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## Protocol Section ### Identification Module **NCT ID:** NCT06417632 **Brief Title:** Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns **Official Title:** Prosthetic Outcomes and Clinical Performance of Two Types of Monolithic Zirconia-based Screw-retained Crowns. A Randomized Clinical Trial #### Organization Study ID Info **ID:** Susan Hattar #### Organization **Class:** OTHER **Full Name:** University of Jordan ### Status Module #### Completion Date **Date:** 2026-11 **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:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2025-02 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-21 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Jordan #### Responsible Party **Investigator Affiliation:** University of Jordan **Investigator Full Name:** Susan Hattar **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:** To compare biological, technical, radiographic, and patient-reported outcomes of two types of monolithic zirconia crowns screw-retained to implant. To assess whether the new form of multilayered zirconia crowns will show similar survival and success rate to conventional monolithic Zirconia screw-retained to implants in molar and premolar regions. First Null Hypothesis: Multilayered monolithic zirconia crowns would have similar survival, success rate compared to conventional monolithic zirconia implant supported crowns. Second Null hypothesis: There would be no difference in clinical and patients related outcomes between multilayered and conventional monolithic zirconia implant supported crowns. **Detailed Description:** Study design: A short-randomized controlled trial study, the (PICO) study design: population will be patients from Jordan University Hospital with implants planned for single screw-retained zirconia crowns in the posterior site (premolar or molar), intervention will be the multilayer monolithic screw-retained zirconia crowns over implants, the comparator is the conventional monolithic zirconia crowns over implants, and the main outcomes will be the prosthetic/technical outcomes, survival and success rates in addition to radiographic, patient-reported outcomes, and biological parameters. Methodology The patients who fulfilled the inclusion/exclusion criteria and entered the study will have a fully digital workflow starting from data acquisition using an intraoral scanner (3Shape TRIOS® 5) , Ti-base abutment design and CAD/CAM milling of the two types of monolithic zirconia blanks (IPS e.max® ZirCAD Prime and IPS e.max® ZirCAD LT). The fabricated zirconia crowns in both groups will have the same treatment and will be cemented to the Ti-base abutment according to the (APC) concept; alumina airborne-particle abrasion 50-μm at 1 bar for 15-20 seconds, intaglio surface primed using MDP for 60 seconds and air blown for 5 seconds, and finally cemented to the abutment by phosphate monomer resin cement PANAVIA™ V5(Blatz-Alvarez-Compendium-APC-2016, n.d.). On the other hand, the Ti-base abutment: height will be standardized at 4mm, and the base abutment surface will have blasting with alumina particles of 50 μm at 2-bar pressure for 15-20 seconds at a 10-mm step-over distance at an angle of 45 degrees. ### Conditions Module **Conditions:** - Dental Restoration - Dental Implant **Keywords:** - implant-supported - patient-reported outcome, - technical, biological outcomes - survival/success rate - single-tooth restorations ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 3Y-TZP/5Y-TZP zirconia crown **Intervention Names:** - Other: Graded Zirconia Crown **Label:** Graded monolithic Zirconia Crowns **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 3Y-TZP zirconia crowns **Intervention Names:** - Other: Conventional Zirconia Crown **Label:** Conventional monolithic Zirconia Crowns **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Graded monolithic Zirconia Crowns **Description:** monolithic implant supported crown **Name:** Graded Zirconia Crown **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Conventional monolithic Zirconia Crowns **Description:** monolithic implant supported crown **Name:** Conventional Zirconia Crown **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The abutments and restoration will be evaluated clinically by two blinded investigators, according to the modified United States Public Health Service (USPHS) criteria USPHS criteria involve four Scales: Alpha, Bravo, Charlie, Delta The criteria of evaluation include: Restoration fracture, Abutment Fracture, Loosening of the restoration, Screw-access hole restoration, Occlusal Wear, Anatomical Form, Color match, Proximal contact, Occlusal Contact, Marginal Fit, Periodontal parameters. **Measure:** Technical & Biological Outcomes **Time Frame:** Baseline, 6 months, 12 months **Description:** All patients will be evaluated for success and survival of restorations at 6 months and 1 year after placement of the restorations (Follow-ups). The success rate is defined as the number of restorations that did not change over time. The survival rate is defined as the number of restorations that did not require replacement. **Measure:** Survival and Success rate **Time Frame:** 6 months, 12 months **Description:** Patient satisfaction in terms of the shape and shade of the crown, their ability to chew (function) and floss (proximal contact) and their overall satisfaction with the restoration provided will be assessed by a questionnaire based on a five-grade ordinal category scale (extremely satisfied, satisfied, neutral, dissatisfied and extremely dissatisfied). Each patient was asked to fill out the questionnaire themselves to ensure as little bias as possible. **Measure:** Patient reported outcomes **Time Frame:** 6 months, 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Partially edentulous area with suitable restorative space more than 5.5 mm * At least 18 years of age * Opposing natural teeth or fixed restorations supported by teeth or implants. * Generally good health (ASA I, ASA II) * Participant complies with good oral hygiene practices (BOP and PI less than 20%) * Healthy integrated implant/s without signs of periimplantitis in the posterior site planned for single tooth replacement (in premolar or molar areas) * Patients received bone-level implants, RC Straumann Implants. Exclusion Criteria: * Inability to provide consent. * Temporomandibular disorders * Smoking of more than 10 cigarettes per day * Untreated caries or periodontal disease of remaining dentition **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** s.hattar@ju.edu.jo **Name:** Susan Hattar, Professor **Phone:** 962795642613 **Role:** CONTACT #### Locations **Location 1:** **City:** Amman **Country:** Jordan **Facility:** The university ofJordan **Zip:** 11181 #### Overall Officials **Official 1:** **Affiliation:** University of Jordan **Name:** Susan Hattar, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Le M, Dirawi W, Papia E, Larsson C. Clinical Outcome of Three Different Types of Posterior All-Ceramic Crowns. A 3-Year Follow-up of a Multicenter, Randomized, Controlled Clinical Trial. Int J Prosthodont. 2023 Nov 1;36(5):546-553. doi: 10.11607/ijp.8016. **PMID:** 36484665 **Citation:** Hosseini M, Worsaae N, Gotfredsen K. A 5-year randomized controlled trial comparing zirconia-based versus metal-based implant-supported single-tooth restorations in the premolar region. Clin Oral Implants Res. 2022 Aug;33(8):792-803. doi: 10.1111/clr.13960. Epub 2022 Jun 11. **PMID:** 35633183 **Citation:** Jung RE, Zembic A, Pjetursson BE, Zwahlen M, Thoma DS. Systematic review of the survival rate and the incidence of biological, technical, and aesthetic complications of single crowns on implants reported in longitudinal studies with a mean follow-up of 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:2-21. doi: 10.1111/j.1600-0501.2012.02547.x. **PMID:** 23062124 **Citation:** Zhang CN, Zhu Y, Zhang YJ, Jiang YH. Clinical esthetic comparison between monolithic high-translucency multilayer zirconia and traditional veneered zirconia for single implant restoration in maxillary esthetic areas: Prosthetic and patient-centered outcomes. J Dent Sci. 2022 Jul;17(3):1151-1159. doi: 10.1016/j.jds.2022.01.012. Epub 2022 Feb 5. **PMID:** 35784115 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417619 **Acronym:** Mindfulness **Brief Title:** The Effect of Mindfulness-Based Psychoeducation **Official Title:** The Effect of Mindfulness-Based Psychoeducation on the Mindfulness, Cognitive Defusion and Depression Level of Depression Patients #### Organization Study ID Info **ID:** Depression Patients #### Organization **Class:** OTHER **Full Name:** University of Gaziantep ### Status Module #### Completion Date **Date:** 2024-12-30 **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:** 2024-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-09 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Gaziantep #### Responsible Party **Investigator Affiliation:** University of Gaziantep **Investigator Full Name:** Rabia Arpaci **Investigator Title:** Principal 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 is a randomized controlled experimental study conducted to determine the effect of mindfulness-based psychoeducation on levels of mindfulness, cognitive defusion, and depression in patients with depression. The sample of the study will consist of 60 patients (30 experimental, 30 control) diagnosed with major depression, recruited from a state hospital. Mindfulness-based psychoeducation will be applied to the experimental group once a week for a total of 8 weeks in the form of group sessions. No intervention other than routine treatment will be applied to the control group. The primary questions that the study aims to answer are as follows: Does mindfulness-based psychoeducation increase levels of mindfulness and cognitive defusion in depression patients? Does mindfulness-based psychoeducation decrease levels of depression in depression patients? **Detailed Description:** In this research, the sample size calculation was performed using the G Power program by conducting a priori power analysis. Previous studies were reviewed and using the Beck Depression Inventory, expected confidence intervals were determined. With a confidence interval of α=0.05 and a test power (1-β) of 0.95, with an effect size of d=0.9632193, a total of 60 patients were calculated, with 30 patients in the experimental group and 30 patients in the control group. Participants included in the study will be assigned to experimental or control groups using block randomization. Inclusion Criteria for Participation in the study: Individuals who are literate.Individuals are willing to participate in the study voluntarily. Individuals without any communication barriers. Individuals aged between 18 and 65 years. Outpatients being followed up with a diagnosis of major depressive disorder according to DSM-5 criteria. Individuals who have not participated in a mindfulness-based psychoeducation program for their illness in the last 5 years. Exclusion Criteria for Participation in the study: Individuals diagnosed with comorbid psychiatric disorders. Patients with intellectual impairment (e.g., intellectual disability) or cognitive conditions that make collaboration impossible, such as dementia. Patients with psychotic symptoms in addition to the depressive picture. Illiterate individuals. Individuals who do not consent to an interview. Individuals receiving inpatient treatment ### Conditions Module **Conditions:** - Depressive Disorder, Major **Keywords:** - Depression - Mindfulness - Cognitive Defusion ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study is a randomized controlled experimental study (Interventional Study Model) ##### Masking Info **Masking:** SINGLE **Masking Description:** Participant (Major depression patients) **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Mindfulness-based psychoeducation will be implemented in the experimental group in the form of group sessions once a week for a total of 8 weeks. Post-tests will be administered immediately after the completion of psychoeducation sessions for the experimental group, and a follow-up test will be conducted 3 months after the post-test. **Intervention Names:** - Behavioral: Mindfulness-Based Psychoeducation **Label:** Patients **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No intervention will be applied to the control group other than routine treatment. For the control group, no intervention will be made, and post-tests will be administered 8 weeks after the pre-test, followed by a follow-up test 3 months after the post-test. **Label:** Depression Patients **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients **Description:** The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients **Name:** Mindfulness-Based Psychoeducation **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Personal Information Data Form prepared by the researcher will consist of a total of 10 questions (gender, age, education level, marital status, employment status, income level, cohabitation status, history of hospitalization, history of suicide attempt, medication use, and adherence to treatment). **Measure:** The Personal Information Data Form baseline and 2 months **Time Frame:** 2 months **Description:** The Beck Depression Inventory, developed by Beck et al. (1961), is designed to measure the risk of depression, level of depressive symptoms, and changes in severity in adults (Beck et al., 1961). The Turkish adaptation of the Beck Depression Inventory was conducted by Hisli (1988). The Beck Depression Scale consists of 21 items, each with four options. Each item scores from 0 to 3. Depression score is obtained by summing these scores. The highest possible score is 63, and a higher total score indicates greater severity of depression. A depression score of 17 or higher indicates depression above normal levels **Measure:** Beck Depression Inventory baseline and 2 months **Time Frame:** 2 months **Description:** The Mindfulness Scale was developed by Brown and Ryan (2003) (Brown \& Ryan, 2003). The Turkish validity and reliability of the scale were conducted by Özyeşil et al. (2011). The scale was designed to measure the overall level of awareness of skills in daily life and attentiveness to them. The scale consists of 15 items, rated on a six-point Likert scale.The scale is also unifactorial, yielding a single score. The lowest possible score on the scale is 15, and the highest is 90. An increase in the score indicates a higher level of mindfulness awareness in individuals. **Measure:** Mindfulness Scale baseline and 2 months **Time Frame:** 2 months **Description:** Drexel Cognitive Defusion Scale: The Drexel Cognitive Defusion Scale was developed by Forman et al. (2012) to measure the ability to distance oneself from emotions and thoughts (Forman et al., 2012). The scale consists of 10 items rated on a 6-point Likert scale (0: None; 1: A little, 2: To some extent, 3: Moderate level, 4: Quite a lot, 5: A lot). It is possible to calculate a total score from the scale, where higher scores indicate a higher ability to distance oneself from internal emotions and thoughts. **Measure:** Drexel Cognitive Defusion Scale baseline and 2 months **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Those who are literate. * Those willing to participate in the study voluntarily. * Those without any communication barriers. * Those aged between 18 and 65 years. * Outpatients being followed up with a diagnosis of major depressive disorder according to DSM-5 criteria. * Those who have not participated in a mindfulness-based psychoeducation program for their illness in the last 5 years. Exclusion Criteria: * Those diagnosed with another comorbid mental illness * Patients with mental conditions that make cooperation impossible, such as intellectual impairment (mental retardation) or dementia * Patients with psychotic symptoms in addition to depression illiterate people * Patients who do not consent to the interview * Those receiving inpatient treatment **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rabiaarpaci118@gmail.com **Name:** Rabia ARPACI, Student **Phone:** +90542 694 52 31 **Role:** CONTACT #### Locations **Location 1:** **City:** Gaziantep **Contacts:** ***Contact 1:*** - **Name:** Gaziantep University Gaziantep University, University - **Role:** CONTACT **Country:** Turkey **Facility:** Gaziantep University **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019964 - Term: Mood 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: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Depressive Disorder, Major - ID: M21835 - Name: Mood 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: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417606 **Brief Title:** Lenvatinib and Adebrelimab Combined With GEMOX in the Perioperative Treatment of Potentially Resectable Intrahepatic Cholangiocarcinoma **Official Title:** A Single-arm, Prospective Clinical Study of Lenvatinib and Adebrelimab Combined With GEMOX in the Perioperative Treatment of Potentially Resectable Intrahepatic Cholangiocarcinoma #### Organization Study ID Info **ID:** IEC-ZN-01-AF 09 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2025-05-30 **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:** 2025-04-20 **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:** 2024-05-07 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhiyong Huang #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Zhiyong Huang **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A single-arm, prospective clinical study was conducted to enroll 20 subjects. Each subject was treated with oral Lenvatinib + Adebrelimab + GEMOX (gemcitabine + oxaliplatin). The treatment phase before surgery was 3 cycles, and the evaluation was performed every 2 cycles. The evaluation was repeated before surgery, and the decision of surgery was made according to the evaluation results. To evaluate the efficacy and safety of Lenvatinib and Adebrelimab combined with GEMOX in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma. ### Conditions Module **Conditions:** - Intrahepatic Cholangiocarcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Lenvatinib（oral，12mg once daily if body weight ≥60Kg; Body weight \< 60Kg, 8mg/ day）； Adebrelimab（intravenous drip，1200mg once every 3 weeks）； GEMOX（intravenous drip，Gemcitabine 1000mg/m2, 2 times every 3 weeks d1+d8; intravenous drip，Oxaliplatin, 100mg/m2, was given every 3 weeks） **Intervention Names:** - Drug: Lenvatinib **Label:** Lenvatinib and Adebrelimab Combined With GEMOX（Gemcitabine and oxaliplatin） **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lenvatinib and Adebrelimab Combined With GEMOX（Gemcitabine and oxaliplatin） **Description:** Lenvatinib（oral，12mg once daily if body weight ≥60Kg; Body weight \< 60Kg, 8mg/ day）； Adebrelimab（intravenous drip，1200mg once every 3 weeks）； GEMOX（intravenous drip，Gemcitabine 1000mg/m2, 2 times every 3 weeks d1+d8; intravenous drip，Oxaliplatin, 100mg/m2, was given every 3 weeks） **Name:** Lenvatinib **Other Names:** - Adebrelimab - GEMOX（Gemcitabine and oxaliplatin） **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective Response Rate **Measure:** ORR **Time Frame:** through study completion, an average of 1 year **Description:** Disease Free Survival **Measure:** DFS **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** The tumor was completely removed with negative margins, meaning no residual tumor **Measure:** R0 resection rate **Time Frame:** 1 year **Description:** Overall Survival **Measure:** OS **Time Frame:** Up to 24 months **Description:** Disease Control Rate **Measure:** DCR **Time Frame:** DCR will be calculated as the percentage of patients who achieved Stable Disease(SD) or better for more than 8 weeks (RECIST v1.1) **Description:** Event Free Survival **Measure:** EFS **Time Frame:** Up to 12/24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Voluntarily participated in this study, signed informed consent, aged 18-80 years * Patients with locally advanced intrahepatic cholangiocarcinoma: (meet at least one of the following) A, the number of intrahepatic tumors was 2-3 B, the intrahepatic tumor is single but \>5cm in diameter C, the tumor was close to the 1/2 grade branch of the hepatic pedicle, making RO resection difficult D. Lymph node metastasis: MRI or PET/CT suggested regional lymph node metastasis * The WHO/ECOG PS score was 0-1 * Imaging examination (CT/MRI/PET-CT) showed no distant metastasis * Child-Pugh grade: A (≤6 points) * Expected survival time ≥6 months * No previous systemic treatment for hepatocellular carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc. Patients who had undergone previous curative surgery or curative ablation were allowed, except those who had a recurrence within 2 years after curative surgery and those who had received other previous local treatment * If you have hepatitis B virus (HBV) infection, such as HBsAg positive, you need to test HBV-DNA, and HBV-DNA should be less than 500IU/mL (; Patients with HBV-DNA of more than 500 IU per milliliter received antiviral therapy (only nucleoside agents such as entecavir, tenofovir dipivoxil fumarate, and tenofovir propofol fumarate tablets) for at least 1 week before randomization and had a decrease in viral copy number by a factor of more than 10. For patients with HBV infection, antiviral therapy should be received throughout the study period. Patients who are positive for hepatitis C virus (HCV) -RNA must receive antiviral therapy according to treatment guidelines * Organs and bone marrow are sufficiently functional, defined as follows: 1. hemoglobin ≥9g/dL 2. absolute neutrophil count ≥1.5 × 109/L 3. platelet count ≥ 100 × 109/L 4. serum bilirubin ≤2.0× upper limit of normal (ULN); This condition does not apply to patients with proven Gilbert's syndrome. Any clinically significant biliary obstruction had to be relieved prior to enrollment in the study. 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤2.5×ULN. For patients with liver metastases, ALT and AST should be ≤5 × ULN. Exclusion Criteria: * The investigator deemed the subject unfit to participate in the study * Have active autoimmune disease or a history of autoimmune disease with possible recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) * Use of immunosuppressant or systemic hormone therapy to achieve immunosuppression within 2 weeks before treatment (dose \>10mg/ day of prednisone or other effective hormones) * patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or white blood cell count \>15×109/L during screening; Therapeutic antibiotics, administered orally or intravenously, were given within 2 weeks before randomization * Patients with innate or acquired immune deficiency (e.g., HIV infection) * History of other primary malignancies, with the exception of malignancies treated with curative treatment, known absence of active disease ≥5 years before the first study intervention, and low potential risk of recurrence; Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has received potentially curative treatment; Or carcinoma in situ that has been adequately treated without evidence of disease * Patients with clinically significant bleeding symptoms or a clear bleeding tendency within 6 months before treatment, such as gastrointestinal bleeding, severe esophagogastric varices, hemorrhagic gastric ulcer, or angiitis, can be reexamined if fecal occult blood is positive at baseline, and if it is still positive after reexamination, gastroscopy is required * Known inherited or acquired bleeding (e.g. coagulopathy) or thrombophilia, such as in patients with hemophilia, coagulation disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use such as low-dose aspirin is allowed) * Known allergies to any study drug or excipients * Participate in other drug clinical trials within 4 weeks before randomization * Pregnant or lactating women * Other factors considered by the investigator to be unsuitable for participation in the study **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zunyizhangtjmu@163.com **Name:** Zunyi Zhang **Phone:** 86-15827413728 **Role:** CONTACT **Contact 2:** **Email:** d202382316@hust.edu.cn **Name:** Guan Tan **Phone:** 86-15971812255 **Role:** CONTACT #### Locations **Location 1:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** zunyizhangtjmu@163.com - **Name:** Zunyi Zhang - **Phone:** 86-15827413728 - **Role:** CONTACT ***Contact 2:*** - **Email:** d202382316@hust.edu.cn - **Name:** Guan Tan - **Phone:** 86-15971812255 - **Role:** CONTACT **Country:** China **Facility:** Tongji Hospital #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** Zhiyong Huang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - 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: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Intrahepatic Cholangiocarcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - 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: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: T3096 - Name: Intrahepatic Cholangiocarcinoma - Relevance: HIGH - As Found: Intrahepatic Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma ### Intervention Browse Module - Ancestors - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2985 - Name: Gemcitabine - Relevance: HIGH - As Found: Activity - ID: M353738 - Name: Lenvatinib - Relevance: HIGH - As Found: Primary care - ID: M1674 - Name: Oxaliplatin - Relevance: HIGH - As Found: Outcomes - ID: M4281 - Name: Antimetabolites - 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 ### Intervention Browse Module - Meshes - ID: D000093542 - Term: Gemcitabine - ID: D000077150 - Term: Oxaliplatin - ID: C000531958 - Term: Lenvatinib ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417593 **Brief Title:** Phenotypic and Genotypic Characteristics of Pseudomonas Aeruginosa Isolates in Sohag University Hospitals **Official Title:** Phenotypic and Genotypic Characteristics of Pseudomonas Aeruginosa Isolates in Sohag University Hospitals #### Organization Study ID Info **ID:** Soh-Med-24-04-016MS #### Organization **Class:** OTHER **Full Name:** Sohag University ### Status Module #### Completion Date **Date:** 2025-03-01 **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:** 2024-11-01 **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:** 2024-05-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sohag University #### Responsible Party **Investigator Affiliation:** Sohag University **Investigator Full Name:** Martina Gamil Fayez **Investigator Title:** principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions from Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections that will be obtained under complete aseptic precautions. ### Conditions Module **Conditions:** - Pseudomonas Aeruginosa Infection ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pseudomonas Aeruginosa Isolates **Label:** group1 ### Outcomes Module #### Primary Outcomes **Description:** Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions **Measure:** Isolation and identification of pseudomonas aeruginosa causing different nosocomial infections. **Time Frame:** 6 months **Description:** Antibiotic susceptibility testing of the isolates will be performed using disc diffusion method according to clinical laboratory standards institute (CLSI) guidelines **Measure:** Identification of antibiotic susceptibility pattern of isolated strains of pseudomonas **Time Frame:** 6 months **Description:** Detection of biofilm forming isolates by tissue culture plate method. **Measure:** Detection of biofilm forming isolates **Time Frame:** 6 months **Description:** Detection of virulence and antibiotic resistance genes by conventional Polymerase Chain Reaction **Measure:** Detection of virulence and antibiotic resistance genes of pseudomonas aeruginosa. **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions. Exclusion Criteria: * Any infection before 48 hours of patient admission at Hospital **Maximum Age:** 80 Years **Minimum Age:** 1 Year **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** martina.gameel@med.sohag.edu.eg **Name:** Martina Gamil Fayez, Demonstrator at Microbiology **Phone:** 01272602453 **Role:** CONTACT #### Locations **Location 1:** **City:** Sohag **Contacts:** ***Contact 1:*** - **Name:** martina - **Role:** CONTACT **Country:** Egypt **Facility:** Faculty of medicine Sohag university hospital **Status:** RECRUITING ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14409 - Name: Pseudomonas Infections - Relevance: HIGH - As Found: Pseudomonas - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative 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 ### Condition Browse Module - Meshes - ID: D000011552 - Term: Pseudomonas Infections ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417580 **Brief Title:** Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity **Official Title:** Effect of Experimental Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity: a Randomized, Double-blind, Controlled Clinical Study #### Organization Study ID Info **ID:** ppgoufpa #### Organization **Class:** OTHER **Full Name:** Universidade Federal do Para ### Status Module #### Completion Date **Date:** 2024-09-28 **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:** 2024-09-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ESTIMATED **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:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jesuína Lamartine Nogueira Araújo #### Responsible Party **Investigator Affiliation:** Universidade Federal do Para **Investigator Full Name:** Jesuína Lamartine Nogueira Araújo **Investigator Title:** Coordinator and professor of the Postgraduate Program in Dentistry at Universidade Federal do Pará **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** This randomized, double-blind, placebo-controlled clinical study aims to evaluate the effect of a gel formulation based on 10% of pregabalin in the treatment of HD and on the participants' quality of life. The sample calculation will be based on previous work. After selecting participants, the participants will be randomly assigned to the following groups: placebo control group (CG), potassium nitrate gel group (GNK) and pregabalin gel group (GPG). A questionnaire (QEDH-15) to assess the impact of desensitizing treatment on oral health-related quality of life (OHRQoL) will be applied at baseline (T0) and in the last sensitivity record (T6). Pain will be assessed using a visual analogue scale after evaporative stimulation with an air jet and tactile stimulation with an exploratory probe. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between them. Sensitivity recording will be performed at T0 (baseline), T1 (after the first session), T2 (after the second session), T3 (after the third session), T4 (7 days after the last session), T5 (one month after the last session) and T6 (3 months after the last session). Data will be collected and subjected to statistical analysis for parametric data (ANOVA followed by Student-Newman-Keuls) or non-parametric data (Friedman's ANOVA followed by Tukey). To analyze the impact on quality of life, the Friedman test will be used. **Detailed Description:** To obtain the experimental pregabalin gel, a carbopol 940 gel base was used. To prepare the base gel for the formulation, each component was weighed on an analytical balance and, after 24 hours, the components were taken to a mechanical shaker, rotating at 1000 rpm for 10 minutes. 50% triethanolamine was added to adjust the pH to ±6 and complete gel formation. The concentrations of the components of the initial base formula were adjusted to obtain a homogeneous, transparent gel with good consistency. A PG solution (10 mg/ml) was prepared by diluting the drug, which is presented as a white, crystalline powder (Vardhman Chemtech Ltd, Punjab, India), with purified water. The solution was stirred for 10 min in a water bath (Taitec) and centrifuged at 4°C for 10 min. The supernatant obtained was collected and then incorporated into the 1% carbopol-based gel. This formulation has already been evaluated in a previous study regarding quality standards, physical/chemical characterization, cytotoxicity and subjected to stability analyzes (preliminary and accelerated). Its characteristics indicate that it is a favorable formulation for clinical application. This randomized clinical study will follow the guidelines for clinical trials recommended by CONSORT (Consolidated Standards Of Reporting Trials) and will be submitted to the Human Research Ethics Committee of the Institute of Health Sciences at the Federal University of Pará (CEP-ICS/UFPA). All selected participants who agree to participate in the research will be informed about the benefits, risks, methods, and goals of the study before consenting to their participation through the Informed Consent Form declaring that the participants agree with all the steps to be taken. The participants can withdraw from the research at any time, following the principles of the Declaration of Helsinki. This randomized clinical trial will be parallel, double-blind, placebo-controlled and all clinical interventions will be conducted in the clinics of the Faculty of Dentistry of the Federal University of Pará (FOUFPa). The research will consist of three groups: a placebo control group (CG) with gel without any active ingredient, a group with potassium nitrate gel (Ultradent, South Jordan, UT, USA) (GNK), and an experimental group with gel 10% Pregabalin (GPG). Applications will be carried out in 3 sessions with an interval of 72 hours between each one. Sensitivity recording will be performed at T0 (baseline), T1 (after the first session), T2 (after the second session), T3 (after the third session), T4 (7 days after the last session), and T5 (one month after the last session) and T6 (3 months after the last session). A questionnaire (QEDH-15) will be applied to evaluate the impact of desensitizing treatment on improving the participants' oral health-related quality of life (HRQoL). The questionnaire will be applied at baseline (T0) and the last sensitivity record (T6). Higher QEHD-15 scores indicate a negative impact on the oral health-related quality of life (OHRQoL) of research participants. The sample size was determined using the GPower 3.1 program (Heinrich-Heine-Universität Düsseldorf, Germany), based on a comparison of intergroup means. According to previous studies, the minimum expected difference is 2.26, and a standard deviation of 2 between groups. An alpha of 5%, power of 80%, and a 20% increase in possible loss of participants were considered. The final sample size determined was 63 teeth in total, 21 sensitive teeth per group. To evaluate the painful sensation of hypersensitivity, a Visual Analogue Scale (VAS) will be used. The initial mark "0" represents no pain and the opposite mark "10" represents extreme pain. The participant will be asked to signal the number compatible with the painful sensation after applying the evaporative stimulus, by applying a jet of air from a triple syringe for two seconds, at room temperature, perpendicular to the buccal surface of the tooth at a distance of 1cm, and also by tactile stimulation, where a cross-shaped exploring probe will slide into the cervical region of the hypersensitive teeth, vertically in the cervical-incisal direction and horizontally in the mesiodistal direction. These stimuli will be performed after relative individual isolation with isolation tape (Isotape, Septodont, Louisville, USA) and cotton rolls (Dental Cremer, SC, Brazil). Random distribution between the groups will be carried out in a block, through a numerical draw that allows each participant to be allocated into one of the three groups (GC, GNK and GPG) using Biostat 5.3 software (Instituto Mamirauá, PA, Brazil). The confidentiality of the allocation will be maintained throughout the sample formation process, through a numerical draw with numbered and coded papers. All participants and the clinical operator will not know the group's codes. This double-blind study guarantees the confidentiality of the interventions since both the research participant and the main researcher will not be able to differentiate the procedure applied. The placebo gel, the experimental desensitizing gel, and the potassium nitrate gel will be inserted into a dappen jar and delivered immediately before the clinical interventions by a research collaborator. The gels have a similar texture, color and odor to prevent identification. The evaluator will also not be aware of the group the participant belonged to, as the clinical operator will not participate in the randomization process. The research will have a single operator to carry out the clinical part. The data will be analyzed for normality of distribution, using the Shapiro-Wilk test. If it presents a normal distribution, the ANOVA parametric analysis will be used to verify the existence of differences between the group means and the Student-Newman-Keuls post-hoc test will be used to verify the differences between the times. In case of abnormal distribution, the Friedman repeated measures test and the Tukey post hoc test will be used. To analyze differences in quality of life-related to oral health at T0 and T6, the Friedman test will be used. Data analysis will be performed using the freely available statistical software Jamovi (Version 2.3). The significance level α will be set at p\<0.05. ### Conditions Module **Conditions:** - Dentin Sensitivity **Keywords:** - pregabalin - dental sensitivity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This randomized clinical trial will be parallel, double-blind, placebo-controlled. Composed of three groups: a placebo control group with gel without any active ingredient (CG), a group with potassium nitrate gel (GNK) and an experimental group with 10% potassium pregabalin gel (GPG). Applications will be carried out in 3 sessions with an interval of 72 hours between each one. Sensitivity recording will be performed at T0 (baseline), T1 (after first session), T2 (after second session), T3 (after third session), T4 (7 days after the last session) and T5 (one month after the last session) and T6 (3 months after the last session). A questionnaire (QEDH-15) will be applied to evaluate the impact of desensitizing treatment on improving the participants' oral health-related quality of life (HRQoL). The questionnaire will be applied at baseline (T0) and at the last sensitivity record (T6). ##### Masking Info **Masking:** DOUBLE **Masking Description:** This double-blind study guarantees the confidentiality of the interventions, since both the research participant and the main researcher will not be able to differentiate the procedure applied. The placebo gel, the experimental desensitizing gel and the potassium nitrate gel will be inserted into a dappen jar delivered immediately before the clinical interventions by a research collaborator. The gels have a similar texture, color and odor to prevent identification. The evaluator will also not be aware of the group the participant belonged to, as they will not participate in the randomization process. The research will have a single operator to carry out the clinical part. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A negative control group with gel without any active ingredient. The protocol used for all groups will be the same: prophylaxis with an extra soft robinson brush and pumice stone, insertion of retractor thread number #000 in the gingival sulcus and then application and friction of the placebo gel with a microbrush applicator for 10 seconds, which will remain in contact with the tooth surface for 10 minutes, and the excess will be subsequently removed. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between each session. **Intervention Names:** - Other: Placebo Treatment **Label:** Negative Control Group **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Potassium nitrate gel group that will serve as a positive control The protocol used for all groups will be the same: prophylaxis with an extra soft robinson brush and pumice stone, insertion of retractor thread number #000 in the gingival sulcus and then application and friction of the potassium nitrate gel with a microbrush applicator for 10 seconds, which will remain in contact with the tooth surface for 10 minutes, and the excess will be subsequently removed. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between each session. **Intervention Names:** - Other: Nitrate Potassium Treatment **Label:** Positive Control Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Experimental group with 10% pregabalin gel. The protocol used for all groups will be the same: prophylaxis with an extra soft robinson brush and pumice stone, insertion of retractor thread number #000 in the gingival sulcus and then application and friction of the pregabalin gel with a microbrush applicator for 10 seconds, which will remain in contact with the tooth surface for 10 minutes, and the excess will be subsequently removed. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between each session. **Intervention Names:** - Other: Pregabalin Treatment **Label:** Experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Negative Control Group **Description:** Desensitizing protocol with none active ingredient to evaluate the control of cervical dentin hypersensitivity **Name:** Placebo Treatment **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Positive Control Group **Description:** Desensitizing protocol with potassium nitrate gel to analyze and compare with other groups the effects of controlling cervical dentin hypersensitivity **Name:** Nitrate Potassium Treatment **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Experimental group **Description:** Desensitizing protocol with experimental 10% pregabalin gel to evaluate the control of cervical dentin hypersensitivity **Name:** Pregabalin Treatment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The use of 10% pregabalin gel influence in the painful symptoms of dentin hypersensitivity. The results will be evaluated through study completion, an average of 3 months for each participant. The data will tell if the positive results were of short, medium and long-term. **Measure:** Number of Participants with dentin hypersensitivity: an average of 6 participants and 21 sensitive teeth in the group. **Time Frame:** Through study completion, an average of 3 months for each participant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Sensitive teeth with a response ≥ 04 on the visual analog scale (VAS) to tactile and evaporative stimuli; * Dentin exposure in anterior and/or posterior teeth, either due to the presence of non-carious cervical lesions and/or gingival recession. Exclusion Criteria: * Allergic to the active ingredient and/or components of the formulation; * Carious lesions and/or dental pulpitis; * Recent medication with analgesics or anti-inflammatories; * Received desensitizing treatment, orthodontic treatment, or having undergone tooth whitening up to six months prior baseline. * Large restorations in sensitive teeth * Eating disorders (bulimia, anorexia,...) * Periodontal disease (moderate to severe) * Bruxism * Cracks or fractures in the enamel; * Pregnant or breastfeeding women. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jesuinalamartine@hotmail.com **Name:** Jesuina L. N. Araujo, Doctor **Phone:** 5591991442849 **Role:** CONTACT **Contact 2:** **Email:** yngrid.paes@ics.ufpa.br **Name:** Yngrid F. O. Paes, Bachelor **Phone:** 5591987059299 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Federal University of Pará **Name:** Jesuina L Nogueira Araujo, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. **PMID:** 24141714 **Citation:** Barros APO, de Melo Alencar C, de Melo Pingarilho Carneiro A, da Silva Pompeu D, Barbosa GM, Araujo JLN, Silva CM. Combination of two desensitizing protocols to control dentin hypersensitivity in non-carious lesions: a randomized, double-blind clinical trial. Clin Oral Investig. 2022 Feb;26(2):1299-1307. doi: 10.1007/s00784-021-04104-2. Epub 2021 Aug 5. **PMID:** 34351504 **Citation:** Douglas-De-Oliveira DW, Lages FS, Paiva SM, Cromley JG, Robinson PG, Cota LOM. Cross-cultural adaptation of the Brazilian version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15). Braz Oral Res. 2018;32:e37. doi: 10.1590/1807-3107bor-2018.vol32.0037. Epub 2018 May 3. **PMID:** 29723336 **Citation:** Tolentino AB, Zeola LF, Fernandes MRU, Pannuti CM, Soares PV, Aranha ACC. Photobiomodulation therapy and 3% potassium nitrate gel as treatment of cervical dentin hypersensitivity: a randomized clinical trial. Clin Oral Investig. 2022 Dec;26(12):6985-6993. doi: 10.1007/s00784-022-04652-1. Epub 2022 Jul 25. **PMID:** 35871702 **Citation:** Sgreccia PC, Dame-Teixeira N, Barbosa RES, Araujo PF, Zanatta RF, Garcia FCP. Assessment of the Oral Health Impact Profile (OHIP-14) improvement of different treatments for dentin hypersensitivity in noncarious cervical lesions-a randomized clinical study. Clin Oral Investig. 2022 Nov;26(11):6583-6591. doi: 10.1007/s00784-022-04610-x. Epub 2022 Jul 7. **PMID:** 35796800 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Hypersensitivity - ID: M7003 - Name: Dentin Sensitivity - Relevance: HIGH - As Found: Dentin Sensitivity - ID: M10200 - Name: Immune System 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: D000003807 - Term: Dentin Sensitivity - ID: D000006967 - Term: Hypersensitivity ### Intervention Browse Module - Ancestors - 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: D000000927 - Term: Anticonvulsants - ID: D000002121 - Term: Calcium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000014151 - Term: Anti-Anxiety Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: Analg - Name: Analgesics - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M476 - Name: Pregabalin - Relevance: HIGH - As Found: Digital - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5384 - Name: Calcium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M16905 - Name: Anti-Anxiety Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069583 - Term: Pregabalin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417567 **Brief Title:** The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study **Official Title:** The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study #### Organization Study ID Info **ID:** NEPA #### Organization **Class:** OTHER **Full Name:** Tianjin Medical University Cancer Institute and Hospital ### 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:** 2025-12-31 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tianjin Medical University Cancer Institute and Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The rapid progress of multiple antiemetic regimens ensures that patients can receive full dose chemotherapy, however, there are still a large number of unmet clinical needs in patient evaluation and treatment. Due to the fact that patients with liver, gallbladder, and pancreatic diseases undergoing surgery are still in the stage of nausea and vomiting, the actual incidence of delayed nausea and vomiting may be underestimated. The long-term effective control of nausea and vomiting by Nitopitan Palonosetron capsules may improve the quality of life of patients during and after treatment, and ultimately improve clinical outcomes ### Conditions Module **Conditions:** - General Anesthesia Gastrointestinal Cancer Surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: NEPA **Label:** experimental group ### Interventions #### Intervention 1 **Arm Group Labels:** - experimental group **Description:** NEPA in Preventing Postoperative Nausea and Vomiting after General Anesthesia Gastrointestinal Cancer Surgery **Name:** NEPA **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** defined as no vomiting, no use of rescue medication, VAS nausea score\<4 **Measure:** Complete response rate within 24 hours after surgery **Time Frame:** 3month #### Secondary Outcomes **Description:** Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours) **Measure:** Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours) **Time Frame:** Complete response rates in the early postoperative period (0-2 hours), delayed period (2-24 hours), and extended observation period (24-48 hours) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Male or female, aged 18-65 years old; 2. The subjects were diagnosed with liver, gallbladder, and pancreatic diseases through histology or cytology and underwent elective surgical treatment, including but not limited to pancreaticoduodenectomy, liver resection, bile duct stone removal, etc., and received treatment with Netopitam Palonosetron capsules; 3. The subject is not in lactation period; 4. When screening female patients with potential pregnancy, it is necessary to confirm that the pregnancy test must be negative; 5. The subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent form. Exclusion Criteria: * 1) Serious liver and kidney dysfunction, cardiopulmonary dysfunction, or other serious diseases have not received standardized treatment; 2) Having a serious mental illness in the past; 3) Take antiemetics or antidepressants within 48 hours before surgery; 4) Patients receiving systemic glucocorticoid treatment within 4 weeks prior to surgery; 5) Take NK1 receptor antagonists or any investigational drugs within 4 weeks prior to the start of the experiment; 6) Use CYP3A4 inducer within 4 weeks prior to surgery, and CYP3A4 substrate or potent, moderate CYP3A4 inhibitor within 1 week; 7) Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures; 8) Drug and/or alcohol abuse; 9) Hypocalcemia or any other condition that may cause vomiting; 10) The subject has an allergic reaction to Netopitam Palonosetron capsules or any of their excipients; 11) Participate in another clinical study within 30 days prior to baseline visit, using any exploratory drugs or devices; Allow participation in observational research; 12) Researchers assess other situations that may affect the progress of clinical research and the determination of research results. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This study is a retrospective study to evaluate the efficacy and safety of Netopitam Palonosetron Capsules in preventing nausea and vomiting caused by surgical treatment in patients with liver, gallbladder, and pancreatic diseases, providing evidence-based evidence and medication basis for the use of Netopitam Palonosetron Capsules in clinical practice. ### Contacts Locations Module #### Locations **Location 1:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** lihuikai@tjmuch.com - **Name:** Huikai Li - **Phone:** +862223340123 - **Phone Ext:** 3091 - **Role:** CONTACT **Country:** China **Facility:** Tianjin Medical University Cancer Institute & Hospital **State:** Tianjin **Status:** RECRUITING **Zip:** 300060 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009325 - Term: Nausea - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M12273 - Name: Nausea - Relevance: LOW - As Found: Unknown - ID: M17582 - Name: Vomiting - Relevance: HIGH - As Found: Vomiting - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: HIGH - As Found: Postoperative Nausea and Vomiting - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Cancer - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - 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 ### Condition Browse Module - Meshes - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000014839 - Term: Vomiting - ID: D000020250 - Term: Postoperative Nausea and Vomiting ### 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:** NCT06417554 **Brief Title:** A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors **Official Title:** A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With or Without Antitumor Therapy in Subjects With Advanced Solid Tumors #### Organization Study ID Info **ID:** SHR-A2102-201 #### Organization **Class:** INDUSTRY **Full Name:** Shanghai Hengrui Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2027-07 **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:** 2027-07 **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:** 2024-04-26 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Shanghai Hengrui Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors. ### Conditions Module **Conditions:** - Advanced Solid Tumors ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-A2102 ; Adebrelimab injection **Label:** Treatment group A: SHR-A2102 + Adebrelimab injection **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: SHR-A2102 **Label:** Treatment group B: SHR-A2102 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment group B: SHR-A2102 **Description:** SHR-A2102 **Name:** SHR-A2102 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment group A: SHR-A2102 + Adebrelimab injection **Description:** SHR-A2102 + Adebrelimab injection **Name:** SHR-A2102 ; Adebrelimab injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** RP2D **Time Frame:** through phase IB completion, an average of 1 years **Measure:** Incidence and severity of AE； **Time Frame:** from Day1 to 90 days after last dose **Measure:** ORR **Time Frame:** 18 months after the last subject was enrolled in the group #### Secondary Outcomes **Measure:** DCR(Investigator evaluation) **Time Frame:** 18 months after the last subject was enrolled in the group **Measure:** DoR(Investigator evaluation) **Time Frame:** 18 months after the last subject was enrolled in the group **Measure:** PFS(Investigator evaluation) **Time Frame:** 18 months after the last subject was enrolled in the group **Measure:** OS(Investigator evaluation) **Time Frame:** 18 months after the last subject was enrolled in the group **Measure:** SHR-A2102 and free toxin PK **Time Frame:** through study completion, an average of 2 years **Measure:** SHR-1316 PK **Time Frame:** through study completion, an average of 2 years **Measure:** SHR-A2102 Immunogenicity **Time Frame:** through study completion, an average of 2 years **Measure:** SHR 1316 Immunogenicity **Time Frame:** through study completion, an average of 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements； 2. The age of signing the informed consent is above 18 years old, regardless of gender； 3. The ECOG score is 0 or 1； 4. Expected survival ≥12 weeks 5. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, stage Ib subjects who have failed standard treatment; Stage II subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors without systemic antitumor therapy； 6. Provide archived or fresh tumor tissue； 7. At least one measurable lesion according to RECIST v1.1 criteria； 8. Good level of organ function； 9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods Exclusion Criteria: 1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases； 2. Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors； 3. Systemic antitumor therapy was received 4 weeks before the start of the study； 4. Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy \>30 Gy within 6 months prior to initial administration； 5. Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria； 6. Systemic immunosuppressive therapy was administered within 14 days prior to the first study； 7. Subjects with known or suspected interstitial pneumonia； 8. ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors； 9. The presence of any active, known, or suspected autoimmune disease； 10. Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion； 11. The presence of clinical cardiac symptoms or diseases that are not well controlled； 12. Any other malignancy diagnosed within the previous 5 years； 13. Subjects who had a severe infection within 28 days prior to the first dose； 14. Active hepatitis B or active hepatitis C； 15. Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment； 16. History of immune deficiency； 17. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period； 18. Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter； 19. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; Presence of non-healing wounds or untreated fractures； 20. Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, or other monoclonal antibody/fusion protein drugs； 21. Female subjects who are pregnant or plan to become pregnant during the study period； 22. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention； 23. In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** chi.zhang@hengrui.com **Name:** Chi Zhang **Phone:** +8618456513908 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417541 **Acronym:** PHOTO CAT **Brief Title:** Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters **Official Title:** Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters (PHOTO CAT) #### Organization Study ID Info **ID:** PHOTO CAT #### Organization **Class:** OTHER **Full Name:** Region Skane ### Status Module #### Completion Date **Date:** 2027-06 **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:** 2026-06 **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:** 2024-05-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Thomas Kander #### Responsible Party **Investigator Affiliation:** Region Skane **Investigator Full Name:** Thomas Kander **Investigator Title:** Sponsor investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Central venous (CVC) is essential in modern healthcare but unfortunately associated with complications, including thrombosis. In a recently published study, it was showed that 12 out of 12 deceased patients had subclinical CVK-related thrombosis (Rockholt et al.). To shed light on this problem, the current studies were designed. In sub-study 1, deceased patients with CVC who are referred for clinical autopsy are included. Before the autopsy, the deceased will be examined with a photon-counting computed tomography (CT) scan and the results will be compared. In sub-study 2, living patients with CVC who are referred for various CT scans without contrast, are included. After informed consent, the patient will be examined with the photon-counting CT, whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported. **Detailed Description:** Purpose and specific objective The aim of the current project (PHOTO CAT) is to evaluate the prevalence of subclinical thromboses related to central venous catheters (CVCs) using a novel high-resolution photon-counting computed tomography (CT) scan and to evaluate the performance of the photon-counting CT compared to clinical autopsy. Scientific questions 1. Can the photon-counting CT diagnose subclinical CVK-related thromboses detected at later autopsy? 2. How common are CVC-related thromboses in autopsies of deceased people with existing CVC? 3. How does the performance of the photon counting DT compare to clinical autopsy? 4. How common are CVC-related thromboses in a cohort that does photon-counting DT for various reasons and has a CVC? 5. Can imaging be improved by adjustments to the DT protocol? 6. Can an ultrasound scan on living patients diagnose subclinical CVK-related thrombosis detected by photon-counting CT? Background CVCs are essential in modern healthcare and have a wide range of applications. They enable direct access to the central bloodstream and are used, among other things, to administer medicines, nutrition and to monitor blood circulation. Unfortunately, they are associated with a variety of complications, including thrombosis. Studies report thrombosis incidences between 5 - 30% in living patients. When the CVC is introduced into the blood vessel, a number of physiological defense systems are initiated. Inflammation and clotting are activated, leading to the formation of a fibrin stocking around the catheter. This can then develop into a catheter-related thrombosis, which in turn can have serious consequences for the patient, such as pulmonary embolism or infection. Photon-counting DT is the new generation of DT. What distinguishes this from the traditional one is that the radiation through the body is detected with a new type of detector that measures each X-ray, which provides significantly greater precision and resolution for a given radiation dose compared to traditional CT. This is particularly valuable in imaging diagnostics that rely on detailed morphology such as high-resolution CT of lungs. In order to achieve its full potential with as little radiation dose and contrast volume as possible with preserved image resolution, the design of protocols for the photon-counting CT needs to be optimized. Autopsy studies on CVC-related thrombosis and vascular changes are few. In a case series from 1994, changes in the vessel wall were examined macroscopically and biofilms were assessed with electron microscopy. The presence of fibrin stocking on the surface of all CVCs (n = 72), and wall-mounted thrombosis was reported in 38% of cases. In another autopsy study, Forauer et al. demonstrated severe CVC-related vascular changes that included intima damage with infiltration of media by inflammatory cells and varying degrees of adherent thrombus. Wichmann et al. published data showing a 38% prevalence of macroscopic catheter-related thrombosis in 61 human autopsies. In a recently published autopsy study, we showed that 12 out of 12 cases had CVC-related mural thrombosis at autopsy, with most being located in the distal part of the CVC (Rockholt et al.). There are also a number of clinical studies that have investigated how common CVC-related thrombosis is using ultrasound. In a well-designed prospective study, 16.9% of ICU patients had subclinical CVK-related thrombosis. The problem with the ultrasound method is that the distal part of the CVC is difficult to visualize with ultrasound, which means that the thrombosis incidence risks being underestimated. Material and method In an attempt to investigate how common subclinical CVK-related thrombosis, the current studies, include photon-counting CT, were designed. In substudy 1, photon counting CT is used to examine deceased intensive care patients referred for autopsy on clinical indication, with CVC in-situ. The CT will be focused on the vein with the CVC but a full body examination will also be done . Both examination results will be compared with the clinical autopsy conducted after the examinations. This first part of PHOTO CAT includes Scientific questions 1-3. In sub-study 2, living patients with CVC who are referred for CT scan without contrast, will be eligable for inclusion. After consent, the study will be carried out with photon counting CT in two phases. First, the examination for which the patient was referred, will be performed. In the second phase, a targeted examination is performed for research purposes of the vein with the CVC. Within 12 hours before or after the CT scan, it is planned to perform an ultrasound scan of the vein where the CVC is located. The aim is to evaluate the performance of ultrasound examination in detecting CVC-related thrombosis, compared to photon-counting CT. Sub-study 2 of PHOTO CAT includes Questions 4-6. Analysis of data and statistics No one has previously reported photon-counting CT to detect CVC-related thromboses. Therefore, the current exploratory study is planned. The results may form the basis for sample size calculation in future studies. Significance In patients with CVC, subclinical CVC-related thromboses are very common. These seem to cause surprisingly few clinical problems. However, it should be noted that several of the actual symptoms that CVC-related thrombosis can cause may go unnoticed or misinterpreted as symptoms of the disease that caused the patient's to need of a CVC. It is important to know the true incidence of subclinical CVC-related thrombosis in order to evaluate the risk-benefit of central venous access compared to alternatives (peripheral venous access, midline, PICCLINE, porth-a-cath), and in the development of new less thrombogenic CVC materials. ### Conditions Module **Conditions:** - Central Venous Catheter Thrombosis **Keywords:** - central venous catheter - thrombosis - photon counting ct ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Sub study 1, Diseased patients with an indwelling central venous catheter **Intervention Names:** - Diagnostic Test: Diseased patients with an indwelling central venous catheter who is referred to autopsy **Label:** Diseased patients with an indwelling central venous catheter #### Arm Group 2 **Description:** Living patients with an indwelling central venous catheter who are referred to a CT-scan without intravenous contrast **Intervention Names:** - Radiation: Living patients with an indwelling central venous catheter referred to a CT scan without iv contrast **Label:** Living patients with an indwelling central venous catheter ### Interventions #### Intervention 1 **Arm Group Labels:** - Diseased patients with an indwelling central venous catheter **Description:** Photon counting CT is performed and the results are compared to the results of the autopsy **Name:** Diseased patients with an indwelling central venous catheter who is referred to autopsy **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Living patients with an indwelling central venous catheter **Description:** Patients will be investigated using a photon counting CT. Prior to the investigation patients will be investigated with ultrasound. The results from the two modalities will be compared **Name:** Living patients with an indwelling central venous catheter referred to a CT scan without iv contrast **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Venous thrombosis related to a central venous catheter detected at autopsy **Measure:** The incidence of venous thrombosis related to a central venous catheter in diseased patients **Time Frame:** At autopsy **Description:** The performance of the photon counting CT will be evaluated by comparing the findings from the CT with the findings from the autopsy **Measure:** The performance of the photon counting CT on diseased patients **Time Frame:** After death. The CT scan and the autopsy will be performed within 1 week after death **Description:** The incidence of venous thrombosis related to a central venous catheter in living patients detected with a photon counting CT **Measure:** The incidence of venous thrombosis related to a central venous catheter in living patients **Time Frame:** At CT scan **Description:** The performance of ultrasound compared to the photon counting CT in detecting enous thrombosis related to central venous catheters **Measure:** The performance of ultrasound compared to the photon counting CT **Time Frame:** Ultrasound will be performed ±24 hours from the CT ### Eligibility Module **Eligibility Criteria:** Substudy 1 Inclusion Criteria: * Diseased patients with an indwelling central venous catheter and a clinical indication for autopsy * Informed and signed consent from next of kind Exclusion Criteria: * None Substudy 2 Inclusion Criteria * Living patients with an indwelling central venous catheter who are referred to a CT scan without iv contrast * Informed and signed consent from the patient Exclusion Criteria - GFR \<15 mL/min/1.73 m2 **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Substudy 1: Diseased patients with an indwelling central venous catheter and a clinical indication for autopsy Substudy 2: Living patients with an indwelling central venous catheter who are referred to a CT scan without iv contrast ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** thomas.kander@med.lu.se **Name:** Thomas Kander, PhD **Phone:** +4646171163 **Role:** CONTACT **Contact 2:** **Email:** emilia.angeby@med.lu.se **Name:** Emilia Ängeby Eriksson, MD **Phone:** +4646175155 **Role:** CONTACT #### Locations **Location 1:** **City:** Lund **Country:** Sweden **Facility:** Intensive and Perioperative Care. Skåne University Hospital. Lund **State:** Skåne **Zip:** 22185 #### Overall Officials **Official 1:** **Affiliation:** Lund University **Name:** Thomas Kander **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers may submit requests through the specified channel, detailing the purpose and proposed analyses. Approved applicants will sign a data access agreement, ensuring responsible and transparent use of the data. **Description:** Upon reasonable request, de-identified individual participant data from this clinical trial will be shared to facilitate scientific collaboration. **Info Types:** - STUDY_PROTOCOL - CSR **IPD Sharing:** YES **Time Frame:** After the publication of the study up to 3 years after the publication of the study ### References Module #### References **Citation:** Forauer AR, Theoharis C. Histologic changes in the human vein wall adjacent to indwelling central venous catheters. J Vasc Interv Radiol. 2003 Sep;14(9 Pt 1):1163-8. doi: 10.1097/01.rvi.0000086531.86489.4c. **PMID:** 14514808 **Citation:** Wichmann D, Heinemann A, Zahler S, Vogel H, Hopker W, Puschel K, Kluge S. Prospective study of device-related complications in intensive care unit detected by virtual autopsy. Br J Anaesth. 2018 Jun;120(6):1229-1236. doi: 10.1016/j.bja.2018.02.031. Epub 2018 Apr 4. **PMID:** 29793590 **Citation:** Rockholt MM, Naddi L, Badri AM, Englund E, Kander T. Macro- and microscopic changes in veins with short-term central venous catheters: an observational autopsy study. BMC Anesthesiol. 2024 Jan 2;24(1):5. doi: 10.1186/s12871-023-02380-x. **PMID:** 38166620 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020246 - Term: Venous Thrombosis ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16686 - Name: Thrombosis - Relevance: HIGH - As Found: Thrombosis - ID: M28601 - Name: Upper Extremity Deep Vein Thrombosis - Relevance: HIGH - As Found: Central Venous Catheter Thrombosis - ID: M22071 - Name: Venous 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: D000013927 - Term: Thrombosis - ID: D000056824 - Term: Upper Extremity Deep Vein Thrombosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417528 **Acronym:** CPoP **Brief Title:** Chronic Postsurgical Pain: Multivariate Prediction Model **Official Title:** Chronic Postsurgical Pain: Multivariate Prediction Model #### Organization Study ID Info **ID:** CPoP #### Organization **Class:** OTHER **Full Name:** Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva ### Status Module #### Completion Date **Date:** 2025-06-14 **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:** 2024-12-14 **Type:** ESTIMATED #### Start Date **Date:** 2022-12-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-03-19 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva #### Responsible Party **Investigator Affiliation:** Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva **Investigator Full Name:** Luigi Cardia **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:** The goal of this observational study is to identify the risk factors of Chronic Postoperative pain (or Chronic Post Surgery Pain - CPSP) three months after surgery and, subsequently. the development of a risk index to identify high-risk patients considering the multifactorial etiology of CPOP in adult patients undergoing any type of elective surgery. **Detailed Description:** The study aims to identify the risk factors of CPSP three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of CPSP. A comprehensive entry pool was derived from a systematic literature search. Data collection will record parameters at four different time points: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; postoperative period (from the third month after the operation). The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS (one-dimensional pain scale from 0 to 10) over the past three days and pain localized to the field surgical (or to the area of the lesion) projected into the innervation territory of a nerve located in this area, or referred to a dermatome. Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index. ### Conditions Module **Conditions:** - Post Surgical Pain - Post Operative Pain - Postoperative Pain, Chronic **Keywords:** - Pain - Chronic Pain - Postoperative Pain - Post Operative Pain - Post Surgical Pain - Multivariate Prediction Model - Prediction Model ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Data collection will record parameters of patients undergoing surgery at four different times: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; and postoperative period (from the third month following surgery). **Intervention Names:** - Procedure: Chronic Post Surgery Pain (CPSP) **Label:** Surgery Patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Surgery Patients **Description:** The outcome variable is the presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 on the NRS scale (11-point one-dimensional pain scale) in the last three days, and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area or referred to a dermatome. Separate prediction models will be developed using data derived from surveys conducted at the relevant time points for the development of the risk index. **Name:** Chronic Post Surgery Pain (CPSP) **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** * Primary version of the risk index, made up of items derived from a systematic bibliographic search (compilation of the item pool). * Authors will analyze the associations between each of these indices and the probability of CPSP 3 months after surgery (dichotomous variable), evaluated using logistic regression models. * Items that were found to be significant in the bivariate analyses will then be analyzed multivariately (logistic regression models). * Authors will safeguard the results of the multivariate analyses by calculating the area under the ROC curve of the model, and then, the cut-off score for a high risk of developing CPSP will be identified with an optimal compromise between sensitivity and specificity. * The items that will generate significant predictive factors in the logistic regression analyses will be collected into an index. For each value of this index, the Authors will calculate the proportion of patients who reported CPSP at 3 months after surgery. **Measure:** Development of the risk index **Time Frame:** 6 months after the primary completion of the study #### Primary Outcomes **Description:** Presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 points on the NRS scale (one-dimensional pain scale - from 0 to 10 points) in the last three days and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area, or referred to a dermatome. **Measure:** Chronic Post Surgery Pain (CPSP) **Time Frame:** 3 months #### Secondary Outcomes **Description:** * Age * 18-35 * 36-55 * ≥55 * Sex * Female * Male * BMI * ≤18.5 - 24.9 * 25 - 29.9 * ≥30 * Alcohol or substances of abuse (Y/N) (specify the substance) * Previous experience of pain NRS ≥5 for 7 days (Y/N) * Presence of chronic pathologies (Y/N) (if yes, provide the list of medications) * Pharmacological treatments including supplements or nutraceuticals (continuous in the last 3 months) (Y/N) (if yes, provide the list of drugs) * Chronic pain (NRS ≥3 for ≥3 months) (Y/N) * Neuropathic pain (Y/N) (assessment using Douleur Neuropathique en 4 questions DN-4 questionnaire) * Pain catastrophizing (Y/N) (assessment via Pain Catastrophizing Scale PCS questionnaire) * Anxiety (Y/N) (assessment using General Anxiety Disorder-7 GAD-7 questionnaire) * Depression (Y/N) (assessment using Beck Depression Inventory BDI-II questionnaire) * Presence of pain in the last three days (NRS ≥3 mean pain intensity in the 24 hours) (Y/N) **Measure:** Pre operative factors **Time Frame:** 60 to 1 day before the scheduled procedure **Description:** * Site of surgery * Head * Vertebral column * Arms/legs * Chest * Abdomen * Genitourinary system * Surgical technique * Open surgery * Minimally invasive surgery * Robotic surgery * ERAS (enhanced recovery after surgery) protocol (Y/N) * Anesthesiologic technique * General Anesthesia * Spinal Anesthesia * Epidural Anesthesia * Peripheral nerve block * Preventive/protective analgesia (Y/N) * Premedication (Y/N) * OFA opioid-free anesthesia protocol (Y/N) * Postoperative analgesic prescription (Y/N) **Measure:** Perioperative factors - before surgery **Time Frame:** The day of the scheduled surgery - before the surgery **Description:** * Pain NRS score ≥3 at the end of the surgery (Y/N) * Presence of pain (NRS ≥5 - average value in the 24 hours) in the region of the operation at rest or during movement after surgery (Y/N) * Analgesic prescription after surgery * ≤12 hours of coverage * 13-24 hours of coverage * ≥ 24 hours of coverage * Postoperative surgical complications (Y/N) * Postoperative infectious complications (Y/N) * Mobilization after surgery ≤6 hours? (Y/N) **Measure:** Perioperative factors - after surgery **Time Frame:** Immediately after the surgery to 48 hours after the surgery **Description:** * Pain assessment: average pain intensity assessed using a standard NRS scale (the cutoff score will be set at ≥3 mean pain intensity over the last three days ) (Y/N). * Diagnosis of CPSP (the pain is localized in the surgical field or in the area of the lesion, projected into the innervation territory of a nerve located in this area, or referred to a dermatome) (Y/N) * Surgical complications (Y/N) * Infectious complications related to surgery (Y/N) * Malignancy (Y/N) * Neuropathic pain (Y/N) (assessed using Douleur Neuropathique in 4 questions DN-4 questionnaire) **Measure:** Post operative factors **Time Frame:** 3 months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult Patients * Patients undergoing any type of elective surgery Exclusion Criteria: * Patients with sensory impairments * Patients unable to communicate * Patients with cognitive impairments * Patients with insufficent knowledge of the language **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients undergoing any type of elective surgery ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lcardia@unime.it **Name:** Luigi Cardia, MD; PhD **Phone:** +39 340 6946866 **Role:** CONTACT **Contact 2:** **Email:** alberto.noto@unime.it **Name:** Alberto Noto, MD; PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Messina **Contacts:** ***Contact 1:*** - **Name:** Luigi Cardia, MD: PhD - **Role:** CONTACT **Country:** Italy **Facility:** AOU G. Martino **Status:** RECRUITING ### References Module #### References **Citation:** Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available. **PMID:** 25844555 **Citation:** Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. **PMID:** 16698416 **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:** Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10. **PMID:** 16095934 **Citation:** Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011 Oct 6;11:770. doi: 10.1186/1471-2458-11-770. **PMID:** 21978149 **Citation:** Phillips CJ. Economic burden of chronic pain. Expert Rev Pharmacoecon Outcomes Res. 2006 Oct;6(5):591-601. doi: 10.1586/14737167.6.5.591. **PMID:** 20528505 **Citation:** Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319. **PMID:** 26241763 **Citation:** Turk DC, Fillingim RB, Ohrbach R, Patel KV. Assessment of Psychosocial and Functional Impact of Chronic Pain. J Pain. 2016 Sep;17(9 Suppl):T21-49. doi: 10.1016/j.jpain.2016.02.006. **PMID:** 27586830 **Citation:** Gerbershagen HJ, Dagtekin O, Rothe T, Heidenreich A, Gerbershagen K, Sabatowski R, Petzke F, Ozgur E. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009 Sep;13(8):853-60. doi: 10.1016/j.ejpain.2008.10.001. Epub 2008 Nov 14. **PMID:** 19010073 **Citation:** Mathes T, Pape-Kohler C, Moerders L, Lux E, Neugebauer EAM. External Validation and Update of the RICP-A Multivariate Model to Predict Chronic Postoperative Pain. Pain Med. 2018 Aug 1;19(8):1674-1682. doi: 10.1093/pm/pnx242. **PMID:** 29121211 **Citation:** Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23. **PMID:** 22337572 **Citation:** Sangesland A, Storen C, Vaegter HB. Are preoperative experimental pain assessments correlated with clinical pain outcomes after surgery? A systematic review. Scand J Pain. 2017 Apr;15:44-52. doi: 10.1016/j.sjpain.2016.12.002. Epub 2016 Dec 19. **PMID:** 28850344 **Citation:** Siao P, Cros DP. Quantitative sensory testing. Phys Med Rehabil Clin N Am. 2003 May;14(2):261-86. doi: 10.1016/s1047-9651(02)00122-5. **PMID:** 12795516 **Citation:** Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a. **PMID:** 19672167 **Citation:** Werner MU, Mjobo HN, Nielsen PR, Rudin A. Prediction of postoperative pain: a systematic review of predictive experimental pain studies. Anesthesiology. 2010 Jun;112(6):1494-502. doi: 10.1097/ALN.0b013e3181dcd5a0. **PMID:** 20460988 **Citation:** Abrishami A, Chan J, Chung F, Wong J. Preoperative pain sensitivity and its correlation with postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2011 Feb;114(2):445-57. doi: 10.1097/ALN.0b013e3181f85ed2. **PMID:** 21245740 **Citation:** Kuner R, Flor H. Structural plasticity and reorganisation in chronic pain. Nat Rev Neurosci. 2016 Dec 15;18(1):20-30. doi: 10.1038/nrn.2016.162. Erratum In: Nat Rev Neurosci. 2017 Feb;18(2):158. Nat Rev Neurosci. 2017 Jan 20;18(2):113. **PMID:** 27974843 **Citation:** Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6. **PMID:** 30983589 **Citation:** Campos ACP, Antunes GF, Matsumoto M, Pagano RL, Martinez RCR. Neuroinflammation, Pain and Depression: An Overview of the Main Findings. Front Psychol. 2020 Jul 31;11:1825. doi: 10.3389/fpsyg.2020.01825. eCollection 2020. **PMID:** 32849076 **Citation:** Tsepilov YA, Freidin MB, Shadrina AS, Sharapov SZ, Elgaeva EE, Zundert JV, Karssen Lcapital ES, Cyrillic, Suri P, Williams FMK, Aulchenko YS. Analysis of genetically independent phenotypes identifies shared genetic factors associated with chronic musculoskeletal pain conditions. Commun Biol. 2020 Jun 25;3(1):329. doi: 10.1038/s42003-020-1051-9. **PMID:** 32587327 **Citation:** Crofford LJ. Chronic Pain: Where the Body Meets the Brain. Trans Am Clin Climatol Assoc. 2015;126:167-83. **PMID:** 26330672 **Citation:** Diatchenko L, Fillingim RB, Smith SB, Maixner W. The phenotypic and genetic signatures of common musculoskeletal pain conditions. Nat Rev Rheumatol. 2013 Jun;9(6):340-50. doi: 10.1038/nrrheum.2013.43. Epub 2013 Apr 2. **PMID:** 23545734 **Citation:** Kalkman JC, Visser K, Moen J, Bonsel JG, Grobbee ED, Moons MKG. Preoperative prediction of severe postoperative pain. Pain. 2003 Oct;105(3):415-423. doi: 10.1016/S0304-3959(03)00252-5. **PMID:** 14527702 **Citation:** Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain. 2009 May;10(5):447-85. doi: 10.1016/j.jpain.2008.12.001. **PMID:** 19411059 **Citation:** Wang L, Guyatt GH, Kennedy SA, Romerosa B, Kwon HY, Kaushal A, Chang Y, Craigie S, de Almeida CPB, Couban RJ, Parascandalo SR, Izhar Z, Reid S, Khan JS, McGillion M, Busse JW. Predictors of persistent pain after breast cancer surgery: a systematic review and meta-analysis of observational studies. CMAJ. 2016 Oct 4;188(14):E352-E361. doi: 10.1503/cmaj.151276. Epub 2016 Jul 11. **PMID:** 27402075 **Citation:** Theunissen M, Peters ML, Bruce J, Gramke HF, Marcus MA. Preoperative anxiety and catastrophizing: a systematic review and meta-analysis of the association with chronic postsurgical pain. Clin J Pain. 2012 Nov-Dec;28(9):819-41. doi: 10.1097/AJP.0b013e31824549d6. **PMID:** 22760489 **Citation:** Hinrichs-Rocker A, Schulz K, Jarvinen I, Lefering R, Simanski C, Neugebauer EA. Psychosocial predictors and correlates for chronic post-surgical pain (CPSP) - a systematic review. Eur J Pain. 2009 Aug;13(7):719-30. doi: 10.1016/j.ejpain.2008.07.015. Epub 2008 Oct 25. **PMID:** 18952472 **Citation:** Meretoja TJ, Andersen KG, Bruce J, Haasio L, Sipila R, Scott NW, Ripatti S, Kehlet H, Kalso E. Clinical Prediction Model and Tool for Assessing Risk of Persistent Pain After Breast Cancer Surgery. J Clin Oncol. 2017 May 20;35(15):1660-1667. doi: 10.1200/JCO.2016.70.3413. Epub 2017 Mar 13. **PMID:** 28524782 **Citation:** Fink R. Pain assessment: the cornerstone to optimal pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):236-9. doi: 10.1080/08998280.2000.11927681. **PMID:** 16389388 **Citation:** Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. doi: 10.1016/0304-3959(95)00156-5. **PMID:** 8826494 **Citation:** Lempa M, Koch G, Neugebauer E, Kohler L, Troidl H. [How much pain is tolerable? Target expectations of surgical patients for pain therapy]. Chirurg. 2000 Oct;71(10):1263-9. doi: 10.1007/s001040051213. German. **PMID:** 11077589 **Citation:** Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20. **PMID:** 17182981 **Citation:** Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available. **PMID:** 32188600 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-11-02 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 334277 - Type Abbrev: Prot_SAP - Upload Date: 2024-03-08T05:38 ## 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: Postoperative Pain, Chronic - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Pain, Chronic - 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: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative - ID: D000059350 - Term: Chronic Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417515 **Brief Title:** The Potential Benefit of Xiao-Yao-San Treatment in Patients With Insomnia **Official Title:** Exploring Changes in Sleep Assessment of Patients With Sleep-related Diseases Treated by Chinese Medicine #### Organization Study ID Info **ID:** B-ER-107-174 #### Organization **Class:** OTHER **Full Name:** Tainan Hospital, Ministry of Health and Welfare ### Status Module #### Completion Date **Date:** 2019-11-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-11-30 **Type:** ACTUAL #### Start Date **Date:** 2019-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2021-08-08 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yu-Ching HSU #### Responsible Party **Investigator Affiliation:** Tainan Hospital, Ministry of Health and Welfare **Investigator Full Name:** Yu-Ching HSU **Investigator Title:** Tainan Hospital, Ministry of Health and Welfare **Type:** SPONSOR_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:** We recruited patients ages 20-65 from 2 groups in Tainan Hospital. One was from a weight loss class, also called WLC, one was from our regular clinic. These patients have no history of schizophrenia, narcolepsy, neurological disease, alcohol and drug addiction but had Pittsburgh Sleep Quality Index (PSQI) scores for psychometric properties ≥ 5 between January 1 to November 30 of 2019. The study group were the patients who received XYS for 28 days and the control group were those who didn't receive any Chinese medicine but attended the WLC. Age, gender, personal biodata, polysomnography findings, and these subjective sleep questionnaires were collected. The Wilcoxon test was used to compare the difference in pre and post evaluation in two groups. After comparing the objective and subjective assessment between the better and poorer performance in the XYS group, we would find more suitable criteria for XYS in traditional Chinese medicine. ### Conditions Module **Conditions:** - Insomnia, Chinese Herbs, Xiao-Yao-San, Polysomnography ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 19 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Received Xiao-Yao-San for 28 days **Intervention Names:** - Drug: Xiao Yao San **Label:** Xiao-Yao-San group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group were those who didn't receive any Chinese medicine but attended the weight loss class. **Intervention Names:** - Other: Weight loss class(WLC) group **Label:** weight loss class group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Xiao-Yao-San group **Description:** Patients who received XYS 9 g/day (Kaiser Pharmaceutical Co. Ltd.) were selected for the XYS group by traditional Chinese doctor with 8 years of experience. **Name:** Xiao Yao San **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - weight loss class group **Description:** Participants who attended the WLCs in our hospital and were willing to participate in our study were included in the WLC group (control group). Our WLCs consisted of 8 sessions of 2-hour dietary advice/exercise guidance and 1 session of weight-loss consultation in 3 months. The participants assessed their weights at the beginning, at 1.5 months, and after every class. They underwent pre-PSG tests in the beginning and post-PSG tests after 3 months of lectures. **Name:** Weight loss class(WLC) group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Sleep quality **Measure:** Pittsburgh Sleep Quality Index (PSQI) scores **Time Frame:** Up to 12 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 20- to 65-year-old patients. * Pittsburgh Sleep Quality Index (PSQI) scores ≥ 5. Exclusion Criteria: * Schizophrenia. * Narcolepsy. * Neurological diseases (history of stroke, neurodegenerative diseases, etc.). * Alcohol addiction. * Drug addiction. **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tainan **Country:** Taiwan **Facility:** Tainan Hospital, Ministry of Health and Welfare **Zip:** 708 #### Overall Officials **Official 1:** **Affiliation:** Tainan Hospital, Ministry of Health and Welfare **Name:** YU-CHING HSU **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases - 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 - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10356 - Name: Sleep Initiation and Maintenance Disorders - Relevance: HIGH - As Found: Insomnia - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake 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: D000007319 - Term: Sleep Initiation and Maintenance Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417502 **Brief Title:** Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry **Official Title:** Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry #### Organization Study ID Info **ID:** JS-3362D #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital #### Secondary ID Infos **Domain:** National Key R&D Program of China **ID:** 2021YFC2702000 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2031-12-31 **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:** 2024-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-04-29 **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 #### Collaborators **Class:** OTHER **Name:** Children's Hospital of Chongqing Medical University **Class:** OTHER **Name:** Central South University **Class:** OTHER **Name:** Beijing Children's Hospital **Class:** OTHER_GOV **Name:** Shenzhen Children's Hospital **Class:** OTHER **Name:** Children's Hospital of Nanjing Medical University **Class:** UNKNOWN **Name:** The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI) **Class:** OTHER **Name:** Zhejiang University **Class:** UNKNOWN **Name:** Third Hospital of Peking University #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Hongmei Song **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** An observational, multi-center, longitudinal registry study for Chinese pediatric patients with rheumatic and immunologic diseases. **Detailed Description:** Pediatric rheumatic and immunologic diseases severely impact the health of children and adolescents. Chinese Alliance of Pediatric Rheumatic \& Immunologic Diseases (CAPRID) was founded in 2022 to form a national collaboration for high-quality data-driven multi-center pediatric rheumatology and immunology research in China. The CAPRID Registry is an observational, multi-center, longitudinal registry for Chinese pediatric patients with rheumatic and immunologic diseases to explore the clinical phenotypes, diagnoses, complications, real-world drug safety, therapeutic efficacy, adverse events, critical illness and outcomes of Chinese pediatric patients with rheumatic and immunologic diseases. Hospital-based databases are established and standardized with Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) for routine data collection. A web-based registry website is established with standardized electronic case report forms to register patients from CAPRID centers. A mobile application is created to allow long-term follow up and patient-reported outcome collection. The data captured in this registry reflects a "real world" situation with no intervention done outside the routine clinical practice. Treatment plans are determined by the investigator. ### Conditions Module **Conditions:** - Autoimmune Diseases - Autoinflammatory Diseases **Keywords:** - Systemic Lupus Erythematosus - Juvenile Idiopathic Arthritis - Vasculitis - Juvenile Dermatomyositis - Sjogren's disease - Autoimmune - Autoinflammatory Disease - Scleroderma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 20000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Years ### Outcomes Module #### Primary Outcomes **Description:** Total number of patients with pediatric rheumatic and immunologic diseases enrolled in the registry **Measure:** Number of Enrolled Patients **Time Frame:** up to 10 years #### Secondary Outcomes **Description:** Visual Analog Score measurement of disease activity by physicians. The minimum value is 0 and the maximum is 10. **Measure:** Physician Global Assessment **Time Frame:** up to 10 years **Description:** Visual Analog Score measurement of disease activity by patient's parent or patient him or her self (above 8 years old). The minimum value is 0 and the maximum is 10. **Measure:** Patient or Parent Global Assessment **Time Frame:** up to 10 years **Description:** Defined by normal disease activity indexes (if available) and normal inflammatory markers (erythrocyte sedimentation rate and C-reactive protein). Disease activity indexes include Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) for systemic lupus erythematosus; Juvenile Arthritis Disease Activity Score (JADAS)-27 for juvenile idiopathic arthritis, Pediatric Vasculitis Activity Score (PVAS) for vasculitis; Manual Muscle Testing(MMT)8, Childhood Myositis Assessment Scale (CMAS) for juvenile dermatomyositis, Sjögren's syndrome disease activity index (ESSDAI) for Sjögren's syndrome, Modified Rodnan Skin Score for scleroderma. **Measure:** Proportion of Participants with Clinically Inactive Disease **Time Frame:** up to 10 years **Description:** Composite measure of functional disability, score from 0 (no disability) to 3 (severe disability) **Measure:** Childhood Health Assessment Questionnaire (CHAQ) **Time Frame:** up to 10 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \<= 18 years old * Diagnosed with rheumatic and immunologic diseases (including diffuse connective tissue diseases, arthritis, vasculitis, inborn errors of immunity) * Diagnosed and Treated in China Exclusion Criteria: * Disagreement of involving in this study by the patient or his/her family. **Maximum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Chinese children with pediatric rheumatic and immunologic diseases enrolled from CAPRID centers. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sihao.gao@gmail.com **Name:** Sihao Gao **Phone:** (+86) 010-6915-5727 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** songhm1021@126.com - **Name:** Hongmei Song, MD, PhD - **Phone:** +86-10-69156271 - **Role:** CONTACT ***Contact 2:*** - **Email:** sihao.gao@gmail.com - **Name:** Sihao Gao - **Phone:** +86-10-69156271 - **Role:** CONTACT ***Contact 3:*** - **Name:** Hongmei Song, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking Union Medical College Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100730 **Location 2:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Huawei Mao, MD, PhD - **Role:** CONTACT **Country:** China **Facility:** Beijing Children's Hospital, Capital Medical University **State:** Beijing **Status:** RECRUITING **Location 3:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** Zhiqiang Yan, PhD - **Role:** CONTACT **Country:** China **Facility:** Third Hospital of Peking University **State:** Beijing **Status:** RECRUITING **Location 4:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Name:** Xuemei Tang, MD - **Role:** CONTACT **Country:** China **Facility:** Chidren's Hospital of Chongqing Medical University **State:** Chongqing **Status:** RECRUITING **Location 5:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Name:** Jun Yang, MD - **Role:** CONTACT **Country:** China **Facility:** Shenzhen Children's Hospital **State:** Guangdong **Status:** RECRUITING **Location 6:** **City:** Shenzhen **Contacts:** ***Contact 1:*** - **Name:** Wanling Yang, PhD - **Role:** CONTACT **Country:** China **Facility:** The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI) **State:** Guangdong **Status:** RECRUITING **Location 7:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Name:** Xiaochuan Wu, MD - **Role:** CONTACT **Country:** China **Facility:** The Second Xiangya Hospital of Central South University **State:** Hunan **Status:** RECRUITING **Location 8:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Name:** Haiguo Yu, MD - **Role:** CONTACT **Country:** China **Facility:** Children's Hospital of Nanjing Medical University **State:** Jiangsu **Status:** RECRUITING **Location 9:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Name:** Meiping Lu, MD - **Role:** CONTACT **Country:** China **Facility:** Children's Hospital of Zhejiang University School of Medicine **State:** Zhejiang **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Hongmei Song, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** The Official Website for Chinese Alliance of Pediatric Rheumatic \& Immunologic Diseases (CAPRID) **URL:** https://caprid.pumch.cn ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Diseases - ID: M15412 - Name: Scleroderma, Systemic - Relevance: LOW - As Found: Unknown - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: LOW - As Found: Unknown - ID: M7077 - Name: Dermatomyositis - Relevance: LOW - As Found: Unknown - ID: M4479 - Name: Arthritis, Juvenile - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: LOW - As Found: Unknown - ID: M17405 - Name: Vasculitis - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: HIGH - As Found: Immunologic Diseases - ID: T5565 - Name: Systemic Scleroderma - Relevance: LOW - As Found: Unknown - ID: T1814 - Name: Dermatomyositis - Relevance: LOW - As Found: Unknown - ID: T3171 - Name: Juvenile Dermatomyositis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417489 **Brief Title:** Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients **Official Title:** Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin Compared to Sequential Metformin Therapy in Newly Diagnosed Type 2 Diabetes Patients #### Organization Study ID Info **ID:** 2024-165-002 #### Organization **Class:** OTHER **Full Name:** Peking University First Hospital ### 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:** 2024-05-11 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **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:** Peking University First 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 evaluated the efficacy and safety of initial combined treatment of Henggliptin, Retagliptin and Metformin by including new type 2 diabetes patients. This study is a multicenter, randomized, open label, positive control study. It is planned to include 160 new type 2 diabetes patients who meet the inclusion criteria of the study. The study is divided into three stages: screening period (V0, -14d-0), treatment period (V1-V8, D1-24w) and safe follow-up period (V9, 28w), with a total of 10 planned visits. This study was divided into an experimental group and a control group. The experimental group received a one-time addition of 10 mg qd of Henggliptin, 100 mg qd of Regagliptin, and 500mg of Metformin. The control group was first treated with metformin. If the blood sugar level did not meet the standard (fasting blood glucose (FPG)\&gt;7mmol/L, postprandial blood glucose (PPG)\&gt;10mmol/L), Henggeliflozin 10 mg qd was sequentially added. If the blood sugar level did not meet the standard after 4 weeks, Regagliptin 100 mg qd was added. During the follow-up period, evaluate blood glucose control, pancreatic islet function, and safety in both groups of patients. ### Conditions Module **Conditions:** - Type 2 Diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Henagliflozin Proline 10 mg qd+Regagliptin 100 mg qd+Metformin 500mg bid. The dose of metformin from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day. **Intervention Names:** - Drug: Combination therapy **Label:** Combination therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Metformin, the dose from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day. After the fourth week of treatment, blood glucose levels were measured. For those whose blood glucose levels did not meet the standard (fasting blood glucose (FPG)\>7mmol/L, postprandial blood glucose (PPG)\>10mmol/L), 10 mg qd of Henagliflozin Proline was sequentially added. If the blood glucose levels did not meet the standard after 4 weeks of treatment (FPG\>7mmol/L, PPG\>10mmol/L), 100 mg qd of Ruigeliflozin was added **Intervention Names:** - Drug: Sequential treatment group **Label:** Sequential treatment group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Combination therapy **Description:** Henagliflozin Proline 10 mg qd+Regagliptin 100 mg qd+Metformin 500mg bid. The dose of metformin from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient\&#39;s tolerance situation. The minimum dose is 1000mg/day. **Name:** Combination therapy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Sequential treatment group **Description:** Metformin, the dose from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient\&#39;s tolerance situation. The minimum dose is 1000mg/day. After the fourth week of treatment, blood glucose levels were measured. For those whose blood glucose levels did not meet the standard (fasting blood glucose (FPG)\&gt;7mmol/L, postprandial blood glucose (PPG)\&gt;10mmol/L), 10 mg qd of Henagliflozin Prolinewas sequentially added. If the blood glucose levels did not meet the standard after 4 weeks of treatment (FPG\&gt;7mmol/L, PPG\&gt;10mmol/L), 100 mg qd of Ruigeliflozin was added **Name:** Sequential treatment group **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Proportion of subjects with HbA1c<7% at 12w **Time Frame:** From enrollment to the end of treatment at 12 weeks #### Secondary Outcomes **Measure:** The proportion of subjects with HbA1c<7% at week 24 **Time Frame:** From enrollment to the end of treatment at 24 weeks **Measure:** The proportion of subjects with HbA1c<6.5% at 12 week **Time Frame:** From enrollment to the end of treatment at 12 weeks **Measure:** The proportion of subjects with HbA1c<6.5% at 24 week **Time Frame:** From enrollment to the end of treatment at 24 weeks **Measure:** Changes in HbA1c compared to baseline at 12 weeks **Time Frame:** From enrollment to the end of treatment at 12 weeks **Measure:** Changes in HbA1c compared to baseline at 24 weeks **Time Frame:** From enrollment to the end of treatment at 24 weeks **Measure:** Changes in fingertip blood glucose (seven point blood glucose spectrum) compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in 2hPPG compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in FBG compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in systolic pressure compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in diastolic pressure compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in body weight compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in waist circumference compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in eGFR compared to baseline at 4w, 8w, 12w, and 24w **Time Frame:** From enrollment to the end of treatment at 4/8/12/24 weeks **Measure:** Changes in C-peptide levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods **Time Frame:** From enrollment to the end of treatment at 12 and 24 weeks **Measure:** Changes in insulin levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods **Time Frame:** From enrollment to the end of treatment at 12 and 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Untreated newly diagnosed T2DM patients; 2. Age ≥ 18 years old; 3. 8.0% ≤ HbA1c\&lt;11.0%; 4. 19 kg/m2 ≤ BMI\&lt;35 kg/m2; 5. eGFR ≥ 60 ml/min1.73m2; 6. Voluntarily participate and sign an informed consent form Exclusion Criteria: 1. Pregnant and lactating women, as well as women of childbearing age who are unwilling to take reliable contraceptive measures; 2. Individuals who are known to be allergic to Henggliflozin, Regagliptin, or Metformin; 3. Other types of diabetes except type 2 diabetes; 4. Type 2 diabetes with a history of ketoacidosis (DKA) in the last 6 months; 5. NYHA cardiac grade IV patients; 6. Within 30 days prior to the screening visit, admission due to acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery; Or plan to undergo percutaneous coronary intervention or cardiac surgery within 3 months. 7. Confirmed respiratory system diseases (such as chronic obstructive pulmonary disease, pulmonary arterial hypertension, etc.); 8. History of acute or chronic pancreatitis; 9. Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (average of three supine blood pressure measurements) during screening visits; 10. Patients with orthostatic hypotension and/or systolic blood pressure\&lt;90 mmHg at visit 0 or visit 1, or clinically diagnosed as having low blood volume; 11. Diagnosed malignant tumor patients with an expected life expectancy of less than 1 year; 12. Patients with a history of recurrent urinary and reproductive tract infections (judged by clinical doctors); 13. Patients who participate in other clinical trials within 3 months; 14. Alcohol or drug addiction. 15. In addition to the above, the researchers determined that patients who are not suitable to participate in this clinical trial. