular classification **Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment #### Primary Outcomes **Description:** The treatment response:complete response,no endometrial lesion **Measure:** 24-week complete response(CR) rate **Time Frame:** baseline,12 weeks after treatment,and 24 weeks of treatment #### Secondary Outcomes **Description:** The treatment response:complete response,no endometrial lesion **Measure:** 36-week CR rate **Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment **Description:** The treatment response:complete response,no endometrial lesion **Measure:** 48-week CR rate **Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment **Description:** analyze the safety of the drug **Measure:** treatment-related adverse events **Time Frame:** baseline,12 weeks after treatment,and 24 weeks of treatment **Description:** cumulative recurrent rate **Measure:** recurrent rate **Time Frame:** baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment **Description:** long term fertility results **Measure:** pregnancy rate **Time Frame:** 1-year after CR ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs Exclusion Criteria: * 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results **Gender Based:** True **Gender Description:** female **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 5516015@zju.edu.cn **Name:** Yang Li, Doctor **Phone:** 0086-18268165386 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** 5516015@zju.edu.cn - **Name:** Li Yang - **Phone:** 0086-18268165386 - **Role:** CONTACT **Country:** China **Facility:** Women's Hospital School of Medicine Zhejiang University **State:** Zhejiang **Status:** RECRUITING **Zip:** 321006 #### Overall Officials **Official 1:** **Affiliation:** Women's Hospital School Of Medicine Zhejiang University **Name:** Yang Li, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M10016 - Name: Hyperplasia - Relevance: HIGH - As Found: Hyperplasia - ID: M7876 - Name: Endometrial Hyperplasia - Relevance: HIGH - As Found: Endometrial Hyperplasia - ID: M19235 - Name: Endometrial Neoplasms - Relevance: HIGH - As Found: Endometrial Carcinoma - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016889 - Term: Endometrial Neoplasms - ID: D000004714 - Term: Endometrial Hyperplasia - ID: D000006965 - Term: Hyperplasia ### Intervention Browse Module - Ancestors - ID: D000003278 - Term: Contraceptives, Oral, Hormonal - ID: D000003276 - Term: Contraceptives, Oral - ID: D000003271 - Term: Contraceptive Agents, Female - ID: D000003270 - Term: Contraceptive Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000080066 - Term: Contraceptive Agents, Hormonal - ID: D000003280 - Term: Contraceptives, Oral, Synthetic - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019167 - Term: Appetite Stimulants - ID: D000000697 - Term: Central Nervous System Stimulants ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSSti - Name: Central Nervous System Stimulants ### Intervention Browse Module - Browse Leaves - ID: M11518 - Name: Megestrol - Relevance: HIGH - As Found: Nor - ID: M21272 - Name: Megestrol Acetate - Relevance: HIGH - As Found: EPI - ID: M14244 - Name: Progestins - Relevance: LOW - As Found: Unknown - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown - ID: M6500 - Name: Contraceptives, Oral - Relevance: LOW - As Found: Unknown - ID: M6502 - Name: Contraceptives, Oral, Hormonal - Relevance: LOW - As Found: Unknown - ID: M6495 - Name: Contraceptive Agents, Female - Relevance: LOW - As Found: Unknown - ID: M2116 - Name: Contraceptive Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008535 - Term: Megestrol - ID: D000019290 - Term: Megestrol Acetate ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417723 **Brief Title:** Effect of Maxillary Nerve Block for Septoplasty **Official Title:** Effect of Maxillary Nerve Block for Septoplasty #### Organization Study ID Info **ID:** ADYU-ANS-NY-04 #### Organization **Class:** OTHER **Full Name:** Adiyaman University Research Hospital ### Status Module #### Completion Date **Date:** 2024-09-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Adiyaman University Research Hospital #### Responsible Party **Investigator Affiliation:** Adiyaman University Research Hospital **Investigator Full Name:** Nezir Yılmaz **Investigator Title:** Associate Professor,MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study was to determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations. **Detailed Description:** Patients who were planned to be operated for septoplasty at Adıyaman University Training and Research Hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study. The patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour were recorded and these values were compared in both groups. Thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations. ### Conditions Module **Conditions:** - Post Operative Pain **Keywords:** - postoperative pain - maxillary nerve block - septoplasty ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** two groups designed from septoplasty patintes for study. 1. only general anesthesia 2. General anesthesia + maxillary nerve block ##### Masking Info **Masking:** DOUBLE **Masking Description:** for patients - closed envelope system for investigator - Maxillary nerve block performer will not participate pain and results assesment **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bilateral maxillary nerve block was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded . **Intervention Names:** - Procedure: Maxillary nerve block **Label:** Block group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No intevention was planned for this group. Only genaeral anesthesia applications will use for surgery. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded . **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Block group **Description:** It is aimed to reach the maxillary nerve trace with a peripheral nerve block needle using the suprazigomatic approach and to create a temporary block in the maxillary nerve with local anaesthetic injection. **Name:** Maxillary nerve block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** postoperative pain scores will be assesed in 24 hours after surgery **Measure:** The visual analog pain score **Time Frame:** three months #### Secondary Outcomes **Description:** a tool that asses recovery quality of paitent after surgery with 15 question will be used at 24th hour after surgery **Measure:** Quality of recovery (QoR -15) **Time Frame:** three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I-II , Septoplasty patints Exclusion Criteria: * ASA III-IV * Deny to participte in study **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yilmaznezirr@gmail.com **Name:** Nezir Yılmaz **Phone:** 05068939496 **Role:** CONTACT #### Locations **Location 1:** **City:** Adıyaman **Country:** Turkey **Facility:** Adıyaman Training and Research Hospital **Zip:** 02200 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417710 **Acronym:** NANO-LM **Brief Title:** Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis **Official Title:** Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis #### Organization Study ID Info **ID:** NANO-LM-01 #### Organization **Class:** OTHER **Full Name:** University of Zurich ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2022-01-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** M.D. Anderson Cancer Center **Class:** OTHER **Name:** The Netherlands Cancer Institute #### Lead Sponsor **Class:** OTHER **Name:** University of Zurich #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice. ### Conditions Module **Conditions:** - Leptomeningeal Metastasis - Leptomeningeal Disease - Leptomeningeal Neoplasms - Leptomeningeal Cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Clinical neurological assessment performed by 2 raters **Name:** Neurological Assessment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters **Time Frame:** December 2026 #### Secondary Outcomes **Measure:** inter-observer reproducibility (agreement) for each item - per center and among all raters **Time Frame:** December 2026 **Measure:** association between items **Time Frame:** December 2026 **Measure:** variability of the interobserver agreement **Time Frame:** December 2026 **Measure:** description of clinical neurological symptoms and signs **Time Frame:** December 2026 **Measure:** association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response **Time Frame:** December 2026 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (18 years or more), female or male * Histologically confirmed diagnosis of extra-CNS primary solid cancer * Diagnosis of leptomeningeal metastases confirmed or probable per EANO ESMO criteria * Performance status compatible with enrolment into clinical trials * Ability to consent * Signed informed consent form from patient * Participation in a parallel clinical trial is allowed in this non-interventional study Exclusion Criteria: * Inability to give informed consent * Inability to adhere to recommended follow-up according to the treating physician Vulnerable participants will not be included. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with leptomeningeal metastases from various extra-central nervous system (CNS) solid primary tumors for whom a tumor-specific treatment is planned ### Contacts Locations Module #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** BJOBrien@mdanderson.org - **Name:** Barbara O'Brien - **Phone:** 832-837-9347 - **Role:** CONTACT **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 **Location 2:** **City:** Amsterdam **Contacts:** ***Contact 1:*** - **Email:** d.brandsma@nki.nl - **Name:** Dieta Bransdma - **Phone:** +31 (0)20 512 9111 - **Role:** CONTACT **Country:** Netherlands **Facility:** Netherlands Cancer Institute **Status:** RECRUITING **Location 3:** **City:** Zurich **Contacts:** ***Contact 1:*** - **Email:** emilie.lerhun@usz.ch - **Name:** Emilie Le Rhun - **Phone:** +41 44 255 38 99 - **Role:** CONTACT **Country:** Switzerland **Facility:** University Hospital Zurich **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms - ID: D000010335 - Term: Pathologic Processes - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M28325 - Name: Meningeal Carcinomatosis - Relevance: HIGH - As Found: Leptomeningeal Metastasis - ID: M11560 - Name: Meningeal Neoplasms - Relevance: HIGH - As Found: Leptomeningeal Neoplasms - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000055756 - Term: Meningeal Carcinomatosis - ID: D000008577 - Term: Meningeal Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417697 **Brief Title:** A Phase 1b Study to Evaluate the Safety of XEN-101 **Official Title:** A Phase 1b, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Effects of XEN-101 on Safety, Tolerability, and Pharmacodynamics in Subjects With Obesity #### Organization Study ID Info **ID:** XB-101-102 #### Organization **Class:** INDUSTRY **Full Name:** Xeno Biosciences ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Xeno Biosciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** This Phase 1b study will evaluate the effects of XEN-101 in subjects with obesity **Detailed Description:** This study will assess the safety, tolerability and weight loss associated with XEN-101 in obese men and women. ### Conditions Module **Conditions:** - Obesity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: XEN-101 **Label:** XEN-101 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - XEN-101 **Description:** capsule formulation **Name:** XEN-101 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** capsule formulation **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Assessing the type and frequency of adverse events **Measure:** Incidence of treatment emergent adverse events (safety and tolerability) **Time Frame:** Day 1 through Day 43 **Description:** change and percent change from baseline **Measure:** Effect on body weight **Time Frame:** Day 1 through Day 43 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female, age 18 to 60 years, inclusive, at Screening 2. Body mass index of 30 to 45 kg/m2 3. Stable body weight for at least 3 months (i.e., fluctuation of ≤5%) 4. If a female of childbearing potential, must agree to use double barrier contraception (e.g., condom and 1 additional form of adequate contraception) from the date of signing of the ICF, throughout the study, and for 4 weeks after the final dose of study drug. In addition, she must be advised not to donate ova during this period. If a non-sterilized male is sexually active with a female partner of childbearing potential, he must use double barrier contraception from the date of signing of the ICF, throughout the study, and for 8 weeks after the final dose of study drug. In addition, he must be advised not to donate sperm during this period 5. If a female of childbearing potential, must have a negative pregnancy test at Screening and on Day 1 (baseline) 6. Able to provide informed consent 7. Willing and able to comply with this protocol and procedures, including feces collection, and be available for the entire duration of the study Exclusion Criteria: 1. Currently enrolled in another investigational device or drug study, or less than 30 days or 5 times the half-life of the drug candidate (whichever is longer) has passed between Screening for this study and the end of the Treatment Period of the previous investigational device or drug study 2. Diagnosed with type 1 diabetes or type 2 diabetes (T2D) (resolution of T2D \>3 years before Screening is allowed) 3. Laboratory evidence during Screening of T2D, including glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥126 mg/dL (≥7.0 mmol/L) 4. Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the Investigator's opinion, would compromise the safety of the subject, interfere with the interpretation of the study results, or otherwise preclude subject participation 5. Female who is pregnant, nursing, or intends to become pregnant during the study. 