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## Protocol Section ### Identification Module **NCT ID:** NCT06434545 **Acronym:** SMEtH **Brief Title:** Symptom Management Essentials at Home **Official Title:** SMEtH - Symptom Management Essentials at Home #### Organization Study ID Info **ID:** 80-86300-98-060 #### Organization **Class:** OTHER **Full Name:** UMC Utrecht ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2026-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Zorgbelang Inclusief **Class:** OTHER **Name:** Comprehensive Cancer Centre The Netherlands **Class:** UNKNOWN **Name:** ROC Midden Nederland **Class:** OTHER **Name:** University of Applied Sciences Utrecht #### Lead Sponsor **Class:** OTHER **Name:** UMC Utrecht #### Responsible Party **Investigator Affiliation:** UMC Utrecht **Investigator Full Name:** Everlien de Graaf **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A cluster Randomized Controlled Trial (cRCT) that aims to determine the effect of the Palliative Reasoning (PR) methodology on the quality of life and symptom burden of patients dealing with a life-limiting illness and their loved ones, receiving palliative care services at home. Palliative Reasoning will be implemented from the first of may 2024 to 30 april 2025 in twenty nursing teams of a large homecare organization in Utrecht, the Netherlands, and will be compared with twenty control nursing teams. The effect of PR will be measured by means of questionnaires filled out by clients with a life expectancy of less than one year according to the surprise question "Would I be surprised if this person would die within one year?" and family caregivers. Parallel to the effect study, a process evaluation will be conducted in order to understand the implications of the results and its' societal and practical impact. **Detailed Description:** The Palliative Reasoning (PR) methodology has been developed by University Medical Centre Utrecht (UMCU) in collaboration with the Netherlands Comprehensive Cancer organization (IKNL) to support nursing teams and other HCPs with the inter- and intradisciplinary communication and the early recognition, analysis and treatment of symptoms in patients requiring palliative care. This stepwise, iterative approach starts with HCPs identifying patients with palliative care needs by asking the surprise question "Would I be surprised if this patient would die within one year?". If the answer to the previous question is no, indicating not being surprised, a patient can be marked as being in a palliative phase of life. After the identification of the patient the method follows four steps: (1) Map out current symptoms, values, wishes and needs of patient and loved ones; (2) Analyze symptoms; (3) develop a proactive treatment plan; (4) Make agreements for the evaluation of the treatment plan. After the training twenty of the forty nursing teams working for a large homecare organization, patients and family caregivers of both intervention teams and control teams can be included. The perceived symptom control, quality of life and symptom burden of patients and symptom burden of family caregivers, will be compared between intervention and control teams, to assess the effectiveness of the intervention. ### Conditions Module **Conditions:** - Symptom Management **Keywords:** - Symptom management - Palliative Care - Primary care - life-limiting illness - Palliative Reasoning ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 800 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group consists of 20 nursing team, each recruiting 20 clients with palliative care needs. This results in a total of 400 clients for the intervention group. A nursing team consists of nurse assistants, registered nurses and specialized nurses. **Intervention Names:** - Behavioral: Palliative Reasoning methodology **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group consists of 20 nursing teams that will continue to provide care as previous to the start of the study. Contact persons also recruit 20 clients per nursing team, resulting in a total of 400 client for the control group. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Twenty nursing teams will be trained in the Palliative Reasoning methodology during a four hour training, split into two sessions. Additionally, teams receive a coaching session ones a month and practice with a real life case every week or two weeks during a one hour team meeting. This will be compared with 20 other nursing teams that will continue to provide care as usual. **Name:** Palliative Reasoning methodology **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** age, gender, marital status, education level, employment status (retired, unemployed, employed), (past) illness, type of employment (in the past), duration of illness, treatment, phase of illness, comorbidity, performance status (KPS), time under nursing care, number of visits per day/week. **Measure:** Client demographics **Time Frame:** Questioned at baseline **Description:** age, gender, education level, role, employment status assessed at enrollment. **Measure:** Primary caregiver demographics **Time Frame:** Questioned at baseline **Description:** education level, local collaborations with GP and paramedics, symptom management practices. **Measure:** Nursing team demographics **Time Frame:** Questioned after baseline #### Primary Outcomes **Description:** This outcome will be measured by asking the participant "Do you feel your symptoms are under control?". **Measure:** Perceived symptom control of clients and family caregivers dealing with a life-limiting illness **Time Frame:** One month after implementation #### Secondary Outcomes **Description:** EORTC QLQ C15 will be used to determine the QoL. **Measure:** Quality of life of clients dealing with a life-limiting illness **Time Frame:** Assessed after one month, three months and six months after implementation. **Description:** Utrecht Symptom Diary Four Dimensional (USD4D) will be used to determine symptom burden. The USD4D comprises of questions regarding the physical, psychological, social, and spiritual dimension, which are rated on a scale from 0-10 (0 = symptom is absent to 10 = severity symptom is the worst imaginable). **Measure:** Symptom burden of clients dealing with a life-limiting illness **Time Frame:** Assessed at one month, three months and six months after implementation. **Description:** The primary caregiver burden Is assessed by means of the Self Rated Burden Scale, which is a one item numerical scale answering the question "How do I perceive the care for my loved one at the moment?"(35-38). The question is answered on a scale of 0 to 10, in which 0 refers to "not at all straining" and 1 refers to "much to straining". In addition, the perceived burden of informal care (Dutch: Ervaren Druk Informele Zorg (EDIZ)) will be used, assessing aspects of informal care contributing to the perceived burden(39). The EDIZ is developed for the use in caregivers of patients suffering from dementia at home, however, this measurement instrument is widely used to assess the level of burden of caregivers of patients with a life-limiting illness. This instrument contains 9 statements to which patients must answer "no!", "no", "more or less", "yes" or "yes!". **Measure:** Primary caregiver burden **Time Frame:** Assessed at one, three and six months after implementation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria client: 1. The client is 18 years or older. 2. The client is diagnosed with a life limiting illness or frailty syndrome with a life expectancy of less than a year, estimated by the nursing team, based on the Surprise Question. 3. The client lives at home and receives homecare 4. The client suffers from at least 1 symptom identified by means of the problem list of the Distress Thermometer. Inclusion Criteria primary caregiver: 1. The primary caregiver is 18 years or older. 2. The primary caregiver has a relative with a life-limiting illness with a life expectancy \<1 year. 3. Is able to speak and read Dutch A nursing team is eligible when: 1. The nurses that are part of the nursing team are motivated to participate in the study. 2. The Nursing team consists of nurses that are sufficiently experienced in the work that they to effectively learn new competences during training sessions. Exclusion Criteria: Clients and primary caregivers that are diagnosed with cognitive impairment and/or unable to read and speak Dutch, will be excluded from the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Utrecht **Country:** Netherlands **Facility:** University Medical Center Utrecht **Zip:** 3584 CX #### Overall Officials **Official 1:** **Affiliation:** UMC Utrecht **Name:** Saskia Teunissen, Prof. dr. **Role:** STUDY_DIRECTOR ## Document Section ### Large Document Module #### Large Docs - Date: 2022-12-20 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 517068 - Type Abbrev: Prot - Upload Date: 2024-04-26T02:42 - Date: 2023-08-04 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 249287 - Type Abbrev: SAP - Upload Date: 2024-04-26T02:44 - Date: 2023-08-04 - Filename: SAP_002.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 249287 - Type Abbrev: SAP - Upload Date: 2024-04-26T02:44 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434532 **Brief Title:** Exploring the Effectiveness of an Interprofessional Game-based Learning **Official Title:** An Exploratory Study on the v-Care Interprofessional Online Game for Healthcare Students #### Organization Study ID Info **ID:** HSEARS20230729001 #### Organization **Class:** OTHER **Full Name:** The Hong Kong Polytechnic University ### Status Module #### Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-19 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-01-24 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Hong Kong Polytechnic University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this waitlist control study is to evaluate the benefits of online game pedagogy to evaluate the readiness of health care students for interprofessional learning in nursing students. Interprofessional (IP) collaboration is a core competence of health care education to enable effective teamwork and improve health outcomes. Taking into account the characteristics of our students and the pragmatic issues, v-Care (Virtual Care) is a novel strategy to deliver Interprofessional Education using gamification. Colleagues from nursing (SN), rehabilitation sciences (RS) and health technology and informatics (HTI) will collaborate in the design of v-Care, and implement and evaluate it effectiveness in nursing, physiotherapy and radiography related subjects. To evaluate the effectiveness of interprofessional learning of the health faculty students using a multi-player point-and-click on line motivational game. Theoretical Framework The v-Care design is based on the Self-Determination Theory (SDT) and Motivational Gamification. Outcomes: The primary outcome is to improve the readiness for interprofessional learning. A peer learning community will be established to improve the motivation to learn based on SDT: (1) autonomy, (2) competence and (3) relatedness. **Detailed Description:** BACKGROUND lnterprofessional education is a core competence of health care education to enable effective collaboration and improve health outcomes \[1\] (lnterprofessional Education Collaborative Expert Panel, 2011). Numerous initiatives were implemented, including the Freshman Seminar for Broad Disciplines in Health Science (FS) in the undergraduate curriculum. IPE was explicitly listed in the FS intended learning outcomes to (1) understand the professional identity of the learners' own discipline and the other professional's roles on the health care team; and (2) Identify innovative strategies in managing selected major health issues implement using an interprofessional (IP) collaborations approach; and (3) reflect on the experience on interprofessional learning and its implications on lifelong learning and career development. Starting from 2002/23 academic year, this subject was replaced by artificial intelligence and data analytics (AIDA). Since IP is an integral part of the curriculum, implementing IPE under other teaching modes (such as gamification, peer-learning or learner-directed) must be reconsidered. Motivational gamification is a strategy rooted in the Self-Determination Theory (SDT), gamification and micro-learning are the merits much preferred by the millennials in learning. This strategy leverages on the millennial characteristics that technology has been embedded to their daily life, they enjoy fun and games and are motivated by immediate positive rewards, such as points and badges. Furthermore, they have relatively shorter attention span and enjoy simulation in virtual environments with high quality visuals and graphics. Game features such as click-to-reveal, drag-and-drop, pop quizzes tend to engage the millennial learners. As such, the proposed project is feasible to improve the learning experience and possibly learning outcomes. AIM To evaluate the effectiveness and impact of interprofessional learning of health faculty students using a multi-player point-and-click on line motivational game. A pretest-posttest non-equivalent waitlist control group design was employed. METHOD Convenience sampling was adopted to recruit subjects. Inclusion criteria - Participants were recruited from the students who had enrolled in the nursing, physiotherapy and radiography subjects. Students retaking the subject will be excluded from the study. They were assigned into two study groups according to the tutorial teaching schedule: the control and the experimental groups. The Control group attended the usual teaching activities: paper case study, whereas the intervention group participated in the vCare eGame (intervention). Surveys will be implemented before any learning activities, and at the same time for both groups after the intervention group completed the vCare eGame. OUTCOME MEASURES Primary outcome will be measured by the Readiness for Interprofessional Learning Scale (19-items). Secondary outcome on students' autonomy will be measured by a 24-items Perceived Peer Autonomy Support Scale and the 18-item Intrinsic Motivation Inventory. ### Conditions Module **Conditions:** - Educational Problems **Keywords:** - Interprofession - online game - nursing - multidisciplinary education ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** waitlist control ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 350 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the v-Care online game consist of a clinical scenario. Participants are requested to join the online game in small groups, consisting of nursing and radiography students, to discuss the patient's condition presented in the scenario. They will also be required to watch relevant mini-videos that cover the knowledge check points within the game. As part of the activity, participants will be expected to submit a mini interprofessional project that explains their respective roles and responsibilities in managing the patient's condition. To enhance engagement and motivation, an online game reward system has been implemented. This system includes the opportunity to earn badges upon completing the knowledge check points or participating in learning activities such as watching tutorials or engaging in interprofessional discussions. These discussions will be recorded and summarized to highlight the key points of their conversation. **Intervention Names:** - Other: v-Care Online Game **Label:** v-Care online game **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants are requested to engage in case-based discussions within small groups, comprising nursing and radiography students. As part of this activity, students are required to complete a conventional assignment using a worksheet, which will allow them to elaborate on their individual roles and responsibilities in managing the patient's condition. In addition, students are encouraged to utilize traditional learning and teaching methods by reading and exploring relevant materials pertaining to the patient's condition. **Intervention Names:** - Other: Case-based online discussion **Label:** Case-based online discussion **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - v-Care online game **Description:** A regular 2 hours traditional learning mode session - case study session and 2-hour online game session with peer-led discussion and interprofessional project submission. This spreads in 3 weeks interval **Name:** v-Care Online Game **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Case-based online discussion **Description:** A 2-hour traditional learning mode session with online peer-led discussion and submission of an interprofessional worksheet as an assignment **Name:** Case-based online discussion **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A 5-point Likert scale questionnaire will be used. There are four subscales that included teamwork and collaboration, negative professional identity, positive professional identity, and roles and responsibility. The higher scores mean a better outcome. **Measure:** Readiness of Health Care Students for Interprofessional Learning (RIPLS) **Time Frame:** This will be administered immediately before the start of the learning activity and immediately after the activity is completed #### Secondary Outcomes **Description:** This is a 9-items instrument with 3 subscales: interest/enjoyment, perceived competence, and pressure/tension; on a 7-point Likert Scale - Not at all true, somewhat true to very true. The higher scores mean a better outcome **Measure:** Intrinsic Motivation Inventory **Time Frame:** This will be administered immediately before the start of the learning activity and immediately after the activity is completed **Description:** One 6-items scale will be used to assess the perceive autonomy after the students have completed the learning activity. This is rated on a 7-point Likert Scale - from 1 strongly disagree to 7 strongly agree. The higher scores mean a better outcome **Measure:** Perceived Autonomy Scale **Time Frame:** This will be administered immediately before the start of the learning activity and immediately after the activity is completed ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All students learning colorectal cancer and or frailty when taking the specified subject in the Bachelor Nursing Programme and, * all students taking Bachelor of Science (Honours) Scheme in Medical Laboratory Science and Radiography in Radiography will be recruited Exclusion Criteria: * Students retaking these specified subjects will be excluded. * Students learning other disorders but not colorectal cancer or frailty are not eligible **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kitty.yy.chan@polyu.edu.hk **Name:** Kitty Chan, PhD **Phone:** 91683233 **Phone Ext:** 6883 **Role:** CONTACT #### Locations **Location 1:** **City:** Hung Hom **Contacts:** ***Contact 1:*** - **Email:** kitty.yy.chan@polyu.edu.hk - **Name:** Kitty Chan - **Phone:** 91683233 - **Role:** CONTACT **Country:** Hong Kong **Facility:** School of Nursing **State:** Hong Kong Island **Status:** RECRUITING **Location 2:** **City:** Hung Hom **Contacts:** ***Contact 1:*** - **Email:** kitty.yy.chan@polyu.edu.hk - **Name:** Kitty Chan - **Phone:** 91683233 - **Phone Ext:** 6883 - **Role:** CONTACT **Country:** Hong Kong **Facility:** The Hong Kong Polytechnic University **State:** Hong Kong Island **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** The Hong Kong Polytechnic University **Name:** Kitty Chan, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** access by sending email to the corresponding author **Description:** Once the project is completed, and paper published, we are happy to share the IPD. **Info Types:** - STUDY_PROTOCOL - CSR **IPD Sharing:** YES **Time Frame:** When the project is completed and publication available ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434519 **Brief Title:** Metronidazole SC Penetrance With Moisturizers **Official Title:** Evaluation of the Effect of Moisturizers on the Absorption of Metronidazole Into the Stratum Corneum of Rosacea Patients With Tape Stripping and Liquid Chromatography-mass Spectrometry #### Organization Study ID Info **ID:** Pro00114776 #### Organization **Class:** OTHER **Full Name:** Duke University ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** National Rosacea Society #### Lead Sponsor **Class:** OTHER **Name:** Duke 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:** Topical metronidazole is a widely used first line treatment for erythemotelangiectatic and inflammatory rosacea. Commonly, a moisturizer is also used to restore the skin barrier and reduce inflammation. The purpose of this study is to assess the whether the common practice of applying moisturizer prior to topical metronidazole affects this medication's stratum corneum penetrance in rosacea patients. Participants will have one research office visit that will consist of having a randomly assigned combination of metronidazole and one of four moisturizers applied to their face, followed by non-invasive tape stripping of skin at the 1 hour and 4 hour time points. These tape strip samples will be analyzed with liquid chromatography mass spectrometry (LC-MS) for assessment of metronidazole penetrance in the stratum corneum in the presence of moisturizers. The target population will be rosacea patients in the age range of 18-60 years of age. This study has minimal risks/safety issues as topical metronidazole is an already FDA approved medication with an indication for rosacea and all investigated moisturizers are over-the-counter formulations commonly used within the rosacea patient population. Tape stripping will remove 5 levels of superficial stratum corneum, and will not result in bleeding, scarring, or other prolonged cosmetic disfigurement. Small, transient bruising may result from tape strip collection. The collected samples will have no to minimal biohazard risk, as the collected specimen for analysis will only contain skin scale; samples will be extracted with organic solvents and decontaminated with a 0.2 micron nylon filter prior to analysis on the LC-MS instrumentation. **Detailed Description:** Rosacea is a debilitating spectrum of disease causing both socially embarrassing erythema and disfiguring rhinophyma. Treatment is challenging and life-long, often requiring clinicians to trial multiple medications, such as azelaic acid, metronidazole, or ivermectin to achieve disease control. The skin of rosacea patients inherently has impaired skin barrier function, resulting in inflammation and hypersensitivity to most therapeutics. Thus, many clinicians encourage patients to augment their topical medications with personal moisturizers to optimize the skin barrier. However, there is limited data to support that moisturizers do not affect drug epidermal penetrance and efficacy. To the investigator's knowledge, only a single trial assessing the effect of moisturizers on skin penetrance of azelaic acid has been published in the English literature. In the era of evidence-based medicine, it is critical to provide either the scientific data to support or to refute this medical dogma. The investigator's proposal addresses this gap in the basic science literature and will provide data to evaluate a long and widely-held dermatologist recommendation for the treatment of rosacea. The investigators anticipate that there may be preferred combinations of medication and moisturizers based upon the matched lipophilicities and other chemical properties of the occlusive agent and therapeutic drug. Identification of such combinations may lead to improved outcomes for those struggling with treatment-resistant rosacea and lead to additional pharmaceutical advances in the treatment of rosacea. Drug formulation is critical to the successful treatment of dermatologic disease. An active ingredient must diffuse through the stratum corneum (SC) to reach the dermis to achieve its therapeutic effect. In addition to the intrinsic chemical properties of the active compound dictating the kinetics of the diffusion process, chemists tweak a topical formulation's vehicle, emulsifiers, and polymers to enhance drug SC penetrance and overcome the skin's evolutionary role as a barrier to the outside world. The combination of drug with additional topical moisturizers inherently changes the chemical environment that the active drug must diffuse through to reach the dermis. Moisturizers and other topical cosmetics are well established to affect dermal drug and toxin absorption. For example, moisturizers have been demonstrated to enhance dermal penetrance of herbicide 2,4-dichlorophenoxacetic acid in murine models. Similarly, occlusive moisturizers are often applied over steroids to enhance their anti-inflammatory efficacy, presumably through improved epidermal penetration. Increased penetrance is a case-by-case scenario, however, and considerable attention is dedicated to topical formulation to appropriately modulate therapeutic drug penetrance of the SC during the drug design process. To the investigator's knowledge, the formulation and timing of moisturizer application on drug efficacy in rosacea is understudied. An extensive literature review revealed only a single study addressing this important question for the special case of azelaic acid with an in vitro Franz cell diffusion assay using donated trunk skin biopsies. In this study, a 14C radiolabeled 15% azelaic acid gel was applied to epidermis before or after the application of Dove Lotion, CeraVe Moisturizer Lotion, and Cetaphil Moisturizing Lotion. The penetrance of azelaic acid into the SC was then assessed up to 48 hours post-application using liquid scintillation spectrometry. Azelaic acid SC penetration was not statistically different between the moisturizers or timing of application, although trends towards decreased penetration was noted in 1 of 3 studied moisturizers. There are several limitations to this study. First, azelaic acid occupies a unique chemical space among rosacea therapies. Azelaic acid's lipophilicity (LogP), an important chemical property affecting epidermal drug penetrance, is 1.6 compared with 5.83, 0.0, -0.3 and -0.7 for ivermectin, metronidazole, monocycline, and doxycycline, respectively, suggesting that azelaic acid is between 1.4e2 times more lipophilic to 1.7e4 times less lipophilic than other therapies. Thus, azelaic acid is a poor standard with which to assess moisturizers' impact on SC drug penetrance. Second, truncal skin was used to assess azelaic acid SC penetrance. Consequently, the study's clinical relevance is limited as rosacea exclusively affects the face, where the skin is much thinner and transdermal absorption occurs more readily. Finally, although a tritium diffusion control was implemented to select skin samples with relatively intact barrier function, a Franz cell diffusion assay inherently utilizes dead, enzymatically inactive skin. Thus, the results of a Franz cell assay is not necessarily clinically relevant or reflective of physiologically active skin on patients. Further work is necessary to determine whether moisturizers affects drug SC penetrance in rosacea patients. In prior work, the investigators made method advances that overcome many of the limitations of the Franz cell assay as it relates to clinical relevance. Specifically, the investigators have established a track record of assessing drug penetrance of topically delivered medications, e.g. tazarotene, allantoin, ketoconazole, and betamethasone dipropionate, in the SC using minimally invasive D-squame tape stripes of human subjects in combination with liquid chromatography mass spectrometry (LC-MS). In these studies, the investigators are able to assess drug penetrance with physiologically relevant skin and on skin affected by the disease of interest. Therefore, the methods the investigators propose for assessing metronidazole SC penetrance in the presence of moisturizers is now established as an efficient and reliable method for quantitating drug in the SC in a minimally invasive and clinically relevant context. ### Conditions Module **Conditions:** - Rosacea, Erythematotelangiectatic **Keywords:** - rosacea - metronidazole - LC-MS - tape strip ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 5 patients will enrolled in 4 study arms. Each study arm will represent a different combination of moisturizer applied to the face, followed by metronidazole cream. No moisturizer will be applied to the left side of each patient's face, permitting for each patient to represent their own negative (no metronidzole cream applied) and positive control (metronidazole cream + no moisturizer). Metronidazole penetrance in the stratum corneum will be assess with tape strips and LC-MS ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Apply Cetaphil (glycerin (humectant) and petrolatum (occlusive)) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application. **Intervention Names:** - Drug: Metronidazole cream - Other: Cetaphil moisturizer **Label:** Metronidazole cream + Cetaphil moisturizer **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Apply CeraVe (glycerin/hyaluronic acid (humectant), ceramides (intercellular lipid component), and dimethicone/petrolatum (occlusive)) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application. **Intervention Names:** - Drug: Metronidazole cream - Other: CeraVe moisturizer **Label:** Metronidzole cream + CeraVe moisturizer **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Apply Eucerin Healing Lotion (mineral oil (occlusive) and sorbitol/propylene glycol (humecants)) followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application. **Intervention Names:** - Drug: Metronidazole cream - Other: Eucerin Healing Lotion moisturizer **Label:** Metronidzole cream + Eucerin Healing Lotion moisturizer **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Apply Aveeno Calm and Restore Oat Gel (glycerin (humectant) and dimethicone (occlusive) and oat kernel flour based gel moisturizer) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application. **Intervention Names:** - Drug: Metronidazole cream - Other: Aveeno Calm and Restore Oat Gel moisturizer **Label:** Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer - Metronidazole cream + Cetaphil moisturizer - Metronidzole cream + CeraVe moisturizer - Metronidzole cream + Eucerin Healing Lotion moisturizer **Description:** After application of one of the moisturizers under investigation in this study to the right side of the patient's face, x5 tape strips will be collected from the left side of a patient's face. These will provide negative controls for quantitation of metronidazole in the stratum corneum. Then, 0.5 mL of a 1% metronidazole cream will be applied to both the right and left sides of a patient's face with clean gloves to prevent cross contamination. Tapes strips x5 will subsequently be collected from the left and right sides of the face at 1 hour and 4 hour time points to assess penetrance of metronidazole through the stratum corneum. **Name:** Metronidazole cream **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Metronidazole cream + Cetaphil moisturizer **Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer. **Name:** Cetaphil moisturizer **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Metronidzole cream + CeraVe moisturizer **Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer. **Name:** CeraVe moisturizer **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Metronidzole cream + Eucerin Healing Lotion moisturizer **Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer. **Name:** Eucerin Healing Lotion moisturizer **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer **Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer. **Name:** Aveeno Calm and Restore Oat Gel moisturizer **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Metronidazole stratum corneum penetrance will be ascertained with LC-MS (liquid chromatography-mass spectrometry). Tape strips (x5) will be collected at the 1 hour and 4 hour time points post application of metronidazole. **Measure:** Metronidazole penetrance through the stratum corneum (SC) **Time Frame:** 1 hours and 4 hours post metronidazole application ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Healthy, non-pregnant individual 18+ years of age; 2. Subjects willing to allow a series of tape pieces to be pressed and removed from their faces over an 4 hour period; 3. Subjects can remain calm and quiet at the research facility for 6 hours; 4. Subjects in general good health as determined from a medical history; 5. Subjects must read and sign the informed consent form after the nature of the study has been fully explained. Exclusion Criteria: 1. Subjects with known allergies or sensitivities to ingredients contained in the test products; 2. Subjects with an allergy to latex or adhesives; 3. Subjects with excessive visible sun damage on the face, such that the dermatologist investigator considers the subject unsuitable for study entry; 4. Subjects with skin growths or other issues on the face that could interfere with the tape sampling; 5. Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.); 6. Subjects viewed by the investigator as not being able to complete the study; 7. Subjects unwilling to refrain from using any type of lotion, medication, or other topical product to the face for a set amount of time prior to the study. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** matthew.draelos@duke.edu **Name:** Matthew M Draelos, MD PhD **Phone:** (919) 684-3432 **Role:** CONTACT **Contact 2:** **Email:** jessica.oxendine@duke.edu **Name:** Jessica Oxendine, CMA III **Phone:** 919-684-1299 **Role:** CONTACT #### Locations **Location 1:** **City:** Durham **Contacts:** ***Contact 1:*** - **Email:** matthew.draelos@duke.edu - **Name:** Matthew M Draelos, MD PhD - **Role:** CONTACT ***Contact 2:*** - **Email:** jessica.oxendine@duke.edu - **Name:** Jessica Oxendine, CMA III - **Phone:** 919-684-1299 - **Role:** CONTACT ***Contact 3:*** - **Name:** Matthew M Draelos, MD PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** John Murray, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Duke University Medical Center **State:** North Carolina **Zip:** 27710 #### Overall Officials **Official 1:** **Affiliation:** Duke University **Name:** Matthew M Draelos, MD PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Duke University **Name:** John Murray, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Thiboutot D, Anderson R, Cook-Bolden F, Draelos Z, Gallo RL, Granstein RD, Kang S, Macsai M, Gold LS, Tan J. Standard management options for rosacea: The 2019 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2020 Jun;82(6):1501-1510. doi: 10.1016/j.jaad.2020.01.077. Epub 2020 Feb 7. **PMID:** 32035944 **Citation:** Gallo RL, Granstein RD, Kang S, Mannis M, Steinhoff M, Tan J, Thiboutot D. Rosacea comorbidities and future research: The 2017 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2018 Jan;78(1):167-170. doi: 10.1016/j.jaad.2017.06.150. No abstract available. **PMID:** 29102687 **Citation:** Del Rosso JQ, Lehman PA, Raney SG. Impact of order of application of moisturizers on percutaneous absorption kinetics: evaluation of sequential application of moisturizer lotions and azelaic acid gel 15% using a human skin model. Cutis. 2009 Mar;83(3):119-24. **PMID:** 19363903 **Citation:** Draelos ZD, Draelos MM, Steele F, Georgiou M, Praestegaard M. Enhanced Skin Deposition of Betamethasone Dipropionate from a Novel Formulation and Drug Delivery Technology. Dermatol Ther (Heidelb). 2023 Aug;13(8):1763-1771. doi: 10.1007/s13555-023-00959-3. Epub 2023 Jun 23. **PMID:** 37351830 **Citation:** Draelos ZD, Draelos MM. Development of a Tape-Stripping Liquid Chromatography-Mass Spectrometry Method for Evaluating Skin Deposition of Topical Tazarotene. J Drugs Dermatol. 2021 Oct 1;20(10):1105-1111. doi: 10.36849/JDD.6211. **PMID:** 34636513 **Citation:** Gether L, Overgaard LK, Egeberg A, Thyssen JP. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol. 2018 Aug;179(2):282-289. doi: 10.1111/bjd.16481. Epub 2018 May 31. **PMID:** 29478264 **Citation:** Turpeinen M. Absorption of hydrocortisone from the skin reservoir in atopic dermatitis. Br J Dermatol. 1991 Apr;124(4):358-60. doi: 10.1111/j.1365-2133.1991.tb00597.x. **PMID:** 2025556 **Citation:** Danby SG, Draelos ZD, Gold LFS, Cha A, Vlahos B, Aikman L, Sanders P, Wu-Linhares D, Cork MJ. Vehicles for atopic dermatitis therapies: more than just a placebo. J Dermatolog Treat. 2022 Mar;33(2):685-698. doi: 10.1080/09546634.2020.1789050. Epub 2020 Jul 16. **PMID:** 32654550 **Citation:** Ghadially R, Halkier-Sorensen L, Elias PM. Effects of petrolatum on stratum corneum structure and function. J Am Acad Dermatol. 1992 Mar;26(3 Pt 2):387-96. doi: 10.1016/0190-9622(92)70060-s. **PMID:** 1564142 **Citation:** Brand RM, Charron AR, Sandler VL, Jendrzejewski JL. Moisturizing lotions can increase transdermal absorption of the herbicide 2,4-dichlorophenoxacetic acid across hairless mouse skin. Cutan Ocul Toxicol. 2007;26(1):15-23. doi: 10.1080/15569520601182791. **PMID:** 17464745 **Citation:** Huh Y, Lee DH, Choi D, Lim KM. Effect of Cosmetics Use on the In Vitro Skin Absorption of a Biocide, 1,2-Benzisothiazolin-3-one. Toxics. 2022 Feb 24;10(3):108. doi: 10.3390/toxics10030108. **PMID:** 35324733 **Citation:** Feldmann RJ, Maibach HI. Regional variation in percutaneous penetration of 14C cortisol in man. J Invest Dermatol. 1967 Feb;48(2):181-3. doi: 10.1038/jid.1967.29. No abstract available. **PMID:** 6020682 **Citation:** Tipthara P, Kobylinski KC, Godejohann M, Hanboonkunupakarn B, Roth A, Adams JH, White NJ, Jittamala P, Day NPJ, Tarning J. Identification of the metabolites of ivermectin in humans. Pharmacol Res Perspect. 2021 Feb;9(1):e00712. doi: 10.1002/prp2.712. **PMID:** 33497030 **Citation:** Vanol PG, Sanyal M, Shah PA, Shrivastav PS. Quantification of metronidazole in human plasma using a highly sensitive and rugged LC-MS/MS method for a bioequivalence study. Biomed Chromatogr. 2018 Aug;32(8):e4242. doi: 10.1002/bmc.4242. Epub 2018 Apr 22. **PMID:** 29572903 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M15214 - Name: Rosacea - Relevance: HIGH - As Found: Rosacea - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012393 - Term: Rosacea ### Intervention Browse Module - Ancestors - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown - ID: M11767 - Name: Metronidazole - Relevance: HIGH - As Found: Markers - ID: M15814 - Name: Sorbitol - Relevance: LOW - As Found: Unknown - ID: M13485 - Name: Petrolatum - Relevance: LOW - As Found: Unknown - ID: M11869 - Name: Mineral Oil - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - 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 ### Intervention Browse Module - Meshes - ID: D000008795 - Term: Metronidazole ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434506 **Brief Title:** Prevalence of the Wire Syndrome **Official Title:** Prevalence and Risk Factors Associated With Wire Syndrome #### Organization Study ID Info **ID:** 24Odonto01 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Nice ### Status Module #### Completion Date **Date:** 2023-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-31 **Type:** ACTUAL #### Start Date **Date:** 2022-07-02 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-01-29 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Nice #### 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 Wire Syndrome problem referred to dental displacements that can be described as aberrant, inaccurate, unexplained, or excessive on teeth still contained by an intact orthodontic wire, without detachment or fracture, leading to evolving dental and periodontal, aesthetic and/or functional consequences. The objective of this study was to define the prevalence of mandibular wire syndrome and the associated risk factors. ### Conditions Module **Conditions:** - Orthodontic Wires ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 59 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** non-wire syndrome group **Intervention Names:** - Other: no intervention **Label:** NWS group #### Arm Group 2 **Description:** wire syndrome group **Intervention Names:** - Other: no intervention **Label:** WS group ### Interventions #### Intervention 1 **Arm Group Labels:** - NWS group - WS group **Description:** No intervention **Name:** no intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The prevalence of wire syndrome is the number of people affected by the wire syndrome at a given time in a given population. The prevalence rate is calculated by dividing this number of cases by the size of the exposed population. This study was design as a cross-sectional study conducted in the Orthodontics Unit of the Nice University Hospital from July 2022 to July 2023. **Measure:** Prevalence of the Wire Syndrome **Time Frame:** End : July 2023 #### Secondary Outcomes **Description:** Questionnaire: 20 clinical questions without score **Measure:** Identify risk factors associated with wire syndrome - questionnaire **Time Frame:** End : July 2023 **Description:** Intraoral clinical examination: type of periodontium: thin and scalloped or flat and thick **Measure:** Identify risk factors associated with wire syndrome - clinical examination periodontium **Time Frame:** End : July 2023 **Description:** Intraoral clinical examinations: molar and canine relationships according to the Angle's classification class I, class II, Class III **Measure:** Identify risk factors associated with wire syndrome - clinical examination - Angle **Time Frame:** End : July 2023 **Description:** Intraoral clinical examinations: overbite and overjet in milimeters **Measure:** Identify risk factors associated with wire syndrome - clinical examination: overbite / overjet **Time Frame:** End : July 2023 **Description:** Intraoral clinical examinations: presence/absence of an incisal guidance (YES / NO), presence/absence of parafunctions signs, (YES / NO) **Measure:** Identify risk factors associated with wire syndrome - clinical examination / presence/absence clinical signs **Time Frame:** End : July 2023 **Description:** Intraoral clinical examinations: clinical signs: observations : swallowing and tongue (no score / no mesure : only clinical observations) **Measure:** Identify risk factors associated with wire syndrome - clinical examination / description clinical signs **Time Frame:** End : July 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:-students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University - have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine. Exclusion Criteria:'- orthodontic treatment in progress * absence/fracture of orthodontic fixed mandibular retainer * wearing a removable mandibular retainer. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University who have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine ### Contacts Locations Module #### Locations **Location 1:** **City:** Nice **Country:** France **Facility:** CHU NICE **State:** Alpes Maritimes **Zip:** 0600 #### Overall Officials **Official 1:** **Affiliation:** Centre Hospitalier Universitaire de Nice **Name:** Carole Charavet **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434493 **Acronym:** EMPHATIC **Brief Title:** Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma **Official Title:** Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma (an Evaluative Commissioning in Protons Study) #### Organization Study ID Info **ID:** CFTSp218 (02) #### Organization **Class:** OTHER **Full Name:** The Christie NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2029-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University College London Hospitals **Class:** OTHER **Name:** University College, London **Class:** OTHER **Name:** Royal Free Hospital NHS Foundation Trust #### Lead Sponsor **Class:** OTHER **Name:** The Christie NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the United Kingdom (UK), in Manchester and London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT. Evaluative Commissioning in Protons (ECIP) is a programme of studies exploring the role of PBT in different types of cancer. The studies are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered PBT. Any eligible patient in the UK can be referred, and accommodation is available for patients who don't live close to a PBT centre. The main benefit of PBT, compared with standard photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects. EMPHATIC is a study within the ECIP programme. In EMPHATIC, the investigators are looking to see whether a combination of treatments, including PBT, chemotherapy and a liver transplant, can be used to treat patients with cholangiocarcinoma (bile duct cancer). EMPHATIC offers patients whose cancer can't be removed with surgery (unresectable) a potentially curative treatment option. There is evidence that liver transplant is a curative treatment option in patients with cholangiocarcinoma. There is a risk that the cancer may grow or spread whilst waiting for a transplant, potentially making patients ineligible. PBT and chemotherapy is thought to be the best way to control the cancer, until a liver transplant can be performed. EMPHATIC will look at how a combination of PBT and chemotherapy, followed by a liver transplant, can be used to curatively treat patients with unresectable cholangiocarcinomas. **Detailed Description:** Liver and bile duct resection with lymphadenectomy is the standard of care for patients with hilar cholangiocarcinoma. Unfortunately, resection is only possible in a minority of patients for many reasons including, the extent of cancer or the presence of background primary sclerosing cholangitis (PSC). For patients with a background of PSC, liver transplantation is a potential treatment, and it was recently approved as an indication for a commissioned pilot service evaluation of liver transplantation in the UK. Until recently, the use of liver transplantation for hilar cholangiocarcinoma was confined to a few centres in the United States. The initial publications from the Mayo Clinic and Nebraska, as well as more recent experience from other centres, support strict selection protocols to identify patients likely to benefit from liver transplantation. In 2000, the initial experience at the Mayo Clinic in which 19 patients enrolled in a pre-transplant neoadjuvant therapy protocol was published. 