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nan.gu@pkufh.cn **Name:** Junqing Zhang **Phone:** 8613611167278 **Role:** CONTACT ### 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 ### 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: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes - 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 - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M11667 - Name: Metformin - Relevance: LOW - As Found: Unknown - ID: T15 - Name: Proline - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417476 **Brief Title:** Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer **Official Title:** A Multicenter, Open, Randomized Phase II Trial：Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer #### Organization Study ID Info **ID:** B2022-714 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### 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:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2022-12-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-02-04 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Yunnan Cancer Hospital **Class:** OTHER **Name:** Liaoning Tumor Hospital & Institute **Class:** OTHER **Name:** Shantou Central Hospital **Class:** OTHER_GOV **Name:** Fujian Cancer Hospital **Class:** OTHER **Name:** Jiangsu Provincial People's Hospital #### Lead Sponsor **Class:** OTHER **Name:** Pei-Rong Ding #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Pei-Rong Ding **Investigator Title:** Clinical Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy, it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer. This approach aims to improve disease-free survival (DFS), while minimizing or circumventing the organ dysfunction and subsequent decline in quality of life associated with radical surgery. Consequently, we propose to initiate a multicenter clinical trial to examine the medium- and long-term effectiveness of complete neoadjuvant therapy (comprising either short-course radiotherapy or long-course chemoradiation, followed by consolidation chemotherapy with mFOLFOXIRI) in increasing organ preservation rates in patients with low rectal cancer. **Detailed Description:** This randomised, open-label, multicentre,phase II trial began in December, 2022, as a neoadjuvant trial about short-course radiotherapy or long-course chemoradiation followed by mFOLFOXIRI consolidation chemotherapy,in patients aged 18 years to 70 with clinical stage II-III locally advanced low rectal cancer from six Chinese institutions. Patients with local advanced rectal cancer (cT2-4aN0-2,M0, 8cm from the anus verge) were recruited. Patients receive short-course radiotherapy (25Gy/5 times) followed by consolidation chemotherapy lor ong-course chemoradiation (50Gy/25 times;capecitabine 825 mg/m² twice daily) with mFOLFOXIRI (Irinotecan 150 mg/m2 iv gtt (2h) d1, Oxaliplatin 85 mg/m2 iv gtt (2h) d1, Calcium folinate 400 mg/m2 iv gtt (2h) d1, Total amount of fluorouracil 2400 mg/m2 iv gtt (48h)), treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. The first efficacy evaluation occurs after the fourth chemotherapy cycle. Patients showing a complete response (CR), partial response (PR), or stable disease (SD) with reduction or stability in tumor size are advised to continue and complete all planned consolidation chemotherapy. However, if the evaluation indicates stable disease with an increase (SD increased) or progressive disease (PD), and if an R0 resection (complete removal of the tumor with no cancer cells at the margins) is feasible, radical total mesorectal excision (TME) should be pursued. In cases where R0 resection is not achievable, the treatment should align with the guidelines for managing unresectable rectal cancer. Upon the final efficacy assessment after the eighth chemotherapy cycle, several pathways are considered based on the outcomes: patients achieving a clinical complete response (cCR) may proceed to a Watch \& Wait approach. Those with a near clinical complete response (near cCR) undergo local transanal resection. If the patient's condition is evaluated as PR/SD with a reduction but does not qualify as near cCR, radical TME is recommended. For patients showing SD with an increase or PD, yet with a potential for R0 resection, radical TME is again the suggested course of action. If R0 resection is unattainable, treatment should adhere to the guidelines for unresectable rectal cancer. ### Conditions Module **Conditions:** - Rectal Neoplasms **Keywords:** - Neoadjuvant chemotherapy - Preoperative radiotherapy - Chemoradiotherapy - Consolidation chemotherapy - mFOLFOXIRI ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive short-course radiotherapy (25Gy/5 times) followed by consolidation chemotherapy with mFOLFOXIRI (Irinotecan 150 mg/m2 iv gtt (2h) d1, Oxaliplatin 85 mg/m2 iv gtt (2h) d1, Calcium folinate 400 mg/m2 iv gtt (2h) d1, Total amount of fluorouracil 2400 mg/m2 iv gtt (48h)), treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. The first efficacy evaluation occurs after the fourth chemotherapy cycle. If there is no progression (a complete response (CR), partial response (PR), or stable disease (SD) with reduction or stability in tumor size) , patients will proceed with an additional four cycles. Upon the final efficacy assessment after the eighth chemotherapy cycle, patients will received several pathways (watch \& wait approach; local resection;total mesorectal excision) are considered based on the assessments. **Intervention Names:** - Radiation: Short-course radiotherapy - Drug: Irinotecan - Drug: Oxaliplatin - Drug: Calcium Formate - Drug: Fluorouracil **Label:** Short-course radiotherapy followed by consolidation chemotherapy with mFOLFOXIRI **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receive long-course chemoradiation (50Gy/25 times;capecitabine 825 mg/m² twice daily) followed by consolidation chemotherapy with mFOLFOXIRI (Irinotecan 150 mg/m2 iv gtt (2h) d1, Oxaliplatin 85 mg/m2 iv gtt (2h) d1, Calcium folinate 400 mg/m2 iv gtt (2h) d1, Total amount of fluorouracil 2400 mg/m2 iv gtt (48h)), treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. The first efficacy evaluation occurs after the fourth chemotherapy cycle. If there is no progression (a complete response (CR), partial response (PR), or stable disease (SD) with reduction or stability in tumor size) , patients will proceed with an additional four cycles. Upon the final efficacy assessment after the eighth chemotherapy cycle, patients will received several pathways (watch \& wait approach; local resection;total mesorectal excision) are considered based on the assessments. **Intervention Names:** - Drug: Irinotecan - Drug: Oxaliplatin - Drug: Calcium Formate - Drug: Fluorouracil - Radiation: Long-course chemoradiation - Drug: Capecitabine **Label:** Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Short-course radiotherapy followed by consolidation chemotherapy with mFOLFOXIRI **Description:** The total dosage was 25Gy consisted of 5 fractions of 5 Gy to clinical target volume without a boost dose **Name:** Short-course radiotherapy **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI - Short-course radiotherapy followed by consolidation chemotherapy with mFOLFOXIRI **Description:** 150 mg/m² iv drip over 2 hours on day 1, repeated every 14 days. **Name:** Irinotecan **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI - Short-course radiotherapy followed by consolidation chemotherapy with mFOLFOXIRI **Description:** 85 mg/m² iv drip over 2 hours on day 1, repeated every 14 days. **Name:** Oxaliplatin **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI - Short-course radiotherapy followed by consolidation chemotherapy with mFOLFOXIRI **Description:** 400 mg/m² iv drip over 2 hours on day 1, repeated every 14 days. **Name:** Calcium Formate **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI - Short-course radiotherapy followed by consolidation chemotherapy with mFOLFOXIRI **Description:** 2400 mg/m² iv drip over 48 hours on day 1-2, repeated every 14 days. **Name:** Fluorouracil **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI **Description:** The total dosage was 50Gy consisted of 25 fractions of 2 Gy to clinical target volume without a boost dose **Name:** Long-course chemoradiation **Type:** RADIATION #### Intervention 7 **Arm Group Labels:** - Long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI **Description:** 825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week. **Name:** Capecitabine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The percentage of patients attaining a complete clinical response (cCR) or near-complete clinical response (near-cCR) following neoadjuvant therapy, who then proceeded with non-surgical management or local excision, was monitored under a Watch \& Wait strategy or for 1 year post-local resection without undergoing radical surgery. **Measure:** Organ preservation rate **Time Frame:** Up to 1 years #### Secondary Outcomes **Description:** The definition of a cCR is (1) substantial downsizing with no residual tumor or residual fibrosis only (with low signal on high b-value DWI, if available), shown in Figure 1. Residual wall thickening due to edema only was also an indication for a possible cCR ; (2) no suspicious lymph nodesonMRI; (3) no residual tumor at endoscopyor onlya small residual erythematousulcer or scar; (4) negative biopsiesfromthe scar, ulcer, orformertumorlocation;and (5)nopalpabletumor,wheninitially palpable with digital rectal examination **Measure:** Clinical complete response **Time Frame:** Up to 24 weeks **Description:** Pathological response will be made based on assessment of the surgical specimen at the primary treatment site. This assessment is made in addition to the AJCC 7th edition summary staging. A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include: No evidence of malignant cells in the primary tumor specimen No lymph nodes that contain tumor. The definition of a non-pCR will include any surgical specimen that has any evidence of residual tumor manifest in the primary or regional lymph nodes. For patients who do not meet criteria for a pCR, the extent of response to preoperative therapy will be graded using the Tumor Regression Grade (TRG) schema that is included in the AJCC 7th edition. This was also used by Rodel in the pre/postoperative rectal cancer study and was subsequently adopted by the AJCC \[Rodel (JCO 2005; 23:8688-8696)\]. **Measure:** Pathological complete response **Time Frame:** Up to 24 weeks **Description:** Near-cCR suggests a significant reduction in tumor size and extent, but with slight evidence of disease that stops short of the criteria for a complete clinical response, which is the total disappearance of all signs of cancer in response to treatment. **Measure:** Near clinical complete response **Time Frame:** Up to 24 weeks **Description:** The time interval between the date of randomization and the date of the first cancer-related event, second cancer, or death from any cause, whichever occurred first. **Measure:** Disease free survival **Time Frame:** Up to 3 years **Description:** The time interval between the date of randomization to the date of death. If the patient has been alive, the time until the last follow-up is taken as the overall survival period. **Measure:** Overall survival **Time Frame:** Up to 3 years **Description:** The local surgery rate is defined as the proportion of patients who undergo surgical intervention limited to the area of the primary tumor site, without extensive removal of surrounding tissue or organs. **Measure:** Local surgery rate **Time Frame:** Up to 24 weeks **Description:** The local recurrence rate refers to the proportion of patients in whom cancer returns at the site of the original tumor after treatment. **Measure:** Local recurrence rate **Time Frame:** Up to 3 years **Description:** The distant metastasis rate is defined as the proportion of patients who develop metastases at sites remote from the primary tumor location after initial treatment. **Measure:** Distant metastasis rate **Time Frame:** Up to 3 years **Description:** The time interval between the date of randomization and the date of the first cancer-related event, second cancer, or death from any cause, whichever occurred first. **Measure:** Relapse-free survival **Time Frame:** Up to 3 years **Description:** Stoma-free survival is defined as the duration of time during which a patient with cancer, particularly colorectal or rectal cancer, remains alive without the need for a stoma following treatment. **Measure:** Stoma-free survival **Time Frame:** Up to 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Diagnosis: Histologically confirmed rectal adenocarcinoma. Preoperative Staging: Clinical stages cT2-4aN0-2. Tumor Location: Tumor's lower edge within 8cm from the anus, potentially affecting anal preservation or function. Metastasis Screening: Preoperative chest, abdomen, and pelvis CT to rule out distant metastasis. Biomarkers: Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry. Staging Methods: Combination of thoracic and abdominal pelvic CT, pelvic MRI, and endoscopic or transrectal ultrasound. Patient Characteristics Age: 18 to 70 years. Performance Status: ECOG score of 0-1. Life Expectancy: At least 2 years. Blood Counts: WBC \>4000/mm\^3, PLT \>100,000/mm\^3, Hb \>10g/dL (chronic anemia with Hb \< 10.0g/dL subject to multidisciplinary team review). Liver Function: Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome); AST and ALT ≤2.5×ULN. Renal Function: Serum creatinine ≤1.5×ULN or creatinine clearance \>50 mL/min. Other Criteria: Non-pregnant, not nursing, no other malignancies (except non-melanoma skin cancer or cervical carcinoma in situ) within the past 5 years, capable of providing informed consent, no severe comorbidities affecting survival. Prior Treatment No prior surgery, chemotherapy, or radiotherapy for rectal cancer. No prior biological therapy. No restrictions on previous endocrine therapy. Exclusion Criteria: Informed Consent: Lack of signed informed consent. Genetic Markers: Tumor biopsy indicating dMMR or MSI-H detected. Advanced Tumor Stage: Preoperative assessment showing tumor invasion of surrounding tissues/organs (T4b). Obstruction: Unresolved colonic obstruction; presence of tumor perforation. Metastasis: Evidence of preoperative distant metastasis. Cardiac Conditions: Arrhythmia requiring antiarrhythmic therapy (excluding beta-blockers or digoxin), symptomatic coronary artery disease or recent myocardial ischemia (within 6 months), or congestive heart failure above NYHA Grade II. Hypertension: Severe, poorly controlled hypertension. Infections: HIV infection, active chronic hepatitis B or C, other serious infections; active tuberculosis or anti-TB therapy within the past year. Organ Function: Poor fluid quality, organ function decompensation. Previous Treatment: History of pelvic or abdominal radiotherapy; multiple primary colorectal cancers. Neurological Conditions: Seizures requiring management (e.g., steroids, antiepileptic therapy). Cancer History: Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin. Substance Abuse: Substance abuse or medical, psychological, or social conditions affecting study participation or result evaluation. Allergies: Known or suspected allergy to study drugs or related medications. Stability: Any unstable condition that may compromise safety or compliance. Reproductive Status: Pregnant or lactating women, or fertile women not using effective contraception. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dingpr@sysucc.org.cn **Name:** Peirong Ding, MD, Ph D **Phone:** 13543478645 **Phone Ext:** +86 **Role:** CONTACT **Contact 2:** **Email:** hankai@sysucc.org.cn **Name:** Kai Han, MD, Ph D **Phone:** 18602042643 **Phone Ext:** +86 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** dingpr@sysucc.org.cn - **Name:** Peirong Ding, Doctor - **Phone:** 13543478645 - **Phone Ext:** +86 - **Role:** CONTACT ***Contact 2:*** - **Email:** hankai@sysucc.org.cn - **Name:** Kai Han, Doctor - **Phone:** 18602042643 - **Phone Ext:** +86 - **Role:** CONTACT **Country:** China **Facility:** 651 Dongfeng Road East **State:** Guangdong **Status:** RECRUITING **Zip:** 510060 #### Overall Officials **Official 1:** **Affiliation:** Sun Yat-sen University **Name:** Peirong Ding, MD, Ph D **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14846 - Name: Rectal Neoplasms - Relevance: HIGH - As Found: Rectal Neoplasms - ID: M17890 - Name: Colorectal Neoplasms - 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: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012004 - Term: Rectal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: Infection - ID: M377 - Name: Capecitabine - Relevance: HIGH - As Found: Function - ID: M6191 - Name: Leucovorin - Relevance: LOW - As Found: Unknown - ID: M8600 - Name: Fluorouracil - Relevance: HIGH - As Found: According - ID: M29233 - Name: Levoleucovorin - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: HIGH - As Found: Outcomes - ID: M5381 - Name: Calcium - Relevance: HIGH - As Found: Double-blind - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - 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: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069287 - Term: Capecitabine - ID: D000005472 - Term: Fluorouracil - ID: D000077150 - Term: Oxaliplatin - ID: D000077146 - Term: Irinotecan - ID: D000002118 - Term: Calcium ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417463 **Brief Title:** Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules **Official Title:** Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules #### Organization Study ID Info **ID:** Soh-Med-24-04-05MS #### Organization **Class:** OTHER **Full Name:** Sohag University ### Status Module #### Completion Date **Date:** 2024-10-12 **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:** 2024-10-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-12 **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 #### Lead Sponsor **Class:** OTHER **Name:** Sohag University #### Responsible Party **Investigator Affiliation:** Sohag University **Investigator Full Name:** Keroless Nagy Boles **Investigator Title:** resident at general surgery department sohag university hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** role of TIRADS and Bethesda scoring system in management of thyroid nodules as these methods are ultrasound clasification that helps increase the diagnostic effectiveness of thyroid nodules and reduces the use of preopeative FNA .that nodules are usually divided into diffent categories based on TIRADS and are then referred to FNA and follow up according to variable risk of maligneny. **Detailed Description:** this study is an observational study will be conducted on patiend with thyroid nodules will be admitted to general surgical department at sohag university hospital . patients will be approved to have single or multinodular goitre and thyroid nodules more than 1 cm . thyroid nodules are very common disease with great clinical importance although most cases are benign and only 4.5% to 6.5% are malignant ... itis necessary to distinguish those cases to reduce frequency of unnecessary thyroidectomies ... ultrasound classification and Fine needle aspiration (FNA) are first line diagnostic procedures and help in decrease cases undergoing unnecessary thyroidectomies as 50% of the nodules removed recently are malignant and the number of patients undergoing surgery is significantly reduced. ### Conditions Module **Conditions:** - Thyroid Nodule ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** correlation between TIRADS and Bethesda scoring system (preoperative) and final histopathology (postoperative) in cases of thyroidectomy **Name:** thyroidectomy opeartion **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** correlation between TIRADS and Behtesda scoring systems (preoperative) and final histopathology (post opeartive) in cases of thyroidectomy **Measure:** managemnt thyroid nodules **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients will proved to have single or multinodular goitre thyroid nodules more than 1cm Exclusion Criteria: * thyroid nodules less than 1 cm history of thyroid surgery history of radiotherapy **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** patients will proved to have single or multinodular goitre \& patients with thyroid nodules more than 1 cm ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kerloesnagy@med.sohag.edu.eg **Name:** kerloes N boulis, resident **Phone:** 01287533690 **Role:** CONTACT #### Locations **Location 1:** **City:** Sohag **Contacts:** ***Contact 1:*** - **Name:** Magdy M Amin, professor - **Role:** CONTACT **Country:** Egypt **Facility:** Sohag university Hospital **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** AlSaedi AH, Almalki DS, ElKady RM. Approach to Thyroid Nodules: Diagnosis and Treatment. Cureus. 2024 Jan 13;16(1):e52232. doi: 10.7759/cureus.52232. eCollection 2024 Jan. **PMID:** 38352091 **Citation:** Bojunga J, Trimboli P. Thyroid ultrasound and its ancillary techniques. Rev Endocr Metab Disord. 2024 Feb;25(1):161-173. doi: 10.1007/s11154-023-09841-1. Epub 2023 Nov 10. **PMID:** 37946091 **Citation:** Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500. **PMID:** 29091573 **Citation:** Pemayun TG. Current Diagnosis and Management of Thyroid Nodules. Acta Med Indones. 2016 Jul;48(3):247-257. **PMID:** 27840362 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000013964 - Term: Thyroid Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M18986 - Name: Thyroid Nodule - Relevance: HIGH - As Found: Thyroid Nodules - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016606 - Term: Thyroid Nodule - ID: D000013959 - Term: Thyroid Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417450 **Brief Title:** Usefulness of NESA Microcurrents in the Treatment of Children With Autism Spectrum Disorders **Official Title:** Utility of NESA Microcurrents in the Treatment of Sleep Disturbances, Disruptive Behaviours of Children With Autism Spectrum Disorders and in the Quality of Life of the Family Unit. #### Organization Study ID Info **ID:** NESATEA #### Organization **Class:** OTHER **Full Name:** University of Las Palmas de Gran Canaria ### Status Module #### Completion Date **Date:** 2024-09-13 **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:** 2024-07-13 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **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 Las Palmas de Gran Canaria #### Responsible Party **Investigator Affiliation:** University of Las Palmas de Gran Canaria **Investigator Full Name:** Aníbal Báez Suárez **Investigator Title:** Clinical 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 term or definition of Autism Spectrum Disorder (ASD) defines a pervasive neurodevelopmental disorder in which deficits in communication and social interaction, altered sensorimotor behaviours, repetitive, restricted and stereotyped interests and activities are observed. One of the disorders most frequently associated with ASD, and which most affects the quality of life of the child and his or her family, is sleep disorders; it is estimated that between 50 and 80 percent of children with ASD present this alteration and generally continue to suffer from it in adolescence and adulthood; It has also been observed that there is a correlation between sleep problems and an increase in aggressive behaviour, social and emotional deficits and deficits in activities of daily living, which severely affects the child and his or her close family environment; they become emotionally destabilised in a notorious way, and this has a negative impact on their work and productive environment. The microcurrents generated by the non-invasive neuromodulation device introduce, by means of a non-invasive technique (surface electrodes), electrical energy to normalise the nervous stimulus. This makes it an excellent complementary treatment to the activity of rehabilitation treatment. Its effects are achieved by establishing several input nerve pathways corresponding to the body's dermis, through which the signals are intellectualised in time-space. These signals are the basis for achieving normalisation of the nerve impulse by means of microcurrents. **Detailed Description:** The main objective will be to test the influence of surface neuromodulation applied NESA on sleep disturbances in children with Autism Spectrum Disorders and how this is related to disruptive behaviours and quality of life in the family environment. It is estimated to take 8 months from the design, management and development of the project, and does not have sources of funding. ### Conditions Module **Conditions:** - Autism Spectrum Disorder **Keywords:** - physical therapy modality - sleep disorder - Quality of Life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level. **Intervention Names:** - Device: Non-invasive Neuromodulation **Label:** Non-invasive Neuromodulation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Intervention with electrical stimulation: application of 6 electrodes per extremity and an adhesive electrode at C7 level. **Intervention Names:** - Device: Placebo Non-invasive Neuromodulation **Label:** Placebo Non-invasive Neuromodulation **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Non-invasive Neuromodulation **Description:** Patients receive non-invasive neurostimulation through the Nesa device **Name:** Non-invasive Neuromodulation **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Placebo Non-invasive Neuromodulation **Description:** The same protocol described for the experimental group will be applied, but electrical stimulation device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents. **Name:** Placebo Non-invasive Neuromodulation **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** The responses experienced by the participant will be observed during the session. As the procedure is sensory imperceptible and easy to handle, it will allow the participant to carry out activities (school/rehabilitation) simultaneously. **Measure:** Recording of adverse phenomena **Time Frame:** From the start of treatment to the end of treatment (2 months) #### Primary Outcomes **Description:** The Sleep Disturbance Scale for Children (SDSC) will be used. The SDSC is a 26-item scale developed to assess the presence of sleep difficulties in children within the previous six months. The measure is completed by the parent of the child and takes approximately 5-10 min to complete. Item 1 measures the child's average hours of sleep, from 1 ('9 - 11 h') to 5 ('less than 5 h'). **Measure:** Change in sleep quality with the Sleep Disturbance Scale for Children (SDSC) **Time Frame:** Measurement of change: before treatment (baseline), at two months (end of treatment). **Description:** Each scored question is rated on a 3-point scale as occurring "usually" (i.e., 5-7 times within the past week), "sometimes" (i.e., 2-4 times within the past week), or "rarely" (i.e., never or 1 time within the past week). **Measure:** Measuring sleep habits with the Children's Sleep Habits Questionnaire scale **Time Frame:** Measurement of change: before treatment (baseline), at two months (end of treatment). **Description:** The investigators want to see if there are improvements in the quality, efficiency, and quantity of sleep. The Pittsburgh Sleep Quality Index (PSQI) will be combined to report changes in the patient's sleep quality. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep **Measure:** Change in parent´s sleep quality with the Pittsburgh Sleep Quality Index (PSQI) **Time Frame:** Measurement of change: before treatment (baseline), at two months (end of treatment). #### Secondary Outcomes **Description:** The Aberrant Behavior Checklist (ABC-C) is a 58-item rating scale derived by factor analysis, and its five subscales are labelled as follows: I- Irritability (15 items); II- inactivity-isolation (16 items); III- stereotypies (7 items); IV- Hyperactivity, non-compliance (16 items) and V- inappropriate language (4 items). The ABC-C is easy to use, it is completed by an informant such as a teacher, therapist, monitor, parent or other adult who has regular contact with the patient. Each behavioural item is rated on a four-point scale from 0 (not a problem) to 3 (problem is severe). **Measure:** Changes to the Register of Disruptive Behaviour Scores with the Aberrant Behavior Checklist (ABC-C) **Time Frame:** Measurement of change: before treatment (baseline), at two months (end of treatment). **Description:** The Parenting Stress Index-Short Form (PSI-SF) is one of the most commonly used measures of parenting stress both in clinical and research contexts. The PSI-SF is a 36-item, self-report measure with three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (PCDI), and Difficult Child (DC). To compute the parental stress score, items 1, 2, 5, 6, 7, 8, 17, and 18 should be reverse scored as follows: (1=5) (2=4) (3=3) (4=2) (5=1). The item scores are then summed. Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress. **Measure:** Change in the stress level of parents with the Change in the stress level of parents **Time Frame:** Measurement of change: before treatment (baseline), at two months (end of treatment). **Description:** The 19-item PSQ assesses parents' cognitions and perceptions regarding the degree and kind of support they provide to their child following the discovery of sexual abuse. The measure yields a total score and scores on Support and Blame subscales **Measure:** Change in parental satisfaction with the Parent Satisfaction Questionnaire (PSQ - FS) **Time Frame:** Measurement of change: before treatment (baseline), at two months (end of treatment). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children with a diagnosis of Autistic Spectrum Disorder, attending school in the City of San Juan de Dios in Las Palmas de Gran Canaria. * Children with symptoms related to sleep disturbances. * Children who present episodes of disruptive behaviour. * Children who may present sensory alterations or cognitive deficits. * Children whose parents sign the informed consent form. Exclusion Criteria: * Present some of the contraindications for treatment with NESA XSIGNAL®: pacemakers, internal haemorrhages, not applying electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity. * If parents do not sign the informed consent form. * Presence of uncontrolled convulsions. **Maximum Age:** 18 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** anibal.baez@ulpgc.es **Name:** Aníbal Báez Suárez, PhD **Phone:** +34 928 45 14 11 **Role:** CONTACT #### Locations **Location 1:** **City:** Las Palmas de Gran Canaria **Contacts:** ***Contact 1:*** - **Email:** anibal.baez@ulpgc.es - **Name:** Anibal Báez, Professor - **Phone:** +34652077692 - **Role:** CONTACT ***Contact 2:*** - **Name:** Aníbal Báez Suárez, Professor - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Martín Eduardo Vílchez Barrera, Professor - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Iraya Padrón Rodríguez, MSc - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Irma Diana Lozano Céspedes, MSc - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Kiowa Cira Álamo Rincón, MSc - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Ana Navarro Said, MSc - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** María del Pilar Etopa Batista, Professor - **Role:** SUB_INVESTIGATOR ***Contact 9:*** - **Name:** Andrea María Hernández Pérez, MSc - **Role:** SUB_INVESTIGATOR **Country:** Spain **Facility:** University of Las Palmas de Gran Canaria **State:** Las Palmas **Status:** RECRUITING **Zip:** 35016 #### Overall Officials **Official 1:** **Affiliation:** University of Las Palmas de Gran Canaria **Name:** Aníbal Báez Suárez, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Parr J. Autism. BMJ Clin Evid. 2010 Jan 7;2010:0322. **PMID:** 21729335 **Citation:** Moss AH, Gordon JE, O'Connell A. Impact of sleepwise: an intervention for youth with developmental disabilities and sleep disturbance. J Autism Dev Disord. 2014 Jul;44(7):1695-707. doi: 10.1007/s10803-014-2040-y. **PMID:** 24442795 **Citation:** Souders MC, Zavodny S, Eriksen W, Sinko R, Connell J, Kerns C, Schaaf R, Pinto-Martin J. Sleep in Children with Autism Spectrum Disorder. Curr Psychiatry Rep. 2017 Jun;19(6):34. doi: 10.1007/s11920-017-0782-x. **PMID:** 28502070 **Citation:** Hirata I, Mohri I, Kato-Nishimura K, Tachibana M, Kuwada A, Kagitani-Shimono K, Ohno Y, Ozono K, Taniike M. Sleep problems are more frequent and associated with problematic behaviors in preschoolers with autism spectrum disorder. Res Dev Disabil. 2016 Feb-Mar;49-50:86-99. doi: 10.1016/j.ridd.2015.11.002. Epub 2015 Dec 10. **PMID:** 26672680 ## Derived Section ### Condition Browse Module - Ancestors - 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 - Abbrev: BC10 - Name: Nervous System Diseases ### 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: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: HIGH - As Found: Autism Spectrum Disorder - 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 - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001321 - Term: Autistic Disorder - ID: D000067877 - Term: Autism Spectrum Disorder - ID: D000002659 - Term: Child Development Disorders, Pervasive ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417437 **Brief Title:** Non-invasive BCI and Application Verification for Depressed People **Official Title:** New Non-invasive Brain-computer Interface: Theory, Technology and Application Demonstration - Studies on and Intervention for Depressed People Based on Non-invasive BCI and Application Verification #### Organization Study ID Info **ID:** 2022ZD0208505 #### Organization **Class:** OTHER **Full Name:** Shanghai Mental Health Center ### Status Module #### Completion Date **Date:** 2027-07-31 **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:** 2027-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-07-01 **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:** 2024-05-12 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Fourth People's Hospital of Chengdu **Class:** OTHER **Name:** Shanghai Jiao Tong University School of Medicine **Class:** OTHER **Name:** University of Electronic Science and Technology of China **Class:** UNKNOWN **Name:** East China Normal University #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Mental Health Center #### 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:** Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is approximately 30 million people. At present, due to the lack of neurobiological markers for screening and diagnosing depression, the identification and diagnosis of MDD are based on the judgment of professional doctors, and the treatment mostly relies on clinical symptoms. In terms of treatment, medication remains the main stream for MDD. Although current methods have certain therapeutic effects, patients still suffer from various side effects and poor cognitive function.In current clinical practice, relying purely on symptomatic diagnosis and treatment is difficult to meet the needs of clinical practice, so there is an urgent need to search for neurobiological markers in depression and develop targeted non-invasive intervention technologies. This study aims to combine advanced brain imaging technology, digital twin-brain models, multi-source information decoding technology, integrated detection and intervention technology. The target is to create two new types of non-invasive BCI systems that can regulate emotions. One is a intervention BCI system for MDD that is suitable for hospital settings with the purpose of precise physical stimulation, and the other one is an ecological BCI system that regulate emotions and intervene with depression which is suitable for both hospital settings and future family environments. This study will collect a comprehensive collection of physiological and biochemical indicators from patients with depression and from healthy control groups, as well as multimodal information such as head surface electroencephalography, MRI, and eye movements under different brain states, to personalize the available BCI information of depression related brain regions, circuits, and networks. The study also tries to explore emotional-interactive games that can intervene with depression and build a game data base that is dedicated to MDD. Other goals include designing and establishing two new types of emotional regulation systems, which are precise external physical stimulation intervention and ecological intervention, constructing a BCI regulation system, and conducting application verification to evaluate the regulation effect. **Detailed Description:** This study aims to establish a BCI regulation scheme and system for individuals with mdd, and to conduct validation for this application. Four more detailed contents are being designed, including 1. providing biological markers in brain regions, circuits, and networks that are probably related to MDD, 2. assessment models of the state of brain and multivariate signal mapping models, 3. virtual regulation paradigms, evaluations on the effect of the regulation , and 4. multimodal information collection and regulation software and hardware technologies. Shanghai Mental Health Center, as the sponsor institution, tends to recruit MDD patients from daily outpatient service. The paticipants' personal information will be noted and then the patients will undergo different assessment on their level of depression, anxiety, anhedonia, manic state, cognitive status, effect and side effects of the current treatment, and their biological rhythm, sleep, quality of life, etc. Peripheral blood will be drawn for different potential biomarkers, as well as multimodal information such as EEG, eye movement, magnetic resonance imaging, magnetoencephalogram, fNIRS, and etc. Then compare the following laboratory indicators between depressed patients and healthy individuals such as differences in the concentration and gene expression of peripheral blood inflammatory factors, oxidative stress indicators, brain-derived neurotrophic factors, brain imaging, electrophysiology, blood oxygen and etc. The work above is to obtain specific neurobiological markers of MDD. Intervention measures are as follows: 1. Traditional medication with SSRIs. MDD patients will be give different SSRIs medication and undergo a two-week treatment, after which the above assessments will be done again to evaluation the efficacy and side effects of the current treatment. For MDD patients with anhedonia, other medication can be considered such as Voxetine and Bupropion. 2. rTMS combined with traditional SSRIs medication. The current brain regions chosen for rTMS include dorsolateral pre-frontal cortex. In this part, the study tends to find out new potential brain regions suitable for physical treatment in MDD patients. The considered brain regions include orbitofrontal cortex, cerebellum and others. It uses a classic 8-shaped coils, butterfly coils, deep coils, etc., neural navigation to locate stimulation targets. 3. Treatment based on neurobiological feedback. In this kind of treatment, MDD patients are treated with neurobiological feedback and will be monitored by EGG to catch unique and specific brain waves that may considered only found in MDD patients. This treatment involves using different psychological paradigms including classic cognitive research paradigms to evaluate the outcome of neuron-training and cognitive function after treatment. Other technologies used in this study includes: 1. Functional Magnetic Resonance Imaging. Brain images will be captures during different functional tasks such as emotional matching, Monetary Incentive Delay Task ( MID ). These images will be further analyzed to figure out the neuro-mechanism of MDD. We will be using 3T Siemens PRISMA, collecting data of rs-fMRI、DTI、T1、T2 and fMRI. 2. Electroencephalography. In this part, the investigators will be using the DSI-24 wireless dry electrode EEG system. Each subject will undergo EEG collection experiments, at least collecting EEG data in a resting state (with eyes closed and open). 3. Eye movement detection. Eye movement will be traced using Tobii Pro Spectrum. 4. Functional Near-Infrared Spectroscopy. Patients will perform different tasks under the monitoring of a portable fNIRS device called Nirsport2 wireless wearable NIRS imaging system. It consists of a 8-channel LED illuminator and 8-channel active sensor for fiberless optical detection. During the tasks, the device will provide the value and changes in the level of oxyhemoglobin and deoxygenated hemoglobin observed in the subjects. 5. Magnetoencephalogram. MEG is a completely non-invasive function detection technique, widely used in the development and research of brain function and the clinical diagnosis of brain diseases. MEG uses a sensitive magnetic sensor SQUID (Superconducting Quantum Interferometer), which is placed around the head to measure the abnormally weak magnetic field generated by neuronal activity. The detected magnetic signal data will then be analyzed and processed by a computer and superimposed on magnetic resonance imaging (MRI). Through software 3D imaging, the results can be more intuitive, making the MEG have extremely high temporal and spatial resolution. MDD patients will be divided into different treatment gourds based on theirs condition and whether the chosen treatment would be the most suitable for them. All individuals will undergo the above assessments to establish a comprehensive, multimodal information data base, and finally after comparing the outcome before and after the treatment, the study tries to find out new and effective measures and validate their feasibility. ### Conditions Module **Conditions:** - Depression - Major Depressive Disorder - Bipolar Depression ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with anhedonia will be using either Bupropion or Voxetine. Patients without anhedonia will be given SSRIs. Frequency and dosage will be guided by psychiatrist. Treatment will last 4 weeks. **Intervention Names:** - Drug: SSRI **Label:** Medication Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has decided to be dlpfc. Treatment will last 4 weeks. **Intervention Names:** - Drug: SSRI - Device: rTMS **Label:** Traditional rTMs Group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** In addition to medication using SSRIs, patients will be also treated with rTMS. The stimulated brain region has not been decided, but rbitofrontal cortex, cerebellum and others are considered. Treatment will last 4 weeks. **Intervention Names:** - Drug: SSRI - Device: rTMS **Label:** New rTMS Group **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** In addition to medication using SSRIs, patients will be also treated with Neuro-Training. The process will be guided under fNIRS and monitored by EGG. Treatment will last 4 weeks. **Intervention Names:** - Drug: SSRI - Behavioral: Neuro-Feedback **Label:** Neuro-Feedback Group **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** In addition to medication using SSRIs, patients will be also treated with games that can regulate emotions. Details are not yet decided. Treatment will last 4 weeks. **Intervention Names:** - Drug: SSRI - Behavioral: Game Regulation **Label:** Game-regulation Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Game-regulation Group - Medication Group - Neuro-Feedback Group - New rTMS Group - Traditional rTMs Group **Description:** Patients are not masked from the types of intervention they receive. Assessment will be done before and after each intervention. Each group is independent from other groups. **Name:** SSRI **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - New rTMS Group - Traditional rTMs Group **Description:** Patients will be treated targeting either the traditional brain region or new region. **Name:** rTMS **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Neuro-Feedback Group **Description:** Patients under 18 years old will first be considered this treatment before other methods. **Name:** Neuro-Feedback **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Game-regulation Group **Description:** Patients will learn how to play several games that can supposedly regulate or affect negative emotions. **Name:** Game Regulation **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks. **Measure:** EEG power in alpha band between the depression patient group and healthy controls. **Time Frame:** 2 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by EEG at 2 weeks. **Measure:** EEG power in beta band between the depression patient group and healthy controls. **Time Frame:** 2 weeks **Description:** Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 2 weeks. **Measure:** MRI imaging of DLPFC between the depression patient group and healthy controls. **Time Frame:** 2 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks. **Measure:** HbO in fNIRS between the depression patient group and healthy controls. **Time Frame:** 2 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by fNIRS at 2 weeks. **Measure:** Hb in fNIRS between the depression patient group and healthy controls. **Time Frame:** 2 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks. **Measure:** EEG power in alpha band between the depression patient group and healthy controls. **Time Frame:** 4 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by EEG at 4 weeks. **Measure:** EEG power in beta band between the depression patient group and healthy controls. **Time Frame:** 4 weeks **Description:** Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 4 weeks. **Measure:** MRI imaging of DLPFC between the depression patient group and healthy controls. **Time Frame:** 4 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks. **Measure:** HbO in fNIRS between the depression patient group and healthy controls. **Time Frame:** 4 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by fNIRS at 4 weeks. **Measure:** Hb in fNIRS between the depression patient group and healthy controls. **Time Frame:** 4 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks. **Measure:** EEG power in alpha band between the depression patient group and healthy controls. **Time Frame:** 8 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by EEG at 8 weeks. **Measure:** EEG power in beta band between the depression patient group and healthy controls. **Time Frame:** 8 weeks **Description:** Changes in brain imaging from baseline in multimodal emotional data as assessed by MRI at 8 weeks. **Measure:** MRI imaging of DLPFC between the depression patient group and healthy controls. **Time Frame:** 8 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks. **Measure:** HbO in fNIRS between the depression patient group and healthy controls. **Time Frame:** 8 weeks **Description:** Changes from baseline in multimodal emotional data as assessed by fNIRS at 8 weeks. **Measure:** Hb in fNIRS between the depression patient group and healthy controls. **Time Frame:** 8 weeks **Description:** Changes from baseline in the score of HAMD-17 at 2 weeks **Measure:** The score of HAMD-17 in depression patient group and healthy controls. **Time Frame:** 2 weeks **Description:** Changes from baseline in depression patient group in the score of HAMD-17 at 4 weeks **Measure:** The score of HAMD-17 in depression patient group and healthy controls. **Time Frame:** 4 weeks **Description:** Changes from baseline in depression patient group in the score of HAMD-17 at 8 weeks **Measure:** The score of HAMD-17 in depression patient group and healthy controls. **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** The state of depression in patient group measured by SDS(0-80) at 2 weeks. **Measure:** The change in the state of depression in depression patient groups **Time Frame:** 2 weeks **Description:** The state of depression in patient group measured by HCL-32(0-32) at 2 weeks. **Measure:** The change in the state of agitation in depression patient groups **Time Frame:** 2 weeks **Description:** The state of depression in patient group measured by SDS(0-80) at 4 weeks. **Measure:** The change in the state of depression in depression patient groups **Time Frame:** 4 weeks **Description:** The state of depression in patient group measured by HCL-32(0-32) at 4 weeks. **Measure:** The change in the state of agitation in depression patient groups **Time Frame:** 4 weeks **Description:** The state of depression in patient group measured by SDS(0-80) at 8 weeks. **Measure:** The change in the state of depression in depression patient groups **Time Frame:** 8 weeks **Description:** The state of depression in patient group measured by HCL-32(0-32) at 8 weeks. **Measure:** The change in the state of agitation in depression patient groups **Time Frame:** 8 weeks **Description:** The state of depression in patient group measured by SHAPS(0-64) at 2 weeks. **Measure:** The change in the state of anhedonia in depression patient groups **Time Frame:** 2 weeks **Description:** The state of depression in patient group measured by SHAPS(0-64) at 4 weeks. **Measure:** The change in the state of anhedonia in depression patient groups **Time Frame:** 4 weeks **Description:** The state of depression in patient group measured by SHAPS(0-64) at 8 weeks. **Measure:** The change in the state of anhedonia in depression patient groups **Time Frame:** 8 weeks **Description:** The state of anxiety in patient group measured by different scales including GAD-7(0-56) at 2 weeks. **Measure:** The change in the state of anxiety in depression patient groups **Time Frame:** 2 weeks **Description:** The state of anxiety in patient group measured by different scales including GAD-7(0-56) at 4 weeks. **Measure:** The change in the state of anxiety in depression patient groups **Time Frame:** 4 weeks **Description:** The state of anxiety in patient group measured by different scales including GAD-7(0-56) at 8 weeks. **Measure:** The change in the state of anxiety in depression patient groups **Time Frame:** 8 weeks **Description:** The level of cognitive function in patient group measured by RBANS at 2 weeks. **Measure:** The change in the level of cognitive function in depression patient group **Time Frame:** 2 weeks **Description:** The level of cognitive function in patient group measured by RBANS at 4 weeks. **Measure:** The change in the level of cognitive function in depression patient group **Time Frame:** 4 weeks **Description:** The level of cognitive function in patient group measured by RBANS at 8 weeks. **Measure:** The change in the level of cognitive function in depression patient group **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥ 12 years old, male or female, right-handed, Han ethnicity * Meets the DSM-5 diagnostic criteria for depression, with HAMD-17 scores greater than 17 and YMRS scores less than 6; * Primary school education or above, able to understand the research content, willing to participate in this study and sign an informed consent form Exclusion Criteria: * Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy; * Severe abnormalities in heart, liver, and kidney function; * Patients with severe physical illnesses; * History of substance dependence or abuse (alcohol, cocaine, drugs, etc.); * Patients with mental disorders caused by organic diseases, drug or alcohol induced mental disorders, and other mental disorders; * Pregnancy or lactation period; * Within six months, physical therapy such as MECT and TMS should be used; * Implants of vegetative nerve stimulation; * Individuals who have implanted electronic or metal instruments (such as pacemakers, defibrillators, stents, orthopedic plates, etc.) and undergo ventriculoperitoneal shunt surgery; * Obvious visual and auditory impairment, unable to cooperate in completing neuropsychological and scale assessments. **Healthy Volunteers:** True **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yizhenghui1971@163.com **Name:** Zhenghui Yi, chief physician **Phone:** 18017311007 **Role:** CONTACT **Contact 2:** **Email:** lvqinyu_louis@163.com **Name:** Qinyu Lv, chief physician **Phone:** 18616550357 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Min Zhao, chief physician - **Phone:** 34773231 - **Role:** CONTACT **Country:** China **Facility:** Shanghai Mental Health Center **State:** Shanghai **Status:** RECRUITING **Zip:** 200030 #### Overall Officials **Official 1:** **Affiliation:** Shanghai Mental Health Center **Name:** Zhenghui Yi, chief physician **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000068105 - Term: Bipolar and Related Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Depression - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood 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: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major - ID: D000001714 - Term: Bipolar Disorder ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19013 - Name: Bupropion - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417424 **Brief Title:** Observe Intestinal Tract Cleaness of Senile Constipation Patients Used Gastrointestinal External Stimulation **Official Title:** A Prospective, Randomized, Double-blind Controlled Clinical Study of Observation the Effect of Gastrointestinal External Stimulation on Intestinal Tract Cleaness in Patients With Senile Constipation #### Organization Study ID Info **ID:** DFSC-2023(CR)-077 #### Organization **Class:** OTHER **Full Name:** Shanghai East Hospital ### 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:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **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:** 2024-01-30 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai East 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 is a prospective, randomized, double-blind controlled trial. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective. **Detailed Description:** The early detection of intestinal lesions is extremely important, and the quality of intestine cleanliness is an important factor for the quality of colonoscopy. The elderly are at high risk of intestinal diseases. However, surveys have found that the overall quality of bowel cleanliness in elderly patients undergoing colonoscopy is poor, which affects the detection rate of colon lesions. This is a prospective, randomized, double-blind, controlled clinical trial to observe whether combined gastrointestinal surface stimulation and transcutaneous electrical acupoint stimulation can improve the quality of bowel cleansing and increase the detection rate of intestinal diseases. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective. ### Conditions Module **Conditions:** - Electric Stimulation **Keywords:** - ntestine cleanliness - senile constipation patients - Gastrointestinal External Stimula ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. ##### Masking Info **Masking:** TRIPLE **Masking Description:** The Participants, investigators and outcomes Assessor don't know receiverd which intervention, only care Providers know it. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation for 3 days, and then oral administration of polyethylene glycol for intestinal cleansing. **Intervention Names:** - Device: gastrointestinal external stimulation **Label:** experimental group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Received gastrointestinal external stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing. **Intervention Names:** - Device: gastrointestinal external stimulation **Label:** experimental group 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Received transcutaneouselectrical acupoint stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing. **Intervention Names:** - Device: gastrointestinal external stimulation **Label:** experimental group 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** No stimulation was given. Oral administration of polyethylene glycol for intestinal cleansing. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - experimental group 1 - experimental group 2 - experimental group 3 **Description:** We used the device Gastrointestinal multifunctional therapeutic instrument. The positive pole was placed 1 to 2cm above the umbilicus, and the negative pole was placed 4 to 10 cm to the right of the midpoint between the xiphoid process and the umbilicus. **Name:** gastrointestinal external stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective. **Measure:** Boston Bowel Preparation Scale (BBPS) **Time Frame:** 1 year **Description:** The positive rate of intestinal diseases including polyps, adenoma, adenocarcinoma, enteritis, inflammatory bowel disease,diverticulum and so on by electronic colonoscopy. **Measure:** The positive rate of intestinal diseases **Time Frame:** 1 year #### Secondary Outcomes **Description:** The adverse reactions included abdominal distension, pain, nausea, vomiting, and fatigue. **Measure:** Adverse reactions **Time Frame:** 1 year **Description:** The Likert scale was used to judge willingness to repeat the same interventions of intestinal cleansing in future electronic colonoscopies. **Measure:** Willingness to repeat **Time Frame:** 1 year **Description:** Collected fresh fecal samples before and 3 days after electrical stimulation, high-throughput sequencing was used to detect intestinal microbiome , analyzed the changes . **Measure:** Gut microbiome alterations **Time Frame:** 1 year **Description:** The serum levels of gastrointestinal hormones including substance P, motilin，ghrelin，growth hormone, neurotensin and vasoactive intestinal peptide were measured before and after intervention. **Measure:** Gastrointestinal hormone **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 60-80 years old; 2. Colonoscopy was planned; 3. The diagnosis of constipation was in accordance with Rome Ⅳ criteria. Exclusion Criteria: 1. Acute myocardial infarction (within 6 months), severe heart failure (New York Heart Association class II-V, chronic renal failure (CKD stage II-V), or mental disorder; 2. Colorectal resection; 3. Drugs of aspirin, warfarin, or other anticoagulants, and coagulopathy; 4. Oral administration any drugs that may affect gastrointestinal motility, such as proton pump inhibitors, non-steroidal anti-inflammatory drugs or antibiotics (within 4 weeks), probiotics (within 2 weeks); 5. The following diseases：inflammatory bowel disease, frequent diarrhea, severe gastroparesis, intestinal perforation or obstruction; 6. Participating in other clinical trials. **Maximum Age:** 80 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** lanzhong@tongji.edu.cn - **Name:** Lan Zhong, MD - **Phone:** +86-13162099450 - **Role:** CONTACT **Country:** China **Facility:** Shanghai easthospital **State:** Pudong New Area **Status:** RECRUITING **Zip:** 200120 ### IPD Sharing Statement Module **IPD Sharing:** YES ## 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 ### 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 ### Condition Browse Module - Meshes - ID: D000003248 - Term: Constipation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417411 **Acronym:** LEARNER **Brief Title:** LEARNER- Low dosE AspiRiN prEterm tRial (Angola) **Official Title:** A Prospective, Randomized Controlled Study to Evaluate the Effects of Daily Low Dose Aspirin in Pregnant Women With Sickle Cell Disease When Initiated at the First Trimester Versus the Second Trimester of the Gestational Period #### Organization Study ID Info **ID:** LEARNER #### Organization **Class:** OTHER_GOV **Full Name:** Instituto Nacional de Investigacao em Saude, Angola ### Status Module #### Completion Date **Date:** 2026-03-16 **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:** 2025-03-16 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-16 **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:** 2024-05-12 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** FUNDACIÓN BANCARIA CAIXA D'ESTALVIS I PENSIONS DE BARCELONA **Class:** UNKNOWN **Name:** FUNDAÇAO CALOUSTE GULBENKIAN **Class:** UNKNOWN **Name:** CLINCOORD SERVICES, INC. **Class:** UNKNOWN **Name:** CLINCOORD PRESTAÇÃO DE SEVIÇOS, LDA ANGOLA **Class:** OTHER **Name:** Escola Superior de Tecnologia da Saúde de Lisboa **Class:** UNKNOWN **Name:** ClinCoord Research Center at Luanda Medical Center #### Lead Sponsor **Class:** OTHER_GOV **Name:** Instituto Nacional de Investigacao em Saude, Angola #### 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 being conducted to evaluate the safety and effect of starting daily use of low dose (100 mg) aspirin in pregnant women with sickle cell disease, who are being followed in two county hospitals in Angola, in the first trimester versus the second trimester of the gestational period. **Detailed Description:** The proposed project is a prospective, randomized controlled study to evaluate the effects of daily low dose aspirin in pregnant women with Sickle Cell Disease at the first trimester versus the second trimester of the gestation period. The study will include 450 female participants of all ages, in multiple maternity hospitals in Luanda, Angola, with an official diagnosis of Sickle Cell Disease and confirmed pregnancy. Patients who consent to take part in the study will be given 100 mg aspirin once daily either at the first trimester (6-13 weeks) or the second trimester (14-27 weeks) of the gestation period. Up to 450 participants will be randomly assigned in a 1:1 ratio to the two study treatment trimester groups (225 starting the low dose of aspirin at the first trimester and 225 starting the low dose of aspirin at the second trimester). In both treatment arms, daily use of low dose aspirin will be prescribed/administered until week 36 or time of delivery, whichever comes earlier. Study Duration: Each participant will be enrolled in the study for the duration of the pregnancy as follow: Screening Visit Randomized Treatment Period Follow Up Period (6 weeks postpartum) ### Conditions Module **Conditions:** - Sickle Cell Disease - Pregnancy Related - Pregnancy Complications - Pre-Eclampsia **Keywords:** - LEARNER - ANGOLA - Maternidade Lucrécia Paim - Hospital Materno Infantil Dr Manuel Pedro Azancot de Menezes - Aspirin - Capacity Building ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 450 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who will start the study medication (Aspirin) during the first trimester **Intervention Names:** - Drug: Aspirin 100mg **Label:** Aspirin in First trimester **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants who will start the study medication (Aspirin) during the second trimester **Intervention Names:** - Drug: Aspirin 100mg **Label:** Aspirin in Second trimester **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Aspirin in First trimester - Aspirin in Second trimester **Description:** Daily use of low dose aspirin. **Name:** Aspirin 100mg **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** The number of investigators and research staff successfully trained will be combined to measure the ability of conducting clinical research and data capture by otherwise research naive personnel. **Measure:** Clinical Research Personnel Capacity Building **Time Frame:** 2 years **Description:** The number of institutions involved in the conduction of the LEARNER project will be reported to measure collaboration between Angolan scientific/medical institutions and other international research entities. **Measure:** Institutional Collaborations **Time Frame:** 2 years #### Primary Outcomes **Description:** Measuring the number of maternal mortalities up to 6 weeks postpartum. **Measure:** Maternal Mortality **Time Frame:** 2 years **Description:** The number of preterm births will be measured by the number of deliveries before 37 weeks gestational age. **Measure:** Life Birth Related Events **Time Frame:** 2 years **Description:** Measuring the number of unintentional abortions late in the pregnancy **Measure:** Late Abortion Related Events **Time Frame:** 2 years #### Secondary Outcomes **Description:** hypertensive disorders, vaginal bleeding, antepartum hemorrhage, and postpartum hemorrhage, will be aggregated to determine the number of morbidity events related to the mother. **Measure:** Maternal Morbidity **Time Frame:** 2 years **Description:** fetal loss due to small gestational age, perinatal mortality, spontaneous abortion, and stillbirth, will be aggregated to quantify the number of fetal mortality events. **Measure:** Fetal Mortality Outcomes **Time Frame:** 2 years **Description:** Early preterm delivery (less than 34 weeks of gestation), extreme preterm delivery (less than 28 weeks of gestation), actual birth weight (measured in grams), post-term delivery (more than 42 weeks of gestation) will be combined to report the number of other fetal related events. **Measure:** Other Fetal Events **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Pregnant women with Sickle Cell Disease 15 years old and older * 2. Attending Maternidade Lucrecia Paim, Hospital Materno Infantil Dr. Manuel Pedro Azancot de Menezes, or any health commodities in the neighboring area of the referred hospitals * 3. Willing to attend the regular consultations, and consent to take part in the study. Exclusion Criteria: * 1. Pregnant women with Sickle Cell Disease in the third trimester (after week 27) * 2. HIV infection * 3. Diabetes mellitus * 4. Chronic hypertension * 5. Liver disease measured by laboratory indication being 3 times above the upper limit of normal * 6. Sickle nephropathy * 7. Multiple pregnancies * 8. Hypersensitivity to aspirin * 9. History of blood transfusion in the last 3 months * 10.Those who did not consent to participate in the study. **Gender Based:** True **Gender Description:** Pregnant women **Minimum Age:** 15 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tatiana.gomes@clincoord.org **Name:** TATIANA GOMES, BA/BS/Pre-MD **Phone:** +1 213 640 7052 **Role:** CONTACT **Contact 2:** **Email:** helena.pitangueira@clincoord.org **Name:** HELENA TEIXEIRA, PhD **Phone:** +55 071 991853687 **Role:** CONTACT #### Locations **Location 1:** **City:** Luanda **Contacts:** ***Contact 1:*** - **Email:** joana.morais@inis.gov.ao - **Name:** JOANA MORAIS, PhD - **Phone:** +244 934640266 - **Role:** CONTACT ***Contact 2:*** - **Email:** tatiana.gomes@clincoord.org - **Name:** TATIANA GOMES, PRE-MD - **Phone:** +1 213 640 7052 - **Role:** CONTACT ***Contact 3:*** - **Name:** JOANA MORAIS, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** MAUER GONÇALVES, PhD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** MIGUEL BRITO, PhD - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** HELENA TEIXEIRA, PhD - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** TATIANA GOMES, PRE-MD - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** LIGIA ALVEZ, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 9:*** - **Name:** MANUELA MENDES, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 10:*** - **Name:** CATARINA GINETE, PhD-Candidate - **Role:** SUB_INVESTIGATOR ***Contact 11:*** - **Name:** PRECIOSA LOURENCO, MD - **Role:** SUB_INVESTIGATOR ***Contact 12:*** - **Name:** FELIX ZAGE, MPH - **Role:** SUB_INVESTIGATOR **Country:** Angola **Facility:** Instituto Nacional de Investigação Em Saúde **Status:** RECRUITING **Zip:** 00000 #### Overall Officials **Official 1:** **Affiliation:** INSTITUTO NACIONAL DE INVESTIGAÇÃO EM SAÚDE **Name:** JOANA MORAIS, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** ClinCoord **Name:** TATIANA GOMES, BA/BS/Pre-MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Borges E, Tchonhi C, Couto CSB, Gomes V, Amorim A, Prata MJ, Brito M. Unusual beta-Globin Haplotype Distribution in Newborns from Bengo, Angola. Hemoglobin. 2019 May;43(3):149-154. doi: 10.1080/03630269.2019.1647230. Epub 2019 Aug 8. **PMID:** 31394941 **Citation:** Afolabi BB, Babah OA, Adeyemo TA, Odukoya OO, Ezeaka CV, Nwaiwu O, Oshodi YA, Ogunnaike BA. Low-dose aspirin for preventing intrauterine growth restriction and pre-eclampsia in sickle cell pregnancy (PIPSICKLE): a randomised controlled trial (study protocol). BMJ Open. 2021 Aug 13;11(8):e047949. doi: 10.1136/bmjopen-2020-047949. **PMID:** 34389570 **Citation:** Atallah A, Lecarpentier E, Goffinet F, Doret-Dion M, Gaucherand P, Tsatsaris V. Aspirin for Prevention of Preeclampsia. Drugs. 2017 Nov;77(17):1819-1831. doi: 10.1007/s40265-017-0823-0. **PMID:** 29039130 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000745 - Term: Anemia, Hemolytic, Congenital - ID: D000000743 - Term: Anemia, Hemolytic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000006453 - Term: Hemoglobinopathies - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7633 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Pre-Eclampsia - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M4085 - Name: Anemia, Sickle Cell - Relevance: HIGH - As Found: Sickle Cell Disease - ID: M14127 - Name: Pregnancy Complications - Relevance: HIGH - As Found: Pregnancy Complications - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M4073 - Name: Anemia, Hemolytic - Relevance: LOW - As Found: Unknown - ID: M4075 - Name: Anemia, Hemolytic, Congenital - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9539 - Name: Hemoglobinopathies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - 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: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: T2019 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia - ID: T5229 - Name: Sickle Cell Anemia - Relevance: HIGH - As Found: Sickle Cell Disease ### Condition Browse Module - Meshes - ID: D000004461 - Term: Eclampsia - ID: D000011225 - Term: Pre-Eclampsia - ID: D000011248 - Term: Pregnancy Complications - ID: D000000755 - Term: Anemia, Sickle Cell ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - 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: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000005343 - Term: Fibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000058633 - Term: Antipyretics ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4548 - Name: Aspirin - Relevance: HIGH - As Found: Grazoprevir - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - 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: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001241 - Term: Aspirin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417398 **Brief Title:** Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases **Official Title:** Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases #### Organization Study ID Info **ID:** PG-005 #### Organization **Class:** INDUSTRY **Full Name:** PersonGen BioTherapeutics (Suzhou) Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-05-01 **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:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-27 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** PersonGen BioTherapeutics (Suzhou) Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID. To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID. To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects. To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects. **Detailed Description:** This clinical trial was designed as a single-arm, open-label, single-center, investigator-initiated early-stage clinical study to evaluate the safety of UTAA09 injection in patients with relapsed/refractory AID. After signing the informed consent letter, qualified subjects were screened for infusion of UTAA09 injection, and their blood was collected before and after infusion for pharmacokinetics, pharmacodynamics, immunogenicity, safety and other evaluation. In addition to the baseline period, therapeutic efficacy was evaluated at a frequency of 28d, 2m, 3m, 4m, 5m, 6m, 8m, 10m, 12m after cell transfusion, and tumors were evaluated until disease progression (PD), new anti-disease therapy, death, intolerable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurred first. All adverse events were recorded from the beginning of the subject's elutriation pre-treatment (if it occurred) until 3 months after the subject received cell transfusion or disease progression/recurrence or initiation of a new anti-disease therapy or the end of the study, whichever occurred first, and 3 months after cell transfusion or disease progression/recurrence or initiation of a new anti-disease therapy (whichever occurred first) until the end of the study. Only adverse events associated with the study product were collected ### Conditions Module **Conditions:** - Systemic Lupus Erythematosus - Idiopathic Inflammatory Myopathies - Systemic Sclerosis - Sjogren's Syndrome - Rheumatoid Arthritis - Immune Thrombocytopenia - Primary Biliary Cholangitis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This clinical trial was designed as a single-arm, open-label, single-center, investigator-initiated early-stage clinical study to evaluate the safety of UTAA09 injection in patients with relapsed/refractory AID. After signing the informed consent letter, qualified subjects were screened for infusion of UTAA09 injection, and their blood was collected before and after infusion for pharmacokinetics, pharmacodynamics, immunogenicity, safety and other evaluation **Intervention Names:** - Biological: T cell injection targeting CD19 chimeric antigen receptor **Label:** T cell injection targeting CD19 chimeric antigen receptor **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - T cell injection targeting CD19 chimeric antigen receptor **Description:** Intravenous administration, 1 bag each time (depending on individual differences), dose: 1×108-1×109 CD19-CAR-gdT (UTAA09 injection), the investigator can decide whether to reduce or increase the dose and whether multiple infusions are required according to the condition of the subject. **Name:** T cell injection targeting CD19 chimeric antigen receptor **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities according to the Common Adverse Event Evaluation Standard NCI CTCAE version 5.0. **Measure:** AE **Time Frame:** 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first) #### Secondary Outcomes **Description:** UTAA09 injection was administered in peripheral bloodCmax **Measure:** Peak Plasma Concentration (Cmax） **Time Frame:** 3 months after cell reinfusion disease progression/recurrence or start of new anti-disease therapy (whichever occurs first) **Description:** UTAA09 injection was administered in peripheral blood **Measure:** Area under the plasma concentration versus time curve (AUC) **Time Frame:** 3 months after cell reinfusion/28d after cell reinfusion **Description:** The proportion and absolute value of CD19 positive cells in peripheral blood at each time point **Measure:** Content of CD19 positive cells in peripheral blood **Time Frame:** every visits after infusion up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: (2) Expected survival time ≥3 months; (3) Subjects with recurrent/refractory autoimmune disease who have failed standard treatment or lack effective treatment, including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc. (4) Liver and kidney function, cardiopulmonary function meet the following requirements: * Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands; * Blood oxygen saturation \>91% in non-oxygen state; * Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN. (5) no serious mental disorders; (6) Can understand this test and have signed the informed consent. Exclusion Criteria: 1. Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery; 2. Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive; 3. Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia; 4. Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment; 5. Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration; 6. Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion; 7. Patients who received CAR-T therapy or other gene-modified cell therapy before screening; 8. Participated in other clinical studies 1 month before screening; 9. Evidence of central nervous system invasion during subject screening; 10. Mental patients with depression or suicidal thoughts; 11. Those who received live vaccine within 28 days prior to screening; 12. Situations considered unsuitable for inclusion by other researchers. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** njwujian@163.com **Name:** jian wu, Doctor **Phone:** 15358805676 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital of Soochow University **Name:** jian wu, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000001172 - Term: Arthritis, Rheumatoid - ID: D000012216 - Term: Rheumatic Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000095542 - Term: Cytopenia - ID: D000012871 - Term: Skin Diseases - ID: D000014987 - Term: Xerostomia - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000001649 - Term: Bile Duct Diseases - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000011696 - Term: Purpura, Thrombocytopenic - ID: D000011693 - Term: Purpura - ID: D000001778 - Term: Blood Coagulation Disorders - ID: D000057049 - Term: Thrombotic Microangiopathies - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000006470 - Term: Hemorrhage - ID: D000012877 - Term: Skin Manifestations - ID: D000002780 - Term: Cholestasis, Intrahepatic - ID: D000002779 - Term: Cholestasis - ID: D000008107 - Term: Liver Diseases - ID: D000008103 - Term: Liver Cirrhosis - ID: D000005355 - Term: Fibrosis ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M15664 - Name: Sjogren's Syndrome - Relevance: HIGH - As Found: Sjogren's Syndrome - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Diseases - ID: M16680 - Name: Thrombocytopenia - Relevance: HIGH - As Found: Thrombocytopenia - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Systemic Lupus Erythematosus - ID: M6002 - Name: Cholangitis - Relevance: HIGH - As Found: Cholangitis - ID: M12172 - Name: Myositis - Relevance: HIGH - As Found: Idiopathic Inflammatory Myopathies - ID: M18945 - Name: Purpura, Thrombocytopenic, Idiopathic - Relevance: HIGH - As Found: Immune Thrombocytopenia - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M11103 - Name: Liver Cirrhosis - Relevance: LOW - As Found: Unknown - ID: M11105 - Name: Liver Cirrhosis, Biliary - Relevance: HIGH - As Found: Primary Biliary Cholangitis - ID: M14547 - Name: Purpura - Relevance: LOW - As Found: Unknown - ID: M14550 - Name: Purpura, Thrombocytopenic - 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 - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M5072 - Name: Blood Platelet Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M3170 - Name: Cytopenia - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M17724 - Name: Xerostomia - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: LOW - As Found: Unknown - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - 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: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M28682 - Name: Thrombotic Microangiopathies - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M15680 - Name: Skin Manifestations - Relevance: LOW - As Found: Unknown - ID: M6019 - Name: Cholestasis - Relevance: LOW - As Found: Unknown - ID: M6020 - Name: Cholestasis, Intrahepatic - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: LOW - As Found: Unknown - ID: T4683 - Name: Primary Biliary Cholangitis - Relevance: HIGH - As Found: Primary Biliary Cholangitis - ID: T3040 - Name: Inclusion Body Myositis - Relevance: HIGH - As Found: Inflammatory Myopathies - ID: T3021 - Name: Immune Thrombocytopenia - Relevance: HIGH - As Found: Immune Thrombocytopenia - ID: T3007 - Name: Idiopathic Thrombocytopenic Purpura - Relevance: HIGH - As Found: Immune Thrombocytopenia - ID: T3001 - Name: Idiopathic Inflammatory Myopathy - Relevance: HIGH - As Found: Idiopathic Inflammatory Myopathies ### Condition Browse Module - Meshes - ID: D000012859 - Term: Sjogren's Syndrome - ID: D000009220 - Term: Myositis - ID: D000002761 - Term: Cholangitis - ID: D000008105 - Term: Liver Cirrhosis, Biliary - ID: D000013921 - Term: Thrombocytopenia - ID: D000016553 - Term: Purpura, Thrombocytopenic, Idiopathic - ID: D000008180 - Term: Lupus Erythematosus, Systemic - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000001327 - Term: Autoimmune Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417385 **Brief Title:** taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge **Official Title:** Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge #### Organization Study ID Info **ID:** Pro00131771 #### Organization **Class:** OTHER **Full Name:** Medical University of South Carolina ### Status Module #### Completion Date **Date:** 2025-02-01 **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:** 2025-02-01 **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:** 2024-04-19 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical University of South Carolina #### Responsible Party **Investigator Affiliation:** Medical University of South Carolina **Investigator Full Name:** Haley Burdge **Investigator Title:** Medical/Dental Resident, Department of Pediatrics, Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities. If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance. ### Conditions Module **Conditions:** - Premature Birth - Breastfeeding, Exclusive - Feeding; Difficult, Newborn ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved. **Intervention Names:** - Device: taVNS soterix device **Label:** taVNS treatment group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - taVNS treatment group **Description:** Soterix is a custom modified, FDA-cleared electrical stimulator that meets the criteria of the FDA for investigational use. Neoleads will be placed in order to deliver electrical stimulation using microcurrent (\<2.5mA) with breastfeeding, on with sucking and swallowing and off with rest for 5 feeds per week for 2 weeks. **Name:** taVNS soterix device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Measured by pre- and post-feed weights (grams) **Measure:** Adequate volume transfer during breastfeeding **Time Frame:** 2 weeks **Description:** Average length of active feeding at the breast (minutes) **Measure:** Infant's ability to sustain breastfeeding for a length of time **Time Frame:** 2 weeks **Description:** Demonstration of successful latch, suck, and swallow techniques by the infant per LATCH scoring (L= latch, A= audible swallowing, T= type of nipple (inverted, flat, everted after stimulation), C= Comfort of mother during feed, H= Hold/positioning of infant), scoring 0-10 (2 points per question) with 10 being the highest and optimal score. **Measure:** Targeted motor learning of skills involved in breastfeeding **Time Frame:** 2 weeks **Description:** Demonstration of successful latch, suck, and swallow techniques by the infant by study personnel descriptions (Only lactation consultants are trained to obtain LATCH scores, thus when no lactation consultant is present, study personnel will simply describe infant's demonstrated skills during the session without a specific measurement tool) **Measure:** Targeted motor learning of skills involved in breastfeeding **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey **Measure:** Frequency of breastfeeding assessed by study specific survey **Time Frame:** 2 months **Description:** Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey **Measure:** Parent satisfaction with infant's ability to breastfeed assessed by study specific survey **Time Frame:** 2 months **Description:** Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey **Measure:** Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Infants ≥ 35 weeks post-menstrual age, * Clinically stable, without significant respiratory support, * Deemed safe to breastfeed by OT/SLP/lactation, * Maternal interest in breastfeeding, * Are not breastfeeding well despite the assistance of a lactation consultant. Exclusion Criteria: * Cardiomyopathy, * Unstable bradycardia, * Significant respiratory support, * Absent maternal interest in breastfeeding, or infant or mother with contraindications to breastfeeding such as infantile galactosemia, * Maternal HIV without adequate viral suppression, * Maternal illicit drug use. **Gender Based:** True **Gender Description:** The study population will include preterm infants at ≥ 35 weeks post-menstrual age or term infants requiring NICU admission due to medical illness. The study population will also include the infants' mothers who will participate in daily breastfeeding sessions and complete parental satisfaction surveys. **Healthy Volunteers:** True **Minimum Age:** 35 Weeks **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** burdge@musc.edu **Name:** Haley Burdge **Phone:** 8432144089 **Role:** CONTACT **Contact 2:** **Email:** jenkd@musc.edu **Name:** Dorothea Jenkins **Role:** CONTACT #### Locations **Location 1:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** burdge@musc.edu - **Name:** Haley Burdge, MD - **Phone:** 843-214-4089 - **Role:** CONTACT ***Contact 2:*** - **Email:** jenkd@musc.edu - **Name:** Dorothea Jenkins, MD - **Role:** CONTACT **Country:** United States **Facility:** Medical University of South Carolina Shawn Jenkins Children's Hospital **State:** South Carolina **Status:** RECRUITING **Zip:** 29425 #### Overall Officials **Official 1:** **Affiliation:** Medical University of South Carolina **Name:** Haley Burdge **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature Birth - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - 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: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417372 **Brief Title:** Intraoperative Fluorescent Staining Combined With Microsurgery for Gliomas **Official Title:** Prospective Study of the Effect of Intraoperative Fluorescent Staining Combined With Microscopy on the Prognosis of Patients With Gliomas #### Organization Study ID Info **ID:** [2023]670-FM #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital, Sun Yat-Sen University ### 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:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **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:** 2024-05-07 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital, Sun Yat-Sen University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital, Sun Yat-Sen University **Investigator Full Name:** Zhang Nu **Investigator Title:** Discipline Leader of Neurosurgery department, Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not. And combined with the existing multimodal surgical techniques (imaging, electrophysiology, neuronavigation and other equipment), the glioma is precisely resected. ### Conditions Module **Conditions:** - Glioma **Keywords:** - glioma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1. any gender, age 18-60 years old; 2. patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy; 3. patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3; 4. subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits; 5. patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months. **Intervention Names:** - Diagnostic Test: intraoperative fluorescent staining combined with microscopy **Label:** experimental group ### Interventions #### Intervention 1 **Arm Group Labels:** - experimental group **Description:** Through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not. **Name:** intraoperative fluorescent staining combined with microscopy **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** progression-free survival (PFS): From date of randomization until the date of first documented progression **Measure:** progression-free survival (PFS) **Time Frame:** From date of randomization until the date of first documented progression, assessed up to 12 months **Description:** overall survival (OS): From date of randomization until the date of death from any cause **Measure:** overall survival (OS) **Time Frame:** From date of randomization until the date of death from any cause, assessed up to 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. any gender, age 5-90 years old; 2. patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy; 3. patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3; 4. subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits; 5. patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. The expected survival period, as judged by the clinician, is not less than 12 months. Exclusion Criteria: 1. Serious or unstable diseases of the heart, lungs, kidneys and hematopoietic system that cannot tolerate surgery 2. Pregnant or lactating women 3. Other factors that, in the judgment of the investigator, could lead to termination of the study, such as other serious medical conditions or serious laboratory abnormalities or other family or social factors that would affect the safety of the subject or the collection of test data and samples. **Maximum Age:** 90 Years **Minimum Age:** 5 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Diagnosed glioma patients who will undergo surgical treatment in the First Affiliated Hospital of Sun Yet-Sen Universtiy. ## Derived Section ### Condition Browse Module - Ancestors - 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: M9020 - Name: Glioma - Relevance: HIGH - As Found: Glioma - 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: T2519 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005910 - Term: Glioma ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11726 - Name: Methylene Blue - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417359 **Brief Title:** Comparison of Mesh Fixation and Non-Fixation in eTEP **Official Title:** Comparison of Mesh Fixation and Non-Fixation in Laparoscopic eTEP Inguinal Hernia Repair #### Organization Study ID Info **ID:** 65656565 #### Organization **Class:** OTHER **Full Name:** Konya City Hospital ### Status Module #### Completion Date **Date:** 2024-10-04 **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:** 2024-04-04 **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:** 2024-05-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Van Training and Research Hospital #### Lead Sponsor **Class:** OTHER **Name:** Mehmet Eşref Ulutaş #### Responsible Party **Investigator Affiliation:** Konya City Hospital **Investigator Full Name:** Mehmet Eşref Ulutaş **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate. One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation. In the eTEP technique, dissection is performed in a larger area than in TEP. For this reason, it can be thought that the possibility of mesh displacement is higher in the eTEP procedure. The purpose of this study is to confirm this idea with a prospective study. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. However, there is no study on mesh detection in the eTEP technique. The aim of the study is to compare patients who underwent withmesh fixation and without mesh fixation laparoscopic eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications. ### Conditions Module **Conditions:** - Migration of Implant - Pain - Postoperative Complications - Relapse ### Design Module #### Design Info **Allocation:** 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:** In 30 patients; Inguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides. During the surgery, the mesh will be fixed to three absorbable tacker the Cooper ligament, süpermedially and laterally. Patients whose pain scores (VAS score) are measured on the first postoperative day and who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined, their pain scores will be measured (VAS score) and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm. **Intervention Names:** - Procedure: Mesh Fixation **Label:** eTEP Mesh Fixation Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In 30 patients; Inguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides. During the surgery, the mesh will not be fixed to the Cooper ligament. Patients whose pain scores (VAS score) are measured on the first postoperative day and who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined, their pain scores will be measured (VAS score) and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm. **Intervention Names:** - Procedure: No Mesh Fixation **Label:** eTEP No Mesh Fixation Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - eTEP Mesh Fixation Group **Description:** That mesh will be fixation with three tackers. **Name:** Mesh Fixation **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - eTEP No Mesh Fixation Group **Description:** That mesh will not be fixation **Name:** No Mesh Fixation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Patients who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm. **Measure:** Status of Mesh Displacement **Time Frame:** postoperative 24 hours, 1 and 6 months #### Secondary Outcomes **Description:** It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10. **Measure:** Rate of Postoperative pain **Time Frame:** postoperative 24 hours **Description:** hernia recurrence after six months of follow-up. It will be checked by physical examination. Imaging methods will be used in suspicious cases. **Measure:** Rate of Hernia recurrence **Time Frame:** postoperative 6th month and first year **Description:** such as wound infection, bleeding **Measure:** Rate of Postoperative complications **Time Frame:** postoperative 24 hours and 1st month **Description:** It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10. **Measure:** Rate of Chronic pain **Time Frame:** postoperative 1st, 6th month and first year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with unilateral inguinal hernias, * Patients aged 18-65. Exclusion Criteria: * Younger than 18 years, and older than 65 years, * Incarcerated or strangulated inguinal hernias, * Patients with bilateral inguinal hernias, * Patients who are contraindicated to receive general anesthesia, * Pregnancy **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drabdullahhilmi@gmail.com **Name:** Abdullah Hilmi Yılmaz, MD **Phone:** 0432 222 00 10 **Role:** CONTACT #### Locations **Location 1:** **City:** Van **Contacts:** ***Contact 1:*** - **Email:** drabdullahhilmi@gmail.com - **Name:** Abdullah Hilmi Yılmaz, MD - **Phone:** 0432 222 00 10 - **Role:** CONTACT **Country:** Turkey **Facility:** University of Health Science Van Training and Research Hospital **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Yildirim MB, Sahiner IT. The effect of mesh fixation on migration and postoperative pain in laparoscopic TEP repair: prospective randomized double-blinded controlled study. Hernia. 2023 Feb;27(1):63-70. doi: 10.1007/s10029-022-02587-w. Epub 2022 Mar 14. **PMID:** 35286511 **Citation:** Claus CMP, Rocha GM, Campos ACL, Paulin JAN, Coelho JCU. Mesh Displacement After Bilateral Inguinal Hernia Repair With No Fixation. JSLS. 2017 Jul-Sep;21(3):e2017.00033. doi: 10.4293/JSLS.2017.00033. **PMID:** 28904521 **Citation:** Claus CM, Rocha GM, Campos AC, Bonin EA, Dimbarre D, Loureiro MP, Coelho JC. Prospective, randomized and controlled study of mesh displacement after laparoscopic inguinal repair: fixation versus no fixation of mesh. Surg Endosc. 2016 Mar;30(3):1134-40. doi: 10.1007/s00464-015-4314-7. Epub 2015 Jun 20. **PMID:** 26092029 ## 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: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications - ID: M9625 - Name: Hernia - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M9630 - Name: Hernia, Inguinal - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011183 - Term: Postoperative Complications ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417346 **Brief Title:** Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients **Official Title:** Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients #### Organization Study ID Info **ID:** 65646564 #### Organization **Class:** OTHER **Full Name:** Konya City Hospital ### Status Module #### Completion Date **Date:** 2024-12-30 **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:** 2024-06-04 **Type:** ESTIMATED #### 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:** 2024-05-11 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Van Training and Research Hospital #### Lead Sponsor **Class:** OTHER **Name:** Mehmet Eşref Ulutaş #### Responsible Party **Investigator Affiliation:** Konya City Hospital **Investigator Full Name:** Mehmet Eşref Ulutaş **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age. ### Conditions Module **Conditions:** - Urinary Retention - Postoperative Complications - Pain - Relapse ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A mini-incision was made at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. The RS was incised, and the rectus muscle was laterally displaced. A 10-mm trocar was inserted into the preperitoneal space, and CO2 insufflation was performed with a pressure set at 12 mmHg. Two additional 5 mm trocars were inserted between the umbilicus and the symphysis pubis under laparoscopic guidance. Using laparoscopic dissectors and graspers, all steps of myopectineal orifice dissection were performed (16). A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. Trocars were removed under camera surveillance after CO2 desufflation, and the skin was closed. **Intervention Names:** - Procedure: Laparoscopic TEP Repair **Label:** Laparoscopic TEP Repair under General Anesthesia **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, a polypropylene mesh measuring approximately 60x110 mm² was placed to completely cover the transverse fascia, and continuous sutures were used to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed. **Intervention Names:** - Procedure: Open Technique (Lichtenstein) **Label:** Open Technique (Lichtenstein) under Spinal Anesthesia **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Laparoscopic TEP Repair under General Anesthesia **Description:** Laparoscopic TEP Repair performed **Name:** Laparoscopic TEP Repair **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Open Technique (Lichtenstein) under Spinal Anesthesia **Description:** Open Technique (Lichtenstein) performed **Name:** Open Technique (Lichtenstein) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** rate of postoperative mortality **Time Frame:** postoperative 24 hours #### Secondary Outcomes **Measure:** rate of urinary retansion **Time Frame:** postoperative 24 hours **Measure:** rate of postoperative pain **Time Frame:** postoperative 24 hours **Measure:** Rate of Hernia recurrence **Time Frame:** first year **Description:** such as wound infection, bleeding **Measure:** Rate of Postoperative complications **Time Frame:** postoperative 24 hours and 1st month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with inguinal hernias. * Patients aged over 65. Exclusion Criteria: * Younger than 65 years. * Incarcerated or strangulated inguinal hernias. **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drabdullahhilmi@gmail.com **Name:** Abdullah Hilmi Yılmaz, MD **Phone:** 0432 222 00 10 **Role:** CONTACT #### Locations **Location 1:** **City:** Van **Contacts:** ***Contact 1:*** - **Email:** drabdullahhilmi@gmail.com - **Name:** Abdullah Hilmi Yılmaz, MD - **Phone:** 0432 222 00 10 - **Role:** CONTACT **Country:** Turkey **Facility:** University of Health Science Van Training and Research Hospital **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Vigneswaran Y, Gitelis M, Lapin B, Denham W, Linn J, Carbray J, Ujiki M. Elderly and octogenarian cohort: Comparable outcomes with nonelderly cohort after open or laparoscopic inguinal hernia repairs. Surgery. 2015 Oct;158(4):1137-43; discussion 1143-4. doi: 10.1016/j.surg.2015.08.002. Epub 2015 Aug 20. **PMID:** 26299283 **Citation:** Xi S, Chen Z, Lu Q, Liu C, Xu L, Lu C, Cheng R. Comparison of laparoscopic and open inguinal-hernia repair in elderly patients: the experience of two comprehensive medical centers over 10 years. Hernia. 2024 Apr 4. doi: 10.1007/s10029-024-03004-0. Online ahead of print. **PMID:** 38573484 **Citation:** Bowling K, El-Badawy S, Massri E, Rait J, Atkinson J, Leong S, Stuart A, Srinivas G. Laparoscopic and open inguinal hernia repair: Patient reported outcomes in the elderly from a single centre - A prospective cohort study. Ann Med Surg (Lond). 2017 Aug 29;22:12-15. doi: 10.1016/j.amsu.2017.08.013. eCollection 2017 Oct. **PMID:** 28878892 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006547 - Term: Hernia - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000010335 - Term: Pathologic Processes - ID: D000046449 - Term: Hernia, Abdominal - ID: D000014555 - Term: Urination Disorders - 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications - ID: M9625 - Name: Hernia - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M18552 - Name: Urinary Retention - Relevance: HIGH - As Found: Urinary Retention - ID: M9630 - Name: Hernia, Inguinal - Relevance: HIGH - As Found: Inguinal Hernia - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M25675 - Name: Hernia, Abdominal - Relevance: LOW - As Found: Unknown - ID: M17305 - Name: Urination Disorders - 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 ### Condition Browse Module - Meshes - ID: D000016055 - Term: Urinary Retention - ID: D000011183 - Term: Postoperative Complications - ID: D000006552 - Term: Hernia, Inguinal ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Coag - Name: Coagulants ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417333 **Brief Title:** A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms **Official Title:** A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms #### Organization Study ID Info **ID:** 230086 #### Organization **Class:** OTHER **Full Name:** Muğla Sıtkı Koçman University ### Status Module #### Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Muğla Sıtkı Koçman University #### Responsible Party **Investigator Affiliation:** Muğla Sıtkı Koçman University **Investigator Full Name:** Baris Ceyhan **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 study, we developed a mobile application that will enable caregivers to continuously monitor the vital health, medication, activity, and location of the patients with MCI with a smart wristband while enabling them caregivers to track the progress of the disease by a machine learning model that predicts MMSE of the patient using speech **Detailed Description:** 3-month vital health data collection has been performed on 30 participants who are over 60 years old via smart fitness wristbands distributed to them. A mobile application has been developed that caregivers can register their patients, wristbands and allow them to monitor their health data along with their location. medication and activities while synchronizing data anonymously to the application database. The data collection has been performed with relatively cheap, simple Xiaomi MI Band 7 wristbands that track only HR, RHR, sleep, steps and move minutes due to reasonable price and light weight and easy wearability of these devices. Mobile application synchronizes data from wristband to application servers continuously using Google Fit services that synchronize with device software. This made it possible for the patient's data to still be collected when he or she is not using any of them. MMSE scores of patients were taken at the beginning and at the end of the 3 month period to correlate scores with the collected aggregated health data and patient information ### Conditions Module **Conditions:** - Dementia, Mild **Keywords:** - dementia health data fitness tracking ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL **Intervention Model Description:** 2 15 people groups were distributes wristbands during a 6 month span ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients with mild dementia have been distributed xiaomi mi band 7 smart wristbands for health data collection **Name:** xiaomi mi band 7 smart wristband **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The Mini Mental State Examination (MMSE) is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30, minimum is 0. A score of 24 or lower is indicative of cognitive impairment. **Measure:** Each participant's written Mini Mental State Examination (MMSE) score was taken in the first and last week of data collection period **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Older patients who are willing to wear a smart wristband and have an Android smart phone Exclusion Criteria: - **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mugla **Country:** Turkey **Facility:** Mugla Sitki Kocman University - Dementia Clinic #### Overall Officials **Official 1:** **Affiliation:** Head of The Bioinformatics Department **Name:** Tugba Suzek, Dr. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **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:** NCT06417320 **Brief Title:** Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years **Official Title:** Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years #### Organization Study ID Info **ID:** MS.22.11.2207 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2025-08 **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:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-01 **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 #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on: 1. Proteinuria 2. Renal survival indices **Detailed Description:** This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks. ### Conditions Module **Conditions:** - Nephrotic Syndrome in Children ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group 1 (ACEI group) **Intervention Names:** - Drug: ACEI, SGLT-2i **Label:** Group 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Group 2 (combined ACEI and SGLT-2i group) **Intervention Names:** - Drug: ACEI, SGLT-2i **Label:** Group 2 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 - Group 2 **Description:** Group 1 (ACEI group) will receive a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg) /kg/ day) ❖ Group 2 (combined ACEI and SGLT-2inhibitrs group) patients on a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg /kg/ day) presenting with persistent nephrotic range proteinuria will add a single dose of oral SGLT-2 inhibitors tablets 5mg per day (weight≤30kg) or 10mg per day (weight \>30kg) **Name:** ACEI, SGLT-2i **Other Names:** - Captopril, forxiga **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula **Measure:** Protein free period, eGFR **Time Frame:** 12 weeks following end of treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 10 and 18 years old, * Nephrotic resistant patients, * No history of diabetes, * Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula, * Caregivers' acceptance to be enrolled in the study. Exclusion Criteria: * Uncontrolled urinary tract infection at screening, * Blood pressure is less than 5th percentile of the same gender, age, height, * At risk of dehydration or volume depletion, * Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase \>2 times the upper limit of normal during screening, * History of organ transplantation, cancer, liver disease, * History of noncompliance to medical regimens or unwillingness to comply with the study protocol. **Maximum Age:** 18 Years **Minimum Age:** 10 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** pediatrics@mans.edu.eg **Name:** Ayman Hammad, MBBCh,MSc,MD **Phone:** +20502262307 **Role:** CONTACT #### Locations **Location 1:** **City:** Mansoura **Contacts:** ***Contact 1:*** - **Email:** pediatrics@mans.edu.eg - **Name:** Ayman Hammad, MBBCh,MSc,MD - **Phone:** 20502262307 - **Role:** CONTACT **Country:** Egypt **Facility:** Mansoura University Children's Hospital **State:** Dakahlia **Status:** RECRUITING **Zip:** 35516 #### Overall Officials **Official 1:** **Affiliation:** Mansoura University-Faculty of Medicine-Pediatric **Name:** Ahmed El Refaey, MBBCh,MSc,MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** any one **Description:** sharing of study protocol **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** 1year ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014555 - Term: Urination Disorders - 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: D000020924 - Term: Urological Manifestations - ID: D000007674 - Term: Kidney 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 ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14368 - Name: Proteinuria - Relevance: HIGH - As Found: Proteinuria - ID: M12349 - Name: Nephrotic Syndrome - Relevance: HIGH - As Found: Nephrotic Syndrome - ID: M12346 - Name: Nephrosis - Relevance: HIGH - As Found: Nephrotic Syndrome - ID: M17305 - Name: Urination Disorders - 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: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011507 - Term: Proteinuria - ID: D000009404 - Term: Nephrotic Syndrome - ID: D000009401 - Term: Nephrosis ### Intervention Browse Module - Ancestors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000806 - Term: Angiotensin-Converting Enzyme Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000959 - Term: Antihypertensive Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M5476 - Name: Captopril - Relevance: HIGH - As Found: Decubitus - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4134 - Name: Angiotensin-Converting Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002216 - Term: Captopril ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417307 **Brief Title:** Exercise Therapy on Mitochondrial Functions of Lymphocyte in Hemodialysis **Official Title:** Supervised Exercise Therapy on Mitochondrial Functions of Platelet and Lymphocyte in Patients With End-Stage Renal Disease on Hemodialysis #### Organization Study ID Info **ID:** 202002321A3C501 #### Organization **Class:** OTHER **Full Name:** Chang Gung Memorial Hospital ### Status Module #### Completion Date **Date:** 2024-07-31 **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:** 2024-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-08-01 **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:** Chang Gung Memorial Hospital #### Responsible Party **Investigator Affiliation:** Chang Gung Memorial Hospital **Investigator Full Name:** Jong-Shyan Wang **Investigator Title:** Consultant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To improve aerobic capacity, muscular function and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise with moderate intensity is an available approach to maintain patients' safety and compliance, and enhance physiological adaptations effectively. The exercise training effects of mitochondrial functions of lymphocyte in ESRD patients, like respiratory capacity, bioenergetic status and thrombosis/immunological regulation remained unclear. Method: ESRD patients (anticipated n=180) would conduct supervised exercise training therapy for 3 days a week for 6 months in the hospital and 3 months at home. Cardiopulmonary exercise therapy would be performed before and after the intervention. A high resolution respirometer and a flow cytometer are used to determine the oxygen consumption rate/mitochondrial respiration in mitochondria and subtypes of lymphocyte, respectively. **Detailed Description:** Renal dysfunction results from cardiovascular-related comorbidities or metabolic disorders, accumulating excessive inflammatory products or damage mitochondrial bioenergetics health in platelet and lymphocyte, then lead to chronic kidney disease (CKD) eventually. End-stage renal disease (ESRD) is the highest level of CKD, patients at ESRD stage suffer from severe uremia and renal failure, preparing renal replacement therapy: dialysis. Hemodialysis (HD) are the most common treatment for ESRD patients, especially in Taiwan, where reports the highest prevalence of HD globally due to related chronic diseases and comprehensive National Health Insurance program. Maintenance (long-term) HD results in physical inactivity and low quality of life; thus, exercise training is recommended to improve physiological adaptations and functional capacity for HD patients. With supervised condition and a safer progression, intradialytic exercise in clinical settings provides low dropout rate and superior compliance. Mitochondrial dysfunction is one of the concerned issues in ESRD, impaired mitochondria also dysregulate circulating lymphocyte, leading to immunological senescence . The purposes of the present study are to establish the measurements of mitochondrial functions of platelet and lymphocyte in HD patients, and determine cardiovascular and muscular fitness along with the effects of intradialytic exercise. ### Conditions Module **Conditions:** - Hemodialysis Complication **Keywords:** - Hemodialysis - Mitochondria - Lymphocyte - Exercise training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 180 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Moderate intensity continuous cycling training. **Intervention Names:** - Behavioral: Supervised exercise training **Label:** Supervised exercise training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Recieve no intervention but only maintain daily lifestyle. **Intervention Names:** - Behavioral: Control group **Label:** Control group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Supervised exercise training **Description:** Participants perform Intradialytic cycling exercise training in the hospital for 6 months (24 weeks) and 3 months (12 weeks) at home. Exercise prescription: 50-60% maximal workload for 20-30 minutes, including low intensity warm-up and cool down (30% of maximal workload). **Name:** Supervised exercise training **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Maintain daily lifestyle until the end of the study. Receive no intervention/supplements. **Name:** Control group **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Evaluate oxygen consumption rate (oxidative phophorylation/electron transport chain), bioenergetic health index (BHI) in lymphocyte by using a high resolution respirometer. Evaluate mitochondrial function and subtypes of lymphocyte by using a aflow cytometer. **Measure:** Mitochondrial function of lymphocyte **Time Frame:** 9 months #### Secondary Outcomes **Description:** ESRD patients performed cardiopulmonary exercise testing (CPET) to assess their aerobic capacity. CPET composed of continuous workload increment of 10 W/min until exhaustion (usually within 8-12 minutes). Oxygen consumption, carbon dioxide production, ventilation, respiratory rate would be recorded. **Measure:** Cardiopulmonary fitness **Time Frame:** 9 months **Description:** We would use a qusionnaire named ESRDkidney disease quality of life-36 (KDQOL-36) to record and scale the qulaity of life in ESRD patients. The content include work status, cognitive funtion, social support, physical functioning and so on. **Measure:** Quality of life in ESRD patients **Time Frame:** 9 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients have been receiving hemodialysis and medication at least for 6 weeks, the Kt/V score must be above 1.2 to show that they were stable. Exclusion Criteria: * Under 20 years-old, hyperkalemia occurs within 3 month, orthopedic or muscular diseases, other medical, psychological or physiological diseases, pregnancy exercise contraindications. **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** s5492@mail.cgu.edu.tw **Name:** Jong-Shyan Wang, PhD **Phone:** +886-3-2118800 **Phone Ext:** 5748 **Role:** CONTACT #### Locations **Location 1:** **City:** Taoyuan **Contacts:** ***Contact 1:*** - **Name:** Jong-Shyan Wang, PhD - **Role:** CONTACT **Country:** Taiwan **Facility:** Chang Gung University **Status:** RECRUITING **Zip:** 333 #### Overall Officials **Official 1:** **Affiliation:** Chang Gung Memorial Hospital **Name:** Jong-Shyan Wang, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sovatzidis A, Chatzinikolaou A, Fatouros IG, Panagoutsos S, Draganidis D, Nikolaidou E, Avloniti A, Michailidis Y, Mantzouridis I, Batrakoulis A, Pasadakis P, Vargemezis V. Intradialytic Cardiovascular Exercise Training Alters Redox Status, Reduces Inflammation and Improves Physical Performance in Patients with Chronic Kidney Disease. Antioxidants (Basel). 