6. Positive result for hepatitis B virus surface antigen, hepatitis C virus ribonucleic acid, and human immunodeficiency virus (HIV) antibody at Screening 7. Use of anti-obesity medications (e.g., glucagon-like peptide-1 analogues, stimulants, bupropion/naltrexone) within 6 months before Screening **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** administrator@xenobiosciences.com **Name:** Dennis Kim, MD **Phone:** 8338073142 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417684 **Acronym:** RCTVM **Brief Title:** Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine **Official Title:** Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine #### Organization Study ID Info **ID:** 240605 #### Organization **Class:** OTHER **Full Name:** Vanderbilt University Medical Center ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vanderbilt University Medical Center #### Responsible Party **Investigator Affiliation:** Vanderbilt University Medical Center **Investigator Full Name:** Richard A. Roberts, Ph.D. **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Vestibular migraine (VM) is one of the most common causes of vertigo attacks, affecting 1 - 5% of people. People with vestibular migraine have lower quality of life compared to others and some may experience completely debilitating symptoms. Symptoms include vertigo, nausea, head motion-induced dizziness, unsteadiness, balance problems, and lightheadedness. There is evidence the medication amitriptyline in isolation and also our lifestyle modification intervention in isolation can each help reduce symptoms of dizziness and headache in patients with VM. However, these data are observational and subject to various types of bias. The purpose of the current investigation is to determine outcomes from each intervention using randomized allocation of participants diagnosed with VM into either the amitriptyline arm or the lifestyle modification arm. We will measure for change in dizziness using the Dizziness Handicap Inventory (DHI) and for change in headache using the Headache Disability Inventory (HDI). For participants in the lifestyle modification arm, we will also measure for change in lifestyle factor to determine improvement on those intervention factors. Measures will be obtained pre-intervention to establish baseline, at 30 days, 60 days, and 90 days. We will also re-survey participants one year after initiation of intervention to determine adherence and status. **Detailed Description:** 1.0 Background Vestibular migraine (VM) is one of the most common causes of vertigo attacks, affecting 1 - 5% of people. People with vestibular migraine have lower quality of life compared to others and some may experience completely debilitating symptoms. Symptoms include vertigo, nausea, head motion-induced dizziness, unsteadiness, balance problems, and lightheadedness. Most reports of vestibular migraine management have focused on treatment with medications; however, we have shown that intervention with lifestyle modification is also effective. 1.1 Lifestyle Modification for Vestibular Migraine Our lifestyle modification intervention focuses on improving four factors: avoidance of dietary triggers, regulated mealtimes, restful sleep, and exercise. By controlling these factors that are often exacerbating for patients with VM, we decrease the symptoms of dizziness and headache. In our studies, we measure outcomes with two validated instruments, the dizziness handicap inventory (DHI) and the headache disability index (HDI). Using this approach, we have found significant improvement within two weeks of starting the lifestyle modification intervention. Further, we have seen that 44.7 - 59% of participants experienced significant improvement in dizziness within 30 days while 13.2 - 18.5% of patients experienced significant improvement in headache. We have shown that 39% of participants experience significant reduction in dizziness and 18% in headache at 105 days of lifestyle modification intervention (Roberts et al, 2021). We have even seen that 25% of participants continue to have significant benefit of lifestyle modification on dizziness at 371 days. Only 2.6 - 3.6 % of patients report worsened dizziness and no one has reported worse headache. We were also able to determine that restful sleep was the modifiable factor most important for improvement when participant group data is evaluated. This lifestyle modification intervention appears effective and safe with long-term outcomes better than reported for oral preventive migraine medication which has adherence rates around 25% at six months and 14% at one year. 1.2 Amitriptyline for Vestibular Migraine Amitriptyline is a medication that is mentioned often as a preventive treatment for VM. This medication is a tricyclic antidepressant (TCA) that blocks the reuptake of both serotonin and norepinephrine neurotransmitters. This medication is considered more sedating and has greater anticholinergic properties than other TCAs. For depression, therapeutic action begins in 2 - 4 weeks. In a retrospective study, Salmito et al. (2017) reported significant improvement in vestibular symptoms and headache for 13 patients treated with amitriptyline 25 mg measured at three months. The authors also included lifestyle modification so this is not solely a medication mediated effect. Domínguez-Durán et al. (2020) used 10 mg of amitriptyline daily, one hour before sleeping, in 18 of their patients with VM. Two participants stopped or did not take the medication as directed. The authors reported significant improvement in dizziness and headache at the five-week follow-up appointment. 12 of the patients reported xerostomia and 11 daytime somnolence as side effects. Neither Salmito et al. nor Domínguez-Durán et al. used the DHI or HDI to measure outcome, making it more challenging to compare across studies. There are some known contraindications to use of amitriptyline including: history of significant mental health problems, pregnancy, cardiac, liver or renal co-morbidities as well as diabetes and glaucoma. Amitriptyline has also been shown to increase seizure activity in patients with epilepsy. 1.3 Randomized Controlled Trials Although VM is among the most common causes of dizziness and is the most common cause of episodic vertigo, the majority of studies investigation outcomes efficacy are observational in design. These studies typically show improvement for the intervention, but the inherent bias in that type of investigation is reduced with the use of randomized controlled trials (RCTs). The process of randomizing allocation of a participant to an intervention arm should balance observed and unobserved participant characteristics between groups and allow attribution of any differences in outcome to the study intervention. Although there are approximately five RCTs comparing various pharmacologic interventions for VM, there are none including amitriptyline and there are none using lifestyle modification without pharmacologic intervention. 