11 patients underwent subsequent liver transplantation. Of the 8 with long term follow up (median 44 months), only one patient developed cancer recurrence. Similarly, the long-term experience of patients in Nebraska, where 11 patients underwent liver transplantation after neoadjuvant chemoradiotherapy was published in 2002. 5 of the 11 patients were alive and disease free at a median follow up of 7.5 years . Most recent experience is based on adopting the Mayo protocol. In general, the inclusion criteria define patients with early cancers, with a dominant stricture or tumour less than 3cm. Intra and extrahepatic disease including any site of nodal metastases precluded selection. Controversially, histology or cytology was not considered essential for diagnosis of cholangiocarcinoma by most centres. Elevated Ca 19.9 of \>100, Fluorescence In Situ Hybridization (FISH) polysomy 9p21 or tumour mass in the presence of a dominant stricture were considered sufficient for enrolment. Prior (attempts at) trans-peritoneal biopsy was another exclusion criterion based on concerns of increased risk of tumour dissemination. Neoadjuvant therapy involved external beam radiation therapy (EBRT) with concurrent chemotherapy (chemo sensitisation), followed by brachytherapy whenever possible. Patients were then re-staged and remain on systemic chemotherapy until the time of transplant. A recent review looked at all studies from 2000 until 2019. 20 studies with 428 patients were eligible for analysis. The pooled 1, 3-, and 5-year overall survival rates following liver transplantation without neoadjuvant therapy (n=156) were 71.2%. In patients who had neoadjuvant therapy prior to transplantation (n=272), the survival improved to 82.8% at 1,3 and 5 years respectively. The cancer recurrence rate was 51.7% in patients who did not receive neoadjuvant therapy compared to 24.1% for patients who had. Only 4 of the 20 studies reported pre-transplant histological confirmation of adenocarcinoma or malignant/suspicious cells on cytology. 98% of liver explants from studies not using neoadjuvant therapy confirmed malignancy, compared to 50.5% in those who had received neoadjuvant therapy. Patients in whom malignancy was not found are presumed to have had complete pathological response to neoadjuvant therapy (approximately 50% following neoadjuvant therapy). Patients with background PSC had better outcomes compared to patients with de novo cancers. Study Design \& development of an evaluative commissioning study within ECIP: It is not possible to design EMPHATIC, a study for patients with unresectable cholangiocarcinoma, as a randomised controlled trial (RCT), because there is no ethically acceptable control arm. In an RCT, patients in a theoretical control arm would be offered either no transplant, or no neoadjuvant therapy prior to the transplant. Based on the published literature summarised above, the adverse anticipated outcomes of patients in such a control arm would not be considered justified. Neoadjuvant therapy is required to control the tumour prior to transplant. In the Mayo protocol described above, patients received external beam (chemo)radiotherapy followed by brachytherapy, and thereafter received chemotherapy until the time of transplant. Unfortunately, in the UK, brachytherapy services were not seen as a viable option, and hence the Mayo protocol is not feasible. There is good scientific rationale that proton beam radiotherapy (PBT) offers the optimal technique for delivering neoadjuvant therapy as it is non-invasive, and spares as much functional liver as possible, compared with alternatives such as photon-EBRT techniques or invasive techniques (e.g. brachytherapy). Compared with photon-EBRT techniques, PBT delivers highly conformal radiotherapy, with a significantly reduced integral body dose, and no exit beam. It is expected to be associated with an improved toxicity profile. ### Conditions Module **Conditions:** - Cholangiocarcinoma **Keywords:** - proton beam therapy - protons - evaluative commissioning - liver transplant ### 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:** All patients to be offered neoadjuvant proton beam therapy to a dose of 45 Gray (Gy) in 15 fractions over 3 weeks, with a tumour boost to 67.5 Gray (Gy), and alongside concurrent oral capecitabine 625mg/m2 twice daily on radiation days. **Intervention Names:** - Radiation: Proton Beam Therapy - Drug: Concurrent oral capecitabine chemotherapy - Drug: Cisplatin & Gemcitabine intravenous chemotherapy - Procedure: Orthotropic Liver Transplant **Label:** Proton Beam Therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Proton Beam Therapy **Description:** All patients to be offered neoadjuvant proton beam therapy to a dose of 45 Gray (Gy) in 15 fractions over 3 weeks, with a tumour boost to 67.5 Gray (Gy) **Name:** Proton Beam Therapy **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Proton Beam Therapy **Description:** All patients to be offered concurrent oral capecitabine 625mg/m2 twice daily on radiation days **Name:** Concurrent oral capecitabine chemotherapy **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Proton Beam Therapy **Description:** Following chemoradiotherapy (PBT + capecitabine), and whilst on the liver transplant waiting list, patients will be offered up to 6 cycles of standard chemotherapy with cisplatin and gemcitabine. **Name:** Cisplatin & Gemcitabine intravenous chemotherapy **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Proton Beam Therapy **Description:** If still eligible after neoadjuvant treatment (PBT + capecitabine), patients will be added to the liver transplant waiting list. **Name:** Orthotropic Liver Transplant **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Incidence of Grade ≥ 3 toxicity using CTCAE (grades 0-5) up to 90 days following completion of neoadjuvant (chemo)-PBT and liver transplant. Higher score indicates worse outcome. **Measure:** Incidence of Common Toxicity Criteria for recording Adverse Events (CTCAE) Grade 3 and above toxicity **Time Frame:** Up to 90 days post neoadjuvant chemo-radiation. **Description:** The proportion of patients who, following neoadjuvant (chemo)-PBT, undergo a successful liver transplant (measured at 90 days post-transplant). **Measure:** Proportion of patients who undergo a successful liver transplant **Time Frame:** 90 days post transplant. #### Secondary Outcomes **Description:** Number of patients completing planned radiotherapy **Measure:** Number of patients completing planned radiotherapy **Time Frame:** Up to 1 year **Description:** Rate of Common Toxicity Criteria for recording Adverse Events (CTCAE) Grade 3 and above toxicity (Grades 0-5). Higher score may mean a worse outcome. **Measure:** Incidence of severe treatment related side effects **Time Frame:** Up to 2 years **Description:** Calculated from date of last PBT treatment and defined as time to death or censoring at 1 year. **Measure:** 1 year post completion of neoadjuvant therapy cancer-related mortality **Time Frame:** At 1 year **Description:** Calculated from date of liver transplant and defined as time to death or censoring at 1 year. **Measure:** 1 year post transplant overall survival **Time Frame:** At 1 year **Description:** Calculated from date of transplant and defined as time to death or censoring at 1 year. **Measure:** 1 year post transplant graft survival **Time Frame:** At 1 year **Description:** Calculated from the date the patient was added to the transplant waiting list and defined as time to death or censoring at 1 year. **Measure:** 1 year post listing patient survival **Time Frame:** At 1 year **Description:** Calculated as time to cancer recurrence or death whichever is earliest, from date of transplant, with censoring at 1 year. **Measure:** Disease free survival from transplant **Time Frame:** At 1 year **Description:** Described as local, regional or metastatic disease **Measure:** Recurrent cancer within 6 months of transplant **Time Frame:** Up to 6 months following transplant **Description:** Reported as time to loss of cancer control with censoring at time of transplant **Measure:** Cancer control at time of transplant **Time Frame:** Up to 2 years **Description:** Reported as time to loss of cancer control with censoring at date of removal from transplant waiting list **Measure:** Cancer control at time of removal from transplant list **Time Frame:** Up to 2 years **Description:** Surgical complication rates according to Clavien Dindo scale, measured from grades 1-5, higher grade may mean worse outcome. **Measure:** Transplant complication rates **Time Frame:** Within 3 months of surgery **Description:** Review of patient pathway deliverability defined as time interval from patient referral to the start of chemo-PBT treatment **Measure:** Patient pathway **Time Frame:** Up to 2 years **Description:** Measured in days from last day of PBT to date of transplant **Measure:** Time to completion of neoadjuvant chemo-PBT treatment to liver transplant **Time Frame:** Up to 2 years **Description:** Measured in weeks from transplant listing date to liver transplant date **Measure:** Time spent on transplant waiting list **Time Frame:** Up to 2 years **Description:** Review annual referral rates to the study **Measure:** Referral rates **Time Frame:** At 6 months, 12 months, 18 months and 24 months following the opening of the study **Description:** Number of patients participating in the study **Measure:** Recruitment rates **Time Frame:** At 6 months, 12 months, 18 months and 24 months following the opening of the study ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: General criteria * Age 17 years and over * Performance status 0 or 1 (Eastern Cooperative Oncology Group) * Suitable for liver transplantation as determined by Multi Disciplinary Team (MDT) * Able to tolerate neoadjuvant therapy. * A history of primary sclerosing cholangitis (PSC) will be a necessary eligibility criterion at the start of the study. Part-way through recruitment to the study, the eligibility criteria may be broadened, allowing patients with sporadic / non-PSC unresectable cholangiocarcinoma to also be considered. The decision to do this will be taken by the Study Management Group, who will be monitor results closely, following an interim analysis after the first 10 patients. Suitability for Orthotropic Liver Transplant will continue to be confirmed in the regional Hepato Biliary cancer MDT. Specific criteria * Presence of a dominant hilar stricture or mass \<3cm on cross-sectional imaging * Histologically proven cholangiocarcinoma by brush cytology or biopsy via Endoscopic Retrograde Cholangiopancreatography (ERCP) or Percutaneous Transhepatic Cholangiography (PTC) * No metastatic disease, including to regional lymph nodes. Exclusion Criteria: General criteria * Inability to consent * Poor performance status * Failed fitness assessment * Extrahepatic disease at any stage of presentation, assessment and treatment * Prior biliary resection or hilar dissection for attempted resection within the past 12 months * Prior malignancy in the last 5 years (excluding early breast, prostate, cervix and non melanoma skin cancers) Specific criteria * Estimated Glomerular Filtration Rate (eGFR) \<30 * Prior radiation to the upper abdomen * Uncontrolled infection * Duodenal invasion **Minimum Age:** 17 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** romelie.rieu@nhs.net **Name:** Romelie Rieu **Phone:** 0044 1619187172 **Role:** CONTACT **Contact 2:** **Email:** sally.falk@nhs.net **Name:** Sally Falk **Phone:** 0044 1619187172 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University College, London **Name:** Maria Hawkins **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** The Royal Free NHS Foundation Trust **Name:** Douglas Thorburn **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** De Vreede I, Steers JL, Burch PA, Rosen CB, Gunderson LL, Haddock MG, Burgart L, Gores GJ. Prolonged disease-free survival after orthotopic liver transplantation plus adjuvant chemoirradiation for cholangiocarcinoma. Liver Transpl. 2000 May;6(3):309-16. doi: 10.1053/lv.2000.6143. **PMID:** 10827231 **Citation:** Sudan D, DeRoover A, Chinnakotla S, Fox I, Shaw B Jr, McCashland T, Sorrell M, Tempero M, Langnas A. Radiochemotherapy and transplantation allow long-term survival for nonresectable hilar cholangiocarcinoma. Am J Transplant. 2002 Sep;2(8):774-9. doi: 10.1034/j.1600-6143.2002.20812.x. **PMID:** 12243499 **Citation:** Cambridge WA, Fairfield C, Powell JJ, Harrison EM, Soreide K, Wigmore SJ, Guest RV. Meta-analysis and Meta-regression of Survival After Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma. Ann Surg. 2021 Feb 1;273(2):240-250. doi: 10.1097/SLA.0000000000003801. **PMID:** 32097164 ## 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: M20430 - Name: Klatskin Tumor - Relevance: HIGH - As Found: Hilar 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: T3241 - Name: Klatskin Tumor - Relevance: HIGH - As Found: Hilar Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma - ID: D000018285 - Term: Klatskin Tumor ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics ### Intervention Browse Module - Browse Leaves - ID: M2985 - Name: Gemcitabine - Relevance: HIGH - As Found: Activity - ID: M377 - Name: Capecitabine - Relevance: HIGH - As Found: Function - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000093542 - Term: Gemcitabine - ID: D000069287 - Term: Capecitabine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434480 **Brief Title:** SBRT in HCC With Oligoprogression on Atezo-Bev **Official Title:** Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma With Oligoprogression on Atezolizumab Plus Bevacizumab #### Organization Study ID Info **ID:** HCC07X #### Organization **Class:** OTHER **Full Name:** Chinese University of Hong Kong ### Status Module #### Completion Date **Date:** 2028-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-02 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chinese University of Hong Kong #### Responsible Party **Investigator Affiliation:** Chinese University of Hong Kong **Investigator Full Name:** Landon Chan **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based combination atezolizumab plus bevacizumab as first-line treatment as a standard of care. At the moment, there is limited evidence to guide subsequent treatments after patients progressed on atezolizumab plus bevacizumab. Oligoprogression is a term used to describe patients who had limited progression (usually less than 3 sites) on systemic therapy, with the rest of the lesions controlled. Previous studies in non-HCCs have shown that addition of locoregional treatment (e.g. radiotherapy) may prolong the use of systemic therapy, resulting in improved survival, but this has been relatively unexplored for HCC. In this prospective, single-arm study, we aim to evaluate the treatment outcome, efficacy and safety of the addition of radiotherapy to oligoprogressive sites for patients who had limited progression on atezolizumab plus bevacizumab. ### Conditions Module **Conditions:** - HCC **Keywords:** - SBRT in HCC ### 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:** After screening procedures, suitable patients are consented and enrolled with the following treatment being given * Continue Atezolizumab 1200mg Day 1 plus Bevacizumab 15mg/kg Day 1, given intravenously every 3 weeks, till the next progression, or death. * Radiotherapy will start 4 to 6 weeks after consent * For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks will be given. * For extrahepatic progression: an aim to give ablative dose (i.e. BED10≥100Gy) will be given (allow lower dose based on nearby OAR dose constraints and is at the discretion of the treating radiation oncologist) * Bevacizumab will need to be withhold 4 weeks prior and after radiotherapy. * Dose constraints to organ at risk (OAR) will take reference from RTOG-1112 and UK 2022 consensus on normal tissue dose-volume constraints **Intervention Names:** - Radiation: Stereotactic Body Radiation Therapy (SBRT) **Label:** Radiotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Radiotherapy **Description:** * For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks will be given. * For extrahepatic progression: an aim to give ablative dose will be given. **Name:** Stereotactic Body Radiation Therapy (SBRT) **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Measure:** Progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites **Time Frame:** 2 years #### Secondary Outcomes **Measure:** Overall survival (OS) **Time Frame:** 2 years **Measure:** Objective response rates (ORR) of the irradiated lesion(s) **Time Frame:** 2 years **Measure:** Overall objective response rates (ORR) **Time Frame:** 2 years **Measure:** Additional treatment related adverse events (TRAE) **Time Frame:** 2 years **Description:** Four types of progression pattern: * EHG (extrahepatic growth) * IHG (intrahepatic growth) * NEH (new extrahepatic lesion) * NIH (new intrahepatic growth) **Measure:** Pattern of progression **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients aged ≥ 18 years old 2. ECOG performance 0 to 1 3. Confirmed diagnosis of HCC 4. Oligoprogression on Atezolizumab plus Bevacizumab, as defined as ≤3 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is counted as one lesion) 5. Progressed lesion(s) amenable to SBRT: * At most one site of intrahepatic and one site of extrahepatic lesion will be irradiated * For intrahepatic progression: * Number of intrahepatic progression ≤ 3 * Total intrahepatic tumours ≤ 5 * Maximum sum of HCC ≤ 20cm * Any one HCC ≤ 15cm * Normal liver volume minus intrahepatic GTV \> 700cc * Mean liver dose ≤ 15Gy * No measurable common or main branch biliary duct involvement * No direct tumor invasion into the stomach, duodenum, small bowel or large bowel * For extrahepatic progression: * Maximal tumor size ≤ 3cm * Respective dose constraints of organ at risks as listed on the UK 2022 Consensus on Normal Tissue Dose-Volume Constraints for Oligometastatic, Primary Lung and Hepatocellular Carcinoma Stereotactic Ablative Radiotherapy can be met. 6. Prior radiofrequency ablation (RFA) or trans-arterial chemoembolization (TACE) are eligible 7. Child-Pugh A liver function 8. Life expectancy longer than 12 weeks 9. At least one measurable treatment lesion according to RECIST 1.1 10. Written informed consent must be obtained prior to any study related procedures 11. Adequate haematological function (Hb ≥ 8.5g/dL; Plt ≥ 75x109/L; ANC ≥ 1.5x109/L; INR ≤ 1.5) 12. Adequate hepatic function (albumin ≥ 28g/l; Bilirubin ≤ 1.5xULN; ALT \< 5 times upper limit normal) 13. Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Na ≥ 130mmol/L; K ≥ 3.0mmol/L) 14. Able to read, understand and provide written consent Exclusion Criteria: 1. History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years 2. Previous radiotherapy to the abdomen 3. Previous yttrium-90 chemoembolization 4. Repetitive history of non-healing wounds or ulcers within 2 months of inclusion 5. Pregnant or lactating females at any time during the study 6. Active autoimmune disease requiring systemic therapy in the past 2 years 7. Diagnosis of immunodeficiency (including HIV) 8. Ongoing corticosteroid therapy \>10mg prednisone daily **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** landon.chan@cuhk.edu.hk **Name:** Landon L CHAN, MBChB, MSc **Phone:** 3505 1042 **Role:** CONTACT #### Locations **Location 1:** **City:** Hong Kong **Contacts:** ***Contact 1:*** - **Email:** landon.chan@cuhk.edu.hk - **Name:** Landon L CHAN, MBChB, MSc - **Phone:** 3505 1042 - **Role:** CONTACT **Country:** Hong Kong **Facility:** Department of Clinical Oncology, Prince of Wales Hospital ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### 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: LOW - As Found: Unknown - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: LOW - As Found: Unknown ### 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: M349417 - Name: Atezolizumab - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434467 **Brief Title:** The Efficacy and Safety of Nelarabine Injection in Patients With T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma **Official Title:** The Efficacy and Safety of Nelarabine Injection in the Treatment of Refractory or Recurrent T-lymphoblastic Leukemia (T-ALL) and T-lymphoblastic Lymphoma (T-LBL) in Children and Adults #### Organization Study ID Info **ID:** NLB-III-01 #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2023-11 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a single-arm, open-label, multicenter, phase III clinical study that aims to evaluate the efficacy and safety of Nelarabine injection in the treatment of refractory or recurrent T-lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LBL) in both children and adults. The trial includes 83 subjects, consisting of 35 adults and 48 children, and aims to evaluate the composite complete response rate (CCR) within 2 cycles, assessed by the Independent Review Committee (IRC), following treatment with Nelarabine injection for children and adults with refractory or recurrent T-ALL and T-LBL. The sample size of this study is estimated according to the treatment period of 4 cycles. ### Conditions Module **Conditions:** - T-lymphoblastic Leukemia - T-lymphoblastic Lymphoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 83 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adults (≥18 years old): 1500 mg/m², administer intravenously for at least 2 hours on days 1, 3, and 5, repeating every 21 days. Children (1-17 years old): 650 mg/m ², administer intravenously for 1 hour daily for 5 consecutive days, repeating every 21 days. **Intervention Names:** - Drug: Nelarabine injection **Label:** Nelarabine injection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Nelarabine injection **Description:** Nelarabine is a prodrug of the nucleotide metabolism inhibitor deoxyguanosine analogue 9-β-arabinoguanine (ARA-G). Nelarabine undergoes catalytic transformation by adenosine deaminase (ADA), resulting in the removal of its methoxy group and conversion into ARA-G, Subsequently, ARA-G undergoes sequential monophosphorylation by deoxyguanosine kinase and deoxycytosine nucleoside kinase, yielding the active compound 5'-Guanosine triphosphate (GTP), ARA-GTP. This active compound accumulates within leukemic blast cells and binds to deoxyribonucleic acid (DNA), effectively inhibiting DNA synthesis and ultimately leading to cell death. **Name:** Nelarabine injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Proportion of complete responses (CCR) after 2 cycles of antineoplastic therapy as determined by independent review committee (IRC) assessment **Measure:** Composite complete response rate (CCR) assessed by the Independent Review Committee (IRC) **Time Frame:** During the study period (Baseline up to two months) #### Secondary Outcomes **Description:** Proportion of complete responses (CCR) after 2 cycles of antineoplastic therapy as determined by the investigator. **Measure:** Composite complete response rate (CCR) assessed by the investigator **Time Frame:** During the study period (Baseline up to two months) **Description:** The best Objective Remission Rate (ORR) for both complete response (CR) and partial response (PR) cases within 2 cycles. **Measure:** Objective Remission Rate (ORR) **Time Frame:** During the study period (Baseline up to two months) **Description:** Proportion of patients whose tumor shrinks or stabilizes for some time, including cases of complete response (CR), partial response (PR), and stable disease (SD). **Measure:** Duration of complete remission (DOCR) **Time Frame:** During the study period (Baseline up to two years) **Description:** It refers to the time from the first day of absence of disease to the recurrence of disease. **Measure:** Disease-free survival (DFS) **Time Frame:** During the study period (Baseline up to two years) **Description:** It indicates the time interval from randomization to death from any cause. **Measure:** Overall survival (OS) **Time Frame:** During the study period (Baseline up to two years) **Description:** Adverse events refer to all adverse medical events that occur after a patient or clinical trial subject receives an experimental drug, which can be expressed as symptoms, signs, diseases, or abnormalities in laboratory tests, but are not necessarily related to the treatment of the experimental drug. **Measure:** Incidence of adverse events (AEs) **Time Frame:** During the study period (Baseline up to two years) **Description:** Serious adverse events include death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and adverse medical conditions such as congenital abnormalities or birth defects. **Measure:** Incidence of serious adverse events (SAEs) **Time Frame:** During the study period (Baseline up to two years) **Description:** Time to maximum plasma concentration. **Measure:** Peak time (Tmax) **Time Frame:** During the study period (Baseline up to two years) **Description:** Pharmacokinetic parameters, including but not limited to: Peak concentration(Cmax) **Measure:** Peak concentration(Cmax) **Time Frame:** During the study period (Baseline up to two years) **Description:** It is the time required for half of the drug to be eliminated from the plasma **Measure:** Half-life(t1/2) **Time Frame:** During the study period (Baseline up to two years) **Description:** The proportion of trace leukemic cells negative in patients with hematologic tumors after treatment. **Measure:** Negative rate of minimal residual disease in bone marrow (MRD) **Time Frame:** During the study period （Baseline up to two years) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The subjects voluntarily joined this study, signed an informed consent form, and had good compliance; * Age: ≥ 1 year old and ≤ 65 years old (if the child has no reading ability, the child's immediate family/guardian can fully read the informed consent form, sign and witness the informed consent process); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-2 points; Expected survival period exceeds 3 months; * Subject population: 1. According to the revised classification criteria for myeloid tumors and acute leukemia in 2016, morphology, immunology, cytogenetic and molecular (MICM) classification and/or pathological and imaging diagnosis confirmed by local laboratories as T-ALL or T-LBL stage II-IV; 2. Philadelphia chromosome negative (Ph -); 3. Difficult to treat or disease recurrence status; 4. Previously received two chemotherapy regimens without response, or experienced recurrence after treatment. * The main organ functions well and meets the following standards: 1. Biochemical examination must meet the following standards: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN) (if T-ALL/T-LBL affects the liver, total bilirubin ≤ 3 times the upper limit of normal value); Alanine transferase (ALT) and aspartate transferase (AST) ≤ 3 × ULN (if T-ALL/T-LBL affects the liver, ALT and/or AST ≤ 5 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate estimated based on Cockcroft Gault glomerular filtration formula ≥ 50 mL/min. 2. The coagulation function test needs to meet the following standards: prothrombin time (PT), activated partial thromboplastin time (APTT), international standardized ratio (INR) ≤ 1.5 x ULN (without receiving anticoagulant treatment). * Before starting to use the investigational drug, all non hematological toxicity (except for hair loss and fatigue) of previous anti leukemia treatments must have been restored to level 1 or baseline levels ((NCI Common Terminology Criteria for Adverse Events(CTCAE) version5.0)); * Female participants of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; Male participants should agree to adopt avoidance measures during the study period and within 6 months after the end of the study period. Exclusion Criteria: * Previous treatment: 1. Within 3 weeks prior to the first medication, chemotherapy (including intrathecal injection, excluding ALL/LBL maintenance therapy) was received. Within 12 weeks prior to the first medication, radiation therapy (brain spine, pelvis, and other radiation areas exceeding 25% of the total bone marrow volume), immune checkpoint inhibitors, Chimeric Antigen Receptor T-Cell (CAR-T) Therapy were received. Other small molecule anti-tumor treatments received before the first medication (washout period calculated from the end of the last treatment) were within 5 half-lives; 2. Within 7 days prior to the first administration, receive ≥ 5 days of intravenous or oral prednisone ≥ 30mg/m2 or an equal amount of other glucocorticoids. Within 28 days prior to the first administration, receive ≥ 14 days of intravenous or oral prednisone ≥ 30mg/m2 or an equal amount of other glucocorticoids. Single dose prevention or treatment of airway stenosis is allowed to be used; Note: If the patient's white blood cell (WBC) is ≥ 30 × 10\^9/L, or if the liver, spleen, or lymph nodes are significantly enlarged; Patients with tumor lysis characteristics (biochemical tests, etc.) may undergo pre-treatment, and the use of prednisone/dexamethasone ± cyclophosphamide during the pre-treatment period is allowed to prevent tumor lysis syndrome; 3. Vaccination received within 4 weeks prior to the first medication, or planned vaccination during the study period; 4. Participated in clinical trials of other anti-tumor drugs within 4 weeks prior to the first medication use; 5. According to the researcher's judgment, there are individuals with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or individuals who are deemed unsuitable for enrollment due to other reasons. * Concomitant diseases and medical history: 1. Has experienced or currently suffers from other malignant tumors within 3 years prior to the first medication use. The following two situations can be included in the study: achieving disease-free survival (DFS) for 5 consecutive years for other malignant tumors treated with a single surgery; Cured cervical cancer in situ, thyroid cancer, non melanoma skin cancer, and superficial bladder tumors \[Ta (non invasive tumor), Ti (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\]; 2. Unresolved neurotoxicity of ≥ CTC AE II grade due to any previous treatment; 3. Within 28 days prior to the start of the research treatment, significant surgical treatment, open biopsy, and obvious traumatic injury were received; 4. Within 3 months prior to the first medication, there have been incidents of arterial/venous thrombosis, such as cerebrovascular accidents (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 5. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders; 6. Within 6 months prior to the first medication, the patient had ≥ grade 2 myocardial ischemia or infarction, arrhythmia (QTcF\>450ms in males and\>470ms in females), ≥ grade 2 congestive heart failure (NYHA classification), and left ventricular ejection fraction (LVEF) assessed by echocardiography\<50%. 7. Existence of active infection (≥ CTC AE level 2 infection); 8. Active hepatitis \*; Hepatitis B reference: hepatitis B virus (HBV) DNA detection value ≥ upper limit of normal value; Hepatitis C reference: hepatitis C virus (HCV) antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value; 9. Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10. Have a history of epilepsy; 11. Have a history of Down syndrome; 12. Merge central nervous system leukemia/lymphoma. * The patient plans to receive chest radiation therapy. **Maximum Age:** 65 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** majun0322@126.com **Name:** Jun Ma, Doctor **Phone:** 13304518000 **Role:** CONTACT **Contact 2:** **Email:** zhangyzh@sysucc.org.cn **Name:** Yizhuo Zhang, Doctor **Phone:** 18819241079 **Role:** CONTACT #### Locations **Location 1:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** xiaoyuz@ustc.edu.cn - **Name:** Xiaoyu Zhu, Doctor - **Phone:** 15255456091 - **Role:** CONTACT **Country:** China **Facility:** Anhui Provincial Hospital **State:** Anhui **Zip:** 230000 **Location 2:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** dpwangjingbo@vip.sina.com - **Name:** Jingbo Wang, Doctor - **Phone:** 13693587668 - **Role:** CONTACT **Country:** China **Facility:** Aerospace Medical Center **State:** Beijing **Zip:** 100049 **Location 3:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** hds5180@sina.com - **Name:** Dongsheng Huang, Doctor - **Phone:** 13601113102 - **Role:** CONTACT **Country:** China **Facility:** Beijing Tongren Hospital,CMU **State:** Beijing **Zip:** 100730 **Location 4:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Email:** 1808106657@qq.com - **Name:** Jie Yu, Doctor - **Phone:** 13983762652 - **Role:** CONTACT **Country:** China **Facility:** Children's Hospital of Chongqing Medical University **State:** Chongqing **Zip:** 400010 **Location 5:** **City:** Chongqing **Country:** China **Facility:** The Second Affiliated Hospital of Army Military Medical University **State:** Chongqing **Zip:** 400037 **Location 6:** **City:** Lanzhou **Contacts:** ***Contact 1:*** - **Email:** ldyy_lizj@lzu.edu.cn - **Name:** Zijian Li, Doctor - **Phone:** 18993115461 - **Role:** CONTACT **Country:** China **Facility:** The first hospital of Lanzhou University **State:** Gansu **Zip:** 730000 **Location 7:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** zhangyzh@sysucc.org.cn - **Name:** Yizhuo Zhang, Doctor - **Phone:** 18819241079 - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-sen University Cancer Prevention Center **State:** Guangdong **Zip:** 510062 **Location 8:** **City:** Nanning **Contacts:** ***Contact 1:*** - **Email:** cen_hong@163.com - **Name:** Hong Cen, Doctor - **Phone:** 13507711671 - **Role:** CONTACT **Country:** China **Facility:** Cancer Hospital Affiliated to Guangxi Medical University **State:** Guangxi **Zip:** 530021 **Location 9:** **City:** Nanning **Contacts:** ***Contact 1:*** - **Email:** yunyanhe@aliyun.com - **Name:** Yunyan He, Doctor - **Phone:** 13607868275 - **Role:** CONTACT **Country:** China **Facility:** First Affiliated Hospital of Guangxi Medical University **State:** Guangxi **Zip:** 530021 **Location 10:** **City:** Yulin **Contacts:** ***Contact 1:*** - **Email:** 371535062@qq.com - **Name:** Zhao Lv, Bachelor - **Phone:** 15277931749 - **Role:** CONTACT **Country:** China **Facility:** Yulin Red Cross Hospital **State:** Guangxi **Zip:** 537000 **Location 11:** **City:** Zunyi **Contacts:** ***Contact 1:*** - **Email:** cyz600@163.com - **Name:** Yan Chen, Doctor - **Phone:** 13985261758 - **Role:** CONTACT **Country:** China **Facility:** Affiliated Hospital of Zunyi Medical University **State:** Guizhou **Zip:** 563000 **Location 12:** **City:** Shijiazhuang **Contacts:** ***Contact 1:*** - **Email:** zhangjy69@163.com - **Name:** Jingyu Zhang, Doctor - **Phone:** 18032227288 - **Role:** CONTACT **Country:** China **Facility:** The second Hospital of Hebei Medical University **State:** Hebei **Zip:** 50004 **Location 13:** **City:** Xingtai **Contacts:** ***Contact 1:*** - **Email:** 1449569258@qq.com - **Name:** Zongjiu Jiao, Doctor - **Phone:** 18631921299 - **Role:** CONTACT **Country:** China **Facility:** Xingtai People's Hospital **State:** Hebei **Zip:** 54001 **Location 14:** **City:** Harbin **Contacts:** ***Contact 1:*** - **Email:** aichun2002@hotmail.com - **Name:** Aichun Liu, Doctor - **Phone:** 13633611958 - **Role:** CONTACT **Country:** China **Facility:** Affiliated cancer hospital of harbin medical university **State:** Heilongjiang **Zip:** 150001 **Location 15:** **City:** Harbin **Contacts:** ***Contact 1:*** - **Email:** majun0322@126.com - **Name:** Jun Ma, Doctor - **Phone:** 13304518000 - **Role:** CONTACT **Country:** China **Facility:** Institute of Hematology & Oncology, Harbin First Hospital **State:** Heilongjiang **Zip:** 150010 **Location 16:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** liuweixinxiang@163.com - **Name:** Wei Liu, Doctor - **Phone:** 13673710016 - **Role:** CONTACT **Country:** China **Facility:** Henan Children's Hospital **State:** Henan **Zip:** 450018 **Location 17:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** drliuaiguo@163.com - **Name:** Aiguo Liu, Doctor - **Phone:** 13807196944 - **Role:** CONTACT **Country:** China **Facility:** Tongji Medical College of HUST **State:** Hubei **Zip:** 430030 **Location 18:** **City:** Changsha **Contacts:** ***Contact 1:*** - **Email:** 13908467333@163.com - **Name:** Mincui Zheng, Master - **Phone:** 13908467333 - **Role:** CONTACT **Country:** China **Facility:** Hunan Children's Hospital **State:** Hunan **Zip:** 410007 **Location 19:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** fyj322@189.cn - **Name:** Yongjun Fang, Doctor - **Phone:** 18951769586 - **Role:** CONTACT **Country:** China **Facility:** Nanjing childrens Hospital **State:** Jiangsu **Zip:** 210008 **Location 20:** **City:** Nanjing **Contacts:** ***Contact 1:*** - **Email:** zhuyu@jsph.org.cn - **Name:** Yu Zhu, Doctor - **Phone:** 13851435363 - **Role:** CONTACT **Country:** China **Facility:** Jiangsu Provincial People's Hospital **State:** Jiangsu **Zip:** 210029 **Location 21:** **City:** Changchun **Contacts:** ***Contact 1:*** - **Email:** 276769165@qq.com - **Name:** Yehui Tan, Doctor - **Phone:** 15804302605 - **Role:** CONTACT **Country:** China **Facility:** The First Hospital Of Jilin University **State:** Jilin **Zip:** 130000 **Location 22:** **City:** Weihai **Contacts:** ***Contact 1:*** - **Email:** yujiejessica@126.com - **Name:** Jie Yu, Doctor - **Phone:** 13869058479 - **Role:** CONTACT **Country:** China **Facility:** Weihai Municipal Hospital **State:** Shandong **Zip:** 264200 **Location 23:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** wangxiaoqin@shmu.edu.cn - **Name:** Xiaoqin Wang, Doctor - **Phone:** 13621851543 - **Role:** CONTACT **Country:** China **Facility:** Huashan Hospital Fudan University **State:** Shanghai **Zip:** 200040 **Location 24:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** zhaixiaowendy@163.com - **Name:** Xiaowen Zhai, Doctor - **Phone:** 18017590808 - **Role:** CONTACT **Country:** China **Facility:** Children's Hospital of Fudan University **State:** Shanghai **Zip:** 201102 **Location 25:** **City:** Xi'an **Contacts:** ***Contact 1:*** - **Email:** 13571936193@163.com - **Name:** Yi Wang, Doctor - **Phone:** 13571936193 - **Role:** CONTACT **Country:** China **Facility:** Shanxi Provincial People's Hospital **State:** Shanxi **Zip:** 710068 **Location 26:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Email:** huangxiaobing@med.uestc.edu.cn - **Name:** Xiaobing Huang, Doctor - **Phone:** 18981838236 - **Role:** CONTACT **Country:** China **Facility:** Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital **State:** Sichuan **Zip:** 610072 **Location 27:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** Drwang2005@163.com - **Name:** Yafei Wang, Doctor - **Phone:** 18622221250 - **Role:** CONTACT **Country:** China **Facility:** Tianjin Cancer Hospital **State:** Tianjin **Zip:** 300202 **Location 28:** **City:** Urumqi **Contacts:** ***Contact 1:*** - **Email:** guoxinhong222@sina.cn - **Name:** Xinhong Guo, Doctor - **Phone:** 15292898288 - **Role:** CONTACT **Country:** China **Facility:** First Affiliated Hospital of Xinjiang Medical University **State:** Xinjiang **Zip:** 830000 **Location 29:** **City:** Kunming **Contacts:** ***Contact 1:*** - **Email:** Shmxia2002@sina.com - **Name:** Mingxia Shi, Doctor - **Phone:** 13888060581 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Kunming Medical University **State:** Yunnan **Zip:** 650000 **Location 30:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** xuxiaojun@zju.edu.cn - **Name:** Xiaojun Xu, Doctor - **Phone:** 13858067554 - **Role:** CONTACT **Country:** China **Facility:** Children's Hospital of Zhejiang University School of Medicine **State:** Zhejiang **Zip:** 310000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M27585 - Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma - Relevance: HIGH - As Found: Lymphoblastic lymphoma - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: HIGH - As Found: Lymphoblastic Leukemia - ID: M18120 - Name: Leukemia-Lymphoma, Adult T-Cell - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: HIGH - As Found: Lymphoblastic lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Lymphoblastic lymphoma - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: HIGH - As Found: Lymphoblastic lymphoma - ID: T224 - Name: Adult T-cell Leukemia/lymphoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000007938 - Term: Leukemia - ID: D000054198 - Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma - ID: D000007945 - Term: Leukemia, Lymphoid - ID: D000008228 - Term: Lymphoma, Non-Hodgkin ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M3595 - Name: Adenosine - Relevance: LOW - As Found: Unknown - ID: M90325 - Name: 9-arabinofuranosylguanine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434454 **Acronym:** EFT STUDENT **Brief Title:** EFT AND SLEEP QUALITY **Official Title:** EFT and Sleep Quality #### Organization Study ID Info **ID:** E-54022451-050.04-137924 #### Organization **Class:** OTHER **Full Name:** Bezmialem Vakif University #### Secondary ID Infos **Domain:** BezmialemVU **ID:** MMeseduzu **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-09-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bezmialem Vakif University #### Responsible Party **Investigator Affiliation:** Bezmialem Vakif University **Investigator Full Name:** Merve Meşedüzü **Investigator Title:** LECTURER **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this clinical study is to determine whether the application of EFT (Emotional Freedom Techniques) is effective in reducing sleep problems among university students. Additionally, the study aims to gather information on the safety of EFT application. The primary questions it seeks to answer are: Does EFT application reduce sleep problems among university students? Is EFT application feasible for addressing sleep problems in university students? Researchers will compare the effectiveness of EFT to traditional sleep education on non-pharmacological interventions for preventing sleep problems among university students. Participants: Pre-EFT application survey scale questions will be asked to university students. EFT will be applied once by the researcher to university students. EFT will be applied a second time by the researcher to university students 15 days after the initial application. For control, the same survey scale questions will be asked to the same students one day after the EFT application for post-test purposes. The same procedures will be applied in the same manner to the control group that will receive education. **Detailed Description:** DATA COLLECTION TOOLS AND THEIR FEATURES For data collection, a questionnaire including socio-demographic characteristics, the Insomnia Severity Index, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index will be used. 1. Personal Information Form The personal information form, prepared by the researchers, includes questions about socio-demographic characteristics such as age and gender. The last part of the questionnaire consists of questions evaluating the sleep status of the participants. 2. Insomnia Severity Index (ISI) This scale, developed to determine the severity of insomnia symptoms, can be used in both general population screenings and clinical assessments of insomnia. It is a seven-item, five-point Likert-type scale. Each item is scored between 0 and 4, with the total score ranging from 0 to 28. Scores of 0-7 indicate no clinically significant insomnia, 8-14 indicate subthreshold insomnia, 15-21 indicate clinical insomnia (moderate severity), and 22-28 indicate severe clinical insomnia. 