2020 Sep 15;9(9):868. doi: 10.3390/antiox9090868. **PMID:** 32942555 **Citation:** Altintas MM, DiBartolo S, Tadros L, Samelko B, Wasse H. Metabolic Changes in Peripheral Blood Mononuclear Cells Isolated From Patients With End Stage Renal Disease. Front Endocrinol (Lausanne). 2021 Mar 9;12:629239. doi: 10.3389/fendo.2021.629239. eCollection 2021. **PMID:** 33790861 **Citation:** Deligiannis A, D'Alessandro C, Cupisti A. Exercise training in dialysis patients: impact on cardiovascular and skeletal muscle health. Clin Kidney J. 2021 Jan 11;14(Suppl 2):ii25-ii33. doi: 10.1093/ckj/sfaa273. eCollection 2021 Apr. **PMID:** 33981417 **Citation:** Chou CH, Fu TC, Tsai HH, Hsu CC, Wang CH, Wang JS. High-intensity interval training enhances mitochondrial bioenergetics of platelets in patients with heart failure. Int J Cardiol. 2019 Jan 1;274:214-220. doi: 10.1016/j.ijcard.2018.07.104. Epub 2018 Jul 27. **PMID:** 30072155 **Citation:** Lopes LCC, Mota JF, Prestes J, Schincaglia RM, Silva DM, Queiroz NP, Freitas ATVS, Lira FS, Peixoto MDRG. Intradialytic Resistance Training Improves Functional Capacity and Lean Mass Gain in Individuals on Hemodialysis: A Randomized Pilot Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):2151-2158. doi: 10.1016/j.apmr.2019.06.006. Epub 2019 Jul 3. **PMID:** 31278924 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417294 **Brief Title:** Effects of a 3D-Printed Port-A Catheter Model Training Course **Official Title:** Effects of a 3D-Printed Port-A Catheter Model Training Course for Patient Discharge Instruction #### Organization Study ID Info **ID:** FJUH112278 #### Organization **Class:** OTHER **Full Name:** Fu Jen Catholic University ### 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:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fu Jen Catholic University #### Responsible Party **Investigator Affiliation:** Fu Jen Catholic University **Investigator Full Name:** Ke-Yun, Chao **Investigator Title:** Group leader of Respiratory Therapists **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 is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education. **Detailed Description:** Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care. Methods： This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach. Effect： The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education. ### Conditions Module **Conditions:** - Patient Satisfaction - Cancer **Keywords:** - 3D printed model - port-a catheter - discharge education ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Received a explanation combined with 3D medical education model **Intervention Names:** - Other: 3D health education model **Label:** 3D model group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Received a regular education **Intervention Names:** - Other: traditional education **Label:** traditional education group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - 3D model group **Description:** explanation combined with 3D health education model **Name:** 3D health education model **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - traditional education group **Description:** Regular education **Name:** traditional education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** higher means a better outcome **Measure:** Patient education effectiveness questionnaire **Time Frame:** immediately after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital * Placed port-A catheter for the first time * Have Chinese communication skills Exclusion Criteria: * Was not placing port-A for the first time. * Refused to participate in the study. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** C00152@mail.fjuh.fju.edu.tw **Name:** Ke-Yun Chao, PhD **Phone:** +886905301879 **Role:** CONTACT #### Locations **Location 1:** **City:** New Taipei City **Country:** Taiwan **Facility:** Fu Jen Catholic University Hospital, Fu Jen Catholic University **Zip:** 24352 #### Overall Officials **Official 1:** **Affiliation:** Fu Jen Catholic University Hospital **Name:** Ke-Yun Chao, PhD **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:** NCT06417281 **Brief Title:** Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA） **Official Title:** A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid #### Organization Study ID Info **ID:** F0009-01 #### Organization **Class:** INDUSTRY **Full Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-08 **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:** 2025-08 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3\~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis. ### Conditions Module **Conditions:** - 5-aminolevulinic Acid - Malignant Glioma of Brain ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is an single arm study. **Intervention Names:** - Drug: 5 Aminolevulinic Acid **Label:** 5 Aminolevulinic Acid **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 5 Aminolevulinic Acid **Description:** 3±1 hours before anesthesia, participants will take 5-ALA orally at a dosage of 20 mg/kg, followed by fluorescence-guided resection of malignant glioma. **Name:** 5 Aminolevulinic Acid **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of biopsy tissues diagnosed as malignant glioma cells positive by pathological examination among all tissues collected from both fluorescent and weakly fluorescent areas. **Measure:** positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites **Time Frame:** within 48h after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient's written informed consent * Age 18-75 years * Radiological suspicion of a malignant glioma * Indication for surgical tumour resection * Karnofsky Performance Status (KPS) ≥ 70 Exclusion Criteria: * Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem * Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases； * known hypersensitivity to the test drug ingredients * Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate; **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wujinsong@huashan.org.cn **Name:** jingsong wu, doctor **Phone:** +8613701707118 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** jingsong wu, Doctor - **Role:** CONTACT **Country:** China **Facility:** Huashan Hospital, Fudan University ## Derived Section ### Condition Browse Module - Ancestors - 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: M9020 - Name: Glioma - Relevance: HIGH - As Found: Glioma - 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: T2519 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005910 - Term: Glioma ### Intervention Browse Module - Ancestors - ID: D000017319 - Term: Photosensitizing Agents - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M3960 - Name: Aminolevulinic Acid - Relevance: HIGH - As Found: Outcome measures - ID: M19608 - Name: Photosensitizing Agents - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000622 - Term: Aminolevulinic Acid ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417268 **Brief Title:** Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block for Pediatric Hip Surgeries **Official Title:** Ultrasound-Guided Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block Versus Caudal Block for Postoperative Analgesia in Pediatric Hip Surgeries. A Randomized Controlled Study. #### Organization Study ID Info **ID:** MD-16-2024 #### Organization **Class:** OTHER **Full Name:** Kasr El Aini Hospital ### Status Module #### Completion Date **Date:** 2024-08 **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:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-03-20 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kasr El Aini Hospital #### Responsible Party **Investigator Affiliation:** Kasr El Aini Hospital **Investigator Full Name:** maged gamal **Investigator Title:** Anesthesia lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** combined pericapsular nerve group PENG block and lateral femoral cutaneous nerve block may be effective in reducing post-operative pain after open hip surgery in children. **Detailed Description:** All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time. Midazolam (0.5mg/kg) will be given orally to each child in both groups as a premedication half an hour before the procedure. General anesthesia will be induced in a supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. Group C will receive caudal analgesia Bupivacaine 0.25% at a dose of 1 ml/kg. Group B will receive PENG block Bupivacaine 0.25% at a dose of 1 ml/kg and lateral femoral cutaneous nerve block Bubivacaine 0.25% at 0.1 ml/kg. After receiving the block, a surgical incision will be done after 15 minutes. Continuous recording of heart rate and blood pressure will be carried out from the moment of injection at timely intervals intra-operative. Intra-operatively, an increase in hemodynamics in response to the skin incision by more than 30% from baseline values 5 min after intubation or thereafter is managed by intravenous administration of fentanyl 1 µg/kg to a maximum dose of 2 µg/kg. Postoperative pain assessment using the FLACC score will then follow for 24 hours. ### Conditions Module **Conditions:** - Pericapsular Nerve Group Block **Keywords:** - Hip surgery - Lateral Femoral Cutaneous Nerve Block ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 68 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive caudal analgesia **Intervention Names:** - Procedure: Caudal epidural analgesia - Drug: Fentanyl - Drug: Morphine - Drug: Acetaminophen **Label:** Group C **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** patients will receive PENG block and Lateral Femoral Cutaneous Nerve block **Intervention Names:** - Procedure: Ultrasound-guided Combined Pericapsular Nerve Group Block - Procedure: Ultrasound-guided Lateral Femoral Cutaneous Nerve Block - Drug: Fentanyl - Drug: Morphine - Drug: Acetaminophen **Label:** Group B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group C **Description:** patient will be placed in the left lateral position with flexed hips.After palpating the landmarks (the upper posterior iliac spine and sacral hiatus from the edges of an equilateral triangle), an epidural puncture is performed in the most proximal region of the sacral hiatus with the needle inclined 45-60° to the skin. While palpating with the index finger of the left hand, the needle is inserted immediately below the spinous process S4. After perforating the membrane, the needle will be advanced no more than 1-3 mm to avoid a bloody puncture or an intrathecal injection, The confirmation of the correct position of the caudal needle before injection by performing the modified 'swoosh' test" performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of saline. Bupivacaine 0.25% at a dose of 1 ml/kg will be injected, with care taken not to exceed the maximum recommended dose (2 mg/kg). **Name:** Caudal epidural analgesia **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group B **Description:** With supine position, the probe will be put in a transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral nerve, and femoral artery (FA). Then the probe will be rotated counter clockwise to align with the pubic ramus to visualize the AIIS, iliopsoas prominence (IPE), FA, iliopsoas, and iliopsoas notch. Under direct vision, a 22-gauge, 50-mm echo needle will be advanced in the lateral-medial plane between the psoas tendon and the pubic ramus until the needle tip touches the IPE. The needle will be withdrawn, and after negative aspiration, 1 ml/kg (Bupivacaine 0.25%) is injected **Name:** Ultrasound-guided Combined Pericapsular Nerve Group Block **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Group B **Description:** patient remains supine, and the transducer is parallel to the inguinal ligament. With the femoral artery and vein as guidance, the lateral part of the sartorius muscle and fascia lata is visualized. Approximately 3 cm inferior from this point, the branches of the lateral femoral cutaneous nerve are visualized in the hypoechoic fat-filled subfascial space between the sartorius muscle medially and the tensor fascia lata muscle laterally. A 22-gauge, 50-mm needle is inserted with in plane approach at a shallow angle to reach the area of the nerve and after negative aspiration, 0.1 ml/kg (Bupivacaine 0.25%) is injected. **Name:** Ultrasound-guided Lateral Femoral Cutaneous Nerve Block **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Group B - Group C **Description:** patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg). **Name:** Fentanyl **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Group B - Group C **Description:** If a FLACC pain Score is ≥ 4/10, the patient in the PACU will receive morphine (intravenous, 0.03 mg/kg), and the maximum allowed dose is 0.1mg/kg every 4 hours. **Name:** Morphine **Other Names:** - rescue analgesia **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Group B - Group C **Description:** P atients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours **Name:** Acetaminophen **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Time (minutes) to first need of rescue analgesia postoperative. **Measure:** Time to first rescue analgesia **Time Frame:** First 24 hours postoperative #### Secondary Outcomes **Description:** systolic, diastolic, mean blood pressure (mmHg) **Measure:** Intraoperative hemodynamic parameters **Time Frame:** intraoperative period **Description:** heart rate (bpm) **Measure:** Intraoperative hemodynamic parameters **Time Frame:** intraoperative period **Description:** total intraoperative consumed fentanyl (mg/kg) **Measure:** Total fentanyl consumption **Time Frame:** intraoperative period **Description:** total postoperative consumed morphine (mg/kg) **Measure:** Total morphine consumption **Time Frame:** First 24 hours postoperative **Description:** In the PACU, quality of analgesia was assessed every 15 minutes for the first hour then after 2, 4 ,6 ,12,18 and 24 hours postoperative using (face, legs, activity, and cry consolability scale) (FLACC) pain score **Measure:** Postoperative pain assessment FLACC **Time Frame:** First 24 hours postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I, II. * Unilateral hip surgery. Exclusion Criteria: * Parents' refusal to participate in the study. * Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR\> 1.5). * Localized infection at the site of needle insertion. * Known hypersensitivity or allergies to any of the used drugs. * Bilateral hip surgery in the same session. **Maximum Age:** 9 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ramyalkonaiesy@gmail.com **Name:** Ramy m alkonaiesy **Phone:** 01224883990 **Phone Ext:** +2 **Role:** CONTACT **Contact 2:** **Email:** ahmed.lotfy@kasralainy.edu.eg **Name:** Ahmed M Lotfy **Phone:** 01000608905 **Phone Ext:** +2 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Name:** Abul-Reesh children hospital - **Role:** CONTACT **Country:** Egypt **Facility:** Cairo University Hospitals **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000759 - Term: Adjuvants, Anesthesia - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000058633 - Term: Antipyretics ### 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: Antipy - Name: Antipyretics ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M8418 - Name: Fentanyl - Relevance: HIGH - As Found: Scan - ID: M2340 - Name: Acetaminophen - Relevance: HIGH - As Found: Compared - ID: M11982 - Name: Morphine - Relevance: HIGH - As Found: Site - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4089 - Name: Adjuvants, Anesthesia - 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: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000082 - Term: Acetaminophen - ID: D000005283 - Term: Fentanyl - ID: D000009020 - Term: Morphine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417255 **Brief Title:** Comparison Of The Effects Of Kinesiotape Application And Foam Roller Exercises **Official Title:** Comparison Of The Effects Of Kinesiotape Application And Foam Roller Exercises in Individuals With Chronic Low Back Pain #### Organization Study ID Info **ID:** CHRONIC LOW BACK PAIN #### Organization **Class:** OTHER **Full Name:** Istanbul Medipol University Hospital ### Status Module #### Completion Date **Date:** 2024-09-21 **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:** 2024-07-26 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-11 **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 #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Medipol University Hospital #### Responsible Party **Investigator Affiliation:** Istanbul Medipol University Hospital **Investigator Full Name:** hazal genc **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:** Low back pain is an important health problem that is common worldwide, with a lifetime prevalence of up to 80%. **Detailed Description:** Low back pain that lasts less than 6 weeks is called acute low back pain, if it continues for 6-12 weeks it is called subacute low back pain, and if it continues for more than 12 weeks it is called chronic low back pain. The majority of low back pain (97%) is of mechanical origin. ### Conditions Module **Conditions:** - Low Back Pain, Mechanical ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: kinesiotape application **Label:** kinesiotape application **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: foam roller application **Label:** foam roller application **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - kinesiotape application **Description:** The strips used for kinesiological taping can be applied by giving different shapes. These shapes are I, Y, X, ring (donut), rake and net **Name:** kinesiotape application **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - foam roller application **Description:** In the foam roller group, "Actifoam" brand non-serrated foam rollers with a size of "15x90" cm were used. **Name:** foam roller application **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The algometer, an effective way of measuring pressure pain threshold (PPT), is used to measure soft tissue pain associated with trigger points. Pittsburgh Sleep Quality Scale The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21 Schober Flexibility Test With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion. **Measure:** Pressure Pain Measurement with Algometer **Time Frame:** 6 weeks **Description:** The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21 **Measure:** Pittsburgh Sleep Quality Scale **Time Frame:** 6 weeks **Description:** With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion. **Measure:** Schober Flexibility Test **Time Frame:** 6 weeks **Description:** The finger-to-floor distance test is a test that measures specific physical disability. This test is performed with the person standing upright with feet together. The patient is asked to lean as far forward as possible with knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the floor is measured with a flexible tape measure. **Measure:** The finger-to-floor distance **Time Frame:** 6 weeks **Description:** The Tampa Kinesiophobia Scale measures fear of movement and fear of (re)injury during movement. High fear of movement and/or (re)injury, as measured by the Tampa Kinesiophobia Scale, has been found to be associated with poor performance on a number of physical tests. The minimum and maximum values of the Tampa Kinesiophobia Fatigue Scale are between 17 and 68. The total score range of this scale is between 0 and 68. **Measure:** Tampa Kinesiophobia Fatigue Scale **Time Frame:** 6 weeks **Description:** The Oswestry Disability Index, first introduced by Fairbank et al. in 1980, is considered close to the gold standard for measuring the severity of disability due to low back pain. The Oswestry scale is a self-administered, free, easy-to-use and easy-to-score questionnaire containing 10 questions on different functional domains. The Oswestry Disability Index (ODI) is a widely used tool to assess disability related to low back pain. It consists of 10 sections addressing various daily activities, each scored on a scale of 0 to 5. The minimum score is 0, indicating no disability, while the maximum score is 50, indicating severe disability. **Measure:** Oswestry Scale **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with chronic low back pain * Individuals aged 18-60 years * Patients without verbal communication barriers * Patients without cognitive impairment (delirium, dementia, amnesia) Exclusion Criteria: * Exercise contraindication (uncontrolled medical conditions) * Patients with previous spinal surgery * Patients who develop an allergic reaction to the kinesiotape tape to be applied **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hazaloksuz@gmail.com **Name:** Hazal GENÇ, PhD **Phone:** 05413204291 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** hazaloksuz@gmail.com - **Name:** Hazal GENÇ - **Phone:** 05413204291 - **Role:** CONTACT **Country:** Turkey **Facility:** Hazal GENÇ **State:** None Selected **Status:** RECRUITING **Zip:** 34353 ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M13066 - Name: Pain - 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: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417242 **Acronym:** PrOAF-HF **Brief Title:** Predicting Outcomes in Atrial Fibrillation and Heart Failure **Official Title:** Predicting Outcomes in Atrial Fibrillation and Heart Failure #### Organization Study ID Info **ID:** 318987 #### Organization **Class:** OTHER **Full Name:** Guy's and St Thomas' NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2026-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **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:** 2024-05-16 **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:** Guy's and St Thomas' NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** PrOAF-HF will aim to test if rhythm control delivered through catheter ablation in patients in whom it is not clear whether atrial fibrillation or heart failure were the first disease results in a greater improvement in left ventricular ejection fraction (LVEF) compared with patients where heart failure was diagnosed first with no evidence of AF. **Detailed Description:** Heart failure is a chronic disease affecting half a million patients in the UK. Up to 40% of patients with heart failure also suffer from atrial fibrillation. A subgroup of patients with atrial fibrillation and heart failure have tachycardia induced cardiomyopathy and benefit from significant improvement of the left ventricular function with restoration of sinus rhythm. Currently those patients can only be identified based on their response to treatment. Investigators aim to improve the treatment of AF-HF patients. The group will develop a robust modelling framework for simulating the hearts of AF-HF patients' hearts to predict patients' response to therapy and infer patient history. This modelling framework will enable integration of predictive simulations into clinical study design where the inferred initiating disease and predicted patient response to therapy are tested for selecting either rate or rhythm control in AF-HF patients. The primary objective is to test if rhythm control delivered through catheter ablation in patients where either the index disease is unclear or where AF was diagnosed prior to the onset of HF improves LVEF more than in patients where HF was diagnosed first with no evidence of AF. The secondary objectives are to examine whether the ability to terminate AF during pulmonary vein isolation is influenced by the identified index disease and to determine whether the identified index disease affects AF recurrence rate at 6 months and/or burden post ablation. This study will also identify whether the index disease affects pressure measurements as predictors of change in ejection fraction, hospitalisation, and death rates during the follow up period. This will be a non-interventional cohort study. Routinely acquired clinical data collected during pre-procedure work up will be accessed for research purposes including: 24-48 hour ambulatory (Holter) monitoring, electrocardiograph (ECG) in AF and in sinus rhythm if available; echocardiography, and clinical history and examination details. Additionally, an atrial cardiac magnetic resonance imaging (MRI) scan will be performed including assessment of atrial structure, function, fibrosis and epicardial fat burden. Symptom questionnaires will be performed During the ablation procedure, additional time will be taken to perform electrophysiological assessment in all four chambers of the heart. ### Conditions Module **Conditions:** - Atrial Fibrillation - Heart Failure **Keywords:** - ablation - atrial fibrillation - AF - heart failure - HF - rhythm control ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with no history of atrial fibrillation at the time of first diagnosis of heart failure **Label:** HF index disease #### Arm Group 2 **Description:** Patients in whom the index disease is unknown or in whom atrial fibrillation is the index disease **Label:** Unclear index disease ### Outcomes Module #### Primary Outcomes **Description:** Change in left ventricular ejection fraction measured on echocardiography **Measure:** Change in LVEF **Time Frame:** 6 months post ablation #### Secondary Outcomes **Description:** Change in left ventricular ejection fraction on echocardiography **Measure:** Immediate change in LVEF **Time Frame:** Immediately post procedure **Description:** Presence of AF **Measure:** AF recurrence **Time Frame:** 6 months post ablation **Description:** Termination of AF during the ablation procedure **Measure:** Termination of AF during the procedure **Time Frame:** Intraprocedural **Description:** Hospitalization for any reason **Measure:** Hospitalization **Time Frame:** 6 months **Description:** Death of any cause and cardiovascular death **Measure:** Death **Time Frame:** 6 months **Description:** Invasive measurements of all four chambers pressure changes during the ablation **Measure:** Pressure measurements as predictors of change in LVEF **Time Frame:** Intraprocedural measurements - change in LVEF as above **Description:** Change in atrial fibrillation burden assessed on a continuous Holter monitor **Measure:** Change in atrial fibrillation burden **Time Frame:** 6 months post ablation **Description:** Change in quality of lide questionnaire scores **Measure:** Change in symptoms **Time Frame:** 6 months post ablation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Symptomatic persistent AF * LVEF ≤40% prior to commencement of treatment * NYHA class ≥2 * Patient must have been commenced on guideline directed medical therapy (GDMT) * Patient planning to proceed to radiofrequency atrial fibrillation ablation * Age 18-80 years * Able and willing to provide written informed consent Exclusion Criteria: * Any clinical contra-indication to ablation * Any disease limiting life expectancy to \<1 year * Potential participant currently pregnant or breast feeding * Contraindication to MRI * Paroxysmal or permanent AF * Unable to understand verbal or written explanations given in English **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients with diagnosis of both heart failure and atrial fibrillation, listed for atrial fibrillation ablation will be recruited for the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** magda.klis@kcl.ac.uk **Name:** Magdalena Klis, MD **Phone:** 02071887188 **Phone Ext:** 56308 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000001281 - Term: Atrial Fibrillation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417229 **Brief Title:** Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants **Official Title:** A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants #### Organization Study ID Info **ID:** CA228-1011 #### Organization **Class:** INDUSTRY **Full Name:** Celgene ### Status Module #### Completion Date **Date:** 2024-12-10 **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:** 2024-11-18 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-16 **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:** Celgene #### 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 evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants. ### Conditions Module **Conditions:** - Healthy Participants **Keywords:** - BMS-986365 - Pharmacokinetics - Relative Bioavailability - Healthy Male Volunteers - CC-94676 - Food Effect - Proton Pump Inhibitor ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 82 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 1: Cohort 1 BMS-986365 Dose 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1 **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2 **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 1: Cohort 3 BMS-986365 Dose 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 1: Cohort 6 BMS-986365 Dose 5 **Type:** EXPERIMENTAL #### Arm Group 6 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 1: Cohort 7 BMS-986365 Dose 6 **Type:** EXPERIMENTAL #### Arm Group 7 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 1: Cohort 8 BMS-986365 Dose 7 **Type:** EXPERIMENTAL #### Arm Group 8 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 2: Cohort 4 BMS-986365 Dose 8 Fasted **Type:** EXPERIMENTAL #### Arm Group 9 **Intervention Names:** - Drug: BMS-986365 **Label:** Part 2: Cohort 4 BMS-986365 Dose 9 Fed **Type:** EXPERIMENTAL #### Arm Group 10 **Intervention Names:** - Drug: Rabeprazole **Label:** Part 2: Cohort 5 BMS-986365 Dose 10 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1: Cohort 1 BMS-986365 Dose 1 - Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1 - Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2 - Part 1: Cohort 3 BMS-986365 Dose 4 - Part 1: Cohort 6 BMS-986365 Dose 5 - Part 1: Cohort 7 BMS-986365 Dose 6 - Part 1: Cohort 8 BMS-986365 Dose 7 - Part 2: Cohort 4 BMS-986365 Dose 8 Fasted - Part 2: Cohort 4 BMS-986365 Dose 9 Fed **Description:** Specified dose on specified days **Name:** BMS-986365 **Other Names:** - CC-94676 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part 2: Cohort 5 BMS-986365 Dose 10 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365 **Description:** Specified dose on specified days **Name:** Rabeprazole **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Maximum observed plasma concentration (Cmax) **Time Frame:** Up to Day 75 **Measure:** Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] **Time Frame:** Up to Day 75 **Measure:** Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] **Time Frame:** Up to Day 75 #### Secondary Outcomes **Measure:** To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation **Time Frame:** Up to Day 75 **Measure:** Incidence of adverse events (AE) **Time Frame:** Up to Day 75 **Measure:** Incidence of serious adverse events (SAE) **Time Frame:** Up to Day 75 **Measure:** Number of participants with physical examination abnormalities **Time Frame:** Up to Day 75 **Measure:** Number of participants with vital sign abnormalities **Time Frame:** Up to Day 75 **Measure:** Number of participants with clinical laboratory abnormalities **Time Frame:** Up to Day 75 **Measure:** Number of participants with electrocardiogram (ECG) abnormalities **Time Frame:** Up to Day 75 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator. * Body mass index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive. Exclusion Criteria: * Any significant acute or chronic illness. * Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval. * History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds. * Other protocol-defined inclusion/exclusion criteria apply. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Clinical.Trials@bms.com **Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com **Phone:** 855-907-3286 **Role:** CONTACT **Contact 2:** **Name:** First line of the email MUST contain NCT # and Site #. **Role:** CONTACT #### Locations **Location 1:** **City:** Lenexa **Contacts:** ***Contact 1:*** - **Name:** Site 0001 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0001 **State:** Kansas **Zip:** 66219 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html **IPD Sharing:** NO ### References Module #### See Also Links **Label:** BMS Clinical Trial Information **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html **Label:** BMS Clinical Trial Patient Recruiting **URL:** https://www.bmsstudyconnect.com/s/US/English/USenHome ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000897 - Term: Anti-Ulcer Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000054328 - Term: Proton Pump Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M30382 - Name: Rabeprazole - Relevance: HIGH - As Found: Total dose - ID: M27630 - Name: Proton Pump Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000064750 - Term: Rabeprazole ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417216 **Acronym:** OCNP **Brief Title:** Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies **Official Title:** Head-Cancelled Virtual Reality for Rehabilitation of Ocular Cranial Nerve Palsies #### Organization Study ID Info **ID:** 00001090 #### Organization **Class:** OTHER **Full Name:** University of Massachusetts, Worcester ### Status Module #### Completion Date **Date:** 2026-06-01 **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:** 2026-06-01 **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:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** American Academy of Optometry #### Lead Sponsor **Class:** OTHER **Name:** Kevin Houston #### Responsible Party **Investigator Affiliation:** University of Massachusetts, Worcester **Investigator Full Name:** Kevin Houston **Investigator Title:** Associate Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is investigating whether eye exercises for abducens palsy and internuclear ophthalmoplegia increase ocular range of motion in the paretic direction when performed in virtual reality under head-cancelled compared to head-active conditions. **Detailed Description:** Participants with abducens palsy or internuclear ophthalmoplegia, two common types of ocular cranial nerve palsies, will perform 3 different tasks in virtual reality under head-cancelled and head-active conditions. Head active is the normal state, where gaze can be shifted by moving the head, the eyes, or a combination of the two. Head-cancelled refers to the condition where the scene moves with the head, rendering head movement ineffective to shift gaze. In this condition, the eyes must move in order to shift gaze. The hypothesis is that this requirement for eye movement will result in larger eye movements, which could be therapeutic. The tasks performed under the two conditions will include horizontal transposition of coins, repetitive horizontal saccades, and game play. The primary analysis will be a within subject's comparison of eye movement amplitude in head-cancelled (experimental) versus head-active (control) conditions. Additionally, as a control comparison for secondary analysis, a group with normal vision will also perform the tasks under both conditions. ### Conditions Module **Conditions:** - Internuclear Ophthalmoplegia - Palsy, Abducens ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Subjects perform study tasks under head-active conditions, and then are crossed over to the head-cancelled condition. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study tasks performed in head-cancelled conditions **Intervention Names:** - Behavioral: Head-cancelled virtual reality **Label:** Head Cancelled **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Study tasks performed in normal conditions. **Label:** Normal **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Head Cancelled **Description:** Scene in virtual reality moves with the head while performing visual tasks. **Name:** Head-cancelled virtual reality **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Maximum amplitude of eye movement **Measure:** Peak saccade amplitude **Time Frame:** 5 minutes #### Secondary Outcomes **Description:** Mean deviation of the head from the neutral position during each task **Measure:** Mean head position **Time Frame:** 5 minutes ### Eligibility Module **Eligibility Criteria:** OCNP Group Inclusion Criteria: * Presence of OCNP in one eye with 50% range-of-motion limitation or worse * Able to provide informed consent and will be able to fluently read and understand spoken English OCNP Group Exclusion Criteria: * Presence of bilateral OCNP * Range of motion better than 50% * Visual acuity worse than 20/100 in either eye * Greater than 4-line difference in visual acuity between the eyes, * Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset Participants will be excluded if they are unable to participate if inclusion criteria are not met. Normal Group Inclusion Criteria: * Absence of OCNP or other neurological or neuro-ophthalmic diseases * No strabismus * Have normal or near-normal vision with glasses or contact lenses. * Be able to provide informed consent and will be able to fluently read and understand spoken English Normal Group Exclusion Criteria: * Visual acuity worse than 20/100 in either eye * Greater than 4-line difference in visual acuity between the eyes * Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset * Known inability to tolerate visual testing of at least 20 minutes continuously. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kevin.houston@umassmed.edu **Name:** Kevin Houston, OD **Phone:** 7744418745 **Role:** CONTACT **Contact 2:** **Email:** michelle.manxhari@umassmed.edu **Name:** Michelle Manxhari, BS **Phone:** 5089488122 **Role:** CONTACT #### Locations **Location 1:** **City:** Worcester **Contacts:** ***Contact 1:*** - **Email:** kevin.houston@umassmed.edu - **Name:** Kevin Houston, OD - **Phone:** 774-441-8745 - **Role:** CONTACT **Country:** United States **Facility:** University of Massachusetts Chan Medical School **State:** Massachusetts **Status:** RECRUITING **Zip:** 01605 #### Overall Officials **Official 1:** **Affiliation:** University of Massachusetts, Worcester **Name:** Kevin E Houston, OD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010243 - Term: Paralysis - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000013285 - Term: Strabismus ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M12817 - Name: Ophthalmoplegia - Relevance: HIGH - As Found: Ophthalmoplegia - ID: M6605 - Name: Cranial Nerve Diseases - Relevance: HIGH - As Found: Cranial Nerve Palsy - ID: M18386 - Name: Ocular Motility Disorders - Relevance: HIGH - As Found: Internuclear Ophthalmoplegia - ID: M22230 - Name: Abducens Nerve Diseases - Relevance: HIGH - As Found: Palsy, Abducens - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M16075 - Name: Strabismus - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009886 - Term: Ophthalmoplegia - ID: D000003389 - Term: Cranial Nerve Diseases - ID: D000015835 - Term: Ocular Motility Disorders - ID: D000020434 - Term: Abducens Nerve Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417203 **Brief Title:** Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty **Official Title:** Hypobaric Spinal or Hyperbaric in Partial Hip Arthroplasty Surgeries? Can an Answer be Found by Perfusion Index? #### Organization Study ID Info **ID:** 11.05.2024-ADYU-ANS-NY-05 #### 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 compare the effects of hypobaric and hyperbaric spinal applications on patient haemodynamics, duration of anaesthetic effect and postoperative analgesia. Thus, it was aimed to determine the method that protects haemodynamics more and suppresses postoperative pain complaints of patients better in this patient group with advanced age, comorbid systemic diseases and high risk of operation. **Detailed Description:** Patients who are planned to be operated for partial hip replacement at Adıyaman University Training and Research Hospital, who are informed about the study and who agree to participate in the study with their written consent will be included in the study. Patients who agree to participate in the study will be divided into two groups: hypobaric and hyperbaric spinal anaesthesia patients will be divided into two groups to be decided by the Anaesthesiology and Reanimation specialist responsible for the operation (hyperbaric/hypobaric). Before the start of the operation, perfusion index (PI) values will be monitored with a probe in both lower extremities with standard ASA monitoring. Haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), PI values of both extremities, duration of motor and sensory block, postoperative numeric pain scores of all patients will be recorded and these values will be compared in both groups. Thus, it was aimed to compare the efficacy, safety, block times and contribution to pain management of each application. ### Conditions Module **Conditions:** - Post Operative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** two gropus planned for study 1. group - Hyperbaric spinal anesthesia 2. group - Hypobaric spinal anesthesia ##### Masking Info **Masking:** DOUBLE **Masking Description:** for patient - closed envelope system for Outcomes Assessor - will not participate perioperative period and will not know group of patients **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this group, hyperbaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery **Intervention Names:** - Procedure: spinal anesthesia with hyberbaric bupivacaine **Label:** Hyberbaric group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In this group, hypobaric bupivacaine was planned to use in spinal anesthesia for partial hip replacement surgery **Intervention Names:** - Procedure: spinal anesthesia with hypobaric bupivacaine **Label:** Hypobaric group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Hyberbaric group **Description:** After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 12.5 mg hyperbaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space. **Name:** spinal anesthesia with hyberbaric bupivacaine **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Hypobaric group **Description:** After standard ASA monitoring in the operation room, spinal anaesthesia was induced by injection of 12.5 mg hyperbaric bupivacaine into the subarachnoid space with the help of a spinal needle through the L4-5 intervertebral space. **Name:** spinal anesthesia with hypobaric bupivacaine **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** a tool that asses patinet paiin level 0 (no pain) -10 (the worst pain ever had) , the tool will be used at postopertaive period **Measure:** Visual analog pain score (VAS) **Time Frame:** three months #### Secondary Outcomes **Description:** a tool that asses recovery quality of patient with 15 question will be used 24th hour after surgery **Measure:** Quality of recovery (QoR-15) **Time Frame:** Three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I-II Exclusion Criteria: * ASA III-IV * Deny to participiate * conditions that spinal anesthesia contraindicated **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 - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### 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: HIGH - As Found: Following - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Imaging - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002045 - Term: Bupivacaine - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417190 **Brief Title:** Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology **Official Title:** IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology #### Organization Study ID Info **ID:** IIT2023-13-BALLAS-VHTMT #### Organization **Class:** OTHER **Full Name:** Cedars-Sinai Medical Center ### Status Module #### Completion Date **Date:** 2030-07 **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:** 2030-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **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:** Leslie Ballas #### Responsible Party **Investigator Affiliation:** Cedars-Sinai Medical Center **Investigator Full Name:** Leslie Ballas **Investigator Title:** Sponsor-Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread. **Detailed Description:** Trimodal therapy (TMT) is accepted as an NCCN category 1 alternative to radical cystectomy (with neoadjuvant chemotherapy) in patients with cT2N0M0 muscle-invasive urothelial cell bladder cancer (MIBC). Not all patients with MIBC have pure urothelial cell carcinoma; urothelial carcinoma with variant histology (VH) described any morphologic variant of conventional urothelial carcinoma that is believed to be derived from urothelial carcinoma and is typically admixed with conventional urothelial carcinoma in the same tumor. Variant histologies described include squamous differentiation, glandular differentiation, micropapillary, sarcomatoid, small cell/neuroendocrine, plasmacytoid and nested variant. This is a rare tumor type and understudied. For patients with variant histologies there is limited data on the use of trimodal therapy. There are a couple single institution retrospective studies and data from the NCDB, but no prospective data. ### Conditions Module **Conditions:** - Muscle-Invasive Bladder Carcinoma - Tumor **Keywords:** - Trimodal Therapy (TMT) - Neoadjuvant Chemotherapy - muscle-invasive urothelial cell bladder cancer (MIBC) ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single-arm, open-label ##### 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:** Neoadjuvant chemotherapy followed by trimodal therapy consisting of TURBT followed by concurrent chemotherapy with radiation therapy **Intervention Names:** - Drug: Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC) **Label:** Single Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Single Arm **Description:** Single-arm, open-label **Name:** Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC) **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** To estimate progression free (\<=T2) survival rates from TMT **Measure:** Progression free (<=T2) survival rates **Time Frame:** 3 year **Description:** To estimate the metastasis-free survival of TMT **Measure:** Metastasis-free survival **Time Frame:** 3 year **Description:** To estimate the rate of salvage cystectomy following TMT **Measure:** Rate of salvage cystectomy **Time Frame:** 3 year **Description:** To investigate blood and urine correlatives of clinical outcomes (Signatera and Oncuria) **Measure:** Blood and urine correlatives of clinical outcomes **Time Frame:** 3 year #### Primary Outcomes **Description:** To evaluate the feasibility of initiating TMT within 45 days of completion of NAC - Feasibility will be defined as at least 17 study participants initiating TMT within 45 days of NAC **Measure:** Feasibility of initiating TMT **Time Frame:** 45 days #### Secondary Outcomes **Description:** To estimate 3-year bladder intact event free survival (BIEFS) in patients undergoing TMT for MIBC with VH-TMT **Measure:** 3-year bladder intact event free survival (BIEFS) **Time Frame:** 3 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Evidence of diffuse cis on pathology * Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral) * Prior radiotherapy to the pelvis * History of systemic therapy for MIBS * Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cancer.trial.info@cshs.org **Name:** Clinical Trial Navigator **Phone:** 3104232133 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** cancer.trial.info@cshs.org - **Name:** Clinical Trial Recruitment Navigator - **Phone:** 310-423-2133 - **Role:** CONTACT ***Contact 2:*** - **Name:** Leslie Ballas, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Anirban Mitra, MD, PhD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Michael Ahdoor, MD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Charles Rosser, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Cedars Sinai Medical Center **State:** California **Zip:** 90048 #### Overall Officials **Official 1:** **Affiliation:** Cedars-Sinai Medical Center **Name:** Leslie Ballas, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - 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: M5030 - Name: Urinary Bladder Neoplasms - Relevance: HIGH - As Found: Bladder Cancer - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - 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: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001749 - Term: Urinary Bladder Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417177 **Brief Title:** Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia **Official Title:** Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia #### Organization Study ID Info **ID:** 2100208 #### Organization **Class:** OTHER **Full Name:** University of Missouri-Columbia ### Status Module #### Completion Date **Date:** 2025-07 **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:** 2025-07 **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:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Missouri-Columbia #### Responsible Party **Investigator Affiliation:** University of Missouri-Columbia **Investigator Full Name:** Jacqueline K Limberg, PhD **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### 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 examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women. ### Conditions Module **Conditions:** - Aging - Menopause - Hypoxia - Vasodilation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be exposed to low oxygen air using a mask. **Intervention Names:** - Drug: Placebo - Drug: Propranolol - Drug: Gemtesa **Label:** Hypoxia **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be exposed to ice water on the foot. **Intervention Names:** - Drug: Placebo - Drug: Propranolol - Drug: Gemtesa **Label:** Cold pressor test **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will be exposed to high carbon dioxide air using a mask. **Intervention Names:** - Drug: Placebo - Drug: Propranolol - Drug: Gemtesa **Label:** Hypercapnia **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cold pressor test - Hypercapnia - Hypoxia **Description:** Participants will receive a placebo in pill form. **Name:** Placebo **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cold pressor test - Hypercapnia - Hypoxia **Description:** Participants will receive oral propranolol (1 mg/kg). **Name:** Propranolol **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Cold pressor test - Hypercapnia - Hypoxia **Description:** Participants will receive oral gemtesa (75 mg). **Name:** Gemtesa **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Blood flow in the forearm measured with venous occlusion plethysmography. **Measure:** Forearm blood flow **Time Frame:** Change from baseline to 5 minutes. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female assigned at birth * Pre, peri- or post-menopausal * Healthy weight (BMI ≥18 and ≤30 kg/m2) Exclusion Criteria: * Male (assigned at birth) * Pregnancy, breastfeeding * Use of hormone replacement therapies * Hysterectomy * Body mass index \>30 kg/m2 * Diagnosed sleep apnea * Current smoking/Nicotine/Drug use * Nerve/neurologic disease * Cardiovascular, hepatic, renal, respiratory disease * Blood pressure ≥140/90 mmHg * Diabetes, Polycystic ovarian syndrome * Communication barriers * Prescription medications * Malignant cancer **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** limberglab@missouri.edu **Name:** Jacqueline Limberg **Phone:** 573-882-2544 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4185 - Name: Hypoxia - Relevance: HIGH - As Found: Hypoxia - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown - ID: T6036 - Name: Menopause - Relevance: HIGH - As Found: Menopause ### Condition Browse Module - Meshes - ID: D000000860 - Term: Hypoxia ### Intervention Browse Module - Ancestors - ID: D000000319 - Term: Adrenergic beta-Antagonists - ID: D000018674 - Term: Adrenergic Antagonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000000959 - Term: Antihypertensive Agents - ID: D000014665 - Term: Vasodilator Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M14298 - Name: Propranolol - Relevance: HIGH - As Found: ER - ID: M3671 - Name: Adrenergic beta-Antagonists - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M20755 - Name: Adrenergic Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011433 - Term: Propranolol ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417164 **Brief Title:** Effects of FMS Functional Movement Training on Body Posture Control in College Female Aerobics Athletes **Official Title:** Effects of FMS Functional Movement Training on Body Posture Control in College Female Aerobics Athletes #### Organization Study ID Info **ID:** LLi #### Organization **Class:** OTHER **Full Name:** Zhengzhou University ### 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:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **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:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lan Li #### Responsible Party **Investigator Affiliation:** Zhengzhou University **Investigator Full Name:** Lan Li **Investigator Title:** lecturers **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** For this experiment, it was planned to randomly assign 40 female college aerobics athletes to two groups: a traditional physical training group (control group, T, N=20) and a functional training group (experimental group, F, N=20). The control group will use traditional physical training methods, while the experimental group will use a training program based on the FMS functional movement design. The experimental group was scheduled to undergo a 12-week FMS functional movement training intervention, with each session lasting 40 minutes. Before and after the experiment, the subjects' FMS scores, body posture control, and competition performance will be measured. **Detailed Description:** Randomized into: Control, Traditional physical training Group, T, N = 20 , Intervention, Functional training Group, F, N = 20). The control group used traditional physical training methods, and the experimental group used FMS-based functional movement training methods. A 12-week functional movement training program was used and the experimental group was given intervention training 4 times a week for 40 min each time, and FMS scores, body posture control, and athletic performance were tested before and after the intervention. It was expected that the main assessment criteria would include the seven movements of the FMS Functional Movement Test (deep squat, hurdle step, lunge squat, shoulder flexibility, active straight leg raise, trunk stability push-up, and trunk rotational stability) as well as dynamic and static body postural control in aerobics movements. Tests of T-run and basic pace Y-jump time and athletic performance were used as secondary outcomes. The main tools included: a set of FMS tester, a roll of yellow tape, a measuring tape, a stopwatch, and a test chart for each index. The test was divided into two phases. Phase 1: corrective training (1-4 weeks), Phase 2 is: the overall movement (functional patterning) 5-12 weeks, while the design concept of the program is shown in the increase of difficulty, specialization, but also includes the process of static stability to dynamic stability, and then finally, the overall movement pattern training. Tools used: balance disk, Swiss ball, solid ball, foam shaft, massage stick. ### Conditions Module **Conditions:** - Postural Balance **Keywords:** - Posture control - Functional movement training - Randomized controlled trial, ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A randomized controlled clinical trial ##### Masking Info **Masking:** TRIPLE **Masking Description:** 1. Participants do not know which group they have been assigned to (treatment or control). This can be done by providing all participants with the same information after grouping, without revealing which group they are in, to ensure that they do not know which intervention they are receiving. 2. Trainer blinding is when the trainer does not know which group the participant is in. This can be done by assigning participants to groups by another researcher or by a randomization system to avoid the trainer knowing the participant's group. 3. Outcome assessment is performed by a researcher who does not know the group the participant is in, hiding information about the participant's group, and using a researcher who is independent of the intervention assignment to perform the outcome assessment. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The control group will use traditional physical training methods. **Label:** Control, Traditional Physical Training Group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Intervention, Functional Training Group will use functional movement training methods based on FMS. **Intervention Names:** - Behavioral: Functional Movement Training Group **Label:** Intervention, Functional Training Group, **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention, Functional Training Group, **Description:** The program control group will use traditional physical training methods, while the experimental group will use a training program based on FMS functional movement design. The experimental group will receive a 12-week FMS functional movement training intervention, with each session lasting 40 minutes. The experimental group will be divided into two phases, a corrective intervention phase and a capacity enhancement phase, and the main assessment criteria will include the seven movements of the FMS Functional Movement Test (squat, hurdle step, deep squat, shoulder mobility, active straight leg raise, trunk stabilizing push-ups, and trunk rotational stabilization), as well as the ability to control the body's dynamic and static postures during aerobic exercise. **Name:** Functional Movement Training Group **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** FMS test scores( in points) **Measure:** FMS Score **Time Frame:** 90days **Description:** Control of body posture stability under static conditions, ( in points) **Measure:** Eight-stage abdominal bridge **Time Frame:** 90days **Description:** Control of frontal body posture stability under static conditions (in points) **Measure:** five-step lateral bridge **Time Frame:** 90days **Description:** Control of back and hip stability under static conditions (in points) **Measure:** six supine bridge **Time Frame:** 90days #### Secondary Outcomes **Description:** examine the control ability of the unilateral lower limb of the aerobic athlete's body posture in the rapid and dynamic state.（second ） **Measure:** T-type running **Time Frame:** 90days **Description:** The body posture control test under the conditions of dynamic movement surface change（second ） **Measure:** Y-type jumping **Time Frame:** 90days **Description:** Four groups of difficulty combinations ABCD and single competition routines were used for comprehensive scoring（points） **Measure:** Aerobics competitive performance **Time Frame:** 90days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: ① Must be able to understand and comply with the study regulations and sign an informed consent form. ② Have a stable summer training schedule with no plans to return home during the summer. ③ No serious diseases or complications. Exclusion Criteria: Athletes with recent sports injuries who may not participate in the training program. **Healthy Volunteers:** True **Maximum Age:** 23 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 1096242208@qq.com **Name:** Lan Li, 2024 **Phone:** +8615038217255 **Role:** CONTACT **Contact 2:** **Email:** 20222102103@kyonggi.ac.kr **Name:** Qinghe Wang, 2024 **Phone:** 01079286663 **Role:** CONTACT #### Locations **Location 1:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** 1096242208@qq.com - **Name:** Lan Li - **Phone:** 15038217255 - **Role:** CONTACT ***Contact 2:*** - **Email:** 20222102103@kyonggi.ac.kr - **Name:** Qinghe Wang - **Phone:** 01079286663 - **Role:** CONTACT **Country:** China **Facility:** ZhengZhouU **State:** Henan **Status:** RECRUITING **Zip:** 450001 #### Overall Officials **Official 1:** **Affiliation:** Zhengzhou University **Name:** Zijian Zhao **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** All IPDs collected, all IPDs used as a basis for results in publications. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** October 2024 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417151 **Acronym:** PITNUTS **Brief Title:** Polish Infants and Toddler Nutritional Study **Official Title:** Comprehensive Dietary Assessment of Children Aged 1 Year to 6 Years (5-72 Months) - a Cross-sectional, Nationwide Study: PITNUTS 2024 #### Organization Study ID Info **ID:** 40/2024 #### Organization **Class:** OTHER **Full Name:** Fundacja Nutricia #### Secondary ID Infos **Domain:** Fundacja Nutricia **ID:** RG 1/2023 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-31 **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:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Institute of Mother and Child, Warsaw, Poland #### Lead Sponsor **Class:** OTHER **Name:** Fundacja Nutricia #### 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 cross-sectional study representative of the Polish population of children aged 5 months to 6 years conducted in the cross-sectional study model, the main objective of which is to assess the nutritional value of the diet of children aged from 5 months to 6 years with regard to the basic macronutrients: protein (P), fat (F), carbohydrates (C). The study will include: dietary interviews, which will include the Food Frequency Questionnaire questionnaire (FFQ) and a 3-day food diary, as well as anthropometric measurements. The study will involve 1,000 children who will be selected by a random draw based on government database. The survey will be conducted by trained field interviewers - training will be provided by a dietician and an anthropologist. The study also included validation of the FFQ questionnaire. **Detailed Description:** Background: Correct nutrition is one of the most important factors for the optimal psychosomatic development of the child. Both short- and long-term observations emphasise the importance of nutritional factors in the childs development already in the foetal period and in the first two years of life (the idea of the first 1,000 days of life). Research shows that the components of the model of safe child nutrition, such as exclusive breastfeeding of the child in the first six months of life, breastfeeding and skilful expansion of the diet in the second six months of life and appropriate nutritional management in the post-natal and pre-school period form the basis for normal growth, the formation of healthy eating behaviour and also reduce the risk of diet-related diseases in adulthood. Parental awareness towards skilful dietary expansion and the introduction of foods with a favourable nutrient profile depends to a large extent on effective nutrition education (PITNUTS 2016). Data on infant and child nutrition in Poland are limited. The PITNUTS study, conducted in Poland in 2016 on a randomly selected sample (N=1059), found that the diet of infants and children aged 5-36 months deviated from the dietary recommendations. An analysis of the nutrient profile in the diets of postnatal children showed a varied energy value and a significantly higher protein supply in relation to population norms (Weker et al, 2017; Weker et al, 2019). A survey conducted during the COVID-19 pandemic by Horvath et al. also showed a discrepancy between mothers; nutritional knowledge and feeding practices of infants aged 4-12 months (Horvath et al, 2022). Inappropriate feeding practices translated into nutritional status, which was confirmed in a study conducted in Poland as part of the National Health Programme 2016-2020 (Kułaga ed. 2021). On the other hand, in a nationwide study conducted in 2017-2020 among pre-school and school children, abnormal body weight was found in more than 30% of respondents (PAN 2023). Observational studies conducted worldwide have confirmed the short- and long-term effects of nutrition on the nutritional status of infants and young children. A beneficial effect of diets including fortified foods on reducing the risk of deficiencies of nutrients such as iron, vitamin D and calcium and the energy balance of the diet has also been found (Lioret et al 2015, Schroeder et al 2015, Ahluwalia et al 2016, Hammer et al 2016, Akkermans et al 2017, McCarthy 2017, Finn et al 2017, Csölle Iet al 2022). In recent years, updated and revised dietary recommendations for the paediatric population, for three age groups, have been issued, based on the latest reports and international recommendations (Fewtrell et al 2017, Hojsak et al 2018, Fidler et al 2017, Dereń et al 2019). Updated Guidelines of nutrition for healthy infants - Position statement of the Polish Society of Gastroenterology, Hepatology and Child Nutrition, in line with current ESPGHAN guidelines, the Position statement of the Committee on Human Nutrition Science of the Polish Academy of Sciences on the principles of nutrition for children aged 1-3 years and the Position statement of the Committee on Human Nutrition Science of the Polish Academy of Sciences on the principles of nutrition for pre-school (4-6 years) and early school age children (7-9 years) were developed. Changes to the guidelines included, among others, the introduction of allergenic foods, the serving of plant-based beverages and fruit juices (in the first year of life), and the updating of safe nutrition models in relation to food rations (in the 1-3 years and 4-9 years groups) (Szajewska H. et al, 2021, PAN 2022, PAN 2023). Understanding current practices and challenges in infant and child nutrition will allow better tailoring of nutrition education interventions targeting parents and children. The aim of this study is to assess the diet and nutritional status of infants and children aged 5-72 months, the consistency of feeding practices with current recommendations and to compare with the results of the previous PITNUTS survey conducted in 2016. On this basis, investigators hypothesise that children aged 5 months to 6 years are not fed according to the principles of proper nutrition (Szajewska et al. 2021 , Weker et al. 2022 , Weker et al.2023 , Jarosz M. et al. 2020 \], and their nutritional status assessed on the basis of anthropometric measurements deviates from the norms based on the WHO centile grids for children 0-5 and for children ≥3 years of age OLA-OLAF (Kułaga 2015). Objectives: The main objective of the study is to assess the nutritional value of the diet of children aged 5 months to 6 years with regard to the main macronutrients: protein (B), fat (T), carbohydrates (C). In addition, specific objectives were also identified: * to assess the nutritional value of the diet in terms of other nutrients: animal protein, vegetable protein, digestible carbohydrates, dietary fibre, lactose, sucrose, starch, polyunsaturated fatty acids (PUFA), monounsaturated fatty acids (MUFA), saturated fatty acids (SFA), vitamins, minerals * assessment of population risk of deficiencies based on nutrient intakes (cut-off point method \[Estimated Average Requirement (EAR)/Adequate Intake (AI)\], with particular reference to vitamin D, LCPUFA and protein * assessment of nutritional status based on Z-score BMI, i.e. body mass index related to age and sex Study Population: The study will include healthy children aged 5 months to 6 years. Sample sizes were determined in two ways: First was ensuring that the results of the study can be generalized to the populations of children aged 5-12 months, 13-36 months and 37-72 months with a 95% confidence interval, and that the maximum assumed error (difference between the population parameter and the sample statistic) will not exceed 6%. The sample will be selected in such a way as to ensure both representativeness for the whole population (infants and children from the whole country at a specific age: 5 months - 6 years). The study will include all drawn children whose parents agree to participate in the study (informed consent form, parents/guardians of children drawn for the study will be offered a quota voucher to be used at a selected retail chain). The draw will be carried out in strata taking into account the age of the child and the type of municipality, and within a stratum, the draw of a specific bundle (municipality) will be carried out with probability proportional to the number of children aged up to six years old in the municipality (based on CSO data - Census 2021). As a result, also the number of bundles per province within the stratum will be roughly proportional to the number of children in the province and the type of municipality. The sample will comprise 300 infants aged 5-12 months, 400 children aged 13-36 months and 300 children aged 37-72 months. Infants up to the age of one year will be further stratified (5-6, 7-9 and 10-12 months with 100 infants each), children aged 13-36 months will be stratified by year: 13- 24 and 25-36 months (200 babies each), and children over 36 months into annual strata of 100 babies each. This scheme ignores the not-quite-uniform distribution of births across months and years, but taking it into account would be extremely difficult, as such detailed population data, even if it were possible to obtain in real time, loses relevance very quickly. The simplification adopted will have minimal impact on the quality of the sample, but will allow a minimum sample size of 100 interviews to be maintained for the narrowest ranges. Children will be selected on the assumption that they will be aged 4, 6, 9, 12, 24, 36, 48 and 60 months respectively on the day of the survey. The need to complete the survey in a short period of time due to sample obsolescence (the age of the children had to be within the assumed ranges) necessitates drawing an appropriately paired sample and providing an adequate reserve sample in case the child/carer did not agree to participate in the survey or was unavailable on the survey date. The municipality was used as the primary sampling unit. For operational reasons, two parallel representative samples of the original sampling units (municipalities) of 100 units each (sample A and sample B) will be drawn. In municipalities drawn into the first group (sample A), one interview each will be conducted with parents/carers of children from age cohorts 1a, 1c, 2a, 2b, 3b (subgroup designations as in the Table below). In municipalities from the second group (sample B) - one interview each with parents/carers of children from subgroups: 1b, 2a, 2b, 3a, 3c. This will yield as many interviews per age cohort as below: 1. Infants (n=300) 1a. Infants 5-6 months (n=100) 1b. Infants 7-9 months (n=100) 1c. Infants 10-12 months (n=100) 2. Children 13-36 months (n=400) 2a. Children 13-24 months (n=200) 2b. Children 25-36 months (n=200) 3. Children 37-72 months (n=300) 3a. Children 37-48 months (n=100) 3b. Children 49-60 months (n=100) 3c. Children 61-72 months (n=100) In addition to ensuring representativeness, abundance was counted for the primary endpoint. For this purpose, P, F, C intake data from PITNUTS 2016 were used (mean and SD) for children 5-6 months, as this age group had the greatest variability in macronutrient intake. An acceptable error of 15% in the estimation of the mean value was assumed; the formulae for the quantitative data (mean and SD) were applied in the design of the descriptive studies. The results of these calculations indicated a minimum sample N calculated for the intake of P: 97; F: 91; C: 94 individuals. Therefore, the assumed sample size of 100 children aged 5-6 months is sufficient with an acceptable 15% error in the estimation of the mean value in this age group. On this a priori basis, similar counts were used for the other age groups, i.e. 100 or 200 individuals each. From the intake data obtained in PITNUTS 2016 and the a priori counts (100 or 200 individuals each), it was concluded that such counts in the age groups 7-9 mo, 10-12 mo and 5-12 mo would allow an estimate of the mean intake of P, F, C with an acceptable error in the range of 5-10%. After the fact, the power of the test for intake will be calculated from the intake data obtained in PITNUTS 2024 (to determine the power of inference in the main study) for the realised counts: * P, F, C in the age groups 13-36 mo, 37-72 mo. * other nutrients in all age groups * percentage of people at risk of deficiency In summary, the numbers of children aged 5-72 months in each age range will be: * 5-12 months \[1 year of age\] (N=300, of which: 5-6 months =100, 7-9 months =100, 10-12 months =100) * 13-36 months \[2, 3 years of age\] (N=400, of which: 13-24 months =200, 25-36 months =200) * 37-72 months \[4, 5, 6 years of age\] (N=300, of which 37-48 months =100, 49-60 months =100, 61-72 months =100) Research tools and methods: The survey will be carried out by field interviewers who will have received prior training in nutrition interviewing and anthropometric measurements. The training will be provided by a dietician and an anthropologist. The parent (legal guardian), together with the interviewer will fill in a survey questionnaire with the inclusion of a food frequency questionnaire (FFQ) computer-assisted personal interview (CAPI), aimed at a qualitative assessment of the diet, including the identification of eating patterns. The survey will also collect socio-demographic characteristics/family/environmental conditions. A quantitative assessment of diet, including the nutritional value of diets will be assessed by recording food intake from 3 consecutive days, including one weekend day \[a diet diary completed by the parent/legal guardian themselves\] in an online format. The data will be entered into the Diet 6 program where the nutritional value of the diets from the individual diaries will be calculated. During the completion of the FFQ form, the interviewer will explain in detail how to complete the food diaries. Anthropometric measurements will be taken using certified medical scales, growth meter and measurement pad. The measurements will be carried out by pre-trained interviewers who will also have detailed instructions on how to carry out the anthropometric measurements (prepared earlier by an anthropologist): * for the 5-24 months group, measurements will be carried out in the supine position using the SECA 834 balance and the SECA 417 measuring pad * for the group of 25 months to 6 years of age, measurements will be carried out in the standing position using the SECA 878 and the stadiometer SECA 217. The results obtained will be entered by the interviewer in the anthropometric measurement record sheet. Validation of the FFQ questionnaires: Validation of the FFQ questionnaires will be carried out as part of the study. It is planned to use the FFQ questionnaire for groups: 5-12 mo. 13-36 mo., 37-72 mo. For all 3 groups, validation will be carried out by determining their internal FFQ concordance (reproducibility) on the following numbers: - 5-12 mo. - 100 subjects; 13-36 mo. - 100 subjects; 37-72 mo. - 100 individuals. FFQ will be completed and administered by the same interviewer during the dietary interview twice, 14 days apart. Statistical analysis plan: 1. Characterization of groups based on socio-demographic data: descriptive statistics, analysis of variable distributions, frequencies of socio-demographic characteristics 2. evaluation of the diet of the groups: a. Qualitative type data on feeding habits: structure indicators on number of feedings, introduction of complementary foods in the following months of infants; life, sweetening/salting of food, number of meals per day b. Qualitative type data collected by the food frequency method (from FFQ questionnaires): structure indicators for the frequency of consumption categories of the different food groups c. Data of quantitative type from the food record method (nutritional value of the diet of 3 days): - descriptive statistics, analysis of variable distributions, structure indicators for population risk of inadequate nutrient intake (i.e. determination of percentage of children): i. group average requirement standard (EAR) or below adequate intake standard (AI), e.g. for protein (EAR), ii. WHO recommended intake, e.g. for sucrose ≥10% of Energy, Cut-off points (EAR, AI, sucrose/added sugars ≥10%E) will be determined based on the Nutrition Standards for the Polish Population (2020) and WHO 2015 recommendations. d. Significance of difference tests to compare children of different age groups: comparison of population structure indicators of inadequate dietary risk, e. Significance of difference tests to compare children of the same age group with different degrees of fit to each identified DP (upper tercile vs lower tercile, upper tercile vs middle tercile): comparison of structure indicators on eating behavior, comparison of daily frequency of food intake, comparison of nutritional value of the diet, comparison of predefined dietary patterns (diet quality indicators) 3. assess the nutritional status of groups of children: 1. Quantitative data (body weight, length/height, weight-to-length/height index, z-score weight-to-length/height, z-score-BMI): descriptive statistics, analysis of variable distributions 2. Qualitative data: indices of the structure of the prevalence of nutritional status disorders according to WHO centile grids for children 0-5, OLA-OLAF for children ≥3 years of age (for children aged 0-35 months z-score weight-to-length/height categories or z-score BMI: (1) normal nutritional status ≥-2 SD to +1 SD; (2)possible risk of overweight 1 SD to 2 SD; (3) overweight 2 SD to 3 SD; (4) obesity (5) weight-to-length/height deficiency 2 SD to -3 SD; (6) significant weight-to-length/height deficiency -3 SD; for children ≥3 years of age, underweight, overweight and obesity categories as defined by OLA-OLAF grids based on z-score BMI 4. evaluation of the relationship between diet and nutritional status of children, taking into account the influence of associated variables (family-environmental determinants): 1. tests of significance of differences to compare children with different nutritional status grouped according to the categories listed in the section Assessment of the nutritional status of groups of children: comparison of structure indicators on eating behavior, comparison of daily frequency of food intake, comparison of nutritional value of the diet, comparison of predefined dietary patterns (diet quality indicators), comparison of structure indicators of the incidence of population risk of inadequate intake; 2. Significance of difference tests to compare children with different degrees of fit to predefined dietary patterns and fit to data-driven dietary patterns: comparison of structure indicators of the prevalence of nutritional status disorders according to WHO centile grids for children 0-5, OLA-OLAF for children ≥3 years of age (listed in the section ;Assessment of nutritional status of groups of children), comparison of structure indicators of the prevalence of population risk of inadequate intake (EAR/AI or recommended intake); 3. Logistic regression analysis for modelling: population risk of inadequate nutrient intake (EAR/AI or recommended intake) according to socio-demographic characteristics of children/families, BMI of parents/guardians, nutritional knowledge of parents/guardians; chance of good dietary adjustment (upper tercile) depending on socio-demographic characteristics of children/family, BMI of parents/guardians, nutritional knowledge of parents/guardians; chance of good diet quality (upper tercile of healthy diet index) depending on socio-demographic characteristics of children/family, BMI of parents/guardians, nutritional knowledge of parents/guardians; the chance of poor diet quality (upper tercile of the unhealthy diet index) depending on socio-demographic characteristics of children/family, BMI of parents/guardians, nutritional knowledge of parents/guardians; the risk (with adjustment for socio-demographic characteristics of children/family, BMI of parents/guardians, nutritional knowledge of parents/guardians) of the occurrence of nutritional disorders (listed in the section ;Assessment of nutritional status of groups of children) depending on good adjustment to the dietary pattern (upper tercile) ### Conditions Module **Conditions:** - Diet Habit - Dietary Habits - Diet, Healthy - Children - Child - Nutritional Deficiency - Nutritional Status - Macronutrients - Consumption - Dietary Assessment - Cross-sectional Study **Keywords:** - diet - habit - nutritional - children - cross-sectional study - macronutrients - child - dietary assessment - consumption ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** Healthy children between the ages of 5 months and 6 years of Polish nationality ### Outcomes Module #### Other Outcomes **Description:** Number of meals and snacking **Measure:** Dietary regime **Time Frame:** the last 14 days of the FFQ **Description:** Frequency of food consumption based on data from the FFQ **Measure:** Frequency of food consumption **Time Frame:** the last 14 days of the FFQ **Description:** Dietary patterns identified by two methods: predefined (diet quality indicators) and data-based (principal component factor analysis) **Measure:** Dietary Patterns **Time Frame:** the last 14 days of the FFQ **Description:** use of dietary supplements in children based on FFQ and food diaries **Measure:** Dietary supplements **Time Frame:** the last 14 days of the FFQ and three-day consumption from food diaries **Description:** level of declared nutritional knowledge of parents from questionairre **Measure:** Nutritional Knowledge **Time Frame:** the last 14 days of the FFQ #### Primary Outcomes **Description:** Nutritional value of the diet in terms of macronutrients: protein, fat, carbohydrates **Measure:** Macronutrient intake **Time Frame:** three-day consumption #### Secondary Outcomes **Description:** Nutritional value of the diet in terms of other nutrients: animal protein, vegetable protein, digestible carbohydrates, dietary fibre, lactose, sucrose, starch, polyunsaturated fatty acids (PUFA), monounsaturated fatty acids (MUFA), saturated fatty acids (SFA), vitamins, minerals (as well as in terms to primary nutrients: protein, fat, carbohydrates) will be calculated (per person/day) using the computer program (DIETA 6, National Food and Nutrition Institute, Warsaw) including Polish food composition tables. To collect dietary data 3-day estimated food record (FR) will be used. **Measure:** Other nutrients intake **Time Frame:** three-day consumption **Description:** Based on nutrient intake cut-off point method \[Estimated Average Requirement (EAR)/Adequate Intake (AI)\] with a focus on vitamin D, Long-Chain Polyunsaturated Fatty Acids (LCPUFA) and protein **Measure:** Population risk of nutritional deficiencies **Time Frame:** the last 14 days of the FFQ **Description:** Assessment of nutritional status based on Z-score BMI, or body mass index related to age and sex **Measure:** Nutritional status **Time Frame:** At the time of the dietary interview ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * healthy children aged 5 months to 72 months born at term * polish nationality Exclusion Criteria: * Presence of chronic diseases affecting nutritional status (metabolic diseases - e.g. diabetes, phenylketonuria, cystic fibrosis; diseases of the digestive system - e.g. coeliac disease, Crohn\&#39;s disease; kidney disease, liver disease or other disorders affecting the absorption of nutrients) * Use of elimination diets for medical reasons (e.g. food allergy) * Developmental disorders that may affect nutrition (e.g. genetic diseases, prematurity) * Acute infectious disease or other illness requiring hospital treatment within 3 months prior to the start of the study * Condition after a prolonged hospital stay (\&gt;10 days) within 6 months prior to the study * Surgical procedures performed in the last 3 months that could affect nutritional status **Maximum Age:** 72 Months **Minimum Age:** 5 Months **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** It will be children randomly selected from different socio-economic backgrounds. The sample will be drawn on the basis of PESEL numbers. The children surveyed will come from the whole area of Poland with territorial representativeness. The respondents in the survey will be parents or legal guardians of the drawn children. The division into age groups is based on the key stages of a child\&#39;s development, i.e. up to 1 year of age (n=300), 1-3 years of age (n=400), after 3 years of age and up to 6 years of age (n=300). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** michal.sawicki@fundacjanutricia.pl **Name:** Michal mr Sawicki, msc **Phone:** +48517026264 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Weker H, Brudnicka E, Baranska M, Rowicka G, Strucinska M, Wiech M, Dylag H, Klemarczyk W, Socha P, Mazur J. Dietary Patterns of Children Aged 1-3 Years in Poland in Two Population Studies. Ann Nutr Metab. 2019;75(1):66-76. doi: 10.1159/000501422. Epub 2019 Jul 2. **PMID:** 31266006 **Citation:** Weker H, Baranska M, Riahi A, Strucinska M, Wiech M, Rowicka G, Dylag H, Klemarczyk W, Bzikowska A, Socha P. Nutrition of infants and young children in Poland - Pitnuts 2016. Dev Period Med. 2017;21(1):13-28. doi: 10.34763/devperiodmed.20172101.1328. **PMID:** 28551688 **Citation:** Schroeder N, Rushovich B, Bartlett E, Sharma S, Gittelsohn J, Caballero B. Early Obesity Prevention: A Randomized Trial of a Practice-Based Intervention in 0-24-Month Infants. J Obes. 2015;2015:795859. doi: 10.1155/2015/795859. Epub 2015 May 11. **PMID:** 26078877 **Citation:** McCarthy EK, Ni Chaoimh C, Hourihane JO, Kenny LC, Irvine AD, Murray DM, Kiely M. Iron intakes and status of 2-year-old children in the Cork BASELINE Birth Cohort Study. Matern Child Nutr. 2017 Jul;13(3):e12320. doi: 10.1111/mcn.12320. Epub 2016 Aug 9. **PMID:** 27501864 **Citation:** Lioret S, Betoko A, Forhan A, Charles MA, Heude B, de Lauzon-Guillain B; EDEN Mother-Child Cohort Study Group. Dietary patterns track from infancy to preschool age: cross-sectional and longitudinal perspectives. J Nutr. 2015 Apr;145(4):775-82. doi: 10.3945/jn.114.201988. Epub 2015 Jan 28. **PMID:** 25833780 **Citation:** Hojsak I, Bronsky J, Campoy C, Domellof M, Embleton N, Fidler Mis N, Hulst J, Indrio F, Lapillonne A, Molgaard C, Vora R, Fewtrell M; ESPGHAN Committee on Nutrition. Young Child Formula: A Position Paper by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):177-185. doi: 10.1097/MPG.0000000000001821. **PMID:** 29095351 **Citation:** Hamner HC, Perrine CG, Scanlon KS. Usual Intake of Key Minerals among Children in the Second Year of Life, NHANES 2003-2012. Nutrients. 2016 Jul 30;8(8):468. doi: 10.3390/nu8080468. **PMID:** 27483313 **Citation:** Finn K, Callen C, Bhatia J, Reidy K, Bechard LJ, Carvalho R. Importance of Dietary Sources of Iron in Infants and Toddlers: Lessons from the FITS Study. Nutrients. 2017 Jul 11;9(7):733. doi: 10.3390/nu9070733. **PMID:** 28696361 **Citation:** Fidler Mis N, Braegger C, Bronsky J, Campoy C, Domellof M, Embleton ND, Hojsak I, Hulst J, Indrio F, Lapillonne A, Mihatsch W, Molgaard C, Vora R, Fewtrell M; ESPGHAN Committee on Nutrition:. Sugar in Infants, Children and Adolescents: A Position Paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2017 Dec;65(6):681-696. doi: 10.1097/MPG.0000000000001733. **PMID:** 28922262 **Citation:** Lapillonne A, Bronsky J, Campoy C, Embleton N, Fewtrell M, Fidler Mis N, Gerasimidis K, Hojsak I, Hulst J, Indrio F, Molgaard C, Moltu SJ, Verduci E, Domellof M; ESPGHAN Committee on Nutrition. Feeding the Late and Moderately Preterm Infant: A Position Paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):259-270. doi: 10.1097/MPG.0000000000002397. **PMID:** 31095091 **Citation:** Deren K, Weghuber D, Caroli M, Koletzko B, Thivel D, Frelut ML, Socha P, Grossman Z, Hadjipanayis A, Wyszynska J, Mazur A. Consumption of Sugar-Sweetened Beverages in Paediatric Age: A Position Paper of the European Academy of Paediatrics and the European Childhood Obesity Group. Ann Nutr Metab. 2019;74(4):296-302. doi: 10.1159/000499828. Epub 2019 Apr 23. **PMID:** 31013493 **Citation:** Csolle I, Felso R, Szabo E, Metzendorf MI, Schwingshackl L, Ferenci T, Lohner S. Health outcomes associated with micronutrient-fortified complementary foods in infants and young children aged 6-23 months: a systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 Aug;6(8):533-544. doi: 10.1016/S2352-4642(22)00147-X. Epub 2022 Jun 24. Erratum In: Lancet Child Adolesc Health. 2022 Dec;6(12):e28. **PMID:** 35753314 **Citation:** Akkermans MD, Eussen SR, van der Horst-Graat JM, van Elburg RM, van Goudoever JB, Brus F. A micronutrient-fortified young-child formula improves the iron and vitamin D status of healthy young European children: a randomized, double-blind controlled trial. Am J Clin Nutr. 2017 Feb;105(2):391-399. doi: 10.3945/ajcn.116.136143. Epub 2017 Jan 4. **PMID:** 28052885 **Citation:** Ahluwalia N, Herrick KA, Rossen LM, Rhodes D, Kit B, Moshfegh A, Dodd KW. Usual nutrient intakes of US infants and toddlers generally meet or exceed Dietary Reference Intakes: findings from NHANES 2009-2012. Am J Clin Nutr. 2016 Oct;104(4):1167-1174. doi: 10.3945/ajcn.116.137752. Epub 2016 Sep 14. **PMID:** 27629049 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Nutritional Deficiency - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417138 **Brief Title:** "Comparative Effect of Different Drugs Used to Tr€at Patients in Rheumatoid Arthritis Saudi Database (RASD)" **Official Title:** Comparative Effectiveness of Different Drugs Used to Treat Patients in Rheumatoid Arthritis Saudi Database (RASD) the Primary Objective of This Study is to Compare the Effectiveness of Different Biological Disease Modifying Antirheumatic Drugs (bDMARDs) and Targeted Synthetic (tsDMARDs) Using DAS-28-CRP and CDAI Scores. #### Organization Study ID Info **ID:** 2023-0*225 #### Organization **Class:** OTHER **Full Name:** Umm Al-Qura University ### Status Module #### Completion Date **Date:** 2025-03-15 **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:** 2025-02-15 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-15 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### 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:** Umm Al-Qura University #### Responsible Party **Investigator Affiliation:** Umm Al-Qura University **Investigator Full Name:** Hani Mohammad Almoallim **Investigator Title:** Professor of Rheumatology **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:** Comparative effectiveness of different drugs used to treat patients in Rheumatoid Arthritis Saudi database (RASD) Introduction Rheumatoid arthritis (RA) is a chronic inflammatory disease-causing significant disability among patients(1). The prevalence rate of RA varies based on the geographical locations, however, several reviews reported a global prevalence rate of 0.5-1.1% with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population(1,2). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis . In Saudi Arabia, recent and generalisable epidemiological data regarding RA in Saudi Arabia are limited and suboptimal(1). One study by Al Dalaan et al in 1998, that was conducted in Al-Qassim region reported that the prevalence rate of RA is about 0.2%(3). In patients with RA, early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state (4). However, the international lag time from the onset of symptoms until the initiation of treatment in patients with RA has been collectively calculated to be around almost one year time (5). Diseases modifying anti rheumatic agents (DMARDS) are the main drugs used for the management of RA, and it mainly reduce the inflammation and improve the outcomes(6). Several DMARSs drugs are available for the management of RA, however, recently, biological DMARDS have also been widely used and recommended in case the conventional DMARDS fail to control the diseases(6,7). Worldwide, there have been multiple studies that examined the effectiveness of DMARDS and bDMARDS drugs for the management of RA, this include large controlled trials which are the gold standard method for investigating medications efficacy(8,9). However, observational real-world data to examine the effectiveness of these medications is also important and can be more generalizable, have longer follow up and can examine different characteristics. Previous observational studies investigating the effectiveness of DMARDS and bDMARDS were mainly in Europe and North America which does not necessarily represent the current situation and the characteristics of the middle eastern population(10,11), as there is so much variability in access to different biological drugs in different countries. In addition, these studies did not compare treatment lines. In the middle east there were limited studies that addressed the effectiveness of different drugs used to treat RA in Saudi Arabia(5,12-14). These studies were mainly cross sectional in nature or reviews, and it is difficult to draw any conclusions with such study designs. Therefore, this research is to compare the effectiveness of multiple DMARDS medication for the treatment of RA patients in Saudi Arabia. Literature Review Rheumatoid arthritis (RA) is a chronic progressive inflammatory disease that causes irreversible joint deformities which can have debilitating effects on a patient's overall wellbeing. RA has a global prevalence rate of 0.5-1.1% with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population (1). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis. RA is strongly associated with the female gender, with a female to male ratio of 2:1 to 3:1. Smoking habits have also been shown to both increase the risk of acquiring RA and of worsening its prognosis(1,15). Early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state. A study found that only 31% of RA patients visited a rheumatologist within less than 12 weeks of symptom onset, those who did had ameliorated progression rates at 6 years as measured by the Sharp/van der Heijde score (SHS) as well as higher rates of DMARD-free remission than patients who delayed their presentation to more than 12 weeks (16) Even though the importance of optimal treatment has been demonstrated, in Africa and the Middle East diagnoses are often delayed for months or even years after symptom onset(5,12,17,18) Our group conducted a study in Saudi Arabia showed that patients may not receive a diagnosis of RA for up to 30 months after the onset of symptoms (12). Raising public awareness of RA and treatment options is also an important tool for reducing time to diagnosis(17). Public education programs can lead to earlier diagnosis and initiation of therapy, as observed in patients in the United Arab Emirates(19). Increased public awareness may also lead to patients with symptoms of RA visiting rheumatology clinics rather than other specialties, thereby receiving adequate and timely treatment. Delayed diagnoses can be attributed to a variety of reasons. In ### Conditions Module **Conditions:** - Rheumatoid Arthritis RA **Keywords:** - Rheumatoid Arthritis - Remission - Biological DMARDs - Targeted synthetic DMARDs - DAS-28-CRP - CDAI - Low disease activity - Comparative effectiveness - Efficacy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 800 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** The primary objective of this study is to compare the effectiveness of different biological Disease Modifying Antirheumatic Drugs (bDMARDs) and targeted synthetic (tsDMARDs) using DAS-28-CRP and CDAI scores. **Time Frame:** one year OR completion of 3 visits - 3 months apart ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All those patients who are \&amp;amp;amp;gt;age of 18 years, meeting 2010 American College of Rheumatology classification criteria for rheumatoid arthritis. Both male and female gender will be included. There should be minimum of 12 months follow up with at least 3 documented visits of these patients to health care facilities. Exclusion Criteria: * Any patient who did not meet the inclusion criteria will be excluded from the study. In addition, any patient who cannot recall the exact date of starting his drugs will be excluded during data analysis. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Rheumatoid arthritis (RA) is a chronic inflammatory disease-causing significant disability among patients(1). The prevalence rate of RA varies based on the geographical locations, however, several reviews reported a global prevalence rate of 0.5-1.1% with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population(1,2). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis . In Saudi Arabia, recent and generalisable epidemiological data regarding RA in Saudi Arabia are limited and suboptimal(1). One study by Al Dalaan et al in 1998, that was conducted in Al-Qassim region reported that the prevalence rate of RA is about 0.2%(3). In patients with RA, early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state (4). However, the international lag ti ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hmmoallim@uqu.edu.sa **Name:** Hani Mohammad O Almoallim Principal investigator, MBBS Professor of Rheumatology **Phone:** 00966+505703935 **Role:** CONTACT **Contact 2:** **Email:** suzan_attar@hotmail.com **Name:** Suzan Mahmoud Attar, Professor of Rheumatology **Phone:** 00966+562222613 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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 - Browse Branches - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417125 **Brief Title:** Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children **Official Title:** Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial #### Organization Study ID Info **ID:** K2024-01-006 #### Organization **Class:** OTHER **Full Name:** Fujian Provincial Hospital ### Status Module #### Completion Date **Date:** 2025-06-22 **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:** 2025-05-22 **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:** 2024-05-09 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Fujian Maternity and Child Health Hospital **Class:** UNKNOWN **Name:** Fujian Children's Hospital #### Lead Sponsor **Class:** OTHER **Name:** Fujian Provincial Hospital #### Responsible Party **Investigator Affiliation:** Fujian Provincial Hospital **Investigator Full Name:** Yao Yusheng **Investigator Title:** Clinical Professor **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 goal of this clinical trial is to learn the effect of dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are: * Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam? * Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium. Participants will: * Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication * Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30 **Detailed Description:** Due to the fear of being separated from parents, fear of venipuncture, and facing unfamiliar operating room environment, children have different degrees of anxiety before surgery. Preoperative anxiety can lead to strong stress response and increase the incidence of emergence delirium. It can even cause psychological trauma and affect children's physical and mental health growth. The study showed that preoperative anxiety was positively correlated with the incidence of emergence delirium and postoperative negative behavior change, and emergence delirium was a risk factor for postoperative negative behavior in children. Currently, midazolam is the most commonly used sedative drug to relieve preoperative anxiety in children. Midazolam has anterograde amnesia effect, reducing the occurrence of intraoperative awareness, and alleviating psychological trauma and memory of malignant stimulation in children. Dexmedetomidine is a highly selective α2 adrenergic agonist with anxiolytic, sedative, and analgesic properties. Our previous study found that preoperative administration of dexmedetomidine can reduce the incidence of emergence delirium in children compared with midazolam However, no clinical studies have directly compared the effects of dexmedetomidine and midazolam premedication on postoperative negative behavior change in children. This prospective randomized controlled trial was conducted to compare the effects of dexmedetomidine and midazolam premedication on preoperative anxiety, the incidence of postoperative delirium, and postoperative negative behavior changes in children to provide a reference for optimizing clinical anesthesia medication regimens. ### Conditions Module **Conditions:** - Behavior Problem **Keywords:** - dexmedetomidine - midazolam - postoperative negative behavior change - emergence delirium - tonsillectomy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 324 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg. **Intervention Names:** - Drug: Dexmedetomidine Hydrochloride - Drug: Glucose solution **Label:** Dexmedetomidine group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg. **Intervention Names:** - Drug: Midazolam - Drug: normal Saline **Label:** Midazolam group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg. **Intervention Names:** - Drug: normal Saline - Drug: Glucose solution **Label:** Placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dexmedetomidine group **Description:** Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area. **Name:** Dexmedetomidine Hydrochloride **Other Names:** - Dexmedetomidine hydrochloride Injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Midazolam group **Description:** Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area. **Name:** Midazolam **Other Names:** - Midazolam oral solution **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Midazolam group - Placebo group **Description:** Patients were premedicated with normal saline 0.02 mL/kg in the holding area. **Name:** normal Saline **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Dexmedetomidine group - Placebo group **Description:** Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area. **Name:** Glucose solution **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). **Measure:** Incidence of postoperative negative behavior changes **Time Frame:** Day 7 postoperatively #### Secondary Outcomes **Description:** Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). **Measure:** Incidence of postoperative negative behavior changes **Time Frame:** Day 1 postoperatively **Description:** Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). **Measure:** Incidence of postoperative negative behavior changes **Time Frame:** Day 3 postoperatively **Description:** Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). **Measure:** Incidence of postoperative negative behavior changes **Time Frame:** Day 30 postoperatively **Description:** Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10). **Measure:** Incidence of emergence delirium **Time Frame:** Within 30 min after extubation **Description:** Preoperative anxiety will be assessed using the modified Yale preoperative anxiety scale. Scores range from 23 to 100 with higher scores indicating greater anxiety. **Measure:** Preoperative anxiety **Time Frame:** Before the intervention in holding area **Description:** Length of postanesthesia care unit stay is defined as the time between arrival in the PACU and readiness for discharge from the PACU (defined as a modified Aldrete score of ≥9). **Measure:** Length of postanesthesia care unit stay **Time Frame:** Up to 60 minutes postoperatively **Description:** Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command. **Measure:** Emergence time **Time Frame:** About up to 30 minutes postoperatively **Description:** Parental satisfaction is self-reported using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied). **Measure:** Parental satisfaction **Time Frame:** Postoperative day 1 **Description:** Preoperative sedation level will be measured using the parental separation anxiety scale (PSAS). The PSAS is a 4-point scale as follows: 1=easy separation; 2=whimpers; 3=cries and cannot be easily reassured, but not clinging to parents; and 4=crying and clinging to parents. A PSAS score of 1 or 2 was considered as "acceptable" separation. **Measure:** Parental separation anxiety **Time Frame:** After intervention 30 minutes **Description:** Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability sacle. **Measure:** Postoperative pain intensity **Time Frame:** After extubation 10, 20, 30 min, and postoperative 1 day **Description:** Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial. **Measure:** Incidence of adverse events **Time Frame:** Up to 24 hours postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ASA physical status I or II; 2. Aged 2-5 years; 3. Scheduled for elective tonsillectomy and (or) adenoidectomy. Exclusion Criteria: 1. Parents refusing to allow their children to participate; 2. Intake of sedative or analgesic medication within 48 hours before surgery; 3. Developmental delay; 4. Psychosis; 5. Body mass index \> 30 kg/m2; 6. Allergy to study drugs; 7. Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.; 8. Any other conditions that precluded study inclusion. **Maximum Age:** 5 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fjslyys@126.com **Name:** Yusheng Yao, MD&PhD **Phone:** +86-13559939629 **Role:** CONTACT **Contact 2:** **Email:** chensisi49@163.com **Name:** Sisi Chen, MD **Phone:** +86-15080109541 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fujian Provincial Hospital **Name:** Xiaochun Zheng, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** All the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author. **Description:** After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** We would like to share our individual deidentified participant data beginning three months following the publication of the main results. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6894 - Name: Delirium - Relevance: LOW - As Found: Unknown - ID: M772 - Name: Emergence Delirium - Relevance: LOW - As Found: Unknown - ID: M85 - Name: Problem Behavior - Relevance: HIGH - As Found: Behavior Problem - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000066553 - Term: Problem Behavior ### 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: D000000759 - Term: Adjuvants, Anesthesia - ID: D000014151 - Term: Anti-Anxiety Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000018757 - Term: GABA Modulators - ID: D000018682 - Term: GABA Agents ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M22662 - Name: Dexmedetomidine - Relevance: HIGH - As Found: Hospitalized Patients - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: HIGH - As Found: Procedure - ID: M11845 - Name: Midazolam - Relevance: HIGH - As Found: Induction - 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: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4089 - Name: Adjuvants, Anesthesia - Relevance: LOW - As Found: Unknown - ID: M16905 - Name: Anti-Anxiety Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - 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: M20827 - Name: GABA Modulators - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008874 - Term: Midazolam - ID: D000020927 - Term: Dexmedetomidine - ID: D000019999 - Term: Pharmaceutical Solutions ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417112 **Brief Title:** Left Atrial Strain Values as an Early Predictor of Atrial Fibrillation **Official Title:** Can Left Atrial Strain Measurements, and Correlating Changes in Left Atrium Area and Volume Size, be Used as an Early Predictor of Atrial Fibrillation? #### Organization Study ID Info **ID:** 324893 #### Organization **Class:** OTHER **Full Name:** Hywel Dda Health Board ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-07 **Type:** ACTUAL #### Start Date **Date:** 2023-08-02 **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 #### Lead Sponsor **Class:** OTHER **Name:** Hywel Dda Health Board #### Responsible Party **Investigator Affiliation:** Hywel Dda Health Board **Investigator Full Name:** Lucy Hwozdyk **Investigator Title:** Trainee Clinical Cardiac Scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Atrial fibrillation (AF) is the most common type of abnormal heart rhythm. This occurs as the chambers of the heart pump irregularly, often resulting in a fast heart rate and symptoms of irregular pounding and fluttering. There are many risk factors predisposing to AF, however, the cause cannot always be easily determined. Additionally, not all AF patients experience symptoms and consequently, this abnormal rhythm may go undetected and may be discovered accidentally. This is detrimental to patients, as untreated AF patients are at an increased risk of stroke. Patients that are suspected of having AF are referred for an ultrasound scan of the heart (echocardiogram). It is expected to see structural changes to the heart's chambers. However, structural and electrical changes of the heart may be the cause of AF but may also be a result of AF, resulting in a chicken and egg situation. It may be possible that a different type of measurement can be used during an echocardiogram to detect subtle changes in heart muscle patterns. This measurement may then serve to be an early predictor of AF. This would be determined by comparing the patterns in patients with a normal, regular rhythm to those with AF. Potential candidates are initially screened based on their echocardiogram referral. If deemed suitable for this study, the study process is explained to the patient and written informed consent is invited and received. The echocardiogram will be performed as normal with a focus on the area and volume measurements taken of one of the top chambers of the heart. An additional measurement will be taken to observe any subtle changes in the arrangement of heart cells within this same heart chamber. These measurements can be compared to each other to establish any relationship as well as compared to patients with and without AF. **Detailed Description:** Atrial fibrillation (AF) is the most prevalent type of arrhythmia within an adult population and is characterised by disorganised, chaotic, electrical activity and thus, ineffective atrial contraction causing irregular ventricular contraction. AF can be categorised into three different groups: paroxysmal, persistent and permanent. The prevalence of AF increases with age and is associated with a range of risk factors including: hypertension, obesity and alcohol consumption. There is a plethora of both cardiac and non-cardiac causes of AF and the cause is not always clear for each patient. Furthermore, causes of AF can also present as the by-product of AF, this increases the difficulty in determining the individual patient's cause of onset. A diagnosis of AF can be incidental as not all patients are symptomatic. If AF goes undetected, this puts the patient at an increased risk of blood clot formation and stroke. Patients suspected of having AF are routinely referred for a transthoracic echocardiogram (TTE). It is common for AF patients to have a dilated left atrium (LA). This can be visually confirmed, and the LA area and volume can be measured during a TTE. LA strain measurements are not routinely measured during TTEs but may be able to detect subtle changes in longitudinal strain patterns of the myocardium. By comparing the strain patterns in patients with normal sinus rhythm (control) to those with AF, a scale can be created to suggest and predict whether a patient is likely to develop AF in the future based on these subtle changes before any changes in LA size occur. Furthermore, this can then be further developed to determine whether there are any significant differences in strain patterns between the three AF groups. Objectives: To determine whether there is a significant difference in atrial strain values between patients that are in normal sinus rhythm (NSR, control group) to patients that are known to have atrial fibrillation (disease group). A disease-control group of controlled hypertensive patients in NSR will also be utilised as hypertension is a known risk factor for atrial fibrillation. Providing that there is a significant difference in the values between NSR and AF patients, a further comparison will be conducted on patients in different type of AF: paroxysmal AF, persistent AF and permanent AF to determine if there is a deterioration in atrial strain values within AF patients. Left atrial area and volume size will also be measured in all patients and this can then be compared to atrial strain values. ### Conditions Module **Conditions:** - Atrial Fibrillation - Hypertension **Keywords:** - atrial fibrillation - hypertension - LA size - LA strain - LA reservoir strain - LA conduit strain - LA contractile strain ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 72 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation. All participants have blood pressure measurements within normal limits and are not prescribed anti-hypertensive medication. **Intervention Names:** - Diagnostic Test: Transthoracic Echocardiogram **Label:** Normal sinus rhythm and normotensive #### Arm Group 2 **Description:** All participants are in normal sinus rhythm at the time of the transthoracic echocardiogram and no previous history of atrial fibrillation. All participants are known to have raised blood pressure measurements previously and are receiving anti-hypertensive medication. **Intervention Names:** - Diagnostic Test: Transthoracic Echocardiogram **Label:** Normal sinus rhythm and hypertensive #### Arm Group 3 **Description:** All participants are known to have a history of atrial fibrillation (paroxysmal, persistent or permanent). **Intervention Names:** - Diagnostic Test: Transthoracic Echocardiogram **Label:** Known atrial fibrillation ### Interventions #### Intervention 1 **Arm Group Labels:** - Known atrial fibrillation - Normal sinus rhythm and hypertensive - Normal sinus rhythm and normotensive **Description:** All participants have been referred for a transthoracic echocardiogram by a clinician. **Name:** Transthoracic Echocardiogram **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Taking measurements to assess left atrial strain from two different views (A4C \& A2C) as well as biplane measurements for reservoir, contractile and conduit LA strain. **Measure:** Left atrial strain values **Time Frame:** Baseline **Description:** Taking measurements to assess left atrial volume from two different views (A4C \& A2C) as well as biplane measurements. **Measure:** LA volume size **Time Frame:** Baseline **Description:** Taking measurements to assess left atrial area from A4C view. **Measure:** LA area size **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Criterion 1: subjects will be included in the study if they are within one of the following groups: * Known to be in normal sinus rhythm, are normotensive and have no underlying health problems. * Known to be in normal sinus rhythm and have controlled hypertension. This must have been diagnosed by a healthcare professional and the patient should be taking appropriate antihypertensive medication. * Known to have chronic atrial fibrillation (persistent or permanent AF). This must have been diagnosed by a healthcare professional and the patient should be appropriately anticoagulated. * Criterion 2: subjects should ideally be ≥ 50 years, but subjects will be age matched across all three groups. * Criterion 3: patients should have an EF ≥ 50%. * Criterion 4: good quality TTE images. * Criterion 5: No valvular pathologies. o Patients with AF that have \< moderate valvular pathologies may be considered (as per the British Society of Echocardiography Guidelines). Exclusion Criteria: * Criterion 1: subjects with any valvular pathologies in the control and disease- control groups. * Criterion 2: subjects with AF that have ≥ moderate valvular pathologies (as per the British Society of Echocardiography Guidelines). * Criterion 3: subjects with an EF \< 50%. * Criterion 4: subjects \< 50 years old. * Criterion 5: poor quality TTE images. * Criterion 6: inability to provide informed consent. * Criterion 7: permanent atrial / ventricular pacing. * Criterion 8: previous cardiac surgery. * Criterion 9: unsatisfactory tracking of the LA endocardial border. * Criterion 10: patients unwilling to have their results potentially published. **Minimum Age:** 50 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** To be included, patients had to be categorised into one of the following categories: normal sinus rhythm and normotensive, normal sinus rhythm and hypertensive, or known chronic atrial fibrillation. Additionally, all eligible patients had to conform to the aforementioned inclusion and exclusion criteria. ### Contacts Locations Module #### Locations **Location 1:** **City:** Haverfordwest **Country:** United Kingdom **Facility:** Lucy Hwozdyk **State:** Pembrokeshire **Zip:** SA61 2PZ #### Overall Officials **Official 1:** **Affiliation:** Hywel Dda University Health Board **Name:** Lucy Hwozdyk **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All participant data has been pseudo-anonymised, this prevents any information from being able to be used to trace back to individual participants. Anonymised data may be able to be shared with other researchers rather than the mean data used in the data analyses. **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Alhakak AS, Biering-Sorensen SR, Mogelvang R, Modin D, Jensen GB, Schnohr P, Iversen AZ, Svendsen JH, Jespersen T, Gislason G, Biering-Sorensen T. Usefulness of left atrial strain for predicting incident atrial fibrillation and ischaemic stroke in the general population. Eur Heart J Cardiovasc Imaging. 2022 Feb 22;23(3):363-371. doi: 10.1093/ehjci/jeaa287. **PMID:** 33175146 **Citation:** Beyls C, Hermida A, Bohbot Y, Martin N, Viart C, Boisgard S, Daumin C, Huette P, Dupont H, Abou-Arab O, Mahjoub Y. Automated left atrial strain analysis for predicting atrial fibrillation in severe COVID-19 pneumonia: a prospective study. Ann Intensive Care. 2021 Dec 7;11(1):168. doi: 10.1186/s13613-021-00955-w. **PMID:** 34874509 **Citation:** Choi HM, Yoon YE, Oh IY, Cho Y, Cho GY. Global Left Atrial Strain as a Predictor of Silent Atrial Fibrillation Following Dual Chamber Cardiac Implantable Electronic Device Implantation. JACC Cardiovasc Imaging. 2018 Oct;11(10):1537-1539. doi: 10.1016/j.jcmg.2017.12.013. Epub 2018 Feb 14. No abstract available. **PMID:** 29454782 **Citation:** Gan GCH, Ferkh A, Boyd A, Thomas L. Left atrial function: evaluation by strain analysis. Cardiovasc Diagn Ther. 2018 Feb;8(1):29-46. doi: 10.21037/cdt.2017.06.08. **PMID:** 29541609 **Citation:** Guo C, Liu J, Zhao S, Teng Y, Shen L. Decreased left atrial strain parameters are correlated with prolonged total atrial conduction time in lone atrial fibrillation. Int J Cardiovasc Imaging. 2016 Jul;32(7):1053-61. doi: 10.1007/s10554-016-0875-3. Epub 2016 Apr 13. **PMID:** 27076225 **Citation:** Hauser R, Nielsen AB, Skaarup KG, Lassen MCH, Duus LS, Johansen ND, Sengelov M, Marott JL, Jensen G, Schnohr P, Sogaard P, Mogelvang R, Biering-Sorensen T. Left atrial strain predicts incident atrial fibrillation in the general population: the Copenhagen City Heart Study. Eur Heart J Cardiovasc Imaging. 2021 Dec 18;23(1):52-60. doi: 10.1093/ehjci/jeab202. **PMID:** 34632488 **Citation:** Her AY, Kim JY, Kim YH, Choi EY, Min PK, Yoon YW, Lee BK, Hong BK, Rim SJ, Kwon HM. Left atrial strain assessed by speckle tracking imaging is related to new-onset atrial fibrillation after coronary artery bypass grafting. Can J Cardiol. 2013 Mar;29(3):377-83. doi: 10.1016/j.cjca.2012.06.006. Epub 2012 Aug 15. **PMID:** 22902158 **Citation:** Hsu PC, Lee WH, Chu CY, Lee HH, Lee CS, Yen HW, Lin TH, Voon WC, Lai WT, Sheu SH, Su HM. Prognostic role of left atrial strain and its combination index with transmitral E-wave velocity in patients with atrial fibrillation. Sci Rep. 2016 Feb 1;6:17318. doi: 10.1038/srep17318. **PMID:** 26833057 **Citation:** Jarasunas J, Aidietis A, Aidietiene S. Left atrial strain - an early marker of left ventricular diastolic dysfunction in patients with hypertension and paroxysmal atrial fibrillation. Cardiovasc Ultrasound. 2018 Oct 31;16(1):29. doi: 10.1186/s12947-018-0147-6. **PMID:** 30382851 **Citation:** Ma XX, Zhang YL, Hu B, Zhu MR, Jiang WJ, Wang M, Zheng DY, Xue XP. The usefulness of global left atrial strain for predicting atrial fibrillation recurrence after catheter ablation in patients with persistent and paroxysmal atrial fibrillation. Arch Cardiovasc Dis. 2017 Aug-Sep;110(8-9):447-455. doi: 10.1016/j.acvd.2016.11.005. Epub 2017 May 18. **PMID:** 28528995 **Citation:** Markides V, Schilling RJ. Atrial fibrillation: classification, pathophysiology, mechanisms and drug treatment. Heart. 2003 Aug;89(8):939-43. doi: 10.1136/heart.89.8.939. No abstract available. **PMID:** 12860883 **Citation:** Mochizuki A, Yuda S, Fujito T, Kawamukai M, Muranaka A, Nagahara D, Shimoshige S, Hashimoto A, Miura T. Left atrial strain assessed by three-dimensional speckle tracking echocardiography predicts atrial fibrillation recurrence after catheter ablation in patients with paroxysmal atrial fibrillation. J Echocardiogr. 2017 Jun;15(2):79-87. doi: 10.1007/s12574-017-0329-5. Epub 2017 Feb 2. **PMID:** 28155065 **Citation:** Motoki H, Negishi K, Kusunose K, Popovic ZB, Bhargava M, Wazni OM, Saliba WI, Chung MK, Marwick TH, Klein AL. Global left atrial strain in the prediction of sinus rhythm maintenance after catheter ablation for atrial fibrillation. J Am Soc Echocardiogr. 2014 Nov;27(11):1184-92. doi: 10.1016/j.echo.2014.08.017. Epub 2014 Sep 23. **PMID:** 25260436 **Citation:** Olsen FJ, Christensen LM, Krieger DW, Hojberg S, Host N, Karlsen FM, Svendsen JH, Christensen H, Biering-Sorensen T. Relationship between left atrial strain, diastolic dysfunction and subclinical atrial fibrillation in patients with cryptogenic stroke: the SURPRISE echo substudy. Int J Cardiovasc Imaging. 2020 Jan;36(1):79-89. doi: 10.1007/s10554-019-01700-y. Epub 2019 Oct 8. **PMID:** 31595399 **Citation:** Pagola J, Juega J, Francisco-Pascual J, Bustamante A, Penalba A, Pala E, Rodriguez M, De Lera-Alfonso M, Arenillas JF, Cabezas JA, Moniche F, de Torres R, Montaner J, Gonzalez-Alujas T, Alvarez-Sabin J, Molina CA; Crypto-AF study group. Predicting Atrial Fibrillation with High Risk of Embolization with Atrial Strain and NT-proBNP. Transl Stroke Res. 2021 Oct;12(5):735-741. doi: 10.1007/s12975-020-00873-2. Epub 2020 Nov 13. **PMID:** 33184686 **Citation:** Park JJ, Park JH, Hwang IC, Park JB, Cho GY, Marwick TH. Left Atrial Strain as a Predictor of New-Onset Atrial Fibrillation in Patients With Heart Failure. JACC Cardiovasc Imaging. 2020 Oct;13(10):2071-2081. doi: 10.1016/j.jcmg.2020.04.031. Epub 2020 Jul 15. **PMID:** 32682715 **Citation:** Parwani AS, Morris DA, Blaschke F, Huemer M, Pieske B, Haverkamp W, Boldt LH. Left atrial strain predicts recurrence of atrial arrhythmias after catheter ablation of persistent atrial fibrillation. Open Heart. 2017 Apr 28;4(1):e000572. doi: 10.1136/openhrt-2016-000572. eCollection 2017. **PMID:** 28674624 **Citation:** Pathan F, Sivaraj E, Negishi K, Rafiudeen R, Pathan S, D'Elia N, Galligan J, Neilson S, Fonseca R, Marwick TH. Use of Atrial Strain to Predict Atrial Fibrillation After Cerebral Ischemia. JACC Cardiovasc Imaging. 2018 Nov;11(11):1557-1565. doi: 10.1016/j.jcmg.2017.07.027. Epub 2017 Nov 15. **PMID:** 29153561 **Citation:** Pessoa-Amorim G, Mancio J, Vouga L, Ribeiro J, Gama V, Bettencourt N, Fontes-Carvalho R. Impaired Left Atrial Strain as a Predictor of New-onset Atrial Fibrillation After Aortic Valve Replacement Independently of Left Atrial Size. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):466-476. doi: 10.1016/j.rec.2017.10.005. Epub 2017 Nov 14. English, Spanish. **PMID:** 29146482 **Citation:** Petre I, Onciul S, Iancovici S, Zamfir D, Stoian M, Scarlatescu A, Diaconeasa A, Acatrinei C, Dorobantu M. Left Atrial Strain for Predicting Atrial Fibrillation Onset in Hypertensive Patients. High Blood Press Cardiovasc Prev. 2019 Aug;26(4):331-337. doi: 10.1007/s40292-019-00326-4. Epub 2019 Jul 15. **PMID:** 31309456 **Citation:** Rasmussen SMA, Olsen FJ, Jorgensen PG, Fritz-Hansen T, Jespersen T, Gislason G, Biering-Sorensen T. Utility of left atrial strain for predicting atrial fibrillation following ischemic stroke. Int J Cardiovasc Imaging. 2019 Sep;35(9):1605-1613. doi: 10.1007/s10554-019-01601-0. Epub 2019 Apr 26. **PMID:** 31028567 **Citation:** Shaikh AY, Maan A, Khan UA, Aurigemma GP, Hill JC, Kane JL, Tighe DA, Mick E, McManus DD. Speckle echocardiographic left atrial strain and stiffness index as predictors of maintenance of sinus rhythm after cardioversion for atrial fibrillation: a prospective study. Cardiovasc Ultrasound. 2012 Dec 3;10:48. doi: 10.1186/1476-7120-10-48. **PMID:** 23199055 **Citation:** Shin DG, Kang MK, Han D, Choi S, Cho JR, Lee N. Enlarged left atrium and decreased left atrial strain are associated with atrial fibrillation in patients with hyperthyroidism irrespective of conventional risk factors. Int J Cardiovasc Imaging. 2022 Mar;38(3):613-620. doi: 10.1007/s10554-021-02450-6. Epub 2021 Oct 27. **PMID:** 34705162 **Citation:** Singh A, El Hangouche N, McGee K, Gong FF, Lentz R, Feinglass J, Akhter N. Utilizing left atrial strain to identify patients at risk for atrial fibrillation on ibrutinib. Echocardiography. 2021 Jan;38(1):81-88. doi: 10.1111/echo.14946. Epub 2020 Dec 7. **PMID:** 33594858 **Citation:** Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017 Apr 28;120(9):1501-1517. doi: 10.1161/CIRCRESAHA.117.309732. **PMID:** 28450367 **Citation:** Svartstein AW, Lassen MH, Skaarup KG, Grove GL, Vyff F, Ravnkilde K, Pedersen S, Galatius S, Modin D, Biering-Sorensen T. Predictive value of left atrial strain in relation to atrial fibrillation following acute myocardial infarction. Int J Cardiol. 2022 Oct 1;364:52-59. doi: 10.1016/j.ijcard.2022.05.026. Epub 2022 May 14. **PMID:** 35577164 **Citation:** Uzieblo-Zyczkowska B, Krzesinski P, Jurek A, Krzyzanowski K, Kiliszek M. Correlations between left atrial strain and left atrial pressures values in patients undergoing atrial fibrillation ablation. Kardiol Pol. 2021;79(11):1223-1230. doi: 10.33963/KP.a2021.0113. Epub 2021 Oct 2. **PMID:** 34599496 **Citation:** van de Vegte YJ, Siland JE, Rienstra M, van der Harst P. Atrial fibrillation and left atrial size and function: a Mendelian randomization study. Sci Rep. 2021 Apr 19;11(1):8431. doi: 10.1038/s41598-021-87859-8. **PMID:** 33875748 **Citation:** von Roeder M, Rommel KP, Kowallick JT, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuss G, Lucke C, Gutberlet M, Schuler G, Schuster A, Lurz P. Influence of Left Atrial Function on Exercise Capacity and Left Ventricular Function in Patients With Heart Failure and Preserved Ejection Fraction. Circ Cardiovasc Imaging. 2017 Apr;10(4):e005467. doi: 10.1161/CIRCIMAGING.116.005467. **PMID:** 28360259 **Citation:** Wyndham CR. Atrial fibrillation: the most common arrhythmia. Tex Heart Inst J. 2000;27(3):257-67. **PMID:** 11093410 **Citation:** Yasuda R, Murata M, Roberts R, Tokuda H, Minakata Y, Suzuki K, Tsuruta H, Kimura T, Nishiyama N, Fukumoto K, Aizawa Y, Tanimoto K, Takatsuki S, Abe T, Fukuda K. Left atrial strain is a powerful predictor of atrial fibrillation recurrence after catheter ablation: study of a heterogeneous population with sinus rhythm or atrial fibrillation. Eur Heart J Cardiovasc Imaging. 2015 Sep;16(9):1008-14. doi: 10.1093/ehjci/jev028. Epub 2015 Mar 6. **PMID:** 25750193 #### See Also Links **Label:** Incremental value of left atrial strain to predict atrial fibrillation recurrence after cryoballoon ablation **URL:** https://researchportal.vub.be/en/publications/incremental-value-of-left-atrial-strain-to-predict-atrial-fibrill ## Document Section ### Large Document Module #### Large Docs - Date: 2023-05-17 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 437090 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-12T17:42 - Date: 2023-05-17 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 373691 - Type Abbrev: ICF - Upload Date: 2024-05-12T17:45 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000014947 - Term: Wounds and Injuries ### 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: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M4586 - Name: Atrial Fibrillation - Relevance: HIGH - As Found: Atrial Fibrillation - ID: M15974 - Name: Sprains and Strains - Relevance: HIGH - As Found: Strain - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000001281 - Term: Atrial Fibrillation - ID: D000013180 - Term: Sprains and Strains ### Intervention Browse Module - Browse Branches - Abbrev: AnAg - Name: Antihypertensive Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4277 - Name: Antihypertensive Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417099 **Brief Title:** Efficacy of Dihydroartemisinin for Treating PCOS **Official Title:** Therapeutic Efficacy of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome #### Organization Study ID Info **ID:** B2020-115(2) #### Organization **Class:** OTHER **Full Name:** Shanghai Zhongshan Hospital ### 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:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Zhongshan Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The primary research hypothesis of this study is that dihydroartemisinin is effective in restoration of regular menstrual cycles of PCOS subjects who meet at least two of three Rotterdam Criteria. Secondary research hypotheses include: dihydroartemisinin is also effective in reducing androgen, total immature follicles, and anti-Mullerian hormone. **Detailed Description:** Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by genetic and environmental factors. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, artemisinin has also been reported to have significant anti-inflammatory, anti-tumor and immune-modulating effects. Our recent study revealed that artemisinin derivatives protect against PCOS development by inhibiting ovarian androgen production. Consistently in a small pilot study, dihydroartemisinin effectively reduced androgen levels, reduced immature follicles, and improved the estrous cycle in PCOS patients who strictly met all the three Rotterdam Criteria, namely hyperandrogenism, ovulation dysfunction, and polycystic ovaries on ultrasound. Nevertheless, clinical diagnosis of PCOS can be established as long as a patient fulfill two of the three Rotterdam Criteria. The present study aims to explore the therapeutic effects of dihydroartemisinin in patients with PCOS who met at least two of three (≥2) Rotterdam Criteria. ### Conditions Module **Conditions:** - Polycystic Ovary Syndrome ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### 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:** The subjects take dihydroartemisinin, 40mg tid for 90 days **Intervention Names:** - Drug: Dihydroartemisinin **Label:** Dihydroartemisinin Treatment Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dihydroartemisinin Treatment Arm **Description:** dihydroartemisinin 40mg tid po for 90 consecutive days **Name:** Dihydroartemisinin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Record of vaginal bleeding within 6 months after start taking dihydroartemisinin **Measure:** Recovery of regular menses **Time Frame:** 180 days #### Secondary Outcomes **Description:** Serum AMH before and after 90 days of medication **Measure:** Serum anti-Mullerian hormone (AMH) **Time Frame:** 90 days **Description:** FAI (Total testosterone in nmol/L / SHBG in nmol/L X 100) before and after 90 days of medication **Measure:** Free androgen index (FAI) **Time Frame:** 90 days **Description:** Total number of immature follicles measuring 2-9 mm in diameter on ultrasound before and after 90 days of medication **Measure:** Number of immature follicles **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * BMI 18.5-28kg/M2 * No plan for pregnancy in the coming 6 months * Patients should meet two of the three following criteria: 1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle 2. Polycystic ovaries: ≥12 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound. 3. Elevated androgen levels: total testosterone\>1.67 nmol/L. Exclusion Criteria: * Pregnancy. * Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc. * Patients with other serious diseases affecting heart, liver, kidney, or other major organs. * Patients with any type of cancer. **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jiang.jingjing@zs-hospital.sh.cn **Name:** JINGJING JIANG, MD, PhD **Phone:** +862164041990 **Phone Ext:** 692023 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** li.xiaoying@zs-hospital.sh.cn - **Name:** JINGJING JIANG, MD, PhD - **Phone:** +862164041990 - **Phone Ext:** 692023 - **Role:** CONTACT ***Contact 2:*** - **Name:** Xiaoying Li, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Zhongshan Hospital, Fudan University **State:** Shanghai **Status:** RECRUITING **Zip:** 200032 #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Xiaoying Li, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - 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: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - 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: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M13970 - Name: Polycystic Ovary Syndrome - Relevance: HIGH - As Found: Polycystic Ovary Syndrome - 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: 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 - 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: D000013577 - Term: Syndrome ### Intervention Browse Module - Ancestors - ID: D000000962 - Term: Antimalarials - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic 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 ### Intervention Browse Module - Browse Leaves - ID: M189432 - Name: Artenimol - Relevance: HIGH - As Found: Carbon dioxide - ID: M4280 - Name: Antimalarials - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000039060 - Term: Artenimol ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417086 **Brief Title:** Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers **Official Title:** Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers: A Randomized Controlled Trial #### Organization Study ID Info **ID:** 23Y11921000 #### Organization **Class:** OTHER **Full Name:** Shanghai University of Traditional Chinese Medicine ### 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:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11-30 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shanghai Minimally Invasive Surgery Center #### Lead Sponsor **Class:** OTHER **Name:** Shanghai University of Traditional Chinese Medicine #### 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 acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture. Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes. Participants will: Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up. Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests. **Detailed Description:** This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12. ### Conditions Module **Conditions:** - Alzheimer Disease - Cognitive Impairment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Streitberger placebo needle will be used as sham acupuncture method to mask the paticipants. The outcome assessors will also be blind to the grouping. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 176 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group will receive acupuncture treatment in combination with donepezil for 12 weeks. **Intervention Names:** - Other: Acupuncture - Drug: Donepezil **Label:** Acupuncture Treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this group will receive sham acupuncture treatment in combination with donepezil for 12 weeks. **Intervention Names:** - Other: Sham Acupuncture - Drug: Donepezil **Label:** Sham Acupuncture Treatment **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Acupuncture Treatment **Description:** The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. There will be 12 weeks of 3-session treatment for each participant in total. **Name:** Acupuncture **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Sham Acupuncture Treatment **Description:** The Streitberger placebo needle will be used to simulate an acupuncture procedure without penetrating the skin. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. There will be 12 weeks of 3-session treatment for each participant in total. **Name:** Sham Acupuncture **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Acupuncture Treatment - Sham Acupuncture Treatment **Description:** Donepezil 5 mg will be given once daily before bed-time for 12 weeks. **Name:** Donepezil **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Plasma p-tau181measured by Single Molecule Array (Simoa) as the plasma biomarker. **Measure:** Phosphorylated tau at threonine 181 (p-tau181) **Time Frame:** Change from baseline to Week 12 and Week 64 (Follow-up 2) **Description:** CBF acquired by arterial spin labeling (ASL) magnetic resonance imaging (MRI) technique measures the blood flow condition of the whole brain. **Measure:** Cerebral Blood Flow (CBF) **Time Frame:** Change from baseline to Week 12 and Week 64 (Follow-up 2) #### Primary Outcomes **Description:** The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction. **Measure:** Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) **Time Frame:** Change from baseline to Week 12 #### Secondary Outcomes **Description:** The maximum score of the ADAS-cog is 70 including 12 items. The questions in this scale contain word recall task, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition task, remembering test directions, spoken language, word-finding difficulty, comprehension and attention. In general, a normal score for someone who does not have AD or another type of dementia is 5. The higher scores indicate higher degree of cognitive dysfunction. **Measure:** Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) **Time Frame:** Change from baseline to Week 38 (Follow-up 1) and Week 64 (Follow-up 2) **Description:** The maximum of the ADCS-ADL score is 54 containing 19 domains about assessment of basic and operational ability of daily living. The higher scores indicate higher ability of daily living. **Measure:** Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL) **Time Frame:** Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2) **Description:** The QOL-AD score includes 13 items about physical health, mental health, social and financial assessment, and quality of life. The total score ranges from 13 to 52. The higher scores indicate higher quality of life. **Measure:** Quality of Life-Alzheimer's Disease(QOL-AD) **Time Frame:** Change from baseline to Week 12, Week 38 (Follow-up 1) and Week 64 (Follow-up 2) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 50-85 years * Diagnosed by the criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) * Cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26 * Magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease * The Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years) * Voluntarily joining this study with informed consents Exclusion Criteria: * Cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders (such as schizophrenia and depression)) * A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition * Aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability * Contraindications to undergoing an MRI scan such as claustrophobia or pacemaker implantation. * Anticoagulant treatments such as warfarin or heparin * Use of pacemakers or receiving acupuncture in the past 2 weeks **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jenniferzhan_lhzj@163.com **Name:** Yijun Zhan **Phone:** +8618917699167 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** jenniferzhan_lhzj@163.com - **Name:** Yijun Zhan - **Phone:** +8618917699167 - **Role:** CONTACT **Country:** China **Facility:** Longhua Hospital, Shanghai University of Traditional Chinese Medicine **Zip:** 200032 #### Overall Officials **Official 1:** **Affiliation:** Shanghai University of Traditional Chinese Medicine **Name:** Yijun Zhan **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Huashan Hospital **Name:** Houguang Zhou **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003704 - Term: Dementia - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: LOW - As Found: Unknown - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M6904 - Name: Dementia - 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: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative 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 - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease ### Condition Browse Module - Meshes - ID: D000000544 - Term: Alzheimer Disease ### Intervention Browse Module - Ancestors - ID: D000002800 - Term: Cholinesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018697 - Term: Nootropic Agents ### Intervention Browse Module - Browse Branches - Abbrev: NootAg - Name: Nootropic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1721 - Name: Donepezil - Relevance: HIGH - As Found: Personal - ID: M6040 - Name: Cholinesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M20774 - Name: Nootropic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077265 - Term: Donepezil ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417073 **Brief Title:** Effects of Task-Oriented Station Training on Cognitive Levels and Hand Functions in Geriatric Residents of Nursing Homes **Official Title:** Effects of Task-Oriented Station Training on Cognitive and Hand Functions in Nursing Home Elders: Comparing Tele-Rehabilitation, Face-to-Face, and Home-Based Interventions #### Organization Study ID Info **ID:** d897232bb89442f7 #### Organization **Class:** OTHER **Full Name:** Çankırı Karatekin 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:** 2024-05-13 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-15 **Type:** ACTUAL #### Start Date **Date:** 2024-01-15 **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:** Çankırı Karatekin University #### Responsible Party **Investigator Affiliation:** Çankırı Karatekin University **Investigator Full Name:** Ceyhun Türkmen **Investigator Title:** Assoc. Prof. **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 explores the impact of task-oriented station training on the cognitive levels and hand functions of elderly residents in nursing homes. Utilizing methods like tele-rehabilitation, face-to-face sessions, and home-based programs, this research aims to determine the most effective approach for improving the cognitive and manual skills of this population. The hypothesis driving this study is that targeted task-oriented training can significantly improve the cognitive functions and hand dexterity of elderly individuals living in nursing homes, potentially enhancing their quality of life and independence. Participants receive different types of interventions-tele-rehabilitation, direct face-to-face training, and guided home programs-to evaluate which modality most effectively supports cognitive and hand function improvements. The study's design is randomized and assesses the outcomes through various established psychological and physical tests. With an aging global population, such strategies are crucial for maintaining the independence and quality of life of our elderly, potentially reducing the need for intensive care solutions and allowing for longer periods of self-sufficiency and well-being. This summary presents the study in a straightforward manner, explaining the purpose, hypothesis, methods, and significance of the research to make it accessible to non-specialist readers. ### Conditions Module **Conditions:** - Cognitive Decline - Motor Function Disorders - Geriatric Health **Keywords:** - Task-Oriented Station Training - Cognitive Function - Hand Function - Tele-Rehabilitation - Face-to-Face Intervention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 35 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Face-To-Face Task-orianted Training **Label:** Face-to-Face Interventions **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Tele-Rehabilitation Task-orianted Training **Label:** Tele-Rehabilitation **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Behavioral: Home-based Task-orianted Training **Label:** Home-Based Training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Face-to-Face Interventions **Description:** In this study, face-to-face task-oriented station training is provided by trained occupational therapists to elderly nursing home residents. Each session involves structured activities that simulate real-world challenges designed to improve cognitive and hand functions. These include exercises to enhance fine motor skills, hand strength, coordination, and cognitive tasks such as problem-solving and memory exercises. **Name:** Face-To-Face Task-orianted Training **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Tele-Rehabilitation **Description:** This intervention utilizes video-conferencing technology to deliver task-oriented training to elderly nursing home residents, focusing on cognitive and hand function improvements. **Name:** Tele-Rehabilitation Task-orianted Training **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Home-Based Training **Description:** Home-Based Task-Oriented Training Intervention Description: This home-based intervention involves a series of task-oriented activities specifically designed to improve cognitive and hand functions for elderly residents in nursing homes. Participants carry out prescribed activities independently, based on detailed guides provided by occupational therapists. The activities are tailored to stimulate cognitive processes and enhance fine motor skills, including tasks like sorting, assembling, and manipulative exercises that replicate daily challenges. Each participant follows a structured program of daily 45-minute sessions for two weeks, with periodic remote check-ins by therapists to assess progress and adjust the difficulty of tasks as needed. This format allows participants to engage in rehabilitation at their own pace, within the comfort of their own living spaces, fostering greater autonomy and adherence to the intervention. **Name:** Home-based Task-orianted Training **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Mini-Mental State Examination (MMSE) is a widely used tool for assessing cognitive function, which measures various aspects of cognitive abilities including orientation to time and place, immediate recall, short-term memory, language use, comprehension, and basic motor skills. The score ranges from 0 to 30, with higher scores indicating better cognitive function. This test will be used to quantify changes in cognitive levels of participants after undergoing task-oriented station training. **Measure:** Change in Cognitive Function Using the Mini-Mental State Examination (MMSE) **Time Frame:** Baseline (start of intervention), Post-intervention (immediately after the 2-week intervention), #### Secondary Outcomes **Description:** The Nine-Hole Peg Test measures dexterity and hand function. Participants are timed on how quickly they can place and then remove nine pegs into a pegboard with one hand. This test is used to evaluate fine motor skills improvement, particularly the ability to coordinate visually guided fine movements. **Measure:** Improvement in Hand Function Using the Nine-Hole Peg Test **Time Frame:** Baseline and Post-intervention (immediately after the 2-week intervention). **Description:** The SF-36 is a survey used to assess quality of life across eight domains: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). This measure will evaluate the impact of the intervention on overall well-being and life satisfaction. **Measure:** Quality of Life Changes Measured by the Short Form Health Survey (SF-36) **Time Frame:** Baseline and Post-intervention (immediately after the 2-week intervention). ### Eligibility Module **Eligibility Criteria:** \*\*Inclusion Criteria:\*\* * Age 65 years and older. * Residency in a nursing home. * Able to provide informed consent, either directly or through a legal guardian. * Sufficient cognitive function to participate in the intervention, as indicated by a Mini-Mental State Examination (MMSE) score of 18 or higher. * Physically able to participate in task-oriented activities, with or without assistive devices. * Stable medical condition, with no hospitalizations due to acute illness in the last three months prior to the study commencement. \*\*Exclusion Criteria:\*\* * Diagnosed with severe dementia or any cognitive impairment severe enough as per the healthcare provider to interfere with participation in the study. * Any medical condition that significantly limits physical activity or requires intensive medical care during the study period, such as unstable cardiovascular disease, severe osteoarthritis, or recent fractures. * Participation in any other experimental rehabilitation or drug trials concurrently. * Severe sensory deficits that would prevent participation in the tasks (e.g., severe vision or hearing loss not correctable with aids). * Life expectancy less than 6 months as estimated by a physician. * Significant psychiatric disorders that might impair the ability to comply with study protocols. **Maximum Age:** 85 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Çankırı **Country:** Turkey **Facility:** Çankırı Karatekin University **Zip:** 06060 **Location 2:** **City:** Çankırı **Country:** Turkey **Facility:** Çakü ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### 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: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Decline - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M6301 - Name: Cognition Disorders - 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: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417060 **Brief Title:** Caudal Anesthesia Versus Local Anesthesia in Hypospadias **Official Title:** THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL #### Organization Study ID Info **ID:** 2 #### Organization **Class:** OTHER **Full Name:** Necmi Kadıoğlu Hospital ### Status Module #### Completion Date **Date:** 2024-05-26 **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:** 2024-05-25 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-25 **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 #### Lead Sponsor **Class:** OTHER **Name:** Necmi Kadıoğlu Hospital #### Responsible Party **Investigator Affiliation:** Necmi Kadıoğlu Hospital **Investigator Full Name:** Mustafa Azizoğlu **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair. **Detailed Description:** The rationale for conducting a comprehensive study arises from the limitations inherent in existing literature, primarily due to selection bias and the retrospective nature of current evidence, which fails to clarify whether caudal blocks lead to higher complication rates after hypospadias repair. To fill this knowledge gap and address the clinical uncertainty surrounding this issue, the only effective approach is to randomly assign patients undergoing hypospadias repair to receive either caudal or penile block anesthesia. The purpose of this pilot study is to evaluate the feasibility of a definitive trial and identify any methodological issues that must be resolved before committing significant resources to a full-scale study. This pilot study will assess the feasibility of conducting a large, definitive, parallel-group, randomized controlled trial (RCT) to determine whether a dorsal penile block results in fewer postoperative complications than a caudal block in boys aged 6 to 48 months undergoing hypospadias repair. Hypospadias repair will be performed under standardized analgesic administration, and participants may receive fentanyl (1-3 mcg/kg) at the anesthesiologist's discretion. Anesthesia will be induced via inhalation of air/nitrous oxide and sevoflurane. Based on a randomized allocation, patients will receive either a caudal anesthetic block (0.25% bupivacaine, 1 ml/kg, up to a maximum of 10 ml) or a dorsal penile block (bupivacaine without epinephrine, 10-20 ml/kg). All patients will receive antiemetic prophylaxis with dexamethasone (150 mcg/kg), ondansetron (50 mcg/kg), acetaminophen suppository (40 mg/kg), and intravenous morphine (0.02-0.1 mg/kg). At discharge, patients will be prescribed oral morphine (0.2 mg/kg) every 4 hours as needed, Ditropan (0.2 mg/kg) every 12 hours as needed, Tylenol (15 mg/kg per dose) every 4 hours, or ibuprofen (10 mg/kg per dose) every 6 hours. Parents will administer these medications at their discretion. Trimethoprim (2 mg/kg) will also be prescribed until catheter removal. ### Conditions Module **Conditions:** - Hypospadias - Hypospadias, Coronal - Caudal Anesthesia - Children **Keywords:** - Hypospadias - Caudal anesthesia - Urethrocutanous fistula ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** participant and outcome assessor **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Anesthesia will be administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal. **Intervention Names:** - Drug: Caudal block anesthesia **Label:** Caudal block **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Anesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis. **Intervention Names:** - Drug: Dorsal penile block anesthesia **Label:** Dorsal Penile Block Anesthesia **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Caudal block **Description:** Anesthesia will be administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal. **Name:** Caudal block anesthesia **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Dorsal Penile Block Anesthesia **Description:** Anesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis. **Name:** Dorsal penile block anesthesia **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A urethrocutaneous fistula (UCF) is characterized by an abnormal connection between the reconstructed urethra and the skin, situated between the original meatus and the tip of the penis. Glans dehiscence refers to the complete separation of the glans wings, which may or may not be connected by a strip of skin. **Measure:** Post-operative complication rate **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged between 6 and 48 months * Distal hypospadias * Acceptance of participation Exclusion Criteria: * Midpenil hypospadias * Proximal hypospadias * Prior surgery * Comorbidity (diabetes, hypertention, cardiac pathology) **Maximum Age:** 48 Months **Minimum Age:** 6 Months **Sex:** MALE **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mdmazizoglu@gmail.com **Name:** Mustafa Azizoğlu, MD, PhD **Phone:** +905447448244 **Role:** CONTACT #### Locations **Location 1:** **City:** Skopje **Contacts:** ***Contact 1:*** - **Name:** Toni Risteski - **Role:** CONTACT ***Contact 2:*** - **Name:** Toni Risteski - **Role:** PRINCIPAL_INVESTIGATOR **Country:** North Macedonia **Facility:** Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia **Status:** RECRUITING **Location 2:** **City:** Moscow **Contacts:** ***Contact 1:*** - **Name:** Sergey Klyuev, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Sergey Klyuev, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Russian Federation **Facility:** Ao Gk Medsi **Status:** RECRUITING **Location 3:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** mdmazizoglu@gmail.com - **Name:** Mustafa Azizoğlu - **Phone:** +905447448244 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mustafa Azizoglu, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Necmi Kadioglu Esenyurt State Hospital **Status:** RECRUITING **Zip:** 34430 #### Overall Officials **Official 1:** **Affiliation:** Necmi Kadıoğlu State Hospital **Name:** Mustafa Azizoğlu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014564 - Term: Urogenital Abnormalities - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000010409 - Term: Penile Diseases - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000000013 - Term: Congenital Abnormalities ### 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: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M8532 - Name: Fistula - Relevance: LOW - As Found: Unknown - ID: M10071 - Name: Hypospadias - Relevance: HIGH - As Found: Hypospadias - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M17314 - Name: Urogenital Abnormalities - 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: M13320 - Name: Penile Diseases - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007021 - Term: Hypospadias ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Imaging - ID: M12546 - Name: Nitrous Oxide - Relevance: LOW - As Found: Unknown - ID: M7992 - Name: Epinephrine - Relevance: LOW - As Found: Unknown - ID: M1673 - Name: Sevoflurane - Relevance: LOW - As Found: Unknown - ID: M30371 - Name: Racepinephrine - Relevance: LOW - As Found: Unknown - ID: M211043 - Name: Epinephryl borate - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417047 **Brief Title:** Effect of Hand Holding on Pain and Anxiety **Official Title:** Effect of Hand Holding on Reducing Intramuscular Injection-Induced Pain and Anxiety: A Randomized Controlled Study #### Organization Study ID Info **ID:** Necmettin Erbakan U #### Organization **Class:** OTHER **Full Name:** Necmettin Erbakan University ### Status Module #### Completion Date **Date:** 2025-04-15 **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:** 2024-10-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **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 #### Lead Sponsor **Class:** OTHER **Name:** Necmettin Erbakan University #### Responsible Party **Investigator Affiliation:** Necmettin Erbakan University **Investigator Full Name:** Serpil SU **Investigator Title:** Assistant professors **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** It was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety. **Detailed Description:** This study was designed as a pre-test-post-test regular parallel group, randomized controlled experimental design. The research will be carried out in the Adult Emergency Service of the Ministry of Health of the Republic of Turkey, Konya City Hospital. Patients will be randomly divided into two groups: handholding (52) and control group (52). For the Hand Holding Group: After the patient is positioned appropriately, the patient's hand will be held by the researcher. Once the intramuscular injection is completed, the patient's hand holding will be stopped. For the Control Group: No application will be made during intramuscular injection in the control group. The primary outcome of this study is to determine patients' pain scores during the intramuscular injection procedure. The secondary outcome is to determine the anxiety levels of patients. ### Conditions Module **Conditions:** - Pain and Anxiety ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel Assignment ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double (Participant, Outcomes Assessor) The patients will be informed about the study and their consent will be obtained without explaining which group they are in. Since the researcher manages the implementation process of the study, researcher blinding cannot be done. In addition, it will be ensured that the researcher learns which group the patients are in after the patients accept to participate in the study. Thus, the internal validity of the research will be ensured. At the same time, blind technique will be applied in terms of statistical analysis in the research. The data will be recorded on the computer by the researcher without using the expression of experimental and control groups, and data analysis will be done by another statistician other than the person who made the randomization. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 104 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the experimental group, hand holding will be done by the researcher, and intramuscular injection will be done by the clinical nurse. All intramuscular injections will be performed by a single nurse and the ventrogluteal region will be used as the injection site. Patients will first fill out the Voluntary Information and Consent Form, and then the Descriptive Characteristics Form and State Anxiety Scale. After the injection site is evaluated, the researcher will hold the patient's hand, the nurse will enter the tissue at a 90-degree angle and administer the drug slowly (1 ml/10 seconds). After removing the needle from the tissue, the nurse will apply pressure with dry cotton, and then the researcher will stop holding the patient's hand. After the procedure, the Numerical Pain Scale and State Anxiety Scale will be filled in within 1 minute. **Intervention Names:** - Other: Hand Holding **Label:** Hand Holding Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In the control group, intramuscular injection will be performed by the clinic nurse. All intramuscular injections will be performed by a single nurse and the ventrogluteal region will be used as the injection site. Patients will first fill out the Voluntary Information and Consent Form, and then the Descriptive Characteristics Form and State Anxiety Scale. After the injection site is assessed, the nurse will enter the tissue at a 90-degree angle and administer the medication slowly (1 ml/10 seconds). After removing the needle from the tissue, the nurse will apply pressure with dry cotton. After the procedure, the Numerical Pain Scale and State Anxiety Scale will be filled in within 1 minute. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Hand Holding Group **Description:** During the intramuscular injection, the aim is to draw the patients' attention elsewhere by holding their hand. **Name:** Hand Holding **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A score of "0" indicated the lowest pain, and a score of "10" indicated the highest pain. **Measure:** Numerical Pain Scale **Time Frame:** It will be filled within 1 minute after the intramuscular injection is completed. #### Secondary Outcomes **Description:** A score between 20-80 is obtained. The highest score obtained from the scale indicates a high level of anxiety, while a low score indicates a low level of anxiety. **Measure:** State Anxiety Scale **Time Frame:** It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Having vitamin B 12 1000 mcg/ml (1 ml ampoule) intramuscular treatment, * Being literate, * Are between the ages of 18-65, * No visual, hearing, sensory or motor loss or cognitive impairment, * Not using centrally or peripherally acting analgesics or sedatives, * There is no scar tissue, incision, lipodystrophy or signs of infection on the skin of the injection area, * Having a body mass index between 18.5 and 29.5, * Injected into the ventrogluteal area, * Individuals who agree to participate in the research will be included. Exclusion Criteria: * Those with chronic pain, * Having a psychiatric disorder, * Foreign nationals, * Patients with contact-communicable diseases will be excluded from the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ssu@erbakan.edu.tr **Name:** Serpil SU **Phone:** 05052611380 **Role:** CONTACT **Contact 2:** **Email:** m1kk.akblt@gmail.com **Name:** Melike AKBULUT **Phone:** 05392822149 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Necmettin Erbakan University **Name:** Serpil SU **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### 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: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M13066 - Name: Pain - 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: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417034 **Brief Title:** Hand Training Device For Cognitive Care **Official Title:** Hand Training Device For Cognitive Care #### Organization Study ID Info **ID:** A-ER-110-485 #### Organization **Class:** OTHER **Full Name:** National Cheng-Kung University Hospital ### Status Module #### Completion Date **Date:** 2022-04-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-04-11 **Type:** ACTUAL #### Start Date **Date:** 2022-03-27 **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 #### Lead Sponsor **Class:** OTHER **Name:** National Cheng-Kung University Hospital #### Responsible Party **Investigator Affiliation:** National Cheng-Kung University Hospital **Investigator Full Name:** Fong Chin Su **Investigator Title:** Chair Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Previous studies indicated that auditory stimulation as an external cue might have positive impacts on sensorimotor synchronization. Additionally, according to previous reports apart from traditional interventions, digitized game-based device, such as FTOMBVG, are beneficial for the brain activation in elderly. Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with cognitive decline. Therefore, this study aims to develop an advanced systems based on the previous one, that can provide hand function rehabilitation, cognitive training, and emotional comfort for the elderly or people suffer from cognitive deficiency. They can enhance their finger force control or visual to motor synchronization by music embedded during the gaming process. ### Conditions Module **Conditions:** - Healthy Elderly - Mild Cognitive Impairment (MCI) **Keywords:** - Functional near infrared spectroscopy - Parameters of digit force independence - Pressing Evaluation and Training System ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will be asked to press their finger while a series of archery target continuously drop down and pass by the bottom line follow the beats of music melody on Tipr. **Intervention Names:** - Device: Game Software **Label:** Music-based game training **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The background music will be disabled. Subjects need to press equally amount of force in certain tolerance that been set by only the visual cue on Tipr. **Intervention Names:** - Device: Game Software **Label:** Non music-based game training **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Music-based game training - Non music-based game training **Description:** The software is interfaced with a modified version of Frets on Fire (FOF)-an open source computer game similar to Guitar Hero. **Name:** Game Software **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions **Measure:** Oxygenated hemoglobin (HbO) **Time Frame:** 30 minutes **Description:** The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: Short term memory, Visuospatial abilities, Executive functions, Attention, concentration and working memory, Language, Orientation to time and place. The sensitivity of MoCA for detecting MCI is 90%. **Measure:** Montreal Cognitive Assessment (MoCA) test **Time Frame:** 10 minutes **Description:** The force independence is collected from the data during force control game in each evaluation session. The parameter of force independence is an index of five digits overall enslaving presented as EN. **Measure:** EN value **Time Frame:** 5 minutes #### Secondary Outcomes **Description:** Maximum voluntary isometric contraction of each digit is measured for training reference. **Measure:** Maximum voluntary isometric contraction (MVIC) **Time Frame:** 10 seconds ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability to communicate in Mandarin Chinese or Taiwanese * MCI, according to clinical neurological assessment, Montreal Cognitive Assessment (MoCA):≦25\&≧19 * Ability to perform ADL independently, no hand function disability * Voluntarily participation and ability to sign the informed consent form Exclusion Criteria: * Alzheimers disease diagnosed by physicians or meeting the diagnostic criteria for dementia * Physician's diagnosis of stroke * Any mental illness or behavior problems and inability to cooperate with the trainer * Visual impairment or hand diseases resulting in an inability to perform finger press * received other cognitive or physical training in the past year * any sight, hearing, or communication impairment **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tainan **Country:** Taiwan **Facility:** National Cheng Kung University **Zip:** 701 #### Overall Officials **Official 1:** **Affiliation:** Chair Professor **Name:** Fong-Chin Su, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Organization, W.H., Global health and aging. 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Effects of multicomponent exercise on cognitive function in older adults with amnestic mild cognitive impairment: a randomized controlled trial. BMC Neurol. 2012 Oct 31;12:128. doi: 10.1186/1471-2377-12-128. **PMID:** 23113898 **Citation:** Park S, Bak A, Kim S, Nam Y, Kim HS, Yoo DH, Moon M. Animal-Assisted and Pet-Robot Interventions for Ameliorating Behavioral and Psychological Symptoms of Dementia: A Systematic Review and Meta-Analysis. Biomedicines. 2020 Jun 2;8(6):150. doi: 10.3390/biomedicines8060150. **PMID:** 32498454 **Citation:** Bernabei V, De Ronchi D, La Ferla T, Moretti F, Tonelli L, Ferrari B, Forlani M, Atti AR. Animal-assisted interventions for elderly patients affected by dementia or psychiatric disorders: a review. J Psychiatr Res. 2013 Jun;47(6):762-73. doi: 10.1016/j.jpsychires.2012.12.014. Epub 2013 Jan 29. **PMID:** 23369337 **Citation:** Wu YH, Truglio TS, Zatsiorsky VM, Latash ML. Learning to combine high variability with high precision: lack of transfer to a different task. J Mot Behav. 2015;47(2):153-65. doi: 10.1080/00222895.2014.961892. Epub 2014 Nov 3. **PMID:** 25365477 **Citation:** Castilla D, Suso-Ribera C, Zaragoza I, Garcia-Palacios A, Botella C. Designing ICTs for Users with Mild Cognitive Impairment: A Usability Study. Int J Environ Res Public Health. 2020 Jul 17;17(14):5153. doi: 10.3390/ijerph17145153. **PMID:** 32708861 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive 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: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Mild Cognitive Impairment - ID: M6301 - Name: Cognition Disorders - 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: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417021 **Brief Title:** Ergonomics in Ultrasound Procedures **Official Title:** The Position of the Ultrasound Machine in the Placement of the Central Venous Catheter: a Randomized Controlled Study #### Organization Study ID Info **ID:** 25148/2024 #### Organization **Class:** OTHER **Full Name:** University of Padova ### Status Module #### Completion Date **Date:** 2025-01-01 **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:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Padova #### Responsible Party **Investigator Affiliation:** University of Padova **Investigator Full Name:** Alessandro De Cassai **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:** The study will compare two different positions of the ultrasound machine during simulated CVC positioning. The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis. **Detailed Description:** We will recruit medical trainees affiliated with the 'Anesthesia and Intensive Care' and 'Emergency Medicine' schools. Data collected for each participant will include: age, gender, specialty school, year of specialization training, expertise in using ultrasound for ultrasound-guided procedures. Once informed consent is obtained, subjects will be divided through simple randomization (a list generated in advance with Excel and subjected to the opaque envelope method) into two groups: A and B. All subjects will be asked to perform CVC placement using the simulator through an 'oblique in-plane' approach. Subjects randomized to group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis. ### Conditions Module **Conditions:** - Procedural Complication - Competence **Keywords:** - Central Venous Access - Ultrasound - Ergonomics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** A clip of the ultrasound procedure will be saved and reviewed by a blind assessor that will value the quality of the procedure **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 254 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will simulate a CVC positioning keeping the ultrasound machine facing them **Intervention Names:** - Other: Frontal Ultrasound Machine **Label:** Frontal position of Ultrasound machine (Ergonomic group) **Type:** OTHER #### Arm Group 2 **Description:** Participants will simulate a CVC positioning keeping the ultrasound machine in a lateral position on the same side of the needle. **Intervention Names:** - Other: Lateral Ultrasound Machine **Label:** Lateral position (90°) of Ultrasound machine (No Ergonomic group) **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Frontal position of Ultrasound machine (Ergonomic group) **Description:** Ultrasound machine will be placed in a frontal position **Name:** Frontal Ultrasound Machine **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Lateral position (90°) of Ultrasound machine (No Ergonomic group) **Description:** Ultrasound machine will be placed in a lateral position **Name:** Lateral Ultrasound Machine **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Investigators will measure time needed to correctly perform the procedure in seconds. The chronometer will be started when the participant takes the ultrasound probe and will be stopped when the guidewire will be correctly placed **Measure:** Time to correct CVC position **Time Frame:** baseline #### Secondary Outcomes **Description:** Procedure will be recorded as a clip in ultrasound machine. A blind assessor will evaluate the clip using the following scale (1-During the advancement of the needles, only the distortion of the tissue could be observed. 2-Only the tip of the needle was visible. 3-The tip of the needle was visible throughout the advancement, but the body of the needle was only partially visible. 4-The needle was completely visible during its advancement.) **Measure:** Needle tip visualization **Time Frame:** baseline **Description:** A complication is defined as participants puncturing the arterial vessel of the simulator **Measure:** Complications **Time Frame:** baseline **Description:** Procedure will be considered successful if participants will be able to insert the guidewire in a 10 minutes timeframe **Measure:** Success of the procedure **Time Frame:** 10 minutes from the baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 'Anesthesia and Intensive Care' and 'Emergency Medicine' residents * Informed consent Exclusion Criteria: * None **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** alessandro.decassai@aopd.veneto.it **Name:** Alessandro De Cassai, MD **Phone:** 0498216739 **Phone Ext:** 0039 **Role:** CONTACT #### Locations **Location 1:** **City:** Padova **Country:** Italy **Facility:** University Hospital of Padova **State:** Veneto **Zip:** 35127 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06417008 **Brief Title:** A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer **Official Title:** A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer #### Organization Study ID Info **ID:** HS-20117-301 #### Organization **Class:** INDUSTRY **Full Name:** Hansoh BioMedical R&D Company ### Status Module #### Completion Date **Date:** 2030-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hansoh BioMedical R&D Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). **Detailed Description:** This is a multicenter Phase Ib/III clinical study evaluating the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20117 in combination with aumolertinib in subjects with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The study is divided into two phases, Phase Ib, a dose expansion study and Phase III, a confirmatory study. In the dose expansion phase (Phase Ib), HS-20117 will first be studied in combination with the standard dose of aumolertinib, to assess the efficacy, safety, tolerability, PK profile, and immunogenicity of HS-20117 in combination with aumolertinib in the target population, as well as to determine the recommended Phase III dose (RP3D). Following confirmation of the safety and efficacy of HS-20117 in combination with aumolertinib and RP3D in Phase Ib, a randomized, active-controlled, open-label, multicenter Phase III study will be initiated to assess the efficacy and safety of HS-20117 in combination with aumolertinib versus aumolertinib in the target population in the confirmatory study phase. ### Conditions Module **Conditions:** - Non-Squamous Non-Small Cell Lung Cancer **Keywords:** - Non-Small Cell Lung Cancer - HS-20117 - Epidermal Growth Factor Receptor - c-Mesenchymal-Epithelial Transition - Bispecific Antibody ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 1080 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) at exploratory doses. Aumolertinib will be administered 110 mg orally once daily. **Intervention Names:** - Drug: HS-20117 - Drug: Aumolertinib **Label:** Phase Ib: HS-20117 and Aumolertinib **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) at exploratory doses. Aumolertinib will be administered 110 mg orally once daily. **Intervention Names:** - Drug: HS-20117 - Drug: Aumolertinib **Label:** Phase III: HS-20117 and Aumolertinib **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive Aumolertinib 110 mg orally once daily. **Intervention Names:** - Drug: Aumolertinib **Label:** Phase III: Aumolertinib **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase III: HS-20117 and Aumolertinib - Phase Ib: HS-20117 and Aumolertinib **Description:** Participants will receive HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) **Name:** HS-20117 **Other Names:** - PM1080 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Phase III: Aumolertinib - Phase III: HS-20117 and Aumolertinib - Phase Ib: HS-20117 and Aumolertinib **Description:** 110 mg orally once daily. **Name:** Aumolertinib **Other Names:** - Almonertinib Mesilate Tablets - HS-10296 - Almonertinib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** ORR is defined as the percentage of participants with DOR of confirmed CR or confirmed PR per RECIST v1.1 **Measure:** [Phase Ib] Objective response rate (ORR) According to response evaluation criteria in solid tumors (RECIST) v1.1 by Investigators (INVs) **Time Frame:** From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months **Description:** PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1 **Measure:** [Phase III] Progression-Free Survival (PFS) According to RECIST v1.1 by Independent Review Committee(IRC) **Time Frame:** Up to approximately 40 months #### Secondary Outcomes **Description:** Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause. **Measure:** [Phase Ib and III] Overall Survival (OS) **Time Frame:** Approximately 60 months **Description:** DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) based on Investigator's assessment per RECIST v1.1. **Measure:** [Phase Ib and III] Disease control rate (DCR) According to RECIST v1.1 by INVs **Time Frame:** From the date of first dose until the date of disease progression or withdrawal from study, approximately 40 months. **Description:** DoR only applies to participants whose best overall response is CR or PR based on Investigator's assessment per RECIST v1.1. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease. **Measure:** [Phase Ib and III] Duration of response (DoR) According to RECIST v1.1 by INVs **Time Frame:** From the date of CR, PR until the date of disease progression or death, approximately 40 months. **Description:** PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1 **Measure:** [Phase Ib and III] Progression-Free Survival (PFS) According to RECIST v1.1 by INVs **Time Frame:** Up to approximately 40 months **Description:** ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 **Measure:** [Phase III] ORR According to RECIST v1.1 by INVs **Time Frame:** From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months **Description:** ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 **Measure:** [Phase III] ORR According to RECIST v1.1 by IRC **Time Frame:** From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months **Description:** DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) **Measure:** [Phase III] DCR According to RECIST v1.1 by IRC **Time Frame:** From the date of first dose until the date of disease progression or withdrawal from study, approximately 40 months. **Description:** DoR only applies to participants whose best overall response is CR or PR. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease. **Measure:** [Phase III] DoR According to RECIST v1.1 by IRC **Time Frame:** From the date of CR, PR until the date of disease progression or death, approximately 40 months. **Description:** Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. **Measure:** [Phase Ib and III] Incidence and severity of treatment-emergent adverse events **Time Frame:** From the date of first dose until 90 days after the final dose. A cycle is 28 days. **Description:** Immunogenicity will be measured by the number of participants that are ADA positive. **Measure:** [Phase Ib and III] Immunogenicity of HS-20117 **Time Frame:** Cycle 1 Day 1: predose through EOT or follow up period (90 days after the last dose). **Description:** The Cmax is the maximum observed serum concentration of HS-20117 **Measure:** [Phase Ib] PK parameters: Maximum serum concentration (Cmax) of HS-20117 **Time Frame:** From the date of first dose until 30 days after the final dose. A cycle is 28 days. **Description:** Ctrough is the observed serum concentration immediately prior to the next administration **Measure:** [Phase Ib] PK parameters: Trough serum concentration (Ctrough) of HS-20117 **Time Frame:** From the date of first dose until 30 days after the final dose. A cycle is 28 days. **Description:** The AUCtau is defined as the area under the serum concentration-time curve during a dose interval time period(tau) **Measure:** [Phase Ib] PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117 **Time Frame:** From the date of first dose until 30 days after the final dose. A cycle is 28 days **Description:** The Tmax is defined as time to reach maximum observed serum concentration of HS-20117 **Measure:** [Phase Ib] PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117 **Time Frame:** From the date of first dose until 30 days after the final dose. A cycle is 28 days. **Description:** The t1/2 is defined as the time it takes for the concentration levels to fall to 50% of their value. **Measure:** [Phase Ib] PK parameters: Terminal elimination half-life (t1/2) of HS-20117 **Time Frame:** From the date of first dose until 30 days after the final dose. A cycle is 28 days. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males or females aged 18 - 75 years (inclusive). * Participants with newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic EGFR-sensitive mutated NSCLC (stage IIIB/IIIC/IV) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation. * Agree to provide fresh or archival tumor tissue. * At least one target lesion per the RECIST v1.1. * ECOG performance status of 0-1. * Minimum life expectancy \> 12 weeks. * Males or Females should be using adequate contraceptive measures throughout the study. * Females must not be pregnant at screening or have evidence of non-childbearing potential. * Have signed Informed Consent Form. Exclusion Criteria: * Received or are receiving the following treatments: 1. Previous or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates (ADC). 2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug. 3. Local radiotherapy within 2 weeks prior to the first dose of study drug, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of study drug. 4. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion. 5. Major surgery within 4 weeks prior to the first dose of study drug. * Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy. * History of other primary malignancies. * Untreated, or active central nervous system metastases. * Inadequate bone marrow reserve or organ functions. * Severe, uncontrolled or active cardiovascular disorders. * Severe or uncontrolled systemic diseases. * Severe bleeding symptoms or bleeding tendencies within 1 month prior to the first dose of study drug. * Severe arteriovenous thrombosis occurred within 3 months prior to the first dose of study drug. * Serious infection within 4 weeks prior to the first dose of study drug. * Active infectious diseases. * Interstitial lung disease (ILD). * Serious neurological or mental disorders. * History of hypersensitivity to any component of HS-20117 and Aumolertinib or their similar drugs. * Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fujl@hspharm.com **Name:** Jialei Fu **Phone:** +86 18652105685 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Tianjin Medical University Cancer Institute and Hospital **Name:** Dingzhi Huang, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Zhejiang Cancer Hspital **Name:** Yun Fan, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## 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 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M20194 - Name: Antibodies, Bispecific - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M11900 - Name: Mitogens - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416995 **Brief Title:** Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes **Official Title:** Investigation of First Trimester Serum Vasohibin-1, Vasohibin-2, Cardiotrophin-1 and Endocan Concentrations in Predicting Adverse Perinatal Outcomes #### Organization Study ID Info **ID:** B.10.1.TKH.4.34.H.GP.0.01I 5q #### Organization **Class:** OTHER_GOV **Full Name:** Umraniye Education and Research Hospital ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-03 **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_GOV **Name:** Umraniye Education and Research Hospital #### Responsible Party **Investigator Affiliation:** Umraniye Education and Research Hospital **Investigator Full Name:** ibrahim kale **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:** Investigation of the relationship between maternal serum vasohibin-1, vasohibin-2, cardiotrophin -1 and endocan concentrations at the 11th and 14th weeks of gestation and adverse perinatal outcomes. **Detailed Description:** Previous animal model studies in the literature have shown that vasohibin-1 released in endothelial cells inhibits angiogenesis, while vasohibin-2 stimulates angiogenesis. Additionally, immunohistochemical studies have shown that vasohibin-2 plays a role in the cellular fusion of trophoblasts in the placenta to form syncytiotrophoblasts. Studies in the literature have shown that cardiotrophin-1 is expressed in cardiac myocytes and vascular endothelial cells and stimulates the synthesis and secretion of endothelin-1 in endothelial cells through the gp130 signaling pathway. Since endothelin 1 plays an important role in the regulation of vascular tone, cardiotrophin-1 can be considered to act as an endothelium-derived biological factor, possibly involved in the regulation of vascular tone under normal physiological conditions or secondary to pathological processes. Studies in the literature have shown that maternal serum endocan levels are higher in pregnant women whose pregnancies were complicated by preeclampsia than in normotensive pregnant women, and that the endocan molecule may be effective in the etiopathogenesis of preeclampsia, especially if it develops early. In the light of this above-mentioned information, we aim to investigate whether serum vasohibin-1, vasohibin-2, cardiotrophin-1 and endocan concentrations measured during the 11th to 14th weeks of pregnancy can be used to predict preeclampsia, gestational hypertension, fetal growth restriction, preterm birth and gestational diabetes mellitus. ### Conditions Module **Conditions:** - Preeclampsia - Gestational Hypertension - Gestational Diabetes - Preterm Birth - Fetal Growth Retardation ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 88 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pregnant women who do not have any pregestational disease, who gave a blood sample in the first trimester for the study, who did not develop any pregnancy-related disease during their pregnancy, and who gave birth at term. **Intervention Names:** - Diagnostic Test: first trimester serum diagnostic test **Label:** Control Group #### Arm Group 2 **Description:** Pregnant women who do not have any pregestational disease and who gave a blood sample in the first trimester for the study and who develop preeclampsia, gestational hypertension, preterm birth, fetal growth restriction, and gestational diabetes mellitus in the later weeks of pregnancy. **Intervention Names:** - Diagnostic Test: first trimester serum diagnostic test **Label:** Adverse Perinatal Outcome Group ### Interventions #### Intervention 1 **Arm Group Labels:** - Adverse Perinatal Outcome Group - Control Group **Description:** First trimester serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations predict adverse perinatal outcomes **Name:** first trimester serum diagnostic test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes **Measure:** Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Those who had the first-trimester screening test between 11 and 14 weeks of pregnancy and are in the low-risk group * Those with singleton pregnancy * Those who did not conceive pregnancy with assisted reproductive treatment methods * Those who do not have any pregestational diseases * Those who do not have any uterine anomalies Exclusion Criteria: * Smokers * Those who are in the high-risk group with the first trimester screening test * Those with multiple pregnancies * Those who conceive with assisted reproductive treatment methods * Those who had any disease before pregnancy * Those who have any uterine anomalies **Gender Based:** True **Gender Description:** pregnant women **Maximum Age:** 39 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Pregnant women with a singleton pregnancy who are between 11 and 14 weeks of gestation, who do not smoke, and do not have any systemic disease. ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** dribakale@hotmail.com - **Name:** İbrahim Kale, Associate Professor - **Phone:** 05326473581 - **Role:** CONTACT **Country:** Turkey **Facility:** Ümraniye Eğitim ve Araştırma Hastanesi **State:** Ümraniye **Status:** RECRUITING **Zip:** 34764 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006973 - Term: Hypertension - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000005315 - Term: Fetal Diseases - ID: D000006130 - Term: Growth Disorders - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M19012 - Name: Diabetes, Gestational - Relevance: HIGH - As Found: Gestational Diabetes - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Preeclampsia - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Preterm Birth - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: HIGH - As Found: Gestational Hypertension - ID: M8447 - Name: Fetal Growth Retardation - Relevance: HIGH - As Found: Fetal Growth Retardation - ID: M7633 - Name: Eclampsia - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - 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: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - 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 - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M8445 - Name: Fetal Diseases - Relevance: LOW - As Found: Unknown - ID: M9230 - Name: Growth Disorders - Relevance: LOW - As Found: Unknown - ID: T2019 - Name: Eclampsia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016640 - Term: Diabetes, Gestational - ID: D000011225 - Term: Pre-Eclampsia - ID: D000047928 - Term: Premature Birth - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000005317 - Term: Fetal Growth Retardation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416982 **Brief Title:** Perineal Massage for Pessary Examinations **Official Title:** Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled Trial #### Organization Study ID Info **ID:** 24-0544 #### Organization **Class:** OTHER **Full Name:** University of North Carolina, Chapel Hill ### Status Module #### Completion Date **Date:** 2025-06 **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:** 2025-06 **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:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of North Carolina, Chapel Hill #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I. ### Conditions Module **Conditions:** - Prolapse, Vaginal - Stress Urinary Incontinence - Pessaries - Pain **Keywords:** - Pessaries - Vaginal prolapse - Stress urinary incontinence - Pain - Conservative management - Perineal massage ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Masking Description:** Participants will be randomized to intervention vs no intervention at the first visit without stratification, then will undergo the opposite intervention at the second visit. While participants cannot be blinded to the intervention, providers performing the pessary checks and providing provider-perceived pain scores will be blinded to the intervention as someone on the research team other than the provider will perform the intervention prior to the pessary check. If there is unexpected breaking of the blind (e.g. participant tells provider which intervention was performed), the provider will report this to the research team and this will be noted in the study results. **Who Masked:** - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 68 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participant will undergo 2 minutes of perineal massage with water-based gel prior to the pessary examination. This consists of 2 minutes of perineal massage at the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times. The massage will be done by trained doctors who are not performing the pessary check. **Intervention Names:** - Other: Perineal massage **Label:** Perineal massage before pessary examination **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participant will not undergo 2 minutes of perineal massage, but will have water-based gel applied to the vaginal introitus and perineum prior to the pessary check. **Label:** No perineal massage before pessary examination **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Perineal massage before pessary examination **Description:** 2 minutes of perineal massage as described in arm/group descriptions. **Name:** Perineal massage **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Participants will be asked rate discomfort during the perineal massage on a VAS pain scale. **Measure:** Patient discomfort during perineal massage **Time Frame:** At the 3 month follow up visit #### Primary Outcomes **Description:** Change in pain scores during pessary check (removal and replacement) compared to baseline pain score prior to pessary check using a visual analog scale (VAS) pain scale, as reported by the participant. The VAS pain scale is a validated scale that is performed by having the participant place a mark on a 10 cm line from 0 to 10 to indicate severity of pain. 0 indicates no pain, 10 indicates the most severe pain. Distance from 0 to the mark is measured and recorded in millimeters. **Measure:** Patient-perceived pain **Time Frame:** 3 months #### Secondary Outcomes **Description:** Participants will be asked to rate satisfaction with perineal massage on a 5-point Likert scale. The 5-point Likert scale is a psychometric response method where respondents can easily answer questions and state their level of agreement in five points. The 5-point Likert scale consists of the below points: (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. **Measure:** Patient satisfaction with perineal massage **Time Frame:** 3 months **Description:** Participants will be asked whether they would choose to undergo perineal massage during future visits. Allowed responses will be Yes/No. **Measure:** Patient preference for future perineal massage **Time Frame:** 3 months **Description:** The provider performing the pessary examination will be asked to rate patient pain before and during the pessary examination (pessary removal and replacement) on a VAS pain scale. The change in pain score during the pessary examination will be compared. The VAS pain scale is a validated scale that is performed by having the provider place a mark on a 10 cm line from 0 to 10 to indicate severity of pain. 0 indicates no pain, 10 indicates the most severe pain. Distance from 0 to the mark is measured and recorded in millimeters. **Measure:** Provider-perceived patient discomfort **Time Frame:** 3 months **Description:** Providers will evaluate ease of pessary removal on a scale of 1 to 10 (with 10 being the most difficult). The ease of pessary removal at the time of the intervention visit will be compared. **Measure:** Provider-perceived ease of pessary removal **Time Frame:** 3 months **Description:** Providers will be asked to note the presence of any perineal or vaginal abrasions that are thought to be due to pessary removal and/or replacement. The proportion of participants who sustain a perineal or vaginal abrasion will be compared. **Measure:** Perineal and vaginal abrasion **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Undergoing routine pessary management by office providers * Able to provide informed consent (as reported by patient or family member) * Able to follow up with the UNC Urogynecology office for two consecutive pessary examination Exclusion Criteria: * Non-English speaking * Found to have a condition such as significant vaginal erosion that precludes replacement of pessary after exam * Unable to undergo massage due to functional or cognitive impediments or significant discomfort during massage * Regular usage of pain medications for prior pessary checks such as lidocaine, and unwilling to forgo lidocaine for two study visits * Pessary visit for pain, pessary expulsion, or significant bleeding, as per provider's judgement **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** christine_chu@med.unc.edu **Name:** Christine Chu, MD, MSCI **Phone:** 9849740496 **Role:** CONTACT **Contact 2:** **Email:** rodney_stephenson@med.unc.edu **Name:** Rodney Stephenson **Phone:** 919-966-4717 **Role:** CONTACT #### Locations **Location 1:** **City:** Raleigh **Country:** United States **Facility:** UNC Urogynecology **State:** North Carolina **Zip:** 27607 #### Overall Officials **Official 1:** **Affiliation:** University of North Carollina at Chapel Hill **Name:** Christine Chu, MD, MSCI **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014555 - Term: Urination Disorders - 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: D000059411 - Term: Lower Urinary Tract Symptoms - ID: D000020924 - Term: Urological Manifestations - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019960 - Term: Elimination Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000091662 - Term: Genital Diseases - ID: D000056887 - Term: Pelvic Organ Prolapse ### 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: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M17299 - Name: Urinary Incontinence - Relevance: HIGH - As Found: Urinary Incontinence - ID: M7936 - Name: Enuresis - Relevance: HIGH - As Found: Urinary Incontinence - ID: M17300 - Name: Urinary Incontinence, Stress - Relevance: HIGH - As Found: Stress Urinary Incontinence - ID: M27171 - Name: Nocturnal Enuresis - Relevance: LOW - As Found: Unknown - ID: M17344 - Name: Uterine Prolapse - Relevance: HIGH - As Found: Prolapse, Vaginal - ID: M17305 - Name: Urination Disorders - 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: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21832 - Name: Elimination 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: M22519 - Name: Pathological Conditions, Anatomical - 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: M28618 - Name: Pelvic Organ Prolapse - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014549 - Term: Urinary Incontinence - ID: D000004775 - Term: Enuresis - ID: D000014550 - Term: Urinary Incontinence, Stress - ID: D000014596 - Term: Uterine Prolapse - ID: D000011391 - Term: Prolapse ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416969 **Brief Title:** Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation **Official Title:** Stimulation of Regional Lipolysis and Adipocyte Lipolysis Proteins #### Organization Study ID Info **ID:** 23-004069 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic #### Secondary ID Infos **ID:** R01DK040484 **Link:** https://reporter.nih.gov/quickSearch/R01DK040484 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-04 **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:** 2027-04 **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:** 2024-05-01 **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:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Michael D. Jensen **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Adults who gain most of their excess weight in the abdominal area typically do not respond to factors that "turn on" fat cells the same way as people who don't have excessive weight. Researchers are trying to understand why fat tissue responds differently in people with different body types. ### Conditions Module **Conditions:** - Obesity ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects that have upper body obesity will receive somatostatin plus epinephrine **Intervention Names:** - Drug: Somatostatin - Drug: Epinephrin **Label:** Obesity Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subject wo are normal weight will receive somatostatin plus epinephrine **Intervention Names:** - Drug: Somatostatin - Drug: Epinephrin **Label:** Lean Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lean Group - Obesity Group **Description:** Intravenous infusion 200 ug/hr for 2 hours, 100 ug/hr for 30 minutes **Name:** Somatostatin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Lean Group - Obesity Group **Description:** Intravenous infusion **Name:** Epinephrin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** regional palmitate release rates (micromol/min) will be measured using a combination of leg and splanchnic blood flow combined with stable isotope tracer measurements of palmitate uptake and release across the leg and splanchnic bed. Upper body, non-splanchnic palmitate release will be calculated as: total palmitate release - (splanchnic palmitate release + (leg palmitate release x 2)). Release rates will be measured at baseline (overnight fasting) and in response to the infusion of somatostatin plus epinephrine. This will allow us to understand the factors that may limit maximum lipolysis stimulation in upper body obesity for leg, splanchnic and upper body non-splanchnic adipose tissue palmitate release. **Measure:** Free Fatty Acid (FFA) release from femoral, splanchnic and upper body subcutaneous adipose tissue **Time Frame:** approximately 2.5 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo Clinical Research and Trials Unit for at least 3 days prior to study. * Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2 o Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \> 0.85 and/or increased visceral fat by single slice CT scan, usually with \> 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of \> 0.30, and/or biochemical evidence of metabolic syndrome as defined by adenosine triphosphate (ATP) III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol \< 50 mg/dL for women and \< 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of \>0.95 and/or increased visceral fat (visceral fat area \> 120 cm2 or a visceral/total fat abdominal ratio by CT of \> 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia. * Female subjects are eligible if they meet the following criteria: * Are not pregnant or nursing * All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug. * Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until 12 weeks after their participation in the other study is complete or \> than five half-lives of the compound, whichever is longer. If Yes look at consent form and f/u visits: * Current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude * Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks * Previous labs: * HbA1C \< 6.5% for non-diabetic UBO * Fasting glucose \< 126 mg/dl for non-diabetic UBO * Hb ≥ 11.0 for women and ≥ 12 for men * platelets \> 100 000 Exclusion Criteria: * Individuals with a history of a disease process such as: * Ischemic heart disease * Atherosclerotic valvular disease * Persistent blood pressure greater than 160/95 despite antihypertensive medication * Peripheral artery disease * Any history of trans-ischemic attacks. * Coronary artery disease. * Liver cirrhosis * Significant renal impairment as documented in medical chart. * Smokers * Diagnosis of Diabetes Mellitus. * Concomitant use of medications that can alter free fatty acid metabolism or pose a drug-drug interaction: statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; Any history of use of pioglitazone; Linezolid; Dihydroergotamine; Phenelzine; Phosphodiesterase inhibitors * Allergy to lidocaine * Allergy to indocyanine green. **Gender Based:** True **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:** reich.pamela@mayo.edu **Name:** Pamela Reich **Phone:** (507) 255-6062 **Role:** CONTACT **Contact 2:** **Email:** lytle.kelli@mayo.edu **Name:** Kelli Lytle, PhD **Phone:** (507) 255-1488 **Role:** CONTACT #### Locations **Location 1:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** reich.pamela@mayo.edu - **Name:** Pamela A. Reich - **Phone:** 507-255-6062 - **Role:** CONTACT ***Contact 2:*** - **Email:** lytle.kelli@mayo.edu - **Name:** Kelli A Lytle, PhD - **Phone:** (507) 255-1488 - **Role:** CONTACT **Country:** United States **Facility:** Mayo Clinic in Rochester **State:** Minnesota **Zip:** 55905 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Michael Jensen, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### 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: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - 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: D000045505 - Term: Physiological Effects of Drugs - ID: D000000318 - Term: Adrenergic beta-Agonists - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System 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 - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7992 - Name: Epinephrine - Relevance: HIGH - As Found: Growth - ID: M15806 - Name: Somatostatin - Relevance: HIGH - As Found: During exercise - ID: M30371 - Name: Racepinephrine - Relevance: LOW - As Found: Unknown - ID: M211043 - Name: Epinephryl borate - 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 - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004837 - Term: Epinephrine - ID: D000013004 - Term: Somatostatin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416956 **Acronym:** Baby-CINO **Brief Title:** Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants **Official Title:** Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants #### Organization Study ID Info **ID:** PID17161 #### Organization **Class:** OTHER **Full Name:** University of Oxford #### Secondary ID Infos **Domain:** Research Ethics Committee **ID:** 23/SC/0397 **Type:** OTHER ### 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:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-11 **Type:** ACTUAL **Status Verified Date:** 2023-12 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2023-12-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Oxford #### 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 investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards. ### Conditions Module **Conditions:** - Infant,Premature - Caffeine ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Preterm infants receiving caffeine (prescribed clinically) will be studied **Intervention Names:** - Drug: Caffeine **Label:** Preterm infant ### Interventions #### Intervention 1 **Arm Group Labels:** - Preterm infant **Description:** We will record infant\&#39;s brain activity and vital signs when caffeine dose is changed or caffeine treatment is stopped. The decision to change dose/stop treatment will be made by the clinical team as part of routine care. No changes in caffeine treatment will be carried out solely for research purposes. **Name:** Caffeine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later **Measure:** Respiration **Time Frame:** From baseline to two days later **Description:** Change in EEG activity between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later **Measure:** Brain activity **Time Frame:** From baseline to two days later #### Secondary Outcomes **Description:** Change in heart rate between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later **Measure:** Heart rate **Time Frame:** From baseline to two days later **Description:** Change in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later **Measure:** Oxygen saturation **Time Frame:** From baseline to two days later ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Born to a mother aged 16 or over * Admitted to the Newborn Care Unit, John Radcliffe Hospital * Born prematurely (before 37 weeks' gestation) * Parent given informed written consent * Receiving caffeine citrate Exclusion Criteria: * Known chromosomal abnormality or life-threatening congenital abnormality * Severe hypoxic insult at birth * Intraventricular haemorrhage grade III or IV or other severe neurological pathology **Maximum Age:** 37 Weeks **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation) ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** caroline.hartley@paediatrics.ox.ac.uk **Name:** Caroline Hartley **Phone:** +44 1865 234537 **Role:** CONTACT #### Locations **Location 1:** **City:** Oxford **Contacts:** ***Contact 1:*** - **Email:** caroline.hartley@paediatrics.ox.ac.uk - **Name:** Caroline Hartley - **Phone:** +44 1865 234537 - **Role:** CONTACT ***Contact 2:*** - **Name:** Caroline Hartley, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Newborn Care Unit, John Radcliffe Hospital **State:** Oxfordshire **Status:** RECRUITING **Zip:** OX3 9DU #### Overall Officials **Official 1:** **Affiliation:** University of Oxford **Name:** Caroline Hartley **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - 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: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth ### Intervention Browse Module - Ancestors - ID: D000000697 - Term: Central Nervous System Stimulants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010726 - Term: Phosphodiesterase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000058915 - Term: Purinergic P1 Receptor Antagonists - ID: D000058914 - Term: Purinergic Antagonists - ID: D000058905 - Term: Purinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: HIGH - As Found: 800 - ID: M4029 - Name: Central Nervous System Stimulants - Relevance: LOW - As Found: Unknown - ID: M13629 - Name: Phosphodiesterase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: HIGH - As Found: 800 ### Intervention Browse Module - Meshes - ID: D000002110 - Term: Caffeine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416943 **Brief Title:** 3D Port-A Catheter Model for New Staff **Official Title:** Effects of a 3D-Printed Port-A Catheter Model Training Course for New Staff #### Organization Study ID Info **ID:** FJUH112278-2 #### Organization **Class:** OTHER **Full Name:** Fu Jen Catholic University ### 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:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fu Jen Catholic University #### Responsible Party **Investigator Affiliation:** Fu Jen Catholic University **Investigator Full Name:** Ke-Yun, Chao **Investigator Title:** Group leader of Respiratory Therapists **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 is to develop a highly realistic 3D-printed Port-A catheter upper body model to enhance the effectiveness of training new nursing staff in Port-A catheter placement and care skills. **Detailed Description:** Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. Proper care and maintenance are crucial for the successful use of Port-A catheters. For nursing staff, acquiring professional knowledge in Port-A catheter care is essential for improving the quality of cancer patient care. Insufficient education and training in Port-A catheter care can lead to clinical errors that endanger patients' lives. Methods： This study involves providing training to participants and assessing their performance and effectiveness. It employs a prospective quasi-experimental design with a single group and pre- and post-test evaluations. The study includes 50 newly recruited nursing staff. Effect： We anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in the training of newly recruited nursing staff. ### Conditions Module **Conditions:** - Personal Satisfaction - Cancer **Keywords:** - 3D printed model - port-a catheter - nursing skill education ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Received a regular learning plus 3D printing model **Intervention Names:** - Other: 3D printed educational model **Label:** 3D medical education model group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 3D medical education model group **Description:** Slide-based presention plus 3D printed port-A catheter model **Name:** 3D printed educational model **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome. **Measure:** Examination score of pre-intervention **Time Frame:** pre-intervention **Description:** score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome. **Measure:** Examination score of post-intervention **Time Frame:** immediately after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * New nursing staff joined Fu Jen Catholic University Hospital. Exclusion Criteria: * Refused to participate in the study. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** C00152@mail.fjuh.fju.edu.tw **Name:** Ke-Yun Chao, PhD **Phone:** +886-905-301-879 **Role:** CONTACT #### Locations **Location 1:** **City:** New Taipei City **Country:** Taiwan **Facility:** Fu Jen Catholic University Hospital, Fu Jen Catholic University **Zip:** 24352 #### Overall Officials **Official 1:** **Affiliation:** Fu Jen Catholic University Hospital **Name:** Ke-Yun Chao, PhD **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:** NCT06416930 **Brief Title:** Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma **Official Title:** Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma #### Organization Study ID Info **ID:** AK104-IIT-039 #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Status Module #### Completion Date **Date:** 2029-06-20 **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:** 2027-06-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **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:** UNKNOWN **Name:** Akesobio #### 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:** Jie Wang **Investigator Title:** Chief physician **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 multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma. ### Conditions Module **Conditions:** - Pleural Mesothelioma **Keywords:** - Cadonilimab - pleural mesothelioma - Bispecific Antibody ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 59 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All subjects in the group will be treated with Cadonilimab plus gemcitabine / vinorelbine / pemetrexed once every three weeks. **Intervention Names:** - Drug: Cadonilimab Combined with chemotherapy **Label:** Cadonilimab combined with chemotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cadonilimab combined with chemotherapy **Description:** Cadonilimab (15mg/kg, intravenous drip, D1) + gemcitabine (1250mg/m2, intravenous drip, D1/D8) or vinorelbine (30mg, oral, tiw, D1/D3/D5) or pemetrexed (500mg/m2, intravenous drip, D1), every 3 weeks. **Name:** Cadonilimab Combined with chemotherapy **Other Names:** - AK104 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. **Measure:** Objective Response Rate (ORR) **Time Frame:** 2 year #### Secondary Outcomes **Description:** defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. **Measure:** Disease Control Rate (DCR) **Time Frame:** 2 year **Description:** defined as the time between the date of first dose of study drug and the date of first documented tumor progression per mRECIST v1.1, or death due to any cause, whichever occurs first. **Measure:** Progression Free Survival (PFS) **Time Frame:** 2 year **Description:** defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first. **Measure:** Duration of Response (DoR) **Time Frame:** 2 year **Description:** defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first. **Measure:** Overall Survival (OS) **Time Frame:** 2 year **Description:** Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results **Measure:** Adverse Events (AEs) **Time Frame:** 2 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically confirmed advanced or metastatic pleural mesothelioma; 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy. 4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. 5. Adequate haematological, renal and liver function. Exclusion Criteria: 1. Primary mesothelioma of peritoneum, pericardium and testes 2. Active, untreated central nervous system (CNS) metastasis. 3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment. 4. Known active autoimmune diseases. 5. Presence of other uncontrolled serious medical conditions. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zlhuxi@163.com **Name:** Jie Wang **Phone:** 13910704669 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000236 - Term: Adenoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018301 - Term: Neoplasms, Mesothelial - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000010997 - Term: Pleural Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M11634 - Name: Mesothelioma - Relevance: HIGH - As Found: Mesothelioma - ID: M2537 - Name: Mesothelioma, Malignant - Relevance: HIGH - As Found: Mesothelioma - ID: M3591 - Name: Adenoma - 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: M20445 - Name: Neoplasms, Mesothelial - 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: M13887 - Name: Pleural 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: T3584 - Name: Malignant Mesothelioma - Relevance: HIGH - As Found: Mesothelioma ### Condition Browse Module - Meshes - ID: D000008654 - Term: Mesothelioma - ID: D000086002 - Term: Mesothelioma, Malignant ### 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: M2985 - Name: Gemcitabine - Relevance: LOW - As Found: Unknown - ID: M1710 - Name: Vinorelbine - Relevance: LOW - As Found: Unknown - ID: M264 - Name: Pemetrexed - 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:** NCT06416917 **Brief Title:** Glenohumeral Internal Rotation Deficit Among Professional Athletes **Official Title:** Prevalence of Glenohumeral Internal Rotation Deficit Among Selected Professional Athletes #### Organization Study ID Info **ID:** prevalence of GIRD #### Organization **Class:** OTHER **Full Name:** Cairo University ### 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:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-29 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Hadeel Ibrahim Ali **Investigator Title:** assistant lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The study aimed to identify the prevalence of GIRD among elite Egyptian volleyball players in selected clubs in Egypt. **Detailed Description:** Volleyball is a highly technical sport that involves powerful overhead movements performed repetitively. The volleyball attack "spike," is a complex overhead movement that professional players perform up to 40,000 times a year (Kugler, 1996). It consists of four phases: windup, cocking, acceleration, and deceleration (follow-through). The windup phase is the arm is elevated to a position that is more than 90° from the anatomical position and the shoulder is slightly horizontally abducted. The cocking phase is abduction and external rotation (ER) reach their maximum levels. The acceleration phase is the shoulder rapidly internally rotates and adducts the arm up to the point where the hand strikes the ball (shoulder abducted at 140°-170° in neutral rotation. The deceleration (follow-through) phase extend from ball impact until the arm finally stops on the side of the trunk (Seminati et al., 2015). The shoulder complex has the widest multi-planar range of motion (ROM), it is a frequently injured body part in volleyball (12%-18%), mainly due to overuse mechanisms (Agel et al., 2007; Clarsen et al., 2015; Cuñado-González et al., 2019). Shoulder injuries are the third-most common volleyball injury (Reeser et al., 2010), According to reports, between (15- 23%) of volleyball players experience shoulder pain or injuries during a season (Clarsen et al., 2015; Cuñado-González et al., 2019; Forthomme et al., 2013). As a result, shoulder injuries are the most common reason for missing volleyball matches and practices (Hao et al., 2019). Glenohumeral internal rotation deficit (GIRD) is an adaptive process in which the throwing shoulder has a loss of internal rotation (IR) ROM (Rose \& Noonan, 2018). The anatomical GIRD is a typical response in overhead athletes with a lowered IR of about 18̊ to 20⁰ and symmetry in the total rotation motion (TRM), while Pathologic GIRD was identified in athletes with an IR deficit greater than 18⁰ and a TRM difference of more than 5⁰ between the shoulders. Not all cases of GIRD are indicative of pathology (Manske et al., 2013). It has been reported that GIRD can be seen in athletes who play softball, tennis, handball, football, baseball and even javelin throwers (Mlynarek \& Lee, 2017). Most of the studies are involved in baseball players, while volleyball and other overhead sports are known to have different throwing kinematics (Reeser et al., 2010). It has been shown that asymptomatic overhead athletes have GIRD at 10-15° whereas symptomatic overhead athletes have GIRD at 19-25° (Kaplan et al., 2011; Myers et al., 2006; Trakis et al., 2008). A higher degree of GIRD was found in the pain group than the no-pain group on symptomatic and asymptomatic handball and tennis players (Almeida et al., 2013; Moreno-Pérez et al., 2015). However, Lubiatowski et al., (2018) found only eleven out of eighty-seven handball players exhibited GIRD, although the author did not account for GIRD unless it reached 20-25°. Ellenbecker et al., (2002) have reported decreases of 5-10 ⁰ on average in the dominant arm TRM parameter in uninjured elite-level tennis players. Regarding volleyball, some authors found that few asymptomatic volleyball players displayed GIRD, but unless a player had a GIRD of \> 18°, they did not consider them to have GIRD (Harput et al., 2016; Saccol et al., 2016). Mizoguchi et al., (2022) studied (123 male and female) of adolescent (15 to 17 years old) volleyball players in Japan and found 38.2% had GIRD and decreased TRM in their shoulders. The GIRD group had an intrinsic external rotation deficiency (ERD) that was unrelated to sex, body composition, a history of shoulder injuries, years of volleyball experience, practice time, or court position. There were sex-specific differences in shoulder ROM, especially in the external rotation (ER) and IR ROM, with males being hypomobile and females being hypermobile. These results find agreement with (Harput et al., 2016) who found that 38.5% of adolescent volleyball players had GIRD with decreased TRM. Reeser et al., (2010) discovered a significant GIRD (8.9°), a non-significant presence of external rotation gain (ERG) (2°), and no change in TRM. It was reported in literature that There is still much to learn about the connection between volleyball players' shoulder pain and GIRD, so more research is required (Schmalzl et al., 2022; Harput et al., 2016). It was found that GIRD is often present in adult volleyball players (Schmalzl et al., 2022), but this may not be related to shoulder pain or injury, but imbalances in muscle strength around the shoulder can affect pain or injury (challoumas et al., 2017). The offensive players of volleyball players have a GIRD of ≥10 ⁰ and a lower TRM are linked to a higher prevalence of posterior-superior impingement (Schmalzl et al., 2022). Alqarni et al., (2022) showed that GIRD was present in pain group and no pain group. The pain group exhibited higher degrees of GIRD (15.65°) than the no pain group (9.06°). The results also revealed that the pain group exhibited a higher difference in TRM (16.17°) than the no pain group (10.17°). Players of volleyball may have changes in glenohumeral (GH) joint mobility and flexibility as a result of their sport-related activities (Harput et al., 2016; Keller et al., 2018; Wilk et al., 2011; Burkhart et al., 2003). They commonly perform spiking and serving (Reeser et al., 2010), which causes the shoulder joint to modify its bony and soft tissue structures. This results in 8-20% of all volleyball players' injuries (Reeser et al., 2010). Deceleration might result in repeated microtrauma as a consequence of the alteration in shoulder biomechanics during throwing exercises. This adaptation is essential for performance, yet it can also be a risk factor for injuries, leading to questions about how much of this deficit can be tolerated before clinical intervention is required (Whiteley \& Oceguera, 2016). In summary, GIRD is a common condition in volleyball players. It is not always associated with pain or injury, but it can be a risk factor for posterior-superior impingement. Up to author knowledge, there is no published study regarding the prevalence of GIRD among professional Egyptian volleyball players. ### Conditions Module **Conditions:** - Internal Rotation Contracture-shoulder **Keywords:** - GIRD ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** to measure range of motion **Name:** bubble inclinometer **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** shoulder range of motion **Measure:** internal rotation, external rotation and total range of motion **Time Frame:** 4 months **Description:** questionnaire **Measure:** physical performance **Time Frame:** 4 months **Description:** visual analog scale **Measure:** pain intensity **Time Frame:** 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. A professional volleyball Egyptian athlete who are playing in the selected clubs around Egypt; the four clubs in Alexandria (Smouha sporting club, Alex sporting club, Ittihad club and Horse owners club) and the three clubs in Cairo (Egyptian shooting club, wadi degla club, Zamalek club). 2. Elite Male and female volleyball players with BMI between (18.5 to 24.9) kg/m². 3. Their age range is between 14 to 30 years old Exclusion Criteria: * 1. Athletes who have a history of shoulder surgery or injury such as rotator cuff tear or labrum tear. 2. Athletes who have a history of injuries (fractures, dislocations) or surgeries in other joints of the upper limb (elbow, forearm, wrist, and hand) (Dabhokar et al., 2018). 3. Athletes who have a history of inflammatory joint disease, or neurological disorders that could affect their shoulder ROM such as arthritis or diabetes (Dabhokar et al., 2018). 4. Athletes who are taking any medications that could affect their shoulder ROM or pain. 5. Athletes who are currently inactive at the professional level due to multiple injuries that have prevented them from practicing. 6. Athletes who have been diagnosed with kyphosis and scoliosis in the shoulder and thoracic regions, as well as other anatomical anomalies (pennella et al., 2022). 7. Athletes who have experienced shoulder pain with stomach discomfort (pennella et al., 2022) **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** professional volleyball athletes from 18 to 30 years old. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hadeelibrahim241@gmail.com **Name:** hadeel I ali, master **Phone:** 01148321112 **Phone Ext:** +20 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Physical Therapy **Status:** RECRUITING **Zip:** 4240101 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009135 - Term: Muscular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M6510 - Name: Contracture - Relevance: HIGH - As Found: Contracture - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003286 - Term: Contracture ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416904 **Brief Title:** Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws **Official Title:** Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper in Comparison to Mini-Screws in Post-Pubertal Patients: A Randomized Clinical Trial #### Organization Study ID Info **ID:** ORTH3-3-3 #### Organization **Class:** OTHER **Full Name:** Cairo 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:** 2024-05-12 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-13 **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 #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mennatallah Moamen Mohamed Mohamed Ali **Investigator Title:** Dentist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims to compare the anchorage control during canine retraction using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion **Detailed Description:** The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars. After leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed. * In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar. * In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws Lastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs. ### Conditions Module **Conditions:** - Orthodontic Appliance Complication ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 26 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars with archwire stoppers mesial to the maxillary first molars. **Intervention Names:** - Device: archwire stopper mesial to the maxillary first molar group **Label:** arch wire stopper mesial to the maxillary first molar group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw. **Intervention Names:** - Device: inter-radicular mini-screw **Label:** maxillary first molar indirectly anchored to the inter-radicular mini-screw group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - arch wire stopper mesial to the maxillary first molar group **Description:** canine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars. **Name:** archwire stopper mesial to the maxillary first molar group **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - maxillary first molar indirectly anchored to the inter-radicular mini-screw group **Description:** canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw. **Name:** inter-radicular mini-screw **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models **Measure:** Amount of anchorage loss of the maxillary first molars **Time Frame:** 6 months from the start of the canine retraction #### Secondary Outcomes **Description:** the degree of tipping of the maxillary first molars will be assessed on the lateral cephalometric radiograph **Measure:** Tipping of the maxillary first molar. **Time Frame:** 6 months from the start of the canine retraction **Description:** The change in the maxillary incisors inclination will be assessed on the lateral cephalometric radiograph **Measure:** Maxillary incisors inclination **Time Frame:** 6 months from the start of the canine retraction ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Post-pubertal female patients. * Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction. * Full permanent dentition (not necessitating third molars). * Good oral hygiene. Exclusion Criteria: * Medically compromised patients. * Active periodontal disease or obvious bone loss in the maxillary arch. * Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting). * Smoking or any systemic diseases. * Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement * Previous orthodontic treatment. * Missing teeth. **Gender Based:** True **Gender Description:** female patients 15-25 years **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 15 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mennatallah.moamen@dentistry.cu.edu.eg **Name:** Mennatallah Ali **Phone:** 01018509275 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** mennatallah.moamen@dentistry.cu.edu.eg - **Name:** Mennatallah Moamen, BDS - **Phone:** +201018509275 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mennatallah Moamen - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Faculty of Dentistry, Cairo University **Status:** RECRUITING **Zip:** 12613 #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Mennatallah Ali **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:** NCT06416891 **Brief Title:** Effect of Adding Dexamethasone to Bupivacaine 0.25% in SCPB on Surgical Field Visibility During Tympanomastoid Surgery **Official Title:** Effect of Adding Dexamethasone to Bupivacaine 0.25% in Superficial Cervical Plexus Block on Surgical Field Visibility During Tympanomastoid Surgery in Adults, A Randomized Controlled Study #### Organization Study ID Info **ID:** MS-426-2023 #### Organization **Class:** OTHER **Full Name:** Cairo University ### 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:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Kareem Mohammed Assem Nawwar **Investigator Title:** Lecturer **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 is to evaluate the efficacy of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery. **Detailed Description:** Tympanomastoid surgery is a commonly performed otological procedure performed to treat various middle ear pathologies, including chronic otitis media, cholesteatoma, and mastoiditis (1). One of the most significant complications associated with tympanomastoid surgery is bleeding, which can result in surgical difficulties, prolonged operative time, and increased morbidity (2). Pain is also a major concern post-surgery and can lead to patient discomfort and dissatisfaction (3). Achieving optimal surgical field visibility is of paramount importance to ensure precise and safe surgical interventions. However, the presence of intraoperative bleeding and inadequate visualization can significantly impede the surgeon's ability to perform the procedure effectively, leading to potential complications and suboptimal outcomes (4). Conventional methods for pain management during tympanomastoid surgery often involve general anesthesia or local infiltration of anesthetic agents around the surgical site. However, these techniques may not adequately address pain control and can be associated with unwanted systemic side effects (5). To minimize bleeding and pain and improve surgical field visualization, anesthetic techniques such as induced hypotension have been used to achieve adequate homeostasis and surgical field visualization during surgery (4). Induced hypotension involves reducing systemic blood pressure, thereby decreasing blood flow to the surgical site, minimizing the risk of bleeding, and improving the surgical field's visualization, leading to better surgical outcomes (5). However, induced hypotension can lead to cerebral hypoperfusion, organ damage, and other serious complications (6). The use of regional anesthesia techniques, such as ultrasound-guided superficial cervical plexus block (SCPB), has gained considerable attention as a potential adjunct to general anesthesia (7). SCPB block involves the deposition of local anesthetic agents around the superficial cervical plexus, which provides sensory innervation to the ear, mastoid, and surrounding structures (8). The SCPB provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions (9). Also, the superficial cervical plexus provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery (10). Modern medicine focuses on enhancing patient outcomes and reducing surgical complications through improved surgical field visualization. Advanced imaging technologies like intraoperative MRI or CT scanners offer real-time, high-resolution images, aiding accurate tumor localization (11). Fluorescence-guided agents like indocyanine green enhance visualization of blood vessels, lymph nodes, and tumors during surgery. Augmented reality (AR) and virtual reality (VR) systems provide valuable guidance, allowing surgeons to identify critical structures, plan optimal incisions, and simulate complex procedures pre-surgery. Robot-assisted surgery offers enhanced precision and 3D visualization through high-definition cameras. These combined methods lead to safer and more effective surgical interventions (12). Recent studies have suggested that combining bupivacaine, a long-acting local anesthetic, with dexamethasone, a potent anti-inflammatory agent, may offer several advantages (13). Bupivacaine provides prolonged pain relief, while dexamethasone reduces local inflammation and edema, potentially improving surgical field visibility (14). To our knowledge, this is the first randomized clinical trial investigating the effect of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery in adults. ### Conditions Module **Conditions:** - Surgical Field - Postoperative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SCPB will be administered using 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + 5 ml of normal saline). **Intervention Names:** - Drug: bupivacaine 0.25% **Label:** Bupivacaine **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** SCPB will be administered using dexamethasone 2 mg in 10 ml of bupivacaine 0.25% (5 ml of bupivacaine 0.5% + dexamethasone 0.5 ml + 4.5 ml of normal saline). **Intervention Names:** - Drug: dexamethasone 2 mg in bupivacaine 0.25% **Label:** Bupivacaine plus dexamethasone **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Bupivacaine **Description:** SCPB using 10 ml of bupivacaine 0.25% **Name:** bupivacaine 0.25% **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Bupivacaine plus dexamethasone **Description:** SCPB using dexamethasone 2 mg in 10 ml of bupivacaine 0.25% **Name:** dexamethasone 2 mg in bupivacaine 0.25% **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Grading of surgical field visualization **Measure:** Modena bleeding score **Time Frame:** up to 5 hours #### Secondary Outcomes **Description:** Scoring surgeon satisfaction with the 3-point scale (1: good, 2: sufficient, 3: unfavorable) **Measure:** Surgeon satisfaction **Time Frame:** 1 hour postoperatively **Description:** Time to first call for a rescue analgesic **Measure:** Analgesia duration **Time Frame:** 24 hours **Description:** Postoperative pain is measured by Visual Analog Scale (0 = no pain, 10 = worst imaginable pain) **Measure:** Postoperative pain **Time Frame:** 24 hours postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. ASA I \& ASA II patients 2. Patients undergoing tympanomastoid surgery. 3. Age group: from 21 to 70 years old. 4. Duration of surgery less than 5 hours. Exclusion Criteria: * Patient refusal. * Uncooperative patients. * Allergy to local anesthetics or dexamethasone. * Anatomical abnormalities include malformations, deformities, growths, or structural irregularities. * Infection at injection site. * Coagulopathy: PTT \> 40 seconds, INR \> 1.4, platelet count \< 100x10⁹. or drug induced bleeding disorders **Maximum Age:** 70 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drknawwar@cu.edu.eg **Name:** Kareem MA Nawwar, M.D. **Phone:** +201003878369 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Medicine, Cairo University #### Overall Officials **Official 1:** **Affiliation:** Professor of Anesthesiology, Surgical ICU & Pain Management, Cairo University **Name:** Sahar MM El-Shall, M.D. **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University **Name:** Mohsen M Waheb, M.D. **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University **Name:** Kareem MA Nawwar, M.D. **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Resident of Anesthesia, Surgical ICU & Pain Management **Name:** Aboumazen A Abouhashem, M.B.B.Ch. **Role:** PRINCIPAL_INVESTIGATOR ## 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: Postoperative 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 - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000018689 - Term: Sensory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M5315 - Name: Bupivacaine - Relevance: HIGH - As Found: Following - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003907 - Term: Dexamethasone - ID: D000002045 - Term: Bupivacaine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416878 **Acronym:** BESCES **Brief Title:** Brief ES for Recovery of Autonomic Function in CES **Official Title:** Can Brief Perioperative Epidural Electrical Stimulation Improve Recovery of Autonomic Function in Cauda Equina Syndrome #### Organization Study ID Info **ID:** UoL001787 #### Organization **Class:** OTHER **Full Name:** University of Liverpool ### Status Module #### Completion Date **Date:** 2025-09-15 **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:** 2024-09-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Liverpool #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** BESCES is a study that aims to explore the feasibility of intraoperative brief epidural electrical stimulation (ES) for patients undergoing routine decompression for cauda equina syndrome. In consenting patients, brief ES will be applied using a CE-marked SCS trial kit once sufficient decompression is achieved. In participants who do not recover function following decompression, brief post-op ES will be applied to see if can facilitate micturition and/or removal of the catheter. The study will assess: The feasibility of intervention. If brief ES can facilitate conduction in residual neurons. If brief ES can facilitate neuronal recovery **Detailed Description:** Cauda equina syndrome (CES), defined as a compression of nerves controlling bowel, bladder and sexual function due to lumbar disc prolapse has a prevalence of 2 per 100,000 UK population per year. It mostly affects individuals 30-49 years of age. Emergency surgery to decompress the nerves is the mainstay of treatment. Despite adequate decompression, 17% of patients are left incontinent and 50% experience persistent bowel, bladder or sexual dysfunction needing long-term supportive symptomatic management and compromising their social cohesion and economic productivity. Theoretically, there are two possible ways of improving these functions - improving regeneration of damaged cells and improving conduction in partially damaged/residual cells. The use of perioperative electrical stimulation (ES) has shown significant promise in facilitating recovery in peripheral nerve compression syndromes. Epidural stimulation is routinely used for treating neuropathic pain and there is anecdotal evidence of improved bladder and bowel function in patients with CES who have received epidural spinal cord stimulation for chronic pain. The overall aim of this feasibility study is to determine if a full definitive RCT is possible. The investigators want to see if it is possible to timely and safely deliver epidural stimulation in patients presenting with bowel, bladder or sexual dysfunction due to cauda equina compression, undergoing emergency lumbar decompression, assess the potential effect size of brief post-decompression ES proximal to the level of compression in facilitating axonal regeneration to support further RCT. The investigators also want to see if brief ES can improve conduction in residual neurons. 40 patients presenting with CES shall be enrolled. At the time of decompression surgery, consenting patients shall receive ES. With standard care, patients who still have symptoms after decompression, remain symptomatic at 1 year. Comparison of functional outcomes post-surgery and at 3, 6 and 12 months will enable assessment of recovery due to axonal regeneration. Results shall assess the safety and feasibility of doing the study in emergency settings - enrolment and consent issues and assess effect size, this will provide sufficient information and, if successful, will lead to a definitive Randomised Control Trial (RCT). ### Conditions Module **Conditions:** - Cauda Equina Syndrome **Keywords:** - cauda equina syndrome - electrical stimulation - spinal cord stimulator - recovery of autonomic function - axonal regeneration ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Consecutive patients presenting to neurosurgical department with acute cauda equina syndrome with autonomic dysfunction. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants **Intervention Names:** - Device: Brief ES at the time of decompression for cauda equina syndrome - Device: Brief ES to facilitate mcturition/removal of catheter **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** In patients operated for acute cauda equina syndrome with autonomic dysfunction epidural ES will be delivered utilising SCS trial electrode. It will be delivered for 10 minutes caudal to compression site and for 60 mins cranial to compression site while the wound is closed and patient recovered. **Name:** Brief ES at the time of decompression for cauda equina syndrome **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Intervention **Description:** In patients who do not fully recover function following decompression, brief ES will be applied before second micturition attempt. **Name:** Brief ES to facilitate mcturition/removal of catheter **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Recruitment rate of 50% or above will be considered sufficient for feasibility of conducting future RCT. **Measure:** Recruitment Rate **Time Frame:** 6 months **Description:** In participants who do not recover autonomic function, Pudendal Nerve SEP will be performed to assess baseline conduction in residual neurons and recovery rate. Results at 3 months will be compared against baseline. **Measure:** Pudendal Somatosensory Evoked Potentials (SEP) - amplitude (uV) **Time Frame:** Post-operatively and at 3 months. **Description:** In participants who do not recover autonomic function, Pudendal Nerve SEP will be performed to assess baseline conduction in residual neurons and recovery rate. Results at 3 months will be compared against baseline. **Measure:** Pudendal Somatosensory Evoked Potentials (SEP) - latency (ms) **Time Frame:** Post-operatively and at 3 months. **Description:** Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Default frequency is 20 Hz and can be modified in 10Hz increments. Descriptive analysis of these parameters shall enable optimisation of settings in future studies. **Measure:** Stimulation parameters - Frequency (Hz) **Time Frame:** At the time of the surgery and immediately post-op **Description:** Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Amplitude is increased in 0.1mA increments until response is ascertained. Maximal safe amplitude is considered to be 15mA. Descriptive analysis of these parameters shall enable optimisation of settings in future studies. **Measure:** Stimulation parameters - Amplitude (mA) **Time Frame:** At the time of the surgery and immediately post-op **Description:** Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Default pulse width is 100 microseconds and it can be adjusted in 10 microsecond increments. Descriptive analysis of these parameters shall enable optimisation of settings in future studies. **Measure:** Stimulation parameters - Pulse width (microseconds) **Time Frame:** At the time of the surgery and immediately post-op #### Secondary Outcomes **Description:** The SFIQ consists of 5 items. Items 1 and 5 are Yes/No questions. Item 2 is an 8-question scale with answers ranging from 0 (best) to 3 (worst) each. Item 3 is a scale ranging from 1 (best) to 8 (worst). Item 4 is a scale ranging from 1 (best) to 6 (worst). **Measure:** Short Form Incontinence Questionnaire (SFIQ) **Time Frame:** On admission and at 3, 6 and 12 months. **Description:** The ASEX consists of 5 questions with answers from 1 (best) to 6 (worst) **Measure:** Arizona Sexual Experiences Scale (ASEX) **Time Frame:** On admission and at 3, 6 and 12 months. **Description:** NBD is a 10-question item with a score range from 0 (best) to 47 (worst). A score of 0-6 is considered very minor, 7-9 minor, 10-13 moderate and 14+ severe. **Measure:** Neurogenic Bowel Dysfunction (NBD) Questionnaire **Time Frame:** On admission and at 3, 6 and 12 months. **Description:** The ODI assesses disability related to back pain. It is a 10-question item, each scored from 0 (best) to 5 (worst). The total score is between 0 (best) and 50 (worst). **Measure:** Oswestry Disability Index (ODI) **Time Frame:** On admission and at 3, 6 and 12 months. **Description:** Rand Short Form Health Survey (SF-36) is a 36-question tool, developed at RAND as part of the Medical Outcomes Study. It assesses the quality of life in 9 categories (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health, Health change). Each category is scored from 0% (worst) to 100% (best). **Measure:** Rand SF-36 Questionnaire **Time Frame:** On admission and at 3, 6 and 12 months. **Description:** PVBS assesses post-micturition bladder volume. Volume above 200mL suggests incomplete bladder emptying or retention. Trends in PVBS will be assessed post-operatively and at 3-month follow-up in patients with incomplete recovery following the surgery. **Measure:** Post-void bladder scan (PVBS) **Time Frame:** At baseline, post-operative (x3) and at 3 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \>18. * Cauda equina syndrome with bladder, bowel or sexual dysfunction (CES-I or CES-R) secondary to acute lumbar disc prolapse. * Selected for emergency surgery. Exclusion Criteria: * No bladder, bowel or sexual dysfunction (Only bilateral radicular symptoms). * Previous spinal surgery with risk of adhesions. * Multilevel degeneration with inadequate safe space to pass epidural electrode. * Pre-existent bladder, bowel or sexual dysfunction. * History of peripheral neuropathy. * Contraindications to neurostimulation (e.g. pacemaker, immune deficiency, uncontrolled diabetes, sepsis, active pressure sore, spinal cord stimulator in situ). * Intraoperative CSF leak. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Rafal.Szylak@nhs.net **Name:** Rafal A Szylak, MBBS eq. **Phone:** 0151 525 3611 **Phone Ext:** 64124 **Role:** CONTACT **Contact 2:** **Email:** Deepti.Bhargava@nhs.net **Name:** Deepti Bhargava, MD **Phone:** 0151 525 3611 **Role:** CONTACT #### Locations **Location 1:** **City:** Liverpool **Contacts:** ***Contact 1:*** - **Email:** rafal.szylak@nhs.net - **Name:** Rafal Szylak, MBBS - **Phone:** 0044 151 525 3611 - **Role:** CONTACT **Country:** United Kingdom **Facility:** The Walton Centre NHS Foundation Trust **State:** Merseyside **Status:** RECRUITING **Zip:** L9 7LJ #### Overall Officials **Official 1:** **Affiliation:** University of Liverpool **Name:** Andrew Marshall, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Al-Majed AA, Neumann CM, Brushart TM, Gordon T. Brief electrical stimulation promotes the speed and accuracy of motor axonal regeneration. J Neurosci. 2000 Apr 1;20(7):2602-8. doi: 10.1523/JNEUROSCI.20-07-02602.2000. **PMID:** 10729340 **Citation:** Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1. **PMID:** 19800329 **Citation:** Juckett L, Saffari TM, Ormseth B, Senger JL, Moore AM. The Effect of Electrical Stimulation on Nerve Regeneration Following Peripheral Nerve Injury. Biomolecules. 2022 Dec 12;12(12):1856. doi: 10.3390/biom12121856. **PMID:** 36551285 **Citation:** Power HA, Morhart MJ, Olson JL, Chan KM. Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. Neurosurgery. 2020 Jun 1;86(6):769-777. doi: 10.1093/neuros/nyz322. **PMID:** 31432080 **Citation:** Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4. **PMID:** 25727139 **Citation:** Barber B, Seikaly H, Ming Chan K, Beaudry R, Rychlik S, Olson J, Curran M, Dziegielewski P, Biron V, Harris J, McNeely M, O'Connell D. Intraoperative Brief Electrical Stimulation of the Spinal Accessory Nerve (BEST SPIN) for prevention of shoulder dysfunction after oncologic neck dissection: a double-blinded, randomized controlled trial. J Otolaryngol Head Neck Surg. 2018 Jan 23;47(1):7. doi: 10.1186/s40463-017-0244-9. **PMID:** 29361981 **Citation:** Rascon-Ramirez FJ. Spinal cord stimulation and cauda equina syndrome: Could it be a valid option? A report of two cases. Neurocirugia (Astur : Engl Ed). 2021 Feb 5:S1130-1473(21)00003-8. doi: 10.1016/j.neucir.2020.12.002. Online ahead of print. English, Spanish. **PMID:** 33558146 **Citation:** Sayanagi J, Acevedo-Cintron JA, Pan D, Schellhardt L, Hunter DA, Snyder-Warwick AK, Mackinnon SE, Wood MD. Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice. J Bone Joint Surg Am. 2021 Oct 20;103(20):e80. doi: 10.2106/JBJS.20.01965. **PMID:** 34668879 **Citation:** Woodfield J, Hoeritzauer I, Jamjoom AAB, Jung J, Lammy S, Pronin S, Hannan CJ, Watts A, Hughes L, Moon RDC, Darwish S, Roy H, Copley PC, Poon MTC, Thorpe P, Srikandarajah N, Grahovac G, Demetriades AK, Eames N, Sell PJ, Statham PFX; UCES Collaborators; British Neurosurgical Trainee Research Collaborative. Presentation, management, and outcomes of cauda equina syndrome up to one year after surgery, using clinician and participant reporting: A multi-centre prospective cohort study. Lancet Reg Health Eur. 2022 Nov 17;24:100545. doi: 10.1016/j.lanepe.2022.100545. eCollection 2023 Jan. **PMID:** 36426378 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000019121 - Term: Burkholderia Infections - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000009408 - Term: Nerve Compression Syndromes - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000011129 - Term: Polyradiculoneuropathy - ID: D000011115 - Term: Polyneuropathies ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M9008 - Name: Glanders - Relevance: HIGH - As Found: Equina - ID: M1874 - Name: Cauda Equina Syndrome - Relevance: HIGH - As Found: Cauda Equina Syndrome - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M21130 - Name: Burkholderia Infections - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative 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: M12352 - Name: Nerve Compression Syndromes - Relevance: LOW - As Found: Unknown - ID: M5853 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: M18092 - Name: Hereditary Sensory and Motor Neuropathy - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M14013 - Name: Polyradiculoneuropathy - Relevance: LOW - As Found: Unknown - ID: M13999 - Name: Polyneuropathies - Relevance: LOW - As Found: Unknown - ID: T2505 - Name: Glanders - Relevance: HIGH - As Found: Equina - ID: T1015 - Name: Cauda Equina Syndrome - Relevance: HIGH - As Found: Cauda Equina Syndrome - ID: T1081 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: T2761 - Name: Hereditary Motor and Sensory Neuropathy - Relevance: LOW - As Found: Unknown - ID: T2766 - Name: Hereditary Neuropathy With Liability to Pressure Palsies - Relevance: LOW - As Found: Unknown - ID: T5067 - Name: Roussy Levy Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005896 - Term: Glanders - ID: D000077684 - Term: Cauda Equina Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416865 **Brief Title:** Efficacy and Safety of AJU-C52 in Essential Hypertension Patients **Official Title:** A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of AJU-C52 in Compared With C52R1M for Essential Hypertension Patients in Inappropriately Controlled on C52R1L Treatment #### Organization Study ID Info **ID:** 21HT30601 #### Organization **Class:** INDUSTRY **Full Name:** AJU Pharm Co., Ltd. ### Status Module #### Completion Date **Date:** 2024-08-31 **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:** 2022-12-12 **Type:** ACTUAL #### Start Date **Date:** 2022-06-27 **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 #### Lead Sponsor **Class:** INDUSTRY **Name:** AJU Pharm 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:** A Randomized, Double-blind, Multi-center, Phase III study to evaluate the efficacy and safety of the AJU-C52 compared with the combination of C52R1M in patients with essential Hypertension Patients who have inappropriately controlled on C52R1L treament ### Conditions Module **Conditions:** - Essential Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 190 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Treatment Period 1: AJU-C52L+C52R1L placebo Treatment Period 2: AJU-C52+C52R1M placebo **Intervention Names:** - Drug: AJU-C52L, AJU-C52 **Label:** AJU-C52L, AJU-C52 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Treatment Period 1: C52R1L+AJU-C52L placebo Treatment Period 2: C52R1M+AJU-C52 placebo **Intervention Names:** - Drug: C52R1L, C52R1M **Label:** C52R1L, C52R1M **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - AJU-C52L, AJU-C52 **Description:** AJU-C52L+C52R1L placebo: Subjects take the investigational products once a day for 2 weeks. AJU-C52+C52R1M placebo: Subjects take the investigational products once a day for 6 weeks. **Name:** AJU-C52L, AJU-C52 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - C52R1L, C52R1M **Description:** C52R1L+AJU-C52L placebo: Subjects take the investigational products once a day for 2 weeks. C52R1M+AJU-C52 placebo: Subjects take the investigational products once a day for 6 weeks. **Name:** C52R1L, C52R1M **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline. **Measure:** Changes in MSSBP(mean sitting systolic blood pressure) **Time Frame:** 8th week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults aged ≤19 years. * Those who voluntarily signed the informed consent to participate in this study. * A patient diagnosed with essential hypertension or Patients taking hypertension medication * Those who are eligible for adequate blood pressure criteria during screening tests: Naïve patient-160 mmHg≤MSSBP\<200 mmHg and MSDBP\<110 mmHg/Patients taking hypertension medication-140 mmHg≤MSSBP\<200 mmHg and MSDBP\<110 mmHg Exclusion Criteria: * At the screening visit (Visit 1), patients had 3 blood pressure measurements in the arm with the higher average MSSBP, those whose maximum and minimum blood pressure differences are MSSBP 20 mmHg and MSDBP 10 mmHg * Secondary hypertension patients or those with a history of suspected secondary hypertension * Cardiovascular/cerebrovascular disease * Those with a history of malignant tumor within 5 years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ajuf13001@ajupharm.co.kr **Name:** INAE PARK **Phone:** +82-02-2630-0700 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** ajuf13001@ajupharm.co.kr - **Name:** INAE PARK - **Phone:** +82-02-2630-0700 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** AJU Pharm Co., Ltd. **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - 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: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M1470 - Name: Essential Hypertension - Relevance: HIGH - As Found: Essential Hypertension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000075222 - Term: Essential Hypertension ### Intervention Browse Module - Ancestors - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M263171 - Name: Cryptophycin 52 - Relevance: HIGH - As Found: PNP - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000114033 - Term: Cryptophycin 52 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416852 **Brief Title:** Clinical Study of 18F-Alfatide Injection PET/CT **Official Title:** A Multicenter, Open, Non-inferiority Phase III Clinical Study to Evaluate the Efficacy of 18F-Alfatide Injection PET/CT Compared With 18F-FDG PET/CT in the Diagnosis of Lymph Node Metastasis in Non-small Cell Lung Cancer #### Organization Study ID Info **ID:** 18F-Alfatide-003 #### Organization **Class:** INDUSTRY **Full Name:** Yantai LNC Biotechnology Singapore PTE. LTD. ### 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:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08 **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:** 2024-05-07 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Yantai LNC Biotechnology Singapore PTE. LTD. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a multicenter, open, non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer. This trial will include 428 patients with non-small cell lung cancer confirmed by imaging, histopathology and/or cytology or highly suspected by investigators, suspected lymph node metastasis and proposed radical surgery and lymph node dissection. Eligible subjects will receive 18F-Alfatide Injection PET/CT and 18F-FDG PET/CT scans within 1 week. Subjects will undergo relevant security checks before and after each scan. The subjects underwent radical surgery and lymph node dissection within 2 weeks of completing both scans, and the obtained lymph nodes were pathologically examined as the gold standard to compare the diagnostic efficacy of 18F-Alfatide versus 18F-FDG for lymph node metastasis. ### Conditions Module **Conditions:** - Non-Small Cell Lung Cancer NSCLC ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 428 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study is designed as a self-controlled trial, in which participants will be injected and scanned with two drugs. **Intervention Names:** - Drug: 18F-Alfatide Injection - Drug: 18F-FDG Injection **Label:** 18F-Alfatide and 18F-FDG Injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 18F-Alfatide and 18F-FDG Injection **Description:** A single dose of (0.1\~0.15）±0.015 mCi/kg IV injection of 18F-Alfatide. The patients will be intravenously injected with 18F-Alfatide Injection and undergo PET/CT scan at 60 min±10 min after the injection. **Name:** 18F-Alfatide Injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 18F-Alfatide and 18F-FDG Injection **Description:** A single dose of 5～10mCi IV injection of 18F-FDG. The patients will be intravenously injected with 18F-FDG Injection and undergo PET/CT scan at 40 min±10 min after the injection. **Name:** 18F-FDG Injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the sensitivity and specificity of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.All subjects in this study underwent 18F-Alfatide PET-CT and 18F-FDG PET-CT examination within one week, radical surgery and lymph node dissection within two weeks after the completion of the two scanning images, and pathological examination of the obtained lymph nodes was used as the gold standard. **Measure:** Sensitivity and specificity evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT **Time Frame:** Through study completion, assessed up to 2 years #### Secondary Outcomes **Description:** To evaluate the accuracy, positive predictive value and negative predictive value of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.All subjects in this study underwent 18F-Alfatide PET-CT and 18F-FDG PET-CT examination within one week, radical surgery and lymph node dissection within two weeks after the completion of the two scanning images, and pathological examination of the obtained lymph nodes was used as the gold standard **Measure:** Accuracy, positive predictive value and negative predictive value evaluation of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT **Time Frame:** Through study completion, assessed up to 2 years **Description:** To evaluate the safety of 18F-Alfatide Injection PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with 18F-FDG PET/CT.The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0. **Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 **Time Frame:** Through study completion, assessed up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The subjects understand the clinical trial procedure and sign the informed consent in person; 2. Patients with non-small cell lung cancer confirmed or highly suspected by investigators based on prior history, imaging, histopathology, and/or cytology, suspected lymph node metastasis and proposed radical surgery and lymph node dissection; 3. Over 18 years old (including 18 years old); 4. ECOG function status score 0\~1 points ; 5. Expected survival \&gt; 3 months. Exclusion Criteria: 1. Known allergic history to 18F-Alfatide Injection and 18F-FDG injection or its excipients; 2. Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history); 3. Patients who are not suitable for PET or cannot complete PET or other imaging tests due to special reasons, including claustrophobia and radiophobia; 4. Workers who need to be exposed to radioactive conditions for a long time; 5. Patients with renal insufficiency were defined as the standard endogenous creatinine clearance (Ccr) estimated by the Cockcroft-Gault formula \&lt;60 ml/min, Ccr(ml/min)=\[(140-age)× body weight (kg)\]/\[72×Scr(mg/dl)\], and the calculated result for females was 0.85; 6. Fasting blood glucose level more than 7.0 mmol/L; 7. There are serious infections that cannot be controlled before screening; 8. Any serious disease that cannot be controlled, such as severe heart dysfunction (such as unstable angina pectoris, myocardial infarction, heart failure, etc.), a large number of pleural effusion patients, patients with mental illness, etc.; 9. Previously diagnosed with other malignant tumors, except in the following cases: * Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing prior to enrollment in the study); * Carcinoma in situ of cervical or breast cancer with curative treatment and no signs of recurrence for at least 3 years prior to the study; * The primary malignancy has been completely removed and in complete remission for ≥5 years. 10. Participants who had participated in clinical trials of radiopharmaceuticals within 1 year before screening; 11. Participating in other interventional clinical trials within 1 month before screening; 12. Poor general condition, heart, lung, liver, kidney, brain and other vital organs can not tolerate surgery; 13. Those who had a birth plan during the trial and within 1 year after the completion of the trial, or the subjects and their spouses did not agree to take strict contraceptive measures during the trial and within 6 months after the completion of the trial (using condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.); 14. Pregnant or lactating female subjects; 15. Subjects with poor compliance or other factors deemed unsuitable for participation in the study by the investigator. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Name:** PI has not yet been identified - **Role:** CONTACT **Country:** China **Facility:** Wuhan Union Hospital **Zip:** 430000 ### 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 - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - 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 ### Intervention Browse Module - Ancestors - ID: D000019275 - Term: Radiopharmaceuticals - 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: M21686 - Name: Fluorodeoxyglucose F18 - Relevance: HIGH - As Found: Valsartan - ID: M21258 - Name: Radiopharmaceuticals - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019788 - Term: Fluorodeoxyglucose F18 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416839 **Acronym:** VRW **Brief Title:** VR Exercise Intervention in a Workplace Setting **Official Title:** Virtual Reality Fitness Program to Promote Active Lifestyle and Psychological Wellbeing #### Organization Study ID Info **ID:** XRW001 #### Organization **Class:** INDUSTRY **Full Name:** XRWorkout, Inc ### 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:** 2024-05-10 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-03 **Type:** ACTUAL **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:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Mississippi Medical Center #### Lead Sponsor **Class:** INDUSTRY **Name:** XRWorkout, Inc #### 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 research study is designed to better understand how a virtual reality (VR) exercise application may influence overall physical activity and well-being. VR games can make exercise more enjoyable and interactive, which has been shown to increase engagement in physical activity. Adult participants will do a progressive exercise program and report on overall physical activity, health, and psychological wellbeing. The intervention is expected to have a positive impact on these lifestyle factors. **Detailed Description:** irtual Reality (VR) fitness applications are promising interventions to promote exercise in a home setting. Multiplayer fitness games for virtual reality platforms, addresses several common challenges associated with decreased exercise adherence such as social accountability, transportation, weather, gym memberships, and self-consciousness. This study aims to assess the impact of regular usage of a commercially available virtual reality fitness application on quality of life measures, including physical activity, health, and well-being. This study will enroll healthy participants, age 18- 50 years old, and they will be issued a Quest 2 virtual reality headset and given access to the virtual reality fitness application (VRWorkout - VRW). Participants will be asked to use VRW on a regular and progressive basis over a six-week period and to complete surveys about physical activity and wellbeing over a 9-week period. The activity completed within VRW is based on participant choice. A suggested progression schedule will be provided, but not enforced. This study of healthy working individuals, is foundational to assessing whether immersive fitness applications may be used as a lifestyle intervention to increase overall physical activity and well-being. ### Conditions Module **Conditions:** - Physical Inactivity - Psychological Well-Being - Work-Related Stress **Keywords:** - virtual reality - exercise - lifestyle factors ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This arm will use a VR exercise game that increases in frequency, intensity and duration with each week of the intervention. **Intervention Names:** - Behavioral: VR exercise **Label:** VR Exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - VR Exercise **Description:** Participation in high intensity interval training delivered on a virtual reality headset over six-week period. Participants may exercise with others in the multiplayer mode and use any feature of the application. **Name:** VR exercise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. A higher score indicates more physical activity. **Measure:** Physical Activity Questionnaire **Time Frame:** Weeks 1, 3, 5, 7, and 9 **Description:** The WHO-5 is a short, self-administered, and positively worded 6 point scale designed to measure the level of subjective well-being over the last two weeks. A higher score indicates better well-being. **Measure:** World Health Organisation- Five Well-Being Index (WHO-5) **Time Frame:** Weeks 1, 3, 5, 7, and 9 **Description:** This 10 point scale is a self-report on 9 items of exercise self-efficacy. A higher score indicates greater self-efficacy. **Measure:** Self-Efficacy for Exercise **Time Frame:** Week 1 and Week 9 **Description:** SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Each of the 36 questions has a yes or no answer or a linear rating scale. These measures rely upon patient self-reporting and have been widely used. A higher score indicates better health. **Measure:** 36-Item Short Form Health Survey (SF-36) **Time Frame:** Week 1 and Week 9 #### Secondary Outcomes **Description:** The Health and Work Questionnaire was developed to assess various aspects of productivity without completely relying on direct subjective estimation. It is a multidimensional measure of productivity. It consists of 24 questions, several of which were multi-part questions, comprising six subscales. High scores indicate greater productivity or health. **Measure:** Health and Work Questionnaire **Time Frame:** Weeks 1, 3, 5, 7, and 9 **Description:** The Job-related Affective Well-being Scale (JAWS) is a scale designed to assess people's emotional reactions to their job. It asks them to indicate for each of 30 emotions (20 emotions in the short form) how often they have experienced them in the past 30 days. Higher scores indicate more positive affects related to work. **Measure:** Job Affect Well-being Scale **Time Frame:** Week 1 and Week 9 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Exclusion Criteria: * Individuals who have been advised by a healthcare provider that they should not participate in moderate to strenuous physical activity for any reason * Individuals with history of seizures with photosensitivity * Individuals with diagnosis of uncontrolled metabolic disorders * Current lice infestation * Current eye infection * Body Mass Index above 30 (obese) **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** julia@xrworkout.ai **Name:** Julia Scott, PhD **Phone:** +1 (650)302-7285 **Role:** CONTACT **Contact 2:** **Email:** Alex@xrworkout.ai **Name:** Alex Azzi **Role:** CONTACT #### Locations **Location 1:** **City:** Jackson **Contacts:** ***Contact 1:*** - **Email:** jbdaniels@umc.edu - **Name:** Jacob Daniels, PhD, PT - **Phone:** 601-815-4038 - **Role:** CONTACT ***Contact 2:*** - **Email:** jreneker@umc.edu - **Name:** Jennifer Reneker, PhD, PT - **Phone:** (601) 984-6326 - **Role:** CONTACT **Country:** United States **Facility:** University of Mississippi Medical Center **State:** Mississippi **Status:** RECRUITING **Zip:** 39056 #### Overall Officials **Official 1:** **Affiliation:** University of Mississippi Medical Center **Name:** Jacob Daniels, PhD, PT **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Mississippi Medical Center **Name:** Jennifer Reneker, PhD, PT **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009784 - Term: Occupational Diseases - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC24 - Name: Occupational Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M1167 - Name: Occupational Stress - Relevance: HIGH - As Found: Work Related Stress - ID: M12719 - Name: Occupational Diseases - Relevance: LOW - As Found: Unknown - 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: D000073397 - Term: Occupational Stress ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416826 **Brief Title:** Rhythmic Sensory Stimulation on Fibromyalgia **Official Title:** An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia #### Organization Study ID Info **ID:** FibroMusicTherapy #### Organization **Class:** OTHER **Full Name:** Women's College Hospital ### Status Module #### Completion Date **Date:** 2020-03-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** WITHDRAWN #### Primary Completion Date **Date:** 2020-03-01 **Type:** ACTUAL #### Start Date **Date:** 2019-04-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2019-04-08 **Study First Submit QC Date:** 2024-05-10 **Why Stopped:** unforeseen circumstances ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Toronto #### Lead Sponsor **Class:** OTHER **Name:** Women's College 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 project is to further examine the effectiveness of Rhythmic Sensory Stimulation (RSS) with low-frequency sounds and somatosensory stimulation as a complementary therapy for fibromyalgia, and to investigate potential mechanisms underlying the effects of RSS on chronic pain. ### Conditions Module **Conditions:** - Chronic Pain, Widespread ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** healthy controls n = 10 **Label:** control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** patients with fibromyalgia n =20 **Intervention Names:** - Device: Vibroacoustic Therapy System - VTS 1000 **Label:** patients **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - patients **Description:** Participants will undertake 15 self-administered sessions of RSS 40Hz low frequency sound stimulation, 30 minutes daily, over 3 weeks (5 days/week). **Name:** Vibroacoustic Therapy System - VTS 1000 **Other Names:** - Rhythmic Sensory Stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia. **Measure:** change in inflammatory cytokine levels **Time Frame:** baseline, 1 month, 2 months #### Secondary Outcomes **Description:** Patients will rate their pain severity on a scale from 0 (no pain) to 10 (extreme pain) **Measure:** change in pain severity **Time Frame:** baseline, 1 month, 2 months **Description:** The investigators will measure EEG dynamics to quantify dysfunctional activity in brain areas that are affected by fibromyalgia **Measure:** change in EEG brain activity **Time Frame:** baseline, 1 month, 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with clinical diagnosis of fibromyalgia * able to read and write English adequately * have satisfactory hearing bilaterally (self-reported) * have the ability to operate the supplied device Exclusion Criteria: * acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease) * medical or psychiatric illness * history of psychosis, epilepsy, seizures * pregnancy or breast feeding * hemorrhaging or active bleeding * thrombosis, angina pectoris * heart disease, such as hypotension, arrhythmia, pacemaker * substance abuse (harmful or hazardous use of psychoactive subtances, including alcohol and illicit drugs) in the last year * suffering from a recently prolapsed vertebral disc * recovering from a recent accident with back or neck injury. **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 65 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: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000009468 - Term: Neuromuscular 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: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M29442 - Name: Chronic Pain - Relevance: HIGH - As Found: Chronic Pain, Widespread - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8486 - Name: Fibromyalgia - Relevance: HIGH - As Found: Fibromyalgia - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - 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: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005356 - Term: Fibromyalgia - ID: D000059350 - Term: Chronic Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416813 **Brief Title:** Preventive Intervention Value of Inclisiran Combined With DCB in Vulnerable Coronary Atherosclerotic Plaques **Official Title:** Preventive Intervention Value of Inclisiran Combined With Drug-Coated Balloons in Vulnerable Coronary Atherosclerotic Plaques #### Organization Study ID Info **ID:** WestChinaH-CVD-005 #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-10 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-01 **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:** 2024-05-02 **Study First Submit QC Date:** 2024-05-10 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yong He #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Yong He **Investigator Title:** Head of Cardiology, Professor, Chief Physician, Principal Investigator **Type:** SPONSOR_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 PASSIVATE-CAP study is an investigator-initiated, prospective, randomized, multicenter, open-label superiority trial focusing on acute coronary syndrome (ACS) patients with nonflow-limiting vulnerable plaques in nonculprit vessels. In this study, eligible patients were randomized at a 1:1 ratio into two groups: patients who received guideline-directed medical therapy (GDMT) and patients who received GDMT combined with a drug-coated balloon (DCB). In this study, the use of PCSK9 inhibitors was limited to inclisiran. The primary endpoint was the minimal lumen area of the target lesion 1 year after randomization. The secondary endpoints encompass a range of factors, including the proportion of patients with vulnerable plaques in the target vessel, fibrous cap thickness, lipid core arc of the target lesion, minimal lumen area of the target vessel, and extent of LDL-C reduction in patients treated with inclisiran. ### Conditions Module **Conditions:** - Acute Coronary Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** GDMT **Type:** NO_INTERVENTION #### Arm Group 2 **Intervention Names:** - Procedure: GDMT+DCB **Label:** GDMT+DCB **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - GDMT+DCB **Description:** Preventive Intervention on Eligible Vulnerable Plaques Using DCB **Name:** GDMT+DCB **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** A composite endpoint event encompassing cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. **Measure:** Target vessel failure **Time Frame:** 1 year #### Primary Outcomes **Description:** Minimum luminal cross-sectional area of the target lesion measured 1 year after randomization. **Measure:** Minimum luminal area **Time Frame:** 1 year #### Secondary Outcomes **Description:** proportion of patients with vulnerable plaques in the target vessel **Measure:** proportion of patients with vulnerable plaques in the target vessel **Time Frame:** 1 year **Description:** Fibrous cap thickness **Measure:** fibrous cap thickness **Time Frame:** 1 year **Description:** The lipid core arc as visualized on optical coherence tomography (OCT) refers to the angular extent and characteristics of the lipid-rich region within an atherosclerotic plaque. On cross-sectional OCT imaging, the lipid core appears as an area with high backscattering and high signal attenuation, distinguishing it from the surrounding fibrous or calcified plaque components. The key features of the lipid core arc include the arc angle (the angular extent of the lipid core in degrees), the arc thickness (the maximal radial thickness of the lipid core), and the arc location (the position of the lipid core relative to the lumen and other plaque components). **Measure:** lipid core arc **Time Frame:** 1 year **Description:** The degree of changes in patients' LDL-C (low-density lipoprotein cholesterol) levels before and after treatment **Measure:** Changes in LDL-C **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Age ≥ 18 years Diagnosis of ACS with the intention to undergo ICA There exists a nonculprit lesion characterized by a single diameter stenosis greater than 50% in the major coronary artery segments (with diameters ranging from 2.75 to 4 mm). QFR value \> 0.8 The OCT examination suggests vulnerable plaques with a fibrous cap thickness of \< 65 µm, along with at least two of the other three OCT criteria Minimum lumen area \<3.5 mm² Lipid core angle \>180° Presence of macrophages lesion length ≤30 mm Provide informed consent Life expectancy greater than 1 year Exclusion Criteria: Patients with three or more target lesions or with two target lesions in the same coronary artery left main stem lesions Ostial lesions Thrombotic lesions Severe calcification or angulated lesions True bifurcation lesions requiring stent implantation Advanced heart failure (NYHA III-IV) Ischemic stroke in the past 6 months or any history of cerebral hemorrhage at any time Severe valve disease or valve disease that may require surgical or percutaneous valve replacement Coronary artery anatomy obstructs the complete imaging of the segment of interest (including at least 5 mm beyond the narrow ends). Diffuse coronary artery disease or the presence of ≥1 untreated nonculprit lesion (nonculprit blood flow-restricting lesion planned for staged PCI). History of myocardial infarction, CABG, or PCI Coronary artery anatomy not suitable for PCI The potential comorbidity that may impact the completion of the trial process. The planned major surgery requires discontinuation of DAPT. History of PCSK9 inhibitor (such as evolocumab or alirocumab) use within 90 days prior to the first study visit. Exposed to Inclisiran or any other non-PCSK9 monoclonal antibody targeted treatment within the 2 years preceding the initial study visit, whether as an investigational drug or a marketed medication. History of allergy to the investigational drug, its excipients, or other siRNA drugs Females of childbearing potential, defined as all female subjects physiologically capable of becoming pregnant, unless they are using effective contraception during the administration of the investigational drug **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: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M29003 - Name: Plaque, Atherosclerotic - Relevance: HIGH - As Found: Atherosclerotic Plaque - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - 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: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000054058 - Term: Acute Coronary Syndrome - ID: D000058226 - Term: Plaque, Atherosclerotic ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416800 **Brief Title:** A Study to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics When Administered Orally to Healthy Adult Participants **Official Title:** An Open-Label Study to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics When Administered Orally to Healthy Adult Participants #### Organization Study ID Info **ID:** INCB54707-110 #### Organization **Class:** INDUSTRY **Full Name:** Incyte Corporation ### Status Module #### Completion Date **Date:** 2024-08-10 **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:** 2024-08-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-19 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Incyte Corporation #### 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 Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics When Administered Orally to Healthy Adult Participants. ### Conditions Module **Conditions:** - Healthy Participants **Keywords:** - INCB054707 ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 54 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Digoxin and povorcitinib will be administered at protocol defined doses. **Intervention Names:** - Drug: Digoxin - Drug: Povorcitinib **Label:** Cohort 1: Dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Rosuvastatin and povorcitinib will be administered at protocol defined doses. **Intervention Names:** - Drug: Rosuvastatin - Drug: Povorcitinib **Label:** Cohort 2: Dose **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Metformin and povorcitinib will be administered at protocol defined doses. **Intervention Names:** - Drug: Metformin - Drug: Povorcitinib **Label:** Cohort 3: Dose **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1: Dose **Description:** Oral; Tablet **Name:** Digoxin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cohort 2: Dose **Description:** Oral; Tablet **Name:** Rosuvastatin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Cohort 3: Dose **Description:** Oral; Tablet **Name:** Metformin **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Cohort 1: Dose - Cohort 2: Dose - Cohort 3: Dose **Description:** Oral; Tablet **Name:** Povorcitinib **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Digoxin concentration in plasma. **Measure:** Pharmacokinetic (PK) in plasma digoxin **Time Frame:** Up to Day 15 **Description:** Rosuvastatin concentration in plasma. **Measure:** PK in plasma rosuvastatin **Time Frame:** Up to Day 11 **Description:** Metformin concentration in plasma. **Measure:** PK in plasma metformin **Time Frame:** Up to Day 14 #### Secondary Outcomes **Description:** Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment. **Measure:** Number of participants with Treatment-emergent Adverse Events (TEAEs) **Time Frame:** Up to Day 25 (Cohorts 1 and 3), Up to Day 22 (Cohort 2) **Description:** Additional digoxin concentration in plasma. **Measure:** Additional digoxin PK parameters in plasma **Time Frame:** Up to Day 15 **Description:** Additional rosuvastatin concentration in plasma. **Measure:** Additional rosuvastatin PK parameters in plasma **Time Frame:** Up to Day 11 **Description:** Additional metformin concentration in plasma. **Measure:** Additional metformin PK parameters in plasma **Time Frame:** Up to Day 14 **Description:** Povorcitinib concentration in plasma. **Measure:** PK in plasma povorcitinib **Time Frame:** Up to Day 15 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Aged 18 to 55 years, inclusive, at the time of signing the ICF. * BMI between 18.0 and 30.5 kg/m2, inclusive. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval. * No clinically significant findings on screening evaluations (eg, clinical, laboratory, and ECG evaluations). * Ability to swallow and retain oral medication. * Willingness to avoid pregnancy or fathering children based on the criteria below: * Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last dose of study treatment and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. * Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in on Day -1 and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last dose of study treatment and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. * Female participants not considered to be of childbearing potential are eligible. Exclusion Criteria: * History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. * History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (ie, systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg at screening, confirmed by repeat testing). * History or presence of cardiovascular symptoms including but not limited to chest pain or pressure, palpitations, irregular heartbeat, syncope (excluding vasovagal from phlebotomy), dyspnea at rest or on exertion, lightheadedness, orthopnea, or paroxysmal nocturnal dyspnea that is considered clinically significant by the investigator. * Resting pulse \< 40 bpm or \> 100 bpm at screening, confirmed by repeat testing. * History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (ie, a QTcF interval \> 450 milliseconds for males and \> 470 milliseconds for females, QRS interval \> 120 milliseconds, and PR interval \> 220 milliseconds). * Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect drug absorption. * Hemoglobin, WBC count, platelet count, or absolute neutrophil count less than the laboratory LLN at screening or check-in, confirmed by repeat testing. Hemoglobin, WBC, platelet, and neutrophil abnormalities must also be clinically significant in the opinion of the investigator to be exclusionary. * Vitamin B12, folate, TSH, or parathyroid hormone levels less than the laboratory LLN at screening that are also clinically significant in the opinion of the investigator. * ALT, AST, ALP, or total bilirubin \> 1.25 × the laboratory-defined ULN at screening or check-in, confirmed by repeat testing (except participants with Gilbert's disease, for whom total bilirubin must be ≤ 2.0 × ULN). * History of malignancy within 5 years before screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer. * Current or recent (within 3 months before screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy) that could affect drug absorption. * Any major surgery within 4 weeks of screening. * Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks before screening (within 2 weeks for plasma-only donation). * Blood transfusion within 4 months before check-in (Day -1). * Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis). * Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator. * Receipt of live (including attenuated) vaccines within 28 days before the first dose of study treatment or anticipation of need for such a vaccine during the study. Note: Nonlive or inactivated vaccines are allowed up to 2 weeks before the first dose of study treatment. * History of significant alcohol use within 3 months before screening. * Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet. * Current treatment, or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study treatment, with another investigational medication or current enrollment in another investigational drug study. * Current treatment, or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study treatment, with an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database \[2024\] for prohibited drugs). * Consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study treatment. * Current use of prohibited medication. * History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator. * Known hypersensitivity or severe reaction to povorcitinib or any excipients of povorcitinib, digoxin, rosuvastatin, or metformin (refer to the IB and applicable package inserts). * Inability to undergo venipuncture or tolerate venous access. * History of tobacco- or nicotine-containing product-use within 1 month before screening. However, use of nicotine-containing products prior to screening that is equivalent to ≤ 2 cigarettes per week may be permitted at the discretion of the investigator. * Use of prescription drugs (including hormonal contraceptives) within 14 days before study treatment administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study treatment administration. However, occasional paracetamol, ibuprofen, and standard-dose multivitamins are permitted. * Women who are pregnant or breastfeeding. * Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * An eGFR \< 90 mL/min/1.73 m2, based on the site's standard formula, at screening. A repeat measurement may be allowed at the investigator's discretion. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** medinfo@incyte.com **Name:** Incyte Corporation Call Center (US) **Phone:** 1.855.463.3463 **Role:** CONTACT **Contact 2:** **Email:** eumedinfo@incyte.com **Name:** Incyte Corporation Call Center (ex-US) **Phone:** +800 00027423 **Role:** CONTACT #### Locations **Location 1:** **City:** Dallas **Country:** United States **Facility:** Fortrea Clinical Research Unit **State:** Texas **Status:** RECRUITING **Zip:** 75247 #### Overall Officials **Official 1:** **Affiliation:** Incyte Corporation **Name:** Incyte Medical Monitor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000924 - Term: Anticholesteremic Agents - ID: D000000960 - Term: Hypolipidemic Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000057847 - Term: Lipid Regulating Agents - ID: D000019161 - Term: Hydroxymethylglutaryl-CoA Reductase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000002316 - Term: Cardiotonic Agents - ID: D000020011 - Term: Protective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M11667 - Name: Metformin - Relevance: HIGH - As Found: Assessment - ID: M7265 - Name: Digoxin - Relevance: HIGH - As Found: Fascia - ID: M298 - Name: Rosuvastatin Calcium - Relevance: HIGH - As Found: Available - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M4243 - Name: Anticholesteremic Agents - Relevance: LOW - As Found: Unknown - ID: M4278 - Name: Hypolipidemic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M28883 - Name: Lipid Regulating Agents - Relevance: LOW - As Found: Unknown - ID: M21155 - Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M5572 - Name: Cardiotonic Agents - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008687 - Term: Metformin - ID: D000004077 - Term: Digoxin - ID: D000068718 - Term: Rosuvastatin Calcium ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416787 **Brief Title:** Safety and Tolerability of IBI355 in Healthy Volunteers **Official Title:** A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Healthy Voluteers #### Organization Study ID Info **ID:** CIBI355A103 #### Organization **Class:** INDUSTRY **Full Name:** Innovent Biologics (Suzhou) Co. Ltd. ### Status Module #### Completion Date **Date:** 2025-12-30 **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:** 2025-02-13 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-17 **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:** 2024-05-15 ### 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:** This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy voluteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy voluteers. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2) **Intervention Names:** - Drug: placebo - Drug: IBI355 **Label:** IBI355 dose-3 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2) **Intervention Names:** - Drug: placebo - Drug: IBI355 **Label:** IBI355 dose-1 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2) **Intervention Names:** - Drug: placebo - Drug: IBI355 **Label:** IBI355 dose-4 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2) **Intervention Names:** - Drug: placebo - Drug: IBI355 **Label:** IBI355 dose-2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - IBI355 dose-1 - IBI355 dose-2 - IBI355 dose-3 - IBI355 dose-4 **Description:** IBI355 7.5mg/kg Q4W **Name:** placebo **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - IBI355 dose-1 - IBI355 dose-2 - IBI355 dose-3 - IBI355 dose-4 **Description:** IBI355 1mg/kg Q4W **Name:** IBI355 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of adverse events and serious adverse events **Time Frame:** Up to week 24 #### Secondary Outcomes **Measure:** Area under the Curve(AUC) of multi-dose of IBI355 **Time Frame:** Up to week 12 **Measure:** Peak serum concentration(Cmax) of multi-dose of IBI355 **Time Frame:** Up to week 12 **Measure:** Clearance (CL) of multi-dose of IBI355 **Time Frame:** Up to week 12 **Measure:** Half-life (t1/2) of multi-dose of IBI355 **Time Frame:** Up to week 12 **Measure:** The ratio of Anti-drug antibody of multi-dose of IBI355 **Time Frame:** Up to week 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Understanding and Signing a written informed consent prior to selection; 2. Aged above 18 years old, male or female; 3. Body mass index (BMI) between 18-28kg/m2; 4. Normal lable test; 5. No parenting plan for at least 6 months Exclusion Criteria: 1. Subjects with a history of allergy； 2. Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)； 3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization; 4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive; 5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis; 6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases; 7. Subject with a hcg positive; 8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yang.yu@innoventbio.com **Name:** Yang Yu **Phone:** 0512-69566088 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** wjlsq@sina.com - **Name:** Jin Wang - **Phone:** 010-59971772 - **Role:** CONTACT **Country:** China **Facility:** Aerospace Center Hospital **State:** Beijing **Zip:** 100049 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416774 **Brief Title:** A Clinical Study of 68Ga-HX01 Injection for PET Imaging **Official Title:** A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging #### Organization Study ID Info **ID:** XLan-0688 #### Organization **Class:** INDUSTRY **Full Name:** Hexin (Suzhou) Pharmaceutical Technology Co., Ltd ### Status Module #### Completion Date **Date:** 2023-10-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-20 **Type:** ACTUAL #### Start Date **Date:** 2022-12-29 **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:** Wuhan Union Hospital, China #### Lead Sponsor **Class:** INDUSTRY **Name:** Hexin (Suzhou) Pharmaceutical Technology Co., Ltd #### 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 single-center, open Phase I clinical study, consisting of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors. **Detailed Description:** Phase Ia design: The Phase Ia study is designed to evaluate the safety, biodistribution (PET imaging), radiation dose, and pharmacokinetics of 68Ga-HX01 injection after a single intravenous administration in healthy Chinese adult subjects. Twelve healthy adult subjects will be enrolled in the Phase Ia program. Phase Ib design: The purpose of the Phase Ib clinical study is to evaluate the safety and biodistribution (PET imaging) of patients with malignant solid tumors receiving a single intravenous administration of 68Ga-HX01 injection, and to explore the characteristics of tumor imaging. Ten patients with malignant solid tumors will be enrolled in Phase Ib. ### Conditions Module **Conditions:** - Healthy - Malignancy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 22 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The injection dose of 68Ga-HX01 for low-dose group is 0.05 mCi/kg. **Intervention Names:** - Drug: 68Ga-HX01 Injection(0.05mCi/kg) **Label:** Ia: Low-dose group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The injection dose of 68Ga-HX01 for the high-dose group is 0.1 mCi/kg. **Intervention Names:** - Drug: 68Ga-HX01 Injection(0.1mCi/kg) **Label:** Ia: High-dose group. **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The injection dose for phase Ib patients was 0.07 mCi/ kg. **Intervention Names:** - Drug: 68Ga-HX01 Injection(0.07mCi/kg) **Label:** Ib: Patients with malignancy. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Ia: Low-dose group **Description:** The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments. **Name:** 68Ga-HX01 Injection(0.05mCi/kg) **Other Names:** - 68Ga-HX01 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Ia: High-dose group. **Description:** The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments. **Name:** 68Ga-HX01 Injection(0.1mCi/kg) **Other Names:** - 68Ga-HX01 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Ib: Patients with malignancy. **Description:** The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for safety monitoring. They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments. **Name:** 68Ga-HX01 Injection(0.07mCi/kg) **Other Names:** - 68Ga-HX01 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Changes in body temperature after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on body temperature. **Measure:** Temperature **Time Frame:** During the screening period (within 7 days), within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2. **Description:** Changes in respiration rate after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on respiration. **Measure:** Respiration **Time Frame:** Time Frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2. **Description:** Changes in pulse after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on pulse. **Measure:** Pulse **Time Frame:** During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2. **Description:** Changes in diastolic pressure and systolic pressure after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on blood pressure. **Measure:** Blood pressure **Time Frame:** During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2. **Description:** Changes in oxygen saturation after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on oxygen saturation. **Measure:** Oxygen saturation **Time Frame:** During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2. **Description:** Electrocardiogram QT interval was recorded to assess the effect of 68Ga-HX01 administration. **Measure:** Electrocardiogram QT Interval **Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2. **Description:** Electrocardiogram QRS interval was recorded to assess the effect of 68Ga-HX01 administration. **Measure:** Electrocardiogram QRS Interval **Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2. **Description:** Electrocardiogram PR interval was recorded to assess the effect of 68Ga-HX01 administration. **Measure:** Electrocardiogram PR Interval **Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2. **Description:** The shape of electrocardiogram T wave was recorded to assess the effect of 68Ga-HX01 administration. **Measure:** Electrocardiogram T Wave **Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2. **Description:** The shape of electrocardiogram ST segment was recorded to assess the effect of 68Ga-HX01 administration. **Measure:** Electrocardiogram ST Segment **Time Frame:** Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2. **Description:** The blood routine of Day 2 was recorded. **Measure:** Number of Participants With Abnormal Laboratory Values in Blood routine **Time Frame:** Day 2. **Description:** Blood biochemistry of Day 2 was recorded. **Measure:** Number of Participants With Abnormal Laboratory Values in Blood biochemistry **Time Frame:** Day 2. **Description:** Coagulation function of Day 2 was recorded. **Measure:** Prothrombin time test and/or a partial thromboplastin time test (PTT) **Time Frame:** Day 2. **Description:** Urine routine of Day 2 was recorded. **Measure:** Number of Participants With Abnormal Laboratory Values in Urine routine **Time Frame:** Day 2. #### Secondary Outcomes **Description:** OLINDA/EXM software was used to calculate the radiation dose using the uptake of each organ and tissue in Ia subjects. The uptake values are calculated from the SUV values of PET images at each time point. **Measure:** Dosimetry **Time Frame:** At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection. **Description:** The blood radioactivity time-activity curve was drawn based on the percentage of injected dose per gram (% ID/g) of blood samples at each time point. **Measure:** The percentage of injected dose per gram (% ID/g) **Time Frame:** Blood samples are collected for the radioactivity determination before (within 30 minutes) and after 68Ga-HX01 injection at different time points (2, 5, 10, 30, 60, 90, 120, and 180 minutes). **Description:** SUVmax was automatically calculated to quantify 68Ga-HX01 uptake in the lesions. **Measure:** The max uptake of each lesion **Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection. **Description:** SUVmean was automatically calculated to quantify 68Ga-HX01 uptake in the lesions. **Measure:** The mean uptake of each lesion **Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection. **Description:** Lesion number was recorded. **Measure:** Lesion number **Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection. **Description:** Lesion size was recorded. **Measure:** The size of each lesion **Time Frame:** At 30 and 60 minutes after 68Ga-HX01 injection. ### Eligibility Module **Eligibility Criteria:** This study consists of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors. Phase Ia: Inclusion Criteria: * 18-50 years old; * Female weight 45-80kg, male weight 50-80kg; * Agree to take effective contraception during the study and for at least three months after the drug administration. Exclusion Criteria: * Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration; * Known or suspected allergic to the test drug or any of its components; * Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment; * Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening; * Clinically significant abnormalities in hematology, blood biochemistry, and urine routine during screening; * Patients with clinically significant diseases within 4 weeks before screening; * Blood pressure higher than 150/100 mmHg or lower than 90/50 mmHg at screening; * Use of any prescription or over-the-counter drugs within 2 weeks before the trial drug administration; * Blood donation or blood loss ≥500 mL within 12 weeks before administration; * History of drug or alcohol abuse within 12 months prior to administration; * Smoking more than 5 cigarettes a day or consuming the same amount of nicotine or nicotine replacement within 3 months before administration; * History of malignancy; * Plan to schedule surgery and other invasive interventions within one week of the test drug injection; * Compliance to lie for about 90 minutes during the PET examination. Phase Ib: Inclusion Criteria: * Patients with malignant solid tumors with measurable lesions (target lesions) confirmed by histopathology or cytology or clinical diagnosis; * 18-75 years old; * Eastern Cooperative Oncology Group (ECOG) score 0 or 1; * life expectancy ≥6 months; * Agree to take effective contraception during the study and for at least three months after the drug administration. Exclusion Criteria: * Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration; * Known or suspected allergic to the test drug or any of its components; * Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment; * Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening; * Any radiotherapeutic drugs used within 90 days before administration, or any radionuclide diagnostic drugs received within 3 days before administration; * Plan to schedule surgery and other invasive interventions within 2 days after trial drug injection; * Abnormal liver and kidney function: serum total bilirubin (TBIL) \> 1.5×ULN (upper limit of normal), or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5×ULN, or serum creatinine \> 1.5×ULN; * With active infection at the time of screening; * Compliance to lie for about 60 minutes during the PET examination. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Wuhan **Country:** China **Facility:** Union Hospital, Tongji Medical College, Huazhong University of Science and Technology **State:** Hubei **Zip:** 430022 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416761 **Brief Title:** Genetics in the Progression of Nephropathies **Official Title:** The Genetic Contribution to Progression of Kidney Disease #### Organization Study ID Info **ID:** GenNefro01 #### Organization **Class:** OTHER **Full Name:** Ospedale San Raffaele ### Status Module #### Completion Date **Date:** 2041-05-19 **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:** 2040-05-19 **Type:** ESTIMATED #### Start Date **Date:** 2006-05-19 **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 #### Lead Sponsor **Class:** OTHER **Name:** Ospedale San Raffaele #### Responsible Party **Investigator Affiliation:** Ospedale San Raffaele **Investigator Full Name:** Chiara Lanzani **Investigator Title:** Clinical Assistant **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 evaluates the role of genetic in the development and progression of different nephropaties with particular attention to: * AKI * CKD * Hypertension * ADPKD * CKD-MBD * Patients with decompensated heart failure undergoing either medical or surgery therapy * Patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation * glomerular diseases **Detailed Description:** Background: In the past ten years there's been a progressive increase in the prevalence of CKD and consequently in the number of dialysed patients (\~4% per year) in Italy. This is probably due to the increasingly ageing population and incidence of CV disease (cf. Lombardy Register). To date, diabetes and CV disease are the most common cause of end-stage renal disease (ESRD) requiring RRT. Nonetheless, intrinsic renal diseases still remain an important cause of CKD. In the past few years, various environmental factors have been identified that affect the clinical progression of kidney disease: blood pressure control, lipid and glycemic profile (expecially in the setting of diabetic nephropaty), uric acid level and acid-base homeostasis. Recently, there have been found some genes responsible for monogenic hereditary diseases such as ADPKD (PKD1 e PKD2) and Alport syndrome (COL4A3/COL4A4/COL4A5). It is known that there's an important phenotypic heterogeneity among different patients with the same disease even in the same family because of incomplete penetrance \[5\]. Furthermore, it is well known that familiarity overbear all other risk factors in predicting the development of hypertension and its progression toward CKD. Many scientific findings show the link between some genetic polymorphisms (e.g ACE, adducin) and disease severity or development of various complications. There is now, increasingly scientific evidence that genetic palys an important role even in the development and progression of multifactorial renal disease with both protective or promoting possible pathways. Thus, It would seem that interactions between environmental and genetic factors are responsible for disease phenotypic heterogeneity and its progression. Aim of the study: * Extend the knowledge on genetic modifiers involved in disease progression to better classify patients in homogeneous groups based on aetiology and concomitant risk factors. According to the underlying pathology, patients will be assessed either alone or with their family to evaluate the phenotypic heterogeneity. * Evaluate the role of drugs that targets genetic or environmental factors. * Assess the role of gentic background in the development of CV complications in CKD patients undergoing dyalisis. * Assess the role of immature progenitor cells in the progression of kidney disease. * Evaluate the role of endogenous Ouabain to identify at increased risk for AKI: 1) Postoperative patients. 2) patients with decompensated heart failure undergoing surgery or PCI. 3) patients with severe hypovolemic shock due to either cardiologic causes (e.g AMI) or from other causes (e.g sepsis, hypertensive crisis) 4) patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation. * Identify the presence of genetic modifiers influencing the development and progression of CKD. * Evaluate the role of genetic polymorphism in the transition from hypertension to kidney disease. * Assess the role of salt intake in BP control and CKD progression either alone or in the presence of genetic modifiers. * Evaluate the role of protein intake restriction in CKD progression eitehr alone or in the presence of genetic modifiers. * Identify cortical bone lesions in CKD * Assess the role of genetic, nutritional and biochemical factors involved in the cortical bone development * Evaluate the role of genetic in the development of hypertension in patients who received allogenic bone marrow transplantation. The genetic polymorphisms that will be considered, based on current knowledge are: * Alpha, beta, gamma Adducin (ADD1, ADD2, ADD3), * Renin Angiotensin System (RAAS), * Glomerular proteins: nephrine, podocin, cadherin. * Renal tubular transport systems (Na-Cl cotransport, Na channel, lithium, Cl channel, K channel, Ca channel, Amino Acids, specialized tubular transporters ouabain, drugs, digoxin, aquaporins, ANP, BNP). * Genes linked to the metabolism and function of endogenous ouabain (eg LSS) and Klotho (eg KL). * Polycystin 1, polycystin 2 (PKD1 and PKD2), uromodulline, S. di Alport (COL4A3/COL4A4/COL4A5) For the study of any further genetic polymorphisms, additional amendments to this research protocol will be formulated. ### Conditions Module **Conditions:** - AKI - CKD - Ckd-Mbd - CKD (Chronic Kidney Disease) Stage 5D - ADPKD - Hypertension - Hematologic Malignancy - Bone Marrow Transplant Complications **Keywords:** - genetic in hypertensive kidney disease - salt intake in BP control and CKD progression - genetic in CKD - endogenous Ouabain as marker of AKI - protein intake restriction in CKD progression - hypertension in allogenic bone marrow transplantation ### Design Module #### Bio Spec **Description:** blood , urine and sample of renal tissue **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 10000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1. Patients with chronic nephropathies 2. Patients with acute nephropathy 3. Patients with nephrectomy 4. Candidate Patients to major surgery 5. Patients with decompensated heart failure undergoing either medical or surgical therapy 6. Acute critically ill patients (e.g sepsis, post-operative) 7. Patients with hypertension 8. Patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation. 9. Long-term surviving patients who received bone marrow transplantation. **Intervention Names:** - Genetic: genetic polymorphisms **Label:** Patients with acute or chronic nephropathy ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with acute or chronic nephropathy **Name:** genetic polymorphisms **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** eGFR value **Measure:** difference in glomerular filtration rate according to genetic profile **Time Frame:** from days to 35 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: . presence of specific renal disease Exclusion Criteria: * to be evaluated in the different sub-protocols **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This study will evaluate different groups of adult patients: 1. Patients with chronic nephropathy 2. Patients with acute nephropathy 3. Patients with nephrectomy 4. Candidate Patients to major surgery 5. Patients with decompensated heart failure undergoing either medical or surgical therapy 6. Acute critically ill patients (e.g sepsis, post-operative) 7. Patients with hypertension 8. Patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation. 9. Long-term surviving patients who received bone marrow transplantation. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lanzani.chiara@hsr.it **Name:** Chiara Livia Lanzani, prof **Phone:** +393408163279 **Role:** CONTACT **Contact 2:** **Email:** zagato.laura@hsr.it **Name:** Laura Zagato, biologist **Phone:** +390226435745 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** lanzani.chiara@hsr.it - **Name:** Chiara Lanzani, MD - **Phone:** +390226433891 - **Role:** CONTACT **Country:** Italy **Facility:** IRCCS Ospedale San Raffaele **Status:** RECRUITING **Zip:** 20132 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular 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: D000009369 - Term: Neoplasms - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000009371 - Term: Neoplasms by Site - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M21314 - Name: Hematologic Neoplasms - Relevance: HIGH - As Found: Hematologic Malignancies - ID: M20559 - Name: Disease Progression - Relevance: HIGH - As Found: Progression - ID: M14921 - Name: Chronic Kidney Disease-Mineral and Bone Disorder - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - 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: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019337 - Term: Hematologic Neoplasms - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000006973 - Term: Hypertension - ID: D000018450 - Term: Disease Progression ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416748 **Acronym:** LASH **Brief Title:** Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer **Official Title:** Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer #### Organization Study ID Info **ID:** LAcc & SHape - LASH trial #### Organization **Class:** OTHER **Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date **Date:** 2030-07-01 **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:** 2027-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **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:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party **Investigator Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS **Investigator Full Name:** Bizzarri Nicolò **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach. **Detailed Description:** The Laparoscopic Approach to Cervical Cancer (LACC) Trial showed that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. Since then, the standard of care in terms of surgical approach to radical hysterectomy has been considered the laparotomy. More recently, the SHAPE trial results were presented showing that in patients with low-risk cervical cancer (defined as FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \< 10 mm on LEEP/cone and \< 50% depth on MRI) simple hysterectomy was not inferior to radical hysterectomy for what concerned pelvic recurrence, with less complications and better quality of life. However, SHAPE trial was not designed to assess the surgical approach. The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria. ### Conditions Module **Conditions:** - Cervical Cancer - Cervix Cancer **Keywords:** - Cervical cancer - Minimally invasive surgery in cervical cancer - Robotic surgery in cervical cancer - Laparoscopic surgery in cervical cancer - LACC trial - SHAPE trial - Low risk cervical cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \< 10 mm on LEEP/cone and \< 50% depth on imaging) should undergo conization with surgical margins free from invasive disease or conization with involved surgical margins followed by MRI scan or expert ultrasound scan showing no residual disease. In case of residual disease at post conization imaging still fitting inclusion criteria, another conization is recommended. After these steps minimally invasive (laparoscopy or robotic) simple hysterectomy is performed with sentinel lymph node biopsy algorithm. Adjuvant therapy is given only in case of positive surgical margins, metastatic lymph nodes, and extensive LVSI with depth of stromal infiltration \>2/3. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 575 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \&amp;amp;lt; 10 mm on LEEP/cone and \&amp;amp;lt; 50% depth on imaging) should undergo conization with surgical margins free from invasive disease or conization with involved surgical margins followed by MRI scan or expert ultrasound scan showing no residual disease. In case of residual disease at post conization imaging still fitting inclusion criteria, another conization is recommended. After these steps minimally invasive (laparoscopy or robotic) simple hysterectomy is performed with sentinel lymph node biopsy algorithm. Adjuvant therapy is given only in case of positive surgical margins, metastatic lymph nodes, and extensive LVSI with depth of stromal infiltration over 2/3. **Name:** Minimally invasive simple hysterectomy **Other Names:** - simple hysterectomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** disease free survival at 3 years **Measure:** 3-year DFS **Time Frame:** 36 months after surgery #### Secondary Outcomes **Measure:** 3-year recurrence rate (including pelvic recurrence rate) **Time Frame:** 36 months after surgery **Measure:** 3-year overall survival **Time Frame:** 36 months after surgery **Measure:** intra-operative and post-operative complications **Time Frame:** 36 months after surgery **Measure:** Rate of upstage after surgery **Time Frame:** 36 months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma of uterine cervix * FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤10mm on conization specimen * FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤50% at pre-conization MRI-scan or "expert" US-scan. * Age ≥18 years Exclusion Criteria: * Neuroendocrine, clear cell, serous carcinoma * Depth of infiltration \>10 mm on conization specimen * Depth of infiltration \>50% at pre-conization imaging * Cervical tumor \>2 cm * Diagnosis on inadvertent hysterectomy * Neoadjuvant chemotherapy * Previous pelvic radiotherapy * Pregnant women * Contraindications to surgery * Lymph nodes \>15 mm short axis * Fertility sparing treatment or desire * Recurrent cervical cancer * Time between cervical cancer diagnosis and hysterectomy \>4 months if conization with tumor negative margins * Time between cervical cancer diagnosis and hysterectomy \>3 months if conization with invasive tumor positive margins **Gender Based:** True **Gender Description:** female patients meeting the inclusion criteria **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nicolo.bizzarri@yahoo.com **Name:** Nicolò Bizzarri, MD **Phone:** 0630155629 **Role:** CONTACT **Contact 2:** **Email:** matteopavone.21@gmail.com **Name:** Matteo Pavone, MD **Phone:** 0630155629 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Nicolò Bizzarri, MD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Giovanni Scambia, Prof. **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Denis Querleu, Prof. **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Francesco Fanfani, Prof. **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Anna Fagotti, Prof. **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Gabriella Ferrandina, Prof. **Role:** STUDY_CHAIR **Official 7:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Valerio Gallotta, MD **Role:** STUDY_CHAIR **Official 8:** **Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome **Name:** Luigi Pedone Anchora, MD **Role:** STUDY_CHAIR ### References Module #### References **Citation:** Plante M, Kwon JS, Ferguson S, Samouelian V, Ferron G, Maulard A, de Kroon C, Van Driel W, Tidy J, Williamson K, Mahner S, Kommoss S, Goffin F, Tamussino K, Eyjolfsdottir B, Kim JW, Gleeson N, Brotto L, Tu D, Shepherd LE; CX.5 SHAPE investigators; CX.5 SHAPE Investigators. Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer. N Engl J Med. 2024 Feb 29;390(9):819-829. doi: 10.1056/NEJMoa2308900. **PMID:** 38416430 **Citation:** Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31. **PMID:** 30380365 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - 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 ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - 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: M5825 - Name: Uterine Cervical Diseases - 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: D000002583 - Term: Uterine Cervical Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416735 **Acronym:** ADD-AMI **Brief Title:** Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant **Official Title:** Natriruetic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant #### Organization Study ID Info **ID:** ADD-AMI #### Organization **Class:** OTHER **Full Name:** Ospedale San Raffaele ### Status Module #### Completion Date **Date:** 2020-07-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-07-20 **Type:** ACTUAL #### Start Date **Date:** 2018-09-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2023-09-04 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ospedale San Raffaele #### Responsible Party **Investigator Affiliation:** Ospedale San Raffaele **Investigator Full Name:** Chiara Lanzani **Investigator Title:** medical doctor in nephrology unit, nephrologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label. **Detailed Description:** The study is carried out to evaluate primarily the difference in the activity of the renal transporter ENaC (through dosage of sodium) through its inhibition with a single dose of Amiloride in hypertensive patients characterized by the polymorphism of alpha Adducin rs496. It's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration ### Conditions Module **Conditions:** - Hypertension Essential - Salt Excess - Genetic Hypertension **Keywords:** - Hypertension - Salt ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The protocol involves a test of oral administration of a single dose of Amiloride (5 or 10 mg based on body weight) to 20 patients carrying the wild-type (GG) genotype of ADD1 rs4961 **Intervention Names:** - Drug: Amiloride **Label:** patients carrying the wild-type (GG) genotype of ADD1 rs4961 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The test involves the administration of a single dose of 5 or 10 mg of Amiloride to 20 hypertensive carriers of the T variant (GT or TT) **Intervention Names:** - Drug: Amiloride **Label:** patients carriers of variant T (GT or TT) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - patients carriers of variant T (GT or TT) - patients carrying the wild-type (GG) genotype of ADD1 rs4961 **Description:** administration of a single dose of 5 or 10 mg of Amiloride (based on body weight) After oral intake of the drug, the increase in sodium in the urine ends within 8 hours **Name:** Amiloride **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of sodium levels after oral administration of Amiloride **Measure:** Evaluate urinary sodium **Time Frame:** 3 hrs and 6 hrs #### Secondary Outcomes **Description:** Evaluation of potassium plasma levels after oral administration of Amiloride **Measure:** Evaluate potassium levels **Time Frame:** 3 hrs and 6 hrs **Description:** Evaluation of systolic blood pressure after oral administration of Amiloride **Measure:** Evaluation of systolic blood pressure **Time Frame:** 3 hrs and 6 hrs **Description:** Evaluation of diastolic blood pressure after oral administration of Amiloride **Measure:** Evaluation of diastolic blood pressure **Time Frame:** 3 hrs and 6 hrs ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * male patients aged 18-60 years; * naïve hypertensive patients: newly diagnosed, never previously treated for hypertension; * BMI\<30 Kg/m2, * documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg or diastolic BP \>=90 mmHg; * signature of the informed consent for participation in the study * patient who has already undergone genomic DNA sampling (accompanied by relative consent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT). Exclusion Criteria: known causes of secondary hypertension; * severe or malignant hypertension; history of renal artery disease; * significant renal disease (creatinine clearance less than 60 ml/min); * hyperkalemia (Kpl \> 6mEq/l) at enrollment visit; * hypercalcaemia (Ca pl \> 2.6 mmol/l) at enrollment visit; * symptomatic hyperuricemia (\> 7.5 mg/dl); * liver disease (transaminases greater than 3 times the normal value); * cardiac pathologies (myocardial infarction, atrial fibrillation, etc.); * diabetes (fasting blood sugar \>125mg/dl); * in therapy with statins, NSAIDs, systemic steroids; * known hypersensitivity to Amiloride or to any of the excipients; * patients unable to express a valid consent - **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Milan **Country:** Italy **Facility:** San Raffaele Hospital **State:** Lombardia **Zip:** 20132 ## Derived Section ### Condition Browse Module - Ancestors - 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: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension ### Intervention Browse Module - Ancestors - ID: D000004232 - Term: Diuretics - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000062646 - Term: Acid Sensing Ion Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000062686 - Term: Epithelial Sodium Channel Blockers - ID: D000062865 - Term: Diuretics, Potassium Sparing ### Intervention Browse Module - Browse Branches - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3925 - Name: Amiloride - Relevance: HIGH - As Found: Heart Valve - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000584 - Term: Amiloride ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416722 **Brief Title:** Telerehabilitation Dual-Task Training for Parkinson's: A Multidimensional Evaluation **Official Title:** Multidimensional Evaluation of the Effectiveness of Telerehabilitation-Based Dual-Task Training in Parkinson's Patients #### Organization Study ID Info **ID:** 28.03.2024/ 59 #### Organization **Class:** OTHER **Full Name:** Fenerbahce University ### Status Module #### Completion Date **Date:** 2025-06-01 **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:** 2024-12-01 **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:** Fenerbahce University #### Responsible Party **Investigator Affiliation:** Fenerbahce University **Investigator Full Name:** Ezgi Gul **Investigator Title:** MSc, PT, Research Asistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In this clinical study, the aim is to assess the effectiveness of telerehabilitation-based dual-task training in improving balance and gait function among individuals diagnosed with Parkinson's Disease. Parkinson's Disease is characterized by motor symptoms such as tremors and slowness of movement, as well as cognitive impairments. While medical treatments help manage symptoms, exercise programs are vital for enhancing physical and cognitive functions. Dual-task training involves combining motor and cognitive activities to enhance gait and balance control, and recent studies have shown its effectiveness in Parkinson's Disease rehabilitation. However, there's limited research on delivering dual-task training through telerehabilitation and determining the optimal content for maximum benefits. This project involves 30 Parkinson's Disease patients who will be randomly assigned to three groups receiving different dual-task exercise programs via telerehabilitation. Each program focuses on combining balance and functional exercises with either cognitive or motor secondary activities. The exercises will be performed three times a week for four weeks under the guidance of a physiotherapist via Zoom. Before and after the intervention, participants will be evaluated for feasibility, gait, balance, cognition, and activity levels. Researchers of this study hypothesize that telerehabilitation-based dual-task training will significantly improve balance and gait function in Parkinson's Disease patients, offering a convenient and effective treatment option to enhance their quality of life. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients included in this group will be given additional cognitive tasks. **Intervention Names:** - Other: Cognitive-Motor Dual Task Activities **Label:** Cognitive-Motor Dual Task Activities Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients included in this group will be given additional motor tasks. **Intervention Names:** - Other: Motor-Motor Dual Task Activities **Label:** Motor-Motor Dual Task Activities Group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Simultaneously with balance and large amplitude functional activities. **Intervention Names:** - Other: Cognitive-Motor & Motor-Motor Dual Task Activities **Label:** Cognitive-Motor & Motor-Motor Dual Task Activities Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cognitive-Motor Dual Task Activities Group **Description:** Patients included in this group will be given additional cognitive tasks (e.g. counting months, subtracting 5 from 100) in accordance with the physiotherapist's commands simultaneously with balance and large amplitude functional activities (such as stepping forward-sideways-backwards, sitting and standing). **Name:** Cognitive-Motor Dual Task Activities **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Motor-Motor Dual Task Activities Group **Description:** Patients included in this group will be given additional motor tasks (e.g. passing the ball from the right hand to the left hand while standing on a soft surface, clapping) in accordance with the physiotherapist's commands simultaneously with balance and large amplitude functional activities (such as stepping forward-sideways-backwards, sitting and standing). **Name:** Motor-Motor Dual Task Activities **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Cognitive-Motor & Motor-Motor Dual Task Activities Group **Description:** Simultaneously with balance and large amplitude functional activities (such as stepping forwards-sideways-backwards, sitting and standing), patients included in this group will be given additional cognitive (e.g. counting while standing with feet closed) and motor (e.g. passing the ball from the right hand to the left hand while standing on a soft surface) tasks in accordance with the physiotherapist's commands. **Name:** Cognitive-Motor & Motor-Motor Dual Task Activities **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The study's feasibility will be assessed through various measures. Firstly, we'll assess Participation Rate by calculating the ratio of attended sessions to the total. Participants will provide reasons for missed sessions, and their feedback will be recorded. After each session, participants will rate their fatigue on the Borg Perceived Exertion Scale, aiming to keep effort levels moderate (scores 12-17). To evaluate difficulty, participants will rate dual-task exercises on a Visual Analog Scale (0-10). Higher scores indicate greater difficulty, averaged over the study. Finally, at the end of the four-week program, participant satisfaction will be evaluated using a telerehabilitation-based exercise program questionnaire. **Measure:** Feasibility Assessment **Time Frame:** Baseline and after the interventions (4th week) **Description:** The Digit Span Test, consisting of forward and backward sequences, is administered separately. Each sequence comprises numbers with digits incrementing sequentially. Numbers are read aloud to the subject at a rate of one per second. Success in any trial prompts the initiation of the next trial. However, failure in both trials results in discontinuation of the test. The length of the last successfully repeated sequence determines the span range. **Measure:** Digit Span Test **Time Frame:** Baseline and after the interventions (4th week) **Description:** In the Mini-Mental State Examination, as part of the Attention and Calculation subsection, individuals are asked to subtract 7 repeatedly from 100, continuing until reaching 65. Those with five years of education or less who cannot complete this task are then asked to perform an alternative task: counting the days of the week starting from Sunday and counting backwards. In both assessments, one point is awarded for each correct operation. **Measure:** Mental Flexibility **Time Frame:** Baseline and after the interventions (4th week) **Description:** This test is based on saying as many words that are not proper nouns or verbs beginning with the letters F, A, S as possible in one minute. One minute is given for each letter. The total score is equal to the total number of words uttered in all letters. It measures verbal-phonemic fluency. In the standardisation study conducted in our country, the letters K, A, S were used. In this study, the total number of words will be evaluated. **Measure:** Word Fluency Test **Time Frame:** Baseline and after the interventions (4th week) **Description:** Kinovea® version 0.8.15 software will be utilized to obtain objective and quantitative data for spatiotemporal parameters of gait (stride length, double stride length, support surface, stride width, cadence, walking speed, step duration) and kinematic parameters of gait. In the study, a 3-meter walking distance of the subjects will be recorded with a camera placed in the sagittal plane. Coloured marks will be placed on the right and left heels, and these marks will be tracked and annotated on the video. The obtained videos will be observed, and the parameters of stride length (the distance between two consecutive heel strikes of one limb and the other limb) and double stride length (the distance between two consecutive heel strikes of the same limb) will be analyzed independently with Kinovea motion analysis software. **Measure:** Gait Assessment **Time Frame:** Baseline and after the interventions (4th week) **Description:** The Mini-BEST test, which will be used for dynamic balance assessment, is a 14-item balance scale and evaluates postural reactions, sensory orientation and dynamic walking sub-parameters. In the last part, it allows the assessment of dual-task performance within the scope of the Forced-Reach-Walk Test (with Cognitive Loading). Each item in the test is scored between (0-2); a score of 0 indicates that the person is unable to perform the task, while a score of 2 is normal. The total score will be between 0 and 28. The total score reflects the balance ability. Higher scores mean better balance ability. It is a valid and reliable measurement method that requires approximately 15 minutes to complete, is one-dimensional and valid for use in Parkinson's Disease. **Measure:** Mini-BEST Test **Time Frame:** Baseline and after the interventions (4th week) **Description:** The four-step square test is a clinical assessment used to evaluate the ability to change direction while stepping, particularly focusing on dynamic balance and mobility. During the test, the patient starts in the upper left square (Square 1) and faces Square 2. The step sequence initially moves clockwise: Square 1, then Squares 2, 4, and 3. Subsequently, the sequence reverses, moving anti-clockwise: Square 3, followed by Squares 4, 2, and back to Square 1. The physiotherapist demonstrates the test, allowing the patient to practice and learn the sequence. If the patient cannot complete the sequence successfully, loses balance, or touches a support cane, the test is repeated. Two scores are obtained, and the better of the two scores is recorded. Timing begins when the patient's first foot touches the floor in Square 2 and ends when their second foot touches the floor in Square 1. The shorter the time, the better the result for this test. **Measure:** Four-step square test **Time Frame:** Baseline and after the interventions (4th week) **Description:** KFORCE Plates are a type of force platform utilized to objectively measure postural control parameters. These plates enable the assessment of both static and dynamic balance across a broad spectrum of movements. Consisting of two independent plates, they have the capability to determine weight distribution during the stance phase and calculate the center of gravity. KFORCE Plates evaluate various positions such as standing, single-leg stance, and squatting, providing a comprehensive report with multiple data points post-assessment. This assessment will significantly enhance the project by offering objective data on changes in postural control following exercise interventions and allowing for a more detailed interpretation compared to scale-based assessments. **Measure:** Postural Stability Assessment **Time Frame:** Baseline and after the interventions (4th week) **Description:** Parkinson's Activity Scale, a scale developed to evaluate functional activities in Parkinson's Disease, provides information about the transfer status of patients. Scored between 0 and 4 points, a high score indicates good performance. The scale has subdivisions including getting up from a chair, in-bed mobilisation and gait akinesia. In this study, it will be used to evaluate the functional activity status of the patients. High score indicates good functional performance. **Measure:** Parkinson's Activity Scale **Time Frame:** Baseline and after the interventions (4th week) **Description:** The Dual Task Questionnaire consists of 10 questions designed to assess the frequency of difficulties associated with daily tasks involving dual tasking. It is used to measure how often individuals have problems with the content of the questionnaire. In response to the questions, individuals are asked to choose from five options ranging from very often to never or not applicable (5-point scale, using a 0-4 scale). The resulting score is divided by 10 for an average rating per question. **Measure:** Dual Task Questionnaire **Time Frame:** Baseline and after the interventions (4th week) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosed with idiopathic Parkinson's Disease * Stage 1-3 on the Hoehn-Yahr scale * A minimum score of 21 on the Montreal Cognitive Assessment Scale test * Stable drug treatment within the last 1 month * Patients are in the "On" period * Ability to walk independently on level ground (3 and above according to Functional Ambulation Classification) Exclusion Criteria: * Serious hearing or vision problems * Having other neurological, cardiovascular or orthopaedic disorders that may prevent walking * Any other neurological disorder (e.g. dementia, cerebrovascular disease) * less than 5 years of education * To have vascular lower extremity pathologies * Not having internet access via smartphone or computer **Maximum Age:** 75 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fzt.ezgigul@gmail.com **Name:** Ezgi Gul, MSc, Pt, Research Assistant **Phone:** 05071180878 **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 - 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:** NCT06416709 **Brief Title:** Stem Cell Treatment for Lung Injury Caused by Major Infectious Diseases **Official Title:** To Study the Clinical Treatment Plan of Lung Injury Caused by Major Infectious Diseases Treated With Stem Cells #### Organization Study ID Info **ID:** KY-2023-2-6-2 #### Organization **Class:** INDUSTRY **Full Name:** Cell Energy Life Sciences Group Co. LTD ### Status Module #### Completion Date **Date:** 2026-05-10 **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:** 2026-05-10 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-10 **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:** Beijing 302 Hospital #### Lead Sponsor **Class:** INDUSTRY **Name:** Cell Energy Life Sciences Group Co. LTD #### 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 study is to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for Lung injury caused by major infectious diseases. **Detailed Description:** For patients with lung injury caused by major infectious diseases, conventional antiviral and anti-inflammatory treatments may not effectively improve lung function in the short term and may increase the risk of secondary infections. Therefore, in the clinical management of viral pneumonia, it is necessary to consider the lung tissue damage caused by acute viral replication and systemic immune stress, while also focusing on the subsequent lung functional impairment due to virus clearance-induced pulmonary fibrosis. Studies have shown that after peripheral intravenous administration of mesenchymal stem cells (MSCs), approximately 50% to 60% of the cells remain in the lung tissue within 1 hour, decreasing to around 30% after 3 hours. After 48 hours, MSCs tend to aggregate in the liver and spleen, and cell retention can still be detected 10 days later. MSCs aggregation in the lung tissue can secrete cell trophic factors such as keratinocyte growth factor (KGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF), promoting the regeneration of type II alveolar epithelial cells, improving the pulmonary microenvironment, and facilitating the repair of the alveolar epithelial barrier after ARDS injury.This study is intended to conduct a prospective, double-blind, randomized placebo-controlled clinical trial to investigate the safety and efficacy of mesenchymal stem cells treatment for Lung injury caused by major infectious diseases. ### Conditions Module **Conditions:** - Lung Injury ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** saline is used as placebo in the placebo comparator group **Intervention Names:** - Other: saline **Label:** placebo control use saline **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Mesenchymal stem cell dose is 5×10\*7/10ml and is transplanted by intravenous infusion. The cells are used once every three days and for three times. **Intervention Names:** - Drug: mesenchymal stem cells **Label:** mesenchymal stem cells treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - mesenchymal stem cells treatment **Description:** Mesenchymal stem cell dose is 5×10\*7/10ml and is transplanted by intravenous infusion. The cells are used once every three days and for three times **Name:** mesenchymal stem cells **Other Names:** - KY-2023-2-6-2 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - placebo control use saline **Description:** 10 ml saline is used as placebo once every three days and for three times **Name:** saline **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Investiagte the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after MSCs infusion. **Measure:** Number of participants with side effects in MSCs treatment groups **Time Frame:** 48 weeks **Description:** at week 2, evaluate high-resolution CT imaging changes in lung lesions and compare with baseline **Measure:** High-resolution CT imaging **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years old; 2. Understand and sign the informed consent form, comply with the relevant requirements of this study, and agree not to participate in other studies and not to receive other immunotherapy during the study participation; 3. meet the diagnosis of viral pneumonia and are in the advanced stage of disease: (1)The etiological diagnosis met any of the following criteria: ①Sars-cov-2 infection: Respiratory specimens (nasal/throat swabs or bronchial secretions/bronchoalveolar lavage fluid) were positive for Sars-cov-2 nucleic acid and/or antigen within 14 days; ②Adenovirus infection: positive for adenovirus nucleic acid and/or antigen in respiratory secretions or blood within 14 days; ③Influenza virus infection: positive respiratory secretions or blood for influenza virus nucleic acid and/or antigen within 14 days; ④Other respiratory virus antigens or nucleic acids were positive in respiratory secretions or blood within 14 days; (2)Imaging manifestations: chest X-ray or CT was consistent with the imaging features of viral pneumonia, manifested as multiple patchy shadows, ground glass shadows or consolidation in both lungs; (3)Respiratory System Indicators:Respiratory distress, respiratory rate (RR) ≥30 breaths/min at rest; In the resting state, oxygen saturation of finger pulse was ≤93% while breathing air; Oxygen and index (partial pressure of arterial oxygen/fraction of inspired oxygen) ≤300mmHg and \> 200mmHg; 4. Invasive mechanical ventilation and vasopressor medications were not required. Exclusion Criteria: 1. Patients tested active for HBV, HCV, HIV, or tuberculosis at the time of screening; 2. patients with solid tumors, leukemia or mental disorders; 3. The peripheral white blood cell count was still more than 12×109/L or less than 4×109/L after effective anti-infective treatment. Plasma C-reactive protein \>2 times the upper limit of normal; Plasma procalcitonin \>2 times the upper limit of normal; 4. There were severe complications or major organ complications: severe cardiovascular and cerebrovascular diseases: acute heart failure NYHAⅢ; uncontrolled myocarditis or valvular disease; malignant arrhythmia; incident (≤6 months) cardio-cerebrovascular events (myocardial infarction or stroke); previous chronic bronchitis, severe asthma, obstructive pulmonary emphysema, pulmonary fibrosis, and other diseases that require long-term oxygen therapy or affect daily activities; patients with acute renal failure (≥44.2 μmol/L daily increase in serum creatinine) or chronic renal insufficiency had serum creatinine ≥442 μmol/L; the liver function was markedly abnormal and ALT≥5×ULN; serum TBil≥10×ULN or daily increase ≥17.1 μmol/L; signs of bleeding, PTA≤ 40% (or INR≥1.5); severe anemia (Hb\<60g/L), moderate or severe thrombocytopenia (PLT\<60×109/L), and DIC; other conditions that the investigators thought might affect treatment effectiveness. 5. Unwillingness to sign informed consent forms; 6. Evidence of drug addiction within 6 months before trial entry; 7. Patients who are currently enrolled in other clinical trials and may violate this treatment regimen and observation indicators; 8. Unable or unwilling to provide informed consent or to comply with the study requirements; 9. Other serious conditions that may preclude the clinical trial. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xuzhe302@139.com **Name:** Zhe Xu, Dr **Phone:** 86 150 0111 1836 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** fswang302@163.com - **Name:** Fu-Sheng Wang, Doctor - **Phone:** 8610-13671005510 - **Role:** CONTACT ***Contact 2:*** - **Name:** Fu-Sheng Wang, Doctor - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Beijing 302 Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Beijing 302 Hospital **Name:** Fu sheng Wang, Dr **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000013898 - Term: Thoracic Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M28143 - Name: Lung Injury - Relevance: HIGH - As Found: Lung Injury - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M22700 - Name: Disease Attributes - 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: M16657 - Name: Thoracic Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000055370 - Term: Lung Injury - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416696 **Brief Title:** Toripalimab for High-risk Locally Advanced Cervical Cancer **Official Title:** Toripalimab Combined With Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk Locally Advanced Cervical Cancer: the Phase II Single-arm TorCH -CC Study #### Organization Study ID Info **ID:** TorCH-CC #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### 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:** 2024-05-11 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-09 **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 #### 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:** SHUANGZHENGJIA **Investigator Title:** Attending Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This phase II clinical study assesses the efficacy and safety of Toripalimab combined with chemoradiotherapy (CRT) followed by Toripalimab maintenance in treating high-risk locally advanced cervical cancer (HR-LACC). Despite CRT being the standard treatment, HR-LACC patients face poor survival outcomes. Toripalimab, a cost-effective PD-1 inhibitor, has shown promise in prior research. The primary endpoint is 2-year progression-free survival, with the study aiming to improve treatment accessibility and patient prognoses in China. **Detailed Description:** Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. Nevertheless, the high cost of pembrolizumab poses a significant barrier for patients in China. Toripalimab, the first domestically approved PD-1 inhibitor in China, has shown good safety and efficacy in previous studies and is more affordable. This phase II, single-arm, open-label study aims to evaluate the efficacy and safety of Toripalimab combined with CRT followed by Toripalimab maintenance therapy in 130 patients with stages III-IVA cervical cancer. The primary endpoint is the 2-year PFS. The study is expected to contribute to the implementation of precision and personalized treatment for HR-LACC in China, with the potential to improve patient survival rates and quality of life. ### Conditions Module **Conditions:** - Cervical Cancers ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy for High-risk Locally Advanced Cervical Cancer **Intervention Names:** - Drug: Toripalimab **Label:** Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy **Description:** 1. Radiotherapy: Both external beam and brachytherapy, with radiation therapy techniques, target delineation, prescribed doses, and organ-at-risk constraints following established guidelines. 2. Chemotherapy: The preferred regimen is cisplatin at a dose of 40mg/m\^2 administered intravenously once weekly for 5-6 cycles; for patients intolerant to cisplatin or with renal impairment, carboplatin (AUC=2) may be considered, also administered once weekly. 3. Toripalimab concurrent immunotherapy: Following the regimens of phase III RCTs such as JUPITER-02, JUPITER-06, CHOICE-01, NEOTORCH, and RENOTORCH, Toripalimab is administered at a fixed dose of 240mg per infusion, given intravenously once every 3 weeks for three doses. 4. The concurrent chemoradiotherapy and immunotherapy phase does not exceed 8 weeks in duration. **Name:** Toripalimab **Other Names:** - Radiotherapy - Chemotherapy(cisplatin) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** 2-year progression-free survival (PFS) rate as assessed by the investigator **Measure:** progression-free survival (PFS) **Time Frame:** 2 year #### Secondary Outcomes **Description:** ORR Duration of efficacy (DoR) **Measure:** short-term efficacy assessment **Time Frame:** 30 days (±7 days) and 90 days (±7 days) after the last dose **Description:** Treatment-related Side Effects (TRAEs) and immune-related Side Effects (iRAEs) **Measure:** side effects **Time Frame:** 30 days (±7 days) and 90 days (±7 days) after the last dose **Description:** 2 years of investigator evaluation -OS and PFS, OS **Measure:** OS **Time Frame:** 2 years **Description:** quality of life assessments utilizing the EORTC QLQ-C30 v3.0 **Measure:** quality of life assessments **Time Frame:** 30 days (±7 days) and 90 days (±7 days) after the last dose ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 2. FIGO 2018 staging criteria classifying the disease as stages III-IVA. 3. Age range from 18 to 70 years inclusive. 4. No prior receipt of surgery, radiotherapy, or systemic anticancer therapy for the treatment of cervical cancer. 5. No previous exposure to the study drug. 6. Presence of at least one measurable or evaluable lesion as per RECIST version 1.1, with the measurable lesion exhibiting a longest diameter of ≥10 mm on spiral CT scan or a shortest diameter of ≥15 mm for enlarged lymph nodes, which has not been previously irradiated. 7. Absence of central nervous system diseases, both primary and metastatic. 8. WHO/ECOG performance status score of 0-1. 9. Anticipated survival duration of at least 12 weeks. 10. Adequate organ function within the following parameters (without the use of any blood components, cytokines, or growth factors within 14 days prior to randomization): 1. Absolute neutrophil count (ANC) ≥1.5×10\^9/L 2. Platelet count ≥90×10\^9/L 3. Hemoglobin level ≥90 g/L 4. Serum albumin level ≥30 g/L 5. Bilirubin level ≤1.5 times the upper limit of normal (ULN) 6. Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≤3×ULN 7. Serum creatinine level ≤1.5×ULN 8. Thyroid-stimulating hormone (TSH) level ≤1×ULN (with eligibility also extended to patients with free triiodothyronine \[FT3\] or free thyroxine \[FT4\] levels ≤1×ULN). 11. For women of childbearing potential not undergoing surgical sterilization, a negative serum pregnancy test (hCG) within 72 hours prior to study randomization is required; breastfeeding must be absent. Additionally, the use of a medically approved contraceptive method is mandatory from the time of informed consent through the study treatment period and for 120 days following the final administration of the trial medication or 180 days after the last chemotherapy/radiotherapy session. Participants must also agree not to donate eggs for reproductive purposes or to freeze/preserve eggs for this use during the aforementioned period. 12. Provision of a tumor tissue biopsy specimen is mandatory. 13. Informed consent must be obtained with documentation. 14. Availability for follow-up assessments. Exclusion Criteria: * 1. Known hypersensitivity to any component of the study medication. 2. Participation in other clinical trials, with a washout period of less than 4 weeks following completion. 3. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 monoclonal antibodies. 4. Patients requiring immunosuppressive pharmacotherapy. 5. Individuals requiring systemic or absorbable topical corticosteroids at immunosuppressive doses. Use of prednisone at a dosage greater than 10mg/day or equivalent is prohibited within two weeks of study drug administration. 6. Presence of active autoimmune diseases or a history thereof, excluding vitiligo, resolved childhood asthma, or resolved atopic diseases. Patients with asthma requiring intermittent bronchodilator therapy or other interventions are also excluded. 7. Active infectious processes necessitating antimicrobial therapy, including the use of antibacterial, antiviral, or antifungal agents. 8. History of immunodeficiency, including HIV seropositivity or other acquired and congenital immunodeficiency disorders. 9. Uncontrolled cardiac symptoms or diseases, such as NYHA class II or higher heart failure, unstable angina, myocardial infarction within the past year, atrial fibrillation, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, PR interval greater than 250 ms, or QTc interval ≥470 ms. 10. A history of arterial or venous thromboembolic events within the past 6 months. 11. Poorly controlled hypertension despite antihypertensive therapy (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg). 12. Proteinuria of 2+ or higher and a 24-hour urinary protein excretion exceeding 1.0 g. 13. Coagulopathy (INR \>2.0, PT \>16 seconds), a bleeding diathesis, or concurrent anticoagulation or thrombolytic therapy. 14. Bilateral hydronephrosis, unless resolved by unilateral stent placement or percutaneous nephrostomy, or deemed mild and without clinical significance by the investigator. 15. Contraindications to chemotherapy administration. 16. Contraindications to receiving brachytherapy. 17. History of other malignancies within the past 5 years, except for basal cell carcinoma and squamous cell carcinoma of the skin. 18. Administration of live vaccines within 4 weeks preceding the first dose of the trial medication. Inactivated seasonal influenza vaccines are permissible. 19. History of substance abuse that has not been successfully managed or presence of psychiatric disorders that may interfere with study participation. 20. Any medical, psychiatric, or social conditions deemed by the investigator to potentially impact the subject's ability to provide informed consent, participate fully in the study, or affect the interpretability of the study results. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jiashuangzheng@cicams.ac.cn **Name:** Shuangzheng Jia, Ph D **Phone:** 00-86-010-87788276 **Role:** CONTACT **Contact 2:** **Email:** jiashuangzheng@cicams.ac.cn **Name:** SHUANGZHENG JIA **Phone:** 00-86-010-87788276 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Name:** SHUANGZHENG JIA - **Role:** CONTACT **Country:** China **Facility:** Cancer Hospital, Chinese Academy of Medical Sciences **State:** Beijing **Status:** RECRUITING **Zip:** 100021 #### Overall Officials **Official 1:** **Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Name:** SHUANGZHENG JIA **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - 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 ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - 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: M5825 - Name: Uterine Cervical Diseases - 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: D000002583 - Term: Uterine Cervical Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: HIGH - As Found: High - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002945 - Term: Cisplatin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416683 **Acronym:** ABCHCaen **Brief Title:** Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma (ABCHCaen) **Official Title:** Study of the Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma. #### Organization Study ID Info **ID:** ABCHCaen #### Organization **Class:** OTHER **Full Name:** University Hospital, Caen ### Status Module #### Completion Date **Date:** 2024-01-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-11 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Start Date **Date:** 2021-01-01 **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 #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Caen #### Responsible Party **Investigator Affiliation:** University Hospital, Caen **Investigator Full Name:** Isabelle OLLIVIER **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 France primary liver cancers (PLC) is the fourth leading cause of cancer-related death in men, and the seventh in women. The number of new cases per year is predicted to increase by 26.5% between 2020 and 2040. Hepatocellular carcinoma (HCC) account for 75% to 85% of PLC. It occurs mostly on cirrhotic livers. Diagnosis remains late in almost half of the patients so that a palliatif treatment is frequent. In advanced cases sorafenib has been so far the first line systemic therapy since 2008. In 2020 a phase 3 study has demonstrated a better overall survival in patients treated with bevacizumab associated with atezolizumab as compared to sorafenib (19.2 months vs 13.4 months) and a better quality of life. Noweday immunotherapy is recommended in first line in cases of ECOG 0/1 unresectable HCC without liver insufficiency. However the study included 70% of viral liver diseases while HCC are related to alcohol and steatohepatitis in 50% of cases in France. Moreover patients with high risk of oesophageal variceal bleeding were excluded. Recent real life data published worldwide confirm the bitherapy efficacy and good tolerability. By contrast french data are scarces, with a single serie of 43 patients in which median overall survival was estimated to 12 months. Our main aim is to determine the overall survival of HCC patients treated with atezolizumab and bevacizumab in Caen from april 2021. ### Conditions Module **Conditions:** - Atezolizumab and Bevacizumab in Hepatocellular Carcinoma **Keywords:** - hepatocellular carcinoma - immunotherapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 109 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Overall survival in patients with hepatocellular carcinoma **Measure:** Overall survival **Time Frame:** 3 years #### Secondary Outcomes **Description:** progression-free survival in patients with hepatocellular carcinoma **Measure:** progression-free survival **Time Frame:** 3 years **Description:** predictors of response to Atézolizumab and Bevacizumab **Measure:** predictors of response to treatment **Time Frame:** 3 years **Description:** treatment tolerance to Atézolizumab and Bevacizumab **Measure:** treatment tolerance **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age superior or equal to 18 years * patients with advanced hepatocellular carcinoma * treatment validated in multidisciplinary consultation meeting Exclusion Criteria: * patients with another kind of liver cancer **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients with advanced hepatocellular carcinoma whose treatment with Atezolizumab and Bevacizumab has been validated in a multidisciplinary consultation meeting ### Contacts Locations Module #### Locations **Location 1:** **City:** Caen **Country:** France **Facility:** CHU de Caen **State:** France/Normandie **Zip:** 14000 ## 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 ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M246 - Name: Bevacizumab - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M349417 - Name: Atezolizumab - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416670 **Brief Title:** Skilled Nursing Facility Care at Home **Official Title:** Skilled Nursing Facility Care at Home: A Randomized Controlled Trial #### Organization Study ID Info **ID:** 2024P000266 #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital ### Status Module #### Completion Date **Date:** 2026-01 **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:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **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 #### Collaborators **Class:** OTHER **Name:** Boston Medical Center **Class:** OTHER **Name:** Cambridge Health Alliance #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** David Levine **Investigator Title:** Associate Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** We will perform a parallel-group multicenter patient-level randomized controlled evaluation of skilled nursing facility care at home. Patients typically referred to a skilled nursing facility following hospitalization will be eligible for enrollment. Instead of admission to a skilled nursing facility, participants will receive care from a technology-enabled team in their own homes or will be allocated to receive care in a traditional skilled nursing facility setting. ### Conditions Module **Conditions:** - Skilled Nursing Facility - Rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Control subjects will receive care at a skilled nursing facility as per usual. **Label:** Usual skilled nursing facility care **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Intervention subjects will receive care in their home from a specialized care team. **Intervention Names:** - Other: Skilled nursing facility care at home **Label:** Rehab at home **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Rehab at home **Description:** Skilled nursing facility care at home delivers a range of advanced rehabilitation services in patients' homes, enabling care at home despite requiring intensive rehabilitative care. Our approach blends personalized, high-level professional care with innovative technology applications to ensure adequate rehabilitation. **Name:** Skilled nursing facility care at home **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Subtract the patient's activities of daily living at discharge from rehab from the patient's activities of daily living on admission to rehab. **Measure:** Change in activities of daily living between admission to rehab and discharge from rehab **Time Frame:** Admission to rehab until discharge from rehab, no more than 6 months #### Secondary Outcomes **Description:** The percentage of time a patient is supine per day, as measured by their wrist-worn accelerometer. **Measure:** Percent time supine per day **Time Frame:** Admission to rehab until discharge from rehab, no more than 6 months **Description:** The percent difference in direct cost of care to deliver rehab care. **Measure:** Total direct medical expenditure **Time Frame:** Admission to rehab until discharge from rehab, no more than 6 months **Description:** The Picker patient experience questionaire-15 **Measure:** Patient experience with care **Time Frame:** Admission to rehab until discharge from rehab, no more than 6 months **Description:** The percentage of patients who are readmitted or deceased within 30-days of discharge from rehab. **Measure:** 30-day readmission or 30-day mortality **Time Frame:** Discharge from rehab until 30-days later, no more than 30-days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \>=18 years old * Requires SNF PAC care following hospitalization, as determined by the inpatient team (requires documented rehabilitative therapy recommendation) * Community-dwelling before hospitalization * Likely to return to community-dwelling status following short-term rehabilitation as determined by RAH liaison * Lives within 10 miles of any study site hospital (or per specified catchment) * Surgical trauma and elective patients (weight bearing as tolerated and transfer with no more than one-person assist) * Neurology patients - Stroke (needs acute rehabilitation, but insurance will not cover, so bound for SNF. Does not meet acute rehabilitation criteria and does not need long-term placement) Exclusion Criteria: * Environmental * Undomiciled * No working heat (October-April), no working air conditioning if forecast \> 80°F, or no running water * In police custody * Resides in a facility that does not allow advanced on-site care * Domestic violence screen positive * Weapons that cannot be appropriately secured * Difficulty accessing the bathroom (unless there is space for a bedside commode where the patient sleeps or if the patient is entirely dependent on toileting) * Home has insufficient accessible space to sleep, eat, and perform rehabilitative therapy * Home lacks sufficient kitchen facilities to either cook or heat meals * Patient, or patient's family caregiver, unable to communicate via telephone * Patient, or patient's family caregiver, lacks consistent access to a telephone * Clinical * Requires more than one assist (unless the family can provide additional 24/7 assistance) * Requires care of new ostomy or teaching ostomy care * Requires frequent suctioning, tracheostomy, and ventilator needs * Requires total parenteral nutrition * Requires nasogastric tube feeds * Requires durable medical equipment not already in place at home and excluded below * Requires daily subcutaneous injection unless patient or family caregiver is teachable and able to administer daily * Acute delirium noted by RAH liaison requiring more than one caregiver * Active psychiatric diagnosis without an adequate treatment plan * On methadone requiring daily pickup of medication * Requires administration of intravenous controlled substances * Requires administration of specialty medications not already in place at home * Requires transfusion of blood products * Requires three times weekly or more transfers back and forth to obtain specialty medical care * Requires hemodialysis * Orthopedic trauma and elective patients * Traumatic brain injury * Wound or appliance care that requires daily nursing care * For spine trauma: neurologic deficits requiring more than one assist * Neurology patients * PRESS score (for ischemic stroke; use PRESS app): no return to pre-stroke diet \> 50% * FUNC score (for primary intracerebral hemorrhage only): \<75% probability of functional independence at 90 days * ASTRAL score (for ischemic stroke only and patients with pre-stroke independence \[Modified Rankin Scale 0-2\]): \<75% probability of a 90-day poor functional outcome (Modified Rankin Scale result of 3-6) * RAH census is full **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dmlevine@bwh.harvard.edu **Name:** David M Levine, MD, MPH, MA **Phone:** 617-732-7063 **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:** NCT06416657 **Brief Title:** General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter **Official Title:** General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial #### Organization Study ID Info **ID:** dragontiger #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2025-06-01 **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:** 2025-01-01 **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:** 2024-05-08 **Study First Submit QC Date:** 2024-05-11 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ming Lv #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Ming Lv **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement. ### Conditions Module **Conditions:** - Intracranial Aneurysm **Keywords:** - Unruptured intracranial aneurysm - Flow diverter - General anesthesia - Local anesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Researchers responsible for outcome assessment are unaware of the allocation of anesthesia modalities, but anesthesiologists and neurosurgeons are aware of the allocation of anesthesia modalities because they need to be involved in the safe administration of general or local anesthesia and related medical care. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 188 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation. **Intervention Names:** - Other: Different anesthesia methods, namely local anesthesia and general anesthesia **Label:** Local anesthesia group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants. **Intervention Names:** - Other: Different anesthesia methods, namely local anesthesia and general anesthesia **Label:** General anesthesia group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - General anesthesia group - Local anesthesia group **Description:** Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation. Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants. **Name:** Different anesthesia methods, namely local anesthesia and general anesthesia **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability) **Measure:** Good neurologic status **Time Frame:** 90 days after intervention #### Secondary Outcomes **Description:** Determination was based on DWI sequences of cranial MRI **Measure:** Newly developed cerebral ischemic foci **Time Frame:** Within 48 hours of flow diverter placement **Description:** Cognitive functioning status assessed by the Montreal Cognitive Assessment (MoCA). The MoCA was developed by Prof. Nasreddine in 2004 as a rapid screening tool for mild cognitive impairment.The MoCA has a total score of 30, with a minimum score of 0. Higher scores indicate better cognitive functioning. By scoring each domain, more detailed information can be obtained to determine the extent of deficits and abnormalities in cognitive functioning. In general, a score of 26 and above can be considered normal cognitive functioning, while a score below 26 may indicate the presence of cognitive impairment or dementia. 18-26 is considered mild cognitive impairment, 10-17 is considered moderate cognitive impairment, and \<10 is considered severe cognitive impairment. **Measure:** Status of cognitive function **Time Frame:** 90 days after intervention **Description:** The perioperative period is defined as up to 7 days after the intervention **Measure:** Postoperative perioperative complication rate **Time Frame:** 7 days after intervention **Description:** Overall complication rate at 90 days postoperatively **Measure:** Overall complication rate at 90 days postoperatively **Time Frame:** 90 days after intervention **Description:** Mortality at 90 days post-intervention **Measure:** Mortality at 90 days post-intervention **Time Frame:** 90 days after intervention **Description:** For patient safety, patients in LA will be referred to GA if they develop the following conditions a) The patient becomes comatose and unconscious; b) Glasgow coma scale (GCS) \<8; c) EtCO2 ≥ 60 mmHg or SpO2 \< 94% despite supplemental oxygen; d) Patient has vomiting, vertigo, agitation that is not controlled by antiemetics and sedation; e) Seizures; f) Complications of endovascular therapy, such as intracerebral hemorrhage from a ruptured aneurysm or SAH. **Measure:** Proportion of local anesthesia converted to general anesthesia during interventional procedures **Time Frame:** Immediately after intervention **Description:** Record the above times in the immediate postoperative period **Measure:** Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time **Time Frame:** Immediately after surgery **Description:** Assessment of aneurysm occlusion status using O'Kelly-Marotta (OKM) grading **Measure:** Rate of complete occlusion of aneurysms **Time Frame:** One year after intervention **Description:** Incidence of intraoperative vasospasm **Measure:** Incidence of intraoperative vasospasm **Time Frame:** Immediately after surgery **Description:** Measured with a VAS ranging from 0 (no pain) to 10 (intolerable) **Measure:** Pain scores at 12 hours postoperatively **Time Frame:** 12 hours after intervention **Description:** Pain medication use within 24 hours after surgery **Measure:** Pain medication use within 24 hours after surgery **Time Frame:** 24 hours after intervention **Description:** Length of hospitalization **Measure:** Length of hospitalization **Time Frame:** Until the patient was discharged from the hospital, an average of 1 week. **Description:** Hospitalization costs **Measure:** Hospitalization costs **Time Frame:** Until the patient was discharged from the hospital, an average of 1 week. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years old and ≤75 years old, gender is not limited; 2. Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA; 3. UIA maximum diameter \&lt;15mm; 4. Baseline mRS score ≤2; 5. Patients voluntarily participated in this study and signed an informed consent form. Exclusion Criteria: 1. The patient\&#39;s aneurysm is located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery; 2. Cases treated with coils assisted therapy 3. Those who are allergic to any components of the anesthetic drugs; 4. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3; 5. Pregnant and lactating female patients; 6. Patients with severe renal disease resulting in renal insufficiency (glomerular filtration rate \&lt;30ml/(min﹒1.73m2)); 7. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.); 8. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination; 9. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year; 10. Patients who are participating in clinical trials of other drugs or devices; 11. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** donglinggen@163.com **Name:** Linggen Dong, MD **Phone:** 18844738529 **Role:** CONTACT **Contact 2:** **Email:** dragontiger@163.com **Name:** Ming Lv, Ph D. **Phone:** 13701376177 **Role:** CONTACT ### References Module #### References **Citation:** Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14. **PMID:** 33447904 **Citation:** Rangel-Castilla L, Cress MC, Munich SA, Sonig A, Krishna C, Gu EY, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Feasibility, Safety, and Periprocedural Complications of Pipeline Embolization for Intracranial Aneurysm Treatment Under Conscious Sedation: University at Buffalo Neurosurgery Experience. Neurosurgery. 2015 Sep;11 Suppl 3:426-30. doi: 10.1227/NEU.0000000000000864. **PMID:** 26284351 **Citation:** Griessenauer CJ, Shallwani H, Adeeb N, Gupta R, Rangel-Castilla L, Siddiqui AH, Levy EI, Boone MD, Thomas AJ, Ogilvy CS. Conscious Sedation Versus General Anesthesia for the Treatment of Cerebral Aneurysms with Flow Diversion: A Matched Cohort Study. World Neurosurg. 2017 Jun;102:1-5. doi: 10.1016/j.wneu.2017.02.111. Epub 2017 Mar 6. **PMID:** 28279774 **Citation:** Simonsen CZ, Sorensen LH, Juul N, Johnsen SP, Yoo AJ, Andersen G, Rasmussen M. Anesthetic strategy during endovascular therapy: General anesthesia or conscious sedation? (GOLIATH - General or Local Anesthesia in Intra Arterial Therapy) A single-center randomized trial. Int J Stroke. 2016 Dec;11(9):1045-1052. doi: 10.1177/1747493016660103. Epub 2016 Jul 12. **PMID:** 27405859 **Citation:** Kilic Y, Bas SS, Aykac O, Ozdemir AO. Nonoperating Room Anesthesia for Interventional Neuroangiographic Procedures: Outcomes of 105 Patients. J Stroke Cerebrovasc Dis. 2020 Feb;29(2):104495. doi: 10.1016/j.jstrokecerebrovasdis.2019.104495. Epub 2019 Dec 2. **PMID:** 31806453 **Citation:** Siddiqui AH, Kan P, Abla AA, Hopkins LN, Levy EI. Complications after treatment with pipeline embolization for giant distal intracranial aneurysms with or without coil embolization. Neurosurgery. 2012 Aug;71(2):E509-13; discussion E513. doi: 10.1227/NEU.0b013e318258e1f8. **PMID:** 22710418 **Citation:** Park MS, Albuquerque FC, Nanaszko M, Sanborn MR, Moon K, Abla AA, McDougall CG. Critical assessment of complications associated with use of the Pipeline Embolization Device. J Neurointerv Surg. 2015 Sep;7(9):652-9. doi: 10.1136/neurintsurg-2014-011265. Epub 2014 Jun 26. **PMID:** 24968879 **Citation:** Chalouhi N, Chitale R, Starke RM, Jabbour P, Tjoumakaris S, Dumont AS, Rosenwasser RH, Gonzalez LF. Treatment of recurrent intracranial aneurysms with the Pipeline Embolization Device. J Neurointerv Surg. 2014 Jan;6(1):19-23. doi: 10.1136/neurintsurg-2012-010612. Epub 2013 Jan 23. **PMID:** 23345630 **Citation:** Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15. **PMID:** 20395617 **Citation:** McDonald JS, Brinjikji W, Rabinstein AA, Cloft HJ, Lanzino G, Kallmes DF. Conscious sedation versus general anaesthesia during mechanical thrombectomy for stroke: a propensity score analysis. J Neurointerv Surg. 2015 Nov;7(11):789-94. doi: 10.1136/neurintsurg-2014-011373. Epub 2014 Sep 26. **PMID:** 25261440 **Citation:** Rajbhandari S, Matsukawa H, Uchida K, Shirakawa M, Yoshimura S. Clinical Results of Flow Diverter Treatments for Cerebral Aneurysms under Local Anesthesia. Brain Sci. 2022 Aug 13;12(8):1076. doi: 10.3390/brainsci12081076. **PMID:** 36009139 **Citation:** Hanel RA, Kallmes DF, Lopes DK, Nelson PK, Siddiqui A, Jabbour P, Pereira VM, Szikora Istvan I, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer C, Hellinger FR, Given Ii C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020 Jan;12(1):62-66. doi: 10.1136/neurintsurg-2019-015091. Epub 2019 Jul 15. **PMID:** 31308197 **Citation:** Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020. **PMID:** 33224273 **Citation:** Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Derelle AL, Chabert E, Costalat V. SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8. **PMID:** 30297539 **Citation:** Becske T, Brinjikji W, Potts MB, Kallmes DF, Shapiro M, Moran CJ, Levy EI, McDougall CG, Szikora I, Lanzino G, Woo HH, Lopes DK, Siddiqui AH, Albuquerque FC, Fiorella DJ, Saatci I, Cekirge SH, Berez AL, Cher DJ, Berentei Z, Marosfoi M, Nelson PK. Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial. Neurosurgery. 2017 Jan 1;80(1):40-48. doi: 10.1093/neuros/nyw014. **PMID:** 28362885 **Citation:** Kallmes DF, Brinjikji W, Cekirge S, Fiorella D, Hanel RA, Jabbour P, Lopes D, Lylyk P, McDougall CG, Siddiqui A. Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms: a pooled analysis of 3 large studies. J Neurosurg. 2017 Oct;127(4):775-780. doi: 10.3171/2016.8.JNS16467. Epub 2016 Oct 28. **PMID:** 27791519 **Citation:** Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74. doi: 10.1016/s0140-6736(02)11314-6. **PMID:** 12414200 **Citation:** van Gijn J, Kerr RS, Rinkel GJ. Subarachnoid haemorrhage. Lancet. 2007 Jan 27;369(9558):306-18. doi: 10.1016/S0140-6736(07)60153-6. **PMID:** 17258671 **Citation:** Ujiie H, Sato K, Onda H, Oikawa A, Kagawa M, Takakura K, Kobayashi N. Clinical analysis of incidentally discovered unruptured aneurysms. Stroke. 1993 Dec;24(12):1850-6. doi: 10.1161/01.str.24.12.1850. **PMID:** 8248967 **Citation:** Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011 Jul;10(7):626-36. doi: 10.1016/S1474-4422(11)70109-0. **PMID:** 21641282 **Citation:** Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available. **PMID:** 16943405 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020765 - Term: Intracranial Arterial Diseases - ID: D000002561 - Term: Cerebrovascular 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: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4113 - Name: Aneurysm - Relevance: HIGH - As Found: Aneurysm - ID: M5781 - Name: Intracranial Aneurysm - Relevance: HIGH - As Found: Intracranial Aneurysm - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M22521 - Name: Intracranial Arterial Diseases - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - 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: D000002532 - Term: Intracranial Aneurysm - ID: D000000783 - Term: Aneurysm ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: Resp - Name: Respiratory System Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Imaging - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M10576 - Name: Isoproterenol - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416644 **Acronym:** SupPORT regist **Brief Title:** The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) **Official Title:** The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) #### Organization Study ID Info **ID:** S-HDES-2023-309 #### Organization **Class:** OTHER **Full Name:** Hospital do Divino Espírito Santo de Ponta Delgada ### Status Module #### Completion Date **Date:** 2025-12-31 **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:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital do Divino Espírito Santo de Ponta Delgada #### Responsible Party **Investigator Affiliation:** Hospital do Divino Espírito Santo de Ponta Delgada **Investigator Full Name:** Dr. Nelson Oliveira **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:** The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry. **Detailed Description:** Primary endpoints (at hospitalization, 30 days, 6 months, 1 year) 1. Limb salvage 2. Target lesion revascularization (TLR) 3. Freedom from major adverse limb events (MALE - Major Amputation, any index limb revascularization) Secondary endpoints (at hospitalization, 30 days, 6 months, 1 year) 1. Freedom from Major adverse cardiovascular events (5-point endpoint: Stroke, myocardial infarction/Acute coronary syndrome, Any limb revascularization, Decompensated Congestive Heart Failure, Cardiovascular death1) 2. All-cause death / Cardiovascular death 3. Primary Patency(defined by Duplex Ultrassound Scan \[DUS\]2) Primary-Assisted Patency, Secondary Patency 4. Ankle-Brachial Index (ABI) 5. Rutherford-Becker classification Inclusion Criteria Clinical * Evidence of symptomatic obstructive peripheral arterial disease * Individuals aged 18 and older * All-comer patients undergoing endovascular lower-limb revascularization with Supera® stent implantation in the superficial femoral (SFA) or popliteal arteries * Patient or legal representative understand the SupPORT registry procedures, and have voluntarily provided informed written consent regarding their participation. * Participant is willing to remain in the SupPORT Registry for at least 1 year. Angiographic * Target lesion is a primary atherosclerotic lesion or a restenosis occurring in a non-stented of the SFA or the popliteal artery, distancing at least ≥ 1 cm from any previously implanted vascular stent. * Target lesion causes a ≥50% arterial obstruction (visually confirmed on digital subtraction angiography). Exclusion criteria * Any contraindication for peri-interventional or post-interventional anti-thrombotic therapy (including, but not restricted to Non-fractioned heparina, low-molecular weight heparina \[LMWH\], Clopidogrel, Ticagrelol, Ticlopidine, Acetylsalicylic acid, dipiridamol, direct thrombin \[factor II\] or factor Xa inhibitors, vitamin-K antagonists). * Participation in other research study that may influence obtained results. * Pregnant or breastfeeding women, or expected pregnancy to occur during the study period. * Treatment of intrastent restenosis/occlusion of previous peripheral vascular stent. * Non-corrected hemodynamically significant obstructive arterial disease of the ipsilateral inflow arteries (aorta, iliac arteries) Procedure Protocol - Endovascular revascularization • Participating centers are invited to maintain local practice standards, used in endovascular peripheral arterial revascularization. Pre-implant ballooning and peri-interventional anti-thrombotic therapy will be captured by the database. Intra-procedural and peri-procedural adjuncts are allowed, and will be recorded. Follow-up Protocol * Minimum follow-up will include a clinical assessment up to 30-days post-intervention, at 6 months, and at 1 year. Routine ABI is mandatory. Routine DUS is recommended. * Post-interventional anti-thrombotic therapy will be captured by the database, and will follow international recommendations, but also local practice standards and will be at the discretion of the assisting-physician. Data collection and storage * Data will be inserted at each center by the Investigation team on an electronic platform, created and managed by Infortucano. * Principal Investigators will have access to the enrolled center's participant data. * System components 1. Registry Database All data regarding each participant's records will be anonymously collected in a Central Database, where it will be stored. There are no limits to the number of participating centers. 2. Web Application - SupPORT Registry 1. Registry - The application will run on internet browser, with individual user authentication required for each Principal investigator. This application will allow the recording of the data and follow-up data by each participating center. 2. Information extraction - Inserted data by each center/investigator will be only accessible to each center/investigator during the study period. The Registry administrator will have access privileges to all participants' data. The application will provide general tables/graphics with generic information throughout the study period, accessible to all investigators (number or participants per center, overall inclusion, to be defined). All inserted data will be exportable to CSV files, allowing import to Microsoft Excel or SPSS software. 3. Technological architecture - All components are developed Microsoft.NET platform. The web application will be developed on ASP.NET 3.5/4.0. The Database Management System (DBMS) will be Microsoft SQL Server 2012/2019. The used Web Server will be Microsoft IIS 7.0. 4. Storage - The Central System and DBMS will be lodged in Safe Cloud Microsoft Azure Servers (InforTucano). The application address will be www.rnsupport.com. Cloud Microsoft Azure Server Characteristics: * Physical Location: Western Europe (The Netherlands) * Data backups with differential archives of the previous 15 days * Availability - 99,9 % * Anti-virus ESET File Security for Windows Server * Double-Firewall (Windows Server e Microsoft Azure Firewall) * Test version: http://test.infortucano.pt/RegistoSupPORT * User: admin * Pwd: admin123 Statistical analysis Statistical analysis: Continuous variables with a normal distribution will be described as mean and standard deviation. Continuous variables are presented as median and interquartile range (IQR) if skewed and will be tested among groups using the Mann-Whitney U-Test for independent samples. Related variables will be compared with the Wilcoxon Signed Rank Test. Categorical variables will be presented as count and percentage and will be compared using the Pearson's χ2 test or the Fisher´s exact test in cases of low number of events. Life-table based analyses will be used for endpoint assessment. Kaplan-Meier curves will be created, and differences tested according to the log rank test. For association between baseline characteristics endpoints, a multivariable logistic regression model (including time as a co-variate) or a Cox hazards proportion model will be created including variables with α-value ≤0.10 on univariate analysis, if appropriate. Stepwise backward elimination of variables with a P-value \>.050 will be also used during multivariable modelling. Confidence-intervals of 95% (95%CI) will be used and statistical significance will be considered for α\<.05. All statistical analyses will be performed using Statistical Package for Social Sciences 21.0 (IBM Inc, Chicago, Ill, USA). ### Conditions Module **Conditions:** - Lower Limb Ischemia - Peripheral Arterial Disease - Chronic Limb-Threatening Ischemia - Chronic Limb Ischemia - Atherosclerosis of Femoral Artery - Superficial Femoral Artery Stenosis - Superficial Femoral Artery Occlusion - Superficial Femoral Artery Disease - Superficial Femoral Artery Lesions - Popliteal Artery Occlusion - Popliteal Artery Stenosis - Popliteal Arterial Stenosis **Keywords:** - Supera - Vasculomimetic - Stent - Chronic limb-threatening ischemia - Chronic limb ischemia - Superficial femoral artery - popliteal artery ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Supera implant **Intervention Names:** - Device: Supera Vasculomimetic Stent **Label:** Supera implant **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Supera implant **Description:** Femoral-popliteal revascularization with Supera Stent **Name:** Supera Vasculomimetic Stent **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Number of limbs surviving without above ankle amputation **Measure:** Freedom from major limb amputation **Time Frame:** 1 year **Description:** Number of target lesions requiring re-intervention **Measure:** Target Lesion Revascularization (TLR) **Time Frame:** 1 year **Description:** Composite endpoint Major Amputation, any index limb revascularization **Measure:** MALE - Major Adverse Limb Event **Time Frame:** 1 year #### Secondary Outcomes **Description:** Composite 5-point endpoint: Stroke, myocardial infarction/Acute coronary syndrome, Any limb revascularization, Decompensated Congestive Heart Failure, Cardiovascular death **Measure:** MACE - Major Adverse Cardiovascular Event **Time Frame:** 1 year **Description:** Death from any cause **Measure:** All-cause Death **Time Frame:** 1 year **Description:** Death from cardiovascular causes **Measure:** Cardiovascular-related death **Time Frame:** 1 year **Description:** Patency of target lesion, without any intervention, with additional interventions **Measure:** Primary Patency, Primary Assisted Patency, Secondary Potency **Time Frame:** 1 year **Description:** Pressure index obtained from ankle and brachial arterial measurements **Measure:** Ankle-Brachial Index **Time Frame:** 1 year **Measure:** Rutherford-Becker Classification **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Evidence of symptomatic obstructive peripheral arterial disease. * All-comer patients undergoing endovascular lower-limb revascularization with Supera® stent implantation in the superficial femoral (SFA) or popliteal arteries. * Patient or legal representative understand the SupPORT registry procedures, and have voluntarily provided informed written consent regarding their participation. * Participant is willing to remain in the SupPORT Registry for at least 1 year. * Target lesion is a primary atherosclerotic lesion or a restenosis occurring in a non-stented of the SFA or the popliteal artery, distancing at least ≥ 1 cm from any previously implanted vascular stent. * Target lesion causes a ≥50% arterial obstruction (visually confirmed on digital subtraction angiography). Exclusion Criteria: * • Any contraindication for peri-interventional or post-interventional anti-thrombotic therapy (including, but not restricted to Non-fractioned heparina, low-molecular weight heparina \[LMWH\], Clopidogrel, Ticagrelol, Ticlopidine, Acetylsalicylic acid, dipiridamol, direct thrombin \[factor II\] or factor Xa inhibitors, vitamin-K antagonists). * Participation in other research study that may influence obtained results. * Pregnant or breastfeeding women, or expected pregnancy to occur during the study period. * Treatment of intrastent restenosis/occlusion of previous peripheral vascular stent. * Non-corrected hemodynamically significant obstructive arterial disease of the ipsilateral inflow arteries (aorta, iliac arteries) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Nelson.FG.Oliveira@azores.gov.pt **Name:** Nelson FG Oliveira, MD, PH.D **Phone:** (+351)296203000 **Role:** CONTACT #### Locations **Location 1:** **City:** Faro **Contacts:** ***Contact 1:*** - **Email:** ladomingos@chalgarve.min-saude.pt - **Name:** Liliana Domingos, MD, PH.D - **Phone:** +351289891100 - **Role:** CONTACT ***Contact 2:*** - **Name:** Liliana Domingos, MD, PH.D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital de Faro - Centro Hospitalar do Algarve **State:** Algarve **Status:** NOT_YET_RECRUITING **Zip:** 8000 **Location 2:** **City:** Ponta Delgada **Contacts:** ***Contact 1:*** - **Email:** Nelson.FG.Oliveira@azores.gov.pt - **Name:** Nelson FG Oliveira, MD PH.D - **Phone:** (+351)296203000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nelson FG Oliveira, MD PH.D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital Divino Espírito Santo **State:** Azores **Status:** RECRUITING **Zip:** 9500 **Location 3:** **City:** Almada **Contacts:** ***Contact 1:*** - **Email:** queiroz.sousa@gmail.com - **Name:** Gonçalo Queiroz Sousa, MD - **Phone:** +351212940294 - **Role:** CONTACT ***Contact 2:*** - **Name:** Gonçalo Queiroz de Sousa, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital Garcia de Orta **State:** Lisboa **Status:** RECRUITING **Location 4:** **City:** Penafiel **Contacts:** ***Contact 1:*** - **Email:** tgabrielateixeira@gmail.com - **Name:** Gabriela Teixeira, MD - **Phone:** +351255714000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Gabriela Teixeira, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Centro Hospitalar Tâmega e Sousa **State:** Porto **Status:** RECRUITING **Zip:** 4564 **Location 5:** **City:** Vila Nova de Gaia **Contacts:** ***Contact 1:*** - **Email:** ricardofagouveia@gmail.com - **Name:** Ricardo Gouveia, MD - **Phone:** +351227865100 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ricardo Gouveia, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Centro Hospitalar Vila Nova de Gaia e Espinho **State:** Porto **Status:** RECRUITING **Zip:** 4430 **Location 6:** **City:** Angra do Heroísmo **Contacts:** ***Contact 1:*** - **Email:** timmytoledo@gmail.com - **Name:** Timmy Toledo, MD - **Phone:** +351295403200 - **Role:** CONTACT ***Contact 2:*** - **Name:** Timmy Toledo, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital Santo Espírito Ilha Terceira **State:** Terceira **Status:** RECRUITING **Zip:** 9700 **Location 7:** **City:** Coimbra **Contacts:** ***Contact 1:*** - **Name:** Luis Antunes, MD - **Phone:** +351239400400 - **Role:** CONTACT ***Contact 2:*** - **Name:** Luis Antunes, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Centro Hospitalar Universitário de Coimbra **Status:** RECRUITING **Zip:** 3004 **Location 8:** **City:** Guimarães **Contacts:** ***Contact 1:*** - **Email:** jcorreiasimoes@gmail.com - **Name:** João Correia Simões, MD - **Phone:** +351253540330 - **Role:** CONTACT ***Contact 2:*** - **Name:** Joao Correia Simões, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital da Senhora da Oliveira de Guimarães **Status:** RECRUITING **Zip:** 4835 **Location 9:** **City:** Lisboa **Contacts:** ***Contact 1:*** - **Email:** ricardo160490@gmail.com - **Name:** Ricardo Correia, MD - **Phone:** +351213594000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ricardo Correia, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital de Santa Marta - Centro Hospitalar Lisboa Central **Status:** NOT_YET_RECRUITING **Zip:** 1169 **Location 10:** **City:** Lisboa **Contacts:** ***Contact 1:*** - **Email:** Orlanda.castelbranco@gmail.com - **Name:** Orlanda Castelbranco, MD - **Phone:** 210431000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Orlanda Castelbranco, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital Egas Moniz - Centro Hospitalar Lisboa Central **Status:** NOT_YET_RECRUITING **Zip:** 1349 **Location 11:** **City:** Lisboa **Contacts:** ***Contact 1:*** - **Email:** amorim.pedromiguel@gmail.com - **Name:** Pedro Amorim, MD - **Phone:** 217805000 - **Role:** CONTACT ***Contact 2:*** - **Name:** Pedro Amorim, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Hospital de Santa Maria - Centro Hospitalar Lisboa Norte **Status:** NOT_YET_RECRUITING **Zip:** 1649 **Location 12:** **City:** Porto **Contacts:** ***Contact 1:*** - **Email:** lploureiro@gmail.com - **Name:** Luis Loureiro, MD - **Phone:** +351222077500 - **Role:** CONTACT ***Contact 2:*** - **Name:** Luis Loureiro, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Centro Hospitalar Universitário de Santo António **Status:** RECRUITING **Zip:** 4099 **Location 13:** **City:** Porto **Contacts:** ***Contact 1:*** - **Email:** marina_f_neto@hotmail.com - **Name:** Marina Neto, MD, PH.D - **Phone:** +351225512100 - **Role:** CONTACT ***Contact 2:*** - **Name:** Marina Neto, MD, PH.D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Centro Hospitalar São João **Status:** RECRUITING **Zip:** 4202 **Location 14:** **City:** Vila Real **Contacts:** ***Contact 1:*** - **Email:** campos.jac82@gmail.com - **Name:** Jacinta Campos, MD - **Phone:** +351259300500 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jacinta Campos, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Centro Hospitalar de Trás-os-Montes e Alto Douro **Status:** RECRUITING **Zip:** 5000 **Location 15:** **City:** Viseu **Contacts:** ***Contact 1:*** - **Email:** andremarinho8@gmail.com - **Name:** André Marinho, MD - **Phone:** +351232420500 - **Role:** CONTACT ***Contact 2:*** - **Name:** André Marinho, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Portugal **Facility:** Centro Hospitalar Tondela Viseu **Status:** RECRUITING **Zip:** 3504 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Gao M, Hua Y, Zhao X, Jia L, Yang J, Liu B. Optimal Ultrasound Criteria for Grading Stenosis of the Superficial Femoral Artery. Ultrasound Med Biol. 2018 Feb;44(2):350-358. doi: 10.1016/j.ultrasmedbio.2017.10.001. Epub 2017 Nov 14. **PMID:** 29150366 **Citation:** Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10. Erratum In: Circulation. 2019 Jun 18;139(25):e1182-e1186. Circulation. 2023 Aug 15;148(7):e5. **PMID:** 30586774 **Citation:** Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12. **PMID:** 24126108 **Citation:** Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):492-493. Eur J Vasc Endovasc Surg. 2020 Jul;60(1):158-159. **PMID:** 31182334 **Citation:** Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10. **PMID:** 24402839 ## Document Section ### Large Document Module #### Large Docs - Date: 2023-04-01 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 211315 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-06T09:48 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000010335 - Term: Pathologic Processes - ID: D000001161 - Term: Arteriosclerosis - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes ### 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: M26188 - Name: Atherosclerosis - Relevance: HIGH - As Found: Atherosclerosis - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemia - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: HIGH - As Found: Peripheral Arterial Disease - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: HIGH - As Found: Peripheral Arterial Disease - ID: M2714 - Name: Chronic Limb-Threatening Ischemia - Relevance: HIGH - As Found: Chronic Limb-Threatening Ischemia - ID: M6475 - Name: Constriction, Pathologic - Relevance: HIGH - As Found: Stenosis - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: HIGH - As Found: Artery Occlusion - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000050197 - Term: Atherosclerosis - ID: D000058729 - Term: Peripheral Arterial Disease - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000089802 - Term: Chronic Limb-Threatening Ischemia - ID: D000003251 - Term: Constriction, Pathologic - ID: D000007511 - Term: Ischemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416631 **Brief Title:** Artificial Intelligence Versus Maunal Planning in Robot Assisted Spinal Surgery **Official Title:** Artificial Intelligence Versus Manual Planning in Patients Undergoing Robot-assisted Pedicle Screw Internal Fixation: a Prospective Controlled Study #### Organization Study ID Info **ID:** AI-RASS #### Organization **Class:** OTHER **Full Name:** Beijing Jishuitan Hospital ### 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:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-27 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Jishuitan 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 learn if the artificial intelligence technology helps to improve the efficiency in robot assited spinal surgery. The main questions it aims to answer are: Does the AI technology shorter the mannual planning time of screw trajectories？ Does the AI technology affect the surgical accuracy？ Researchers will compare the artificial intelligence technology to the conventional mannual planning in robotic surgery. Participants who met inclusion criteria and do not have any exclusion criterion will be randomized to artificial intelligence or mannual planning group. **Detailed Description:** Study design: multicenter, non-inferiority, open-label, randomized controlled trial in patients undergoing robotic spinal surgery. Monitoring: Monitoring of patient's safety and effectiveness data is performed by a designated independent Data Safety and Monitoring Board (DSMB). The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki. Sample Size Calculation: Group size calculation is focused on demonstrating non-inferiority. Assuming that the percentage of clinically acceptable screws would be 90% in the artificial intelligence planning group and 95% in the manual planning group, with a non-inferiority margin of 10% and a one-sided significance level of 2.5%, we calculated that a sample of 79 screws per treatment group would give the trial approximately 95% power to show noninferiority of artificial intelligence planning group to manual planning group with regard to the primary end point. ### Conditions Module **Conditions:** - Surgery ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: artificial intelligence based screw planning **Label:** artificial intelligence planning group **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: manually screw planning **Label:** manual planning group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - artificial intelligence planning group **Description:** artificial intelligence technology helps to plan screws in robot assisted spinal surgery **Name:** artificial intelligence based screw planning **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - manual planning group **Description:** the screw trajcetories are manually planned **Name:** manually screw planning **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** according to the Gertzbein and Robbins scale, including grade A (screw was completely within the pedicle), grade B (pedicle cortical breach \<2 mm), grade C (pedicle cortical breach \<4 mm), grade D (pedicle cortical breach \<6 mm), and grade E (pedicle cortical breach \>6 mm). Grade A + B were considered clinically acceptable. The percentage of clinically acceptable screws was recorded. **Measure:** The accuracy of screw positioning or placement **Time Frame:** 1 month #### Secondary Outcomes **Description:** Time from start to finish of planning **Measure:** The planning time **Time Frame:** 1 day **Description:** Nerve injury, epidural hematoma, and infection **Measure:** postoperative complication **Time Frame:** 3 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Admission to one of the participating centers； * Need for and start of robotic spinal surgery * Patients had complete medical records and imaging data; Exclusion Criteria: * Age less than 18 years; * Patients with severe comorbidities; * Patients diagnosed with tumor diseases; * Inability to carry out the intervention (mental of physical conditions that limited participation); * Patients with morbid obesity (body mass index \> 40); * Missing medical records and imaging data; * Patients with suspected or confirmed pregnancy; * Patients participating in another RCT with the same clinical endpoint, or interventions possibly compromising the primary outcome; * No informed consent. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416618 **Acronym:** PHF50-65 **Brief Title:** Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years **Official Title:** Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial #### Organization Study ID Info **ID:** PHF5065 #### Organization **Class:** OTHER **Full Name:** Zealand University Hospital ### Status Module #### Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **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:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Tampere University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Zealand University Hospital #### Responsible Party **Investigator Affiliation:** Zealand University Hospital **Investigator Full Name:** Line Lojbert Houkjaer **Investigator Title:** Principal Investigator, M.D. **Type:** PRINCIPAL_INVESTIGATOR ### 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 study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture. The main questions it aims to answer are: • Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up? Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale. The study compare operation with either plate or nail fixation to non-surgical treatment. Participants will: * Receive either surgical treatment or non-surgical treatment. * At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L). The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit. **Detailed Description:** Proximal humerus fractures (PHF) are common injuries. At the age of 60 and above, no clinically important difference between surgical and non-surgical treatment after one year has been reported based on a recent Cochrane review of 10 trials. The treatment of choice for displaced PHF in adults 50-65 years is anatomical reconstruction, and osteosynthesis if possible, which is why many patients in this age group with a displaced PHF undergo surgical treatment. Orthopaedic surgeons may encounter challenges in guiding patients and formulating treatment strategies within specific age groups due to the absence of inclusion of this younger patient demographic in existing evidence. Knowledge is primarily derived from studies on the population aged 60 years and above. There exists an intermediate age group of patients for whom it remains uncertain whether the benefits and harms of non-surgical and surgical interventions are comparable This trial is a two-center, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment following a displaced proximal humerus fractures in patients aged 50-65 years. The participants will be included and allocated equally to surgical treatment with osteosynthesis (comparator) with non-surgical treatment (intervention). The surgical group will visit the outpatient clinic after 2, 12, and 24 weeks, while the non-surgical group will visit after 6, (12) and 24 weeks. X-rays will be obtained before every visit. Both groups will be referred to rehabilitation in the municipalities. Without a patient-derived MCID for PHF, a relevant difference of 9,6 was assumed to represent clinically meaningful difference. This is equivalent to approximately a 20 % difference between the surgical group and the non-surgical group on a 0-48 OSS scale. With a power of 80% and a 5% level of significance, a sample size of 25 participants per group is required. Assuming a 15 % loss to follow-up, the recruitment target is 30 patients in each group, meaning 60 participants overall. In case of treatment failure in either group, defined as persistent pain or a failed osteosynthesis, a salvage procedure with secondary osteosynthesis or a reverse shoulder arthroplasty (RSA), will be offered. Additionally, there are plans for a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial (decliner cohort), and their baseline characteristics, treatment preferences. The decliner cohort will receive the same treatment, follow-up, and outcome measurements as the included patients. Statistical analysis: For the primary outcome, a two-sample t-test will be used. P-value \< 0.05. For secondary outcome - considering the hierarchical nature of the data - clustered and repeated measure data - linear mixed models will be utilized for the statistical analysis. Salvage procedures and adverse events will be reported descriptively. Reoperation in the form of amotio will be considered a complication and, therefore, not included in the statistics of salvage procedures. The time of salvage procedures in both groups will be recorded and analysed using the Cox proportional hazard model As suggested in the extension of the CONSORT 2010 statement, the primary endpoints will be analysed for the intention-to-treat (ITT) population and, for sensitivity reasons, for the per-protocol (PP) population. There will be two analyses for both ITT and PP populations: one including salvage procedures and one excluding them. These analyses will be used to evaluate the occurrence of salvage procedures and the intervention's effect. The length of rehabilitation will be presented with a mean and standard division for each of the groups. Differences in adherence to rehabilitation within the groups will be reported using the chi-squared test. Linear mixed models will be employed to test whether adherence to rehabilitation modifies the effect of the groups. All statistical analyses will also be conducted for the decliner cohort, including a comparison of the primary outcome between those with a preference for surgical treatment and those with a preference for non-surgical treatment ### Conditions Module **Conditions:** - Proximal Humeral Fracture - Shoulder Fractures ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study is a two-center, parallel-group, randomized, superiority trial ##### Masking Info **Masking:** SINGLE **Masking Description:** The primary investigator will conduct the blinded statistical analysis through data anonymization and will be supervised by a biostatistician. After the blinded statistical analysis has been completed, two abstracts will be written based on the pre-blinding analysis results before the blinding is revealed. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit, **Intervention Names:** - Procedure: Non surgical **Label:** Non-surgical treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The surgical group will receive osteosynthesis with a locking plate or an intramedullary locking nail, according to the surgeon's choice **Intervention Names:** - Procedure: Surgical **Label:** Procedure: Surgical treatment **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Procedure: Surgical treatment **Description:** Surgical group: After osteosynthesis, they will be provided with a sling and swathe immediately after the surgery. From the first postoperative day, only the sling will be used. Two weeks postoperatively, patients will undergo clinical and radiological follow-up in the outpatient clinic. They will be referred to post-operative rehabilitation in the municipalities. At 12 weeks postoperatively, patients will have another clinical and radiological follow-up. This is the current standard care for surgical treatment with a plate or intramedullary nail. **Name:** Surgical **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Non-surgical treatment **Description:** Non-surgical group: Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit, 10-14 days post-injury. Patients will be referred to rehabilitation in the municipalities. At week 6 post-injury, all patients will undergo clinical and radiological follow-up. This represents the current standard care for non-surgical treatment of displaced PHF at the departments. **Name:** Non surgical **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Oxford Shoulder Score is a patient-reported shoulder-specific outcome measure. It is a patient-administrated questionnaire to assess shoulder function. It consists of 12 questions on a 5-point Likert scale (both pain- and function-related), each offering five ordinal response options. The cumulative score ranges between 0 and 48, being 0 (worst) to 48 (best: no pain or no functional limitation). **Measure:** Oxford Shoulder Score 12 months **Time Frame:** 12 months #### Secondary Outcomes **Description:** Oxford Shoulder Score is a patient-reported shoulder-specific outcome measure. It is a patient-administrated questionnaire to assess shoulder function. It consists of 12 questions on a 5-point Likert scale (both pain- and function-related), each offering five ordinal response options. The cumulative score ranges between 0 and 48, being 0 (worst) to 48 (best: no pain or no functional limitation). **Measure:** Oxford Shoulder Score **Time Frame:** 6 and 24 months **Description:** Q-5D-3L is a generic health-related quality-of-life assessment tool. It consists of a 5-dimension descriptive questionnaire about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as a measure for health-related quality of life. Each dimension has 3 levels: No problems, some/moderate problems and unable/extreme problems. Each dimension is weighted differently and results in a total score based on the EQ-5D index calculator (TTO). The EQ-5D-3L also includes an overall scale (numeric rating scale) in which patient rates overall health condition today on a scale between 1 - 100, with 100 being the highest level of health imaginable **Measure:** EQ-5D-3L **Time Frame:** 6, 12 and 24 months **Description:** Treatment failure: In case of treatment failure in either group, defined as persistent pain or a failed osteosynthesis, a salvage procedure with secondary osteosynthesis, including the possibility to use graft or a reverse shoulder arthroplasty (RSA), will be offered. Failed osteosynthesis and the most appropriate salvage procedure will be defined by the surgeon. Cross-over to reverse shoulder arthroplasty or revision osteosynthesis is considered a failure of treatment regardless of group allocation. The patient will remain in the study. The reason for crossing over will be noted and reported. **Measure:** Conversion to surgery after inclusion, or additional surgery **Time Frame:** 24 months **Description:** Serious adverse events, as defined by the WHO. Systemic reviews on terms and definitions for complications after surgical and non-surgical treatment have been conducted. Based on international consensus on the core event set for PHF, both surgical and non-surgical treatment, 8 event groups are defined. The following adverse event groups will be monitored: implant, osteochondral, shoulder instability, peripheral neurology, vascular, infection, device, superficial soft tissue, and deep soft tissue. In addition to this, we have chosen to monitor clinical symptoms such as persistent severe pain. **Measure:** Adverse events. **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility. * Patients should be cognitively capable of answering the follow-up questionnaires. Exclusion Criteria: * The patient does not understand written and spoken native language (Danish or Finnish/Swedish) * Inability to give informed consent * Fractures assessed to be unreconstructedly by the treating surgeon * Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface * Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks. * Pathological fractures or previous fractures in the same proximal humerus * Concomitant fractures, which could influence the outcome * Paralysis in upper extremity **Maximum Age:** 65 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lihol@regionsjaelland.dk **Name:** Line Løjbert Houkjær, M.D., ph.d.-student **Phone:** 61711681 **Role:** CONTACT **Contact 2:** **Email:** sbror@regionsjaelland.dk **Name:** Stig Brorson, Prof. **Role:** CONTACT #### Locations **Location 1:** **City:** Køge **Contacts:** ***Contact 1:*** - **Email:** lihol@regionsjaelland.dk - **Name:** Line Løjbert Houkjær, M.D., ph.d.-student - **Phone:** 61711681 - **Role:** CONTACT ***Contact 2:*** - **Email:** sbror@regionsjaelland.dk - **Name:** Stig Brorson - **Role:** CONTACT ***Contact 3:*** - **Name:** Zaid Issa, M.D. - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Kenneth B Holtz, M.D. - **Role:** SUB_INVESTIGATOR **Country:** Denmark **Facility:** Centre for Evidence-Based Orthopaedics, Zealand University Hospital **State:** Region Zealand **Zip:** 4600 **Location 2:** **City:** Tampere **Contacts:** ***Contact 1:*** - **Name:** Antti P Launonen, M.D. - **Role:** CONTACT ***Contact 2:*** - **Name:** Bakir O. Sumrein, M.D. - **Role:** SUB_INVESTIGATOR **Country:** Finland **Facility:** Tampere University Hospital **Zip:** 33520 #### Overall Officials **Official 1:** **Affiliation:** Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge. **Name:** Line Løjbert Houkjær, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** No individual participant data (IPD) available to other researchers. **IPD Sharing:** NO ### References Module #### References **Citation:** Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. **PMID:** 35727196 **Citation:** Alispahic N, Brorson S, Bahrs C, Joeris A, Steinitz A, Audige L. Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions. BMC Musculoskelet Disord. 2020 May 26;21(1):327. doi: 10.1186/s12891-020-03353-8. **PMID:** 32456631 **Citation:** Brorson S, Alispahic N, Bahrs C, Joeris A, Steinitz A, Audige L. Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions. BMC Musculoskelet Disord. 2019 Feb 23;20(1):91. doi: 10.1186/s12891-019-2459-6. **PMID:** 30797232 **Citation:** Audige L, Brorson S, Durchholz H, Lambert S, Moro F, Joeris A. Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process. BMC Musculoskelet Disord. 2021 Nov 30;22(1):1002. doi: 10.1186/s12891-021-04887-1. **PMID:** 34847888 #### See Also Links **Label:** EMEA: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting **URL:** https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-topic-e-2-clinical-safety-data-management-definitions-and-standards-expedited-reporting-step_en.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000001134 - Term: Arm Injuries - ID: D000070599 - Term: Shoulder Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M9869 - Name: Humeral Fractures - Relevance: HIGH - As Found: Humeral Fractures - ID: M15592 - Name: Shoulder Fractures - Relevance: HIGH - As Found: Shoulder Fractures - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone - ID: D000006810 - Term: Humeral Fractures - ID: D000012784 - Term: Shoulder Fractures ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416605 **Brief Title:** Autogenous Tooth Graft for Ridge Augmentation **Official Title:** Tooth Shell Versus Bone Shell Technique For Horizontal Maxillary Alveolar Ridge Augmentation #### Organization Study ID Info **ID:** A03030123 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-12 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-01-01 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **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 #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Investigator Affiliation:** Mansoura University **Investigator Full Name:** Heba Elsheikh **Investigator Title:** Assistant Professor of Oral and Maxillofacial Surgery **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 is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft. **Detailed Description:** twenty eight patients with one or two maxillary extracted teeth in need for horizontal bone augmentation and implant placement will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University patients will be divided into two equal groups: • Group I: Horizontal bone augmentation will be done by bone shell technique. • Group II: Horizontal bone augmentation will be done by autogenous tooth shell technique. Evaluation: A-Clinical evaluation: * All patients were followed up on a weekly basis for the first postoperative month, then monthly for the rest of the postoperative period (6months) until implantation. * The patients were evaluated regarding pain, edema and hematoma at recipient and donor sites as well as healing of the mucosa. * A neurosensory evaluation was carried out at each clinical check up by asking the patient if there were any areas of hypoesthesia, numbness or tingling in the lower lip and chin at the side of the donor site. B-Radiographic evaluation •Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement. According to the measurements obtained from CBCT, appropriate implant size and length will be chosen and placed 6 months postoperative after removal of the micro screws. Radiographic analysis: Linear measurements of alveolar bone width were taken using CBCT scan at three stages; prior to grafting (T0) and immediately (T1), and 4 months post grafting (T2). Then three horizontal alveolar width measurements (crestal, middle and apical) were recorded at T0, T2 and T1. The measurement was performed with fixed points each time, the buccolingual width was measured at different levels. At the bone crest, 3mm from the bone crest and 6mm from the bone crest. The measurements were tabulated for statistical analysis. ### Conditions Module **Conditions:** - Dental Implant ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 28 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Horizontal bone augmentation will be done by bone shell technique **Intervention Names:** - Procedure: Maxillary Alveolar Ridge Augmentation **Label:** group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Horizontal bone augmentation will be done by autogenous tooth shell technique **Intervention Names:** - Procedure: Maxillary Alveolar Ridge Augmentation **Label:** group B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - group A - group B **Description:** using tooth graft or bone graft to increase alveolar ridge width to be able to insert dental implant **Name:** Maxillary Alveolar Ridge Augmentation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement. **Measure:** horizontal alveolar width measurements **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - 1- One or two maxillary extracted teeth with crestal bone width of 4 mm or less. 2- Age ranging from 18_50 years 3- 3- Adequate oral hygiene. 4- Non smoking patients. 5-Free from any pathological lesions related to the tooth to be extracted. 6- Physically fit to withstand the whole procedure. Exclusion Criteria: * 1- Active infection in the site to be treated. 2- Patients on chemotherapy or radiotherapy. 3- Alcohol or drug abuse. 4- Patients who have systemic disorders that interfere with bone healing {uncontrolled diabetes mellitus, autoimmune disease, * etc.} 5- Pregnancy. 6- Patients with bone disease. 