2.0 Rationale and Specific Aims There is evidence that amitriptyline in isolation and also our lifestyle modification intervention in isolation can both help reduce symptoms of dizziness and headache in patients with VM. However, these data are observational and subject to various types of bias. The purpose of the current investigation is to determine outcomes from each intervention using randomized allocation of participants diagnosed with definite VM into either the amitriptyline arm or the lifestyle modification arm. We will measure for change in dizziness using the DHI and for change in headache using the HDI. For participants in the lifestyle modification arm, we will also measure for change in lifestyle factor to determine improvement on those intervention factors. Measures will be obtained pre-intervention to establish baseline, at 30 days, at 60 days, and at 90 days. We will also re-survey participants one year after initiation of intervention to determine adherence and status. We hypothesize that amitriptyline and lifestyle modification intervention will improve symptoms of dizziness and headache similarly in patients with vestibular migraine measured at 60 days, but that the improvement will occur sooner (30 days) for participants in the lifestyle modification arm. Further, we hypothesize there will be fewer reported side effects from participants in the lifestyle modification arm compared to participants in the amitriptyline arm. Although VM is now recognized as a common cause of vertigo, there are few RCTs comparing efficacy of interventions and there are none comparing lifestyle modification to amitriptyline. Therefore, the results of the proposed investigation are intended to fill a critical void in our understanding of management of one of the most common causes of dizziness. ### Conditions Module **Conditions:** - Vestibular Migraine **Keywords:** - vestibular ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** amitriptyline, tablet, 25 mg, once daily, 90 days **Intervention Names:** - Drug: Amitriptyline **Label:** Amitriptyline **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Written and video instructions to help improve restful sleep, mealtime regularity, avoidance of dietary triggers, and exercise for 90 days. **Intervention Names:** - Drug: Amitriptyline **Label:** Lifestyle Modification **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Amitriptyline - Lifestyle Modification **Description:** 25 mg prescribed to be taken once daily for 90 days each evening. **Name:** Amitriptyline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** We will measure for reduction of dizziness using the Dizziness Handicap Inventory (DHI) **Measure:** Reduction of Dizziness **Time Frame:** Baseline DHI pre-intervention, 30, 60, 90 days and 1 year. **Description:** We will measure for reduction of dizziness using the Headache Disability Inventory Inventory (HDI) **Measure:** Reduction of Headache **Time Frame:** Baseline HDI pre-intervention, 30, 60, 90 days and 1 year. **Description:** Participants will report any side effects **Measure:** Side Effects **Time Frame:** 30, 60, 90 days and 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * English-speaking adults * Diagnosed with Definite Vestibular Migraine * Currently prescribed rescue medication for migraine is acceptable Exclusion Criteria: * Non-English speaking * Diagnosed and undergoing treatment for active Definite Meniere's disease * Already using amitriptyline * Contraindicated for intervention with amitriptyline including: Patients with Hepatic Impairment, Patients with Renal Impairment, Pregnancy, Breastfeeding, Elderly Patients, Allergy to amitriptyline, Heart attack, Used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazide, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others, Used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone, Bipolar disorder (manic-depression) or schizophrenia, Mental illness or psychosis; Stroke, Seizures, Diabetes (amitriptyline may raise or lower blood sugar); Glaucoma, Problems with urination **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** richard.a.roberts@vumc.org **Name:** Richard A Roberts, PhD **Phone:** 615-322-7384 **Role:** CONTACT #### Locations **Location 1:** **City:** Nashville **Contacts:** ***Contact 1:*** - **Email:** richard.a.roberts@vumc.org - **Name:** Richard A Roberts, Ph.D. - **Phone:** 615-322-7384 - **Role:** CONTACT **Country:** United States **Facility:** Vanderbilt University Medical Center **State:** Tennessee **Zip:** 37232 #### Overall Officials **Official 1:** **Affiliation:** Vanderbilt University Medical Center **Name:** Richard A Roberts, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders ### Intervention Browse Module - Ancestors - ID: D000000929 - Term: Antidepressive Agents, Tricyclic - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018759 - Term: Adrenergic Uptake Inhibitors - ID: D000014179 - Term: Neurotransmitter Uptake Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3977 - Name: Amitriptyline - Relevance: HIGH - As Found: FLT - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M4248 - Name: Antidepressive Agents, Tricyclic - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000639 - Term: Amitriptyline ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417671 **Acronym:** PB-EIOS **Brief Title:** The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress. **Official Title:** The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress. #### Organization Study ID Info **ID:** PostBiotics-Exercise #### Organization **Class:** OTHER **Full Name:** University of Thessaly ### Status Module #### Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Thessaly #### Responsible Party **Investigator Affiliation:** University of Thessaly **Investigator Full Name:** Chariklia K. Deli **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Scientific data on the effect of supplementation of postbiotics on exercise-induced oxidative stress are scarce. The main purpose of the research is to investigate the effect of postbiotics supplementation on exercise-induced oxidative stress and performance indicators after intense exercise. The study will be a cross-over, randomized, double-blind, controlled study that will be conducted in two cycles. Participants will be randomly assigned into one of the two trials: i) Postbiotics supplementation for 4 weeks, ii) Placebo supplementation for 4 weeks. Participants will then perform a 45-min treadmill running at (-15% slope, \~70% VO2max) followed by a time-trial (0% slope, \~95% VO2max) until exhaustion. Before, as well as 24 h, 48 h and 72 h after the exercise, participants will undergo measurements of exercise-induced muscle damage (EIMD) \[delayed onset of muscle soreness (DOMS), creatine kinase\], blood redox status \[total antioxidant capacity, catalase, protein carbonyls, reduced glutathione, oxidized glutathione\], and isokinetic performance (knee-extensors and knee-flexors isometric, concentric, eccentric torque) evaluation. In addition, metabolism (lactic acid) will be assessed before and 4 min after exercise. Afterwards, the participants will receive the postbiotics supplement or the placebo for 4 weeks, and will repeat the exercise protocol and measurements of EIMD, blood redox status and performance indices at the same time-points. At the second cycle, the participants will repeat the above procedures under the remaining condition. Between conditions, there will be a 14-day washout period. The results of the research will provide important information for coaches and physically active individuals, regarding the effectiveness of postbiotics in alleviating oxidative stress and improving performance after intense exercise. **Detailed Description:** Acute, vigorous and/or unaccustomed exercise can induce muscle injury and oxidative stress. At moderate concentrations, reactive oxygen and nitrogen species (RONS) act as signaling molecules and promote adaptations to systematic training. Conversely, excessive production of RONS may cause destructive effects, due to the oxidation of important biomolecules such as lipids and proteins, but also DNA. Disruption of the redox balance can bring about adverse effects on exercise-induced adaptations, such as muscle damage and fatigue. For this reason, many professional as well as amateur