3. Epworth Sleepiness Scale (ESS) The ESS is an easy-to-administer and widely used scale. It is a four-point Likert-type scale. Each item is scored 0, 1, 2, or 3, with higher scores indicating greater daytime sleepiness. It aims to measure the general level of daytime sleepiness and is a simple self-report tool. 4. Pittsburgh Sleep Quality Index (PSQI) The PSQI\&amp; index comprises 18 items grouped into 7 component scores. Each item is evaluated on a scale of 3 points. The sum of the seven component scores provides the total PSQI score, ranging from 0 to 21. Higher total scores indicate poorer sleep quality. A total PSQI score of 0-4 signifies good sleep quality, while scores between 5-21 indicate poor sleep quality. indicates and shows a serious deterioration in at least two components or moderate deterioration in three components of the PSQI. 5. Fatigue Severity Scale (FSS) The FSS consists of 9 questions measuring the degree of fatigue experienced in the past week. Each question is rated on a scale from 0 (strongly disagree) to 7 (strongly agree), and the total score is the sum of these ratings. The highest possible total score is 63. A score of 36 or above indicates significant fatigue. 6. Sleep Education (control group): The sleep education content will be prepared by the researcher based on the literature and will be reviewed by at least three experts. ### Conditions Module **Conditions:** - Sleep Quality **Keywords:** - student - sleep qualıty - emotioanal freedom techniques ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The young individuals in the control group will be informed about the study, including its purpose and methodology, and their consent will be obtained. The control group will receive sleep education, consisting of two educational presentations provided 15 days apart. The questionnaires of the scales used for analysis will be administered to assess their sleep problems. The content of the education will be prepared based on the literature and will be reviewed by at least three experts. The young individuals in the experimental group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The young individuals in the intervention group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis will be conducted. **Intervention Names:** - Behavioral: EFT Group:Emotional Free Technıcal **Label:** EXPERİMENTAL: EFT GROUP **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The young individuals in the control group will be informed about the study, including its purpose and methodology, and their consent will be obtained. The control group will receive sleep education, consisting of two educational presentations provided 15 days apart. The questionnaires of the scales used for analysis will be administered to assess their sleep problems. The content of the education will be prepared based on the literature and will be reviewed by at least three experts. **Label:** CONTROL GROUP **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - EXPERİMENTAL: EFT GROUP **Description:** The young individuals in the intervention group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis will be conducted. **Name:** EFT Group:Emotional Free Technıcal **Other Names:** - emotional free technıcal **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The FSS consists of 9 questions measuring the degree of fatigue experienced in the past week. Each question is rated on a scale from 0 (strongly disagree) to 7 (strongly agree), and the total score is the sum of these ratings. The highest possible total score is 63. A score of 36 or above indicates significant fatigue. **Measure:** Fatigue Severity Scale (FSS) **Time Frame:** one month **Description:** The index comprises 18 items grouped into 7 component scores. Each item is evaluated on a scale of 3 points. The sum of the seven component scores provides the total PSQI score, ranging from 0 to 21. Higher total scores indicate poorer sleep quality. A total PSQI score of 0-4 signifies good sleep quality, while scores between 5-21 indicate poor sleep quality. indicates and shows a serious deterioration in at least two components or moderate deterioration in three components of the PSQI. **Measure:** Pittsburgh Sleep Quality Index (PSQI) **Time Frame:** one month #### Primary Outcomes **Description:** This scale is a seven-item, five-point Likert-type scale. Each item is scored between 0 and 4, with the total score ranging from 0 to 28. Scores of 0-7 indicate no clinically significant insomnia, 8-14 indicate subthreshold insomnia, 15-21 indicate clinical insomnia (moderate severity), and 22-28 indicate severe clinical insomnia **Measure:** Insomnia Severity Index Scale **Time Frame:** 1 months #### Secondary Outcomes **Description:** The ESS is a four-point Likert-type scale. Each item is scored 0, 1, 2, or 3, with higher scores indicating greater daytime sleepiness. It aims to measure the general level of daytime sleepiness and is a simple self-report tool. **Measure:** Epworth Sleepiness Scale (ESS) **Time Frame:** 1 months ### Eligibility Module **Eligibility Criteria:** * Inclusion Criteria: * Görsel Analog Ölçeğe (VAS) göre 5 ve üzerinde uyku sorunu bildiren öğrenciler * 18-24 yaş aralığında olan öğrenciler * Herhangi bir kronik hastalığı bulunmayan öğrenciler * Araştırmaya gönüllü olarak katılmak isteyen öğrenciler yer almaktadır. * Exclusion Criteria: * Individuals who wish to withdraw from the study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mervemeseduzu@gmail.com **Name:** MERVE MESEDUZU **Phone:** 800-555-5555 **Role:** CONTACT **Contact 2:** **Name:** HANDAN ÖZCAN LECTURER **Phone:** 800-555-5555 **Role:** CONTACT #### Locations **Location 1:** **City:** İ̇stanbul **Contacts:** ***Contact 1:*** - **Email:** mervemeseduzu@gmail.com - **Name:** Merve MESEDUZU, LECTURER - **Phone:** 800-555-5555 - **Role:** CONTACT **Country:** Turkey **Facility:** Bezmialem Vakif Universty **State:** Topkapı Mahallesi **Zip:** 34093 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434441 **Brief Title:** Bone Augmentation Using Calvarial Versus Iliac Crest Bone Blocks. **Official Title:** Radiographic Assessment of Horizontal Bone Augmentation of Full Atrophic Maxillary Alveolar Ridges Using Calvarial Versus Iliac Crest Bone Blocks: #### Organization Study ID Info **ID:** 13 #### Organization **Class:** OTHER **Full Name:** Beni-Suef University ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beni-Suef University #### Responsible Party **Investigator Affiliation:** Beni-Suef University **Investigator Full Name:** Amr Gibaly **Investigator Title:** Associate Professor of Oral and Maxillofacial Surgery **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 aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones **Detailed Description:** Although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft. The anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. However, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. Pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation. This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones. ### Conditions Module **Conditions:** - Bone Atrophy **Keywords:** - Bone graft - Iliac crest blocks - Calverial bone blocks - Horizontal bone gain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** A) The Study group: The patients within the study group will receive mono-cortical bone block calvarial grafts B) The Control group: The patients within the control group will receive mono-cortical bone block iliac crest grafts, ##### Masking Info **Masking:** SINGLE **Masking Description:** Masking in not applicable for the patients or the operators **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients will receive calverial grafts, to reconstruct the deficient maxillary ridge **Intervention Names:** - Procedure: Autogenous bone augmentation **Label:** Study group: **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The patients will receive iliac crestgrafts, to reconstruct the deficient maxillary ridge **Intervention Names:** - Procedure: Autogenous bone augmentation **Label:** Control group: **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control group: - Study group: **Description:** Maxillary alveolar bone reconstruction **Name:** Autogenous bone augmentation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** the study compares the horizontal bone gain of reconstructed maxillary alveolar ridges after being augmented with calverial and iliac crest bone grafts radiographically by millimeters **Measure:** Horizontal bone gain **Time Frame:** 6 months consolidation period #### Secondary Outcomes **Description:** the study compares the bone area percent of the consolidated calverial and iliac crest bone grafts **Measure:** Immunohistochemical bone formation **Time Frame:** 6 months consolidation period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm Exclusion Criteria: * Any previous maxillary reconstructive or dental implant treatment. * Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing. **Maximum Age:** 55 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** amrgibaly@dent.bsu.edu.eg **Name:** Amr Gibaly **Phone:** 01113336634 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** amrgibaly@dent.bsu.edu.eg - **Name:** Amr Gibaly - **Phone:** 01113336634 - **Role:** CONTACT **Country:** Egypt **Facility:** Amr Gibaly **Status:** RECRUITING **Zip:** 62764 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4589 - Name: Atrophy - Relevance: HIGH - As Found: Atrophy - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001284 - Term: Atrophy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434428 **Brief Title:** Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders. **Official Title:** Comparison Between Intranasal Versus Intravenous Administration of Dexmedetomidine for EEG in Children With Behavior Disorders #### Organization Study ID Info **ID:** AO/18/4422 #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliera di Padova ### Status Module #### Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08-30 **Type:** ACTUAL #### Start Date **Date:** 2018-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliera di Padova #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliera di Padova **Investigator Full Name:** angela amigoni **Investigator Title:** Head of the Pediatric Intensive Care Unit **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders. Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive pediatric patients affected by behavioural disorders, who needed sedation for EEG recording. A group of children received IV administration of DEX, the following year a second group of children received IN administration of the same drug. Target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS). **Detailed Description:** OBJECTIVE: The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders. METHODS: Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive patients \< 18 years old affected by behavioural disorders, who needed sedation for EEG recording. From 2018 to 2020 a group of children received IV administration of DEX (IV DEX), the following year a second group of children received IN administration of the same drug (IN DEX). In both groups, target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS). Heart rate (HR), pulse oxygen saturation and blood pressure (BP) were registered. EEG recording quality and caregivers' satisfaction were collected. ### Conditions Module **Conditions:** - Sedation Complication **Keywords:** - sedation - dexmedetomidine - safety ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 48 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients treated intravenously receives a bolus of DEX (2 mcg/kg over ten minutes), followed by continuous infusion (1-2 mcg/kg/hour), stopped at the end of the procedure. The bolus could be repeated up to three times to reach the optimal target level of sedation before starting the continuous infusion. **Intervention Names:** - Drug: dexmedetomidine (IV) **Label:** IV DEX #### Arm Group 2 **Description:** For the IN administration, after a first bolus of 4 mcg/kg it is possible to repeat boluses of 1-2mcg/kg of DEX (maximum dose for each administration is 200mcg). The drug dose is divided into two equal aliquots, with one aliquot administered into each nostril by a nurse using an atomizer device. **Intervention Names:** - Drug: dexmedetomidine (IN) **Label:** IN DEX ### Interventions #### Intervention 1 **Arm Group Labels:** - IV DEX **Description:** Administration of IV dexmedetomidine **Name:** dexmedetomidine (IV) **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - IN DEX **Description:** Administration of IN dexmedetomidine **Name:** dexmedetomidine (IN) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** the patient reaches the level 2 of the Pediatric Sedation State Scale **Measure:** efficacy (PSSS level 2) **Time Frame:** 20 minutes after dexmedetomidine administration #### Secondary Outcomes **Description:** presence of adverse events (desaturation, bradycardia, tachycardia, hypertension, hypotension) **Measure:** safety (Sat > 90%; change < 25% of heart frequency and systemic pressure values) **Time Frame:** during the procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * children affected by behavioural disorders, who need sedation to perform EEG * American Society of Anaesthesiologists (ASA) status \< 3 * Written informed consent by a parent or legal guardian. Exclusion Criteria: * previous hypersensitivity reaction or contraindications to administration of DEX (cardiac failure, cardiac arrhythmias, long QT syndrome, bradycardia, hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, recent stroke or intracranial bleeding, Moya-Moya syndrome) * for IN administration, children with runny nose/mild respiratory infection **Maximum Age:** 18 Years **Minimum Age:** 1 Month **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** children affected by behavioural disorders ### Contacts Locations Module #### Locations **Location 1:** **City:** Padova **Country:** Italy **Facility:** University Hospital of Padova **Zip:** 35128 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Behavior Disorder - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001523 - Term: Mental Disorders ### 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 ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M22662 - Name: Dexmedetomidine - Relevance: HIGH - As Found: Twice daily - 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 ### Intervention Browse Module - Meshes - ID: D000020927 - Term: Dexmedetomidine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434415 **Brief Title:** Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients **Official Title:** Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients #### Organization Study ID Info **ID:** 2024005 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-01-31 **Type:** ACTUAL #### Start Date **Date:** 2017-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. This study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool. ### Conditions Module **Conditions:** - Hypertrophic Cardiomyopathy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 470 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** HCM patients with low IMR #### Arm Group 2 **Label:** HCM patients with high IMR ### Outcomes Module #### Primary Outcomes **Description:** a composition of cardiac death, readmission for heart failure, and cardiac infraction **Measure:** MACE composite **Time Frame:** within 24 months' follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines 2. have qualified image for analysis of angio-IMR Exclusion Criteria: 1. referred to hospital due to ST-segment elevation myocardial infarction(STEMI), heart failure and cardiopulmonary arrest; 2. severe valve dysfunction; 3. history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 4. meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 5. impaired life-span expectancy due to cancer or other clinical conditions； **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** We retrospectively enrolled patients who were diagnosed with hypertrophic cardiomyopathy(HCM) and underwent invasive coronary angiography between 2017 and 2024 at the Second Affiliated Hospital of Zhejiang University School of Medicine.The diagnosis of HCM was based on current clinical guidelines. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Second affiliated Hospital Zhejiang University School of Medicine **Name:** Jun Jiang, MD, PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000001020 - Term: Aortic Stenosis, Subvalvular - ID: D000001024 - Term: Aortic Valve Stenosis - ID: D000082862 - Term: Aortic Valve Disease - ID: D000006349 - Term: Heart Valve Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophic - ID: M12154 - Name: Cardiomyopathies - Relevance: HIGH - As Found: Cardiomyopathy - ID: M5568 - Name: Cardiomyopathy, Hypertrophic - Relevance: HIGH - As Found: Hypertrophic Cardiomyopathy - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M4340 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown - ID: M2379 - Name: Aortic Valve Disease - Relevance: LOW - As Found: Unknown - ID: M9437 - Name: Heart Valve Diseases - Relevance: LOW - As Found: Unknown - ID: T449 - Name: Aortic Valve Stenosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009202 - Term: Cardiomyopathies - ID: D000002312 - Term: Cardiomyopathy, Hypertrophic - ID: D000006984 - Term: Hypertrophy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434402 **Brief Title:** A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer **Official Title:** A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer #### Organization Study ID Info **ID:** 2024-0440 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Registry **ID:** NCI-2024-04531 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To learn more about the experiences of adolescent and young adult cancer survivors and investigate whether a group-based writing intervention can help to improve quality of life of adolescent and young adult cancer survivors. **Detailed Description:** Primary Objective: To evaluate the feasibility of a virtual, group-based expressive writing intervention for survivors of adolescent and young adult cancer. Secondary Objective: To preliminarily assess the impact of the study for cancer survivors. ### Conditions Module **Conditions:** - Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### 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:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff. You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later. **Intervention Names:** - Behavioral: Emerging adults (ages18-25 years) **Label:** Emerging adults (ages18-25 years) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff. You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later. **Intervention Names:** - Behavioral: Young adults (ages 26-39 years) **Label:** Young adults (ages 26-39 years) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff. You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later. **Intervention Names:** - Behavioral: General group (ages 18-39 years) **Label:** General group (ages 18-39 years) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Emerging adults (ages18-25 years) **Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details. **Name:** Emerging adults (ages18-25 years) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Young adults (ages 26-39 years) **Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details. **Name:** Young adults (ages 26-39 years) **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - General group (ages 18-39 years) **Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details. **Name:** General group (ages 18-39 years) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Assed utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) will be used to measure multidimensional QOL (physical, social, emotional, and functional well-being) **Measure:** Quality of Life (QoL) **Time Frame:** Through study completion; an average of 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Age 15-39 years at cancer diagnosis * Age 18-39 years at study entry * Within 5 years of diagnosis of stage II-IV cancer * Completed active treatment (participants receiving maintenance therapy remain eligible) * No evidence of disease * Can speak, read, and write in English. Exclusion criteria: * Nonmelanoma skin cancer * Major mental health disorder (e.g., schizophrenia or bipolar disorder \[determined from patient records or self-disclosure\]) * No internet access. **Maximum Age:** 39 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** qlu@mdanderson.org **Name:** Qian Lu, MD,PHD **Phone:** (713) 745-8324 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** qlu@mdanderson.org - **Name:** Qian Lu, MD,PHD - **Phone:** 713-745-8324 - **Role:** CONTACT ***Contact 2:*** - **Name:** Qian Lu, MD,PHD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Qian Lu, MD,PHD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434389 **Brief Title:** A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery **Official Title:** A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery #### Organization Study ID Info **ID:** 2024-0415 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **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:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study compares the results of the existing fibrinogen concentration monitoring technology to the Electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in Type A Aortic Dissection Surgery. **Detailed Description:** Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms. The novel fibrinogen detection based on Gel electrodes combined with immunobiosensing strategies and use magnitude of current to characterize the fibrinogen concentration , which will be a POC assay of fibrinogen detection for critically ill patients. This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional Clauss laboratory reference method. ### Conditions Module **Conditions:** - Hypofibrinogenemia ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** Part1 Phase I-Laboratory calibration. Phase II-Assay performance using clinical samples. using human biological samples already collected for routine coagulation analysis. Part2 Subject underwent surgery for acute type A aortic dissection and requires routine TEG test， residual blood samples collected for fibrinogen detection by the Clauss method and electrochemical method. **Intervention Names:** - Diagnostic Test: the Electrochemical-based device **Label:** The patients undergoing routine coagulation tests ### Interventions #### Intervention 1 **Arm Group Labels:** - The patients undergoing routine coagulation tests **Description:** Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms. **Name:** the Electrochemical-based device **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Measure:** The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared **Time Frame:** 1 day #### Secondary Outcomes **Measure:** the time of the two detection methods **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Part1 Phase I-Laboratory calibration. The electrochemical method was employed to detect the fibrinogen concentration of standard quality control materials with varying concentration gradients, and the corresponding current values were recorded for constructing a standard curve of fibrinogen concentration. Phase II-Assay performance using clinical samples. Subject is 18 years and underwent routine hemostasis analysis. using human biological samples already collected for routine hemostasis analysis, The samples were centrifuged at 2500g for 15 min at room temperature, to obtain PPP (residual platelet count of \<10 × 10\^9/L) and stored at-20℃used for determination by electrochemical method within 2 weeks, Each clinical sample was tested three times Part2 Inclusion Criteria: Subject underwent surgery for acute type A aortic dissection at our hospital, Subject is 18 years, Subject requires routine TEG measurement, Subject use human fibrinogen concentrate during surgery. Exclusion Criteria: Use Extracorporeal Membrane Oxygenation after surgery, inability to obtain written informed consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. For part 1:The study participants will be adult underwent routine hemostasis analysis. For part 2:The study participants will be adult underwent surgery for acute type A aortic dissection and requires routine TEG test, residual blood samples collected for fibrinogen detection by the Clauss method and electrochemical method. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zrzfj@zju.edu.cn **Name:** Fengjiang ZHANG **Phone:** +8613858007629 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** zrzfj@zju.edu.cn - **Name:** Fengjiang ZHANG - **Phone:** +8613858007629 - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital of Zhejiang University anesthesiology department **State:** Zhejiang **Zip:** 310009 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000094683 - Term: Acute Aortic Syndrome - ID: D000001018 - Term: Aortic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4114 - Name: Aortic Dissection - Relevance: HIGH - As Found: Aortic Dissection - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3085 - Name: Acute Aortic Syndrome - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000784 - Term: Aortic Dissection ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434376 **Brief Title:** MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis **Official Title:** Study on Adjuvant Treatment of MRD-positive Colorectal Cancer Patients With Routine Chemotherapy Combined With Personalized Immune Regulation Diagnosis and Treatment Technology #### Organization Study ID Info **ID:** SAHoWMU-CR2024-02-110 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital of Wenzhou Medical University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital of Wenzhou Medical 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:** Establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy: Patients with MRD positive and high risk of recurrence after colorectal cancer surgery were enrolled. Surgical tumor tissue and blood samples were collected, tumor tissue samples were sequenced, neoantigens were analyzed, personalized immunomodulators were prepared, and routine adjuvant therapy combined with personalized immunomodulatory diagnosis and treatment technology were performed to prevent postoperative recurrence. To establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy ### Conditions Module **Conditions:** - Colorectal Cancer ### 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:** Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology **Intervention Names:** - Biological: Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology **Label:** Experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** Blood samples were collected for MRD detection within one month (week 3) after colorectal cancer surgery, and MRD-positive patients were selected for routine chemotherapy (course of 6 months). Blood and tumor tissue samples of enrolled patients were collected, and relevant clinical data were recorded. The whole exon and expression profile of surgical tumor tissue samples were sequenced, neoantigens were analyzed, and immunomodulators were prepared. After the preparation of individualized immunomodulators, combined treatment was performed simultaneously with chemotherapy. During the treatment process, patients' response to treatment and survival were observed, and tumor load, ctDNA changes, imaging and other indicators before and after treatment were compared. To evaluate the efficacy of immunotherapy. **Name:** Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Exploration of the efficacy of Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology **Measure:** ORR **Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months #### Secondary Outcomes **Description:** Observe and evaluate the progression free survival (PFS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technolog **Measure:** PFS **Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months **Description:** Observe and evaluate the overall survival(OS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technology **Measure:** OS **Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. They must give informed consent, indicating that they understand the purpose of the study and the procedures required, and are willing to participate in the study. 2. Age 18-80. 3. Pathological examination confirmed colorectal adenocarcinoma. 4. For patients with stage II with high risk factors or stage III with radical surgery, stage II (high risk) colon cancer is defined as (any of): a )T4 b)≥ Level 3 c) The clinical manifestations are intestinal obstruction or intestinal perforation d) Histological signs of vascular, lymphatic, or perineural invasion e) Check \< 12 nodes 5. Patients with liver or lung metastases that can be resected in one stage with the primary lesion. 6. There must be sufficient formalin to fix the tumor material in the paraffin embedded (FFPE) block or section tissue (only after sponsor approval), preferably obtained from excision. 7. Patients should meet the following biochemical indicators: total bilirubin ≤2× upper limit of normal (ULN); AST and ALT≤2× upper limit of normal (ULN); Creatinine clearance ≥60 ml/min. 8. Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L. 9. Expected survival ≥ 3 months. 10. Postoperative ctDNA MRD test was positive, routine blood indexes were negative, and imaging was negative. Exclusion Criteria: 1. Stage I patients and stage II patients without risk factors or MSI-H. 2. Stage IV patients who cannot be surgically resected. 3. Patients with liver, kidney, heart, lung and other dysfunction, unable to tolerate surgery or unable to complete follow-up chemotherapy. 4. Patients who refuse adjuvant therapy such as chemotherapy, are allergic to chemotherapy drugs and have poor compliance. 5. Patients who have received other immunotherapy within 1 month (such as immune checkpoint inhibitor therapy, therapeutic antibody therapy, immune cell therapy, and immune system modulator therapy) 6. Patients with a known past or current malignancy, except where a diagnosis is included, except in the following cases: 1. Stage 1B or below cervical cancer. 2. Non-invasive basal cell or squamous cell skin cancer. 3. Non-invasive superficial bladder cancer. 4. Prostate cancer with a current PSA level \< 0.1 ng/mL. 5. Any curable cancer with a complete response (CR) duration of \> 2 years. 7. Patients with hematological and autoimmune diseases. 8. Patients with active hepatitis B or C. 9. Patients affected by drug abuse, clinical or psychological or social factors that make informed consent or the implementation of research. 10. Pregnant and lactating women. 11. Patients with mental illness, senile dementia, etc. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** liweiying@pnp-med.com **Name:** Yaojun Yu **Phone:** +86 138 6884 9180 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** publication **IPD Sharing:** NO ## 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 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434363 **Brief Title:** Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders **Official Title:** Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders #### Organization Study ID Info **ID:** 2024-0208 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Trials Registry **ID:** NCI-2024-04434 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease. The goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease. **Detailed Description:** Primary Objectives: To determine the safety, tolerability and optimal cell dose of AD-PluReceptor plus Tafasitamab cxix and lymphodepleting chemotherapy in patients with systemic sclerosis and systemic lupus erythematosus (including lupus nephritis). Secondary Objectives: To assess the overall response rate. To evaluate the persistence and kinetics of infused allogeneic donor AD-PluReceptor cells in the recipient. To conduct comprehensive immune reconstitution studies. To evaluate the number of patients not requiring any systemic immunosuppressive therapy for their autoimmune disease at 1 year post infusion. ### Conditions Module **Conditions:** - Autoimmune Disorders - Systemic Sclerosis ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 47 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Tafasitamab **Label:** Safety Lead-In **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Tafasitamab - Drug: Fludarabine phosphate - Drug: Cyclophosphamide **Label:** Dose Escalation **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: Tafasitamab - Drug: Fludarabine phosphate - Drug: Cyclophosphamide **Label:** Dose Expansion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dose Escalation - Dose Expansion - Safety Lead-In **Description:** Given by vein (IV) **Name:** Tafasitamab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Dose Escalation - Dose Expansion **Description:** Given by vein (IV) **Name:** Fludarabine phosphate **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Dose Escalation - Dose Expansion **Description:** Given by vein (IV) **Name:** Cyclophosphamide **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 **Measure:** Adverse Event **Time Frame:** Through study completion; an average of 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 4.1.1 Systemic Sclerosis Specific Inclusion Criteria A. Diagnosis of SSc defined as follows: i) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening. B. SSc disease activity i) Diffuse SSc meeting the following criteria: (1) Disease duration ≤ 5 years (from onset of first non-Raynaud manifestation) AND (2) mRSS ≥ 15 at screening (Appendix 2) ii) Participants diagnosed with diffuse or limited cutaneous SSc AND progressive ILD on HRCT and ≤ 5 years duration (from onset of first non-Raynaud manifestation) defined by either (1) or (2) 1. Progressive ILD as defined by Raghu et al47 (≥ 2 of the following): 1. worsening respiratory symptoms 2. physiological evidence of disease progression (≥ 1 of the following): (i) Absolute decline in FVC ≥ 5% predicted within 1 year of follow-up (ii) Absolute decline in DLCO (corrected for Hb) ≥ 10% predicted within 1 year of follow-up radiological evidence of disease progression (iii) Increased extent or severity of traction bronchiectasis and bronchiolectasis. (iv) New ground-glass opacity with traction bronchiectasis (v) New fine reticulation (vi) Increased extent or increased coarseness of reticular abnormality. (vii) New or increased honeycombing (viii) Increased lobar volume loss 2. FVC \< 80% predicted and moderate to severe ILD, as assessed by a radiologist. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and/or tocilizumab. 4.1.2 SLE Specific Inclusion Criteria 1. A clinical diagnosis of SLE, based on the 2019 EULAR/ ACR classification criteria for adult SLE. 2. Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening. 3. For LN subjects only: Active, biopsy-proven lupus nephritis class III or IV, with or without the presence of Class V, using the 2018 Revised International Society of Nephrology/Renal Pathology Society criteria48. 4. Diagnosed with active SLE. Subjects with either LN or without LN will be eligible if they meet the following criteria: 1. For LN subjects: urine protein-to-creatinine ratio (UPCR) ≥1 mg/mg on 2 first morning void urine samples during screening despite prior or current treatment with standard of care therapy for at least 12 weeks, including corticosteroids, MMF/mycophenolic acid (MPA), CY, calcineurin inhibitors, belimumab, and/or rituximab. 2. For non-renal SLE subjects: SLEDAI-2K ≥8 and clinical SLEDAI-2K ≥6 (excluding headache, alopecia, mucosal ulcers, fever, and organic brain syndrome) during screening despite prior or current treatment with standard of care therapy, including corticosteroids, rituximab or other B cell depleting agents, CY, MMF/MPA, azathioprine, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, mizorbine, anifrolumab, and/or belimumab. 5. If a subject is currently receiving: 1. Standard immunosuppressive therapy (including MMF/MPA, CY, azathioprine, antimalarial therapy, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, or mizorbine), the therapy must have been initiated at least 12 weeks prior to screening and on a stable dose for at least 8 weeks prior to screening, except for dose reduction due to safety or tolerability. 2. A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject must be on a stable dose for at least 8 weeks prior to screening.A sodium-glucose cotransporter-2 (SGLT2) inhibitor, the subject must be on a stable dose for at least 8 weeks prior to screening. 3. Regarding oral corticosteroid, doses \<0.5 mg/kg prednisone equivalent at the time of infusion are required. 6. Adequate renal function, defined as: 1. For LN subjects: Estimated glomerular filtration rate of ≥45 mL/min/1.73m2 using the chronic kidney disease-epidemiology equation. 2. For non-renal SLE subjects: Estimated glomerular filtration rate of ≥60 mL/min/1.73m2 using the chronic kidney disease-epidemiology equation 4.2.3 Inclusion Criteria: For both SLE and SSc 1. Able to provide informed consent. 2. Age ≥18 to ≤65 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix 1). 4. Adequate organ function i) Peripheral blood absolute neutrophil count (ANC) ≥ 1 × 109/L. iii) Hemoglobin ≥ 8 g/dl. iv) Platelet count ≥ 50 × 109/L without platelet transfusion support, no active bleeding. vi) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 1.5 × upper limit of normal (ULN) and total bilirubin \< 1.5 × ULN (or direct bilirubin \< 1.5× ULN with documented Gilbert's syndrome). viii) Oxygen saturation (SaO2) ≥ 92% on room air. ix) Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan. 5. Recovery to ≤ Grade 1 or baseline of any non-hematological toxicities due to prior therapy. 6. Negative pregnancy test in WOCBP. 7. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of therapy. Acceptable forms of birth control for female patients include hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor. Participant is willing and able to adhere to the study visit schedule and other protocol requirements and willing to sign informed consent. Exclusion Criteria: * 4.2 Exclusion Criteria 4.2.1 SSc specific exclusion criteria 1. SSc related pulmonary arterial hypertension (PAH) requiring active treatment. 2. Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia. 3. Prior scleroderma renal crisis. 4. Uncontrolled or rapidly progressive ILD (FVC \< 50; DLCO \< 50%); oxygen saturation (SaO2) \< 92% (room air at rest); or who have required mechanical breathing assistance (ventilator) within 1 year of signing informed consent. 4.2.2 SLE specific Exclusion Criteria Subjects are excluded from the study if any of the following criteria apply: 1. Treatment with rituximab or other B cell-depleting agent within 26 weeks prior to screening, or within 12 weeks if there are laboratory results indicating presence of CD19+ B cells. 2. Treatment with voclosporin or other calcineurin inhibitor within 8 weeks prior to screening. 3. Treatment with anifrolumab, belimumab, or other biologic agent within 12 weeks prior to screening. 4. For LN subjects only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following individual biopsy features: total glomerulosclerosis score, fibrous crescents, tubular atrophy, or interstitial fibrosis. 5. A diagnosis of antiphospholipid antibody syndrome by the 2006 Revised Sapporo International Consensus Criteria at the time of screening49 6. The presence of biopsy-proven kidney disease other than active lupus nephritis 7. Moderate-to-severe chronic pulmonary disease, including asthma requiring or refractory to medium or high-dose inhaled corticosteroids combined with other longer-acting medications, In subjects who have had pulmonary function tests: Spirometry results of forced expiratory volume (FEV1)/forced vital capacity \<0.7 and FEV1 \<80% predicted after bronchodilators, or diffusing capacity of the lungs for carbon monoxide results \<60% predicted. 8. Active, severe cardiac manifestations of SLE, including constrictive pericarditis, hemodynamically significant pericardial effusions, and myocarditis at the time of screening. 4.2.4 Exclusion Criteria for both SLE and SSc Subjects are excluded from the study if any of the following medical conditions apply: 1. Other systemic autoimmune diseases (e.g., multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded. 2. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol. 3. Active, clinically significant central nervous system pathology 4. Prior history of malignancies or lymphoproliferative disease, following are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or breast. History of malignancy that has been treated with a curative intent and is in remission \> 5 years may be allowed after discussion with PI. 5. Active hepatitis B, active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and/or type 2 (HTLV-1 and/or HTLV-2 6. Uncontrolled or active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at screening or within 72 hours before LD chemotherapy, or 5 days before AD-PluReceptor administration. 7. History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina, or other clinically significant cardiac disease. 8. Prior CAR T cell therapy, genetically modified T cell therapy, concurrent immunosuppressive drugs, e.g., mycophenolate mofetil, systemic steroids, tocilizumab. 9. History of anaphylactic or severe systemic reaction to FLU, CY, or any of their metabolites. 10. Active infection requiring medical intervention at screening. 11. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (on TPN), pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections. 12. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures. 13. Autoimmune disorder other than SLE or SSc requiring immunosuppressive therapies. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cmhosing@mdanderson.org **Name:** Chitra Chitra Hosing, MD **Phone:** (713) 745-3219 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** cmhosing@mdanderson.org - **Name:** Chitra Chitra, MD - **Phone:** 713-745-3219 - **Role:** CONTACT ***Contact 2:*** - **Name:** Chitra Hosing, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 ### References Module #### See Also Links **Label:** MD Anderson Cancer Center Website **URL:** http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Disorders - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: HIGH - As Found: Systemic Sclerosis ### Condition Browse Module - Meshes - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000045743 - Term: Scleroderma, Diffuse - ID: D000001327 - Term: Autoimmune Diseases ### Intervention Browse Module - Ancestors - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018501 - Term: Antirheumatic Agents - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019653 - Term: Myeloablative Agonists - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M283230 - Name: Fludarabine - Relevance: HIGH - As Found: Combined - ID: M225513 - Name: Fludarabine phosphate - Relevance: HIGH - As Found: In the morning - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003520 - Term: Cyclophosphamide - ID: C000024352 - Term: Fludarabine - ID: C000042382 - Term: Fludarabine phosphate ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434350 **Brief Title:** Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) **Official Title:** Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) #### Organization Study ID Info **ID:** 2024-0071 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Registry **ID:** NCI-2024-04592 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-09-24 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease. **Detailed Description:** Primary Objectives: 1. Primary Objective #1: To estimate progression free survival for concurrent enfortumab vedotin with RT in locally advanced MIBC 2. Primary Objective #2: To evaluate the safety/tolerability of enfortumab vedotin with RT in participants with locally advanced MIBC 3. Primary Objective #3: To evaluate global health-related quality of life (HRQOL) using EQ-5D-5L, EORTC MIBC module, and EPIC bowel domain surveys Secondary Objectives: 1. Secondary Objective #1: To estimate the overall survival at 12 months after study enrollment. 2. Secondary Objective #2: To estimate the metastasis free survival at 12 months after study enrollment. 