7- Patients with parafunctional habits **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mansoura **Country:** Egypt **Facility:** Heba Elsheikh ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416592 **Brief Title:** Reliability and Validity of Hand Dynamometer Trunk Muscle Strength Measurements in Patients With AIS **Official Title:** Intra-rater and Inter-rater Reliability and Validity of Hand Dynamometer Trunk Flexor, Extensor and Lateral Flexor Muscle Strength Measurements in Patients With Adolescent Idiopathic Scoliosis #### Organization Study ID Info **ID:** IUC5 #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### 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:** 2024-05-12 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Irem Kurt **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:** Adolescent idiopathic scoliosis (AIS) is a three-dimensional complex deformity of the spine characterized by lateral deviation of 10 degrees or more in the frontal plane, rotation in the transverse plane and hypokyphosis in the sagittal plane. It has been reported that in the presence of scoliosis, there is a change in muscle strength of people compared to their healthy peers due to the deterioration of their postural balance. There are many studies in the literature that evaluate the muscle strength of cases diagnosed with scoliosis with objective devices. Among these objective devices, reliability studies on hand dynamometry devices, which are easy to use, portable and cheaper than other devices, have been conducted for different populations. However, no reliability study of the handheld dynamometer device in patients with AIS has been found in the literature. Therefore, the aim of our study is to study the intra-rater and inter-rater reliability and validity of the trunk flexion, extension and lateral flexion muscle strengths of the hand dynamometer device in cases with AIS, which are known to have changes in muscle strength compared to their peers as a result of the change in spinal alignment. After obtaining the demographic information of the cases that meet the inclusion criteria within the scope of the study, the isometric muscle strength of the trunk flexor, extensor and right-left lateral flexor muscles will be evaluated by two different evaluators using a Lafayette hand dynamometer. To avoid systematic error, each participant will perform the isometric handheld dynamometer protocol in a random testing order. In order to determine interobserver reliability, on the first day of the test, the same hand dynamometer protocol will be applied to each participant by two different evaluators, after a 1-hour rest to prevent fatigue. To determine intraobserver reliability and compliance, participants will be re-evaluated by the same researchers at the same protocol, place and day period, 1 week apart to prevent learning effects. This study will reveal the intraobserver and interobserver reliability and validity of the handheld dynamometer device, which can be used in the evaluation of trunk muscle strength for clinicians working with AIS. **Detailed Description:** Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional complex deformity of the spine characterized by lateral deviation of 10 degrees or more in the frontal plane, rotation in the transverse plane and hypokyphosis in the sagittal plane, and is an important public health problem with a global prevalence of 0.47-5.2%. Muscle strength is an important factor in maintaining postural balance in AIS, and it is observed that both clinicians and researchers evaluate the muscle strength of cases with AIS using different objective devices. Objective muscle strength assessment methods include electromyography, hand dynamometry and isokinetic dynamometry. Electromyography devices and isokinetic dynamometers are expensive and their use in the clinic is limited because they are not easily portable. Therefore, it has been shown to be a valid and reliable method to evaluate trunk muscle strength in different populations and pathologies such as healthy adults, healthy athletic individuals, chronic low back pain or hemiplegic patients; The handheld dynamometer device, which has the advantage of being cheaper and more portable than other devices, appears as a suitable option for clinicians to evaluate trunk isometric muscle strength. No reliability studies of hand dynamometer devices have been found in the AIS population. Therefore, our aim in the study is to study the intra-observer and inter-observer reliability and validity of the trunk flexion, extension and lateral flexion muscle strengths of the hand dynamometer device in patients with AIS, who are known to have changes in muscle strength compared to their peers as a result of the change in spinal alignment. This study will reveal the validity of the hand dynamometer device that can be used in the evaluation of trunk muscle strength for clinicians working with AIS. ### Conditions Module **Conditions:** - Scoliosis; Adolescence - Adolescent Idiopathic Scoliosis **Keywords:** - Scoliosis - Rehabilitation - Exercise - Reliability ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 41 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intra-rater and inter-rater validity and reliability of trunk flexion, extension and right-left lateral flexion isometric muscle strength in cases with AIS will be performed with the Lafeyette hand dynamometer device ((Lafayette Manual Muscle Testing System, Lafayette Instrument Co, Lafayette, Indiana). To avoid systematic error, each participant will perform the isometric handheld dynamometer protocol in a random testing order. In order to determine inter-rater reliability, the same hand dynamometer protocol will be applied to each participant by two different assessors on the first day of the test. Participants will be given a 1-hour rest period between evaluators to prevent fatigue in the evaluations to be held on the same day. To determine inter-rater reliability and agreement, participants will be re-evaluated by the same researchers, at the same protocol, place and day, with a 1-week interval to prevent learning effects. **Label:** Intra-rater and inter-rater validity and reliability ### Outcomes Module #### Primary Outcomes **Description:** Isometric trunk flexor strength, two different test positions were adapted based on current literature. The first position will be measured on the back at 0 degrees of extension, with the knees straight. The dynamometer will be placed below the suprasternal notch of the sternum. Participants will be instructed to place their hand on the opposite acromion. To prevent pelvic rotation, participants will be fixed with the help of a belt from the anterior superior iliac spine and 10 cm above the lateral malleolus. The second position will be measured on the back in a 30 degree flexion position with the knees straight. The dynamometer will be placed below the suprasternal notch of the sternum. Participants will be instructed to place their hand on the opposite acromion. To prevent pelvic rotation, participants will be fixed with the help of a belt from the anterior superior iliac spine and 10 cm above the lateral malleolus. **Measure:** Isometric trunk flexor strength **Time Frame:** Baseline (All rater), after 1 hour (Rater 1) and 1 week (Rater 1) **Description:** Isometric trunk extension strength, two different test positions were adapted based on current literature. The first position will be measured face down in 0 degree extension position. The dynamometer will be placed at the height T4. Participants will be instructed to place their hands on their foreheads. Participants will be fixed with the help of a belt from the posterior superior iliac spine and 10 cm above the lateral malleolus to prevent pelvic rotation. The second position will be measured face down in a 30 degree flexion position. The dynamometer will be placed at the height T4. Participants will be instructed to place their hands on their foreheads. Participants will be fixed with the help of a belt from the posterior superior iliac spine and 10 cm above the lateral malleolus to prevent pelvic rotation. **Measure:** Isometric trunk extension strength **Time Frame:** Baseline (All rater), after 1 hour (Rater 1) and 1 week (Rater 1) **Description:** Isometric trunk lateral flexion strength will be measured in the sitting position. Participants will sit on a chair with their feet not touching the ground and their hips in 90° flexion, and the participant will be fixed with the help of a strap. The dynamometer will be placed at shoulder level. Participants will be instructed to place their hand on the opposite acromion. Trials in which excessive motion (a detectable amount of movement or rotation in the transverse plane) occurs will be rejected and measured as. **Measure:** Isometric trunk lateral flexion strength **Time Frame:** Baseline (All rater), after 1 hour (Rater 1) and 1 week (Rater 1) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being between the ages of 10-18 * Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist * Ability to understand instructions * Volunteering to participate in the study Exclusion Criteria: * History of traumatic trunk or pelvic injury * History of acute, subacute or chronic low back pain or neurological disease * Having had spinal surgery * Participating in heavy physical activity at least one day before the test days * Having experienced any acute situation that could affect muscle strength between the two tests (within 7 days) **Maximum Age:** 18 Years **Minimum Age:** 10 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Adolescent idiopathic scoliosis patients ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fztiremkurt@gmail.com **Name:** İrem Kurt Ulusoy **Phone:** +905326904872 **Role:** CONTACT **Contact 2:** **Email:** oskanelcin@gmail.com **Name:** Elcin Akyurek **Phone:** +905077403731 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** İrem Kurt **Zip:** 34147 #### Overall Officials **Official 1:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** İrem Kurt Ulusoy **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** Elcin Akyurek **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** İpek Yeldan **Role:** PRINCIPAL_INVESTIGATOR **Official 4:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** Ayse Zengin Alpozgen **Role:** PRINCIPAL_INVESTIGATOR ## 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: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - 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:** NCT06416579 **Acronym:** RCT **Brief Title:** Comparison of the Efficiency of Schroth Method and Virtual Reality Exercises in Individuals With AIS **Official Title:** Comparison of the Efficiency of Schroth Method and Schroth Method Based Virtual Reality Exercises in Individuals With Adolescent Idiopatic Scoliosis #### Organization Study ID Info **ID:** IUC4 #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2025-11-01 **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:** 2025-06-01 **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:** 2024-05-12 **Study First Submit QC Date:** 2024-05-12 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Irem Kurt **Investigator Title:** PhD (c) **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine of unknown etiology, in the treatment of which physiotherapy-specific scoliosis-specific exercise (PSSE), corset and surgical treatment approaches are used depending on the severity of the curvature \[8, 9\]. The Schroth method, one of the PSSE methods, has been shown to reduce the severity of the curvature, Cobb angles and the need for surgery, especially in curvatures between 10-30 degrees, slow down the progression of the curvature, increase back muscle strength and improve respiratory functions \[10-12\]. In the Schroth method, mental imagery, exteroceptive, proprioceptive stimulations and mirror control, which follow motor learning principles and include internal focus, are used to increase body awareness and facilitate the individual's self-posture corrections with postural, sensorimotor and rotational breathing exercises specific to scoliosis \[5, 10\]. In cases that require long-term treatment, such as scoliosis, the motivation and participation of the child and adolescent population in particular decreases and negatively affects the success of treatment \[1, 2\]. Additionally, it has been reported in the literature that patients have difficulty in performing Schroth exercises at home and adapting the corrected posture to daily life\[5\]. For this reason, in order to maintain the corrected posture and make it permanent, motor learning-based approaches must be used \[6\]. Virtual reality rehabilitation (VR) creates an external focus on the individual, allows for a large number of repetitions, and thus encourages motor learning. It is also known that VR increases motivation, participation and exercise performance in children and adolescents\[7\]. When the literature was examined, no studies were found regarding VR in individuals with AIS. We think that our study will show that Schroth-based VR will be effective on spinal parameters, trunk rotation and spinal mobility parameters in cases with AIS. Our aim is to examine the effects of Schroth-based VR in comparison with Schroth exercises in cases with AIS. **Detailed Description:** Schroth method, applied in the conservative treatment of adolescent idiopathic scoliosis (AIS), uses internally focused feedback to increase body awareness and maintain corrected posture. However, it has been reported in the literature that patients have difficulty in performing exercises at home and adapting the corrected posture to daily life\[5\]. In addition, since scoliosis rehabilitation requires long-term follow-up, patients' participation in treatment, motivation and exercise performance decrease over time \[1, 2\]. Virtual reality rehabilitation (VR) creates an external focus on the individual, allows for a large number of repetitions, and thus encourages motor learning \[3, 4, 6\]. It is also known that SGR increases motivation, participation and exercise performance in children and adolescents\[7\]. When the literature was examined, no studies were found regarding SGR in individuals with AIS. The primary aim of our study is to investigate the comparative effects of Schroth-based VR and Schroth exercises on spinal parameters, trunk rotation and spinal mobility in cases with AIS. Our secondary aim is that these exercise trainings; To comparatively examine the effects on postural parameters, trunk isometric muscle strength, endurance, proprioception, deformity perception, quality of life and satisfaction. H1 hypothesis: There is a difference between the effects of Schroth-based SGR and Schroth exercises on spinal parameters, trunk rotation and spinal mobility in cases with AIS. H0 hypothesis: In cases with AIS, there is no difference between the effects of Schroth-based SGR and Schroth exercises on spinal parameters, trunk rotation and spinal mobility. Cases that meet the inclusion criteria will be randomly divided into groups as Group I - Schroth Group, Group II - SGR Group -, Group III - Control Group, and a 24-week program will be applied. Evaluations will be performed at baseline, 12 and 24 weeks. We think that our study will be an effective, innovative, technology-based approach that will contribute to the development of spinal and postural parameters in cases with AIS. ### Conditions Module **Conditions:** - Scoliosis; Adolescence - Scoliosis - Scoliosis Lumbar Region - Adolescent Idiopathic Scoliosis **Keywords:** - Scoliosis - exercise - rehabilitation - Adolescent - exercise therapy - Physical Therapy Modalities ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be given individually structured scoliosis-specific three-dimensional exercises according to the Schroth method, 2 days a week for 12 weeks, 1 day a week for the next 12 weeks, under the supervision of a physiotherapist, for a total of 36 sessions. Participants will be given a home exercise program to do on the days they do not come to the session, and will be asked whether they have done it or not when they come to each session. The exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Progress in the exercises will be made positionally by increasing the number of repetitions and the number of rotational breathing during the exercise. **Intervention Names:** - Other: Schroth Exercise Group **Label:** Group I-Schroth Exercise Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will undergo a Schroth method-based virtual reality exercise program under the supervision of a physiotherapist, 2 days a week for 12 weeks, and 1 day a week for the next 12 weeks, for a total of 36 sessions. Participants will be given a home exercise program to do on the days they do not come to the session, and will be asked whether they have done it or not when they come to each session. Schroth method based virtual reality exercise program will be made on Nintendo Wii. Games within Nintendo Wii will be implemented in individually configured positions in accordance with the Schroth method.The virtual reality exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Sessions will last 40 minutes in total, including 5 minutes of warm-up, 30 minutes of balance and sports games, and 5 minutes of cool-down. Progression will be made by difficulty level and positional in all games. **Intervention Names:** - Other: Schroth Method Based Virtual Reality Group **Label:** Group II-Schroth Method Based Virtual Reality Group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants in the control group will be placed on a waiting list for 24 weeks. Participants will be given initial, intermediate and final evaluations. Participants will not receive any exercise intervention for 24 weeks and will be able to continue their routine physical activities. **Intervention Names:** - Other: Control Group **Label:** Group III-Control Group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I-Schroth Exercise Group **Description:** Exercises will be given in lying, sitting and standing positions. In each exercise, elongation of the spine will be ensured and the person will be positioned according to the type of scoliosis. Exercises will be given progressively in supine, prone, side sitting, sitting and standing positions. In each exercise, elongation of the spine will be ensured and the person will be positioned according to the upper and lower extremities. The exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Progress in the exercises will be made positionally by increasing the number of repetitions and the number of rotational breathing during the exercise. **Name:** Schroth Exercise Group **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Group II-Schroth Method Based Virtual Reality Group **Description:** During Schroth method-based virtual reality exercises, continuity in stabilization will be ensured by using external focus and muscular activation in positions appropriate to the Schroth method and in corrected posture. Sessions will last 40 minutes in total, including 5 minutes of warm-up, 30 minutes of balance and sports games, and 5 minutes of cool-down. Warm-up and cool-down will consist of aerobic games available in Nitendo wii. Balance games will consist of Penguin Slide, Soccer Heading, Table Tilt, Balance Bubble, Ski Slalom, Ski Jump, Tilt City and Snowboard Slalom. Among the sports games, Bowling, Boxing, Tennis and Baseball will be included in the program. Progression will be made by difficulty level and positional in all games. The exercises will be made more difficult by side sitting, side sitting on a stool, sitting position, knight position, standing, sitting on a balance ball, standing on a soft floor, on a bosu ball and moving towards the balance board. **Name:** Schroth Method Based Virtual Reality Group **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Group III-Control Group **Description:** Participants in the control group will be placed on a waiting list for 24 weeks. Participants will not receive any exercise intervention for 24 weeks and will be able to continue their routine physical activities. **Name:** Control Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The most commonly used method to measure the size of the scoliosis curve is the Cobb angle. As a standard, measurement is made on a posteroanterior spine radiograph taken while standing. To determine the boundaries of scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines parallel to these two lines are drawn and the angle between the two lines is recorded. In our study, the Cobb angle will be measured and recorded in the sagittal and frental planes, based on the same vertebral endplates, on the spine x-ray taken at the beginning and after 24 weeks of treatment by the orthopedic and traumatology physician during the routine follow-up of the patient. **Measure:** Spinal Parameters **Time Frame:** Baseline and 24th week **Description:** Risser sign is defined as the change of the pelvic growth plate from cartilage to bone. Gradual ossification of the growth plate on the iliac apophysis from anterolateral to posteromedial is evaluated. Evaluations will be determined by the orthopedic and traumatology physician during routine follow-ups of the patient based on x-rays. **Measure:** Risser Sign Evaluation **Time Frame:** Baseline and 24th week **Description:** Trunk rotation angle will be measured with a Bunnell scoliometer. There is a metal sphere inside the scoliometer that moves between 0-30˚ in the water bed. Measurements will be made by placing the scoliometer vertically on the axial axis of the spine, perpendicular to the spinosus processes of the vertebra. The evaluation will be carried out standing, in a forward bending position with hands extended forward. To adjust the distance between the feet, the physiotherapist places one foot between the patient's two feet and the patient is positioned. By moving the scoliometer from the beginning of the thoracic region to the sacrum, the largest rotation angle in the major curvature will be recorded. In our study, trunk rotation angle will be measured and recorded at baseline, at week 12, and after 24 weeks of treatment. **Measure:** Angle of Trunk Rotation Measurement **Time Frame:** Baseline, 12th week and 24th week **Description:** Evaluation of spinal mobility was performed with a portable, computer-aided electromechanical device (the Spinal Mouse System, Idiag, Fehraltorf, Switzerland) called "Spinal Mouse" (SM). The SM is an external, non-invasive measurement device that can evaluate spinal angles and curvatures in the frontal and sagittal planes. It has been reported that SM can be used as a reliable, fast and easy-to-use measurement method with no side effects for clinical research and patient follow-up in AIS. Measurements were made between the spinous process of the 7th cervical vertebra and the top of the anal fold (approximately the level of the sacral 3rd vertebra). Maximum right-left lateral flexion degrees in the frontal plane and maximum flexion-extension degrees in the sagittal plane will be measured and recorded. **Measure:** Spinal Mobility Evaluation **Time Frame:** Baseline, 12th week and 24th week #### Secondary Outcomes **Description:** In our study, a dual inclinometer (Acumar) with an inter-individual reliability of 0.90 and an inter-test reliability of 0.85 will be used to evaluate the active repositioning sensation of the spine. Active repositioning sensation of participants' thoracic and lumbar spines; It will be measured for flexion, extension and right-left lateral flexion. In addition to these measurements in the thoracic region, right-left rotation movements will also be included in the evaluation. The absolute difference in degrees between two positions is noted as the reposition deviation value. This test is repeated 5 times for each movement. In the evaluation made before, at the 12th week and after the treatment, the average of 5 measurements will be taken and the results will be compared. The decrease in the reposition deviation value is evaluated as the improvement in the reposition feeling. **Measure:** Spinal proprioception assessment: **Time Frame:** Baseline, 12th week and 24th week **Description:** Evaluation of trunk flexion, extension and right-left lateral flexion isometric muscle strength will be performed with a manual muscle testing device, which is an objective, valid and reliable method. Trunk flexion evaluation will be performed in the 30-degree supine position, trunk extension in the prone position, and lateral flexion in the sitting position. **Measure:** Trunk Isometric Muscle Strength **Time Frame:** Baseline, 12th week and 24th week **Description:** Three core endurance tests created by McGill, consisting of the lateral bridge test, trunk extension test and trunk flexion test, will be evaluated. Before each test, the required test position will be explained to the participant and he/she will be asked to try the appropriate position. **Measure:** Trunk Muscle Endurance **Time Frame:** Baseline, 12th week and 24th week **Description:** POTSI is a valid and reliable objective method used in the evaluation of trunk asymmetry. The POTSI parameter is defined as the sum of six indices: three frontal plane asymmetry indices (C7, axilla folds, and waist lines) and three frontal plane height difference indices (acromions, axilla folds, and waist lines). The POTSI score is calculated by placing the indices in the formula on the patient's photograph taken from the posterior. The POTSI score, which indicates complete symmetry, is zero, and a higher score indicates increasing body asymmetry. In our study, SCODIAC (SCOliotic DIAgnostiCs) computer software program will be used to calculate POTSI. **Measure:** Posterior Trunk Symmetry Index (POTSI) **Time Frame:** Baseline, 12th week and 24th week **Description:** ATSI is another valid and reliable objective method used to evaluate trunk asymmetry, and its use together with POTSI is recommended in studies. It is defined as the sum of six indices determined on the patient's anterior photograph: three frontal plane asymmetry indices (stern notch, axillary folds and waist lines) and three frontal plane height difference indices (acromions, axillary folds and waist lines). Calculation is made by placing the indices into the formula. In our study, SCODIAC (SCOliotic DIAgnostiCs) computer software program will be used to calculate ATSI. **Measure:** Anterior Trunk Symmetry Index (ATSI) **Time Frame:** Baseline, 12th week and 24th week **Description:** It is a scale developed to evaluate the physical deformity perceived by patients with idiopathic scoliosis. A high score means high deformity. The scale can be completed by the patient, the person responsible for the patient's care, and the clinician performing the evaluation. In our study, this scale will be filled in by the patient. **Measure:** Walter Reed Visual Assessment Scale (WRVAS) **Time Frame:** Baseline, 12th week and 24th week **Description:** GRC is used frequently in clinical research, especially in the field of the musculoskeletal system. This scale is designed to determine the extent of improvement or deterioration of the patient over time. It also indicates the effect of an intervention or the clinical course of a condition. In the GRC scale, the patient is asked to indicate the difference between his current health status and his health status before a specific point in time. The questions asked, the number of points on the scale, and the labels assigned to the scale points may vary \[29\]. A 7-point scale (-3: much worse, -2: worse, -1: slightly worse, 0: the same, 1: slightly better, 2: quite better, 3: much better) will be used in our study. **Measure:** Global Rating of Change (GRC): **Time Frame:** Baseline, 12th week and 24th week **Description:** SRS-22 is a scoliosis-specific quality of life questionnaire with 22 questions and five subgroups. Subgroups of the survey; pain, image/appearance, function/activity, mental health and treatment satisfaction. It is defined as 0 (worst) and 5 (best) points for each question. The form will be filled out by asking patients to mark the answers that apply to them. If they do not understand the questions, the questions will be explained and the answers will be marked. **Measure:** "Scoliosis Research Society Scale-22 (SRS-22)" **Time Frame:** Baseline, 12th week and 24th week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist * Being between the ages of 10 and 15 * Risser 0-3 stage * The Cobb angle determined on the anteroposterior radiograph should be 10-30 degrees. * Major curvature being lumbar curvature * No pulmonary or rib cage-related disease such as rib fracture, atelectasis, or asthma * Ability to understand and follow instructions * Volunteering to participate in the study Exclusion Criteria: * Using a brace * Having received any scoliosis treatment or spine surgery within the last year * The patient has any contraindications to exercise * Presence of neuromuscular, orthopedic, rheumatic diseases or vestibular problems that may affect balance, vision-related diseases or mental problems. * Another exercise or physical activity that may affect trunk muscle strength or balance * Presence of any problem that may affect walking other than scoliosis * Patients who cannot understand and follow instructions **Maximum Age:** 18 Years **Minimum Age:** 10 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fztiremkurt@gmail.com **Name:** İrem KURT ULUSOY, PhD(C) **Phone:** +905326904872 **Role:** CONTACT **Contact 2:** **Email:** iyeldan@gmail.com **Name:** İpek YELDAN **Phone:** +905326904872 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** İrem Kurt **Zip:** 34147 #### Overall Officials **Official 1:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** İrem KURT ULUSOY, PhD(C) **Role:** PRINCIPAL_INVESTIGATOR ## 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: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - 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:** NCT06416566 **Brief Title:** Low-Dose Enoxaparin in Psoriasis **Official Title:** The Efficacy of Low-Dose Enoxaparin in Psoriasis #### Organization Study ID Info **ID:** Enoxaparin in psoriasis #### Organization **Class:** OTHER_GOV **Full Name:** Zagazig University ### Status Module #### Completion Date **Date:** 2024-10-01 **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:** 2024-09-01 **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:** 2024-05-10 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Zagazig University #### Responsible Party **Investigator Affiliation:** Zagazig University **Investigator Full Name:** Norhan Anees **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Rationale: * Psoriasis is a chronic immune-mediated inflammatory skin disorder where T cells play a fundamental role in its pathogenesis. * Low molecular weight heparin has been reported to exert immunomodulatory effect at small doses through inhibition of T cells heparinase enzyme. * Low molecular weight heparin may have promising results for treatment of psoriasis. Research question: * Can low molecular weight heparin be used safely for treatment of psoriasis with good outcome? * Is enoxaparin inhibitory effect on T cell heparinase enzyme responsible for its beneficial effect? Hypothesis: * Low molecular weight heparin can achieve good results when used at small doses for treatment of psoriasis. * Heparin can exert immunomodulatory effect in psoriasis through inhibition of T cell heparinase enzyme. AIM OF WORK -The aim of this work is to assess the possible clinical efficacy and safety of low-dose enoxaparin in the treatment of psoriasis and to detect if inhibition of heparinase enzyme might account for its beneficial therapeutic effect. Objectives: * To evaluate safety and efficacy of low molecular weight heparin at small dose for treatment of psoriasis. * Contribute to the ongoing efforts to optimize psoriasis management and improve the lives of individuals affected by this chronic condition. ### Conditions Module **Conditions:** - Psoriasis ### 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 **Description:** will receive subcutaneous enoxaparin **Intervention Names:** - Drug: Subcutaneous Enoxaparin **Label:** Enoxaparin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Enoxaparin **Description:** Selected patients will receive subcutaneous low dose enoxaparin once a week for 6 weeks.The level of serum heparinase enzyme will be measured before and after treatment **Name:** Subcutaneous Enoxaparin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The studied patients will be clinically evaluated weekly for 6 weeks and at follow up period; biweekly for 6 weeks **Measure:** Psoriatic Area and Severity Index score **Time Frame:** weekly for 6 weeks and at follow up period of 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with plaque psoriasis, who met the following criteria will be enrolled. 1. Age 18 and above. 2. No systemic (oral, parenteral, photobiological) treatment for psoriasis within the last 2 months. 3. No topical treatment for psoriasis within the last 2 weeks. Exclusion Criteria: * 1. Pregnancy or lactation. 2. Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia. 3. History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer, liver disease and/or abnormal liver function tests or abnormal kidney function tests. 4. History of major surgery within the last 3 months. 5. A family history of bleeding diathesis, or cerebrovascular accident. 6. Concomitant use of oral anticoagulants, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** norhan_hn_as@yahoo.com **Name:** Nourhan Anis **Phone:** +201149947355 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14422 - Name: Psoriasis - Relevance: HIGH - As Found: Psoriasis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011565 - Term: Psoriasis ### Intervention Browse Module - Ancestors - ID: D000000925 - Term: Anticoagulants - ID: D000005343 - Term: Fibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M20152 - Name: Enoxaparin - Relevance: HIGH - As Found: Fast - ID: M137075 - Name: Enoxaparin sodium - Relevance: LOW - As Found: Unknown - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017984 - Term: Enoxaparin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416553 **Brief Title:** Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinson's Disease **Official Title:** Home-based Non-invasive Brain Stimulation in Combination With Lee Silverman Voice Treatment on Hypokinetic Dysarthria in Parkinson's Disease #### Organization Study ID Info **ID:** NU22J-04-00074 #### Organization **Class:** OTHER **Full Name:** Masaryk University ### Status Module #### Completion Date **Date:** 2025-12-30 **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:** 2025-11-15 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-02-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Masaryk University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Up to 90% of patients with Parkinson's disease (PD) have hypokinetic dysarthria (HD) in the early phase of the illness. HD is characterized by a harsh breathy voice quality, reduced variability of pitch and loudness and imprecise articulation. This project investigates the novel combination of speech therapy and home-based non-invasive brain stimulation (tDCS) treatment in order to increase overall positive effects on HD in PD. Using a novel multimodal analysis approach based on functional magnetic resonance and acoustic signal processing, we will be able to monitor changes in different domains of speech, as well as associated changes in brain plasticity. **Detailed Description:** Study will investigate the long-term effects of repeated (20) sessions of home-based tDCS as an add-on to well-established remote LSVT (i.e. the gold standard procedure for HD treatment) as compared to LSVT alone (coupled with sham stimulation) in patients with PD in their "on" dopaminergic condition without dyskinesias. A two parallel-group, double-blinded, randomized, sham-stimulation-controlled design will be used. Forty PD patients will be randomized into two parallel groups by independent researcher by a computer-generated random number list, 20 subjects in each arm. Participants in the real tDCS group and the sham tDCS group will undergo a baseline assessment (V0), a follow-up assessment after four weeks of combined tDCS and LSVT treatments (V1) and another follow-up assessment 8 weeks after the baseline assessment (V2). Each visit will consist of EEG, speech tasks recording and speech evaluation by a speech therapist; MR scanning will be done at V0 and V1. Both groups will undergo the same speech therapy (LSVT) via telepractice as the gold standard treatment for HD, in combination with real or sham tDCS. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated for 4 weeks (20 sessions), stimulation will be combined with speech therapy . Other twenty PD patients will be stimulated with the same protocol using sham stimulation, sham stimulation will be combined with speech therapy. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive real tDCS during 4 weeks, 5 sessions per week. Altogether 20 sessions, each 20 minutes long. Stimulation is combined with Lee-Silverman voice treatment, 4 sessions per week. Altogether 16 sessions, each 1 hour long. **Intervention Names:** - Device: Home-based transcranial direct current stimulation- real tDCS - Behavioral: Lee-Silverman voice treatment **Label:** PD patients with real tDCS and speech therapy **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients will receive sham tDCS during 4 weeks, 5 sessions per week. Altogether 20 sessions, each 20 minutes long. Stimulation is combined with Lee-Silverman voice treatment, 4 sessions per week. Altogether 16 sessions, each 1 hour long. **Intervention Names:** - Device: Home-based transcranial direct current stimulation- sham tDCS - Behavioral: Lee-Silverman voice treatment **Label:** PD patients with sham tDCS and speech therapy **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - PD patients with real tDCS and speech therapy **Description:** Home-based transcranial direct current stimulation- anode over right STG, cathode over left STG, 2 mA stimulation with 1x1 tDCS mini-CT device by Soterix Medical **Name:** Home-based transcranial direct current stimulation- real tDCS **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - PD patients with sham tDCS and speech therapy **Description:** Home-based transcranial direct current stimulation- anode over right STG, cathode over left STG, sham stimulation with tDCS mini-CT device by Soterix Medical **Name:** Home-based transcranial direct current stimulation- sham tDCS **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - PD patients with real tDCS and speech therapy - PD patients with sham tDCS and speech therapy **Description:** Remote Lee Silverman Voice Treatment (LSVT) delivered via telepractice by speech therapist. LSVT is a high-effort speech therapy that is primarily focused on improving speech loudness during 16 individual one-hour sessions in one month. **Name:** Lee-Silverman voice treatment **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The 3F Test Dysarthric Profile enables clinicians to characterize a wide range of signs and symptoms of dysarthria. The minimum value of this scale is 0 (anarthria), the maximum value is 90 (no disorder). Higher scores of this scale mean better outcome. This test will be administrated by speech pathologist. **Measure:** Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile") **Time Frame:** At baseline assessment (Visit- V0), after completion of 4 weeks of intervention (stimulation+ speech therapy) (Visit V1) and 4 weeks after completion of intervention (Visit V2) #### Secondary Outcomes **Description:** The effect of stimulation on the resting state networks will be studied using fMRI measurement. **Measure:** Resting state fMRI **Time Frame:** At baseline assessment (Visit- V0), after completion of 4 weeks of intervention (stimulation+ speech therapy) (V1) and 4 weeks after completion of intervention (V2) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with clinically established PD (Postuma et al. 2016) Exclusion Criteria: * psychiatric disorders, including major depression, hallucinations * any MRI-incompatible metal in the body * epilepsy * lack of cooperation * presence of dementia **Maximum Age:** 85 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lubos.brabenec@ceitec.muni.cz **Name:** Lubos Brabenec **Phone:** +420731076102 **Role:** CONTACT #### Locations **Location 1:** **City:** Brno **Contacts:** ***Contact 1:*** - **Email:** lubos.brabenec@ceitec.muni.cz - **Name:** Lubos Brabenec - **Phone:** +420731076102 - **Role:** CONTACT **Country:** Czechia **Facility:** Central European Institute of Technology **Status:** RECRUITING ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - 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: M20582 - Name: Hypokinesia - Relevance: LOW - As Found: Unknown - ID: M6374 - Name: Communication Disorders - Relevance: LOW - As Found: Unknown - ID: M7575 - Name: Dysarthria - Relevance: LOW - As Found: Unknown - 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:** NCT06416540 **Brief Title:** Upper Extremity Theraband Exercises in Intensive Care Patients **Official Title:** The Effect of Upper Extremity Theraband Exercises on Respiratory Functions, Muscle Strength, Functional Mobility and Quality of Life in Intensive Care Patients #### Organization Study ID Info **ID:** ICU-THERABAND-35 #### Organization **Class:** OTHER **Full Name:** Izmir Democracy University ### Status Module #### Completion Date **Date:** 2024-11-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Izmir Democracy University #### Responsible Party **Investigator Affiliation:** Izmir Democracy University **Investigator Full Name:** Betül Taşpınar **Investigator Title:** Study Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Intensive Care Unit (ICU) is a special unit that deals with the diagnosis, treatment, and follow-up of patients who are in critical or severe condition and can not maintain their body balance. In this unit, appropriate examinations and treatments are applied to patients by experts using continuous monitoring and advanced technology 24 hours a day, 7 days a week. Immobilization is often a part of treatment in intensive care units. Long-term immobilization can lead to respiratory system problems such as mucociliary dysfunction, compromise of airway integrity, decreased lung capacity and decreased cough efficiency. Theraband exercises have been used in many settings as part of the therapeutic treatment of patients with poor motor abilities. However, there is not enough evidence in the literature as there is no study on the effectiveness of theraband exercises in the intensive care unit. Therefore, the aim of our study is; To examine the effects of upper extremity theraband exercises on respiratory functions, muscle strength, functional mobility and quality of life in intensive care patients. **Detailed Description:** Intensive Care Unit (ICU) is a special unit that deals with the diagnosis, treatment and follow-up of patients who are in critical or severe condition and can not maintain their body balance. In this unit, appropriate examinations and treatments are applied to patients by experts using continuous monitoring and advanced technology 24 hours a day, 7 days a week. Patients who require constant cardiovascular monitoring, need mechanical ventilation and renal support, have major metabolic disorders, have head trauma, chest injuries or other multiple injuries are generally admitted to this unit. Although care in the intensive care unit reduces the mortality risk of patients by up to 60%, controlled mechanical ventilation can cause musculoskeletal problems due to reasons such as inactivity, sepsis, malnutrition, insulin resistance and systemic inflammation. Immobilization is often a part of treatment in intensive care units. Long-term immobilization can lead to respiratory system problems such as mucociliary dysfunction, compromise of airway integrity, decreased lung capacity and decreased cough efficiency. These problems are associated with factors such as sedation practices, artificial airway use, and airway obstruction. These factors disrupt natural airway clearing mechanisms, make it difficult to expel phlegm, and cause secretion accumulation. Accumulation of secretion may cause obstruction of the airways, increased respiratory resistance, alveolar hypoventilation, obstruction atelectasis and the development of pneumonia. Airway closure can lead to problems associated with body weight, decrease functional residual capacity, result in consolidation, changes in endotracheal tube position, pneumonia, lobar atelectasis, collapse, acute respiratory distress syndrome (ARDS), weakness of respiratory muscles, and lung volume loss due to acute lung injury. Loss of strength in the respiratory muscles in patients connected to mechanical ventilation frequently triggers lung complications such as atelectasis, pneumothorax and pneumonia. Decrease in respiratory function, continued muscle weakness, long-term mechanical ventilation and muscle contractures may negatively affect patients' quality of life. Inadequate or incomplete treatment is associated with recurrent symptoms. In addition, immobilization may also trigger neuromuscular weakness due to disuse atrophy, decreased muscle strength, and functional impairment. This weakness can range from severe paralysis, with or without loss of deep tendon reflexes. Acquired muscle weakness involves a complex mechanism. Factors such as immobility, local and systemic inflammation affect this process. During bed rest, the use of skeletal muscles decreases, which affects the morphology, contractility and aerobic capacity of the muscles, causing atrophy and muscle weakness. The period with the greatest loss of strength is the first week of immobilization. It has been observed that the quality of life of patients hospitalized in the intensive care unit for a long time decreases and their dependency increases while performing daily life activities. This condition has been associated with decreased mobility of patients as a result of muscle weakness and immobilization. According to studies in the literature, it can generally take an average of 12 months for patients' functional levels to improve after discharge. These findings emphasize the importance of factors that may affect the quality of life and daily living activities of patients who stay in the intensive care unit for a long time. Physiotherapists working in intensive care units deal with the complications and problems associated with this type of immobilization. Early rehabilitation plays an important role in the management of these patients to create an appropriate physiotherapy program, increase mobilization levels, reduce intensive care unit and hospital stays, and improve functional ability. In the systematic review and meta-analysis by Anekwe et al., in which they examined the effects of early rehabilitation on preventing the development of muscle weakness in the intensive care unit, it was revealed that physiotherapy applications in the intensive care unit reduced the development of acquired muscle weakness in the intensive care unit by a rate ranging from 29% to 37% in the randomized population. Physiotherapy and rehabilitation practices in intensive care address the basic problems of patients while also taking into account accompanying problems. Among the objectives of these interventions are to increase mobility, prevent muscle weakness and conditioning loss, optimize function, enhance mobility, clear airway secretions, reduce the frequency of atelectasis and pneumonia, maintain or regain lung volume, reduce respiratory workload, increase oxygen transport, and improve ventilation-perfusion matching. These interventions also aim to decrease and prevent dependence on mechanical ventilation, reduce and correct complications associated with immobility, minimize morbidity, improve quality of life, increase survival, and minimize the need for post-intensive care rehabilitation. In intensive care, physiotherapy and rehabilitation interventions often require the use of different modalities in combination. In these patients, resistance muscle training can increase muscle mass and force production. In order for these exercises to be effective, it is recommended to perform 3 sets of 8-10 repetitions at an intensity between 50% and 70% of the maximum repetition, in accordance with the patient's tolerance. Equipment such as elastic bands and free weights can be used to perform in-bed exercises, but the use of these equipment should be carefully managed for the comfort and safety of the patient. These exercises facilitate weaning from mechanical ventilation and help the patient gain maximum functional capacity. Muscle exercises applied in the intensive care unit are aimed at achieving goals such as being able to perform basic daily living activities and walking 20-50 meters independently. Exercise of the lower and upper extremities is performed in intensive care patients to maintain joint mobility, as well as to improve soft tissue resistance, muscle strength and functions, and to reduce the risk of thromboembolism. Lower extremity exercise training programs can increase muscle strength and endurance in patients with peripheral muscle weakness, which may improve quality of life. Upper extremity exercises should be included in the program due to their participation in daily life activities and support for breathing. These exercises target the upper body and arm muscles, as well as the respiratory muscles. Especially in patients with severe airway obstruction, the diaphragm must be supported by accessory respiratory muscles because it cannot create sufficient inspiratory pressure. Unsupported arm exercises can reduce the support of these muscles for breathing and affect the breathing pattern. The upper extremity exercise program may include various activities such as arm ergometer, free weights and elastic bands, thus increasing upper extremity endurance and strength. Theraband is an elastic band designed to be used for a variety of purposes, introduced by the Akron Hygenic company in 1978. These bands are available in different colors and resistance levels, allowing users to tailor their workouts to their needs and skill level. Theraband exercises have been used in many settings as part of the therapeutic treatment of patients with poor motor abilities. These exercises provide activation of antagonist, stabilizer and accessory muscles. One of the most distinctive features that distinguish these bands from other resistance devices is their ability to work independently of gravity. The resistance of this flexible exercise band varies depending on how much the user stretches and is therefore based on tension level, not gravity. As you stretch the Therabands, their resistance increases, so users can achieve their desired level of difficulty. When using elastic bands, difficulty levels vary depending on the stretched measurements. Additionally, the colors of these bands also guide users on their resistance levels. Therabands come in eight different colors, and each color represents a specific level of difficulty. The color sequence progresses from easy to difficult, including tan, yellow, red, green, blue, black, gray and golden yellow. This color-coding system allows users to choose a resistance level that suits their needs and skill level, and also helps them keep track of their progress. Theraband exercises are an attractive option that can be preferred in the intensive care unit because it is a cheap and simple technique. However, the application of theraband exercises in critical illness situations such as Intensive Care Units has not yet been described in detail. In a case report, it was shown that upper extremity theraband exercises applied to a patient in the intensive care unit for 31 days provided significant improvements in the patient's movements. It was also stated that the patient's ability to maintain a sitting position on the edge of the bed improved from the 27th day. For this reason, theraband exercises are thought to be a suitable, safe and applicable method to maintain upper extremity motor activities and improve trunk control. However, there is not enough evidence in the literature as there is no study on the effectiveness of theraband exercises in the intensive care unit. Therefore, the aim of our study is; To examine the effects of upper extremity theraband exercises on respiratory functions, muscle strength, functional mobility and quality of life in intensive care patients. ### Conditions Module **Conditions:** - Exercise - Intensive Care Unit Patients **Keywords:** - Intensive Care Units - Exercise - Quality of Life - Physical Therapy Techniques ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 78 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Upper Extremity Theraband Exercises Program Exercise training will be applied in a total of 3 sets, 30-60 min/session, 5 days/week, 8-10 repetitions/set, depending on the condition of each patient, during the patients' stay in the intensive care unit. Conventional Physiotherapy and Rehabilitation Program Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. These movements will be performed once a day for 10 repetitions. **Intervention Names:** - Other: Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program - Other: Conventional Physiotherapy and Rehabilitation Program **Label:** Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group will receive only conventional rehabilitation treatment. Although the duration of the session varies depending on the patient's condition, it will last approximately 30-60 minutes. Conventional Physiotherapy and Rehabilitation Program Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. These movements will be performed once a day for 10 repetitions. **Intervention Names:** - Other: Conventional Physiotherapy and Rehabilitation Program **Label:** Conventional Physiotherapy and Rehabilitation Group (CPRG) **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG) **Description:** Upper extremity, shoulder flexion, abduction, elbow flexion and wrist extension movements will be applied to the study group by the physiotherapist in combination with the breathing pattern. The program will start with yellow therabant and the difficulty level will be increased according to the patient's condition. Exercise training will be applied in a total of 3 sets, 30-60 min/session, 5 days/week, 8-10 repetitions/set, depending on the condition of each patient, during the patients' stay in the intensive care unit. Conventional Physiotherapy and Rehabilitation Program Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. Hemodynamic and respiratory values for each level are monitored on the monitor. In addition, the patient will be monitored for symptoms such as blackness and dizziness by asking the patient. **Name:** Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Program **Other Names:** - Theraband Exercises in ICU **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Conventional Physiotherapy and Rehabilitation Group (CPRG) - Theraband Exercises plus Conventional Physiotherapy and Rehabilitation Group (TB+CPRG) **Description:** Normal joint range movements, airway clearing techniques, breathing exercises and mobilization will be applied to both groups included in the study by the physiotherapist. Hemodynamic and respiratory values for each level are monitored on the monitor. In addition, the patient will be monitored for symptoms such as blackness and dizziness by asking the patient. **Name:** Conventional Physiotherapy and Rehabilitation Program **Other Names:** - Control Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The patients' consciousness will be evaluated with the Glasgow coma scale. Scores between 3 and 7 indicate severe coma, between 8 and 11 indicate moderate coma, between 12 and 14 indicate mild coma, and 15 points indicate that the patient is not in a coma. **Measure:** Assessment of Consciousness **Time Frame:** At baseline and on average day 10 **Description:** The Charlson Comorbidity Index (CKI) will be used to evaluate the patients' accompanying problems. The total CKI score varies between 0-33. As the score increases, the degree of comorbidity also increases. **Measure:** Assessment of Comorbidity **Time Frame:** At baseline and on average day 10 **Description:** APACHE II score is a measure used to estimate the severity of the disease and the risk of mortality, taking into account the patient's clinical condition and age. This score is based on an initial 12-component score and is evaluated on a range from 0 to 71 points. As the total APACHE II score increases, the severity of the patient's condition also increases. **Measure:** Assessment of Disease Severity **Time Frame:** At baseline and on average day 10 **Description:** Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) with spirometry will be evaluated. **Measure:** Assessment of Respiratory Functions **Time Frame:** At baseline and on average day 10 **Description:** Upper and lower extremity peripheral muscle strength will be evaluated with the Medical Research Council (MRC) scale, which is a manual muscle testing method. Each muscle group is classified between 0 (complete paralysis) and 5 (normal muscle strength) points. The total MRC scale score is evaluated between 0 and 60. MRC score \<48 points indicates muscle weakness. **Measure:** Assessment of Peripheral Muscle Strength **Time Frame:** At baseline and on average day 10 **Description:** Mobilization status of the participants will be evaluated using the ICU Mobility Scale. The scale includes 11 different mobility levels. These levels range from passive mobilization (0: bedridden) to independent mobilization (10: active mobilization without assistance). As the YMS score increases, the mobility level also increases **Measure:** Assessment of Functional Mobility **Time Frame:** At baseline and on average day 10 **Description:** Participants' quality of life will be assessed using the Nottingham Health Profile (NSP). NSP is a quality of-life scale that aims to evaluate a person's self-perceived health status in emotional, physical, and social aspects. The total score varies between 0-600, and higher scores indicate worse quality of life. **Measure:** Assessment of Quality of Life **Time Frame:** At baseline and on average day 10 **Description:** The anxiety and depression status of the participants will be evaluated using the Hospital Depression and Anxiety Score (HADS). The scale has two subparameters: anxiety (HAD-A) and depression (HAD-D). It consists of fourteen items, seven of which investigate symptoms of depression and seven of which investigate symptoms of anxiety. Answers are scored between 0-3. 0-1 is considered healthy, 2 is borderline and 3-4 is considered sick. As a result of the studies, the cut-off score for the anxiety subscale was found to be 10, and the cut-off score for the depression subscale was found to be 7. Patients can score a minimum of '0' and a maximum of '21' from two subscales. **Measure:** Assessment of Anxiety and Depression Status **Time Frame:** At baseline and on average day 10 **Description:** Voluntary measurement of respiratory muscle strength will be made with a portable, electronic mouth pressure measurement device. Maximum static inspiratory pressure (MIP) and maximum static expiratory pressure (MEP) measurement are practical, voluntary measurement methods frequently used in the clinic to measure the strength of the inspiratory and expiratory muscles. The highest pressure value from the measurements will be selected for analysis. **Measure:** Assessment of respiratory muscle strength **Time Frame:** At baseline and on average day 10 **Description:** For thoracic mobility, the circumference of the thorax will be measured with a tape measure after expiration and inspiration. **Measure:** Assessment of thoracic mobility **Time Frame:** At baseline and on average day 10 **Description:** Patients' general perception of body fatigue and dyspnea will be recorded with the Modified Borg scale. A value of 0 indicates no dyspnea and fatigue, and a value of 10 indicates severe dyspnea and fatigue. **Measure:** Assessment of fatigue **Time Frame:** At baseline and on average day 10 **Description:** The patients' hand grip strength will be measured with a Jamar hydraulic hand dynamometer. With the help of the device, measurements will made three times in both hands of the patient and the grip strength is determined by taking the average. **Measure:** Assessment of hand grip strength **Time Frame:** At baseline and on average day 10 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being 18 years or older * Being conscious * Being clinically stable * Not dependent on mechanical ventilation * Being deemed suitable for physiotherapy and rehabilitation practices by an intensive care specialist Exclusion Criteria: * Having psychiatric disorders and extreme agitation * Having cooperation disorders * Having the progressive neuromuscular disease * Having any trauma to the chest wall * Having any deformity of the thorax that will affect breathing * Having diseases that require constant use of sedative or analgesic agents * Being in shock stiuation * Having cardiac and respiratory instability (FiO₂\> 55%, PaO₂\< 65 mmHg, respiratory rate \>30 breaths/min, systolic blood pressure \>200 mmHg or \<80 mmHg, diastolic blood pressure \>100 mmHg or \<50 mmHg) **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ptbetul@gmail.com **Name:** Betul Taspinar, Prof. Dr. **Phone:** 05066804426 **Role:** CONTACT **Contact 2:** **Email:** ozdemircnsu@gmail.com **Name:** Cansu Ozdemir, PT. **Phone:** 05544147277 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Izmir Democracy University **Name:** Pınar Unde Ayvat, Assoc. Prof. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Izmir Democracy University **Name:** Ferruh Taspinar, Prof. Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416527 **Brief Title:** Pompage and Photobiomodulation on Pain, Range of Motion, and Quality of Life in Patients With Neck Pain **Official Title:** Effects of Pompage Associated or Not With Photobiomodulation on Pain, Range of Motion, and Quality of Life in Patients With Neck Pain: a Controlled, Randomized, and Blinded Study #### Organization Study ID Info **ID:** 77505024300005511 #### Organization **Class:** OTHER **Full Name:** University of Nove de Julho ### Status Module #### Completion Date **Date:** 2025-03 **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:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Nove de Julho #### Responsible Party **Investigator Affiliation:** University of Nove de Julho **Investigator Full Name:** Anna Carolina Ratto Tempestini Horliana **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:** The aim of this study is to evaluate the effects of Pompage associated or not with PBM, using a cluster of LEDs, on pain and neck disability. This controlled, randomized, and blinded clinical study includes participants of both genders, aged 18 to 55, with non-specific chronic neck pain will be included. Participants will be randomized into two groups: (1) Pompage (n=28) focusing only on manual therapy through Pompage technique and (2) Pompage + PBM Group (n=28) involving the same procedures as the first group, followed by PBM with a LED cluster applied for 10 minutes to the neck region for 10 sessions. Pain and functional disability will be assessed using the visual analog scale (VAS) and Neck Pain Disability Index before and after the intervention. The resulting data will be submitted to statistical analysis considering α=0.05. **Detailed Description:** Chronic neck pain is a persistent condition affecting the spinal region, resulting in pain and restricted mobility. The management of neck pain often involves manual therapies, encompassing both passive and active interventions, aimed at alleviating pain, enhancing function, improving mobility, motor control, and reducing inflammatory processes. This pain can persist for at least three months and is considered non-specific when it is not associated with any specific underlying condition, such as inflammatory rheumatic disease, osteoporosis, cancer, or radiculopathy. The use of lasers and LEDs for photobiomodulation (PBM) represents an advantageous approach to treating neck pain, given their demonstrated therapeutic efficacy in the literature. Moreover, these resources are non-invasive and easy to apply, making them an attractive option for both patients and healthcare professionals. Therefore, the aim of this study is to evaluate the effects of Pompage associated or not with PBM, using a cluster of LEDs, on pain and neck disability. This controlled, randomized, and blinded clinical study includes participants of both genders, aged 18 to 55, with non-specific chronic neck pain will be included. Participants will be randomized into two groups: (1) Pompage (n=28) focusing only on manual therapy through Pompage technique and (2) Pompage + PBM Group (n=28) involving the same procedures as the first group, followed by PBM with a LED cluster applied for 10 minutes to the neck region. The treatment protocol consists of 10 sessions, three times weekly, excluding weekends. For PBM, a cluster comprising 264 LEDs (8 mW; 4.89J; 9.6 J/cm2; 16 mW/cm² per LED) will be used, with 132 red (660nm) and 132 infrared (850nm) LEDs. Pain and functional disability will be assessed using the visual analog scale (VAS) and Neck Pain Disability Index before and after the intervention. The resulting data will be submitted to statistical analysis considering α=0.05. ### Conditions Module **Conditions:** - Cervicalgia **Keywords:** - neck pain - photobiomodulation - LED - manual therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The participants will be divided into 2 groups: 1. Pompage Group (Control): Patients will receive treatment through the application of the pompage technique in the cervical region during 10 sessions performed 3 times per week, excluding weekends. 2. Pompage + FBM Group (Experimental): Treatment will consist of 10 sessions in which the pompage technique will be applied associated with photobiomodulation in the form of LED cluster in the cervical region, performed 3 times per week, excluding weekends. ##### Masking Info **Masking:** DOUBLE **Masking Description:** The study will be conducted by a team of researchers, including one researcher who will supervise the interventions, i.e., the application of pompages associated or not with PBM using LED clusters. This researcher will be the only one to know the intervention performed on each participant. Another researcher will conduct the initial assessment of outcomes and reevaluations (blinded to the experimental and control groups). The statistical analysis will also be performed blindly by a statistician who will receive the data without identification of the group. The patient will be blinded to the treatment with PBM (or its simulation). **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** (1) Pompage Group + photobiomodulation placebo (Control): Patients will receive treatment through the application of the pompage technique in the cervical region during 10 sessions performed 3 times per week, excluding weekends. **Intervention Names:** - Procedure: Pompage Technique (manual therapy) - Device: Photobiomodulation (Placebo) **Label:** Pompage and photobiomodulation (placebo) **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** (2) Pompage + photobiomodulation (PBM) Group (Experimental): Treatment will consist of 10 sessions in which the pompage technique will be applied associated with photobiomodulation in the form of LED cluster in the cervical region, performed 3 times per week, excluding weekends. **Intervention Names:** - Device: Photobiomodulation (Experimental) - Procedure: Pompage Technique (manual therapy) **Label:** Pompage + photobiomodulation (Experimental) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Pompage + photobiomodulation (Experimental) **Description:** The photobiomodulation with a diode emitting light (LED) cluster device will be positioned on the cervical region of each patient (for 10 minutes each). **Name:** Photobiomodulation (Experimental) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Pompage + photobiomodulation (Experimental) - Pompage and photobiomodulation (placebo) **Description:** To perform cervical Pompage the patient lies comfortably on their back or sits upright. The therapist locates the target area on the cervical spine. Using gentle pressure, the therapist applies traction to the cervical spine, stretching the muscles and fascia. The traction is held for 20 seconds. The therapist then releases the traction, allowing the cervical spine to return to its neutral position. This process will be repeated 3 times, with adjustments made based on the patient's response and comfort level. **Name:** Pompage Technique (manual therapy) **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Pompage and photobiomodulation (placebo) **Description:** The photobiomodulation with a diode emitting light (LED) cluster device will be positioned on the cervical region of each patient (for 10 minutes each) with the device turned off (inactive), simulating the time with a recorded beep sound. **Name:** Photobiomodulation (Placebo) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The Visual Analog Scale (VAS) consists of a visual graduated scale from 0 to 10 cm, where 0 represents the absence of pain and 10 represents very intense pain, used to measure the pain experienced by the patient. This scale will be used for assessment and to monitor treatment progression. The patient is asked about the intensity of their pain, and the corresponding number on the scale is marked. **Measure:** Pain baseline **Time Frame:** Baseline **Description:** The Visual Analog Scale (VAS) consists of a visual graduated scale from 0 to 10 cm, where 0 represents the absence of pain and 10 represents very intense pain, used to measure the pain experienced by the patient. This scale will be used for assessment and to monitor treatment progression. The patient is asked about the intensity of their pain, and the corresponding number on the scale is marked. **Measure:** Pain at the end **Time Frame:** At the 50th day of the protocol (at the end of Session 10) #### Secondary Outcomes **Description:** The Goniometer is an instrument used to measure the degrees of range of motion (ROM) of the cervical region, with normal standards considered as follows: flexion from 0 to 65 degrees; extension from 0 to 50 degrees; lateral flexion to the right and left from 0 to 40 degrees; right and left rotation from 0 to 55 degrees. It will be used for assessment and monitoring of treatment progression. **Measure:** Cervical Range of Motion at baseline **Time Frame:** Baseline **Description:** The Goniometer is an instrument used to measure the degrees of range of motion (ROM) of the cervical region, with normal standards considered as follows: flexion from 0 to 65 degrees; extension from 0 to 50 degrees; lateral flexion to the right and left from 0 to 40 degrees; right and left rotation from 0 to 55 degrees. It will be used for assessment and monitoring of treatment progression. **Measure:** Cervical Range of Motion at the end **Time Frame:** At the 50th day of the protocol (at the end of Session 10) **Description:** To assess the quality of life of the participants, the WHOQOL-BREF will be utilized, an abbreviated instrument developed by the World Health Organization. This questionnaire will consist of 26 items distributed across four main domains: Physical, Psychological, Social Relationships, and Environment. Each item will be rated on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"). The scores for each domain will be calculated from the averages of the corresponding item responses, multiplied by 4 to transform the results into a scale of 0 to 100. Higher scores will indicate a better perception of quality of life in the specific domain **Measure:** Quality of Life at baseline **Time Frame:** Baseline **Description:** To assess the quality of life of the participants, the WHOQOL-BREF will be utilized, an abbreviated instrument developed by the World Health Organization. This questionnaire will consist of 26 items distributed across four main domains: Physical, Psychological, Social Relationships, and Environment. Each item will be rated on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"). The scores for each domain will be calculated from the averages of the corresponding item responses, multiplied by 4 to transform the results into a scale of 0 to 100. Higher scores will indicate a better perception of quality of life in the specific domain **Measure:** Quality of Life at the end **Time Frame:** At the 50th day of the protocol (at the end of Session 10) **Description:** The Neck Disability Index (NDI) questionnaire, which assesses the degree of functional disability of the cervical region, is a self-administered questionnaire consisting of 10 sessions with 6 responses, reflecting 6 stages of functional disability, with scores ranging from 0 to 5, where 0 represents the lowest and 5 represents the highest level of disability. **Measure:** Degree of Functional Disability at the baseline **Time Frame:** Baseline **Description:** The Neck Disability Index (NDI) questionnaire, which assesses the degree of functional disability of the cervical region, is a self-administered questionnaire consisting of 10 sessions with 6 responses, reflecting 6 stages of functional disability, with scores ranging from 0 to 5, where 0 represents the lowest and 5 represents the highest level of disability. **Measure:** Degree of Functional Disability at the end **Time Frame:** At the 50th day of the protocol (at the end of Session 10) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 18 and 55 years; * Both genders; * Without comorbidities. Exclusion Criteria: * Presentation of rheumatic or degenerative diseases in the cervical region; * Undergoing orthodontic or physiotherapeutic treatment; * Initiation of the use of any medication during any phase of the study; * Using bite plate. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dedekau@gmail.com **Name:** Denise Cekaunaskas Kalil Lauand, pHD **Phone:** +55(11)997710040 **Role:** CONTACT **Contact 2:** **Email:** raquelmesquita@uni9.pro.br **Name:** Raquel Agneli Mesquita Ferrari, pHD **Phone:** +55(11) 999192988 **Role:** CONTACT #### Locations **Location 1:** **City:** São Paulo **Country:** Brazil **Facility:** Anna Carolina R.T. Horliana **State:** SP **Zip:** 11030-480 ## 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 - Abbrev: BXM - Name: Behaviors and Mental Disorders ### 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 - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000019547 - Term: Neck Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416514 **Brief Title:** Personalized Interventions Via Health Portraits in Mild Behavioral Impairment **Official Title:** Construction and Empirical Study of Personalized Intervention Based on Health Portrait in Mild Behavioral Impairment #### Organization Study ID Info **ID:** 2023-177 #### Organization **Class:** OTHER **Full Name:** Fujian Provincial Hospital ### Status Module #### Completion Date **Date:** 2027-12-30 **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:** 2026-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-16 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fujian Provincial Hospital #### Responsible Party **Investigator Affiliation:** Fujian Provincial Hospital **Investigator Full Name:** Yuanjiao Yan **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The incidence of MBI and the probability of progression to dementia are high. Early detection and intervention have important clinical significance to reduce the occurrence of dementia, delay the progression of dementia and promote healthy aging to active aging. The occurrence and development of NPS in MBI patients may be related to genetic and degenerative changes in the central nervous system. The evaluation of MBI patients is mainly based on neuropsychological tests, including NPS and cognitive function assessment. Landmark model is an effective tool for dynamic risk prediction of the progress of MBI. It can make dynamic prediction at different time points according to various existing measurement indicators of an individual and calculate the individual prediction probability, which is one of the best models for studying the outcome of disease at present. The Landmark model is applied to the elderly MBI population to study the influencing factors of normal aging, MBI and dementia and the probability of metastasis, which is a beneficial attempt to further advance the defense line of dementia. Personalized non-drug intervention is the preferred treatment for MBI, which mainly includes cognitive/emotional intervention, sensory stimulation, exercise therapy, etc. Currently, it is recommended to adopt diversified strategies to implement individualized precision treatment programs for patients. The hierarchical and classified health management of elderly MBI patients combined with health portrait technology is helpful to improve management efficiency and better meet the needs of personalized health management for the elderly. **Detailed Description:** Combined with the current situation of relevant research at home and abroad, it can be seen that the research in this field still has the following limitations:First, as a population with a high incidence of dementia, there are many studies on the influencing factors of dementia in elderly MBI, but there is heterogeneity in research design and other aspects, and no studies have effectively integrated it. Therefore, determining the risk factors of MBI in the elderly is helpful for effective risk factor management in the early stage of dementia, which is of great significance for delaying the speed of MBI in the elderly and reducing the burden of family and society.Second, most current studies are cross-sectional studies or the development and testing of assessment tools, and few studies pay in-depth attention to the development and change of NPS, ignoring the possibility of reversal of MBI. Further understanding of the natural history of MBI and the influence of demography, environment, lifestyle and other related factors on the occurrence and development of MBI, and understanding the change law of the occurrence and development of MBI are of great importance to find the breakthrough point of early and effective intervention.Third, there is still a lack of management guidelines for MBI, and it is urgent to develop personalized non-drug interventions for MBI patients. "Human-centered" multiple personalized intervention is expected to improve NPS symptoms in MBI patients, reduce the occurrence of dementia, and delay the progression of dementia.Fourth, as an emerging technology, health portrait has made some progress in the management of chronic disease symptoms at home and abroad, but its application in the specific subdivision of chronic disease management in the elderly is still limited. The application of health portrait in the management of NPS symptoms in elderly MBI patients is a new exploration.Therefore, this study raises three research questions: First, what is the current situation of mild behavioral impairment in the elderly? What are the relevant factors? Second, what are the risk factors that affect the outcome of mild behavioral impairment in the elderly? What is the probability of metastasis between different states in elderly patients with mild behavioral impairment? Third, how to build a personalized program for elderly MBI patients in China based on user portraits? How scientific, feasible and safe is it?In view of the above research problems, this study first understood the status quo of mild behavioral impairment in the elderly and explored its related factors; Then, the prediction model of mild behavioral impairment in the elderly was constructed to explore the factors affecting its outcome and its transfer probability. Finally, a personalized intervention system for elderly patients with mild behavioral impairment based on health profiles was developed and tested. The significance of this study is that in the context of the rapid development of population aging, the increasing promotion of the strategy of healthy China and the national strategy of actively coping with population aging, the completion of this study is expected to clarify the development and change mechanism of MBI, provide new ideas and new methods for the management of MBI patients, and also provide new evidence for the prevention and treatment of dementia high-risk groups. This is a low-cost and efficient strategic choice to deal with the aging population and reduce the burden of dementia, and has a good scientific application prospect and practical significance. ### Conditions Module **Conditions:** - Neurocognitive Disorders **Keywords:** - Mild behavioral impairment - Older adults - Personalized intervention - Health portrait - Neuropsychiatric symptoms ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with high social participation were more active in health management and monitoring due to their high social participation. NPS symptoms were monitored regularly for patients in the different groups, and personalized interventions were developed according to the development of NPS symptoms and patient preferences. **Intervention Names:** - Other: Personalized intervention **Label:** Patients with high social participation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In the low social participation group, due to the low social participation of patients, their initiative to participate in health management and monitoring is also low. For the patients in the reorganized group, their self-confidence and enthusiasm to participate in activities are first enhanced through health education and health popularization, and NPS symptoms are regularly monitored, and personalized intervention measures are formulated according to the development of NPS symptoms and patient preferences. **Intervention Names:** - Other: Personalized intervention **Label:** Patients with low social participation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with high social participation - Patients with low social participation **Description:** Personalized intervention means implementing multi-component non-pharmacological interventions based on different health profiles，such as art therapy, exercise therapy, cognitive therapy and other monotherapies. Usual care means care as routine. **Name:** Personalized intervention **Other Names:** - Usual care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Montreal Cognitive Assessment Scale, developed by Nasreddine in 2004 to assess participants' general cognitive function, covers eight areas of cognitive assessment, including visuospatial and executive function, naming, memory, attention, speech, abstraction, delayed recall, and orientation. The Changsha version of the Montreal Cognitive Assessment Scale was used in this study, and its Cronbach's α coefficient was 0.846, retest reliability was 0.974, and investigator reliability was 0.969. The score of the Montreal Cognitive Assessment Scale ranges from 0 to 30 points. The higher the score, the better the cognitive function of the study subjects. The illiterate group ≤13, the primary school group ≤19, and the junior high school and above group ≤24 can be judged as impaired cognitive function to correct the bias caused by education level **Measure:** General cognitive function **Time Frame:** The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately #### Secondary Outcomes **Description:** The Pittsburgh Sleep Quality Index, developed by Buysse equals in 1989, was used to evaluate the sleep status of the participants over the past month. The Pittsburgh Sleep Quality Index includes seven components: subjective sleep quality, sleep duration, sleep duration, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function, with good internal consistency (Cronbach's α=0.83) and retest reliability (r=0.85). The cumulative score for each component of the Pittsburgh Sleep Quality Index Scale is the total score of the scale, ranging from 0 to 21, with a score of 0 to 3 for each component, with higher scores associated with poorer sleep quality **Measure:** Sleep condition **Time Frame:** The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately **Description:** The Social Support Rating Scale was used to assess participants' social participation. This study adopted the social support assessment compiled by domestic scholar Xiao Shuiyuan, which has good reliability and validity (Cronbach's α coefficient is 0.83). There are 10 items in the social support evaluation, including objective support, subjective support and social support utilization. The score ranges from 11 to 40 points. The higher the score of each dimension, the higher the degree of social support. It is generally believed that the total score of 20 is poor social support, 20-30 is general social support, and 30-40 is satisfactory social support **Measure:** Social participation **Time Frame:** The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately **Description:** The Condensed Mental State Scale, developed by Folstein et al., is increasingly being used to screen patients for dementia, determine the severity of cognitive impairment, and determine dementia transition. The sensitivity and specificity of the concise mental State scale in the screening diagnosis of dementia are 80-90% and 70-80%. The scale covers cognitive areas such as orientation, memory, attention and computation, speech and visuospatial. The Condensed Mental State Scale ranges from 0 to 30 points. Dementia can be graded according to the Condensed Mental State Scale, with mild dementia scoring 21-26, moderate dementia 11-20, and severe dementia 0-10 **Measure:** Dementia conversion rate **Time Frame:** The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately **Description:** The Neuropsychiatric Scale (NPI) is also a suitable tool for assessing NPS in patients with MBI. The Neuropsychiatric Scale is a scale developed by Cummings et al. to assess NPS in dementia patients, including hallucinations, delusions, agitation/aggression, anxiety, depression, euphoria, loss, disinhibition, abnormal movement, appetite disorders, sleep and nocturnal behavior disorders. The Chinese version of neuropsychiatric scale has good reliability and validity with Cronbach's α coefficient of 0.851, bias coefficient of 0.83, and total retest reliability of 0.86. The neuropsychiatric scale is easy to use and provides a way for semi-structured interviews to distinguish symptoms of inhibition from symptoms of apathy. Neuropsychiatric scale patient scores ranged from 0-144, caregiver pain scores ranged from 0-60, the lower the score the better **Measure:** Psychological symptoms **Time Frame:** The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately **Description:** The Mild Behavioral Impairment checklist (MBI-Checklist) asseses subjects to assess the symptoms and severity of MBI and was developed by ISTAART after the publication of diagnostic criteria for MBI in 2016. The mild behavioral impairment Checklist, filled out by a family member or someone in the know, has five categories, including lack of motivation, emotional incoordination, impulse control disorders, social withdrawal, and perceptual or thinking abnormalities. The sensitivity and specificity of the mild behavioral impairment checklist were 86.96% and 86.00%. The mild behavioral Impairment Checklist scores range from 0 to 102, with the higher the total score, the higher the degree of mild behavioral impairment **Measure:** Behaviour impairment **Time Frame:** The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Meet the ISTAART diagnostic criteria for MBI; * Age ≥60 years old; * No obvious visual or hearing impairment; * Have the ability of language communication, can complete the scale assessment. Exclusion Criteria: * Patients with severe physical diseases and unable to complete cognitive function screening; * Patients with other neurological diseases and serious medical diseases that can cause brain dysfunction. **Healthy Volunteers:** True **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Cordelia88@163.com **Name:** Shi Yanhong **Phone:** 89-15150947040 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Shengli clinical medical college of Fujian Medical university **Name:** Yuanjiao Yan, PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - 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: M21836 - Name: Neurocognitive Disorders - Relevance: HIGH - As Found: Neurocognitive Disorders - 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: D000019965 - Term: Neurocognitive Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416501 **Brief Title:** The Impact of Colorectal Cancer Screening on Surgical Outcomes **Official Title:** The Impact of Colorectal Cancer Screening on Surgical Outcomes #### Organization Study ID Info **ID:** FudanUcf #### Organization **Class:** OTHER **Full Name:** Fudan University ### Status Module #### Completion Date **Date:** 2024-06-15 **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:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-11 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **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:** Fudan University #### Responsible Party **Investigator Affiliation:** Fudan University **Investigator Full Name:** LI XIN-XIANG **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:** This study aims to investigate the pathological characteristics and surgical outcomes of stage III CRC patients detected through screening. Data extracted from the database included the following patient information: age at diagnosis, gender, tumor location, neoadjuvant therapy, surgical procedures, histologic type, differentiation, vascular invasion, perineural invasion, pathological T stage, pathological N stage, and survival outcomes. ### Conditions Module **Conditions:** - Prognosis - Colorectal Cancer - Screening ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 4000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who were detected through any screening test were categorized into the screening group **Intervention Names:** - Other: Mode of detection **Label:** screening #### Arm Group 2 **Description:** Patients who were detected based on symptoms formed the non-screening group. **Label:** nonscreening ### Interventions #### Intervention 1 **Arm Group Labels:** - screening **Description:** Mode of detection **Name:** Mode of detection **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first. Assessed up to 100 months. **Measure:** overall survival **Time Frame:** the duration from the initial treatment to either death from any cause or the last recorded follow-up, whichever came first. Assessed up to 100 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who underwent radical surgery for CRC, had confirmed stage III CRC through postoperative pathology, had no prior history of cancer before surgery, and had clear cancer detection information. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients who underwent surgical intervention for CRC at Fudan University Shanghai Cancer Center. ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** Xinxiang Li **State:** Shanghai **Zip:** 200032 ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: 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 ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - 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 ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416488 **Brief Title:** High-Intensity Interval Training(HIIT) on Cardio-metabolic Risk in School-age Children **Official Title:** The Effect of High-Intensity Interval Training(HIIT) on Cardio-metabolic Indicators in School-age Children With High Cardiovascular Diseases Risk--a Randomised Intervention Trial #### Organization Study ID Info **ID:** M-TABATA #### Organization **Class:** OTHER **Full Name:** Children's Hospital of Fudan University ### 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:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **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:** 2024-05-09 **Study First Submit QC Date:** 2024-05-15 ### 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:** False ### Description Module **Brief Summary:** This study aims to evaluate the health promotion effects of high-intensity interval training (HIIT) intervention on school-age children who are at high risk for cardiovascular disease (CVD), as well as the long-term adherence and acceptability of HIIT in this population for future application. **Detailed Description:** Evidence shows that physical activity is positively associated with cardiovascular and metabolic health in children and adolescents, including promoting lipid health, regulating blood pressure levels, and glucose metabolism. Physical activity intervention for overweight or obese children can lower body mass index, total fat mass, and abdominal fat mass, and further prevent chronic diseases such as cardiovascular and metabolic diseases. High-intensity interval training (HIIT) has been a recent research focus. Previous studies have demonstrated that HIIT can contribute to improving body composition, reducing visceral fat, and enhancing cardiovascular and pulmonary function. Moreover, compared to other trainings, HIIT is time-efficient and adaptable to various sports, thus leading to higher compliance. However, there has been a lack of evidence regarding the intervention effects of this exercise in overweight and obese children and adolescents, and whether it can impact or even reverse cardio-metabolic risks remains unknown. Therefore, this intervention trial might have implications and practical significance on the feasibility of promoting HIIT among this population. ### Conditions Module **Conditions:** - Cardiovascular Syndrome, Metabolic **Keywords:** - Cardiovascular diseases - Metabolic disorders - High-Intensity Interval Training - School-aged children - Childhood obesity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 336 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HIIT group will follow modified HIIT in Tabata mode, at least 3 times per week, with 3-month compulsory period and 9-month follow-up period. General health education on promoting health diet and exercise will be sent to HIIT group via offline and online promotion materials during the whole study period of 12 months. **Intervention Names:** - Behavioral: HIIT intervention - Behavioral: General health education **Label:** HIIT group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** General health education on promoting health diet and exercise will be sent to general health education group via offline and online promotion materials during the whole study period of 12 months. **Intervention Names:** - Behavioral: General health education **Label:** General health education group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - HIIT group **Description:** Modified HIIT in Tabata mode, which followed a pattern of 3 sets, with each set consisting of 4 repetitions of 20 seconds of high-intensity exercise followed by 10 seconds of rest, at least 3 times per week. **Name:** HIIT intervention **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - General health education group - HIIT group **Description:** General instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants. **Name:** General health education **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 3rd month of study phrase. Reversal of cardiometabolic abnormalities is defined as: at 3rd month of study phrase, at least one of the following status changed from abnormal at baseline to normal: i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure. **Measure:** Number of participants with reversal of at least one cardio-metabolic abnormalities **Time Frame:** 3rd month since baseline #### Secondary Outcomes **Description:** It is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 12th month of study phrase. Reversal of cardiometabolic abnormalities is defined as: at 12th month of study phrase, at least one of the following status changed from abnormal at baseline to normal: i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure. **Measure:** Number of participants with reversal of at least one cardio-metabolic abnormalities **Time Frame:** 12th month since baseline **Description:** Body mass index(BMI) will be calculated by body weight(kg)/(height(m)\^2), based on BMI z score and percentiles by sex and age according to Chinese children growth curves. Body weight and height will be measured by trained professionals. **Measure:** Body mass index **Time Frame:** 3rd and 12th month since baseline **Description:** Waist-to-height ratio(WHtR) will be calculated by waist circumference(cm)/height(cm). Waist circumference and height will be measured by trained professionals. **Measure:** Waist-to-height ratio **Time Frame:** 3rd and 12th month since baseline **Description:** Body fat(%) will be directly derived from non-invasive DEX body composition analyser, assessed by professional operator. **Measure:** Body fat (%) **Time Frame:** 3rd and 12th month since baseline **Description:** Average amount of calories(kcal) when at complete rest (2 hours after meals), measured by a Parvo Medics TrueOne 2400 mask to measure exchanges of gases. **Measure:** Resting metabolic rate **Time Frame:** 3rd and 12th month since baseline **Description:** Maximal oxygen uptake(VO2max) will be measured by a Parvo Medics TrueOne 2400 mask after treadmill (Pulsar 4.0，h/p/Cosmos Sports and Medical GMBH , Germany). **Measure:** Maximal oxygen uptake（ml/min/kg) **Time Frame:** 3rd and 12th month since baseline **Description:** Sleep quality monitoring for 1 week using sleep watch （Micro Motionlogger Watch）to measure total duration of sleeping (minutes). **Measure:** Sleep quality **Time Frame:** 3rd and 12th month since baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 7-18 years at baseline. * At least one of the following cardio-metabolic abnormalities: 1. Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/L; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/L). 2. Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol/L; or Low-density lipoprotein cholesterol ≥ 3.37 mmol/L; or Triglycerides ≥ 1.70 mmol/L, or Total cholesterol ≥ 5.18 mmol/L). 3. Elevated blood pressure (Systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmHg). * Written consent from participants and their guardians. Exclusion Criteria: * Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation. * Taking weight loss drugs, or undergone weight loss surgery. * Attending behavior-based intervention programs (exercise or diet) within a year. * Regular HIIT (at least once per week). * Secondary obesity, such as neuropsychiatric disorders, endocrine disorders, sleep apnea syndrome, or other conditions. * Unable to take interventions due to health conditions, such as joint diseases, fractures, injuries. * Other situations unsuitable for participation. **Maximum Age:** 18 Years **Minimum Age:** 7 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wennanhe@fudan.edu.cn **Name:** Wennan He **Phone:** +8664932921 **Role:** CONTACT **Contact 2:** **Email:** yanwl@fudan.edu.cn **Name:** Weili Yan **Phone:** +8664931215 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007333 - Term: Insulin Resistance - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### 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: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M30155 - Name: Pediatric Obesity - Relevance: LOW - As Found: Unknown - ID: M23005 - Name: Metabolic Syndrome - Relevance: HIGH - As Found: Cardiovascular Syndromes, Metabolic - ID: M10370 - Name: Insulin Resistance - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000024821 - Term: Metabolic Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416475 **Brief Title:** The Effect of Mankai on Glycemic Control Among Patients With T2D **Official Title:** The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A 3-month Randomized Controlled Pilot Trial #### Organization Study ID Info **ID:** SOR-0259-23 #### Organization **Class:** OTHER **Full Name:** Ben-Gurion University of the Negev ### Status Module #### Completion Date **Date:** 2024-08-15 **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:** 2024-08-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-03-21 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Soroka University Medical Center #### Lead Sponsor **Class:** OTHER **Name:** Ben-Gurion University of the Negev #### Responsible Party **Investigator Affiliation:** Ben-Gurion University of the Negev **Investigator Full Name:** Iris Shai **Investigator Title:** Prof. Iris Shai **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators aim to explore the effect of daily supplementation of Wolfia globosa Mankai on HbA1c and insulin resistance response among participants with type 2 diabetes (T2D). The investigators hypothesize that adding daily Mankai to T2D's healthy nutrition might lower HbA1c and promote glycemic control. Methods: A 3-month pilot RCT among 104 patients with T2D, with two intervention arms consuming comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or water (60ml) 3 times/day postprandially over 3 months. Blood, urine, fecal, and clinical measures will be taken at 0 and 3 months. Overall appetite, food intake, symptoms, and medical treatment will be monitored. Importance: This study's results will shed light on the effects of regular Mankai consumption on HbA1c among patients with T2D, which may reveal a new nutritional source to improve glycemic control in T2D. **Detailed Description:** Type 2 diabetes (T2D), most commonly stemming from sustained obesity, adiposity, and a sedentary lifestyle, is strongly associated with increased cardiovascular risk. Glycated hemoglobin A1c (HbA1c), reflecting glycemic control, is tightly related to cardiovascular risk. In the recent decade, several antihyperglycemic medications have been shown to modify cardiovascular risk among patients with established cardiovascular disease. Maintaining a healthy diet, preferably a Mediterranean-like diet, rich in plant-based protein and low in meat products, is the first-line intervention to promote glycemic control and reduce cardiovascular risk among T2D. However, whether specific nutritional products may independently promote glycemic control beyond medical treatment is unclear. Mankai, a newly cultivated duckweed Wolffia-globosa strain, has been extensively studied in recent years. Mankai is rich in whole bioavailable protein, iron, and vitamin B12 and is rich in 200 different potent polyphenols, potentially affecting the metabolomic-gut-clinical axis. Mankai consumption, as a dominant part of the green-Mediterranean diet, was shown to promote weight loss, systemic inflammation lowering, and cardiometabolic risk reduction and was associated with regressions in hepatosteatosis, visceral abdominal adiposity, and proximal aortic stiffness among patients with abdominal obesity with or without T2D. Also, Mankai consumption was mainly linked with improved glycemic control, dramatic elevation in fasting Ghrelin levels, and insulin sensitivity recovery. Regular Mankai consumption promoted microbiome optimization, mainly impacting bacterial glucose metabolism and human glucose control. In this proposed study, The investigators aim to explore the effect of daily consumption of 60mL crude plant Mankai beverage boost after 3 meals among patients with T2D on HbA1c levels (gold-standard for assessing glycemic control, primary outcome). "Mankai" is a cultivated strain of Wolffia globosa, an aquatic plant, part of the family of plants known commonly as duckweeds. Duckweeds are elementary flowering aquatic plants floating on or beneath still or slow-moving water bodies. There is a long history of using Wolffia species, particularly Wolffia globosa, as food, especially in Southeast Asia: Burma, Laos, and northern Thailand, where it has been used as a vegetable for many generations. The plant is cultivated locally in rain-fed open ponds, grown commercially in Thailand, and sold in local markets throughout Thailand and Laos. There are numerous ways of Wolffia globosa consumption and a variety of recipes, using it either as the main ingredient (such as Wolffia crisps or "Kaeng pum" - a popular vegetable dish in northeastern Thailand) or incorporating it in other foods (e.g., Wolffia-meat ball, fermented Wolffia-meat sausage, Wolffia rice noodle, Wolffia cookies, Wolffia bread, and various soups and salads). Moreover, Wolffia is known as one of the essential food sources in northern Thailand. Along with its long history as a food source in Southeast Asia, it is recognized as an edible vegetable for humans in several databases, including the USDA (2014) GRIN database and a database dedicated to tropical species. For the proposed clinical trial, Mankai will be provided as a beverage, refrigerated at ±4°C. Participants will consume Mankai as an additional additive to a standardized healthy Mediterranean diet. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 **Keywords:** - clinical trial - Diabetes Mellitus, Type 2 - nutritional intervention - Mankai Duckweed - Wolffia-globosa - polyphenols ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A 3-month Randomized Controlled pilot Trial among 104 patients with T2D, who will be randomly allocated to consume comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or water (60ml) on top of a standardized MediterraneanT2D-recommended healthy diet, after morning, lunch, and dinner over 3 months. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 104 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Three times a day supplementation of postprandial Mankai duckweed drink (60mL crude plant Mankai beverage) right after breakfast, lunch, and dinner while maintaining the recommended Mediterranean diet lifestyle and medical treatment. **Intervention Names:** - Dietary Supplement: Mankai supplementation **Label:** Mankai supplementation group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Three times a day consumption of postprandial water (60mL) right after breakfast, lunch, and dinner while maintaining the recommended Mediterranean diet lifestyle and medical treatment. **Intervention Names:** - Other: Water consumption **Label:** Water group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Mankai supplementation group **Description:** The overall dose of the three Mankai duckweed beverages/day contains \~10 grams of dry matter. **Name:** Mankai supplementation **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Water group **Description:** Water consumption **Name:** Water consumption **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Glycated hemoglobin-HbA1c; as detected by a standard laboratory measure **Measure:** HbA1c **Time Frame:** Baseline and three months time points **Description:** Fasting glycemic and insulin resistance profiling \[using calculated homeostatic model assessment of insulin resistance (HOMA-IR) as detected by laboratory assessment\] **Measure:** Fasting glycemic and insulin resistance profiling **Time Frame:** Baseline and three months time points #### Secondary Outcomes **Description:** Changes in lipid biomarkers (blood draw), such as LDL (mg/dL), HDL (mg/dL), TG (mg/dL), total cholesterol (mg/dL), Lipoprotein (a) (mg/dL) **Measure:** Lipid profile **Time Frame:** Baseline and three months time points **Description:** Changes in lipid biomarkers (blood draw), such as apo(A)1(g/L), apo(B)100 (g/L) **Measure:** Lipid profile **Time Frame:** Baseline and three months time points **Description:** Changes in hormone and adipokine biomarkers (blood draw); such as total adiponectin (ug/ml), RBP4 (ug/ml), chemerin (ng/ml), vaspin (ng/ml), omentin-1(ng/ml), MCP-1 (pg/ml) **Measure:** Hormones and adipokines **Time Frame:** Baseline and three months time points **Description:** Changes in inflammatory biomarkers (blood draw); such as CRP (mg/dl), IL-1 (pg/mL), IL-6 (pg/mL), IL10 (pg/mL), IL-17 (pg/mL), TNF-alpha (pg/mL) **Measure:** Inflammatory biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in Hunger/satiety hormones (blood draw); such as leptin(ng/ml), ghrelin(pg/ml), neuropeptide Y (NPY) (pg/ml), cholecystokinin (CCK) (pmol/L), peptide YY (PYY) (pmol/L), and incretins (e.g., oxyntomodulin (pmol/L) and glucagon-like peptide-1 (GLP-1)(pmol/L)\] **Measure:** Hunger/satiety hormones **Time Frame:** Baseline and three months time points **Description:** Changes in CVD biomarkers (blood draw); such as Homocysteine (ug/dL) **Measure:** CVD biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in CVD biomarkers (blood draw); such as Renin (iU/ml) **Measure:** CVD biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in CVD biomarkers (blood draw); such as Troponin (cardiac troponin I and T) (ng/ml) **Measure:** CVD biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in CVD biomarkers (blood draw); such as NT-pro-BNP (pg/ml) **Measure:** CVD biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in liver function biomarkers (blood draw); such as Alkaline Phosphatase (U/L), Alanine Aminotransferase (U/L), Aspartate Aminotransferase (U/L), bilirubin (mg/dL) **Measure:** Cardiometabolic health-Liver function (blood biomarkers) **Time Frame:** Baseline and three months time points **Description:** Changes in liver function biomarkers (blood draw); such as bilirubin (mg/dL) **Measure:** Cardiometabolic health-Liver function (blood biomarkers) **Time Frame:** Baseline and three months time points **Description:** Changes in HPA axis biomarkers (blood draw); such as ACTH (pmol/L) **Measure:** HPA axis biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in HPA axis biomarkers (blood draw); such as cortisol (nmol/L) **Measure:** HPA axis biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in HPA axis biomarkers (blood draw); such as cortisone (microg/L) **Measure:** HPA axis biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in HPG axis; such as Testosterone (nmol/L), SHBG (nmol/L), IGF1 (nmol/L) **Measure:** HPG axis biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in HPG axis; such as LH (IU/mL) **Measure:** HPG axis biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in HPG axis; such as FSH (IU/L) **Measure:** HPG axis biomarkers **Time Frame:** Baseline and three months time points **Description:** Changes in HPG axis; such as GH (pmol/L) **Measure:** HPG axis biomarkers **Time Frame:** Baseline and three months time points **Description:** Assessed by questionnaires; 1. Screening questionnaire 2. I-MEDAS (Mediterranean Diet Adherence Screener) questionnaire - the 14-item MEDAS questionnaire (scale 0-17, higher score indicated higher adherence to Mediterranean diets), 3. Validated physical activity questionnaire, 4. Symptoms questionnaire, 5. Medical questionnaire, and 6. A follow-up questionnaire. **Measure:** Well being **Time Frame:** Baseline and three months time points **Description:** Shannon Diversity Index (where 0 indicates no diversity, there is no upper limit to the index, usually between 1.5 - 3.5). **Measure:** Microbiota profiling **Time Frame:** Baseline and three months time points **Description:** Bodyweight will be measured without shoes to the nearest 0.1 kg. **Measure:** Weight **Time Frame:** Baseline and three months time points **Description:** WC will be measured halfway between the last rib and the iliac crest to the nearest millimeter by standard procedures using a 150-cm anthropometric measuring tape. **Measure:** Waist circumference **Time Frame:** Baseline and three months time points **Description:** Weight and Height will be combined to report BMI in kg/m\^2 **Measure:** BMI **Time Frame:** Baseline and three months time points **Description:** Blood pressure will be measured and determined using an automated system in mmHg. Both systolic and diastolic blood pressure will be measured. **Measure:** Blood pressure **Time Frame:** Baseline and three months time points **Description:** Pulse will be measured and determined using an automated system in Beats per minute. **Measure:** Resting pulse **Time Frame:** Baseline and three months time points **Description:** Urine albumin (mg/dL) **Measure:** Urine biomarkers **Time Frame:** Baseline and three months time points **Description:** UACR (mg/g) **Measure:** Urine biomarkers **Time Frame:** Baseline and three months time points **Description:** Urine creatinine (g/dL) **Measure:** Urine biomarkers **Time Frame:** Baseline and three months time points **Description:** eGFR (ml/min/1.73m\^2) **Measure:** Urine biomarkers **Time Frame:** Baseline and three months time points **Description:** Urine polyphenols for adherence as measured by mass spectrometry. **Measure:** Urine biomarkers **Time Frame:** Baseline and three months time points ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 30 years * A formal diagnosis of T2D (126mg/dl fasting glucose or higher, or HbA1c\>6.5%) or taking T2D medications with HbA1c levels over 7% * Medication stability for at least 3 months prior to Intervention initiation * Adherence to medical follow-up in primary care clinic or diabetes-centered outpatient services Exclusion Criteria: * HbA1c lower than 7% or higher than 10% * Known insulinopenia * Treatment with coumadin (warfarin) * Advanced renal failure * Significantly disturbed liver enzymes (liver transaminases or bilirubin levels more than time three upper-normal-limit) * A significant illness that might require hospitalization * Regular Mankai consumption * State of pregnancy or lactation * Presence of active cancer or chemotherapy treatment in last three years * Participation in another trial **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Be'er Sheva **Country:** Israel **Facility:** Soroka Medical Center #### Overall Officials **Official 1:** **Affiliation:** Soroka University Medical Center **Name:** Idit Liberty **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ben-Gurion University of the Negev **Name:** Iris Shai **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Piche ME, Tchernof A, Despres JP. 