athletes, often consume nutritional supplements such as antioxidants, anticipating to reduce inflammation and oxidative stress after intense exercise. The human gastrointestinal tract is inhabited by various microorganisms, called the gut microbiome (GM). GM, among other things, contributes to the normal functioning of the immune system, contributes to the production of short-chain fatty acids (SCFAs) and vitamin synthesis as well as the digestion and absorption of food, protects against enteropathogens and regulates inflammatory and redox responses. Recent evidence also suggests that GM may be involved in athletic performance. In contrast, disruption of GM composition (dysbiosis) is characterized by reduced diversity, reduced abundance of health-promoting bacteria, and increased abundance of gram-negative and other pathogenic bacteria and is associated with various metabolic diseases such as obesity, diabetes, and various forms of cancer, systemic inflammation, oxidative stress and reduced performance. Thus, the supplementation of several "biotics" has been emerged as a means to regulate the GM in favor of health-promoting bacteria. Postbiotics is defined as a "preparation of inanimate microorganisms and/or their components that confers a health benefit on the host". Evidence suggests that supplementation with postbiotics may regulate the GM, and consequently, strengthen the immune system, reduce intestinal permeability, improve antioxidant mechanisms, as well as accelerate recovery after exercise-induced inflammation, enhance adaptations to exercise, and improve performance. However, the scientific data regarding the possible beneficial effect of supplemental administration of postbiotics is limited. More research is needed, in order to determine the role of postbiotics supplementation on exercise-induced inflammation and redox status, but also on performance after intense exercise. This study will investigate the potential of postbiotics supplementation to affect the recovery of exercise-induced oxidative stress and performance following intense, eccentrically biased acute exercise. The study will be cross-over, randomized, double-blind, controlled, and will be conducted in two cycles. The participants, will be primarily informed of the study procedures, as well as the benefits and possible risks, they will also sign an informed consent form for participation in the study. Before the experimental procedure, they will be involved in a week of familiarization to the evaluation tests and the exercise protocol, at a low intensity. In addition, the participants will record their diet via a 7-days recall before their participation in the first experimental condition, and dietary data will be analyzed with ScienceFit Diet 200A diet analysis program (Science Technologies, Athens, Greece), in order to estimate that they do not consume nutrients that may affect muscle injury, inflammation and oxidative stress (e.g. antioxidants, etc.). Baseline measurements will take place at the Laboratory of Biochemistry, Physiology and Nutrition of Exercise (SmArT Lab), Department of Physical Education and Sports, University of Thessaly: anthropometric characteristics (body height, body mass, body mass index) via a stadiometer-scale (Stadiometer 208; Seca, Birmingham, UK), body composition (amount of body fat, lean body mass, fat mass, bone density) via by dual emission X-ray absorptiometry (DXA, GE-Healthcare, Lunar DPX NT, Belgium), aerobic capacity (VO2max) via an automated online pulmonary gas analyzer (Vmax Encore 29, BEBJO296, Yorba Linda, CA, USA) during a graded exercise protocol on a treadmill (Stex 8025T, Korea), isokinetic strength (isometric, concentric and eccentric torque of the knee extensors and knee flexors) on an isokinetic dynamometer (Cybex, HUMAC NORM 360, Ronkonkoma, NY), and muscle power via the assessment of countermovement jump (CMJ) via an optical measurement system (Optojump next, Microgate, USA). Participants will then be randomized in one of the two conditions: i) Postbiotics supplementation (50mg/day of Heat-killed Lactobacillus plantarum L-137, Immuno-LP20TM) for 4 weeks, or ii) placebo supplementation for 4 weeks. Randomization of the conditions will be done by a software generating random integers available on the internet (Random.org). Seven days later, participants will perform an exercise protocol comprised of 45 min downhill running (-15% slope, \~70-75% VO2max) on a treadmill followed by a time-trial (0% slope, \~95% VO2max) until exhaustion. Before the exercise protocol, as well as 24 h, 48 h and 72 h after exercise, delayed onset of muscle soreness (DOMS) via palpation of the knee extensors and knee flexors on a scale of 1 to 10 (1 = no pain at all; 10 = extreme pain), and muscle performance (CMJ, isometric, concentric and eccentric torque of the knee extensors and knee flexors) will be assessed. Additionally, blood samples will be collected at the same time-points for the assessment of creatine kinase (CK), and blood redox status \[reduced glutathione (GSH), oxidized glutathione (GSSG), GSH/GSSG ratio, total antioxidant capacity (TAC), catalase (CAT), protein carbonyls (PC), uric acid, bilirubin)\]. Furthermore, metabolism (lactic acid) will be assessed before and 4 min after exercise by analyzing capillary blood with a portable lactate analyzer (Lactate Plus, Nova Biomedical, USA). After a 14-days washout period, participants will repeat the exact same procedures for the remaining condition in the second cycle. Additionally, the 7-day diet recall will be given to the participants to follow the same diet before the experimental exercise protocol at the second cycle. ### Conditions Module **Conditions:** - Postbiotics Supplement ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Masking Description:** The randomization of the participants to the supplement or placebo condition will be performed via a random integer set generator (Random.org) available online. Neither the participants, nor the supplement provider will be aware of whether participants receive the postbiotic supplement or the placebo. Additionally, blood samples will be masked during the biochemical analysis, and during the statistical analysis. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Supplementation of postbiotics for 4 weeks **Intervention Names:** - Dietary Supplement: Postbiotics supplementation **Label:** Postbiotics supplementation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Supplementation of placebo for 4 weeks **Intervention Names:** - Dietary Supplement: Placebo supplementation **Label:** Placebo supplementation **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Postbiotics supplementation **Description:** The participants will consume one capsule per day. **Name:** Postbiotics supplementation **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo supplementation **Description:** The participants will consume one capsule per day. **Name:** Placebo supplementation **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Concentration of PC will be measured in plasma **Measure:** Changes in PC **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Concentration of MDA will be measured in plasma **Measure:** Changes in malondialdehyde (MDA) **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Concentration of GSH will be measured in red