3. Secondary Objective #3: To determine the treatment related toxicities associated with enfortumab vedotin with RT as part of definitive local therapy for advanced MIBC. 4. Secondary Objective #4: To estimate the freedom from GU events after enfortumab vedotin with RT 5. Exploratory Objective #1: To determine the association of translational biomarkers including peripheral blood tumor markers and urine tumor markers with participant outcomes. ### Conditions Module **Conditions:** - Advanced Bladder Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 41 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Particpants will receive enfortumab vedotin by vein over about 1-2 hours on Days 1 and 8 of every 28-day cycle. Two dose levels of enfortumab vedotin will be tested. The dose of enfortumab vedotin participants receive will depend on when the participant join the study. Participants will also receive radiation therapy 5 times a week (Monday through Friday) for about 4-5 weeks. **Intervention Names:** - Drug: Enfortumab Vedotin - Radiation: Radiation Therapy **Label:** Enfortumab Vedotin with Radiation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Enfortumab Vedotin with Radiation **Description:** Given by IV **Name:** Enfortumab Vedotin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Enfortumab Vedotin with Radiation **Description:** Given by Radiation Therapy **Name:** Radiation Therapy **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0 **Measure:** Safety and adverse events (AEs) **Time Frame:** Through study completion; an average of 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Pathologically confirmed diagnosis of urothelial carcinoma of the bladder including patients with T4N0 and T1-4N2-3 disease. Participants with mixed urothelial carcinoma of bladder will also be included. 2. Be ≥ 18 years of age on the day of signing informed consent. 3. ECOG performance status 0-2. NOTE: If participants is unable to walk due to paralysis, but is mobile in a wheelchair, participants is ambulatory for the purpose of assessing their performance status. 4. The participant has the following baseline laboratory data: 1. Hemoglobin ≥ 9 g/dL 2. Platelet count ≥ 100 x 109 g/dL 3. Creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards (glomerular filtration rate \[GFR\] can also be used instead of CrCl) 4. Absolute neutrophil count (ANC) ≥ 1500/mm3 5. Male participants must consistently use highly effective methods of birth control starting at screening and continue throughout study period and for at least 6 months after radiation completion 6. Female participants must consistently use highly effective methods of birth control starting at screening and continue throughout the study period and for at least 6 months after radiation completion As the CORe system in MDACC is set up as a one-step enrollment process, the above inclusion criteria will be assessed prior to CORe enrollment. Following CORe enrollment, the below inclusion criteria will be assessed. 1. Candidate for definitive local therapy to active disease per the discretion of the treating physicians. Exclusion Criteria: 1. Has a diagnosis of active scleroderma, lupus, ulcerative colitis, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy. 2. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and/or member of the study team. 3. Distant metastatic disease beyond lymph node metastases, which by the discretion of the treating physician cannot be treated definitively in a radiation field 4. Has history of prior pelvic radiation therapy 5. Has ongoing clinically significant toxicity (Grade 2 or higher with exception of alopecia) associated with prior systemic therapy 6. History of uncontrolled diabetes mellitus within 3 months of enrollment. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and \< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. 7. Has estimated life expectancy of less than 12 weeks 8. Has preexisting sensory or motor neuropathy Grade ≥ 2 9. Participants receiving ongoing systemic intravenous antimicrobial treatment for active infection at time of randomization 10. Participants have a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. No testing for hepatitis B and hepatitis C is required unless mandated by local health authority. 11. Has a known history of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by the local health authority. 12. Has conditions requiring high doses of steroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency. 13. Has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. 14. Has received a prior allogeneic stem cell or solid organ transplant. 15. Has active tuberculosis As the CORe system in MDACC is set up as a one-step enrollment process, the above inclusion criteria will be assessed prior to CORe enrollment. Following CORe enrollment, the below exclusion criteria will be assessed. 1. Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit. * Female participants of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation. * Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cjhassanzadeh@mdanderson.org **Name:** Comron Hassanzadeh, MD **Phone:** (713) 657-9802 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** cjhassanzadeh@mdanderson.org - **Name:** Comron Hassanzadeh, MD - **Phone:** 713-657-9802 - **Role:** CONTACT ***Contact 2:*** - **Name:** Comron Hassanzadeh, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Comron Hassanzadeh, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## 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: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - 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:** NCT06434337 **Brief Title:** Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV) **Official Title:** Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV) #### Organization Study ID Info **ID:** 2024-0020 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center #### Secondary ID Infos **Domain:** NCI-CTRP Clinical Registry **ID:** NCI-2024-04598 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-29 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible. **Detailed Description:** Primary Objectives 1. To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test"). Secondary Objectives 1. To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+). 2. To assess how different sample processing methods affect the performance of the Rice HPV test. 3. To assess how different test readout methods affect the performance of the Rice HPV test. Exploratory Objectives 1. Compare the performance of the Rice HPV test between provider-collected and self-collected samples. 2. Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling. 3. Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert. ### Conditions Module **Conditions:** - Human Papillomavirus ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 600 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants that agree to take part in this study, then 2 additional cervical swabs will be collected for research purposes during a routine clinical visit. The leftover material from the routine HPV test will also be collected under this study. **Intervention Names:** - Diagnostic Test: Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") **Label:** Standard-of-care (SOC) ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard-of-care (SOC) **Description:** Given by Diagnostic Test **Name:** Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** To assess the evaluation for the performance of the 3 verisions of a novel point of care diagnostic test for detecting hpv (rice hpv test) **Measure:** Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") **Time Frame:** Through study completion; an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. People with a cervix 21 years of age or older. 2. Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment. 3. Willing and able to provide informed consent. 4. Able to perform protocol-required activities. Able to speak and read English or Spanish. Exclusion Criteria 1. Participant or provider decision not to perform HPV testing. 2. Participant or provider decision not to collect a sample for this study. 3. Participants that are pregnant. **Minimum Age:** 21 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** MD Anderson Cancer Center ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kschmele@mdanderson.org **Name:** Kathleen Schmeler, MD **Phone:** (713) 745-3518 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** kschmele@mdanderson.org - **Name:** Kathleen Schmeler, MD - **Phone:** 713-745-3518 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kathleen Schmeler, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Kathleen Schmeler, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434324 **Brief Title:** Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion **Official Title:** A Study to Evaluate the Efficacy of Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in the Management of Empyema/Complicated Parapneumonic Effusion #### Organization Study ID Info **ID:** 23-013234 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic #### Secondary ID Infos **Domain:** US Dept of Defense **ID:** HT9425-24-C-0010 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-05-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### Responsible Party **Investigator Affiliation:** Mayo Clinic **Investigator Full Name:** Dagny K. Anderson **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 purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection. **Detailed Description:** Pleural space infections portend considerable morbidity and require procedural and sometimes surgical intervention in the context of prolonged hospital stays (median length of stay has been reported as 14-19 days) for definitive management. Key aspects of management include pleural space evacuation and appropriate antimicrobial therapy. The antimicrobial regimen is initiated intravenously and is often transitioned to an oral regimen as guided by clinical improvement, radiographic improvement, and microbiologic studies though conventional bacterial cultures remain negative in as many as 40% of cases of pleural space infection. There is variability in antimicrobial duration though this is typically continued for at least 3 weeks. The MIST 2 trial investigated the role of intrapleural tissue plasminogen activator (t-PA) and dornase (DNase) in the management of pleural space infections, noting that disrupting septations and reducing pleural fluid viscosity were necessary steps to achieve successful drainage in in-vitro studies. MIST 2 demonstrated that a combination of intrapleural t-PA and DNase improved pleural space evacuation on serial chest x-ray and reduced the frequency of surgical referral and hospital length of stay. Saline irrigation of the pleural space has been proposed to reduce stasis and dilute bacteria, cytokines, and coagulation factors, which induce pleural space organization. The Pleural Irrigation Trial was a pilot study evaluating the role of 250 cc 0.9% sodium chloride irrigation three times daily for 3 days in comparison to standard care, which included maintaining thoracostomy tubes on suction and flushing with 30 cc three times daily. Saline irrigation led to a 32.3% reduction in pleural fluid volume as assessed by computed tomography in comparison to 15.3% in the standard care arm. Fewer patients in the irrigation group were referred for surgery (OR 7.1). To our knowledge, the efficacy of intrapleural saline irrigation in addition to fibrinolytic therapy has not been studied in comparison to fibrinolytic therapy alone. The Mayo Clinic Interventional Pulmonary practice in Rochester, MN intends to study this in the context of the inpatient pleural service, the team that is routinely consulted for patients with proven or suspected pleural space infections. This team routinely places and manages ultrasound-guided locking-loop thoracostomy tubes and additionally manages patients with thoracostomy tubes placed by intensivists, surgeons, and interventional radiologists when consulted. Our team intends to recruit hospitalized patients that meet the inclusion/exclusion criteria of the study. Those that provide informed consent to participate in the study will be randomized to usual care versus intrapleural saline irrigation + usual care. ### Conditions Module **Conditions:** - Pleural Infection ### 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:** Subjects will receive twice daily fibrinolytic therapy in addition to daily saline irrigation through their chest tube until the treating physician determines that the pleural space has been adequately evacuated **Intervention Names:** - Procedure: Saline Irrigation **Label:** Saline Irrigation Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will receive twice daily fibrinolytic therapy through their chest tube until the treating physician determines that the pleural space has been adequately evacuated **Label:** Standard of Care Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Saline Irrigation Group **Description:** 250 cc waves of warmed saline irrigation (up to 2000 cc) through thoracostomy tube on a daily basis **Name:** Saline Irrigation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Number of intrapleural fibrinolytic doses to achieve adequate pleural space evacuation (defined as \<=2.5 cm separation between parietal and visceral pleural layers on bedside ultrasound or no more than small residual effusion on clinically-directed CT chest imaging). **Measure:** Adequate pleural space evacuation **Time Frame:** Approximately 3 days #### Secondary Outcomes **Description:** Number of additional interventions to achieve satisfactory pleural space evacuation, such as additional paired lytics beyond 6 doses, ipsilateral thoracentesis, additional ipsilateral thoracostomy tube placement, surgical intervention, or discharge with an empyema tube in situ. **Measure:** Need for additional interventions **Time Frame:** Approximately 10 days **Description:** Number of thoracostomy tube days from the time that treatment is initiated **Measure:** Thoracostomy tube days **Time Frame:** Approximately 10 days **Description:** Number of hospital days from the time that treatment is initiated **Measure:** Number of hospital days **Time Frame:** Approximately 14 days **Description:** Measured using a visual analog scale (VAS) questionnaire that assesses pain experienced during treatment utilizing a scale of 0 to 10, with 10 meaning the worst pain imaginable. **Measure:** Pain tolerance of pleural space irrigation **Time Frame:** Approximately 3 days **Description:** Total number of adverse events including new/worsened respiratory failure, septic shock, hemothorax **Measure:** Number of adverse events **Time Frame:** Approximately 10 days ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Purulent pleural fluid versus pleural fluid analysis demonstrating pH \<7.2, glucose \<60 mg/dL, positive Gram stain, or positive pleural fluid culture versus multiseptated pleural effusion with infection at top of differential diagnosis * Patients initiating intrapleural lytic therapy under the care of the Interventional Pulmonary consult service at Mayo Clinic in Rochester, MN Exclusion Criteria: * Unwillingness to give informed consent * Patients with known bleeding diathesis * Platelet count \<50,000 per μL * INR \>2.2 (of note, INR can be allowed to drift down or be reversed pharmacologically prior to initiation of intrapleural lytics/saline) * Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable) * Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment * Incarcerated patients * Presence of ipsilateral bronchopleural fistula * Current or recent (within past 30 days) presence of tunneled pleural catheter on the same side as the current proven/suspected pleural space infection **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** Mayo Clinic in Rochester **State:** Minnesota **Zip:** 55905 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Dagny Anderson, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bedawi EO, Ricciardi S, Hassan M, Gooseman MR, Asciak R, Castro-Anon O, Armbruster K, Bonifazi M, Poole S, Harris EK, Elia S, Krenke R, Mariani A, Maskell NA, Polverino E, Porcel JM, Yarmus L, Belcher EP, Opitz I, Rahman NM. ERS/ESTS statement on the management of pleural infection in adults. Eur Respir J. 2023 Feb 2;61(2):2201062. doi: 10.1183/13993003.01062-2022. Print 2023 Feb. **PMID:** 36229045 **Citation:** Birkenkamp K, O'Horo JC, Kashyap R, Kloesel B, Lahr BD, Daniels CE, Nichols FC 3rd, Baddour LM. Empyema management: A cohort study evaluating antimicrobial therapy. J Infect. 2016 May;72(5):537-43. doi: 10.1016/j.jinf.2016.02.009. Epub 2016 Mar 15. **PMID:** 26987740 **Citation:** Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740. **PMID:** 21830966 **Citation:** Mismetti V, Froudarakis ME. Medical management of pleural infection: Why not saline intrapleural lavage? Clin Respir J. 2022 Nov;16(11):693-695. doi: 10.1111/crj.13548. Epub 2022 Sep 29. No abstract available. **PMID:** 36173249 **Citation:** Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28. **PMID:** 26022948 #### See Also Links **Label:** Mayo Clinic Clinical Trials **URL:** https://www.mayo.edu/research/clinical-trials ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-24 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 366679 - Type Abbrev: ICF - Upload Date: 2024-05-22T18:41 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013492 - Term: Suppuration - ID: D000007239 - Term: Infections - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes ### 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: M7819 - Name: Empyema - Relevance: HIGH - As Found: Empyema - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M16273 - Name: Suppuration - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004653 - Term: Empyema ### Intervention Browse Module - Browse Branches - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434311 **Brief Title:** Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis **Official Title:** Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis #### Organization Study ID Info **ID:** MarmaraU- AYDOĞDU-SÜZÜK001 #### Organization **Class:** OTHER **Full Name:** Marmara University ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-15 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Marmara University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Osteoarthritis of the knee is a common joint disease that causes loss of balance and proprioception. Changes in the knee joint such as mechanoreceptor loss, muscle strength imbalance, muscle weakness, capsular hypertrophy, subchondral edema, and increased loss of balance and proprioception lead to an increased risk of falls. In the literature, knee osteoarthritis is repeatedly mentioned as an independent risk factor for falls, and knee osteoarthritis is associated with recurrent falls. There are many performance-based clinical measurement tests that assess fall risk in knee osteoarthritis. Some of these tests include the timed up and walk test, the five-step sit-to-stand test, and the one-leg stand test. These tests cannot evaluate backward walking. Backward walking requires more neuromuscular control and proprioception than forward walking. The 3-meter backward walk test is a performance-based test that assesses backward walking, balance, proprioception, and neuromuscular control. The participant is asked to walk 3 meters backwards on a flat surface at the highest speed at which they feel comfortable without running. It is administered by recording the time elapsed. The validity and reliability of the 3-meter walk back test have been previously investigated in many patient populations and healthy individuals. However, to our knowledge, there is no research on the reliability and validity of a 3-meter walk back test in knee osteoarthritis. Clinical measurement tests should be valid and reliable in the patient population to which they are applied. The aim of this study was to examine the test-retest reliability and concurrent validity of the 3-meter backward walk test in participants with knee osteoarthritis. In addition, we aim to compare the 3-meter backward walk test scores of individuals with and without knee osteoarthritis and to examine the change in 3-meter backward walk test scores with the change in disease severity. The data collection tools to be used in the study are the 3-meter walk back test, the timed get up and walk test, the Knee Injuries and Osteoarthritis Outcome Score, the Frail Scale, the Modified Falls Efficacy Scale, and fall history. All of these measures will be taken at the initial assessment, and the 3-meter walk back test will be repeated after 3-7 days. We hope that our study will help physiotherapists working in this field in the clinical decision-making process by providing a valid and reliable performance test for the assessment of fall risk. ### Conditions Module **Conditions:** - Knee Osteoarthritis ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who who have knee osteoarthritis categorized as 1 or 2 according to Kellgren - Lawrence **Intervention Names:** - Diagnostic Test: 3 meter Backward Test **Label:** Early knee Osteoarthritis #### Arm Group 2 **Description:** Patients who who have knee osteoarthritis categorized as 3 or 4 according to Kellgren - Lawrence **Intervention Names:** - Diagnostic Test: 3 meter Backward Test **Label:** Severe Knee Osteoarthritis ### Interventions #### Intervention 1 **Arm Group Labels:** - Early knee Osteoarthritis - Severe Knee Osteoarthritis **Description:** evaluation **Name:** 3 meter Backward Test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** It is a performance-based test developed by Carter et al. A 3 meter long strip is drawn on the ground. It assesses fall risk, balance, neuromuscular control. Participants are expected to walk backwards for 3 meters as fast as possible. The time until the participant completes the walk is recorded. A lower score indicates higher performance (Carter et al., 2019). **Measure:** 3 meter Backward Test **Time Frame:** At the baseline **Description:** It is a performance-based test developed by Carter et al. A 3 meter long strip is drawn on the ground. It assesses fall risk, balance, neuromuscular control. Participants are expected to walk backwards for 3 meters as fast as possible. The time until the participant completes the walk is recorded. A lower score indicates higher performance (Carter et al., 2019). **Measure:** 3 meter Backward Test **Time Frame:** One week later #### Secondary Outcomes **Description:** The timed up and go test was developed in 1991 as a modified version of the get up and go test (Barry et al., 2014). The participant is asked to sit on a chair approximately 46 cm tall. Then, the participant gets up from the chair, walks 3 meters, walks the same distance back, and sits on the chair. The elapsed time is recorded (Barry et al., 2014; Ortega-Bastidas et al., 2023). A shorter time means a better score. The participant's failure to complete the test in less than 12 seconds indicates a high risk of falling (Nightingale et al., 2019). **Measure:** Timed Up Go Test **Time Frame:** At the baseline **Description:** It is a scale used to evaluate frailty in the elderly. The scale, consisting of 5 items, questions resistance, fatigue, ambulation, illness, and weight loss. Each question takes one of the values 0 or 1, with a total value of 0, indicating that the person is not frail. Values ranging from 1 to 2 are called pre-frail, and values above 2 are called fragile. In the disease questioning, the participant is asked how many of the 11 diseases he has. Having more than 5 diseases indicates a score of 1. The lowest score that can be obtained is zero, while the highest score is 5 (HYMABACCUS et al., 2023; Morley et al., 2012). Turkish validity and reliability study by Hymabaccus et al. Made by. Its reliability and validity have been reported as excellent, and the intraclass consistency coefficient varies between 0.68 and 0.82. (HYMABACCUS et al., 2023). **Measure:** Frail Scale **Time Frame:** At the baseline **Description:** It has been translated into more than fifty languages. The commonly used knee injury and osteoarthritis outcome score consists of 5 subcategories. It is a 5-point Likert type scale consisting of 42 questions. A score ranging from 0 to 4 is given for each question. The total score for each subcategory is one hundred. While 0 indicates serious knee problems, 100 indicates no knee problems (Roos, 2023). Turkish validity and reliability were determined by Paker et al. It was conducted in 2007 and reported moderate validity and reliability (Paker et al., 2007). Internal consistency was calculated with Cronbach's alpha and was reported as 0.66 - 0.95 (Paker et al., 2007). **Measure:** Knee injury and Osteoarthritis Outcome Score (KOOS) **Time Frame:** At the Baseline **Description:** It evaluates the individual's self-confidence regarding the fall. It is an expanded version of the falls effectiveness scale. It consists of 14 items. It evaluates a person's self-confidence during various daily activities. Each item is given a value ranging from 0-10. While 0 represents unsafe, the number 10 is considered completely safe. The highest score that can be obtained is 140 and the lowest score is 0 (Soh et al., 2021). Turkish validity and reliability study by Korkmaz et al. Made by. The intra-class consistency coefficient was reported as 0.978 (Korkmaz et al., 2019). **Measure:** Modified Falls Efficacy Scale **Time Frame:** At the Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * To have been diagnosed with osteoarthritis by a specialist physician according to the clinical and radiological criteria of the American College of Rheumatology. Be between 40 and 75 years of age. Being in grade 1-4 according to Kellgren-Lawrence staging. To participate in the study voluntarily Exclusion Criteria: * Having undergone surgery involving the lower extremity Having prosthesis or orthosis in the lower extremity Other neurological and cardiopulmonary diseases that may affect walking and balance Having undergone surgery or invasive treatment in the last 6 months Body mass index above 45 Having severe heart disease that prevents exercise Having pain originating from L3 - S1 **Maximum Age:** 75 Years **Minimum Age:** 40 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** People who have diagnosed as knee osteoarthritis ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mervesuzuk@halic.edu.tr **Name:** Merve SÜZÜK Research Assistant **Phone:** 05317351127 **Role:** CONTACT **Contact 2:** **Email:** onur.aydogdu@marmara@edu.tr **Name:** Onur AYDOĞDU Assistant Professor **Phone:** 05055377277 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** ptmervesuzuk@gmail.com - **Name:** Merve SÜZÜK - **Phone:** 05317351127 - **Role:** CONTACT ***Contact 2:*** - **Email:** onur.aydogdu@marmara.edu.tr - **Name:** Onur AYDOĞDU - **Phone:** 05055377277 - **Role:** CONTACT **Country:** Turkey **Facility:** Marmara University **State:** Maltepe **Status:** RECRUITING **Zip:** 34854 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434298 **Brief Title:** Continued Evaluation of Choose to Move (CTM) Phase 4 **Official Title:** Continued Evaluation of Provincial Scale-up of Choose to Move (CTM) Phase 4 #### Organization Study ID Info **ID:** H23-02336 #### Organization **Class:** OTHER **Full Name:** University of British Columbia ### Status Module #### Completion Date **Date:** 2027-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2026-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** British Columbia Ministry of Health #### Lead Sponsor **Class:** OTHER **Name:** University of British Columbia #### Responsible Party **Investigator Affiliation:** University of British Columbia **Investigator Full Name:** Heather McKay **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:** Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. In this project, the investigators will expand delivery of the optimized Phase 4 program with large and small partner organizations and will describe and assess scale-up, implementation, and impact of CTM Phase 4. **Detailed Description:** Choose to Move (CTM) a 3-month, choice-based health-promoting program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. To date (Phases 1-4), CTM participants have included mostly white older women living in large urban centres. In this project, the investigators aim to expand the reach of CTM to include even more older adults living in communities across BC. Within CTM (Phase 4), trained activity coaches support older adults in two ways. First, in a one-on-one consultation, activity coaches help participants to set goals and create action plans for physical activity tailored to each person's interests and abilities. Older adults can choose to participate in individual or group-based activities. Second, activity coaches facilitate 8 group meetings with small groups of participants either in person or online. In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations in large and small communities across BC to deliver CTM to more older adults. The investigators will then evaluate implementation of CTM programs, and the impact of the CTM program on older adults' physical and social health. Objectives: To assess whether CTM (Phase 4) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale across BC (Part I - Implementation Evaluation). To assess the impact (effectiveness) of CTM (Phase 4) on the physical activity, mobility, and social connectedness of older adult participants (Part II - Impact Evaluation). Study Design: The investigators use a hybrid type 2 effectiveness-implementation (Curran et al. 2012) pre-post study design to evaluate scale-up of CTM Phase 4. The investigators use mixed methods (quantitative and qualitative) and collect data at 0 (baseline) and 3 (post-intervention) months to assess implementation and impact of CTM. ### Conditions Module **Conditions:** - Aging - Physical Inactivity - Mobility Limitation - Loneliness - Social Isolation **Keywords:** - Older adults - Physical activity - Mobility - Social isolation - Loneliness - Social connectedness - Behavior change - Implementation - Scale-up - Health equity ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 5720 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** CTM (Phase 4) is a 3-month, flexible, choice-based health-promoting program for low active older adults. CTM includes: 1-on-1 Consultation: Participants meet 1-on-1 with their activity coach at the start of the program to set goals and develop a physical activity action plan tailored to their abilities, interests and resources. Older adults can choose to participate in individual or group-based activities. Group Meetings: Participants will attend eight, 1-hour group-based meetings (max of 15 participants) led by an activity coach. Meetings cover a health-related discussion topic and provide time for social connection among participants. Meetings can be held online or in-person. Community-based seniors' services organizations that deliver CTM may adapt the program (e.g., deliver in a different language, adapt for cultural or geographical factors) to fit the needs of the older adults they serve but the two components listed above will be retained. **Intervention Names:** - Behavioral: Choose to Move **Label:** Choose to Move **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Choose to Move **Description:** As described under study arm description **Name:** Choose to Move **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Number of organizations and older adults participating in adapted CTM programs will be obtained from program records. **Measure:** Reach-individual **Time Frame:** 3 months **Description:** The neighbourhood characteristics of the regions where CTM programs were delivered will be determined using the Canadian Social Environment Topology (CanSET) tool. **Measure:** Reach-regional **Time Frame:** 3 months **Description:** Number of activity coaches trained to deliver the CTM program will be obtained from program records. **Measure:** Adoption - CTM program **Time Frame:** 3 months **Description:** Number of group meetings (0-8) delivered by activity coaches will be assessed by survey (developed in house). **Measure:** Dose delivered - CTM program (survey) **Time Frame:** 3 months **Description:** Fidelity to planned delivery will be assessed via survey (designed in house) for activity coaches and older adult participants. Higher scores (1-5 Likert scale) indicate better adherence to planned delivery. **Measure:** Fidelity - CTM program (survey) **Time Frame:** 3 months **Description:** Program satisfaction will be assessed via participant (older adults) survey (designed in house). Higher scores (1-5 Likert scale) indicate higher participant satisfaction with the intervention. **Measure:** Participant Responsiveness - CTM program (survey) **Time Frame:** 3 months **Description:** Program delivery costs will be recorded using a cost capture template developed in house. **Measure:** Cost **Time Frame:** 0, 3 months **Description:** Adaptations or modifications to the Choose to Move program include any additions, deletions, substitutions, repetitions, etc will be assessed by survey (developed in house). **Measure:** Adaptation - CTM program (survey) **Time Frame:** 3 months #### Primary Outcomes **Description:** The single item physical activity questionnaire will be used to measure physical activity. Output variable is self-reported number of days/week ≥30 min physical activity in the past week (range 0-7). **Measure:** Change in physical activity **Time Frame:** 0, 3 months #### Secondary Outcomes **Description:** Two items will assess participants' ability to walk a quarter of a mile and up 10 steps. The output variable is self- reported presence of mobility-disability (no/any difficulty walking 400m or climbing one flight of stairs). **Measure:** Change in capacity for mobility **Time Frame:** 0, 3 months **Description:** The Physical Functioning Subscale of the SF-36 will be used to assess the physical function aspect of mobility. The measure asks participants to rate if their health limits them in performing 10 different activities. The output variable is an average score (range 0-100) of physical functioning, where a higher score indicates a more favourable health state. **Measure:** Change in physical functioning **Time Frame:** 0, 3 months **Description:** The three-item loneliness scale will be used to assess loneliness. Participants rate three aspects of loneliness. The output variable is loneliness score (range 3-9); lower scores indicate lower levels of loneliness. **Measure:** Change in loneliness **Time Frame:** 0, 3 months **Description:** A four-item questionnaire adapted from two questions on social contact frequency will be used to assess social isolation. The output variable is social isolation score (range 0-20); higher scores indicate lower levels of social isolation. **Measure:** Change in social isolation **Time Frame:** 0, 3 months **Description:** A six-item questionnaire will be used to assess social network. The output variable is an equally weighted sum (range 0-30) where higher scores indicate more social engagement. **Measure:** Change in social network **Time Frame:** 0, 3 months **Description:** A single item will be used to assess sense of belonging as an indicator of social connectedness. The output variable is sense of belonging score (range 1-4) where lower scores indicate a stronger sense of belonging. **Measure:** Change in social connectedness **Time Frame:** 0, 3 months **Description:** A single item will be used to assess frequency (days/week) of activities that increase bone and/or muscle strength. **Measure:** Change in bone/muscle-strengthening physical activity **Time Frame:** 0, 3 months **Description:** A single item will be used to assess frequency (days/week) of activities that improve balance. **Measure:** Change in balance-enhancing physical activity **Time Frame:** 0, 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Central support unit staff member * Activity coach hired by delivery partner organization (activity coaches must speak English to participate in the evaluation); * English-speaking older adults (aged \>=50 years) who participate in CTM (recruited by delivery partner organizations) will be invited to participate in the evaluation; * Non-English speaking older adults will also be invited to participate in the evaluation as long as an intermediary who has the necessary language skills to ensure effective communication/translation of the consent and surveys is present. Exclusion Criteria: * None **Healthy Volunteers:** True **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Vancouver **Country:** Canada **Facility:** Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia **State:** British Columbia **Zip:** V5Z 1M9 #### Overall Officials **Official 1:** **Affiliation:** University of British Columbia **Name:** Heather A McKay, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of British Columbia **Name:** Joanie Sims Gould, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. **PMID:** 22310560 **Citation:** Milton K, Bull FC, Bauman A. Reliability and validity testing of a single-item physical activity measure. Br J Sports Med. 2011 Mar;45(3):203-8. doi: 10.1136/bjsm.2009.068395. Epub 2010 May 19. **PMID:** 20484314 **Citation:** Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574. **PMID:** 18504506 **Citation:** Macdonald HM, Nettlefold L, Bauman A, Sims-Gould J, McKay HA. Pragmatic Evaluation of Older Adults' Physical Activity in Scale-Up Studies: Is the Single-Item Measure a Reasonable Option? J Aging Phys Act. 2022 Feb 1;30(1):25-32. doi: 10.1123/japa.2020-0412. Epub 2021 Aug 4. **PMID:** 34348228 **Citation:** Simonsick EM, Newman AB, Visser M, Goodpaster B, Kritchevsky SB, Rubin S, Nevitt MC, Harris TB; Health, Aging and Body Composition Study. Mobility limitation in self-described well-functioning older adults: importance of endurance walk testing. J Gerontol A Biol Sci Med Sci. 2008 Aug;63(8):841-7. doi: 10.1093/gerona/63.8.841. **PMID:** 18772472 **Citation:** Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200. **PMID:** 7267859 **Citation:** Bauer GR, Braimoh J, Scheim AI, Dharma C. Transgender-inclusive measures of sex/gender for population surveys: Mixed-methods evaluation and recommendations. PLoS One. 2017 May 25;12(5):e0178043. doi: 10.1371/journal.pone.0178043. eCollection 2017. **PMID:** 28542498 **Citation:** Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. **PMID:** 1593914 **Citation:** Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. **PMID:** 20957426 **Citation:** McKay H, Naylor PJ, Lau E, Gray SM, Wolfenden L, Milat A, Bauman A, Race D, Nettlefold L, Sims-Gould J. Implementation and scale-up of physical activity and behavioural nutrition interventions: an evaluation roadmap. Int J Behav Nutr Phys Act. 2019 Nov 7;16(1):102. doi: 10.1186/s12966-019-0868-4. **PMID:** 31699095 **Citation:** Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008 Jun;41(3-4):327-50. doi: 10.1007/s10464-008-9165-0. **PMID:** 18322790 **Citation:** Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022. Available at: https://www150.statcan.gc.ca/n1/pub/17-20-0002/172000022022002-eng.htm #### See Also Links **Label:** Choose to Move website **URL:** http://choosetomove.ca **Label:** Active Aging Research Team website **URL:** http://activeagingrt.ca ## 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: M26689 - Name: Mobility Limitation - Relevance: HIGH - As Found: Mobility Limitation ### Condition Browse Module - Meshes - ID: D000051346 - Term: Mobility Limitation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434285 **Acronym:** 4PiQ **Brief Title:** A 4Pi Questionnaire for Service User and Carer Involvement Experience **Official Title:** Development of a 4Pi Framework-based Questionnaire to Evaluate Service User and Carer Involvement Experience in SLaM #### Organization Study ID Info **ID:** 321452 #### Organization **Class:** OTHER **Full Name:** King's College London ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** South London and Maudsley NHS Foundation Trust #### Lead Sponsor **Class:** OTHER **Name:** King's College London #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Service user (SU) and carer involvement in planning healthcare services and improving their quality is crucial and required by the NHS. Research has shown that SUs and carers can greatly benefit healthcare; however, effective involvement can be challenging due to barriers such as language, lack of training or support, and undervaluing the input of patients and the public compared to that of professionals. The 4Pi framework sets out standards for good involvement practices by focusing on principles such as respect and inclusivity, shared purposes, diversity, accurate planning, and ensuring involvement leads to improvements in people's lives. This study, funded by King's Health Partners, aims to take the 4Pi framework a step further by developing a questionnaire to evaluate how well patients and carers are involved in improving mental health services. The researchers will work closely with SUs and carers to create this questionnaire, with the ultimate goal to ensure that involvement in healthcare leads to real, positive changes for everyone involved. The research questions for the study is: to what extent, from SUs and carers' perspectives, is the questionnaire understandable and successful in capturing the meaning of 4Pi domains? To be eligible for the study, participants need to be at least 18 years old and have experience of involvement activities/projects in SLaM. Researchers, SUs, and carers will define the questionnaire to ensure it is understandable, comprehensive, and feasible; this will be done via virtual (or in person at Denmark Hill/King's College London campus depending on participants' preferences) group interviews. The questionnaire will then be piloted on a small sample of individuals, and the final questionnaire refined based on any potential additional feedback from them. This study is part of the King's Improvement Science programme's research portfolio that is funded by King's Health Partners. ### Conditions Module **Conditions:** - Mental Health ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 8 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Cognitive interviewing group will be run to inform questionnaire development. **Name:** Questionnaire development **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Questionnaire **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. be at least 18 years old; 2. have experience of being involved in service involvement activities in SLaM NHS Foundation Trust. Exclusion Criteria: a) No experience of being involved in service improvement activities. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Service users and carers with experience in service involvement activities. ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434272 **Acronym:** BEAN **Brief Title:** Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture **Official Title:** The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically #### Organization Study ID Info **ID:** BEAN (1-10-72-192-23) #### Organization **Class:** OTHER **Full Name:** University of Aarhus ### Status Module #### Completion Date **Date:** 2026-01-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Aarhus University Hospital **Class:** OTHER **Name:** Gødstrup Hospital **Class:** UNKNOWN **Name:** Regional Hospital Horsens **Class:** OTHER **Name:** Aalborg University Hospital #### Lead Sponsor **Class:** OTHER **Name:** University of Aarhus #### 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 gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are: Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for initiating BFRE: In the early treatment stage or at the later stage after hospital treatment? Participants will receive an intervention comprising 12 weeks of BFRE as an adjunct to usual care. * Either in the initial 1-12 weeks after Achilles tendon rupture, or * In the following 13-24 weeks after Achilles tendon rupture Researchers will compare the two groups at 13 weeks to compare BFRE to usual care, and at 25 weeks to compare the two time points for initiating BFRE (early vs. late). **Detailed Description:** This is an assessor-blinded, randomized, controlled multicenter trial with patients allocated 1:1 to one of two parallel groups, with follow-up times at weeks 13 and 25 after allocation. Patients with an acute Achilles tendon rupture treated non-surgically are eligible for inclusion. All patients will receive a 12-week BFRE program, either in weeks 1-12 or 13-24 post allocation, as an add-on to usual care. The BFRE program is performed three times weekly on the injured leg at 80% of the limb occlusion pressure required to restrict the arterial blood flow fully. Outcome measures are assessed at baseline, week 13, and week 25 after allocation. The primary outcome at the week 13 follow-up is the Single-Leg Heel-Raise test which assesses the patient's ability to raise the heel of the injured leg a minimum of 2 cm. The primary outcome at the week 25 follow-up is the Achilles Total Tendon Rupture Score which assesses the patient's self-reported symptoms and physical activity. During most of the initial trial phase (weeks 1-12), patients are treated at local hospitals, where recruitment, assessment, and randomization occur. Usual care at the hospitals consists of ankle immobilization with a gradual return to weight-bearing in the following weeks. In the latter half of the trial phase (weeks 13-24), patients have transitioned to municipal care, where usual care includes diverse exercises performed at home or training facilities. ### Conditions Module **Conditions:** - Achilles Tendon Rupture ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 218 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Receives an intervention in adjunct to usual care in weeks 1-12, and continues with usual care in weeks 13-24. **Intervention Names:** - Other: Exercise with partial Blood Flow Restriction **Label:** Early initiated Blood Flow Restriction Exercise **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Receives usual care in weeks 1-12, and receives an intervention in weeks 13-24. **Intervention Names:** - Other: Exercise with partial Blood Flow Restriction **Label:** Late initiated Blood Flow Restriction Exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Early initiated Blood Flow Restriction Exercise - Late initiated Blood Flow Restriction Exercise **Description:** The intervention comprises of 12 weeks of Blood Flow Restriction Exercise (BFRE). Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks. Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is epmployed in both interventions arms (Early BFRE and Late BFRE) The Early BFRE intervention comprises two exercises: Seated leg extension and seated heel-rise, performed at home. The Late BFRE intervention comprises three exercises: Leg press in machine, heel-rise in machine, knee flexion in machine, performed at training facilities. Each exercise, regardless of study arm, is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible. Pause in between sets is 30 seconds. Pause in between exercises are 120 seconds. **Name:** Exercise with partial Blood Flow Restriction **Other Names:** - BFR - BFRE - Blood Flow Restriction Exercise - BFR-T - Blood Floow Restriciton Training - LL-BFR - Low Load Blood Flow Restriction **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** ultrasound using the Copenhagen Achilles length measure (CALM) will be used in a subset of the study population to validate the tendon length results. **Measure:** Copenhagen Achilles Length Measure (CALM) **Time Frame:** CALM is measured at 13 week test and 25 week test. **Description:** The Achilles tendon cross-sectional area is measured using ultrasound \[28\] in a subset of the study population. **Measure:** Tendon cross-sectional area. **Time Frame:** Tendon cross-sectional area is measured at 13 week test and 25 week test. #### Primary Outcomes **Description:** Patient's ability to perform a Single-Leg Heel-rise, defined as the ability to raise the heel of the injured leg at least 2 cm while keeping the knee straight. The test is performed with patients standing on a flat surface with the ankle in a neutral position. Patients will be allowed to keep their balance by lightly touching a wall. **Measure:** Single-leg heel-rise test **Time Frame:** 13 week test **Description:** The ATRS is a validated patient-reported, injury-specific questionnaire regarding physical activity and symptoms. The ATRS consists of 10 items scored from 0 (major limitations) to 10 (no limitations), resulting in a score between 0 (worst) to 100 (best). **Measure:** Achilles tendon Total Rupture Score (ATRS) **Time Frame:** 25 week test #### Secondary Outcomes **Description:** The unilateral 30 second Sit to Stand test (unilateral 30STS) is a clinical test of lower extremity function. The unilateral 30STS tests how many correct repetitions of a sit to stand from a chair, a patient can complete in 30 seconds **Measure:** 30 seconds unilateral Sit to Stand test **Time Frame:** The test will be performed on both legs at 13 week test and 25 test. **Description:** The calf circumference is measured on both legs using a tape measure 15 cm below the medial pal-pable joint line of the knee. Repeated measurements will be made until a consistent measurement is found. **Measure:** Calf circumference **Time Frame:** The measurement will be performed on both legs at baseline, 13 week test, and 25 test. **Description:** Thigh circumference is measured on both legs using a tape measure 10 cm proximal to the apex pa-tella. During measurement patients lay supine on an examination table with knees bent in a 90-degree angle. **Measure:** Thigh circumference **Time Frame:** The measurement will be performed on both legs at baseline, 13 week test, and 25 test. **Description:** The Achilles tendon length is indirectly measured by the Achilles tendon resting angle (ATRA), measuring the difference in passive dorsiflexion when lying prone with knees in a 90-degree angle. **Measure:** Achilles tendon elongation (ATRA) **Time Frame:** The test will be performed on both legs at 13 week test and 25 test. **Description:** The TSK-13 is a 13-item self-reported measure for fear of movement or reinjury \[29\]. It was origi-nally validated for patients with backpain but has previously been used in patients with Achilles tendon rupture. **Measure:** Tampa Scale of Kinesiophobia 13-items (TSK-13) **Time Frame:** TSK-13 is measured at baseline, 13 week test, and 25 test. **Description:** The EQ-5D-5L is a generic self-reported measure for health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five severity levels each. **Measure:** EQ-5D-5L **Time Frame:** EQ-5D-5L is measured at baseline, 13 week test, and 25 week test. **Description:** The IPAQ-SF consists of 7 items on physical activity as time spent performing vigorous and moder-ate activities, the time spent walking, and time spent sitting during the past week. The IPAQ pro-vides an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting. **Measure:** International Physical Activity Questionnaire-short form (IPAQ-SF) **Time Frame:** IPAQ-SF is measured at baseline (re-call prior to rupture), 13 week test, and 25 week test. **Description:** Patients' adherence with the exercise sessions (completed sessions) and progression during the inter-vention period will be recorded in self-reported exercise diaries by the patients. . Exercise diaries will also be provided to patients in the control group, to monitor usual care exercise. **Measure:** Exercise adherence and progression **Time Frame:** Measured continously, and evaluated at 13 week test and 25 week test. **Description:** The number of adverse events and serious adverse events will be recorded and reported to a Data Safety Monitoring Board. Adverse events are defined as unexpected medical events related to the initial treatment. Serious adverse event are complications requiring further inpatient care, such as re-rupture of the Achilles tendon, non-union of the Achilles tendon, or deep venous thromboembolism and pulmonary embolism. Muscle soreness or mild pain following exercise is expected and not con-sidered an adverse event. **Measure:** Adverse events **Time Frame:** Measured continously, and evaluated at 13 week test and 25 week test. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * aged 18 years or older * have started initial treatment within 72 hours of Achilles tendon rupture * understand written and spoken Danish Exclusion Criteria: * bilateral Achilles tendon rupture * previous Achilles tendon rupture in either leg * decreased lower extremity function, caused by conditions other than Achilles tendon rupture * treated with fluoroquinolones or corticosteroids within the last six months * diabetes * previous diagnosed thrombosis * no identifiable pulse in the injured leg * other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** andreas.bentzen@clin.au.dk **Name:** Andreas Bentzen, MHSc **Phone:** (+45) 5310 9112 **Role:** CONTACT **Contact 2:** **Email:** inger.mechlenburg@clin.au.dk **Name:** Inger Mechlenburg, DMSc **Phone:** (+45) 2167 9062 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Aarhus **Name:** Andreas Bentzen, MHSc **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Aarhus **Name:** Inger Mechlenburg, DMSc **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Aarhus University Hospital **Name:** Per H. Gundtoft, MD, PhD **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Regional Hospital Horsens **Name:** Stian L. Jørgensen, PT, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement. **Description:** Anonymised patient-level data will be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Data will be available after publication of the trial. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15241 - Name: Rupture - Relevance: HIGH - As Found: Rupture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012421 - Term: Rupture ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434259 **Brief Title:** Evaluation of Long-term Digital Childhood Obesity Treatment **Official Title:** Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial #### Organization Study ID Info **ID:** Evira100 #### Organization **Class:** OTHER **Full Name:** Karolinska Institutet ### Status Module #### Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-09-30 **Type:** ACTUAL #### Start Date **Date:** 2018-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karolinska Institutet #### Responsible Party **Investigator Affiliation:** Karolinska Institutet **Investigator Full Name:** Pernilla Danielsson **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits. **Detailed Description:** Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment. In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app. The present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period. The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS. ### Conditions Module **Conditions:** - Childhood Obesity - Treatment Adherence **Keywords:** - Mobile Health - Support System - Behavioral Treatment - Self-Monitoring ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 428 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Usual care (behavioral treatment) plus the support system for self- monitoring of weight and communication with the clinic during three years of treatment. **Intervention Names:** - Device: Digi-physical support system **Label:** Digi-physical treatment group #### Arm Group 2 **Description:** Children treated with usual care according to regular treatment routines registered in the Swedish childhood obesity treatment register, BORIS **Label:** Control group ### Interventions #### Intervention 1 **Arm Group Labels:** - Digi-physical treatment group **Description:** A support system named Evira will be used to provide behavioral treatment. **Name:** Digi-physical support system **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Measured by BMI standard deviation score. Digi-physical group vs. control group **Measure:** Change in degree of obesity **Time Frame:** From start of treatment to three years follow-up #### Secondary Outcomes **Description:** Number of weighings/week **Measure:** The use of the support system - weighings **Time Frame:** From start of treatment to three years follow-up **Description:** Number text messages/week **Measure:** The use of the support system - text messages **Time Frame:** From start of treatment to three years follow-up **Description:** Visits to the clinic. Digi-physical group vs. control group **Measure:** Number of physical visits **Time Frame:** From start of treatment to three years follow-up **Description:** Visits to the clinic. Digi-physical group vs. control group **Measure:** Number of cancelation of physical visits **Time Frame:** From start of treatment to three years follow-up **Description:** Visits to the clinic. Digi-physical group vs. control group **Measure:** Number of patients not showing up to physical visit **Time Frame:** From start of treatment to three years follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Obesity according to International Obesity Task Force (IOTF) Exclusion Criteria: * None **Maximum Age:** 18 Years **Minimum Age:** 4 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. 107 children in the digit-physical group and 321 children in the control group, aged 4-17.9 years, will be included. ### Contacts Locations Module #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Childrens Hospital Martina **Zip:** 114 28 #### Overall Officials **Official 1:** **Affiliation:** Karolinska Institutet, CLINTEC, Division of pediatrics **Name:** Pernilla Danielsson Liljeqvist, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31. **PMID:** 35641569 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M30155 - Name: Pediatric Obesity - Relevance: HIGH - As Found: Childhood Obesity - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity - ID: D000063766 - Term: Pediatric Obesity ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434246 **Brief Title:** Effect of Pully System on Hemiplegic Children **Official Title:** Effect of Pully System Exercise on Upper Limb Function in Hemiplegic Cerebral Palsy Children: A Randomized Clinical Trials #### Organization Study ID Info **ID:** KFSIRB200-193 #### Organization **Class:** OTHER **Full Name:** Kafrelsheikh University ### Status Module #### Completion Date **Date:** 2025-11-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kafrelsheikh University #### Responsible Party **Investigator Affiliation:** Kafrelsheikh University **Investigator Full Name:** Ahmed Ali Mohammed Torad **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:** Introduction Cerebral palsy (CP) is a group of sensory, motor, and postural disorders caused by non-progressive brain injury in early development. It can manifest in various forms, including hemiplegia, which affects about 21% to 40% of CP cases. Upper extremity (UE) impairments in CP individuals are significant, impacting daily activities and quality of life. Objective This study aims to investigate the effects of pulley system exercises on improving upper limb function in children with hemiplegic CP. Methods Design: Randomized controlled double-blinded trial. Participants: 32 children aged 3-7 years with hemiplegic CP, divided into intervention and control groups. Intervention: The intervention group receives pulley system exercises plus standard care, while the control group receives standard physical therapy. Duration: Conducted between June 2024 and August 2024. Inclusion Criteria: Diagnosed with hemiplegic CP, aged 3-7 years, able to follow instructions, and with upper limb motor deficits. Exclusion Criteria: Additional neurological disorders, recent upper limb surgery, previous rehabilitation programs, severe medical conditions, or contraindications to physical activity. Assessment Tools: Assisting Hand Assessment (AHA), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Quality Upper Extremity Skills Test (QUEST), and Lafayette Manual Muscle Tester. Timing: Baseline and after 3 months of intervention. Treatment Intervention Group: 45-60 minute sessions, three times a week, involving warm-up, pulley system exercises, and cool-down. Control Group: Standard care physical therapy, twice a week, 45-60 minute sessions. Statistical Analysis Methods: Descriptive statistics and Analysis of Covariance (ANCOVA) to analyze improvements in upper limb function. Significance Level: p \< 0.05. Analysis: Intention-to-treat to handle missing data. This study aims to provide evidence on the effectiveness of pulley system exercises in enhancing upper limb function in children with hemiplegic CP, potentially improving their independence and quality of life. **Detailed Description:** Cerebral palsy (CP) is a collection of sensory and motor disorders, as well as postural disorders, caused by non-progressive injury to the immature brain1,2. It can be classified according to the topographical presentation as monoplegia, hemiplegia, diplegia, and quadriplegia2 . These obvious motor difficulties are frequently accompanied by cognitive disturbances and other neurologic difficulties3 . CP is considered the most prevalent mobility disorder in children, with an average frequency of 3 per 1,000 live births worldwide and a high prevalence of 60 to 150 per 1,000 among preterm infants who are born weighing less than 1,500 g 4 . Hemiplegic CP accounts for 21% to 40% of all cases of CP5,6. Impairments in the upper extremity (UE) are a major factor for activity limitation and participation restriction in individuals with CP and may affect up to 50% of CP subjects \[7\]. UE limitations are mostly due to a lack of trunk control, decrease in shoulder girdle motor control and imbalance between spastic and paretic muscles \[8\]. That makes it difficult for people with CP to perform UE-specific tasks, such as reaching, grasping and manipulation, and it leads to the significant involvement of the positioning and functioning of the elbows, wrists and hands . Moreover, a lack of autonomy and dependence on other people may affect the individuals' quality of life \[9\]. Pulley therapy is a part of universal exercise unit which formed of spider cage and a system of pulley, straps and weights for resistance. It is a new method used for strengthening of weak muscles by isolating the target specific muscle for training \[10\] . There are several benefits of pulley therapy as: improving passive/active ROM, flexibility of muscle, enhancing strength and endurance of muscle without any associated movement and improving functional skills and dynamic movement \[11\] . So, this study was conducted to investigate the effect of pully system exercise in improvement of upper limb function in hemiplegic cerebral palsy children Subjects materials and methods: Randomized controlled double blinded study design was used. The study will be conducted at El salam university out- patient clinic between June 2024 and August 2024 Subjects G power v2.1.9.7 was used to calculate proper sample size based on pilot testing that revealed effect size of 1.05. the proposed sample size is 32 when using alpha of 0.05 and power of 80%. The sample size will equal 32 (randomly divided into two group) study group will receive poly system exercise on upper limb, Control group will receive designed physical therapy programme. Once participants meet the inclusion criteria and consent to participate, they are randomly assigned to either the intervention group (receiving pulley system exercises in addition to standard care) or the control group (receiving standard care). Use a computer-generated random number table or software to assign participants. The therapists or researchers who conduct the evaluations (e.g., AHA, BOT-2, QUEST) will not be informed of the participant's group assignment. This can be achieved by using different individuals to provide the intervention and assess the outcomes, or by ensuring that assessment data are coded in such a way that the assessor does not know the group codes. Participants will be randomly assigned to one of two groups: Group (A): Intervention Group: 16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP. Group (B): Control Group: Children will receive designed physical therapy program for CP only. ### Conditions Module **Conditions:** - Cerebral Palsy, Spastic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP. **Intervention Names:** - Behavioral: pulley system exercise regimen - Biological: physical therapy program for CP **Label:** Intervention Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Children will receive designed physical therapy program for CP only **Intervention Names:** - Biological: physical therapy program for CP **Label:** Control Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Group **Description:** The warm-up consists of gentle stretching and basic mobility exercises to prepare the muscles and joints for the activity. Following this, the main segment of the session involves specific exercises using the pulley system, designed to target and improve motor function, strength, and coordination of the upper limbs. The therapist will adjust the exercises according to each child's individual abilities and progression over time. The session concludes with a cool-down period involving light activities and relaxation techniques to ensure a gradual return to baseline physiological states. **Name:** pulley system exercise regimen **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control Group - Intervention Group **Description:** Participants in the control group will attend physical therapy sessions twice per week. These sessions aim to maintain or improve physical functioning and manage the symptoms of cerebral palsy. Each session lasts approximately 45 to 60 minutes, These sessions include a variety of therapeutic exercises tailored to each child's needs but do not include the use of the pulley system. Typical activities might involve stretching, strengthening exercises, and manual therapy techniques to enhance joint mobility and muscle function. **Name:** physical therapy program for CP **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** will be used to evaluate how effectively children with upper limb impairments can use their affected hand together with their well-functioning hand to perform bimanual tasks. This assessment involves observing the child while they engage in play activities that require bimanual coordination. The performance is video-recorded and scored based on specific criteria that assess the spontaneous use of the involved hand. The scoring system provides a measure of the child's ability to effectively use their affected hand in bimanual tasks, with higher scores indicating better function. **Measure:** Assisting Hand Assessment (AHA) **Time Frame:** 3 months **Description:** will be conducted to measures fine and gross motor skills, including hand function. Specific subtests related to hand function are administered, such as fine motor precision, fine motor integration, and manual dexterity tasks. Performance on these tasks is quantitatively scored, allowing for the assessment of motor proficiency and hand function improvements **Measure:** The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) for Hand Function **Time Frame:** 3 months **Description:** will be used to assess movement patterns and hand function in children with cerebral palsy. It evaluates dissociated movements, grasp patterns, protective extension, and weight bearing under four domains: dissociated movements, grasp, weight bearing, and protective extension. Each item is scored based on the child's ability to perform the task, with scores reflecting the quality of upper extremity skills. **Measure:** Quality Upper Extremity Skills Test (QUEST) **Time Frame:** 3 months **Description:** will be used to objectively measure the strength of specific muscles and muscle groups. The muscle tester is applied to the muscle group being evaluated while the child performs a muscle contraction. The device provides a digital readout of the force exerted, which can be measured in pounds or kilograms. In this study, the tester will be used to evaluate the strength of upper limb muscles before and after the intervention to assess any changes due to the pulley system exercises **Measure:** Lafayette Manual Muscle Tester **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Children aged between 3 and 7 years. * Diagnosed with hemiplegic cerebral palsy, confirmed by a pediatric neurologist. * Ability to follow simple instructions and participate in exercise sessions. * Presence of upper limb motor function deficits attributable to hemiplegic cerebral palsy. Exclusion Criteria 1. Children with additional neurological disorders or severe cognitive impairments that might interfere with the ability to participate in exercise regimens. 2. Recent surgery (within the last 6 months) on the upper limbs. 3. Children who have been involved in similar rehabilitation programs in the past 3 months. 4. Severe uncontrolled medical conditions such as cardiac or respiratory diseases. Presence of any contraindication to physical activity as advised by a medical professional. **Maximum Age:** 7 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ahmed.ali.torad@gmail.com **Name:** Ahmed Ali M Torad, PHD **Phone:** 01008889975 **Role:** CONTACT **Contact 2:** **Email:** Drsaraelsabahy@gmail.com **Name:** Sara Elsebahy, PHD **Phone:** 01094998882 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of physical therapy, Kafrelsheik university #### Overall Officials **Official 1:** **Affiliation:** Department of pediatric physical therapy and its surgery, Elsalam University **Name:** Ahmed salim, PHD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Paediatric physical therapy department, Kafrelsheik University **Name:** Sara Elsebahy, PHD **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Basic science department, kafrelsheik university **Name:** Ahmed Ali M Torad, PHD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers who wish to access the data must submit a formal request to the principal investigator. The request should include a research proposal outlining the purpose of the data use, the intended analysis, and the potential benefits of the research. Requests will be reviewed based on scientific merit and ethical considerations. **Description:** Data to be Shared: The de-identified individual participant data that will be shared includes baseline demographic information, outcome measures from the Assisting Hand Assessment (AHA), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Quality Upper Extremity Skills Test (QUEST), and muscle strength data from the Lafayette Manual Muscle Tester. This also includes data on the intervention details such as session frequency, duration, and adherence. Time Frame: Data will be available for sharing beginning 6 months after the publication of the study results. The data will be accessible for a period of 5 years. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Data will be available for sharing beginning 6 months after the publication of the study results. The data will be accessible for a period of 5 years. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M12085 - Name: Muscle Spasticity - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - 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: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### 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:** NCT06434233 **Brief Title:** Opioid Use After Laparoscopic Salpingectomy **Official Title:** A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy #### Organization Study ID Info **ID:** IRB00308549 #### Organization **Class:** OTHER **Full Name:** Johns Hopkins University ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Johns Hopkins 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 purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids. The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy. ### Conditions Module **Conditions:** - Opioid Use - Post-operative Pain - Sterility, Female ### 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:** Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge. These medications include: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter **Intervention Names:** - Drug: Acetaminophen - Drug: Ibuprofen - Drug: Oxycodone **Label:** Arm 1 - Opioid Post-Op Pain Regimen **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter. Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1. **Intervention Names:** - Drug: Acetaminophen - Drug: Ibuprofen **Label:** Arm 2 - Non-Opioid Post-Op Pain Regimen **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 - Opioid Post-Op Pain Regimen - Arm 2 - Non-Opioid Post-Op Pain Regimen **Description:** All patients will receive Acetaminophen 500 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Acetaminophen around the clock for the first 72 hours and as needed thereafter. **Name:** Acetaminophen **Other Names:** - Tylenol **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm 1 - Opioid Post-Op Pain Regimen - Arm 2 - Non-Opioid Post-Op Pain Regimen **Description:** All patients will receive Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Ibuprofen around the clock for the first 72 hours and as needed thereafter. **Name:** Ibuprofen **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Arm 1 - Opioid Post-Op Pain Regimen **Description:** Patients randomized to Arm 1 will receive Oxycodone 5 mg orally every 4 hours as needed x 12 tablets at post-operative discharge Patients randomized to Arm 2 will not receive an Oxycodone prescription at post-operative discharge. However, participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of Oxycodone as in arm 1 **Name:** Oxycodone **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Patient reported pain on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" using the Likert pain scale from 0 to 10, where 0 is no pain and 10 is severe pain. A higher score indicates a worse outcome. **Measure:** Numeric post-operative pain score **Time Frame:** post-operative day 1 and post-operative day 7 #### Secondary Outcomes **Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome. **Measure:** Satisfaction with post-operative pain relief **Time Frame:** post-operative day 1 and post-operative day 7 **Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome. **Measure:** Satisfaction with post-operative mobility **Time Frame:** post-operative day 1 and post-operative day 7 **Description:** Number of Oxycodone pills used by each patient by the end of post-operative day 7 **Measure:** Total narcotic consumption at one week post-operative **Time Frame:** post-operative day 7 **Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "No" indicates a favorable outcome and "yes" indicates a worse outcome. **Measure:** Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness) **Time Frame:** post-operative day 1 and post-operative day 7 **Description:** Number of patients who request additional pain medications at the time of post-operative surveys, call provider phone line for additional pain medications, or return to an Emergency Department, clinic/office, etc due to a pain related issue. **Measure:** Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern **Time Frame:** Within 30 days of surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals with a fallopian tube (unilateral and/or bilateral) * Age 18 years old and above * Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure * Benign indications for salpingectomy/tubal sterilization * Agreeing to participate Exclusion Criteria: * Chronic pain syndromes patients including fibromyalgia * Patients currently on long-term (i.e. for more than three months) opioid use * Conversion to laparotomy * Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone * Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc) * Salpingectomy performed for treatment of ectopic pregnancy * Patients with a history of gastritis and/or GI bleeding **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mboraha1@jhmi.edu **Name:** Mostafa Borahay, MD **Phone:** 4439970400 **Role:** CONTACT **Contact 2:** **Email:** sosbor13@jh.edu **Name:** Shannon Osborne, MD **Phone:** 4105502786 **Role:** CONTACT #### Locations **Location 1:** **City:** Baltimore **Contacts:** ***Contact 1:*** - **Email:** mboraha1@jhmi.edu - **Name:** Mostafa Borahay, MD - **Phone:** 443-997-0400 - **Role:** CONTACT **Country:** United States **Facility:** Johns Hopkins Bayview Medical Center **State:** Maryland **Status:** RECRUITING **Zip:** 21224 #### Overall Officials **Official 1:** **Affiliation:** Johns Hopkins University **Name:** Mostafa Borahay, MD **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 - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications ### 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: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Sterility - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M10291 - Name: Infertility, Female - Relevance: HIGH - As Found: Sterility, Female - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - 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: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility - ID: D000007247 - Term: Infertility, Female - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - 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: D000058633 - Term: Antipyretics - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000701 - Term: Analgesics, Opioid - ID: D000009294 - Term: Narcotics - ID: D000002492 - Term: Central Nervous System Depressants ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Antipy - Name: Antipyretics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M13020 - Name: Oxycodone - Relevance: HIGH - As Found: Valve - ID: M2340 - Name: Acetaminophen - Relevance: HIGH - As Found: Compared - ID: M10102 - Name: Ibuprofen - Relevance: HIGH - As Found: Wound - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - 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 - 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: M20604 - Name: Antirheumatic Agents - 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: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000082 - Term: Acetaminophen - ID: D000007052 - Term: Ibuprofen - ID: D000010098 - Term: Oxycodone ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434220 **Brief Title:** Effect of Predictive Model on ED Physician Assessments of Patient Disposition **Official Title:** Effect of Predictive Model on ED Physician Assessments of Patient Disposition #### Organization Study ID Info **ID:** IRB-P00048537 #### Organization **Class:** OTHER **Full Name:** Boston Children's Hospital ### Status Module #### Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2026-05-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Boston Children's Hospital #### Responsible Party **Investigator Affiliation:** Boston Children's Hospital **Investigator Full Name:** William La Cava **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to measure the impact of fairness-aware algorithms on physician predictions of ED patient admission. Using an experimentally validated machine learning model tuned for equitable outcomes, the investigators quantify the impact of model recommendations on ED physician assessments of admission risk in a silent, prospective study. The investigators survey ED physicians who are not currently caring for patients using live site data. To quantify the impact of the model on ED physician assessments of admission risk, the investigators collect physician assessments before and after consulting the (original or updated) model prediction. The investigators measure ED physician adherence to model suggestions, along with the predictive accuracy and equity of downstream patient outcomes. The outcome of this study is an empirical measure of the extent to which fair ML models may influence admission decisions to mitigate health care disparities. **Detailed Description:** Specific Aims/Objectives: 1. Measure the effect of the sharing of a model prediction of admission on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital. 2. Measure the effect of the sharing of a model prediction from a model tuned for equal subgroup performance on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital. Background and Significance: Machine learning (ML) models increasingly provide clinical decision support (CDS) to care teams to help prioritize individuals for specific care based on their predicted health needs and outcomes. AI/ML methods can have a particularly high impact on resource allocation in emergency departments (EDs) across the U.S., which have been described by the Institute for Medicine as "nearing the breaking point" of over-capacity. Unfortunately, models often perform poorly on disinvested subpopulations relative to the population as a whole. As a result, ML models may exacerbate downstream health disparities by under-performing on marginalized patient subpopulations, especially when models are expanded to multiple care centers and or used without subgroup monitoring for long periods of time. Many prediction models have been developed in recent years to predict patient disposition from the ED, including a prediction tool developed by our group and currently in piloting stages at Boston Children's Hospital, South Shore Hospital, and Children's Hospital of Los-Angeles. Our prediction tool, the Predictor of Patient Placement (POPP) provides an accurate, real-time likelihood of admission based on data available in the electronic health record at the time of the visit. Advance notice of likely admissions can have an important impact on ED waiting and boarding times with the potential to improve flow and patient satisfaction. To this end, the investigation team has submitted a grant proposal to the National Library of Medicine (NLM) \[1R01LM014300 - 01A1\] that researches the development and validation of fairness-aware prediction models of patient admission. Aim 2 of this grant studies the effect of these models on ED physician assessments of patient disposition, and corresponds to this protocol. The NLM has indicated its intention to fund this proposal and the investigators are in the process of submitting documents to finalize the award. This component of the study is slated for year 3 of the study. Preliminary Studies The investigators conducted a series of initial retrospective studies that established that patient admission could be predicted with machine learning models ahead of time in the BCH ED, progressively during the visit, as well as across other medical centers with good accuracy (AUROC 0.9-0.93). Next, the investigators found that the accuracy of POPP in predicting admission likelihood added value to the gestalt assessments of ED attending physicians. The positive predictive value for the prediction of admission was 66% for the clinicians, 73% for POPP, and 86% for a hybrid model combining the two. Finally, the investigators developed methods for post-processing the ED prediction models to make them well-calibrated across patient demographic groups defined by race, sex, and insurance product. The model predictions are currently used to help with bed coordination, but given their high value, may also improve decision making at the bed-side. With this study, our goal is to now test, in a simulated, safe, and realistic setting, how model recommendations affect the assessments of admission likelihood by ED attending physicians. ### Conditions Module **Conditions:** - Patient Outcome Assessment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** TRIPLE **Masking Description:** We conduct a randomized, double-blind, controlled before-after (CBA) study of board-certified ED attending physicians not currently caring for patients in the BCH ED over a period of six to twelve weeks. In this experiment, the "treatment" consists of an ML recommendation provided to the ED physicians, who predict admission decisions for individual patients before and after receiving it. The "control" surveys receive the original POPP model recommendation, and "treatment" surveys receive a "fairness-aware" model, determined in prior work to mitigate biases in performance with respect to patient demographics **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** No intervention. Physician is surveyed to provide their assessment of patient disposition. **Label:** Physician assessment before intervention **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Physician is shown a baseline model recommendation for patient disposition including description of factors driving the model prediction. **Intervention Names:** - Diagnostic Test: Baseline model **Label:** Physician assessment after baseline model intervention **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Physician is shown a model recommendation form a model tuned for subgroup performance for patient disposition including description of factors driving the model prediction. **Intervention Names:** - Diagnostic Test: Fairness-aware model **Label:** Physician assessment after fairness-aware model intervention **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Physician assessment after baseline model intervention **Description:** Model prediction of patient disposition including feature importance scores driving prediction. **Name:** Baseline model **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Physician assessment after fairness-aware model intervention **Description:** Model prediction of patient disposition including feature importance scores driving prediction. This model has been tuned to minimize subgroup calibration errors. **Name:** Fairness-aware model **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is physician-assessed ED disposition (categorized as admission or discharge), before and after viewing a model prediction, compared to final disposition of patient **Measure:** Physician-assessed ED disposition (likelihood of admission) **Time Frame:** Within 24 hours of survey **Description:** The final disposition of the patient, whether admitted to an inpatient service or discharged **Measure:** Patient final disposition (admitted/discharged) **Time Frame:** Within 24 hours of survey #### Secondary Outcomes **Description:** The model prediction's assessment of ED disposition compared to final disposition of patient **Measure:** Model-assessed ED disposition **Time Frame:** Within 24 hours of survey ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Board certified emergency department attending physicians currently employed by Boston Children's Hospital Exclusion Criteria: * Physicians are excluded from completely surveys for patients who they are currently caring for **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:** william.lacava@childrens.harvard.edu **Name:** William La Cava, PhD **Phone:** 4133200544 **Role:** CONTACT **Contact 2:** **Email:** andrew.fine@childrens.harvard.edu **Name:** Andrew Fine, MD **Phone:** 617-355-9696 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Barak-Corren Y, Israelit SH, Reis BY. Progressive prediction of hospitalisation in the emergency department: uncovering hidden patterns to improve patient flow. Emerg Med J. 2017 May;34(5):308-314. doi: 10.1136/emermed-2014-203819. Epub 2017 Feb 10. **PMID:** 28188202 **Citation:** Barak-Corren Y, Agarwal I, Michelson KA, Lyons TW, Neuman MI, Lipsett SC, Kimia AA, Eisenberg MA, Capraro AJ, Levy JA, Hudgins JD, Reis BY, Fine AM. Prediction of patient disposition: comparison of computer and human approaches and a proposed synthesis. J Am Med Inform Assoc. 2021 Jul 30;28(8):1736-1745. doi: 10.1093/jamia/ocab076. **PMID:** 34010406 **Citation:** Barak-Corren Y, Chaudhari P, Perniciaro J, Waltzman M, Fine AM, Reis BY. Prediction across healthcare settings: a case study in predicting emergency department disposition. NPJ Digit Med. 2021 Dec 15;4(1):169. doi: 10.1038/s41746-021-00537-x. **PMID:** 34912043 **Citation:** Barak-Corren Y, Fine AM, Reis BY. Early Prediction Model of Patient Hospitalization From the Pediatric Emergency Department. Pediatrics. 