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Epub 2018 Dec 11. **PMID:** 30591380 **Citation:** Yaskolka Meir A, Tsaban G, Zelicha H, Rinott E, Kaplan A, Youngster I, Rudich A, Shelef I, Tirosh A, Brikner D, Pupkin E, Sarusi B, Bluher M, Stumvoll M, Thiery J, Ceglarek U, Stampfer MJ, Shai I. A Green-Mediterranean Diet, Supplemented with Mankai Duckweed, Preserves Iron-Homeostasis in Humans and Is Efficient in Reversal of Anemia in Rats. J Nutr. 2019 Jun 1;149(6):1004-1011. doi: 10.1093/jn/nxy321. **PMID:** 30915471 **Citation:** Sela I, Yaskolka Meir A, Brandis A, Krajmalnik-Brown R, Zeibich L, Chang D, Dirks B, Tsaban G, Kaplan A, Rinott E, Zelicha H, Arinos S, Ceglarek U, Isermann B, Lapidot M, Green R, Shai I. Wolffia globosa-Mankai Plant-Based Protein Contains Bioactive Vitamin B12 and Is Well Absorbed in Humans. Nutrients. 2020 Oct 8;12(10):3067. doi: 10.3390/nu12103067. **PMID:** 33049929 **Citation:** Yaskolka Meir A, Tuohy K, von Bergen M, Krajmalnik-Brown R, Heinig U, Zelicha H, Tsaban G, Rinott E, Kaplan A, Aharoni A, Zeibich L, Chang D, Dirks B, Diotallevi C, Arapitsas P, Vrhovsek U, Ceglarek U, Haange SB, Rolle-Kampczyk U, Engelmann B, Lapidot M, Colt M, Sun Q, Shai I. The Metabolomic-Gut-Clinical Axis of Mankai Plant-Derived Dietary Polyphenols. Nutrients. 2021 May 30;13(6):1866. doi: 10.3390/nu13061866. **PMID:** 34070816 **Citation:** Tsaban G, Yaskolka Meir A, Rinott E, Zelicha H, Kaplan A, Shalev A, Katz A, Rudich A, Tirosh A, Shelef I, Youngster I, Lebovitz S, Israeli N, Shabat M, Brikner D, Pupkin E, Stumvoll M, Thiery J, Ceglarek U, Heiker JT, Korner A, Landgraf K, von Bergen M, Bluher M, Stampfer MJ, Shai I. The effect of green Mediterranean diet on cardiometabolic risk; a randomised controlled trial. Heart. 2021 Jun 11;107(13):1054-1061. doi: 10.1136/heartjnl-2020-317802. **PMID:** 33234670 **Citation:** Yaskolka Meir A, Rinott E, Tsaban G, Zelicha H, Kaplan A, Rosen P, Shelef I, Youngster I, Shalev A, Bluher M, Ceglarek U, Stumvoll M, Tuohy K, Diotallevi C, Vrhovsek U, Hu F, Stampfer M, Shai I. Effect of green-Mediterranean diet on intrahepatic fat: the DIRECT PLUS randomised controlled trial. Gut. 2021 Nov;70(11):2085-2095. doi: 10.1136/gutjnl-2020-323106. Epub 2021 Jan 18. **PMID:** 33461965 **Citation:** Zelicha H, Kloting N, Kaplan A, Yaskolka Meir A, Rinott E, Tsaban G, Chassidim Y, Bluher M, Ceglarek U, Isermann B, Stumvoll M, Quayson RN, von Bergen M, Engelmann B, Rolle-Kampczyk UE, Haange SB, Tuohy KM, Diotallevi C, Shelef I, Hu FB, Stampfer MJ, Shai I. The effect of high-polyphenol Mediterranean diet on visceral adiposity: the DIRECT PLUS randomized controlled trial. BMC Med. 2022 Sep 30;20(1):327. doi: 10.1186/s12916-022-02525-8. **PMID:** 36175997 **Citation:** Tsaban G, Shalev A, Katz A, Yaskolka Meir A, Rinott E, Zelicha H, Kaplan A, Wolak A, Bluher M, Stampfer MJ, Shai I. Effect of Lifestyle Modification and Green Mediterranean Diet on Proximal Aortic Stiffness. J Am Coll Cardiol. 2023 Apr 25;81(16):1659-1661. doi: 10.1016/j.jacc.2023.02.032. No abstract available. **PMID:** 37076220 **Citation:** Tsaban G, Yaskolka Meir A, Zelicha H, Rinott E, Kaplan A, Shalev A, Katz A, Brikner D, Bluher M, Ceglarek U, Stumvoll M, Stampfer MJ, Shai I. Diet-induced Fasting Ghrelin Elevation Reflects the Recovery of Insulin Sensitivity and Visceral Adiposity Regression. J Clin Endocrinol Metab. 2022 Jan 18;107(2):336-345. doi: 10.1210/clinem/dgab681. **PMID:** 34643713 **Citation:** Rinott E, Meir AY, Tsaban G, Zelicha H, Kaplan A, Knights D, Tuohy K, Scholz MU, Koren O, Stampfer MJ, Wang DD, Shai I, Youngster I. The effects of the Green-Mediterranean diet on cardiometabolic health are linked to gut microbiome modifications: a randomized controlled trial. Genome Med. 2022 Mar 10;14(1):29. doi: 10.1186/s13073-022-01015-z. **PMID:** 35264213 **Citation:** Rinott E, Youngster I, Yaskolka Meir A, Tsaban G, Zelicha H, Kaplan A, Knights D, Tuohy K, Fava F, Scholz MU, Ziv O, Rubin E, Tirosh A, Rudich A, Bluher M, Stumvoll M, Ceglarek U, Clement K, Koren O, Wang DD, Hu FB, Stampfer MJ, Shai I. Effects of Diet-Modulated Autologous Fecal Microbiota Transplantation on Weight Regain. Gastroenterology. 2021 Jan;160(1):158-173.e10. doi: 10.1053/j.gastro.2020.08.041. Epub 2020 Aug 26. **PMID:** 32860791 **Citation:** Zelicha H, Kaplan A, Yaskolka Meir A, Tsaban G, Rinott E, Shelef I, Tirosh A, Brikner D, Pupkin E, Qi L, Thiery J, Stumvoll M, Kloting N, von Bergen M, Ceglarek U, Bluher M, Stampfer MJ, Shai I. The Effect of Wolffia globosa Mankai, a Green Aquatic Plant, on Postprandial Glycemic Response: A Randomized Crossover Controlled Trial. Diabetes Care. 2019 Jul;42(7):1162-1169. doi: 10.2337/dc18-2319. Epub 2019 May 10. **PMID:** 31076421 **Citation:** Gepner Y, Golan R, Harman-Boehm I, Henkin Y, Schwarzfuchs D, Shelef I, Durst R, Kovsan J, Bolotin A, Leitersdorf E, Shpitzen S, Balag S, Shemesh E, Witkow S, Tangi-Rosental O, Chassidim Y, Liberty IF, Sarusi B, Ben-Avraham S, Helander A, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Rudich A, Stampfer MJ, Shai I. Effects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Type 2 Diabetes: A 2-Year Randomized, Controlled Trial. Ann Intern Med. 2015 Oct 20;163(8):569-79. doi: 10.7326/M14-1650. Epub 2015 Oct 13. **PMID:** 26458258 **Citation:** Dorans KS, Bazzano LA, Qi L, He H, Chen J, Appel LJ, Chen CS, Hsieh MH, Hu FB, Mills KT, Nguyen BT, O'Brien MJ, Samet JM, Uwaifo GI, He J. Effects of a Low-Carbohydrate Dietary Intervention on Hemoglobin A1c: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238645. doi: 10.1001/jamanetworkopen.2022.38645. **PMID:** 36287562 ## 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 ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - 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 - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416462 **Brief Title:** Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot **Official Title:** Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study #### Organization Study ID Info **ID:** 6.296.354 #### Organization **Class:** OTHER **Full Name:** University of Nove de Julho ### Status Module #### Completion Date **Date:** 2024-12-30 **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:** 2024-11-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-30 **Type:** ESTIMATED **Status Verified Date:** 2023-10 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2023-10-02 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Nove de Julho #### Responsible Party **Investigator Affiliation:** University of Nove de Julho **Investigator Full Name:** Kristianne Porta Santos Fernandes **Investigator Title:** Clinical colaborator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds. **Detailed Description:** Diabetic foot ulcer affects 10.5% of the Brazilian/world population, compromising the quality of life of these patients and burdening the public health system. Studies show that antimicrobial photodynamic therapy (aPDT) accelerates its repair, however, there is not enough evidence for decision-making in clinical practice, which prevents this treatment from being used on a large scale. Controlled and randomized clinical studies are needed to increase the level of evidence on this subject, promoting the improvement of the quality of life of people affected by diabetic foot ulcers. The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds. A clinical, controlled, randomized and double-blind study will be carried out. Patients will be randomized (1:1) into 2 groups: (1) experimental (n= 45) - standard care from the Polyclinic wound sector + aPDT and (2) control (n= 45) - standard care + simulation of use aPDT with equipment off). All patients will be seen three times a week, with 10 sessions of aPDT or simulation performed by the same operator. A cluster with an average radiant power of 100 mW, radiant energy per emitter of 6 J/cm² of red light (wavelength 660 nm) will be used. The research will be carried out in a Municipal Health Center in the city of Rio de Janeiro. Patients affected by neuropathic wounds of the diabetic foot, assisted by the Programmatic Care Health Coordination will be included 5.1. The initial assessment will consist of collecting data from medical records to establish the sociodemographic and clinical profile of patients affected by diabetic foot injuries.) by a researcher blinded to the interventions. This scale assesses the size of the lesion, depth, borders, detachment, type of necrotic tissue, amount of necrotic tissue, type of exudate, amount of exudate, skin color around the wound, perilesional tissue edema, perilesional tissue hardening, granulation tissue, epithelialization. As secondary outcomes: the sensitivity of the foot will be evaluated, through neurological evaluation with tuning fork and monofilament, the instrument for assessing quality of life - Diabetes-21, the Wagner Scale, the evaluation of the degree of ischemia by the Fontaine scale and Runtherford, the WiFi and Taxonomy Nursing Outcomes Classification scale that assesses skin integrity. Data from this research will be collected after approval by the ethics committee of Universidade Nove de Julho and the City Hall of Rio de Janeiro. ### Conditions Module **Conditions:** - Diabetic Foot Ulcer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in the control group will be treated in exactly the same way as the aPDT group, however the light treatment will be simulated. The device will be placed in position, however it will be switched off. After three weeks of monitoring in the control group, the patient will be informed that they were in the placebo group and will be offered treatment with aPDT and irradiation, for ethical reasons. **Intervention Names:** - Procedure: antimicrobial photodynamic therapy **Label:** group control **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** In the experimental group (aPDT), 1% methylene blue applied with the aid of a syringe will be used as a photosensitizer (with a pre-irradiation time of 5 minutes, 6 J of red laser will be applied. **Intervention Names:** - Procedure: antimicrobial photodynamic therapy **Label:** experiment group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - experiment group - group control **Description:** When starting the research, all wounds, regardless of the study group, will be cleaned with 0.9% saline solution (SF0.9%), using a 40x12 needle and a 500ml bottle of SF0.9%, in order to maintain pressure. for equal cleaning of all wounds and a hydrofiber plate with silver was used as standard coverage. Experimental group (n=45): When starting the intervention, all services in both groups will follow the cleaning standard described previously. In the aPDT group, 1% methylene blue will be used as a photosensitizer applied with the aid of a syringe (with a pre-irradiation time of 5 minutes), 6 J of laser will be applied. **Name:** antimicrobial photodynamic therapy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions. **Measure:** Bates-Jensen Wound Assesment Tool **Time Frame:** Before the intervention **Description:** The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions. **Measure:** Bates-Jensen Wound Assesment Tool **Time Frame:** First day after intervention **Description:** The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions. **Measure:** Bates-Jensen scale **Time Frame:** Third day after intervention **Description:** The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions. **Measure:** Bates-Jensen scale **Time Frame:** Fifth day after intervention **Description:** The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5, where 1 indicates the best wound condition, and 5 represents the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with higher scores indicating worse wound conditions. **Measure:** Bates-Jensen scale **Time Frame:** Tenth day after intervention #### Secondary Outcomes **Description:** Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument **Measure:** Diabetes-21 instrument **Time Frame:** Before the intervention **Description:** Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument **Measure:** Diabetes-21 instrument **Time Frame:** First day after intervention **Description:** Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument **Measure:** Diabetes-21 instrument **Time Frame:** Third day after intervention **Description:** Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument **Measure:** Diabetes-21 instrument **Time Frame:** The fifth day after intervention **Description:** Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument **Measure:** Diabetes-21 instrument **Time Frame:** Tenth day after intervention **Description:** Classify the diabetic foot wound with the Wagner Scale **Measure:** Wagner Scale **Time Frame:** Before the intervention **Description:** Classify the diabetic foot wound with the Wagner Scale **Measure:** Wagner Scale **Time Frame:** First day after intervention **Description:** Classify the diabetic foot wound with the Wagner Scale **Measure:** Wagner Scale **Time Frame:** Third day after intervention **Description:** Classify the diabetic foot wound with the Wagner Scale **Measure:** Wagner Scale **Time Frame:** Fifth day after intervention **Description:** Classify the diabetic foot wound with the Wagner Scale **Measure:** Wagner Scale **Time Frame:** Tenth day after intervention **Description:** Assess the risk of amputation using the WiFi scale **Measure:** WiFi scale **Time Frame:** Before the intervention **Description:** Assess the risk of amputation using the WiFi scale **Measure:** WiFi scale **Time Frame:** First day after intervention **Description:** Assess the risk of amputation using the WiFi scale **Measure:** WiFi scale **Time Frame:** Third day after intervention **Description:** Assess the risk of amputation using the WiFi scale **Measure:** WiFi scale **Time Frame:** Fifth day after intervention **Description:** Assess the risk of amputation using the WiFi scale **Measure:** WiFi scale **Time Frame:** Tenth day after intervention **Description:** Assess skin integrity using the Nursing Outcomes Classification Taxonomy **Measure:** Nursing Outcomes Classification Taxonomy **Time Frame:** Before the intervention **Description:** Assess skin integrity using the Nursing Outcomes Classification Taxonomy **Measure:** Nursing Outcomes Classification Taxonomy **Time Frame:** First day after intervention **Description:** Assess skin integrity using the Nursing Outcomes Classification Taxonomy **Measure:** Nursing Outcomes Classification Taxonomy **Time Frame:** Third day after intervention **Description:** Assess skin integrity using the Nursing Outcomes Classification Taxonomy **Measure:** Nursing Outcomes Classification Taxonomy **Time Frame:** Fifth day after intervention **Description:** Assess skin integrity using the Nursing Outcomes Classification Taxonomy **Measure:** Nursing Outcomes Classification Taxonomy **Time Frame:** Tenth day after intervention **Description:** Rutherford et al. (1997) also base their classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result. **Measure:** Runtherford Scale for ischemia evaluation **Time Frame:** Before the intervention **Description:** Rutherford et al. (1997) also base their classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result. **Measure:** Runtherford Scale for ischemia evaluation **Time Frame:** First day after intervention **Description:** Rutherford et al. (1997) also base their classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result. **Measure:** Runtherford Scale for ischemia evaluation **Time Frame:** Third day after intervention **Description:** Rutherford et al. (1997) also base their classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result. **Measure:** Runtherford Scale for ischemia evaluation **Time Frame:** Fifth day after intervention **Description:** Rutherford et al. (1997) also base their classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result. **Measure:** Runtherford Scale for ischemia evaluation **Time Frame:** Tenth day after intervention **Description:** Assess the protective sensitivity of the feet through the monofilament and tuning fork test **Measure:** protective sensitivity of the feet **Time Frame:** Before the intervention **Description:** Assess the protective sensitivity of the feet through the monofilament and tuning fork test **Measure:** protective sensitivity of the feet **Time Frame:** First day after intervention **Description:** Assess the protective sensitivity of the feet through the monofilament and tuning fork test **Measure:** protective sensitivity of the feet **Time Frame:** Third day after intervention **Description:** Assess the protective sensitivity of the feet through the monofilament and tuning fork test **Measure:** protective sensitivity of the feet **Time Frame:** Fifth day after intervention **Description:** Assess the protective sensitivity of the feet through the monofilament and tuning fork test **Measure:** protective sensitivity of the feet **Time Frame:** Tenth day after intervention **Description:** Fontaine et al. (1957) primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV). **Measure:** Fontaine Classification **Time Frame:** Before the intervention **Description:** Fontaine et al. (1957) primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV). **Measure:** Fontaine Classification **Time Frame:** First day after intervention **Description:** Fontaine et al. (1957) primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV). **Measure:** Fontaine Classification **Time Frame:** Third day after intervention **Description:** Fontaine et al. (1957) primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV). **Measure:** Fontaine Classification **Time Frame:** Fifth day after intervention **Description:** Fontaine et al. (1957) primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV). **Measure:** Fontaine Classification **Time Frame:** Tenth day after intervention **Description:** To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity (IWGDF, 2019). **Measure:** Vibration Sensation **Time Frame:** Before the intervention **Description:** To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity (IWGDF, 2019). **Measure:** Vibration Sensation **Time Frame:** First day after intervention **Description:** To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity (IWGDF, 2019). **Measure:** Vibration Sensation **Time Frame:** Third day after intervention **Description:** To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity (IWGDF, 2019). **Measure:** Vibration Sensation **Time Frame:** Fifth day after intervention **Description:** To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity (IWGDF, 2019). **Measure:** Vibration Sensation **Time Frame:** Tenth day after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * both sexes * chronic wounds originating from the neuropathic diabetic foot * contaminated lesions * total score obtained on the Bates-Jensen scale between 13 and 60 * who submits all requested exams Exclusion Criteria: * wounds with etiologies that are not related to the diabetic foot * ischemic diabetic foot who has an ankle-brachial index with a value between 0.7 and 1.3. * glycated hemoglobin greater than 8%. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** raquel.mesquita@gmail.com **Name:** Raquel Agnelli Mesquita-Ferrari, PhD **Phone:** +55 (11) 2633-9000 **Role:** CONTACT #### Locations **Location 1:** **City:** São Paulo **Contacts:** ***Contact 1:*** - **Email:** annacrth@gmail.com - **Name:** Raquel R Agnelli Mesquita-Ferrari - **Role:** CONTACT **Country:** Brazil **Facility:** Raquel Agnelli Mesquita-Ferrari **State:** SP **Zip:** 11030-480 #### Overall Officials **Official 1:** **Affiliation:** University of Nove de Julho **Name:** Raquel Agnelli Mesquita-Ferrari, PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000007871 - Term: Leg Ulcer - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases - ID: D000003929 - Term: Diabetic Neuropathies - ID: D000005534 - Term: Foot Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M19933 - Name: Diabetic Foot - Relevance: HIGH - As Found: Diabetic Foot - ID: M18919 - Name: Foot Ulcer - Relevance: HIGH - As Found: Foot Ulcer - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M10883 - Name: Leg Ulcer - Relevance: LOW - As Found: Unknown - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7124 - Name: Diabetic Neuropathies - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000017719 - Term: Diabetic Foot - ID: D000016523 - Term: Foot Ulcer ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: HIGH - As Found: Residents - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: HIGH - As Found: Residents - ID: M11726 - Name: Methylene Blue - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: M19608 - Name: Photosensitizing Agents - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000900 - Term: Anti-Bacterial Agents ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416449 **Brief Title:** The Impact of Kinesio Taping on Balance, Agility, and Jumping in Adolescent Basketball Players Aged 12-18. **Official Title:** The Effect of Kinesio Taping on Balance, Agility, and Jumping Performance in Adolescent Basketball Players Aged 12-18. #### Organization Study ID Info **ID:** İstanbulBUuuuu #### Organization **Class:** OTHER **Full Name:** Istanbul Bilgi University ### 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:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-12 **Type:** ACTUAL #### Start Date **Date:** 2024-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-04-17 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Bilgi University #### Responsible Party **Investigator Affiliation:** Istanbul Bilgi University **Investigator Full Name:** AYCAN ÇAKMAK REYHAN **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In this study involving adolescent individuals who play basketball, we will investigate the effect of kinesio taping. Kinesio taping can be applied with appropriate technique and tension to reduce pain, swelling, and muscle spasms, as well as to correct mechanical issues. In this study, researchers will apply kinesio taping to the ankle and knee and thes assess its impact on balance, agility, and jumping performance through various tests. Specifically, researchers will conduct the star balance test for balance, the T-test for agility, and the vertical jump test for jumping performance. researchers plan to carry out this research with 30 participants at the Dev Ataşehir Sports Club to gather the necessary data. **Detailed Description:** Basketball is a physically demanding and high-paced sport that requires balance, strength, stability, and agility. Kinesio taping, a method commonly used in athlete health where physiotherapists are involved, will be examined for its effect on the lower extremities of young basketball players. Kinesio tape allows for approximately 50-60% elongation of its own length and has a thickness similar to that of the epidermis layer of the skin. It can be applied with appropriate technique and tension to reduce pain, swelling, and muscle spasms, as well as to correct mechanical issues. In this study, researchers aimed to investigate the effect of kinesio taping on adolescent male basketball players. Kinesio taping will be applied to two different areas: the ankle and knee regions. The overall goal of this application is to increase stability and balance. The results of the applied tests will be evaluated. The effects of kinesio taping on balance, agility, and jumping performance in basketball players will be examined. In the research, parameters of balance, agility, and jumping performance will be examined. Researchers have specific tests for these parameters, including the Star Balance Test for balance, the T-Agility Test for agility, and the Vertical Jump Test for jumping performance. In the Star Balance Test, lines are drawn on the ground. The individual stands on their dominant foot and reaches out with the tip of the contralateral foot to touch these lines, and points are recorded. In the T-Agility Test, a course is set up, and the participant is asked to complete it as quickly as possible, with time being recorded. As implied by its name, cones are placed in a T-shape for the T-Agility Test, and the individual is required to touch the cones and return to the starting point as quickly as possible. In the Vertical Jump Test, the individual is asked to jump as high as possible against a wall-mounted ruler, and the highest point reached is recorded. The Kinesio tape used in the study is designed to reflect the characteristics of the skin and allow for approximately 55-60% elongation of its original length. These tests are first conducted without Kinesio tape and then repeated with Kinesio tape applied. Rest intervals are provided between tests. All participants will be asked to fill out a sociodemographic form and a consent form ### Conditions Module **Conditions:** - Balance - Jumping Performance - Agility Test **Keywords:** - kinesio taping, , balance, agility and jumping performance - basketball players - balance, agility - jumping performance ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** We'll assess balance, agility, and jumping. Tests include Star Balance Test, T-Agility Test, and Vertical Jump Test. In Star Balance, lines are drawn on the ground, the individual stands on one foot, reaching out with the other to touch lines. In T-Agility, a course is set, and time is recorded. The Vertical Jump Test measures the highest point reached against a wall-mounted ruler. Kinesio tape, allowing 55-60% elongation, will be used. Tests are conducted both with and without tape, with rest intervals. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the Star Balance Test, lines are drawn on the ground. The individual stands on their dominant foot and reaches out with the tip of the contralateral foot to touch these lines, and points are recorded. the T-Agility Test, a course is set up, and the participant is asked to complete it as quickly as possible, with time being recorded. the Vertical Jump Test, the individual is asked to jump as high as possible against a wall-mounted ruler, and the highest point reached is recorded. The Kinesio tape used in the study is designed to reflect the characteristics of the skin and allow for approximately 55-60% elongation of its original length. These tests are first conducted without Kinesio tape and then repeated with Kinesio tape applied. Rest intervals are provided between tests. **Intervention Names:** - Other: kinesiotape application **Label:** participants **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - participants **Description:** In the Star Balance Test, lines are drawn on the ground. The individual stands on their dominant foot and reaches out with the tip of the contralateral foot to touch these lines, and points are recorded. For the T-Agility Test, a course is set up, and the participant is asked to complete it as quickly as possible, with time being recorded. As implied by its name, cones are placed in a T-shape for the T-Agility Test, and the individual is required to touch the cones and return to the starting point as quickly as possible. In the Vertical Jump Test, the individual is asked to jump as high as possible against a wall-mounted ruler, and the highest point reached is recorded. The Kinesio tape used in the study is designed to reflect the characteristics of the skin and allow for approximately 55-60% elongation of its original length. These tests are first conducted without Kinesio tape and then repeated with Kinesio tape applied. Rest intervals are provided between tests. **Name:** kinesiotape application **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Star Balance Test" is a method used to evaluate balance and stability. It involves standing on one leg at the center of a star-shaped platform. This test assesses an individual's ability to maintain balance, providing insight into proprioception and coordination skills. It's commonly used in sports medicine and rehabilitation **Measure:** The Star Balance Test **Time Frame:** baseline and Immediately after application **Description:** The T-Agility Test is a fitness assessment that evaluates agility, speed, and change-of-direction ability. Participants sprint forward, laterally shuffle to touch markers on each side, and return to the starting point. It's commonly used in sports training and fitness testing to measure quick directional changes. **Measure:** T-Agility Test **Time Frame:** baseline and Immediately after application **Description:** The Vertical Jump Test measures lower body power and explosiveness. Participants jump vertically, reaching upwards to mark their maximum height. It's widely used in sports and fitness testing for assessing performance and tailoring training programs. **Measure:** Vertical Jump Test **Time Frame:** baseline and Immediately after application ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants must be athletes. They must have been engaged in sports for at least 1 year. Only male individuals will be included. Male individuals aged between 12 and 18 will be included. Exclusion Criteria: * Participants must not have experienced ankle or knee injuries in the last 3 months. **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 12 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aycan.cakmak@bilgi.edu.tr **Name:** Aycan Cakmak Reyhan, PhD **Phone:** +90 212 311 5338 **Role:** CONTACT **Contact 2:** **Email:** furkan.cakir@bilgi.edu.tr **Name:** furkan çakır, MSc **Phone:** +90 212 311 5432 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** aycan.cakmak@bilgi.edu.tr - **Name:** aycan çakmak reyhan, phd - **Phone:** 3115338 - **Phone Ext:** 212 - **Role:** CONTACT **Country:** Turkey **Facility:** Istanbul Bilgi University **Status:** RECRUITING ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416436 **Brief Title:** Dose-escalation Study of Ultra-high Dose Ablative Radiosurgery With Immunotherapy for Bulky Metastatic Cancer Patients **Official Title:** Immunotherapy in Combination With Ablative Radiosurgery to Ultra-high DoSes (ICARUS): A Phase I Dose-escalation Radiosurgery Study in Metastatic Cancers #### Organization Study ID Info **ID:** IIT-2022-ICARUS #### Organization **Class:** OTHER **Full Name:** University of Kansas Medical Center ### Status Module #### Completion Date **Date:** 2027-07-01 **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:** 2027-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **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:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Kansas Medical Center #### Responsible Party **Investigator Affiliation:** University of Kansas Medical Center **Investigator Full Name:** Gregory Gan **Investigator Title:** Translational Physician Scientist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine whether cytoreduction of bulky metastatic disease using ultra high dose SBRT in combination with immunotherapy is tolerable and feasible In patients who have exhausted SoC treatment options. **Detailed Description:** Patients that provide informed consent will undergo a 30-day screening period to determine eligibility for the trial. If eligible, patients will begin treatment on SBRT (delivered to metastases over 3-5 fractions within 1-2 weeks) with concurrent and adjuvant atezolizumab (1680 mg on Day 1 of each 28-day cycle) immunotherapy regimen for up to one year. ### Conditions Module **Conditions:** - Solid Tumor **Keywords:** - Stereotactic Ablative Radiotherapy - SBRT - Atezolizumab - Tecentriq - Metastatic - Phase I ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Traditional 3+3 model ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 54 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Atezolizumab - Radiation: Stereotactic Ablative Radiotherapy (SBRT) **Label:** SBRT with concurrent and adjuvant atezolizumab immunotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SBRT with concurrent and adjuvant atezolizumab immunotherapy **Description:** Atezolizumab will be administered at a fixed dose of 1680 mg IV route every 4 weeks (1680 mg on Day 1 of each 28-day cycle), which is an approved dosage for atezolizumab, as outlined in the prescribing information. **Name:** Atezolizumab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - SBRT with concurrent and adjuvant atezolizumab immunotherapy **Description:** Ultra-High Doses of Ablative Radiosurgery SBRT is delivered to metastases over 3-5 fractions within 1-2 weeks **Name:** Stereotactic Ablative Radiotherapy (SBRT) **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Maximum tolerated dose of ultra-high dose SBRT for 3 different body sites (i.e., peripheral lung, mediastinum-central lung, and abdomen-pelvis) **Measure:** Maximum tolerated dose of ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) for 3 different body sites **Time Frame:** 1 Month #### Secondary Outcomes **Description:** To assess the safety of ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options **Measure:** Evaluate the number of participants receiving ultra-high dose ablative radiosurgery with immunotherapy who develop treatment-related adverse events as assessed by CTCAE v4.0 **Time Frame:** Enrollment to 1 month after end of SBRT treatment (approximately 2 months) **Description:** To assess the overall tumor response rate of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab **Measure:** Overall tumor response rate to ultra-high dose SBRT for 3 different body sites **Time Frame:** Pre-treatment to 3 and 6 months after SBRT (approximately 7 months) **Description:** To assess the progression-free survival of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options. **Measure:** Progression-Free Survival of participants receiving ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) with concurrent and adjuvant atezolizumab **Time Frame:** Up to 2 years **Description:** To assess the overall survival of participants receiving ultra-high dose SBRT with concurrent and adjuvant atezolizumab in participants with cancer who have exhausted standard of care treatment options **Measure:** Overall Survival of participants receiving ultra-high dose Stereotactic Ablative Radiotherapy (SBRT) with concurrent and adjuvant atezolizumab **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability of participant to understand this study, and participant willingness to sign a written informed consent * Males and females age ≥ 18 years * Measurable disease by RECIST 1.1 Participants must have at least two radiographically identifiable lesions measurable by RECIST v1.1 criteria and one of those lesions must be ≥65 cc. NOTE: 'cc' equals (width x length x height)/2 to provide rough approximation. For example, a 5.1 x 5.1 x 5.1 cm tumor would be 66.3 cc and appropriate for trial enrollment * Participants must have washout period of 5 elimination half-lives or 28 days (whichever is longer) from time of last systemic therapy to start of study treatment * Women of childbearing potential must have a negative serum pregnancy test at time of enrollment (at screening and up to 48 hours prior to start of radio- or immuno- therapy) * Participants with biopsy and radiographically confirmed metastatic cancer (i.e., Lung, head and neck, ovarian, colorectal, sarcoma) * At least 1st line (1L) systemic therapy or immunotherapy must have failed for participants and standard of care therapy options must also be exhausted. Standard of care options that have been discontinued for reasons other than disease progression are eligible. NOTE: Participants who are off systemic therapy who are being monitored with surveillance imaging, who then develop disease progression and are without standard of care therapy options are eligible for enrollment. * At least one lesion (and up to a maximum of four lesions) must be ≥65 cc (calculated using tumor length x width x height to closest approximation) * Prior RT is permitted if the lesion to be treated and surrounding region (no appreciable dosimetric overlap, assessed on case-by-case basis as needed) with ultra-high dose SBRT was not previously treated * Participants with CNS metastatic disease will be allowed on protocol if all lesions are managed prior to starting extra-CNS ablative therapy * Availability of a representative (FFPE) tumor specimen from metastatic diagnosis of cancer done prior to any study intervention for exploratory study-related biomarker research * Adequate organ function, defined as the following laboratory test results, obtained within 14 days prior to initiation of study treatment: 1. Leukocytes ≥ 3K/µL 2. Lymphocyte count ≥ 0.5 x 10\^9/L (500/µL) 3. Absolute Neutrophil Count ≥1.5K/µL without granulocyte colony-stimulating factor support. NOTE: Participants with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the participant 4. Platelets ≥100K/μL) without transfusion 5. Hemoglobin ≥ 9 g/dL 6. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) \[calculated using the Cockcroft-Gault formula\] 7. Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN. Participants with known Gilbert disease: serum bilirubin ≤ 3 x ULN 8. Serum albumin ≥ 35 g/L (3.5 g/dL) 9. Aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN 10. For participants not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN 11. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen 12. Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/µL, and have an undetectable viral load. \*\*\* NOTE: A participant may be eligible if test is positive and will be left to the investigator to determine appropriateness for trial enrollment if medically stable and without signs of active, uncontrolled disease. Prior to formal enrollment, please contact protocol study PI to review. 13. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test must be performed for participants who have a positive HCV antibody test.\*\*\* NOTE: A participant may be eligible if test is positive and will be left to the investigator to determine appropriateness for trial enrollment if medically stable and without signs of active, uncontrolled disease. Prior to formal enrollment, please contact protocol study PI to review. 14. Negative hepatitis B surface antigen (HbsAg) test at screening. Negative total hepatitis B core antibody (HbcAb) test at screening, or positive total HbcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for participants who have a negative HbsAg test and a positive total HbcAb test. \*\*\* NOTE: A participant may be eligible if test is positive and will be left to the investigator to determine appropriateness for trial enrollment if medically stable and without signs of active, uncontrolled disease. Prior to formal enrollment, please contact protocol study PI to review. 15. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section and below for the duration of study participation and for 180 DAYS/6 MONTHS following completion of therapy. Men must refrain from donating sperm during this same period. 1. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. 2. Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. 3. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. Exclusion Criteria: * Simultaneously enrolled in any therapeutic clinical trial * Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study * Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements * Is pregnant or breastfeeding * Female of childbearing potential planning to become pregnant while receiving study treatment or for less than 180 DAYS/6 MONTHS after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result at time of enrollment (at screening and up to 48 hours prior to start of radio- or immuno- therapy). * Male of childbearing potential planning to father a child or donate sperm while receiving study treatment or for less than 180 DAYS / 6 MONTHS after the last dose of study treatment * Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment * COVID-19: Participants with active COVID-19 symptoms and/or hospitalized for severe or critical COVID-19 symptoms * Participants with uncontrolled concurrent illness or infection (i.e., active pneumonia or infection) * Participants with only bone metastatic disease * Immunosuppressive disorders (i.e., solid organ transplant recipient, allogeneic stem cell transplant) (please refer Appendix D for full list) * Participants who are enrolled in hospice or felt to have less than 6 months life expectation * Uncontrolled or untreated CNS metastases 1. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases 2. Asymptomatic participants with treated CNS lesions are eligible, provided that all of the following criteria are met: 1. Measurable disease, per RECIST v1.1, must be present outside the CNS 2. The participant has no history of intracranial hemorrhage or spinal cord hemorrhage 3. The participant has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment. 4. The participant has no ongoing requirement for corticosteroids as therapy for CNS disease 5. If the participant is receiving anti-convulsant therapy, the dose is considered stable * History of leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). • Participants with indwelling catheters (e.g., PleurX) are allowed. * Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN * Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry. * Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: 1. Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study 2. Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study 3. Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: 1. Rash must cover \< 10% of body surface area 2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids 3. There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months 4. See also Appendix D for list of autoimmune diseases and immune deficiencies * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Active tuberculosis * Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina * Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact participant safety * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab * Current treatment with anti-viral therapy for HBV * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with checkpoint blockade therapy * History of prior immunotherapy induced pneumonitis and/or peritonitis that is Grade ≥3 is not permitted (instance of Grade 1 or 2 that have fully recovered and tolerated subsequent immunotherapy is permitted) * Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment * Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: 1. Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study 2. Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation * Known allergy or hypersensitivity to any component of the atezolizumab formulation * Has a known allergic reaction to any excipient contained in the study drug formulation **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** CTNurseNav@kumc.edu **Name:** Nurse Navigator **Phone:** 913-945-7552 **Role:** CONTACT **Contact 2:** **Email:** mthomas37@kumc.edu **Name:** Maggie Thomas **Phone:** 913-945-9383 **Role:** CONTACT #### Locations **Location 1:** **City:** Kansas City **Contacts:** ***Contact 1:*** - **Email:** CTNurseNav@kumc.edu - **Name:** Nurse Navigator - **Phone:** 913-945-7552 - **Role:** CONTACT **Country:** United States **Facility:** The University of Kansas Medical Center **State:** Kansas **Zip:** 66160 #### Overall Officials **Official 1:** **Affiliation:** University of Kansas Medical Center **Name:** Gregory Gan, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Hanahan D, Weinberg RA. 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Oncoimmunology. 2017 Aug 3;6(10):e1356153. doi: 10.1080/2162402X.2017.1356153. eCollection 2017. **PMID:** 29123967 **Citation:** Oweida A, Hararah MK, Phan A, Binder D, Bhatia S, Lennon S, Bukkapatnam S, Van Court B, Uyanga N, Darragh L, Kim HM, Raben D, Tan AC, Heasley L, Clambey E, Nemenoff R, Karam SD. Resistance to Radiotherapy and PD-L1 Blockade Is Mediated by TIM-3 Upregulation and Regulatory T-Cell Infiltration. Clin Cancer Res. 2018 Nov 1;24(21):5368-5380. doi: 10.1158/1078-0432.CCR-18-1038. Epub 2018 Jul 24. **PMID:** 30042205 **Citation:** Cheng Y, Wang T, Lv X, Li R, Yuan L, Shen J, Li Y, Yan T, Liu B, Wang L. Detection of PD-L1 Expression and Its Clinical Significance in Circulating Tumor Cells from Patients with Non-Small-Cell Lung Cancer. Cancer Manag Res. 2020 Mar 19;12:2069-2078. doi: 10.2147/CMAR.S245425. eCollection 2020. **PMID:** 32256114 **Citation:** Berggren KL, Restrepo Cruz S, Hixon MD, Cowan AT, Keysar SB, Craig S, James J, Barry M, Ozbun MA, Jimeno A, McCance DJ, Beswick EJ, Gan GN. MAPKAPK2 (MK2) inhibition mediates radiation-induced inflammatory cytokine production and tumor growth in head and neck squamous cell carcinoma. Oncogene. 2019 Nov;38(48):7329-7341. doi: 10.1038/s41388-019-0945-9. Epub 2019 Aug 15. **PMID:** 31417185 **Citation:** Witek MA, Aufforth RD, Wang H, Kamande JW, Jackson JM, Pullagurla SR, Hupert ML, Usary J, Wysham WZ, Hilliard D, Montgomery S, Bae-Jump V, Carey LA, Gehrig PA, Milowsky MI, Perou CM, Soper JT, Whang YE, Yeh JJ, Martin G, Soper SA. Discrete microfluidics for the isolation of circulating tumor cell subpopulations targeting fibroblast activation protein alpha and epithelial cell adhesion molecule. NPJ Precis Oncol. 2017;1:24. doi: 10.1038/s41698-017-0028-8. Epub 2017 Jul 25. **PMID:** 29657983 **Citation:** Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. **PMID:** 19097774 **Citation:** Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25. **PMID:** 30592986 **Citation:** Rotz SJ, Leino D, Szabo S, Mangino JL, Turpin BK, Pressey JG. Severe cytokine release syndrome in a patient receiving PD-1-directed therapy. Pediatr Blood Cancer. 2017 Dec;64(12). doi: 10.1002/pbc.26642. Epub 2017 May 24. **PMID:** 28544595 **Citation:** Adashek ML, Feldman M. Cytokine Release Syndrome Resulting From Anti-Programmed Death-1 Antibody: Raising Awareness Among Community Oncologists. J Oncol Pract. 2019 Sep;15(9):502-504. doi: 10.1200/JOP.19.00160. Epub 2019 Jul 16. No abstract available. **PMID:** 31310573 **Citation:** Merad M, Martin JC. Pathological inflammation in patients with COVID-19: a key role for monocytes and macrophages. Nat Rev Immunol. 2020 Jun;20(6):355-362. doi: 10.1038/s41577-020-0331-4. Epub 2020 May 6. Erratum In: Nat Rev Immunol. 2020 Jun 2;: **PMID:** 32376901 **Citation:** Riegler LL, Jones GP, Lee DW. Current approaches in the grading and management of cytokine release syndrome after chimeric antigen receptor T-cell therapy. Ther Clin Risk Manag. 2019 Feb 28;15:323-335. doi: 10.2147/TCRM.S150524. eCollection 2019. **PMID:** 30880998 **Citation:** Ravelli A, Minoia F, Davi S, Horne A, Bovis F, Pistorio A, Arico M, Avcin T, Behrens EM, De Benedetti F, Filipovic L, Grom AA, Henter JI, Ilowite NT, Jordan MB, Khubchandani R, Kitoh T, Lehmberg K, Lovell DJ, Miettunen P, Nichols KE, Ozen S, Pachlopnik Schmid J, Ramanan AV, Russo R, Schneider R, Sterba G, Uziel Y, Wallace C, Wouters C, Wulffraat N, Demirkaya E, Brunner HI, Martini A, Ruperto N, Cron RQ; Paediatric Rheumatology International Trials Organisation; Childhood Arthritis and Rheumatology Research Alliance; Pediatric Rheumatology Collaborative Study Group; Histiocyte Society. 2016 Classification Criteria for Macrophage Activation Syndrome Complicating Systemic Juvenile Idiopathic Arthritis: A European League Against Rheumatism/American College of Rheumatology/Paediatric Rheumatology International Trials Organisation Collaborative Initiative. Ann Rheum Dis. 2016 Mar;75(3):481-9. doi: 10.1136/annrheumdis-2015-208982. **PMID:** 26865703 **Citation:** La Rosee P. Treatment of hemophagocytic lymphohistiocytosis in adults. Hematology Am Soc Hematol Educ Program. 2015;2015:190-6. doi: 10.1182/asheducation-2015.1.190. **PMID:** 26637720 **Citation:** Schram AM, Berliner N. How I treat hemophagocytic lymphohistiocytosis in the adult patient. Blood. 2015 May 7;125(19):2908-14. doi: 10.1182/blood-2015-01-551622. Epub 2015 Mar 10. **PMID:** 25758828 **Citation:** La Rosee P, Horne A, Hines M, von Bahr Greenwood T, Machowicz R, Berliner N, Birndt S, Gil-Herrera J, Girschikofsky M, Jordan MB, Kumar A, van Laar JAM, Lachmann G, Nichols KE, Ramanan AV, Wang Y, Wang Z, Janka G, Henter JI. Recommendations for the management of hemophagocytic lymphohistiocytosis in adults. Blood. 2019 Jun 6;133(23):2465-2477. doi: 10.1182/blood.2018894618. Epub 2019 Apr 16. **PMID:** 30992265 #### See Also Links **Label:** Study of PD1 Blockade by Pembrolizumab With Stereotactic Body Radiotherapy in Advanced Solid Tumors **URL:** https://clinicaltrials.gov/ct2/show/NCT02608385 **Label:** Frebel H, Nindl V, Schuepbach RA, et al. Programmed death 1 protects from fatal circulatory failure during systemic virus infection of mice **URL:** https://pubmed.ncbi.nlm.nih.gov/23230000/ **Label:** McClain KL, Eckstein O. Clinical features and diagnosis of hemophagocytic lymphohistiocytosis **URL:** https://www.uptodate.com/contents/clinical-features-and-diagnosis-of-hemophagocytic-lymphohistiocytosis ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastatic Cancer - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis ### 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 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M349417 - Name: Atezolizumab - Relevance: HIGH - As Found: Relapsed - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000594389 - Term: Atezolizumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416423 **Acronym:** FFHI **Brief Title:** Filipino Family Health Initiative 1.0 **Official Title:** Virtual Positive Parenting Intervention to Promote Filipino Family Wellness: A Randomized Controlled Trial: Filipino Family Health Initiative 1.0 #### Organization Study ID Info **ID:** CHLA-23-00309 #### Organization **Class:** OTHER **Full Name:** Children's Hospital Los Angeles #### Secondary ID Infos **ID:** 1R01MD017003-01A1 **Link:** https://reporter.nih.gov/quickSearch/1R01MD017003-01A1 **Type:** NIH ### Status Module #### Completion Date **Date:** 2030-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **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:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Minority Health and Health Disparities (NIMHD) #### Lead Sponsor **Class:** OTHER **Name:** Children's Hospital Los Angeles #### Responsible Party **Investigator Affiliation:** Children's Hospital Los Angeles **Investigator Full Name:** Joyce Javier **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:** The goal of this clinical trial is to test the effectiveness of an online parenting program on Filipino parents living in California. The main questions it aims to answer are * Test the effectiveness of the online Incredible Years® model of parent training and its impact on primary outcomes. * Determine the level of intervention engagement (i.e, higher attendance) on parenting practices and child behavior outcomes. * Describe Intervention delivery and its online implementation in real-world community settings. The study involves two phases: * Phase 1: Participants will receive the Online Incredible Years® School Age Basic \& Advanced Parent Training Program (intervention) and complete parent-reported and child-reported measures at baseline, 3 months and 6 months. * Phase 2: Parenting Group Leaders will each participate in one semi-structure interview to inform the sustainability of the intervention in real-world community settings. Researchers will compare 250 Filipino immigrant families, half of which will receive the intervention and the other half will receive the American Academy of Pediatrics' Bright Futures handouts (control) and be placed on a 3-month waitlist for the IY parenting program. Both groups will be followed for a minimum of 6 months with follow- up assessments that include parent-report and child-report measures. **Detailed Description:** Evidence-based parenting interventions provided in early childhood have proven to be effective in preventing the onset and escalation of child mental health disorders. The overall objective of the proposed research is to test the effectiveness of a parenting program (Incredible Years® School Age Advance and Basic Parent Training Program, IYP) on Filipino parents recruited from multiple community-based settings and its impact on trajectories of parenting practices, parenting stress, and child problem behavior. IYP is one of the best-studied and most highly regarded parent training programs. As a result of pilot studies funded by a NIH K23 and a NCATS KL2 award, the investigators have identified IYP as a community-identified solution for preventing behavioral health disparities, demonstrated IYP efficacy in improving parenting practices and parenting stress in Filipino parents, and child problem behavior. This population was chosen because: 1) Filipinos are the second largest immigrant population in the U.S. with the highest concentration living in Los Angeles; 2) Filipinos are exposed to multiple adversities, including immigration stress and relocation, loss of social status, and lower self-esteem due to discrimination, placing young children at risk for future behavioral and mental health problems; 3) U.S. -born Filipino youth exhibit higher rates of mental health problems than non-Hispanic whites and attain significantly lower levels of education than their foreign-born counterparts and other U.S. -born Asian American populations; and 4) Filipinos are less likely than non-Hispanic whites to participate in mental health and preventive care interventions. The sample size will include 250 Filipino parent-child dyads. Data will be obtained using process evaluation tracking system and self-report instruments. The specific aim is to test the effectiveness of the Incredible Years model of parent training and its impact on parenting practices (primary outcome). It is hypothesized that 1) Parents will report and demonstrate improvements in parenting practices after IYP, as compared to baseline and to the control condition; 2) Parents in the experimental group will show more rapid improvement in parenting practices and these effects will be sustained over time compared to those in the control condition; and 3) Parents will report improvements in parenting stress, child problem behavior, such as internalizing, externalizing, and depressive symptoms (secondary outcomes) after IYP as compared to baseline and to the control condition. Findings will contribute to the scientific literature on preventive and early intervention programs for children at high risk for future behavioral problems. The data will also provide important information to understand the processes underlying how IYP affects parenting practices and subsequent child problem behavior among Filipino families. The importance of this research rests on its potential to prevent behavioral health disparities in this understudied and high-risk population. The investigators also aim to describe intervention delivery and its online implementation in real-world community settings. RQ 1: What are the facilitators/barriers to implementing the intervention at multiple levels (consumer, staff/provider, community setting)? RQ 2: What are the facilitators and barriers to sustaining the intervention during and after the study? ### Conditions Module **Conditions:** - Depression - Anxiety - Parenting **Keywords:** - Filipino Families - Incredible Years - Mental Health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Parents assigned to the intervention arm will receive the Incredible Years® School Age Basic \& Advanced Parent Training Program. It consists of twelve (12) 2-hour online workshops led by Aviril Sepulveda, a certified peer coach in the Incredible Years Parent Training Series. **Intervention Names:** - Behavioral: Incredible Years® School Age Basic Parent Training Program **Label:** Experimental: Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Parents assigned to the control arm will be emailed and mailed written parent education materials from the American Academy of Pediatrics called the Bright Futures handouts. The control group is offered the Incredible Years® School Age Basic \& Advanced Parent Training Program after a 3-month wait list period. **Intervention Names:** - Other: American Academy of Pediatrics, Bright Futures Handouts **Label:** Control **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: Intervention **Description:** The Incredible Years® School Age Basic Parent Training Program targets many of the proposed mechanisms and risk factors for internalizing distress in early childhood: harsh and unpredictable or critical parenting behaviors. Parents also learn cognitive strategies; such as self-praise, coping thoughts, how to challenge negative thoughts, and how to get support that they are encouraged to model for and teach their children. Finally, the participants learn how to be more positive and nurturing through academic, social and emotional coaching. **Name:** Incredible Years® School Age Basic Parent Training Program **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control **Description:** Written materials that include age-group specific tips on how parents can support their child's development and social and academic success. **Name:** American Academy of Pediatrics, Bright Futures Handouts **Other Names:** - Control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Parenting practices will be assesed using scores from the Parent Practices Interview (PPI). The PPI asks questions regarding parenting styles and behavior management techniques. Questions are rated on a scale ranging from never to always. **Measure:** Parent Reported Positive Verbal Discipline **Time Frame:** Baseline, 3 months, and 6 months **Description:** Child depression will be measured using the Child Depression Inventory CDI). Each item in this self-report instrument includes a list of sentences that describe how children typically feel. Children are asked to pick out the sentence that best describes how they feel over the past 2 weeks. **Measure:** Child Reported Depression Symptoms **Time Frame:** 2 Weeks **Description:** Child anxiety will be measured using the Screen for Child Anxiety Related Emotional Disorders (SCARED). Screen includes a list of sentences that describe how people feel over the last 3 months. Answers are rated on a scale from 0 (not true) to 2 (very true or often true). **Measure:** Child Reported Anxiety Symptoms **Time Frame:** 3 Months #### Secondary Outcomes **Description:** Parent reported use of physical punishment will be assessed using scores from the Parent Practices Interview (PPI). The PPI asks questions regarding parenting styles and behavior management techniques. Questions are rated on a scale ranging from never to always. **Measure:** Parent Reported Use of Physical Punishment **Time Frame:** Baseline, 3 months, and 6 months **Description:** Child problem behavior will be measured using scores from Child Behavior Checklist (CBCL). Parents describe their child's behavior within the past 6 months. Questions are rated on a scale from 0 (not true) to 2 (very true or often true). The CBCL screens for the following behaviors: Aggressive Behavior, Anxious/Depressed, Attention Problems, Rule-Breaking Behavior, Somatic Complaints, Social Problems, Thought Problems, Withdrawn/Depressed. Results for each subscale are presented as a percentile and T-score, with scores above 97th percentile considered as "clinical range" based on the DSM-V. **Measure:** Parent Reported Change in Child Behavioral Problems **Time Frame:** 6 months **Description:** Parent reported child anxiety will be measured using scores from the Screen for Child Anxiety Related Disorders (SCARED). Screen includes a list of sentences that describe how people feel over the last 3 months. Answers are rated on a scale from 0 (not true) to 2 (very true or often true). **Measure:** Parent Reported Child Anxiety **Time Frame:** 3 Months **Description:** Parent Reported Child Depression will be measured using scores from the Children's Depression Inventory (CDI). Screen includes statements that describes observations of subject's child over the past 2 weeks. Answers are rated on a scale from 0 (not at all) to 3 (much or most of the time). **Measure:** Parent Reported Child Depression **Time Frame:** 2 weeks **Description:** Parent Reported Child Resilience will be measured using scores from the Child \& Youth Resilience Measure- Revised Person Most Knowledgeable Version (PMK-CYRM-R). Questions include statements designed to better understand how the subject's child copes with daily life. Answers are rated on a scale from 1( not at all) to 5 (a lot). **Measure:** Parent Reported Child Resilience **Time Frame:** Baseline, 3 months, and 6 months **Description:** Child Reported Child Resilience will be measured using scores from the Child \& Youth Resilience Measure (CYRM-R). Questions include statements designed to better understand how the child copes with daily life. Answers are rated on a scale from 1( not at all) to 5 (a lot). **Measure:** Child Reported Child Resilience **Time Frame:** Baseline, 3 months, and 6 months **Description:** Parenting Self Efficacy will be measured using scores from the Parenting Sense of Competence (PSOC). Questions include agree/ disagree statements about perceived self efficacy and satisfaction with parenting. Answers are rated on a scale from 1( Strongly Disagree) to 6 (Strong Agree). **Measure:** Parenting Self Efficacy **Time Frame:** Baseline, 3 months, and 6 months ### Eligibility Module **Eligibility Criteria:** NOTE: All parent participants in the study are 18 years or older. Youth participants are 8-12 years old. Since parents are the MAIN participants in this study (parents are randomized; children only fill out surveys), the age limits in this record are set for parents. Inclusion Criteria: Phase 1: 1. parent of at least one child 8-12 years of age; 2. parent is of Filipino descent. 3. Pregnant women or legal guardians may be included if they have a child who meets the inclusion and exclusion criteria. 4. both English- and Tagalog- (the official language of the Philippines) speaking participant Phase 2: 1. community social workers, psychologists, marriage, family therapists, and health educators. 2. An individual is eligible for an individual online interview once they have co-led a parenting group or served as community liaison during the context of the study. 3. English speaking individuals 4. 18 years old or over. Exclusion Criteria: Phase 1. 1. family plans to move out of the state of California within the next 6 months 2. previous participation in the IY Advanced program 3. Parents who are not fluent in English. 4. Adults unable to consent, children unable assent 5. Prisoners. Phase 2. 1. individuals who are under 18 years old 2. individuals that are not fluent in English 3. individuals who have not co-led a parenting group or served as community liaison in the context of the study. **Healthy Volunteers:** True **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jojavier@chla.usc.edu **Name:** Joyce R Javier, MD, MPH, MS **Phone:** 323-671-2093 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Children's Hospital Los Angeles, USC Keck School of Medicine **Name:** Joyce R Javier, MD, MPH, MS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers studying parenting and child behavior outcomes. **Description:** Individual participant data will be provided to the NIH National Institute of Mental Health Data Archives (NDA) repository. The de-identified individual data will be shared with the NIH National Institute of Mental Health Data Archives (NDA) repository. Any information that could be used to identify you will be removed before any data is shared. NDA provides infrastructure for sharing research data, tools, methods, and analyses enabling collaborative science and discovery. De-identified human subjects data, harmonized to a common standard, are available to qualified researchers. The NDA makes available human subjects data collected from hundreds of research projects across many scientific domains. De-indentified human subjects data, harmonized to a common standard, are available to qualified researchers. **IPD Sharing:** YES **Time Frame:** Data will be shared with authorized users upon publication (via an NDA Study) or 1-2 years after the grant end date specified on the first Notice of Award, as defined in the applicable Data Sharing Terms and Conditions. Specific data used in a publication will be shared at the time of publication. All other data that are part of the principal investigator's final dataset as defined in the Data Sharing Terms and Conditions will be shared 2 years after the original project end date. **URL:** https://nda.nih.gov/ ## 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: 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: 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:** NCT06416410 **Brief Title:** JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation **Official Title:** An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation #### Organization Study ID Info **ID:** JAB-21822-3002 #### Organization **Class:** INDUSTRY **Full Name:** Jacobio Pharmaceuticals Co., Ltd. ### Status Module #### Completion Date **Date:** 2027-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jacobio Pharmaceuticals Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). ### Conditions Module **Conditions:** - Advanced Non-squamous Non-small-cell Lung Cancer - Metastatic Non-squamous Non Small Cell Lung Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 392 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle **Intervention Names:** - Drug: JAB-21822 - Drug: JAB-3312 **Label:** JAB-21822+JAB-3312 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle **Intervention Names:** - Drug: Tislelizumab - Drug: Pemetrexed - Drug: Carboplatin **Label:** Tislelizumab combined with Pemetrexed + Carboplatin **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - JAB-21822+JAB-3312 **Description:** JAB-21822 administered orally as a tablet **Name:** JAB-21822 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tislelizumab combined with Pemetrexed + Carboplatin **Description:** Tislelizumab administered as an intravenous (IV) infusion **Name:** Tislelizumab **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - JAB-21822+JAB-3312 **Description:** JAB-3312 administered orally as a tablet or capsule **Name:** JAB-3312 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Tislelizumab combined with Pemetrexed + Carboplatin **Description:** Pemetrexed administered as an intravenous (IV) infusion **Name:** Pemetrexed **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Tislelizumab combined with Pemetrexed + Carboplatin **Description:** Carboplatin administered as an intravenous (IV) infusion **Name:** Carboplatin **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** To be assessed by EORTC OLO-LC13 **Measure:** Patient Self-Evaluation Results (PRO) **Time Frame:** From Baseline up to 4 years **Description:** To be assessed by EORTC OLO-C30 **Measure:** Patient Self-Evaluation Results (PRO) **Time Frame:** From Baseline up to 4 years **Description:** To be assessed by EuroQoL(EQ)5D **Measure:** Patient Self-Evaluation Results (PRO) **Time Frame:** From Baseline up to 4 years #### Primary Outcomes **Description:** PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC). **Measure:** Outcome Progression-free Survival (PFS) **Time Frame:** From Baseline up to 4 years #### Secondary Outcomes **Description:** Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1 **Measure:** Objective Response Rate (ORR) **Time Frame:** From Baseline up to 4 years **Description:** OS is defined as the time from randomization until death due to any cause **Measure:** Overall Survival (OS) **Time Frame:** From Baseline up to 4 years **Measure:** Number of Participants With Treatment-Emergent Adverse Events **Time Frame:** From Baseline up to 4 years **Measure:** Number of Participants With Clinically Significant Changes in Vital Signs **Time Frame:** From Baseline up to 4 years **Measure:** Time to Maximum Plasma Concentration (Tmax) **Time Frame:** Pre-dose Day 1 up to Day 64 **Measure:** Half life (t1/2) **Time Frame:** Pre-dose Day 1 up to Day 64 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A signed written informed consent is required before performing any study-related operations * Age greater than or equal to 18 years old * Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab * No history of systemic anticancer therapy to the local advanced/metastatic disease * Expected survival period greater than or equal to 3 months * Having at least one target lesion according to RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) ≤ 1 Exclusion Criteria: * Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types * Carry other driver gene mutations with available target therapy, or carry other KRAS mutations * Subjects with untreated central nervous system (CNS) metastases were excluded; * Uncontrolled pleural effusion, pericardial effusion, and ascites * Subjects with impaired heart function or clinically significant heart disease **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** clinicaltrials@jacobiopharma.com **Name:** Jacobio Pharmaceuticals **Phone:** 86-10-56315466 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Jacobio Pharmaceuticals **Name:** Jacobio Pharmaceuticals **Role:** STUDY_DIRECTOR ## 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 ### 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: D000074322 - Term: Antineoplastic Agents, Immunological ### 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 ### Intervention Browse Module - Browse Leaves - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M264 - Name: Pemetrexed - Relevance: HIGH - As Found: Strategies - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Meet - 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: M1346 - Name: Antineoplastic Agents, Immunological - 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 ### Intervention Browse Module - Meshes - ID: D000016190 - Term: Carboplatin - ID: D000068437 - Term: Pemetrexed - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416397 **Acronym:** PROTEOBILE **Brief Title:** Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy **Official Title:** Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy #### Organization Study ID Info **ID:** CHUBX 2023/69 #### Organization **Class:** OTHER **Full Name:** University Hospital, Bordeaux ### Status Module #### Completion Date **Date:** 2026-02 **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:** 2026-02 **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:** 2024-02-01 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Bordeaux #### 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 aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling). **Detailed Description:** Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage. New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples. Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established. Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis. ### Conditions Module **Conditions:** - Cholangiocarcinoma **Keywords:** - Cholangiocarcinoma - Diagnosis - Cancer - Proteomic profiling ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Proteomic analysis of bile samples will be performed every 5 bile samples. Bile samples will be taken during endoscopy with retrograde papillary catheterization or radiological procedures in selected patients. In clinical practice, bile samples are taken for bacteriological purposes. An average of 10 mL is taken. Five mL are required for bacteriological analysis. The remaining millilitres, which are usually discarded, will be kept for storage and to form the bile bank at the Biological Resources Centre before to be analyzed in proteomics. **Name:** Proteomic profile **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** rate of positive diagnosis of cholangiocarcinoma obtained from bile samples using proteomic profile analysis compared with the rate of positive diagnosis using histological reference tools. **Measure:** positive diagnosis of cholangiocarcinoma **Time Frame:** Baseline #### Secondary Outcomes **Description:** pecific analysis of proteomic data to identify a recurrent, malignancy-specific target protein **Measure:** Identification of diagnostic biomarkers for cholangiocarcinoma **Time Frame:** Baseline **Description:** differential diagnosis rates obtained by proteomic profiling compared with histological results **Measure:** differential diagnosis rates **Time Frame:** Baseline **Description:** rate of positive diagnoses with the Next-Generation Sequencing technique **Measure:** positive diagnoses with the Next-Generation Sequencing technique **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient 18 years and older * Patients with bile duct stenosis who require endoscopy with retrograde papillary catheterization or a radiological procedure for diagnostic purposes (histological samples) as part of their management * Oral consent Exclusion Criteria: * Pregnant woman * Patient under legal protection **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients with bile duct stenosis who require ERCP or a radiological procedure for diagnostic purposes (histological samples) as part of their management ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** arthur.marichez@chu-bordeaux.fr **Name:** Arthur Marichez, MD **Phone:** +33557656005 **Role:** CONTACT #### Locations **Location 1:** **City:** Pessac **Contacts:** ***Contact 1:*** - **Email:** arthur.marichez@chu-bordeaux.fr - **Name:** Arthur Marichez, MD - **Phone:** +33557656005 - **Role:** CONTACT **Country:** France **Facility:** CHU Bordeaux ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - 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: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - 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: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416384 **Brief Title:** Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients **Official Title:** The Effect of Hand Massage on Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients #### Organization Study ID Info **ID:** AU-SBE-SA-02 #### Organization **Class:** OTHER **Full Name:** Amasya University ### Status Module #### Completion Date **Date:** 2024-05-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-02-07 **Type:** ACTUAL #### Start Date **Date:** 2024-01-09 **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:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Amasya 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:** This study aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time. **Detailed Description:** After obtaining the necessary permissions for the research, informing the patients about the purpose, importance and method of the study by the researcher, and having the volunteer patients read and sign a consent form, the patients were randomly divided into two groups. Randomization of the groups was done in a computer environment. ### Conditions Module **Conditions:** - Hemodialysis - Fatigue - Massage **Keywords:** - hemodialysis patient - fatique - hand massage - nursing - recovery time ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** It is a randomized controlled, single-blind, experimental study. ##### Masking Info **Masking:** SINGLE **Masking Description:** Single-blind (outcomes assessor) **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 48 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The researcher applied a hand massage to the hand area of the patients in the experimental group on the side without fistula for five minutes, three times a week for four weeks. **Intervention Names:** - Other: Control Group **Label:** Hand Massage Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the control group received routine nursing care in the clinic for four weeks. **Intervention Names:** - Other: Hand Massage Group **Label:** Control Group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group **Description:** The patients in the hand massage application group were asked by the researcher; Hand massage with olive oil was applied 12 times in total, three times a week for four weeks. No application was made to the side with fistula. **Name:** Hand Massage Group **Other Names:** - Experimental **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Hand Massage Group **Description:** Patients in the control group received routine nursing care in the clinic for four weeks. **Name:** Control Group **Other Names:** - Control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Fatigue severity was evaluated before starting the application (pre-test) Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11. **Measure:** fatigue severity **Time Frame:** one week= first session **Description:** Recovery time after dialysis was evaluated before starting the application (pre-test) **Measure:** recovery time **Time Frame:** One week= first session #### Secondary Outcomes **Description:** The effect of hand massage on fatigue severity was measured Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11. **Measure:** fatique severity **Time Frame:** After 4 weeks **Description:** The effect of hand massage on recovery time after dialysis was measured **Measure:** recovery time after dialysis **Time Frame:** After 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Those who are 18 years or older, * Receiving hemodialysis treatment for at least 3 months, * Receiving hemodialysis treatment three times a week, * Does not have any open wounds in the area to be applied, * No active fistula in the arm to be treated, * Does not have a hearing impairment, * Sufficient to understand the questions, * Open to communication and cooperation, * Volunteer and willing for research Exclusion Criteria: * Having an active oncological problem or receiving oncological treatment, * Those with health problems that require contact isolation, * The number of dialysis sessions changed during the study, * Those who lost their lives while working, * Those who had a kidney transplant during the study, * Those who want to leave voluntarily at any stage of the study **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Amasya **Country:** Turkey **Facility:** Amasya University İnstitute of Health Sciences **State:** Merkez **Zip:** 05100 #### Overall Officials **Official 1:** **Affiliation:** Amasya University **Name:** Eylem Topbaş, Phd **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Amasya University health sciences institute **Name:** Seyit Ahmet KORKMAZ **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** It can only be shared after publication upon special request from the authors. **IPD Sharing:** NO ## 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: M8364 - Name: Fatigue - Relevance: HIGH - As Found: Fatigue ### Condition Browse Module - Meshes - ID: D000005221 - Term: Fatigue ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T242 - Name: Olive - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416371 **Brief Title:** Retinal Vessel Leakage in Cerebral Small Vessel Disease **Official Title:** Retinal Vessel Leakage in Cerebral Small Vessel Disease: a Sub-study of the Mild Stroke Study 3 #### Organization Study ID Info **ID:** AC24000 #### Organization **Class:** OTHER **Full Name:** University of Edinburgh ### Status Module #### Completion Date **Date:** 2025-07 **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:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-16 **Type:** ACTUAL **Study First Submit Date:** 2024-01-15 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Edinburgh #### 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 goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are: * Does retinal vessel leakage occur in cerebral small vessel disease? * If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally? Participants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels. Participants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests. **Detailed Description:** Cerebral small vessel disease (SVD) is a common cause of stroke and dementia. The molecular causes are unclear, limiting new therapies. Breakdown of the blood-brain barrier (BBB) is characteristic and may damage brain tissue. However, specialist MRI scans to measure BBB breakdown are expensive and time-consuming. In contrast, measuring leakage from retinal blood vessels is relatively simple. The blood-retina barrier is very similar to the BBB, and SVD is likely to damage retinal and brain blood vessels in the same way. If so, then retinal angiography could be used to study SVD pathogenesis and measure the effect of new treatments with much greater resolution and lower cost than MRI. We have three aims: 1. Test the feasibility of fluorescein angiography in people with SVD 2. Discover if retinal vessel leakage occurs people with SVD 3. Discover whether the severity of retinal vessel leakage is associated with clinical features of SVD We will recruit participants from a well-established cohort of people with SVD - the Mild Stroke Study 3 (MSS3). ### Conditions Module **Conditions:** - Cerebral Small Vessel Diseases - Lacunar Stroke - Vascular Dementia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Intravenous injection of sodium fluorescein for angiography of retinal blood vessels **Name:** Fundus fluorescein angiography, with ultrawide field retinal imaging **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The presence and severity of retinal vessel leakage will be measured for each eye in terms of change in pixel brightness over the duration of the angiogram. **Measure:** Retinal vessel leakage by automated segmentation **Time Frame:** within one angiogram **Description:** The presence and severity of retinal vessel leakage will be measured using an manual ordinal grading scale **Measure:** Retinal vessel leakage by manual grading **Time Frame:** within one angiogram #### Secondary Outcomes **Description:** BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium **Measure:** Baseline blood-brain barrier breakdown **Time Frame:** Within one MRI scan **Description:** This is measured from the most recent structural MRI scan **Measure:** White matter hyperintensity (WMH) volume adjusted for brain volume **Time Frame:** Within one MRI scan **Description:** This is measured by comparing the most recent structural MRI scan with the baseline structural MRI scan **Measure:** Change in white matter hyperintensity (WMH) volume adjusted for brain volume **Time Frame:** Difference in MRI scans up to 5 years prior **Description:** This is measured from the most recent structural MRI scan **Measure:** Fazekas score **Time Frame:** Within one MRI scan **Description:** This is measured by comparing the most recent structural MRI scan with the baseline structural MRI scan **Measure:** Change in Fazekas score **Time Frame:** Difference in MRI scans up to 5 years prior **Description:** BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium **Measure:** Baseline average leakage in white matter hyperintensities **Time Frame:** Within one MRI scan **Description:** BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium **Measure:** Baseline average leakage in deep grey matter **Time Frame:** Within one MRI scan **Description:** BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium **Measure:** Baseline number of leakage hotspots **Time Frame:** Within one MRI scan ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Membership in the Mild Stroke Study 3 cohort * Contrast enhanced MRI within 12 months * Clear optical media in both eyes, as assessed by study investigator * Best corrected visual acuity (near vision) ≥N36 Exclusion Criteria: * Any condition known to cause retinal leakage (i.e., worse than background diabetic retinopathy, retinal vein occlusion, active uveitis, wet age-related macular degeneration, malignant hypertension) * Previous treatment for retinal leakage (retinal laser, intravitreal anti-VEGF) * Recent eye surgery * Shallow anterior chambers as assessed by torch test * Pregnancy, renal failure * Severe dementia * Known allergy to fluorescein * History of allergy such as food or drug induced urticaria or history of bronchial asthma * Any other severe or acute medical or psychiatric conditions * Inability to give informed consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adults \>18 years old with mild ischaemic stroke with a modified Rankin scale (mRS) greater or equal to 2 at recruitment presenting to Edinburgh/Lothian stroke services. For details see Clancy, et al (2021) Rationale and design of a longitudinal study of cerebral small vessel diseases, clinical and imaging outcomes in patients presenting with mild ischaemic stroke: Mild Stroke Study 3. European Stroke Journal 6:81-88. https://doi.org/10.1177/2396987320929617 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Clancy U, Garcia DJ, Stringer MS, Thrippleton MJ, Valdes-Hernandez MC, Wiseman S, Hamilton OK, Chappell FM, Brown R, Blair GW, Hewins W, Sleight E, Ballerini L, Bastin ME, Maniega SM, MacGillivray T, Hetherington K, Hamid C, Arteaga C, Morgan AG, Manning C, Backhouse E, Hamilton I, Job D, Marshall I, Doubal FN, Wardlaw JM. Rationale and design of a longitudinal study of cerebral small vessel diseases, clinical and imaging outcomes in patients presenting with mild ischaemic stroke: Mild Stroke Study 3. Eur Stroke J. 2021 Mar;6(1):81-88. doi: 10.1177/2396987320929617. Epub 2020 Jun 5. **PMID:** 33817338 **Citation:** MacCormick IJ, Maude RJ, Beare NA, Borooah S, Glover S, Parry D, Leach S, Molyneux ME, Dhillon B, Lewallen S, Harding SP. Grading fluorescein angiograms in malarial retinopathy. Malar J. 2015 Sep 24;14:367. doi: 10.1186/s12936-015-0897-7. **PMID:** 26403288 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020521 - Term: Stroke - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000003704 - Term: Dementia - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000002537 - Term: Intracranial Arteriosclerosis - ID: D000020765 - Term: Intracranial Arterial Diseases - ID: D000056784 - Term: Leukoencephalopathies - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000083244 - Term: Thrombotic Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000020520 - Term: Brain Infarction - ID: D000007238 - Term: Infarction - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M29437 - Name: Cerebral Small Vessel Diseases - Relevance: HIGH - As Found: Cerebral Small Vessel Disease - ID: M17861 - Name: Dementia, Vascular - Relevance: HIGH - As Found: Vascular Dementia - ID: M29463 - Name: Stroke, Lacunar - Relevance: HIGH - As Found: Lacunar Stroke - ID: M5810 - Name: Cerebrovascular Disorders - 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: M17400 - Name: Vascular 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 - ID: M5786 - Name: Intracranial Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M22521 - Name: Intracranial Arterial Diseases - Relevance: LOW - As Found: Unknown - ID: M28591 - Name: Leukoencephalopathies - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M2401 - Name: Thrombotic Stroke - Relevance: LOW - As Found: Unknown - ID: M2400 - Name: Ischemic Stroke - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M10282 - Name: Infarction - Relevance: LOW - As Found: Unknown - ID: M22305 - Name: Brain Infarction - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059345 - Term: Cerebral Small Vessel Diseases - ID: D000015140 - Term: Dementia, Vascular - ID: D000059409 - Term: Stroke, Lacunar ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416358 **Brief Title:** A Study to Evaluate the Efficacy of ALMB-0168 in Solid Tumor Patients With Bone Metastatic Whose Prior Standard Treatment Have Failed **Official Title:** A Phase IIa, Multi-center, Single-Arm, Open-Label Study to Evaluate the Efficacy of ALMB-0168 in Solid Tumor Patients With Bone Metastatic Whose Prior Standard Treatment Have Failed #### Organization Study ID Info **ID:** ALMB-0168-002 #### Organization **Class:** INDUSTRY **Full Name:** AlaMab Therapeutics (Shanghai) Inc. ### 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:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **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:** 2024-05-10 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AlaMab Therapeutics (Shanghai) Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Bone metastasis is a common disease of advanced tumors. It refers to the metastasis of malignant tumors originating in a certain organ to the bones through the blood circulation or lymphatic system. The incidence of bone metastasis in breast and prostate cancer is as high as 65%-75%. Bone metastasis of malignant tumors often leads to severe bone lesions, including bone pain, pathological fractures, spinal cord compression, hypercalcemia and other bone-related events (SRE). SRE caused by bone metastasis of tumors can greatly reduce the quality of life of tumor patients. In severe cases, it can lead to rapid deterioration of the condition or even death, which greatly affects the extension of the patient's survival period. ALMB-0168 is designed to activate Cx43 hemichannels, which release key anti-cancer factors (such as ATP) into the extracellular environment. In several mouse models of breast cancer bone metastasis and orthotopic osteosarcoma, ALMB-0168 dose-dependently inhibited tumor growth and was able to extend the lifespan of tumor-bearing animals, indicating its potential as a therapeutic drug for malignant bone tumors. . Clinical research data from China and Australia show that ALMB-0168 is safe and initially effective in patients with bone metastasis and osteosarcoma; **Detailed Description:** Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures. ### Conditions Module **Conditions:** - Advanced Solid Tumors With Bone Only Metastasis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 144 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: ALMB-0168 **Label:** ALMB-0168 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ALMB-0168 **Description:** ALMB-0168 will be administered intravenously until either the disease progresses or intolerable toxicity occurs. **Name:** ALMB-0168 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** time (in months) from enrollment to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 3 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG3 criteria): first bone scan with \>= 2 new lesions compared to Baseline observed less than (\<) 12 weeks from enrollment and confirmed by a second bone scan performed \>=6 weeks; first bone scan with \>=2 new lesions compared to Baseline observed \>=12 weeks from enrollment **Measure:** The 6-month progression-free survival rate (6m-PFSR) of cohort A breast cancer IRC assessed according to RECIST 1.1 criteria **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to approximately 3 years **Measure:** The 4-month progression-free survival rate (6m-PFSR) assessed by cohort B prostate cancer Independent Review Committee（IRC） based on PCWG 3 criteria Progression-free survival rate (4m-PFSR); **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to approximately 3 years **Description:** To determine the recommended Phase 2 dose (RP2D) of single agent ALMB-0168 (monotherapy) for further exploration **Measure:** RP2D **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to approximately 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically or cytologically pathologically confirmed solid tumors. 2. presence of any of the following: a. Cohort A breast cancer with bone metastases: patients with disease progression or intolerance to prior standard therapy (e.g., radiotherapy, chemotherapy, endocrine therapy, anti-Her2 targeted therapy) and the presence of bone metastatic lesions only. Among them, Cohort A needs to fulfill the following points: i. For hormone receptor-positive breast cancer: endocrine therapy (including, but not limited to, ET with or without combination of CDK 4/6 inhibitors, the mTOR inhibitor everolimus, the HDAC inhibitor cedarbenamide, and the PI3Kα inhibitor Alpelisib, among others) is required and progression or intolerance; ii. For Her2-positive (defined as FISH/CISH/SISH positive or IHC 3+ or IHC 2+ but confirmed HER2-positive by in situ hybridization) breast cancers: anti-Her2 targeted therapies (including trastuzumab/patuzumab or marketed biosimilars or initumumab or anti-Her2 ADCs such as T-DM1/DS8201 or TKIs) are required. DS8201 or TKI analogs (lapatinib, pyrrolitinib, neratinib, tucatinib, etc.)) and progression or intolerance; iii. For BRCA1/2 germline mutant breast cancer: progression or intolerance to olaparib is required; iv. PD-L1-positive with combined positive (CPS) score ≥10 requiring anti-PD-1, PD-L1 progression or intolerance; v. Disease progression or intolerance from at least 1 chemotherapy regimen, or unsuitable for chemotherapy; b. Cohort B prostate cancer with bone metastases: metastatic desmoplasia-resistant prostate cancer that meets PCWG3 progression criteria after prior standard therapy (e.g., docetaxel or abiraterone, enzalutamide, etc.), and the presence of bone metastatic lesions (≥2) only. Of these, Cohort B needs to fulfill the following points: i. Receiving or maintaining androgen deprivation therapy (ADT) during the study period (i.e., ongoing treatment with gonadotropin-releasing hormone (GnRH) agonists or antagonists (pharmacologic depot) or previous bilateral orchiectomy (surgical depot)), and serum testosterone must be at depot levels (\< 50 ng/mL or \< 1.7 nmol/L); ii. Must have progressed or been intolerant to at least 1 novel endocrine therapy (including enzalutamide/abiraterone/apatadine/darotarolimide, etc.) during the mCRPC phase; iii. Have received 1 paclitaxel-based chemotherapy regimen disease progression or intolerance, or are not suitable to receive paclitaxel. 3. 18 years old and above, male and female. 4. ECOG (Eastern Cooperative Oncology Group) PS score of 0, 1, or 2. 5. Major systemic functions are defined as follows: i. Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count ≥ 75 x 109/L; hemoglobin ≥ 90 g/L, and no related supportive therapy such as GCS-F, EPO, or transfusion had been used in the 14 days prior to dosing; ii. Liver function: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (unless the patient has grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome of slow bilirubin binding). Transaminases (AST/SGOT and/or ALT/SGPT) ≤ 3 times ULN; iii.Renal function: Normal serum creatinine ≤ 1.5 mg/dL (133 μmol / L) and calculated creatinine clearance ≥ 60 mL/min (Cockroft - Gault formula); iv. Coagulation: Coagulation parameters defined as an international normalized rate (INR) ≤ 2. 6 Eligible individuals of childbearing potential (males and females) must agree to use a reliable method of contraception (hormonal contraceptives, barrier method, or abstinence) with their partner for the duration of the trial and for at least 60 days after the last dose. Female individuals of childbearing age must have a negative blood pregnancy test within 7 days prior to enrollment and must be non-lactating. Male subjects are prohibited from donating sperm during their participation in the study and female subjects are prohibited from donating eggs during the study. 7. Expected survival of ≥ 3 months. 8. Be able to understand the whole process of the study, participate voluntarily and sign the informed consent form. Exclusion Criteria: 1. Clinically uncontrolled pleural effusion, abdominal effusion, pericardial effusion (except for small amounts detected by imaging) within 4 weeks prior to dosing. 2. Poorly controlled bone pain, pathologic long bone fracture (\> 50% cortical erosion on imaging), or neoplastic spinal cord compression. 3. Systemic glucocorticoid therapy within 4 weeks prior to dosing (except \>20 mg/day of prednisone or equivalent dose of other hormones for prevention of contrast reactions during radiologic exams or inhalation or topical administration). 4. Following cardiac conditions within 6 months prior to dosing: 1. Left ventricular ejection fraction (LVEF) \< 45% as measured by echocardiography (ECHO); 2. Screening electrocardiogram (ECG) suggesting a QTcF interval \> 470 ms in women and \> 450 ms in men; 3. Unstable angina; 4. Congestive heart failure (New York Heart Association \[NYHA\] \> class 2); 5. Acute myocardial infarction; 6. Poorly controlled arrhythmias; 7. Stent implantation. 5. Uncontrolled hypertension. (Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg. 6. Severe active bacterial, fungal, or viral infection (defined as requiring intravenous antibacterial, antifungal, or antiviral drug therapy) within 2 weeks prior to the first dose, or other serious medical condition that would interfere with the subject's ability to receive the test drug. 7. Positive anti-human immunodeficiency virus antibody or anti-syphilis spirochete-specific antibody tests, or active hepatitis B (defined as hepatitis B surface antigen positive and HBV-DNA above the lower measurable limit or ≥ 500 IU/ml) or active hepatitis C (defined as HCV antibody positive and HCV-RNA positive). 8. Other active tumors or a history of treatment for invasive tumors within 3 years. Subjects with a history of definitive local therapy for stage I tumors that are considered unlikely to recur are acceptable. Patients with a history of prior treatment for carcinoma in situ (e.g., non-invasive) and a history of non-melanoma skin cancer may be accepted. 9. Recent antineoplastic therapy (including but not limited to chemotherapy, immunotherapy, endocrine therapy and targeted therapy, but also including unlisted antineoplastic therapy) ≤ 4 weeks or within 5 half-lives of the drug, whichever is shorter, prior to the first dose, or relevant side effects NCI CTCAE v5.0 \> Grade 1, except alopecia. 10. Participation in a clinical trial of another drug within 4 weeks prior to the first dose or within 5 half-lives of the trial drug, whichever is shorter, and enrollment in treatment, unless it is an observational (non-interventional) clinical trial or in the follow-up period of an interventional trial. 11. Radiation therapy (including radioisotope therapy such as strontium 89) ≤ 4 weeks prior to the first dose or localized radiation therapy ≤ 1 week prior to treatment, or have not recovered from the side effects of such therapy. 12. Surgery within 4 weeks prior to the first dose or outpatient surgery within 1 week prior to the start of treatment. There is no waiting period after artificial blood vessel placement. 13．Herbal or proprietary Chinese medicine with antitumor activity within 1 week prior to the first dose; 14. Previous grade ≥ 3 hypersensitivity and/or contraindications to human monoclonal antibodies or fusion proteins; 15. Pregnant or lactating women. 16. Individuals who, in the opinion of the investigator, are otherwise unsuitable for participation in this clinical trial. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ctr-contact@cspc.cn **Name:** Clinical Trials Information Group officer **Phone:** 86-0311-69085587 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** First Affiliated Hospital, Sun Yat-Sen University **Name:** Jingnan Shen, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Metastases - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000009362 - Term: Neoplasm Metastasis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06416345 **Brief Title:** Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease **Official Title:** Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease #### Organization Study ID Info **ID:** NL86310.018.24 #### Organization **Class:** OTHER **Full Name:** Amsterdam UMC, location VUmc ### Status Module #### Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **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:** 2024-05-10 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Radboud University Medical Center #### Lead Sponsor **Class:** OTHER **Name:** Amsterdam UMC, location VUmc #### Responsible Party **Investigator Affiliation:** Amsterdam UMC, location VUmc **Investigator Full Name:** Dr. Erwin E. H. van Wegen **Investigator Title:** Principal Investigator, Associate Professor Neurorehabilitation **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The majority of people with Parkinson's disease incur Freezing of Gait (FoG), which is not addressed adequately by medication. Cueing is a proven strategy to overcome FoG. The Cue2Walk is a device with automated detection of FoG and provision of rhythmic cues. In this study, the (cost-)effectiveness of the Cue2Walk device as compared to usual care is investigated. **Detailed Description:** Freezing of gait (FoG) is one of the most common and disabling motor symptoms of Parkinson's disease and is associated with poorer quality of life. However, current pharmacological or even surgical treatments do not address FoG adequately and innovative rehabilitation strategies are needed. Cueing is a proven strategy to overcome FoG episodes and an essential part in the management of FoG. The Cue2Walk, a Medical Device Class I CE-certified leg-worn device, addresses the debilitating effects of FoG episodes at home with 'smart cueing' by combining automatic detection of a freezing episode with manual or automatic rhythmic cues (auditory or vibro-tactile). This study aims to investigate the (cost-)effectiveness of the Cue2Walk device as compared to usual care. This study is a multicenter randomized clinical trial with 2 parallel groups (24-week intervention group and 24-week 'waiting list' group). After 24 weeks, an 8-week naturalistic follow-up will be implemented for the intervention group, while participants in the waiting list group will also receive the intervention, but for 8 weeks. Frequently repeated assessment of outcomes measures will be conducted. ### Conditions Module **Conditions:** - Parkinson Disease **Keywords:** - Parkinson's Disease - Freezing of Gait - (Smart) Cueing - Costeffectiveness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** At-home use of the Cue2Walk **Intervention Names:** - Device: Cue2Walk **Label:** Intervention Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Usual Care (+ Waiting List) **Intervention Names:** - Other: Usual Care **Label:** Control Group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Group **Description:** 24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up **Name:** Cue2Walk **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Control Group **Description:** 24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment **Name:** Usual Care **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** For the economic evaluation, resource utilization will be determined by a cost questionnaire **Measure:** Resource Utilization **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24) #### Primary Outcomes **Description:** Self-reported quality of life will be determined using the Parkinson's Disease Questionnaire (PDQ-39) **Measure:** Self-reported quality of life **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** General health-related quality of life will be determined using the EuroQol 5 Dimensions 5 Level Survey (EQ-5D-5L) **Measure:** General health-related quality of life **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Time in Freezing of Gait (i.e. frequency and duration of FoG) will be determined by the Cue2Walk medical device **Measure:** Time in Freezing of Gait **Time Frame:** Continuously from baseline (week 0) up to week 32 #### Secondary Outcomes **Description:** The level of concern about falling during various activities will be determined by the Falls Efficacy Scale International (FES-I) **Measure:** Falls Efficacy **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** The number of falls and near-falls will be determined with a weekly diary **Measure:** Numbers of falls **Time Frame:** Weekly from baseline (week 0) up to week 32 **Description:** Freezing of Gait severity will be determined by the New Freezing of Gait Questionnaire (NFOG-Q) **Measure:** Freezing of Gait severity **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Freezing of Gait severity will be determined by the Patient Reported Outcomes for Freezing of Gait (PRO-FOG) **Measure:** Freezing of Gait severity **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Independence in Activities of Daily Living will be determined by the Nottingham Extended Activities of Daily Living Index (NEADL) **Measure:** Independence in Activities of Daily Living **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Motor Aspects of Experiences of Daily Living will be determined by MDS-UPDRS part II **Measure:** Motor Aspects of Experiences of Daily Living **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Daily mobility will be determined by the Cue2Walk step count **Measure:** Daily mobility **Time Frame:** Continuously from baseline (week 0) up to week 32 **Description:** Mood will be determined by Hospital Anxiety and Depression Scale (HADS) **Measure:** Mood **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Gait-Specific Attentional Profile will be determined by the Gait-Specific Attentional Profile questionnaire (G-SAP) **Measure:** Gait-Specific Attentional Profile **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Acceptance of illness will be determined by the Chronic Illness Acceptance Questionnaire (CIAQ) **Measure:** Acceptance of Illness **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** Caregiver burden will be determined by Zarit's Burden Interview Short Form (ZBI-12) **Measure:** Caregiver burden **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 **Description:** We will use patient reported experience measures (PREMS) to quantify patient experiences regarding the care they receive during the intervention phase and we will record user experiences **Measure:** Patient experiences **Time Frame:** Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of Parkinson's disease according to UK Brain bank criteria * Daily Freezing of Gait * Hoehn-Yahr stage 2-4 * Stable medication regime and/or DBS settings as determined by the treating neurologist * Ability to walk 5 minutes while unassisted by another person Exclusion Criteria: * Participation in another clinical study * Use of a personal cueing device at home * Previous use of the Cue2Walk medical device * Presence of co-morbidities that would hamper participation * Cognitive impairment preventing understanding of therapeutic instructions (Montreal Cognitive Assessment (MoCA) Score \<16) **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** e.vanwegen@amsterdamumc.nl **Name:** Erwin EH van Wegen, Dr. **Phone:** 020-4440461 **Role:** CONTACT #### Locations **Location 1:** **City:** Amsterdam **Contacts:** ***Contact 1:*** - **Email:** e.vanwegen@amsterdamumc.nl - **Name:** Erwin EH van Wegen, Dr. - **Phone:** 020-4440461 - **Role:** CONTACT ***Contact 2:*** - **Name:** Erwin EH van Wegen, Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Matthijs van der Laan, MSc - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Marc B. Rietberg, Dr. - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Jorik H. Nonnekes, Dr. - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Vincent de Groot, Prof. dr. - **Role:** SUB_INVESTIGATOR **Country:** Netherlands **Facility:** Amsterdam UMC, location VUmc **State:** Noord-Holland **Zip:** 1081HZ #### Overall Officials **Official 1:** **Affiliation:** Amsterdam UMC, location VUmc **Name:** Erwin EH van Wegen, Dr. **Role:** PRINCIPAL_INVESTIGATOR ## 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