blood cells **Measure:** Changes in reduced glutathione (GSH) **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Concentration of GSSG will be measured in red blood cells **Measure:** Changes in oxidized glutathione (GSSG) **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** GSH/GSSG ratio will be calculated **Measure:** Changes in GSH/GSSG ratio **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Concentration of catalase will be measured in red blood cells **Measure:** Changes in catalase **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** TAC will be measured in plasma **Measure:** Changes in total antioxidant capacity (TAC) **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Concentration of uric acid will be measured in plasma **Measure:** Changes in uric acid **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Concentration of bilirubin will be measured in plasma **Measure:** Changes in bilirubin **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Concentration of lactate will be measured in capillary blood **Measure:** Changes in blood lactate **Time Frame:** At baseline (pre), and 4 min post-trial **Description:** Muscle soreness of the KF and KE will be assessed via palpation of the muscle belly and the distal regions following 3 squats, and the subjective pain will be recorded on a 10-point scale (1 = no pain, 10 = extreme pain) **Measure:** Changes in in delayed onset of muscle soreness (DOMS) in the knee flexors (KF) and extensors (KE) of both limbs **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** CK will be will be measured in serum **Measure:** Changes in creatine kinase (CK) **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** CMJ height will be measured with an optical system **Measure:** Changes in countermovement jump (CMJ) height **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Isometric, concentric and eccentric peak torque of the KE and KF of both limbs will be assessed on an isokinetic dynamometer **Measure:** Changes in isokinetic strength of knee extensors (KE) and knee flexors (KF) **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Physically active subjects (VO2max ≥35ml/kg/min) * Absence of musculoskeletal injury (≥6 months) * Abstinence from the use of ergogenic supplements (≥1 month) * Abstinence from anti-inflammatory drugs (≥1 month) * Abstinence from pre-pro-postbiotic supplements (≥6 months) * Abstinence from participating in exercise with eccentric content for at least 7 days before exercise * Abstinence from alcohol and energy drinks before exercise Exclusion Criteria: * Recent history of musculoskeletal injury (\<6 months) * Use of ergogenic performance supplements (\<1 month) * Taking anti-inflammatory drugs (\<1 month) * Taking pre-pro-postbiotic supplements (\<6 months) * Participation in exercise with eccentric content in the previous 7 days before exercise * Consumption of alcohol and energy drinks before exercise **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** delixar@pe.uth.gr **Name:** Chariklia K Deli, PhD **Phone:** +302431047011 **Role:** CONTACT **Contact 2:** **Email:** ajamurt@pe.uth.gr **Name:** Athanasios Z Jamurtas, PhD **Phone:** +302431047054 **Role:** CONTACT #### Locations **Location 1:** **City:** Trikala **Contacts:** ***Contact 1:*** - **Email:** delixar@pe.uth.gr - **Name:** Chariklia K Deli, PhD - **Phone:** 2431047011 - **Role:** CONTACT **Country:** Greece **Facility:** Department of Physical Education and Sport Science, Uninersity of Thessaly **State:** Thessaly **Status:** RECRUITING **Zip:** 42100 #### Overall Officials **Official 1:** **Affiliation:** University of Thessaly, DPESS **Name:** Chariklia K Deli, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Jamurtas AZ, Garyfallopoulou A, Theodorou AA, Zalavras A, Paschalis V, Deli CK, Nikolaidis MG, Fatouros IG, Koutedakis Y. A single bout of downhill running transiently increases HOMA-IR without altering adipokine response in healthy adult women. Eur J Appl Physiol. 2013 Dec;113(12):2925-32. doi: 10.1007/s00421-013-2717-5. Epub 2013 Sep 26. **PMID:** 24068487 **Citation:** Deli CK, Fatouros IG, Paschalis V, Tsiokanos A, Georgakouli K, Zalavras A, Avloniti A, Koutedakis Y, Jamurtas AZ. Iron Supplementation Effects on Redox Status following Aseptic Skeletal Muscle Trauma in Adults and Children. Oxid Med Cell Longev. 2017;2017:4120421. doi: 10.1155/2017/4120421. Epub 2017 Jan 22. **PMID:** 28203319 **Citation:** Deli CK, Poulios A, Georgakouli K, Papanikolaou K, Papoutsis A, Selemekou M, Karathanos VT, Draganidis D, Tsiokanos A, Koutedakis Y, Fatouros IG, Jamurtas AZ. The effect of pre-exercise ingestion of corinthian currant on endurance performance and blood redox status. J Sports Sci. 2018 Oct;36(19):2172-2180. doi: 10.1080/02640414.2018.1442781. Epub 2018 Feb 22. **PMID:** 29469654 **Citation:** Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234. **PMID:** 22699609 **Citation:** Sales KM, Reimer RA. Unlocking a novel determinant of athletic performance: The role of the gut microbiota, short-chain fatty acids, and "biotics" in exercise. J Sport Health Sci. 2023 Jan;12(1):36-44. doi: 10.1016/j.jshs.2022.09.002. Epub 2022 Sep 9. **PMID:** 36089243 **Citation:** Jager R, Mohr AE, Carpenter KC, Kerksick CM, Purpura M, Moussa A, Townsend JR, Lamprecht M, West NP, Black K, Gleeson M, Pyne DB, Wells SD, Arent SM, Smith-Ryan AE, Kreider RB, Campbell BI, Bannock L, Scheiman J, Wissent CJ, Pane M, Kalman DS, Pugh JN, Ter Haar JA, Antonio J. International Society of Sports Nutrition Position Stand: Probiotics. J Int Soc Sports Nutr. 2019 Dec 21;16(1):62. doi: 10.1186/s12970-019-0329-0. **PMID:** 31864419 **Citation:** Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4. Erratum In: Nat Rev Gastroenterol Hepatol. 2021 Jun 15;: Nat Rev Gastroenterol Hepatol. 2022 Aug;19(8):551. **PMID:** 33948025 **Citation:** Lee CC, Liao YC, Lee MC, Cheng YC, Chiou SY, Lin JS, Huang CC, Watanabe K. Different Impacts of Heat-Killed and Viable Lactiplantibacillus plantarum TWK10 on Exercise Performance, Fatigue, Body Composition, and Gut Microbiota in Humans. Microorganisms. 2022 Nov 3;10(11):2181. doi: 10.3390/microorganisms10112181. **PMID:** 36363775 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417658 **Brief Title:** Comparing Cosmetic Outcomes: Endoscopic vs. Conventional Craniotomy for Frontal Skull Base Lesions **Official Title:** A Comparison of Cosmetic Results in Terms of Scar Assessment and Complications in Endoscopic Supraorbital Eyebrow Craniotomy vs Conventional Craniotomy for Frontal Skull Base Lesions #### Organization Study ID Info **ID:** Exp122 #### Organization **Class:** OTHER **Full Name:** University of Health Sciences Lahore ### Status Module #### Completion Date **Date:** 2025-02-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Health Sciences Lahore #### Responsible Party **Investigator Affiliation:** University of Health Sciences Lahore **Investigator Full Name:** Syeda Ayesha Hashmi **Investigator Title:** Post Graduate Resident **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This research study will compare the cosmetic outcomes, specifically scar assessment and complications, between two surgical approaches for treating frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy. The study will aim to evaluate the differences in scar appearance, spread, erythema, suture marks, hypertrophy/atrophy, and overall impression between the two approaches using the Scar Cosmesis Assessment Rating (SCAR) scale. Additionally, it will examine patient-reported outcomes such as itch and pain. The study will follow a structured protocol, including random allocation to groups, preoperative assessments, surgery, postoperative follow-ups, and statistical analysis. It will emphasize the importance of understanding cosmetic outcomes to improve patient satisfaction and inform treatment regimens. **Detailed Description:** The proposed research study will undertake a comparative analysis of the cosmetic outcomes associated with two distinct surgical approaches utilized in the treatment of frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy. This investigation will primarily focus on evaluating scar assessment and complications arising from these surgical procedures. 1. Surgical Approaches: The study will compare two different techniques: the endoscopic supraorbital eyebrow craniotomy, which is a minimally invasive neurosurgical procedure involving a small incision within the eyebrow to access anterior skull base pathologies, and the conventional frontal craniotomy, a traditional approach involving a larger incision. 2. Purpose: The primary objective will be to assess and compare the cosmetic outcomes, particularly scar appearance and related complications, between these two surgical methods. The emphasis will lie on evaluating parameters such as scar spread, erythema, suture marks, hypertrophy/atrophy, and overall impression using the Scar Cosmesis Assessment Rating (SCAR) scale. 3. Study Protocol: Random Allocation: Patients will be randomly assigned to either the endoscopic supraorbital eyebrow craniotomy group or the conventional frontal craniotomy group. Preoperative Assessment: Comprehensive preoperative evaluations will be conducted to ascertain baseline data and ensure suitability for surgery. Surgery: Patients will undergo the assigned surgical procedure based on random allocation. Postoperative Follow-up: Close monitoring of patients post-surgery to assess scar healing and detect any complications. Data Collection: Data regarding scar assessment, complications, patient-reported outcomes, and other relevant parameters will be collected at specified intervals. Statistical Analysis: Rigorous statistical analysis of collected data will be conducted to draw comparisons and conclusions regarding cosmetic outcomes between the two surgical approaches. 4. Patient-Reported Outcomes: In addition to clinician-assessed scar parameters, the study will also consider patient-reported outcomes such as itch and pain, providing a comprehensive understanding of the patient experience following these surgical interventions. 5. Significance: The study will underscore the significance of evaluating cosmetic outcomes in neurosurgical procedures, aiming to enhance patient satisfaction and inform treatment decisions. By comparing the two surgical approaches, the research will seek to contribute valuable insights that may lead to the refinement of surgical techniques and improved patient care. Overall, this proposed research endeavors to offer a detailed examination of the cosmetic results associated with endoscopic supraorbital eyebrow craniotomy versus conventional frontal craniotomy, thereby facilitating informed decision-making and optimizing patient outcomes in the management of frontal skull base lesions. ### Conditions Module **Conditions:** - Brain Tumor ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study employs a structured protocol involving random allocation to groups, preoperative assessments, surgery, postoperative follow-ups, and statistical analysis. It aims to evaluate differences in scar appearance, spread, erythema, suture marks, hypertrophy/atrophy, and overall impression between the two surgical approaches using the Scar Cosmesis Assessment Rating (SCAR) scale. Additionally, patient-reported outcomes such as itch and pain will be examined. This model ensures comprehensive evaluation of cosmetic outcomes and patient satisfaction, providing valuable insights to inform treatment regimens. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** his minimally invasive neurosurgical procedure accesses brain tumors by making a small incision within the eyebrow, providing access to pathologies of the anterior skull base. Compared to traditional frontal craniotomy, this approach aims to minimize tissue disruption, potentially reducing postoperative complications and improving cosmetic outcomes. The procedure involves precise surgical techniques guided by endoscopic visualization, allowing for targeted tumor resection while preserving surrounding healthy tissue. Additionally, the use of smaller incisions may lead to reduced scarring and faster recovery times compared to conventional approaches. **Intervention Names:** - Procedure: Endoscopic Supraorbital Eyebrow Craniotomy **Label:** Endoscopic Supraorbital Eyebrow Craniotomy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This arm represents the standard surgical approach for treating frontal skull base lesions. In this arm, surgeons perform the craniotomy through a conventional frontal approach rather than the endoscopic supraorbital eyebrow approach. This arm serves as the comparator against the experimental arm to evaluate the differences in cosmetic outcomes, scar assessment, and complications between the two surgical techniques. **Intervention Names:** - Procedure: Conventional Frontal Craniotomy **Label:** Conventional Frontal Craniotomy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Endoscopic Supraorbital Eyebrow Craniotomy **Description:** The Endoscopic Supraorbital Eyebrow Craniotomy is a minimally invasive neurosurgical procedure used to access and remove brain tumors located in the anterior skull base region. In this approach, surgeons make a small incision within the eyebrow area to gain access to the underlying pathology, avoiding larger incisions and more extensive tissue disruption associated with traditional open craniotomies. **Name:** Endoscopic Supraorbital Eyebrow Craniotomy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Conventional Frontal Craniotomy **Description:** The Conventional Frontal Craniotomy is a traditional surgical approach used to access and treat lesions located in the frontal region of the skull base. In this procedure, surgeons make a single or multiple large incisions in the scalp overlying the frontal bone to gain access to the underlying pathology. **Name:** Conventional Frontal Craniotomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Comparison between two surgical approaches for treating frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy will be made. The Scar Cosmesis and Assessment Rating (SCAR) scale will be used to determine the cosmetic outcome of the approach. The range of SCAR scale is 0 to 15. A score ≤ 5 on the SCAR scale will be considered cosmetic success. (Ziai et. al., 2022) **Measure:** Comparing Cosmetic Outcomes in Frontal Craniotomy Approaches **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients having frontal skull base lesion on MRI 2. Lesion size \<5cm on MRI with IV contrast 3. Both male and female 4. 25-65 years of age Exclusion Criteria: 1. Patients with redo surgery (on medical record) 2. Lesion size \>5cm 3. Vascular tumors 4. Previous trauma 5. Anticoagulant medications 6. Comorbidities(uncontrolled hypertension and diabetes) 7. Skin diseases **Maximum Age:** 65 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016543 - Term: Central Nervous System Neoplasms - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M5209 - Name: Brain Neoplasms - Relevance: HIGH - As Found: Brain Tumor - ID: M18937 - Name: Central Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001932 - Term: Brain Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417645 **Acronym:** Eleved PD **Brief Title:** Re-evaluation of the Effect Site Model of the PKPD Propofol Eleveld Model **Official Title:** the BIS Index Response is Poorly Described by Propofol Effect Site Eleveld's Model After Applying a Perturbation #### Organization Study ID Info **ID:** CEC-SSLR ord: 459 #### Organization **Class:** OTHER **Full Name:** Universidad del Desarrollo ### Status Module #### Completion Date **Date:** 2024-09-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-09-15 **Type:** ACTUAL #### Start Date **Date:** 2013-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Technical University of Munich #### Lead Sponsor **Class:** OTHER **Name:** Universidad del Desarrollo #### Responsible Party **Investigator Affiliation:** Universidad del Desarrollo **Investigator Full Name:** Pablo O. Sepulveda **Investigator Title:** Dr. Med **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** in healthy patients undergoing elective surgery, after a very slow induction, using Eleveld's kinetics as a reference, after loss of consciousness (LOC) and intubation, proceed to infuse propofol until 1% burst suppression ratio is obtained. Then return to the LOC concentration. The BISindex predicted by the model and the real one will be evaluated. The evolution of spectral density frequencies over time will also be evaluated. **Detailed Description:** Eleveld is a recently developed PKPD model of propofol, which includes multiple covariates in its pharmacokinetics. This model, called Universal, includes data from all studies conducted with plasma levels in the world, where the principal investigator (PSV) has been directly involved. For pharmacodynamics (PD), Eleveld, includes processed electroencephalogram (EEG) readings, but only by nominal BIS index. The use of BIS as a unique marker of propofol hypnosis shows multiple limitations as it results from a computer algorithmic application, which can be influenced by drugs, inter-individual variability, among others. Therefore, to determine the effect there are nowadays more accurate tools such as spectrogram processing and determination of alpha power by spectral density (PDS). This project aims to re-evaluate the modelling of the temporal behaviour of the effect in the BIS index, using the reference of the Eleveld kinetic model, associated to a spectrogram that allows the evaluation of the alpha and delta band dynamics as a predictor of the propofol effect. In our study we intend to replace the BIS value by the alpha and delta power progress in decibels (dB) and eventually build a pharmacodynamic (PD) model with a marker more associated to the specific cortical electrical phenomenon. ### Conditions Module **Conditions:** - Healthy - Surgery **Keywords:** - propofol, Eleveld, BIS, predicted effect site model, non-lineal behavior ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** healthy patients proposed for elective surgery longer than 60 min, received a standard protocol TCI iv anesthesia with EEG BIS index monitoring ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After slow propofol induction and standard monitoring with BIS EEG monitor. The propofol infusion guided by iTIVA simulator (Android / iOS) using Eleveld kinetic model. LOC (defined as loss of response to loud call and shoulder movement-touch), the same concentration of propofol will be maintained for 5 minutes to assess EEG stability. .Intubation will proceed as usual, starting remifentanil at 4.5 ng/ml and rocuronium bromide 0.6 mg/kg. After 5 min and before the start of surgery, propofol will be infused at 15 mg/kg/h until 1% BSR is reached, observed on the BIS monitor, and then return to the rate that represents the LOC concentration. EEG data shall be retrieved from the BIS monitor via USB. Post hoc using the software tivatrainer.com we will simulate the Eleved calculated plasma concentration and the Bis prediction with our BIS real data. **Intervention Names:** - Drug: fixed propofol infusion 15 mg/kg/h until 1% BSR (burst suppression ratio) **Label:** BIS predicted vs real **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BIS predicted vs real **Description:** after a slow induction with propofol to loss of consiousness (LOC), we proceed to give remifentanil TCI and rocuronium and intubate the patient. After 5 min we infuse 15 mg/kg/h until 1%BSR observe in the BIS monitor. Then we reduce the TCI LOC predicted concentration. **Name:** fixed propofol infusion 15 mg/kg/h until 1% BSR (burst suppression ratio) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** we compare the BIS predicted from the Eleveld model vs the response of our patients uring all the anesthesia procedure **Measure:** predicted BIS index vs real BIS index **Time Frame:** anesthesia #### Secondary Outcomes **Description:** Evaluate the differents EEG frequency bands at LOC, at maximal perturbation and when we reach again the LOC predicted concentration **Measure:** evaluation of the evolution of the EEG frequency bands **Time Frame:** anesthesia ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I-II patients between 18 and 60 years of age, who undergo elective surgery in the central ward of the Hospital Base San José Osorno, Chile. Consecutive patients from the beginning of the study up to 12 months from the admission of the first patient. Exclusion Criteria: * Emergency surgery patient. * Patients with dementia, delirium or altered state of consciousness. * Full stomach or risk of aspiration. * Allergic to propofol. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Osorno **Contacts:** ***Contact 1:*** - **Email:** pasevou@gmail.com - **Name:** Pablo O Sepulveda, Dr. Med - **Phone:** 056994793336 - **Role:** CONTACT ***Contact 2:*** - **Email:** ignaciobarrac@icloud.com - **Name:** Ignacio Barra, Dr. Med - **Phone:** 056951883419 - **Role:** CONTACT **Country:** Chile **Facility:** Hospital Base san José de Osorno **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sepulveda PO, Mora X. [Reevaluation of the time course of the effect of propofol described with the Schnider pharmacokinetic model]. Rev Esp Anestesiol Reanim. 2012 Dec;59(10):542-8. doi: 10.1016/j.redar.2012.07.019. Epub 2012 Oct 4. Spanish. **PMID:** 23040653 **Citation:** Eleveld DJ, Colin P, Absalom AR, Struys MMRF. Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12. Erratum In: Br J Anaesth. 2018 Aug;121(2):519. **PMID:** 29661412 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M1666 - Name: Rocuronium - Relevance: LOW - As Found: Unknown - ID: M18307 - Name: Propofol - Relevance: HIGH - As Found: Symptoms - ID: M5241 - Name: Bromides - Relevance: LOW - As Found: Unknown - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000015742 - Term: Propofol ### Misc Info Module - Version Holder: 2024-05-31