2017 May;139(5):e20162785. doi: 10.1542/peds.2016-2785. **PMID:** 28557729 **Citation:** La Cava WG, Lett E, Wan G. Fair admission risk prediction with proportional multicalibration. Proc Mach Learn Res. 2023;209:350-378. **PMID:** 37576024 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434207 **Acronym:** EVmiRNA **Brief Title:** Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis **Official Title:** Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis #### Organization Study ID Info **ID:** IRB-P00048093 #### Organization **Class:** OTHER **Full Name:** Boston Children's Hospital ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **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:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Boston Children's Hospital #### Responsible Party **Investigator Affiliation:** Boston Children's Hospital **Investigator Full Name:** Juan Ibla **Investigator Title:** Principal Investigator, MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described. The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period. ### Conditions Module **Conditions:** - Congenital Heart Disease - Single-ventricle - Thrombosis ### Design Module #### Bio Spec **Description:** Whole blood from neonate **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Neonates born with severe Congenital Heart Disease undergoing corrective heart surgery within the first week of life under cardiopulmonary bypass at Boston Children's Hospital will be eligible for participation. As part of standard clinical care, neonates having cardiac surgery at Boston Children's Hospital have clinical labs drawn during and after surgery. All blood collected from neonates as part of this study will be discarded blood from those routine clinical samples. One sample will be taken before surgery and one sample will be taken after surgery. **Intervention Names:** - Other: Collecting discarded blood samples **Label:** Neonates with Congenital Heart Disease ### Interventions #### Intervention 1 **Arm Group Labels:** - Neonates with Congenital Heart Disease **Description:** Discarded blood samples will be collected from routine clinical labs collected before and after surgery. **Name:** Collecting discarded blood samples **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** isolation, purification and sequencing of patterns of miRNA and clustering analysis will be performed to determine predominant populations of miRNA related to inflammation, complement activation, and coagulation among other pathways **Measure:** Characterization of microRNA in whole blood samples from neonates **Time Frame:** 2 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life Exclusion Criteria: * None **Maximum Age:** 7 Days **Minimum Age:** 1 Day **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rachel.bernier@childrens.harvard.edu **Name:** Rachel Bernier, MPH **Phone:** 857-218-5348 **Role:** CONTACT **Contact 2:** **Email:** hanna.vanpelt@childrens.harvard.edu **Name:** Hanna Van Pelt, BS **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Boston Children's Hospital **State:** Massachusetts **Zip:** 02115 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000016769 - Term: Embolism and Thrombosis - ID: D000014652 - Term: Vascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M16686 - Name: Thrombosis - Relevance: HIGH - As Found: Thrombosis - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Disease - ID: M2100 - Name: Univentricular Heart - Relevance: HIGH - As Found: Single Ventricle - 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 - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown - ID: T5247 - Name: Single Ventricular Heart - Relevance: HIGH - As Found: Single Ventricle ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases - ID: D000013927 - Term: Thrombosis - ID: D000006330 - Term: Heart Defects, Congenital - ID: D000080039 - Term: Univentricular Heart ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434194 **Brief Title:** Serrantor OCT Study **Official Title:** Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT) #### Organization Study ID Info **ID:** CSP #### Organization **Class:** INDUSTRY **Full Name:** Cagent Vascular LLC ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **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:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Cagent Vascular LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True ### Description Module **Brief Summary:** TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque. ### Conditions Module **Conditions:** - Critical Limb Ischemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon **Intervention Names:** - Device: Serranator PTA Serration Catheter **Label:** Serrantor **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon. **Intervention Names:** - Drug: PTA (Standard of Care) **Label:** PTA **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Serrantor **Description:** The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications. **Name:** Serranator PTA Serration Catheter **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - PTA **Description:** A percutaneous transluminal angioplasty catheter will be used to treat the target lesion. **Name:** PTA (Standard of Care) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated. **Measure:** Residual Lumen Volume Stenosis **Time Frame:** Baseline #### Secondary Outcomes **Description:** Residual stenosis as measured by OCT **Measure:** OCT Residual Diameter Stenosis **Time Frame:** Baseline **Description:** Residual stenosis as measured by angiography **Measure:** Angiography Residual Diameter Stenosis **Time Frame:** Baseline **Description:** The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration. **Measure:** Dissection Pattern **Time Frame:** Baseline **Description:** The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab. **Measure:** Correlation of Luminal Gain and Plaque Modification **Time Frame:** Baseline **Description:** Rate of procedures that achieve optimal PTA (\<30% diameter stenosis without flow-limiting dissection measured by angiography) **Measure:** Rate of Optimal PTA **Time Frame:** Baseline **Description:** Rate of bail-out stenting **Measure:** Bail-out Stenting **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Rutherford clinical category 4-6 of the target limb * Age of subjects is \>18 years old * Patients has given informed consent to participate in this study Exclusion Criteria: * De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion * Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries. * Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm. * Lesion length less than 220 mm **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kjclinconsulting@gmail.com **Name:** Feeny **Phone:** 4197878496 **Role:** CONTACT **Contact 2:** **Email:** twittwer@mededge.io **Name:** Wittwer **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000058729 - Term: Peripheral Arterial Disease - ID: D000050197 - Term: Atherosclerosis - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes ### 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: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M2714 - Name: Chronic Limb-Threatening Ischemia - Relevance: HIGH - As Found: Critical Limb Ischemia - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: LOW - As Found: Unknown - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M26188 - Name: Atherosclerosis - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - 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: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000089802 - Term: Chronic Limb-Threatening Ischemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434181 **Brief Title:** Beetroot Juice for Boosting Immunity During a Time of Stress. **Official Title:** Beetroot Juice for Boosting Immunity During a Time of Stress. #### Organization Study ID Info **ID:** 1866308 #### Organization **Class:** OTHER **Full Name:** Baylor University ### Status Module #### Completion Date **Date:** 2022-12-13 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-12-13 **Type:** ACTUAL #### Start Date **Date:** 2022-04-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Southern Methodist University #### Lead Sponsor **Class:** OTHER **Name:** Baylor University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the present study is to explore the effects of a dietary nitrate supplement (i.e., beetroot juice) on nitric oxide levels, immunity, mood, and cardiovascular activity during and following final exam stress in healthy individuals. **Detailed Description:** Research has demonstrated that during times of high stress (i.e., during final exam period), there is a decrease in fraction of exhaled nitric oxide (FeNO) in healthy undergraduate students. Additionally, a separate line of research has demonstrated periods of high stress impact immunity and the cardiovascular system. Nitric oxide may have a benefit in improving the physiological and psychological consequences of stress. The present research aims to explore the impact of a dietary supplement (beetroot juice drink) on immunity, nitric oxide levels, cardiovascular activity, and mood during and following final exam stress. In this study, investigators monitor changes in cold symptoms, IL-8, blood pressure, airway nitric oxide, and mood in students during the time of final exams and a comparable time of low stress during the term. There are three laboratory assessment visits, as well as a brief questionnaire on a separate day. During the final exam period, half of the participants are randomly assigned to the experimental group provided with a dietary supplement (beetroot juice drink) of which they are asked to take two doses every day (one in the morning and one in the evening) for seven days. The other half of the participants are randomly assigned to the placebo control group provided with a placebo supplement (placebo drink) of which they are asked to take two doses every day (one in the morning and one in the evening for seven days). For the final exam period, the first of the two sessions takes place early in the examination period (first half), and the second assessment takes place in the later exam period (second half). The online questionnaire assessing symptoms is measured 3 days after the final examination period. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Masking Description:** The lead researcher, data collectors, and participants were blinded to the conditions. The distribution of the supplements for each condition was performed by a member of the staff that was not involved with the study. **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 114 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group are given 7 daily doses of a dietary nitrate supplement (Beet-it Sport beetroot juice shots, ) and asked to drink two doses daily during the week of their final academic examinations of that term in college. **Intervention Names:** - Dietary Supplement: Beetroot Juice **Label:** Beetroot Juice **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this group are given 7 daily doses of a placebo matched in appearance and taste (Beet-it Sport placebo juice shots) and asked to drink two doses daily during the week of their final academic examinations of that term in college. **Intervention Names:** - Dietary Supplement: Placebo Control **Label:** Placebo Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Beetroot Juice **Description:** Beet-It Sports Shot, 70mL, containing 6.5 mmol nitric oxide (taking two shots per day in active group) **Name:** Beetroot Juice **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo Control **Description:** Beet-It Placebo Shot, 70mL (taking two shots per day in placebo group) **Name:** Placebo Control **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Assesses symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire **Measure:** Wisconsin Upper Respiratory Symptom Survey (WURSS) **Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations) **Description:** Change in IL-8 levels **Measure:** Changes in IL-8 levels **Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) #### Secondary Outcomes **Description:** Resting blood pressure (systolic and diastolic) **Measure:** Resting blood pressure **Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) **Description:** Perceived Stress Scale **Measure:** Acute stress **Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) **Description:** PANAS negative affect scale **Measure:** Change in negative affect **Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) **Description:** Participants will upload a cell phone video of their intake for that day to a secure cloud folder, time stamp in comparison to assigned intake windows provides measure of adherence **Measure:** Adherence monitoring (feasibility ) **Time Frame:** Every day, twice a day during active beetroot **Description:** The Fraction of NO in Exhaled Breath (FENO, in ppb) will be measured with an electrochemical gas analyzer (NIOX vero). **Measure:** Exhaled Nitric Oxide **Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) **Description:** Hospital Anxiety and Depression Scale **Measure:** Change in depressive symptomology **Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Currently enrolled at Baylor University or Southern Methodist University Exclusion Criteria: * Current smoker * Clinically significant asthma, COPD, Emphysema, heart disease, cerebrovascular disease, thyroid dysfunction, out of control diabetes * Pregnancy, diagnosis of schizophrenia, psychosis, mood disorder, psychosis, drug or alcohol dependance **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Dallas **Country:** United States **Facility:** Southern Methodist University **State:** Texas **Zip:** 75205 **Location 2:** **City:** Waco **Country:** United States **Facility:** Annie T. Ginty **State:** Texas **Zip:** 76798 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12507 - Name: Nitric Oxide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434168 **Brief Title:** Impact of Yoga on Cognitive Function **Official Title:** A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment #### Organization Study ID Info **ID:** AU-24-001 #### Organization **Class:** OTHER **Full Name:** Auburn University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** VCOM, Auburn campus #### Lead Sponsor **Class:** OTHER **Name:** Auburn University #### Responsible Party **Investigator Affiliation:** Auburn University **Investigator Full Name:** Chin-Yen Lin **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment. **Detailed Description:** A prospective, 2-arm comparative feasibility design will be used. The investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment. Patients will be randomized equally into yoga intervention or control group. Patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week. Survey, cognitive function data, MRI scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention). ### Conditions Module **Conditions:** - Heart Failure - Mild Cognitive Impairment **Keywords:** - Yoga intervention - cognitive function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Yoga intervention **Label:** Yoga intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Control condition **Label:** Control condition **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Yoga intervention **Description:** Patients in the yoga group will receive a 60-minute session, twice per week over 12 weeks for a total of 24 sessions. Each yoga session consists of a warm-up, yoga postures standing or seated depending on the capability of the patient, and relaxation. **Name:** Yoga intervention **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control condition **Description:** Patients in the control group will receive care-as-usual from their healthcare providers and will be asked to avoid engaging in yoga during their 3 months in the study. **Name:** Control condition **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal. **Measure:** Brain structure **Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention **Description:** Functional magnetic resonance imaging is used to examine functional connectivity between intervention and control groups. A balance of activity across different brain regions is optimal. **Measure:** Brain functional connectivity **Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention **Description:** Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function. **Measure:** Cognitive function **Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention **Description:** A blood sample will be obtained using phlebotomy to measure the levels of serum brain-derived neurotrophic factor and reported in pg/mL. Higher concentrations are optimal. **Measure:** Serum brain-derived neurotrophic factor **Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged 55 years and older * Confirmed heart failure diagnosis with mild cognitive impairment * New York Heart Association functional class II-IV Exclusion Criteria: * Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses * Have implanted defibrillator, left ventricular assist device placement or cardiac transplant * Have any other implanted metals that interfere with the MRI magnetic field for patient safety * Substance abuse * Pregnant * Unable to perform yoga due to physical limitations or severity of illness **Maximum Age:** 70 Years **Minimum Age:** 55 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** czl0194@auburn.edu **Name:** Chin-Yen Lin, RN, PhD **Phone:** 334-844-5619 **Role:** CONTACT #### Locations **Location 1:** **City:** Auburn **Contacts:** ***Contact 1:*** - **Email:** czl0194@auburn.edu - **Name:** Chin-Yen Lin, RN, PhD - **Phone:** 334-844-5619 - **Role:** CONTACT **Country:** United States **Facility:** Auburn University **State:** Alabama **Zip:** 36849 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - 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: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Mild Cognitive Impairment - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - 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: D000006333 - Term: Heart Failure - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434155 **Acronym:** OCT **Brief Title:** Social History and Glaucoma Progression **Official Title:** Social History and Glaucoma Progression: The Effect of Body Mass Index, Tobacco, and Alcohol Consumption on the Rates of Structural Change in Patients With Open Angle Glaucoma #### Organization Study ID Info **ID:** 17200545 #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2022-07-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-07-01 **Type:** ACTUAL #### Start Date **Date:** 2022-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Khaled Abdelazeem **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments **Detailed Description:** Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH. When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time. ### Conditions Module **Conditions:** - Glaucoma Open-Angle **Keywords:** - Glaucoma - OCT ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1584 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Arms Interventions Module #### Arm Group 1 **Description:** 1. Patients older than 18 years of age with primary open-angle glaucoma (POAG) 2. POAG diagnosed on the basis of IOP measurements more than 21 mmHg, Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes. 3. Eyes with baseline macular and ONH OCT images and ONH photographs of adequate quality and r performed within 6 months of each other were selected **Label:** Primary Open Angle Glaucoma ### Outcomes Module #### Primary Outcomes **Description:** RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT **Measure:** OCT structural parameters **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * IOP measurements more than 21 mmHg * Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width) * Glaucomatous visual field defects consistent with glaucomatous optic disc changes. * Eyes with baseline macular and ONH OCT images and ONH photograps Exclusion Criteria: * Participants with significant retinal disease. * non-glaucomatous optic neuropathy. * anomalous discs * any retinal pathology. * history of cataract or glaucoma surgery will not be exclusion criteria. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients older than 18 years of age with primary open-angle glaucoma (OAG) ### Contacts Locations Module #### Locations **Location 1:** **City:** Assiut **Country:** Egypt **Facility:** Faculty of Medicine **Zip:** 71515 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009798 - Term: Ocular Hypertension - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9013 - Name: Glaucoma - Relevance: HIGH - As Found: Glaucoma - ID: M9014 - Name: Glaucoma, Open-Angle - Relevance: HIGH - As Found: Glaucoma Open-Angle - ID: M3774 - Name: Alcohol Drinking - Relevance: LOW - As Found: Unknown - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M12731 - Name: Ocular Hypertension - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005901 - Term: Glaucoma - ID: D000005902 - Term: Glaucoma, Open-Angle ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434142 **Brief Title:** Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture **Official Title:** Wear Assessment of Novel PEEK Telescopic Attachment for Implant Retained Mandibular Overdenture #### Organization Study ID Info **ID:** 751/306 #### Organization **Class:** OTHER **Full Name:** Al-Azhar University ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-20 **Type:** ACTUAL #### Start Date **Date:** 2024-02-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hamada Zaki Mahross Atia #### Responsible Party **Investigator Affiliation:** Al-Azhar University **Investigator Full Name:** Hamada Zaki Mahross Atia **Investigator Title:** Assistant Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture. **Detailed Description:** Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test. ### Conditions Module **Conditions:** - Attachment Disorder - Stress Disorder **Keywords:** - Telescopic attachment - Attachment Wear - Zirconia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group I (study group) was the group of patients with zirconia as a primary copings that attach to the abutment and PEEK as a secondary coping telescopic attachment that attaches to the fitting surface of the denture. **Intervention Names:** - Procedure: implant overdenture **Label:** patient with zirconia copy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Group II (control group) was the group of patients with cobalt chromium (CoCr) as primary copings attached to the abutment and PEEK as a secondary coping's telescopic attachment attached to the fitting surface of the denture. **Intervention Names:** - Procedure: implant overdenture **Label:** patients with cobalt chromium (CoCr) as primary copings **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - patient with zirconia copy - patients with cobalt chromium (CoCr) as primary copings **Description:** Following the two-stage surgical protocol, two dental implant fixtures with a length of 10 mm and a diameter of 3.7 mm were inserted at the canine area of the mandibular alveolar ridge. **Name:** implant overdenture **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** measurement of the mean of wear between two test groups **Measure:** the mean wear values **Time Frame:** at baseline **Description:** measurement of the mean of wear between two test groups **Measure:** the mean wear values **Time Frame:** after 3 months interval **Description:** measurement of the mean of wear between two test groups **Measure:** the mean wear values **Time Frame:** after 6 months interval ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * completely edentulous * free from any dental or systemic diseases Exclusion Criteria: * medically ill fit patient * female patient **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 50 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Hamada Zaki Mahross **Zip:** 11884 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Stress Disorder - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000040921 - Term: Stress Disorders, Traumatic ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6097 - Name: Chromium - Relevance: LOW - As Found: Unknown - ID: M6265 - Name: Cobalt - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434129 **Brief Title:** Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss **Official Title:** Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss #### Organization Study ID Info **ID:** 1a #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2026-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Mahmoud Mohammad Aly **Investigator Title:** Assistant lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** DTI and auditory tractography can be incorporated into the diagnostic toolkit for patients who are scheduled to undergo cochlear implantation and whose standard assessments have been unable to determine the functional integrity of the auditory pathway. These techniques aid in decision-making processes regarding potential outcomes, determining the optimal side for implantation, providing counseling regarding the possibility of limited benefits from surgery, and considering alternative forms of rehabilitation. The investigators including patients with varying degrees of hearing loss, as well as patients with normal radiological findings who are scheduled for cochlear implantation. The ultimate goal is to create a comprehensive map across the entire hearing spectrum and validate the findings of this study.. **Detailed Description:** Hearing is a complex process in which many parts of the ear contribute to transmit signals to the brain. The auditory system consists of both peripheral structures (external, middle, and inner ear)as well as central regions (cochlear nuclei in the medulla oblongata, superior olivary nuclei and lateral lemniscus in the pons, inferior colliculus in the midbrain, medial geniculate nuclei in the thalamus, and auditory cortex in the superior temporal Heschl gyrus). Most of auditory fibres undergo a contralateral decussation to the opposite superior olive in the region known as the trapezoid body. The broad term "sensorineural hearing loss" (SNHL) It accounts for a substantial proportion of hearing impairment cases globally, affecting individuals of various age groups. It has been used by clinicians to refer to either malfunctioning inner ear or a retrocochlear problem affecting the canalicular vestibule-chochlear (VIII) cranial nerve and cerebellopontine angle or that involves the higher (central) auditory nuclei and neural tracts. Identifying the etiology of hearing loss is valuable to establish a treatment strategy that can help to prevent or slow down complete loss of auditory function. The central auditory structures are involved in various processes that may occur in isolation from those involving peripheral receptors .SNHL can be a consequence of different conditions, including viral infection, tumor, ischemia, multiple sclerosis, or congenital malformations. Despite continuous efforts to delineate the pathophysiological attributes of SNHL, the aetiology remains mostly unclear with nearly 90% of cases being idiopathic. Therefore, finding a method to accurately predict microstructural changes of the auditory circuit is extremely important. Conventional imaging modalities, including computed tomography (CT) and magnetic resonance imaging (MRI), have offered invaluable insights into the macroscopic changes associated with SNHL, such as cochlear morphology and structural abnormalities. However, these techniques lack the sensitivity to discern subtle alterations occurring at the microstructural level, impeding a comprehensive understanding of the underlying pathophysiological processes. DTI-MRI's ability to capture subtle changes in tissue microstructure makes it an ideal candidate for probing the intricate auditory pathways affected by SNHL. By quantifying the diffusion of water molecules along axonal pathways, DTI-MRI can uncover alterations in the integrity of auditory neural connections, which are often missed by conventional imaging methods. Furthermore, DTI-derived metrics, such as fractional anisotropy (FA), axial diffusivity (AD), radial diffusivity (RD), and mean diffusivity (MD), offer quantitative measures to characterize the white matter integrity and myelination in auditory pathways. ### Conditions Module **Conditions:** - Sensorineural Hearing Loss **Keywords:** - DTI - Sensorineural hearing loss ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 72 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** cases with SNHL **Intervention Names:** - Diagnostic Test: DTI **Label:** Cases #### Arm Group 2 **Description:** Normal people **Intervention Names:** - Diagnostic Test: DTI **Label:** Controls ### Interventions #### Intervention 1 **Arm Group Labels:** - Cases - Controls **Description:** Diffusion MRI imaging **Name:** DTI **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Assess the integrity of auditory pathway via measuring DTI metrics ( Fractional anisotropy and mean diffusivity) **Measure:** Assessment of role of DTI in SNHL **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with audiometrically proven SNHL Exclusion Criteria: * Neurologically or psychiatric conditions affecting patient stability during MRI examination. * Cochlear implants. * Contraindications for MRI. **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Assiut university hospital patients ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** am.8892@gmail.com **Name:** Mahmoud Aly, Master **Phone:** 00201011367958 **Role:** CONTACT #### Locations **Location 1:** **City:** Assiut **Contacts:** ***Contact 1:*** - **Email:** am.8892@gmail.com - **Name:** Mahmoud Aly, Master - **Phone:** 00201011367958 - **Role:** CONTACT **Country:** Egypt **Facility:** Faculty of Medicine of Assuit **Status:** RECRUITING **Zip:** 71515 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M24420 - Name: Hearing Loss - Relevance: HIGH - As Found: Hearing Loss - ID: M6840 - Name: Deafness - Relevance: HIGH - As Found: Hearing Loss - ID: M9407 - Name: Hearing Loss, Sensorineural - Relevance: HIGH - As Found: Sensorineural Hearing Loss - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000034381 - Term: Hearing Loss - ID: D000003638 - Term: Deafness - ID: D000006319 - Term: Hearing Loss, Sensorineural ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434116 **Acronym:** RVI-ERS **Brief Title:** Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit. **Official Title:** Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit #### Organization Study ID Info **ID:** APHP240431 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2025-06-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patient's ability to breathe without the assistance of a ventilator. This test is highly susceptible to induce dyspnea, with 62% of patients reporting a dyspnea score on VAS greater than 3. Similarly, the prevalence of anxiety is high during weaning trials. 60% of patients treated in a respiratory weaning unit report psychological symptoms. Dyspnea can be a traumatic experience for patients. In intensive care, up to half of patients suffer from dyspnea, which is described by patients as one of the worst memories of their stay in intensive care. The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support. The research hypothesis is that virtual reality during a spontaneous breathing trial would relieve the respiratory discomfort induced by the weaning trial. The secondary hypotheses are that virtual reality could reduce the anxiety associated with spontaneous breathing trials. These benefits could be associated to a reduction in ventilatory drive. To assess dyspnea a VAS scale will be used, as the MV-RDOS scale, and the amplitude of EMG activity of inspiratory muscles. **Detailed Description:** A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patient's ability to breathe without the assistance of a ventilator. This test is highly susceptible to induce dyspnea, with 62% of patients reporting a dyspnea score on VAS greater than 3. Similarly, the prevalence of anxiety is high during weaning trials. 60% of patients treated in a respiratory weaning unit report psychological symptoms. Dyspnea can be a traumatic experience for patients. In intensive care, up to half of patients suffer from dyspnea, which is described by patients as one of the worst memories of their stay in intensive care. Dyspnea exposes patients to the risk of neuropsychological sequel, in particular the occurrence of post-traumatic stress. Dyspnea is define by the ATS as "a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity " . It represents a conscious and distressing sensation of breathing difficulty. It is characterized by its multidimensional aspect with a sensory and affective dimension. To assess dyspnea a VAS scale will be used, the MV-RDOS scale, which is a recently developed tool for the hetero-assessment of dyspnea in intubated patients. The amplitude of EMG activity of the extradiaphragmatic inspiratory muscles is proportional to the intensity of dyspnea and reflects the intensity of ventilatory command. The activity of the parasternal and scalene muscles can be collected using surface electrodes. The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support. Several studies have shown that medical hypnosis can improve the sensory and affective components of pain, and also appears to have a beneficial effect on the management of dyspnea and anxiety. Numerous studies have shown that the use of virtual reality reduces the intensity of acute and chronic pain. Several studies have also shown that immersive virtual reality helps to reduce anxiety associated with medical procedures. A study has also found that the use of virtual reality in patients hospitalized with acute SARS-CoV-2 infection improves dyspnea, anxiety, well-being and fatigue. The research hypothesis is that virtual reality during a spontaneous breathing trial would relieve the respiratory discomfort induced by the trial. The secondary hypotheses are that virtual reality could reduce the anxiety associated with spontaneous breathing trials. This will be an open label, monocentric, randomized controlled study in the intensive care unit of PItié-Salpêtrière hospital. Patient will be recruited if they are undergoing a spontaneous breathing trial as part of their usual care. The main objective is to measure the effect of virtual reality during a ventilatory weaning trial in comparison with current practice on respiratory discomfort. Respiratory discomfort will be assessed using a visual analogue scale at the end of the ventilatory weaning trial. The secondary objectives are to evaluate the effect of virtual reality on the intensity of anxiety, to evaluate the effect of virtual reality on respiratory discomfort assessed by the MV-RDOS score, to evaluate the effect of virtual reality on ventilatory drive assessed by the P 0.1 and EMG of scalene and parasternal muscle , to describe the effect of virtual reality on respiratory rate and heart rate, and to evaluate tolerance of virtual reality. The study will be conducted as follows: Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period). A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care). The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual care, with one of the two interventions according to randomisation. Patients with a VAS \<3 cm after the first weaning trial will not be randomised. In line with standard care, a second weaning test lasting a further 15 minutes will also be performed without intervention. Throughout the study, the investigator will record clinical and functional data. EMG monitoring of the paraspinal and scalene muscles will be carried out throughout the test. Similarly, P 0.1 will be monitored at the beginning and end of the weaning test. The respiratory discomfort VAS, the MV-RDOS and the anxiety VAS will be assessed at the end of the weaning trial. Completion of the sickness simulator questionnaire after the use of virtual reality in order to assess tolerance. Virtual reality will be achieved using a virtual reality headset (GAMIDA®, Pico G2 4K, France) and audio headphones with noise reduction (Bose® Quiet Comfort 35 II, France). A tablet (Samsung® Galaxy Tab A 2019, 4G / Lenovo M8, France) equipped with Healthy Mind software will enable patients to enjoy a 360° visual and auditory 3D experience via a Bluetooth connection." ### Conditions Module **Conditions:** - Spontaneous Breathing Trial in ICU **Keywords:** - Spontaneous breathing trial - dyspnea - virtual reality - anxiety ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### 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:** Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period). A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care). The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual management, with one of the two interventions according to randomisation. **Intervention Names:** - Device: Immersive virtual reality **Label:** Immersive virtual reality in patient with VAS dyspnea ≥ 3 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period). A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care). The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual management, with one of the two interventions according to randomisation. **Intervention Names:** - Device: Immersive virtual reality **Label:** Control in patient with VAS dyspnea ≥ 3 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control in patient with VAS dyspnea ≥ 3 - Immersive virtual reality in patient with VAS dyspnea ≥ 3 **Description:** The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support. Virtual reality will be achieved using a virtual reality headset (GAMIDA®, Pico G2 4K, France) and audio headphones with noise reduction (Bose® Quiet Comfort 35 II, France). A tablet (Samsung® Galaxy Tab A 2019, 4G / Lenovo M8, France) equipped with Healthy Mind software will enable patients to enjoy a 360° visual and auditory 3D experience via a Bluetooth connection. **Name:** Immersive virtual reality **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint is the comparison of the respiratory discomfort VAS between the intervention group (VR) and the control group (standard care) at the end of the ventilatory weaning test. **Measure:** Respiratory discomfort VAS **Time Frame:** At inclusion (day1) #### Secondary Outcomes **Description:** Comparison of the VAS anxiety at the end of the weaning trial between the VR group and the control group **Measure:** Effect of IVR on anxiety intensity at the end of the withdrawal test **Time Frame:** At inclusion (day1) **Description:** Comparison of the MV-RDOS scale between the VR group and the control group **Measure:** Evaluation of the effect of virtual reality on respiratory discomfort assessed by the MV-RDOS score **Time Frame:** At inclusion (day1) **Description:** Evolution of physiological measurements (RMS of the parasternal and scalene EMG, P 0.1) between the VR group and the control group **Measure:** Evaluation of the effect of virtual reality on respiratory drive assessed by the P 0.1, and EMG of scalene and parasternal muscle **Time Frame:** At inclusion (day1) **Description:** Evolution of physiological measurements (respiratory rate, heart rate) between the VR group and the control group **Measure:** Description of the effect of virtual reality on respiratory rate and heart rate **Time Frame:** At inclusion (day1) **Description:** Measurement of tolerance by the simulator sickness questionnaire in the VR group. **Measure:** Evaluation of the tolerance of virtual reality. **Time Frame:** At inclusion (day1) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years 2. Patients intubated and on mechanical ventilation for more than 24 hours 3. Patients eligible for a weaning trial (resolution of acute phase of pathology, low bronchial congestion, effective cough, SpO2 \> 90% with Fio2 \< 40%, PEEP \< 8 cmH20, respiratory rate \< 40/min, haemodynamically stable) 4. Decision by the doctor in charge to initiate a respiratory weaning trial as part of treatment 5. RASS score between -1 and +1 6. Patient able to answer questionnaires 7. Informed of the study and whose free and informed written consent has been obtained 8. Beneficiary of a social security plan (excluding AME) Exclusion Criteria: 1. Non french speaker 2. Acute confusion or cognitive disorders 3. No reliable assessment of dyspnea 4. Acrophobia 5. Claustrophobia 6. Photophobia 7. Hearing loss 8. Visual impairment 9. Subject under guardianship or curatorship **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** capucine.morelot@aphp.fr **Name:** Capucine MORELOT-PANZINI, MD,PHD **Phone:** +33 1 42 16 78 59 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Researchers who provide a methodologically sound proposal **Description:** The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7591 - Name: Dyspnea - Relevance: HIGH - As Found: Dyspnea - ID: M27137 - Name: Respiratory Aspiration - Relevance: HIGH - As Found: Breathing - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000053120 - Term: Respiratory Aspiration - ID: D000004417 - Term: Dyspnea ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434103 **Brief Title:** Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC **Official Title:** An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC #### Organization Study ID Info **ID:** SHR-A1921-205 #### Organization **Class:** INDUSTRY **Full Name:** Suzhou Suncadia Biopharmaceuticals Co., Ltd. ### Status Module #### Completion Date **Date:** 2027-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **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:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Suzhou Suncadia Biopharmaceuticals Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer ### Conditions Module **Conditions:** - Advanced Non-small Cell Lung Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 124 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin **Label:** SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin **Description:** SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days. **Name:** SHR-A1921；Adebrelimab；SHR-8068；carboplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** DLT **Time Frame:** 21 days after the first dose **Measure:** ORR based on RECIST v1.1 assessment. **Time Frame:** All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years #### Secondary Outcomes **Measure:** Adverse event **Time Frame:** All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years **Measure:** DCR based on RECIST v1.1 assessment **Time Frame:** All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up; 2. Aged 18-75 at the time of signing the informed consent; 3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy; 4. At least one measurable lesion consistent with RECIST v1.1; 5. ECOG PS score: 0-1; 6. The organ function level is good; Exclusion Criteria: 1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.; 2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms; 3. Previous or co-existing malignant neoplasms; 4. The presence of any active or known autoimmune disease; 5. Have clinical symptoms or diseases of the heart that are not well controlled; 6. People with past or current interstitial pneumonia/interstitial lung disease; 7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies; 8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment; **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mengbo.zhao@hengrui.com **Name:** Mengbo Zhao **Phone:** 0518-82342973 **Role:** CONTACT **Contact 2:** **Email:** ze.zhang.zz1@hengrui.com **Name:** Ze Zhang **Phone:** 0518-82342973 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### 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: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: 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 ### Condition Browse Module - Meshes - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### 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: HIGH - As Found: System ### Intervention Browse Module - Meshes - ID: D000016190 - Term: Carboplatin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434090 **Brief Title:** Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer **Official Title:** Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer:a Multicenter, Phase I/II Trial. #### Organization Study ID Info **ID:** CSPC-DEY-CRC-K06 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Yanhong Deng **Investigator Title:** Director of Medical Oncology, Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To evaluate the efficacy and safety of liposomal irinotecan plus bevacizumab in irinotecan-refractory metastatic colorectal cancer **Detailed Description:** The standard treatment regimen based on irinotecan with or without bevacizumab is commonly used in metastatic colorectal cancer. With administration of traditional irinotecan, the parent drug and active metabolite SN-38 exist in the form of active lactone and carboxylate, and the lactone ring structure is unstable in neutral and alkaline solutions. In physiological pH conditions, the active lactone rapidly hydrolyzes to the inactive carboxylate, thereby reducing the efficacy, so there is certain limitation in clinical application. Liposomes Irinotecan load the active substance irinotecan into liposomes, so that it can be slowly released in the body and achieve the effect of reducing toxicity and increasing efficacy.After being rationally designed, irinotecan liposomes can also take advantage of the high permeability and retention effect (EPR) to specifically target the tumor area, increase the amount of drug taken up by cancer cells, reduce the dosage, improve efficacy, and reduce side effects. We are currently conducting an Phase I/II study in mCRC patients who have previously received irinotecan. After determining the maximum tolerable dose (MTD) of irinotecan liposomes in the combined regimen of irinotecan liposomes and bevacizumab, we will further explore the safety and initial efficacy of irinotecan liposomes combined with bevacizumab. ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - Liposomal irinotecan - bevacizumab ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients received Liposomal irinotecan (a '3+3' design was adopted in the experimental arm, with 3 dose levels of 70mg/m2, 80mg/m2, and 90mg/m2 for dose exploration) every 2 weeks (Q2W). bevacizumab, 5mg/m2, every 2 weeks The two-drug combination therapy was continued every 2 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol. **Intervention Names:** - Drug: Liposomal irinotecan - Drug: Bevacizumab **Label:** Liposomal irinotecan plus bevacizumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Liposomal irinotecan plus bevacizumab **Description:** Liposomal irinotecan will be given biweekly at a dose from 70mg/m2 to 90mg/m2. **Name:** Liposomal irinotecan **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Liposomal irinotecan plus bevacizumab **Description:** bevacizumab will be given biweekly at a dose of 5mg/m2 **Name:** Bevacizumab **Other Names:** - avastin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Defined as the highest dose of DLT in\<33% of subjects . **Measure:** Maximum tolerated dose (MTD) of liposomal irinotecan **Time Frame:** 1 months **Description:** Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1. **Measure:** Objective Response Rate **Time Frame:** 5 months #### Secondary Outcomes **Description:** Defined as adverse events that occur during the DLT observation period and are related to the study drug . **Measure:** Dose-Limiting Toxicities (DLT) of liposomal irinotecan **Time Frame:** 1 months **Description:** Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1. **Measure:** Disease Control Rate **Time Frame:** 5 months **Description:** Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause. **Measure:** Duration of Response **Time Frame:** 5 months **Description:** Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause. **Measure:** Progression free Survival **Time Frame:** 1 years **Description:** Defined as the time between signing the informed consent form to death due to various causes. **Measure:** Overall survival **Time Frame:** 1 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age: ≥18 years old； 2. Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma； 3. Previous treatment with irinotecan , and have progression of disease during treatment or within three months thereafter； 4. At least one measurable lesion (according to RECIST v1.1)； 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1； 6. The expected survival time ≥3 months； 7. Adequate bone marrow function : no blood transfusion and/or use of increasing leukocyte drugs (excluding oral medication) within 14 days prior to enrollment Absolute neutrophil count (ANC) ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin (Hgb) ≥90 g/L； 8. Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, ≤5 × ULN if liver metastases are present. Serum albumin ≥30 g/L； (9Adequate renal function as evidenced by: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. proteinuria\<2+（those with proteinuria ≥2+ at baseline had to demonstrate ≤1 g protein per 24 hours）； (10)Coagulation function: International normalised ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5 × ULN； (11)Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening； Exclusion Criteria: 1. Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc； 2. Patients with the primary lesion located in the left colon and RAS/BRAF wild-type who did not use cetuximab on the first-line； 3. Patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)； 4. Massive pleural effusion or ascites requiring intervention； 5. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment； 6. Active HIV infection； 7. Combined with uncontrollable systemic diseases within 6 months before the first administration； 8. Presence of severe gastrointestinal disease； 9. History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration,or plan to undergo major surgery during the study period； 10. Presence of interstitial pneumonia or pulmonary fibrosis； 11. History of allergy or hypersensitivity to drug or any of their excipients； 12. History of pulmonary hemorrhage/hemoptysis ≥Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration； 13. Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before the first administration； 14. Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome； 15. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration； 16. Participate in other study and use study drug within 1 month or within 5 half-lives of the drug (whichever comes first) before the first administration； 17. Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception； 18. Patients who are not suitable to participate in this trial for any reason judged by the investigator； **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dengyanh@mail.sysu.edu.cn **Name:** Yanhong Deng, PhD **Phone:** 020-38379762 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** dengyanh@mail.sysu.edu.cn - **Name:** Yanghong Deng, Phd - **Phone:** 02038379762 - **Role:** CONTACT **Country:** China **Facility:** The Sixth Affiliated Hospital of Sun Yat-sen University **State:** Guangdong **Zip:** 510655 #### Overall Officials **Official 1:** **Affiliation:** Sixth Affiliated Hospital, Sun Yat-sen University **Name:** Yanhong Deng, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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 ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: Infection - ID: M246 - Name: Bevacizumab - Relevance: HIGH - As Found: Non- - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - 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 ### Intervention Browse Module - Meshes - ID: D000068258 - Term: Bevacizumab - ID: D000077146 - Term: Irinotecan ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434077 **Brief Title:** Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer **Official Title:** Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer #### Organization Study ID Info **ID:** SW011 #### Organization **Class:** OTHER **Full Name:** S.LAB (SOLOWAYS) ### Status Module #### Completion Date **Date:** 2025-10-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Center of New Medical Technologies #### Lead Sponsor **Class:** OTHER **Name:** S.LAB (SOLOWAYS) #### 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 randomized, double-blind, placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF in reducing nagalase levels and improving clinical outcomes in female patients with metastatic breast cancer over six months. Sixty patients will be randomized into two groups receiving either weekly GcMAF or placebo injections. The primary endpoint is the change in serum nagalase levels from baseline to six months. Secondary endpoints include clinical status, quality of life, adverse effects, and markers of inflammation and immune activity. Tumor response will be assessed using RECIST criteria, and quality of life will be measured with the EORTC QLQ-C30 questionnaire. Immune and inflammation markers will be evaluated using flow cytometry and ELISA. Adverse events will be monitored and categorized according to severity. Inclusion criteria include confirmed metastatic breast cancer, completion of one line of systemic therapy, adequate organ function, and elevated serum nagalase levels. The study will involve baseline measurements, monthly assessments, and final evaluations to compare changes in nagalase levels and other clinical outcomes between the GcMAF and placebo groups. **Detailed Description:** This randomized, double-blind, placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF (Gc Macrophage Activating Factor) in female patients with metastatic breast cancer. The primary objective is to assess the reduction in serum nagalase levels, an enzyme associated with tumor activity, over a six-month period, and to evaluate improvements in clinical outcomes. The study involves 60 patients who will be divided into two groups: one receiving weekly injections of GcMAF and the other receiving a placebo. Patients eligible for the study must have histologically or cytologically confirmed metastatic breast cancer, completed at least one line of systemic therapy, and have elevated serum nagalase levels. Additional inclusion criteria include female patients aged 18 to 70 years, ECOG performance status of 0 to 2, adequate bone marrow, liver, and renal function, and an estimated life expectancy of at least six months. Patients must also agree to use effective contraception and provide informed consent. The primary endpoint is the change in serum nagalase levels from baseline to six months. Measurements will be taken at baseline, monthly, and at the end of the study using standardized enzymatic assays. Secondary endpoints include clinical status, assessed through objective tumor response using RECIST criteria and performance status using the ECOG scale, quality of life evaluated through EORTC QLQ-C30 questionnaires, immune activity measured by flow cytometry for various immune cell subsets, and inflammation markers such as CRP, interleukins, and TNF-alpha measured by ELISA. Adverse effects will be monitored weekly and categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The study procedures include initial screening to measure baseline nagalase levels and assess eligibility, followed by randomization into the GcMAF or placebo groups. Patients will receive weekly injections for six months, with monthly assessments of nagalase levels, clinical status, quality of life, and blood samples for immune and inflammation markers. Interim assessments will occur at three months, with final assessments and data analysis at six months. Exclusion criteria include the presence of other active malignancies, severe uncontrolled illnesses, pregnancy or breastfeeding, previous treatment with GcMAF, and known hypersensitivity to the study drug components. The study timeline consists of patient recruitment and baseline measurements in the first month, followed by six months of treatment and monitoring, with interim and final assessments and subsequent data analysis. This study aims to determine if GcMAF can significantly reduce serum nagalase levels and improve clinical outcomes, including tumor response, performance status, quality of life, and immune and inflammation markers, in patients with metastatic breast cancer. The results will provide insight into the potential therapeutic benefits of GcMAF for this patient population. ### Conditions Module **Conditions:** - Breast Cancer **Keywords:** - Metastatic Breast Cancer - GcMAF (Gc Macrophage Activating Factor) - Nagalase - Inflammation Markers - Response Evaluation Criteria in Solid Tumors ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** GcMAF injections (100 ng) **Intervention Names:** - Biological: GcMAF injections (100 ng) **Label:** CGMAF group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** placebo injections (100 ng) **Intervention Names:** - Other: placebo **Label:** placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - CGMAF group **Description:** The GcMAF 100 ng (Gc protein macrophage-activating factor) will be injected subcutaneously. **Name:** GcMAF injections (100 ng) **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - placebo group **Description:** the placebo solution will be injected subcutaneously 100 ng. **Name:** placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Change in Serum Nagalase Levels **Time Frame:** 6 months #### Secondary Outcomes **Measure:** Change in RECIST (Response Evaluation Criteria in Solid Tumors) criteria. **Time Frame:** 6 months **Measure:** MRI changes in cancer volume **Time Frame:** 6 months **Description:** one of 4 categories Complete Response (CR), Partial Response (PR), Stable Disease (SD),Progressive Disease (PD) **Measure:** Tumor response **Time Frame:** 6 months **Measure:** Eastern Cooperative Oncology Group (ECOG) performance status change **Time Frame:** 6 months **Description:** (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire **Measure:** EORTC QLQ-C30 change **Time Frame:** 6 months **Measure:** CD4+T cells percentage **Time Frame:** 6 months **Measure:** CD8+T cells percentage **Time Frame:** 6 months **Measure:** NK cells percentage **Time Frame:** 6 months **Measure:** CRP percentage **Time Frame:** 6 months **Measure:** IL-6 percentage **Time Frame:** 6 months **Measure:** IL-10 percentage **Time Frame:** 6 months **Measure:** tumor necrosis factor-alpha (TNF-α) necrosis factor-alpha (TNF-α) **Time Frame:** 6 months **Description:** any adverse events will be reported **Measure:** Adverse events **Time Frame:** 6 months **Measure:** rank of adverse event severity in numbers **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis: * Histologically or cytologically confirmed metastatic breast cancer. * Evidence of metastatic disease, confirmed by imaging studies (CT, MRI, or PET scans) and/or biopsy. 2. Prior Treatment: * Patients must have completed at least one line of systemic therapy (e.g., chemotherapy, hormone therapy, targeted therapy) for metastatic breast cancer. * A minimum of 4 weeks must have elapsed since the last chemotherapy, targeted therapy, or radiotherapy before starting the study treatment. 3. Age: * Female patients aged 18 to 70 years. 4. Performance Status: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Life Expectancy: * Estimated life expectancy of at least 6 months. 6. Laboratory Values: * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, and hemoglobin ≥ 9 g/dL. * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases). * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m\^2 (calculated using the Cockcroft-Gault formula). 7. Contraception: * Women of childbearing potential must agree to use effective contraception (e.g., hormonal contraceptives, intrauterine device, barrier methods, or abstinence) during the study and for at least 6 months after the last dose of study treatment. 8. Informed Consent: * Ability to understand and willingness to sign a written informed consent document. 9. Compliance: * Willingness and ability to comply with the study protocol, including scheduled visits, treatment plans, laboratory tests, and other study procedures. 10. Nagalase Levels: • Elevated serum nagalase levels above the normal range, indicating active tumor burden. Exclusion Criteria: * Concurrent Malignancies: * Presence of other active malignancies (excluding adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix). 2. Severe Comorbid Conditions: * Severe uncontrolled concurrent illness, such as significant cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction), severe pulmonary conditions (e.g., uncontrolled asthma, chronic obstructive pulmonary disease), or active infections requiring systemic therapy. 3. Pregnancy and Lactation: * Pregnant or breastfeeding women. 4. Previous GcMAF Treatment: * Previous treatment with GcMAF. 5. Allergies and Sensitivities: * Known hypersensitivity to any component of the study drug or its formulation. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Novosibirsk **Country:** Russian Federation **Facility:** Center of New Medical Technologies **State:** Novosibisk Region **Zip:** 630090 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434064 **Brief Title:** Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer **Official Title:** A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer #### Organization Study ID Info **ID:** I-3671523 #### Organization **Class:** OTHER **Full Name:** Roswell Park Cancer Institute #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-03909 **Type:** REGISTRY **Domain:** Roswell Park Cancer Institute **ID:** I-3671523 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Roswell Park Cancer Institute #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (locally advanced) and is unable to be operated on (inoperable). Tamoxifen works by blocking the effects of estrogen in the breast. This may help stop the growth of tumor cells that need estrogen to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable, locally advanced triple negative breast cancer than giving either of these drugs alone. **Detailed Description:** PRIMARY OBJECTIVE: I. To determine the efficacy of the combination of tamoxifen and pegylated liposomal doxorubicin in patients with metastatic or inoperable locally advanced triple negative breast cancer (TNBC) (estrogen receptor \[ER\] \< 10%) as assessed by overall response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of pegylated liposomal doxorubicin given in combination with tamoxifen. II. To determine clinical benefit including overall and progression free survival (overall survival \[OS\] and progression free survival \[PFS\]) as defined by RECIST v1.1. III. To determine the duration of response. EXPLORATORY OBJECTIVES: I. To analyze changes in circulating tumor deoxyribonucleic acid (ctDNA) from longitudinal liquid biopsy to follow therapeutic response. II. To determine estrogen receptor beta (ERβ)-mutant p53 interaction in tumors with in situ proximity ligation assay (PLA). III. To analyze changes in gene expression by global ribonucleic acid (RNA)-sequencing (seq). IV. To determine changes in the tumor microenvironment (TME) of tumors in response to treatment by analyzing tumor infiltrating lymphocytes (TILS) selected markers in the tumor and stromal tissues combined with CYBERSORT analysis of the transcriptome data. V. Analyze changes in immune cell populations and circulating protein biomarkers as detectable from blood. OUTLINE: Patients receive tamoxifen orally (PO) once daily (QD) on days 1-28 of each cycle and pegylated liposomal doxorubicin intravenously (IV) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography, computed tomography (CT) scan or magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days and every 6 months for up to 2 years. ### Conditions Module **Conditions:** - Anatomic Stage III Breast Cancer AJCC v8 - Anatomic Stage IV Breast Cancer AJCC v8 - Locally Advanced Unresectable Triple-Negative Breast Carcinoma - Metastatic Triple-Negative Breast Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 31 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive tamoxifen PO QD on days 1-28 of each cycle and pegylated liposomal doxorubicin IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography, CT scan or MRI, tumor biopsy, and blood sample collection throughout the study. **Intervention Names:** - Procedure: Biopsy - Procedure: Biospecimen Collection - Procedure: Computed Tomography - Procedure: Echocardiography - Procedure: Magnetic Resonance Imaging - Drug: Pegylated Liposomal Doxorubicin Hydrochloride - Drug: Tamoxifen **Label:** Treatment (tamoxifen, pegylated liposomal doxorubicin) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment (tamoxifen, pegylated liposomal doxorubicin) **Description:** Undergo tumor biopsy **Name:** Biopsy **Other Names:** - BIOPSY_TYPE - Bx **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Treatment (tamoxifen, pegylated liposomal doxorubicin) **Description:** Undergo blood sample collection **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Treatment (tamoxifen, pegylated liposomal doxorubicin) **Description:** Undergo CT scan **Name:** Computed Tomography **Other Names:** - CAT - CAT Scan - Computed Axial Tomography - Computerized Axial Tomography - Computerized axial tomography (procedure) - Computerized Tomography - Computerized Tomography (CT) scan - CT - CT Scan - tomography **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Treatment (tamoxifen, pegylated liposomal doxorubicin) **Description:** Undergo echocardiography **Name:** Echocardiography **Other Names:** - EC **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Treatment (tamoxifen, pegylated liposomal doxorubicin) **Description:** Undergo MRI **Name:** Magnetic Resonance Imaging **Other Names:** - Magnetic Resonance - Magnetic Resonance Imaging (MRI) - Magnetic resonance imaging (procedure) - Magnetic Resonance Imaging Scan - Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance - MR - MR Imaging - MRI - MRI Scan - MRIs - NMR Imaging - NMRI - Nuclear Magnetic Resonance Imaging - sMRI - Structural MRI **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Treatment (tamoxifen, pegylated liposomal doxorubicin) **Description:** Given IV **Name:** Pegylated Liposomal Doxorubicin Hydrochloride **Other Names:** - ATI-0918 - Caelyx - Dox-SL - Doxil - Doxilen - Doxorubicin HCl Liposomal - Doxorubicin HCl Liposome - Doxorubicin Hydrochloride Liposome - Duomeisu - Evacet - LipoDox - Lipodox 50 - Liposomal Adriamycin - Liposomal Doxorubicin Hydrochloride - Liposomal-Encapsulated Doxorubicin - Pegylated Doxorubicin HCl Liposome - Pegylated Liposomal Doxorubicin - S-Liposomal Doxorubicin - Stealth Liposomal Doxorubicin - TLC D-99 **Type:** DRUG #### Intervention 7 **Arm Group Labels:** - Treatment (tamoxifen, pegylated liposomal doxorubicin) **Description:** Given PO **Name:** Tamoxifen **Other Names:** - TMX **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized using frequencies and relative frequencies. **Measure:** Overall response rate **Time Frame:** Up to 4 years #### Secondary Outcomes **Description:** Per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be summarized by attribution and grade using frequencies and relative frequencies. **Measure:** Incidence of adverse events **Time Frame:** Until progression or end of treatment, up to 4 years **Description:** Will be summarized using standard Kaplan-Meier methods, where the median times will be estimated with 90% confidence intervals. **Measure:** Duration of response **Time Frame:** From initial response to disease progression (per RECIST version1.1) up to 4 years **Description:** Will be summarized using standard Kaplan-Meier methods, where the median times will be estimated with 90% confidence intervals. **Measure:** Overall survival **Time Frame:** From treatment initiation until death due to any cause, up to 4 years **Description:** Will be summarized using standard Kaplan-Meier methods, where the median times will be estimated with 90% confidence intervals. **Measure:** Progression free survival **Time Frame:** From treatment initiation until disease progression or death due to any cause, up to 4 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines of therapy in the metastatic setting * Patients must have ERα (estrogen receptor alpha) and PgR (progesterone receptor) status assessed using current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Patients are eligible if the tumor staining is ERα low/negative (ER ≤ 10%) and PgR negative by ASCO/CAP guidelines * The tumor must be HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative * Patients must be ≥ 18 years of age * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Absolute neutrophil count (ANC) ≥ 1500/ μL * Hemoglobulin (hb) ≥ 9 g/dL * Platelet count ≥ 100,000/ μL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x ULN * Creatinine clearance \> 60 mL/min (Cockroft-Gault Equation) * Left ventricular ejection fraction (LVEF) assessment must be performed within 30 days prior to enrollment. (LVEF assessment performed by 2-D echocardiogram is preferred; however, multigated acquisition scan \[MUGA\] scan may be substituted based on institutional preferences). The LVEF must be ≥ 50% regardless of the cardiac imaging facility's lower limit of normal * Patients must be able to swallow oral medications * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients must not have any known contraindications to endocrine therapy, in the opinion of the treating investigator * Participants who have had chemotherapy, hormonal/endocrine therapy, immunotherapy, biologics or radiotherapy (as well as any other investigational agents/devices) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Have a known history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or any of its excipients * Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, transient ischemic attack (TIA), or pulmonary embolism * Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness * Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimen. This includes angina pectoris, arrhythmias except for benign premature ventricular contractions, a history of myocardial infarction, documented congestive heart failure (CHF) or cardiomyopathy * Patients with cirrhosis or severe hepatic impairment * Patients must not have a condition or an uncontrolled intercurrent illness including, but not limited to any of the following: ongoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection (UTI), or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Buffalo **Contacts:** ***Contact 1:*** - **Email:** Sheheryar.Kabraji@roswellpark.org - **Name:** Sheheryar Kabraji - **Phone:** 716-845-3429 - **Role:** CONTACT ***Contact 2:*** - **Name:** Sheheryar Kabraji - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Roswell Park Cancer Institute **State:** New York **Zip:** 14263 #### Overall Officials **Official 1:** **Affiliation:** Roswell Park Cancer Institute **Name:** Sheheryar Kabraji **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative Breast Cancer - 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: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000001943 - Term: Breast Neoplasms - ID: D000064726 - Term: Triple Negative Breast Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000004965 - Term: Estrogen Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000020845 - Term: Selective Estrogen Receptor Modulators - ID: D000020847 - Term: Estrogen Receptor Modulators - ID: D000050071 - Term: Bone Density Conservation Agents ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M16403 - Name: Tamoxifen - Relevance: HIGH - As Found: Less than - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Women - ID: M227339 - Name: Liposomal doxorubicin - Relevance: HIGH - As Found: Tip - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M8114 - Name: Estrogen Antagonists - Relevance: LOW - As Found: Unknown - ID: M30483 - Name: Estrogen Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: 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: M22597 - Name: Selective Estrogen Receptor Modulators - Relevance: LOW - As Found: Unknown - ID: M22599 - Name: Estrogen Receptor Modulators - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000013629 - Term: Tamoxifen - ID: D000004317 - Term: Doxorubicin - ID: C000506643 - Term: Liposomal doxorubicin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434051 **Brief Title:** The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial **Official Title:** The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial #### Organization Study ID Info **ID:** Manipulation CGH #### Organization **Class:** OTHER **Full Name:** Hong Kong Baptist University ### Status Module #### Completion Date **Date:** 2026-03-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hong Kong Baptist University #### Responsible Party **Investigator Affiliation:** Hong Kong Baptist University **Investigator Full Name:** CHOW Chi Ho **Investigator Title:** Associate Professor of Practice **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background Cervical spondylosis is a prevalent condition. Studies has shown that it is a leading cause for headache, which is termed cervicogenic headache (CGH). The prevlance of CGH among severe headache is 17.5%. While conventional treatments, such as physical therapy and surgery, is effective in controlling symptoms, the effect was found to be short-lasting. There is existing clinical evidence supporting traditional Chinese cervical manipulation (CCM) as a viable treatment for CGH. Objective To preliminarily assess the feasibility, safety, and effectiveness of CCM on patients with CGH, and to optimize parameters for a future large-scale trial. Method This study is a pilot randomized, controlled, single-blind trial. 84 participants will be randomized evenly to receive either CCM or sham manipulation for 4 weeks. Outcome measurements will be conducted at baseline, week 2, week 4 and week 8 on cervical functional disability, cervical range of motion, and data on headache onset and painkiller assumption. Adverse events will be recorded using the Common Terminology Criteria for Adverse Events (CTCAE). ### Conditions Module **Conditions:** - Cervicogenic Headache ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This intervention involves cervical mobilization that constitutes elements of cervical rotation and traction. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The CMP will first palpate the transverse processes of C1 and C2. The transverse process with apparent tenderness will be regarded as the pain side. The right side will be the painful side for the following example). During the manipulation, the CMP will use his left hand to support the lower jaw and passively rotate the neck to the left side by 70-75 degrees (or to the maximum angle without discomfort). The physician's right-hand fingers will support the left-side transverse processes of C1 and C2, and the thumb and thenar muscle will be placed on the spinous process and occipital area. While maintaining a passive left neck rotation, the physician will increase the rotation angle by 5-10 degrees with both hands under a sudden pulling force. The above procedure will be repeated on the right side (pain side). **Intervention Names:** - Other: Traditional Chinese cervical manipulation **Label:** Traditional Chinese cervical manipulation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The posture and position of the participant and the practitioner and the procedure are the same as the CCM technique. The right side will be regarded as the pain side once again. When performing the sham technique, the CMP uses the left hand to support the lower jaw position and passively rotates the neck to the left side by 70-75 degrees or to the maximum angle. The right hand presses the upper inner corner of the right scapula. While maintaining the passive left rotation of the neck, the right hand slowly exerts force downwards and outwards on the inner side of the scapula. The left hand only maintains the left rotation of the neck without any pulling force. After completion, repeat the above actions on the right side. After the technique is completed, participants can get up after resting for 5-10 minutes. **Intervention Names:** - Other: Sham manipulation **Label:** Sham manipulation **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Traditional Chinese cervical manipulation **Description:** The CMP will first palpate the transverse processes of C1 and C2. The transverse process with apparent tenderness will be regarded as the pain side. The right side will be the painful side for the following example). During the manipulation, the CMP will use his left hand to support the lower jaw and passively rotate the neck to the left side by 70-75 degrees (or to the maximum angle without discomfort). The physician's right-hand fingers will support the left-side transverse processes of C1 and C2, and the thumb and thenar muscle will be placed on the spinous process and occipital area. While maintaining a passive left neck rotation, the physician will increase the rotation angle by 5-10 degrees with both hands under a sudden pulling force. The above procedure will be repeated on the right side (pain side). **Name:** Traditional Chinese cervical manipulation **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Sham manipulation **Description:** The posture and position of the participant and the practitioner and the procedure are the same as the CCM technique. The right side will be regarded as the pain side once again. When performing the sham technique, the CMP uses the left hand to support the lower jaw position and passively rotates the neck to the left side by 70-75 degrees or to the maximum angle. The right hand presses the upper inner corner of the right scapula. While maintaining the passive left rotation of the neck, the right hand slowly exerts force downwards and outwards on the inner side of the scapula. The left hand only maintains the left rotation of the neck without any pulling force. After completion, repeat the above actions on the right side. After the technique is completed, participants can get up after resting for 5-10 minutes. **Name:** Sham manipulation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It is used to evaluate cervical functional disability It has good reliability and validity, reflecting the degree of limitation on living ability and the impact on quality of life. The higher the score, the more severe the symptoms. **Measure:** Neck Disability Index (NDI) scoring **Time Frame:** Baseline, week 2, week 4 and week 8 #### Secondary Outcomes **Description:** to evaluate the range neck flexion, extension, left and right lateral flexion, left and right rotation. The measuring instrument will be the cervical goniometer. **Measure:** Active cervical range of motion **Time Frame:** Baseline, week 2, week 4 and week 8 **Description:** All participants are required to complete an online headache diary daily. It will include the following items: the time of headache onset, duration, pain intensity, and the type and frequency of painkillers taken **Measure:** Online headache diary: **Time Frame:** Baseline, week 2, week 4 and week 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The diagnostic criteria of cervical spondylosis according to "The expert consensus on the classification, diagnosis, and non-surgical treatment of cervical spondylosis (2018)" are as follows: 1. Patients must have a chief complaint of abnormal sensations such as pain in the occipital, neck, or shoulder area, and can be accompanied by related localized pain and tenderness 2. X-ray imaging shows degenerative changes in the cervical spine 3. Other conditions that could cause symptoms of the neck are excluded 2. The diagnostic criteria of CGH as listed by ICHD-3: a. Any headache fulfilling criterion C b. Clinical and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache c. Evidence of causation demonstrated by at least two of the following: i. headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion ii. headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion iii. cervical range of motion is reduced and headache is made significantly worse by provocative manoeuvre iv. headache is abolished following diagnostic blockade of a cervical structure or its nerve supply v. Not better accounted for by another ICHD-3 diagnosis 3. Of age between 18 to 65 years old 4. Headache recurs for at least three months 5. The frequency of headaches in the past three months is at least once a week 6. The frequency, dosage, and type of painkillers have remained stable over the past 6 weeks 7. Score at least 10 points on the Neck Disability Index - Exclusion Criteria: 1. Presented with red flag presentations of headache listed in the SNNOOP10 list (systemic symptoms/signs and disease, neurologic symptoms or signs, onset sudden or onset after the age of 40 years, and change of headache pattern), including fever, vascular and non-vascular intracranial diseases, history of brain tumor, brain neurological dysfunction or disorder, etc. 2. With suspected cervical spinal stenosis, cervical spinal cord lesions, cervical vascular disease, cervical nerve root disease, cervical instability, or cervical fracture 3. Has suffered from a whiplash injury within the past 6 weeks 4. Had surgery on the neck or head 5. Currently pregnant or breastfeeding **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:** barton@hkbu.edu.hk **Name:** Chi Ho Chow, Phd **Phone:** 34118728 **Role:** CONTACT #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Hong Kong Baptist University **Location 2:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000051271 - Term: Headache Disorders, Secondary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M9351 - Name: Headache - Relevance: HIGH - As Found: Headache - ID: M26669 - Name: Post-Traumatic Headache - Relevance: HIGH - As Found: Cervicogenic Headache - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M26658 - Name: Headache Disorders, Secondary - 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: D000051298 - Term: Post-Traumatic Headache - ID: D000006261 - Term: Headache ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434038 **Acronym:** INI-CSF-MA **Brief Title:** Measurement of Insulin Levels in the Cerebrospinal Fluid of Healthy Adults After a Single Intranasal Dose - Middle Age **Official Title:** Measurement of Insulin Levels in the Cerebrospinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose - Middle Age #### Organization Study ID Info **ID:** A22-210 #### Organization **Class:** OTHER **Full Name:** HealthPartners Institute #### Secondary ID Infos **Domain:** Department of Defense **ID:** CDMRP-SC220220 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Uniformed Services University of the Health Sciences **Class:** FED **Name:** United States Department of Defense #### Lead Sponsor **Class:** OTHER **Name:** HealthPartners Institute #### 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 find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with neurological diseases such as mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes. 18 healthy middle-aged adults will be randomly assigned to receive a single intranasal dose of 40 units insulin ("low dose" group), 80 units insulin ("high dose" group), or saline (placebo, or control group). Participants will undergo an image-guided lumbar puncture (spinal tap) performed by a study clinician. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of insulin to reach the brain after intranasal administration. ### Conditions Module **Conditions:** - Healthy **Keywords:** - insulin - intranasal - Healthy Adults - Middle Age ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants will be randomized into one of 3 groups: 40 IU insulin, 80 IU insulin, or saline control. ##### Masking Info **Masking:** SINGLE **Masking Description:** Single-blind **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device. **Intervention Names:** - Drug: Low Dose Regular insulin **Label:** Low dose intranasal insulin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device. **Intervention Names:** - Drug: High Dose Regular insulin **Label:** High dose Intranasal Insulin **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** One dose of 0.9% saline administered intranasally using the SipNose SP1N1C1 device **Intervention Names:** - Other: 0.9% Saline **Label:** Placebo Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Low dose intranasal insulin **Description:** Administered intranasally at 40 IU **Name:** Low Dose Regular insulin **Other Names:** - Novolin-R **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - High dose Intranasal Insulin **Description:** Administered Intranasally at 80 IU **Name:** High Dose Regular insulin **Other Names:** - Novolin-R **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo Control **Description:** Placebo control **Name:** 0.9% Saline **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30, 40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard error. **Measure:** Concentration of insulin over Time - Cerebrospinal fluid **Time Frame:** 0-40 minutes post-intranasal administration **Description:** CSF insulin concentration will also be reported by Cmax (peak concentration) **Measure:** Cmax of insulin concentration- Cerebrospinal Fluid **Time Frame:** 0-40 minutes post- intranasal administration **Description:** CSF insulin concentration will also be reported by Tmax (time of peak concentration) **Measure:** Tmax of insulin concentration-Cerebrospinal FLuid **Time Frame:** 0-40 minutes post-intranasal administration **Description:** CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration) **Measure:** AUC (area under the curve) of insulin concentration-Cerebrospinal Fluid **Time Frame:** 0-40 minutes post-intranasal administration #### Secondary Outcomes **Description:** Insulin concentration detected in blood at 5 time points (pre-insulin dose; and 10, 20, 30, 40 minutes after dose). Values will be reported at μIU/mL. Higher values indicate a greater concentration of insulin in the blood. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard error. **Measure:** Insulin Concentration Over Time- Serum **Time Frame:** 0-40 minutes post-intranasal administration **Description:** Serum insulin concentration will also be reported by Cmax (peak concentration) **Measure:** Cmax of insulin concentration - Serum **Time Frame:** 0-40 minutes post-intranasal adminitration **Description:** Serum insulin concentration will also be reported by Tmax (time to peak concentration) **Measure:** Tmax of insulin - Serum **Time Frame:** 0-40 minutes post-intranasal administration **Description:** Serum insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration). **Measure:** AUC (area under the curve) of insulin concentration - Serum **Time Frame:** 0-40 minutes post-intranasal administration ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject is between ≥36 and ≤ 55 years of age 2. Subject's BMI is between \>=18.5 and \<=24.9, or can safely undergo a lumbar puncture at the discretion of the radiologist 3. MOCA score ≥26 4. Subject must be proficient in speaking English to comply with instructions and measures for the study 5. Subject can provide written informed consent 6. Female subjects must have either: (1) a negative pregnancy test at the screening visit and treatment visit OR (2) be at least 2 years post-menopausal / surgically sterile. Exclusion Criteria: 1. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies. 2. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator 3. Subject has participated in a clinical trial investigation within 3 months of this study. 4. Subject has an insulin allergy 5. Subject has Insulin-dependent diabetes 6. Subject is pregnant or breast feeding 7. Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion 8. Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 36 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Meghan.E.Obrien@HealthPartners.com **Name:** Meghan E O'Brien **Phone:** 651-495-6363 **Role:** CONTACT **Contact 2:** **Email:** Bethany.K.Crouse@HealthPartners.com **Name:** Bethany K Crouse, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Saint Paul **Contacts:** ***Contact 1:*** - **Email:** Meghan.E.Obrien@HealthPartners.com - **Name:** Meghan E O'Brien - **Role:** CONTACT ***Contact 2:*** - **Email:** Bethany.K.Crouse@HealthPartners.com - **Name:** Bethany K Crouse, PhD - **Role:** CONTACT ***Contact 3:*** - **Name:** Leah R Hanson, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** HealthPartners Neuroscience Center **State:** Minnesota **Zip:** 55130 #### Overall Officials **Official 1:** **Affiliation:** HealthPartners Institute **Name:** Leah R Hanson, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Uniformed Services University of the Health Sciences **Name:** Kimberly Byrnes, PhD **Role:** PRINCIPAL_INVESTIGATOR ### 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 ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: HIGH - As Found: Premenopausal - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: C000557859 - Term: Insulin, Globin Zinc ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434025 **Acronym:** COMBINED-HF **Brief Title:** IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency **Official Title:** Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency. #### Organization Study ID Info **ID:** 78861724.0.0000.5327 #### Organization **Class:** OTHER **Full Name:** Hospital de Clinicas de Porto Alegre #### Secondary ID Infos **Domain:** AGH-Use HCPA **ID:** 2023-0428 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-11-24 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Vifor Pharma #### Lead Sponsor **Class:** OTHER **Name:** Hospital de Clinicas de Porto Alegre #### Responsible Party **Investigator Affiliation:** Hospital de Clinicas de Porto Alegre **Investigator Full Name:** Luis Beck Da Silva Neto **Investigator Title:** Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content. This study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deficiency. **Detailed Description:** Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content. This study aims to measure cardiac magnetic resonance changes in myocardial iron content after administration of intravenous iron and to assess changes in left ventricular function in patients with HFrEF and iron deficiency. Methods. Ninety-nine outpatient with symptomatic HFrEF, left ventricular ejection fraction (LVEF) \<40%, SGLT2i naive, and iron deficiency will be assigned, to receive intravenous iron + SGLT2i; or intravenous iron + placebo of SGLT2i; or placebo of both therapies for 30 days. Myocardial iron will be evaluated by T2-star (T2\*) cardiac magnetic resonance (CMR) sequencing before intravenous iron infusion. After 30 days, all patients will be reassessed by T2\* CMR sequencing. The primary endpoint will be changes in LVEF and myocardial iron content at 30 days. Secondary endpoints will include correlations of these changes with myocardial iron content, functional capacity, quality of life, and cardiac biomarkers. Conclusions. This study will determine the effect of ferric carboxymaltose and its combination with SGLT2i on LVEF and its relationship with measures of myocardial iron content, functional capacity, and biomarkers in HFrEF and iron deficiency. ### Conditions Module **Conditions:** - Heart Failure, Systolic - Iron Deficiencies **Keywords:** - heart failure - iron deficiency - SGLT2 inhibitor - intravenous iron - clinical trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** HFrEF, LVEF \<40%, SGLT2i naive, and iron deficiency. Assigned to receive: 1. intravenous iron + SGLT2i; 2. intravenous iron + placebo of SGLT2i; 3. placebo of both therapies. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 99 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, CSL-Vifor) IV, once; and Dapagliflozin 10 mg PO, OD, for 30 days. **Intervention Names:** - Drug: Iron Carboxymaltose **Label:** IV iron + SGLT2 inhibitor **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, CSL-Vifor) IV, once; and placebo PO, OD, for 30 days. **Intervention Names:** - Drug: Iron Carboxymaltose **Label:** IV iron + placebo of SGLT2 inhibitor **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Patients will receive 2 vials of placebo IV, once; and placebo PO, OD, for 30 days. **Intervention Names:** - Drug: Iron Carboxymaltose **Label:** Placebo of IV iron and placebo of SGLT2 inhibitor **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - IV iron + SGLT2 inhibitor - IV iron + placebo of SGLT2 inhibitor - Placebo of IV iron and placebo of SGLT2 inhibitor **Description:** Combination of Iron Carboxymaltose and Dapagliflozin **Name:** Iron Carboxymaltose **Other Names:** - Dapagliflozin **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** distance walked in six minute walk test **Measure:** six minute walk test (6MWT) **Time Frame:** 30 days **Description:** NT-terminal pro-B-type natriuretic peptide (NT-proBNP) levels **Measure:** NT-proBNP **Time Frame:** 30 days **Description:** Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire **Measure:** MLHFQ **Time Frame:** 30 days **Description:** Serum Hepcidin levels **Measure:** Hepcidin **Time Frame:** 30 days **Description:** Reticulocyte hemoglobin content **Measure:** Reticulocyte hemoglobin content **Time Frame:** 30 days **Description:** Transferrin soluble receptors **Measure:** Transferrin soluble receptors **Time Frame:** 30 days **Description:** Glomerular filtration rate **Measure:** Glomerular filtration rate **Time Frame:** 30 days #### Primary Outcomes **Description:** LVEF assessed by Cardiac Magnetic Ressonance **Measure:** left ventricular function assessed (LVEF) by CMR. **Time Frame:** 30 days #### Secondary Outcomes **Description:** Myocardial iron content assessed by T2\* CMR **Measure:** Myocardial iron content assessed by T2* CMR **Time Frame:** 30 days **Description:** myocardial strain assessed by T2\* CMR **Measure:** myocardial strain assessed by T2* CMR **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18 years or over; 2. Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography; 3. Serum ferritin \<100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation \<20%; 4. Serum hemoglobin between 9.5 and 13.5 mg/dL; 5. Patients must be SGLT2 naive; 6. Informed consent form (ICF) signed. Exclusion Criteria: 1. Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular filtration rate \<30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; 2. Severe primary valve disease; 3. Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months; 4. Patients already being treated for some type of non-iron deficiency anemia; 5. Blood transfusion within 30 days prior to CMR examination; 6. Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator; 7. Diagnosis of hemochromatosis. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lbneto@hcpa.edu.br **Name:** LUIS BECK DA SILVA, MD ScD **Phone:** 55 51 997330870 **Role:** CONTACT #### Locations **Location 1:** **City:** Porto Alegre **Contacts:** ***Contact 1:*** - **Email:** apbsilveira@hcpa.edu.br - **Name:** Ana Paula Silveira, BMD - **Phone:** 55 51 33596223 - **Role:** CONTACT ***Contact 2:*** - **Email:** mraymundo@hcpa.edu.br - **Name:** Marcia Raymundo - **Phone:** 55 51 33596224 - **Role:** CONTACT **Country:** Brazil **Facility:** Hospital de Clínicas de Porto Alegre **State:** RS **Zip:** 90450120 #### Overall Officials **Official 1:** **Affiliation:** Hospital de Clinicas de Porto Alegre **Name:** LUIS BECK DA SILVA, MD ScD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: HIGH - As Found: Iron Deficiency - ID: M2781 - Name: Iron Deficiencies - Relevance: HIGH - As Found: Iron Deficiency - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M27579 - Name: Heart Failure, Systolic - Relevance: HIGH - As Found: Heart Failure, Systolic - ID: M27583 - Name: Systolic Murmurs - Relevance: LOW - As Found: Unknown - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M21177 - Name: Iron Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M4077 - Name: Anemia, Hypochromic - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000054143 - Term: Heart Failure, Systolic - ID: D000018798 - Term: Anemia, Iron-Deficiency - ID: D000090463 - Term: Iron Deficiencies ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M348449 - Name: Dapagliflozin - Relevance: HIGH - As Found: COPD - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000529054 - Term: Dapagliflozin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06434012 **Brief Title:** Barts Endocarditis Research Registry **Official Title:** Barts Endocarditis Research Registry #### Organization Study ID Info **ID:** 249740 #### Organization **Class:** OTHER **Full Name:** Queen Mary University of London ### Status Module #### Completion Date **Date:** 2029-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2029-04-24 **Type:** ESTIMATED #### Start Date **Date:** 2019-04-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Queen Mary University of London #### Responsible Party **Investigator Affiliation:** Queen Mary University of London **Investigator Full Name:** Innocent Bvekerwa **Investigator Title:** Mr **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The Barts Endocarditis Research Registry is being set up to give a unique opportunity to assess the characteristics of Infective Endocarditis (IE) in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies. The endocarditis research registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment. We have a series of studies planned that we believe will influence the management of endocarditis (we are working up proposals for genomic and therapeutic trials that will subsequently be presented for ethical and hospital approval). The registry will be generic to all our planned studies, and will allow us to capture data to assess treatment effectiveness **Detailed Description:** This research registry will give us the unique opportunity to assess the characteristics of IE in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies. Infective endocarditis (IE) is a rare but serious disease, associated with high morbidity and in-hospital mortality. Despite improvements in diagnostic and therapeutic strategies the mortality remains at 15-30% in most published studies. The reasons for this persistent poor prognosis are numerous and include older patients with more severe disease, changes in the epidemiologic profiles and more patients with prosthetic or device related IE. Following the formation of Barts Heart Centre (BHC) there was a sharp and noticeable increase in the number of patients with infective endocarditis (IE) referred to our centre. Recognising this change, the complexity of patients, and the coincident publication of the European Society of Cardiology Guidelines on Infective Endocarditis (2015), our Specialised Cardiology Directorate set up a new referral pathway, Standard Operating Procedure and Endocarditis Team meeting (MDT). The aim was to ensure focussed, consistent, and evidence-based care with joint medical and surgical input to this unique group of very unwell patients, with high inpatient mortality. In addition, the MDT would discuss and co-ordinate the care of all IE patients, with a weekly discussion of those on site, as well as at our referring hospitals. The MDT started in October 2015 and is composed of representatives from Cardiology (including imaging), Cardiac Surgery, Microbiology, Radiology/Nuclear Medicine and Pharmacy. Since its inception, the MDT has discussed 367 patients at BHC and our wider referral centres (October 2015 - January 2018). Of those patients, 298 have been confirmed/probable as having IE: 144 surgically managed; 139 medically managed; 16 device extractions with intracardiac infection, all following international guidance. This does not include the grown-up congenital heart disease patients who are discussed and managed separately. An audit database to track outcomes was started in January 2018, but there is a need to expand this work and make a registry that will form the foundation of all other research that we will undertake. Mortality across the cohort has been at the lower end of international publications at 17.1% (51/298). Our current surgical mortality stands at 4.7% (14/298), which represents a significant reduction compared to pre-merger where combined mortality at the individual hospitals was 12.2%. In those patients who have died with medical management (37/51), the vast majority have had advanced life-limiting non-cardiac co-morbidities that preclude cardiac surgery (n=19) or on-going intravenous drug use after previous cardiac surgery for IE (n=6). Six patients have not been referred in time for surgery, having presented locally with septic shock and deteriorated rapidly, and this is an area of further education for our referring centres. Six patients have had operations without intra-operative evidence of infection. However, these patients had indications for surgery due to haemodynamically significant regurgitant valve disease. Our morbidity and mortality reviews have allowed us to learn from all these cases, across all specialties and imaging modalities. Not only has this approach led to improvements in patient care, but it has also raised the profile of BHC as a centre of special expertise. Our referring centres now include the DGH's of Barts Health NHS Trust (Whipps Cross University Hospital, Newham University Hospital, and The Royal London Hospital), plus many other district general hospitals in our locale. ### Conditions Module **Conditions:** - Infective Endocarditis - Endocarditis - Endocarditis, Bacterial ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** This is registry for Infective Endocarditis **Name:** registry **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment. **Measure:** To define current mortality, morbidity, reinfection and relapse rates for patients treated at Barts Heart Centre **Time Frame:** 10 years #### Secondary Outcomes **Description:** A secondary aim will be to use the registry to develop a series of observational studies, especially how the infecting organism interacts with the diagnostic indices in our labs and imaging protocols **Measure:** To collect data regarding infecting organism, valve appearances and pathological markers and investigate their relationship to mortality, morbidity, reinfection and relapse rates **Time Frame:** 10 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Patients aged 16 and over (Patients under 16 years of age are not admitted to Barts Heart Centre) * Patients admitted to Barts Heart Centre with confirmed Endocarditis (see above) * Patients attending outpatients with confirmed/suspected Endocarditis * Patients with possible IE who complete treatment for endocarditis * Patients with cardiac device related Endocarditis * Patients with the ability to provide informed consent Exclusion Criteria: * • Patients with pacemaker pocket infection with no evidence of pacemaker lead or valve infection * Patients who refuse consent to be included in the research database * Patients with "rejected" endocarditis **Minimum Age:** 16 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** There are approximately 150 cases of endocarditis each year treated within the trust and recruitment is expected to be rapid ### Contacts Locations Module #### Locations **Location 1:** **City:** London **Country:** United Kingdom **Facility:** St Bartholomews Hospital #### Overall Officials **Official 1:** **Affiliation:** St Bartholomews Hospital **Name:** Simon Woldman, MSc **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000053821 - Term: Cardiovascular Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - 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: M7859 - Name: Endocarditis, Bacterial - Relevance: HIGH - As Found: Endocarditis, Bacterial - ID: M7858 - Name: Endocarditis - Relevance: HIGH - As Found: Endocarditis - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M27489 - Name: Cardiovascular Infections - Relevance: LOW - As Found: Unknown - ID: T3065 - Name: Infective Endocarditis - Relevance: HIGH - As Found: Infective Endocarditis ### Condition Browse Module - Meshes - ID: D000004697 - Term: Endocarditis, Bacterial - ID: D000004696 - Term: Endocarditis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433999 **Brief Title:** A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis **Official Title:** A 12-Week Open-Label Pilot Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Skin-Predominant Dermatomyositis #### Organization Study ID Info **ID:** PVT-2201-202 #### Organization **Class:** INDUSTRY **Full Name:** Priovant Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Priovant Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks. ### Conditions Module **Conditions:** - Dermatomyositis - Dermatomyositis, Adult Type **Keywords:** - skin-predominant dermatomyositis - dermatomyositis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 5 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Brepocitinib 30 mg **Label:** Arm 1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 1 **Description:** Oral Brepocitinib 30 mg PO QD **Name:** Brepocitinib 30 mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** The primary endpoint is the change in CDASI-A score from baseline through Week 12 **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies * At least 2 of the following skin characteristics of dermatomyositis at screening; * Gottron's papules; * Gottron's sign; * Heliotrope rash; * Nailfold changes; * Photo distributed violaceous erythema; * History of positive dermatomyositis serology (e.g., transcriptional intermediary factor 1-lambda \[TIF1-λ\], nuclear matrix protein 2 \[NXP2\], nucleosome-remodelling deactylase complex, Mi2, melanoma differentiation antigen 5 \[MDA5\], small ubiquitin-like modifier activating enzyme 1/2, or anti-transfer ribonucleic acid \[tRNA\] synthetase). * For participants with onset of dermatomyositis symptoms within 3 years prior to screening, have a documented CT (or PET-CT) scan with contrast of the chest, abdomen, and pelvis, taken after the onset of symptoms and within 1 year prior to screening, without findings suggestive of malignancy. * Current therapy consisting of corticosteroid ≤ 20 mg/day (including a dose of 0 mg \[i.e., not taking corticosteroid\]) of prednisone or equivalent * At most, one systemic non-steroid immunomodulatory/immunosuppressive therapy * Adult subjects (18-75 years old) * Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) \< 40 kg/m2. Exclusion Criteria: * Dermatomyositis with end-stage organ involvement * Dermatomyositis with irreversible muscle involvement History of: * Any lymphoproliferative disorder * Active malignancy; * History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis * Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome) * Participants at a risk of thrombosis or cardiovascular disease * Participants with a high risk for herpes zoster reactivation * Participants with active or recent infections **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lindsey.rios@priovanttx.com **Name:** Lindsey Rios, BS **Phone:** (860) 307-5311 **Role:** CONTACT **Contact 2:** **Email:** matt.cascino@priovanttx.com **Name:** Matt Cascino, MD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Mangold, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017285 - Term: Polymyositis - ID: D000009220 - Term: Myositis - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7077 - Name: Dermatomyositis - Relevance: HIGH - As Found: Dermatomyositis - ID: M19579 - Name: Polymyositis - Relevance: LOW - As Found: Unknown - ID: M12172 - Name: Myositis - 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: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T1814 - Name: Dermatomyositis - Relevance: HIGH - As Found: Dermatomyositis - ID: T4623 - Name: Polymyositis - Relevance: LOW - As Found: Unknown - ID: T3001 - Name: Idiopathic Inflammatory Myopathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003882 - Term: Dermatomyositis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433986 **Brief Title:** MCAT Versus VISTA With Volume Stable Collagen Matrix in RT3 Gingival Recession **Official Title:** Management of Isolated RT 3 Gingival Recession With Modified Coronally Advanced Tunnel Versus Vestibular Incision Subperiosteal Tunnel Access With Volume Stable Collagen Matrix: A RCT #### Organization Study ID Info **ID:** Rohan Goyal Perio 24/35 #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Postgraduate Institute of Dental Sciences Rohtak #### 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 compare MCAT technique (supraperiosteal approach with coronal advancement of flap) with VISTA technique(subperiosteal approach with coronal advancement of flap), Further, it may be hypothesized that supraperiosteal placement of graft material (in MCAT technique) may be better due to better blood supply, and MCAT technique utilizes a microsurgical concept, including microsurgical blades and suture material, which improves wound healing and establishes a better esthetic result and results in better outcome in terms of root coverage percentage compared to VISTA. Therefore, this study aims to compare minimally invasive technique MCAT and VISTA using VCMX as a graft in RT3 gingival recession in anterior teeth. **Detailed Description:** Gingival recession is the migration of the gingiva to a point apical to the cement-enamel junction and is considered one of the most common periodontal problems.Besides aesthetic complaints, GR may also cause root hypersensitivity, risk for development of caries or non-carious cervical lesions, and difficulties to achieve optimal plaque control. In modified coronally advanced Tunnel (MCAT) technique partial-thickness flap is created on the entire buccal aspect, no parts of the alveolar bone are exposed, and resorption of bony structures, which occurs when using a full-thickness flap can be avoided, also,it minimizes trauma and ensure a better blood supply for the graft. Zadeh H. in 2011 introduced a conservative modification in tunnel technique; vestibular incision subperiosteal tunnel access (VISTA) which preserve the papillary integrity and enhances patients compliance. Vista technique allows gingival tissue regeneration through subperiosteal undermining of soft tissues using a vestibular incision instead of elevating the whole flap.VISTA offers broader access and maximum esthetic outcome because of placement of incision in the frenum region. ### Conditions Module **Conditions:** - Gingival Recession **Keywords:** - gingival recession - esthetics - phenotype ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 34 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT. **Intervention Names:** - Procedure: Modified Coronally Advanced Tunnel (MCAT)Technique **Label:** Modified Coronally Advanced Tunnel (MCAT)Technique **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA. **Intervention Names:** - Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique **Label:** Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Modified Coronally Advanced Tunnel (MCAT)Technique **Description:** Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT. **Name:** Modified Coronally Advanced Tunnel (MCAT)Technique **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique **Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA. **Name:** Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** percentage of root coverage will be calculated by using pre and post operative recession depth **Measure:** Root coverage percentage **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** INCLUSION CRITERIA- * Patients with RT 3 isolated recession defects present Labially in Anterior teeth region,with vestibular depth\>=6mm * Systemically healthy individuals. * Age \>18 years old. * A full mouth plaque score (FMPS) and full mouth BOP (FMBOP) \< 20% * Patient showing adequate compliance and willing to participate in the study. EXCLUSION CRITERIA- * Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy. * Previous surgical attempt to correct gingival recession. * Crowding of affected teeth and tooth without adjacent contact teeth. * Patients with active periodontal disease. * Smokers and tobacco users. * Pregnant and lactating women. * Involved tooth with trauma from occlusion * Involved tooth with prosthesis. * Endodontically treated tooth. * Tooth with cervical abrasion/undetectable CEJ/ caries. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drshikhatewari@yahoo.com **Name:** SHIKHA TEWARI, MDS **Phone:** 9416514600 **Role:** CONTACT #### Locations **Location 1:** **City:** Rohtak **Contacts:** ***Contact 1:*** - **Email:** drshikhatewari@yahoo.com - **Name:** Dr. Shikha Tewari, MDS - **Phone:** 09416514600 - **Role:** CONTACT ***Contact 2:*** - **Name:** ROHAN GOYAL - **Role:** PRINCIPAL_INVESTIGATOR **Country:** India **Facility:** PGIDS **State:** Haryana **Zip:** 124001 #### Overall Officials **Official 1:** **Affiliation:** PGIDS, Rohtak **Name:** ROHAN GOYAL, BDS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000055093 - Term: Periodontal Atrophy ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9001 - Name: Gingival Recession - Relevance: HIGH - As Found: Gingival Recession - ID: M1112 - Name: Surgical Wound - Relevance: LOW - As Found: Unknown - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal 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: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M28025 - Name: Periodontal Atrophy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005889 - Term: Gingival Recession ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433973 **Brief Title:** Chorion Membrane With Photobiostimulation ,Chorion Membrane & SCTG in Treating Isolated RT 2 Recession Defects **Official Title:** Comparative Evaluation of Root Coverage Outcome by Using CM With Photobiostimulation ,CM & SCTG in Treating Isolated RT 2 Recession Defects Utilizing Minimally Invasive Technique: A RCT #### Organization Study ID Info **ID:** Anisha Kumari Perio 24/36 #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Postgraduate Institute of Dental Sciences Rohtak #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Gingival recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root. Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III and IV or Cairo RT2 andRT3 gingival recessions (GRs). Taking all this into account, numerous techniques have been attempted to achieve root coverage of single-rooted tooth, Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity.Thus making placental allografts in dentistry a topic of growing interest and recent advancement. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group. **Detailed Description:** Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, therefore, these were classified as Miller class III and IV or Cairo RT2 and RT3 gingival recessions (GRs). The growing emphasis on aesthetics and the desire to minimize patient discomfort have led to the advancement of various mucogingival techniques aimed at covering exposed roots. numerous techniques have been attempted to achieve root coverage of single-rooted tooth. Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity. Thus making placental allografts in dentistry a topic of growing interest and recent advancement. Other advantages like their capacity to self hydrate with blood. While these techniques have proven effective, the integration of devices capable of accelerating wound healing could enhance the outcomes of the latest graft techniques for root coverage, facilitating more predictable results. Progress in low-level laser therapy (LLLT) within Periodontics has empowered periodontists to attain enhanced clinical outcomes. LLLT accelerates wound healing by enhancing the motility of human keratinocytes, stimulating early epithelialization, increasing fibroblast proliferation and matrix synthesis, and promoting neo vascularization. .LLLT induces tissue surface sterilization, there by reducing the risk of bacteremia, and diminishing edema, swelling, and scarring .Additionally, it may provide greater tensile strength and stability to gingival margins, potentially preventing wound failure and reducing clinical recession. Besides all the advantages of LLLT and chorion membrane, there are very few studies which are published using theses two techniques in the recession defects. No prior research has examined the comparative efficacy of SCTG, CM + LLLT and CM for Miller's class III/RT2 recession defects. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group ### Conditions Module **Conditions:** - Gingival Recession ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 51 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Photobiostimulation will be done using of diode laser. **Intervention Names:** - Procedure: Test group 1 - CM+LLLT+VISTA **Label:** Test group 1 - CM+LLLT+VISTA **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. **Intervention Names:** - Procedure: Test group 2 - CM+VISTA **Label:** Test group 2 - CM+VISTA **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique. **Intervention Names:** - Procedure: Control group - SCTG+VISTA **Label:** Control group - SCTG+VISTA **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Test group 1 - CM+LLLT+VISTA **Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. LLLT will be applied on the site for 10 sec. **Name:** Test group 1 - CM+LLLT+VISTA **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Test group 2 - CM+VISTA **Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts. Adequate size of CM will be trimmed and applied over the recession defect using minimally invasive technique and secured with sutures. **Name:** Test group 2 - CM+VISTA **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Control group - SCTG+VISTA **Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique. **Name:** Control group - SCTG+VISTA **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** ( Preoperative recession depth) - (Postoperative recession depth) × 100 Preoperative recession depth **Measure:** Percentage root coverage **Time Frame:** 6 months **Description:** recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction. **Measure:** Keratinised tissue width **Time Frame:** 6 months **Description:** recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the interproximal region **Measure:** interproximal Clinical attachment level (iCAL) **Time Frame:** 6 months #### Secondary Outcomes **Description:** will be recorded as 1(present) if bleeding occurs within 15 seconds of probing and 0(absent) if no bleeding occurs. It will be calculated in percentage %. After adding all the scores, total score will be divided by the total number of surfaces accessed and multiplied by hundred. It will be designed as percentage sites with bleeding on probing **Measure:** Bleeding on probing (BOP) **Time Frame:** 6 months **Description:** recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the mid-buccal region **Measure:** Buccal Clinical attachment level **Time Frame:** 6 months **Description:** The GT will be assessed by probe transparency (TRAN) method . Gingival thickness will be measured from the keratinized mucosa to the periosteum with a finger spreader and a silicon slider and digital calliper at a point lying in the centre of a line drawn from the gingival margin to mucogingival junction **Measure:** change in Gingival thickness **Time Frame:** 6 months **Description:** recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at the mid-labial region. **Measure:** Recession depth **Time Frame:** 6 months **Description:** recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction **Measure:** Recession width **Time Frame:** 6 months **Description:** Measured in mm from the crest of the gingival margin to the base of the pocket at the mid-labial region **Measure:** Pocket probing depth **Time Frame:** 6 months **Description:** The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain. Postoperative pain using visual analog scale at treated site (VAS: a scale from 0-10 ; 0 means no pain/discomfort, 10 means maximum pain /discomfort ) **Measure:** Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS) **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with Millers class3or RT2 isolated recession defects in labial mandibular anterior teeth region. * Systemically healthy individuals. * Absence of clinical tooth mobility. * Age \>18 years old. * A full mouth plaque index \< 20% * Patient showing adequate compliance and willing to participate in the study. Exclusion Criteria: * Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy. * patient with active periodontal disease * smokers and tobacco users * mal-alingned lower anteriors. * patients who had already undergone root coverage procedure on the selected site. * pregnant and lactating females * Involved tooth with trauma from occlusion. * Involved tooth with prosthesis. * Endodontically involved/ RCT treated tooth * Tooth with cervical abrasion / undetectable CEJ/ carious. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drshikhatewari@yahoo.com **Name:** Shikha Tewari, MDS **Phone:** 8708249475 **Role:** CONTACT #### Locations **Location 1:** **City:** Rohtak **Country:** India **Facility:** PGIDS **State:** Haryana **Zip:** 124001 #### Overall Officials **Official 1:** **Affiliation:** PGIDS, Rohtak **Name:** Anisha Kumari, BDS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000055093 - Term: Periodontal Atrophy ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9001 - Name: Gingival Recession - Relevance: HIGH - As Found: Gingival Recession - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal 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: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M28025 - Name: Periodontal Atrophy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005889 - Term: Gingival Recession ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433960 **Brief Title:** Radial Artery Assessment in Surgical Coronary Revascularisation **Official Title:** A Cross-Sectional Study and a Novel Screening Survey for Radial Artery Assessment in Surgical Coronary Revascularisation #### Organization Study ID Info **ID:** 24/SC/0076 #### Organization **Class:** OTHER_GOV **Full Name:** Papworth Hospital NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Papworth Hospital NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this observational study is to learn about how screening tests inform the radial artery (RA) suitability for harvesting and coronary bypass grafting in adults with ischaemic heart disease. The main question it aims to answer is: • What factors influence the diagnostic accuracy of RA screening in patients undergoing surgical coronary revascularisation? Participants will: * Receive an assessment of their RA through routinely used techniques (Modified Allen Test +/- pulse-oximetry, Barbeau Test and Ultrasound examination) * Answer a symptoms scale about their physical experience after surgery **Detailed Description:** A multi-centre cross-sectional study design to investigate the validity of radial artery (RA) assessment techniques in adults with ischaemic heart disease undergoing surgical coronary revascularisation with their RA being selected as an autologous graft conduit. Patients taking part in the study will receive an assessment of the arterial forearm circulation from their non-dominant upper extremity through multiple observations. Pre-operative observations. Before surgery (in the ward environment after the patient is being admitted or whilst patient in the anaesthetic room) the forearm blood circulation is measured through a Modified Allen Test (MAT) (+/- pulse-oximetry), Barbeau Test and Ultrasonography examination. Assessment will be performed by experienced Surgical Care Practitioners/Advanced Nurse Practitioners/Cardiac Specialist Registrars. These assessments will inform the decision to surgically expose the RA. Intra-operative observations. Oxygen saturation readings are taken prior to harvest the RA. Once the RA is surgically harvested a series of measures are taken through a validated structured questionnaire: the Radial Artery Quality Evaluation Survey (RAQES). Observations at 4-6 weeks post operation. Patients finger movements, cold tolerance sensitivity and tactile/touch perception is measured through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale) at post-operative day 2-5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms will be undertaken. A Surgical Care Practitioner will perform this assessment post-operatively. Consecutive sampling will be used for the recruitment of study participants. The minimum required number of participants to test and verify research hypotheses is sixty-nine patients (N=69). An adaptive trial design will be implemented: at quarterly assessment points the statistical power is assessed and the remaining sample size required is updated accordingly. Sample size calculation was undertaken using G\*Power software (version 3.1) using Chi-squared Test and adopting optimal effect size (w=0.4) and power (0.8). Descriptive and inferential statistics will be used to perform quantitative analyses. Descriptive statistics (mode, median) will be implemented to analyse RAQES answers and ordinal symptoms scale findings and cross-tabulation used to record relationship between variables. Data analysis will also include measurement of sensitivity, specificity, positive and negative predictive values to investigate the validity of the RA assessment techniques. Correlational analysis will be implemented and Receiver Operating Characteristic curve analysis will be used to compare the diagnostic accuracy of the MAT, pulse-oximetry guided MAT and Barbeau Test with the ultrasonography examination. ### Conditions Module **Conditions:** - Coronary Artery Bypass Grafting - Coronary Artery Disease **Keywords:** - Radial Artery - Modified Allen Test - Barbeau Test - Ultrasonography ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 69 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals. **Intervention Names:** - Diagnostic Test: Modified Allen Test - Diagnostic Test: Pulse-oximetry guided Modified Allen Test - Diagnostic Test: Barbeau Test - Diagnostic Test: Ultrasound examination of the forearm arteries - Diagnostic Test: Measurement of oxygen saturation - Other: Radial Artery Quality Evaluation Survey - Other: Follow-up Radial Artery Harvesting Scale **Label:** Cardiovascular sample group ### Interventions #### Intervention 1 **Arm Group Labels:** - Cardiovascular sample group **Description:** Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute. Instruct the patient to clench their wrist while the examiner occlude with three fingers the patients ulnar and radial arteries; instruct the patient to unclench their wrist; release the ulnar artery. The MAT result is negative or positive considering in how long the palm flushes: ≤5 seconds: negative MAT; good collateral hand circulation (suggesting harvestable radial artery). greater than 5 seconds: positive MAT; poor collateral hand circulation (suggesting not-harvestable radial artery). **Name:** Modified Allen Test **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Cardiovascular sample group **Description:** Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute. A pulse-oximetry probe is positioned on the patients index finger; both radial and ulnar arteries are occluded by the examiner (with three fingers) until flattening of pulse waveform is obtained. Pressure on the ulnar artery is released and the result of the assessment is calculated considering in how long the pulse waveform returns to baseline: ≤5 seconds: negative result (suggesting harvestable radial artery). greater than 5 seconds: positive result (suggesting not harvestable radial artery). (Busti and Kellogg, 2015) **Name:** Pulse-oximetry guided Modified Allen Test **Type:** DIAGNOSTIC_TEST #### Intervention 3 **Arm Group Labels:** - Cardiovascular sample group **Description:** Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 2 minutes. A pulse-oximetry probe is positioned on the patients thumb; the radial artery is then compressed by the examiner, and the pulse waveform is analysed for up to 120 seconds, providing four result patterns of ulno-palmar patency: 1. No damping of the pulse tracing immediately after compression (suggesting harvestable radial artery) 2. Damping of the pulse tracing (suggesting harvestable radial artery) 3. Loss of the pulse tracing, followed by recovery within 120 sec (suggesting harvestable radial artery) 4. Loss of the pulse tracing, without recovery within 120 sec (suggesting not harvestable radial artery). (Zalocar et al., 2020) **Name:** Barbeau Test **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Cardiovascular sample group **Description:** Pre-operative intervention aimed at evaluating morphological characteristics (diameter, presence of calcifications) of the radial and ulnar arteries. Duration: 5 minutes. The radial artery is surgically exposed (negative result) when the following apply: 1. ulnar artery inner diameter ≥2 mm 2. radial artery inner diameter ≥2 mm 3. absence of radial artery intraluminal calcifications and plaques. (Vukovic et al., 2017) **Name:** Ultrasound examination of the forearm arteries **Type:** DIAGNOSTIC_TEST #### Intervention 5 **Arm Group Labels:** - Cardiovascular sample group **Description:** Intra-operative intervention aimed at evaluating the blood oxygen level in the hand if the radial artery was harvested. Duration: 1 minute. The radial artery is surgically harvested when the oxygen saturation reading (SpO2) from the thumb through pulse-oximetry remains at 95% or above when an occlusive atraumatic clamp is applied on the mobilised radial artery. **Name:** Measurement of oxygen saturation **Type:** DIAGNOSTIC_TEST #### Intervention 6 **Arm Group Labels:** - Cardiovascular sample group **Description:** Intra-operative intervention (validated structured questionnaire) aimed at evaluating anatomical and physiological characteristics of the radial artery and suitability for coronary graft implantation. The radial artery is surgically harvested when its morphology and pathology (diameter, calcifications, presence of pulsatile flow), quality of harvesting technique and surgical accessibility are considered satisfactory, good or optimal. The Radial Artery Quality Evaluation Survey is completed by surgical care practitioners. **Name:** Radial Artery Quality Evaluation Survey **Type:** OTHER #### Intervention 7 **Arm Group Labels:** - Cardiovascular sample group **Description:** Postoperative intervention (ordinal symptoms scale) aimed at evaluating patients finger movements, cold tolerance sensitivity and tactile/touch perception at post-operative day 2 to 5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms is undertaken. Tactile perception is assessed through monofilaments (single touch). Cold sensitivity is assessed through the use of ice-pack. The Follow-up Radial Artery Harvesting Scale was developed from a verbal rating scale (VRS) questionnaire documented in the literature. The VRS questionnaire was re-adapted to appreciate people postoperative experience with their finger movements, cold sensitivity and tactile/touch perception of their forearm. **Name:** Follow-up Radial Artery Harvesting Scale **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measure the sensitivity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination. **Measure:** Sensitivity of Radial Artery Assessment Techniques **Time Frame:** From enrollment to the end of treatment at 12 weeks. **Description:** Measure the specificity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination. **Measure:** Specificity of Radial Artery Assessment Techniques **Time Frame:** From enrollment to the end of treatment at 12 weeks. **Description:** Measure the negative and positive predictive values of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination. **Measure:** Negative and Positive predictive values of Radial Artery Assessment Techniques **Time Frame:** From enrollment to the end of treatment at 12 weeks. #### Secondary Outcomes **Description:** Measure the morphological and physiological quality of radial arteries through a validated structured questionnaire (Radial Artery Quality Evaluation Survey) **Measure:** Radial Artery Quality Evaluation **Time Frame:** From enrollment to surgical harvesting of the radial artery at day 1-2 after hospitalisation. **Description:** Measure the patients' finger movements, cold tolerance sensitivity and tactile/touch perception through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale). **Measure:** Patients Physical Experience Evaluation **Time Frame:** From day of surgery to the end of treatment at 12 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male and female adults patients undergoing elective or urgent coronary artery bypass graft (CABG) surgery and radial artery (RA) harvesting in two Cardiothoracic hospitals. Exclusion Criteria: * Paediatric patients and/or adult patients undergoing emergency CABG will not be considered within the participants of this cross-sectional study, as well as patients lacking capacity to consent and non-English speaking patients requiring use of interpreters. Patients not wishing to participate in the study will also not be recruited. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** People with ischaemic heart disease undergoing coronary bypass surgery and radial artery harvest at Royal Papworth and Royal Brompton hospitals will be invited to participate in this study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** vincenzo.defranco@nhs.net **Name:** Vincenzo De Franco, MSc SCP **Phone:** +441223638000 **Role:** CONTACT **Contact 2:** **Email:** naim.abdulmohdi@aru.ac.uk **Name:** Naim Abdulmohdi, PhD **Phone:** +441223695538 **Role:** CONTACT #### Locations **Location 1:** **City:** Cambridge **Contacts:** ***Contact 1:*** - **Name:** Vincenzo De Franco - **Role:** CONTACT **Country:** United Kingdom **Facility:** Royal Papworth Hospital **State:** England/Cambridgeshire **Zip:** CB20AY **Location 2:** **City:** London **Contacts:** ***Contact 1:*** - **Name:** Vincenzo De Franco - **Role:** CONTACT **Country:** United Kingdom **Facility:** Royal Brompton Hospital **State:** England **Zip:** SW3 6NP #### Overall Officials **Official 1:** **Affiliation:** Royal Papworth Hospital NHS Foundation Trust **Name:** Vincenzo De Franco, MSc SCP **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers wishing to conduct a diagnostic accuracy analysis of the tests (interventions) under investigation car require copy of the anonymised IPD and supporting information to the principal investigator. A proposal describing the planned analysis must be provided and a data sharing agreement form (requested to the sponsoring institution) must be signed. Further instructions for obtaining access are available at the link below: https://royalpapworth.nhs.uk/research-and-development or contacting: papworth.randdadmin@nhs.net **Description:** All IPD that underlie results in a publication. Shared IPD will be presented in a de-identified (anonymised) format for each participant and will include information about interventions or tests received and outcomes observed. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Beginning 6 months and ending 3 years after the publication of results. **URL:** https://royalpapworth.nhs.uk/research-and-development ### References Module #### References **Citation:** Zalocar LAD, Doroszuk G, Goland J. Transradial approach and its variations for neurointerventional procedures: Literature review. Surg Neurol Int. 2020 Aug 15;11:248. doi: 10.25259/SNI_366_2020. eCollection 2020. **PMID:** 32905334 **Citation:** Vukovic P, Peric M, Radak S, Aleksic N, Unic-Stojanovic D, Micovic S, Stojanovic I, Milojevic P. Preoperative Insight Into the Quality of Radial Artery Grafts. Angiology. 2017 Oct;68(9):790-794. doi: 10.1177/0003319716686014. Epub 2017 Jan 5. **PMID:** 28056520 #### See Also Links **Label:** Busti, A.J. and Kellogg, D. (2015) Allens Test. **URL:** https://www.ebmconsult.com/articles/physica-exam-allens-test **Label:** Kinoue, T. and Arai, M. (2021) Comparison of Rating Scale Methods for Cold Sensation in Kampo Medicine, International Medical Journal, 28(1), pp.94-97. **URL:** https://seronjihou.files.wordpress.com/2021/05/281094.pdf ## Document Section ### Large Document Module #### Large Docs - Date: 2024-04-09 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 408471 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-23T08:51 - Date: 2024-05-23 - Filename: ICF_002.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 122008 - Type Abbrev: ICF - Upload Date: 2024-05-29T07:46 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433947 **Brief Title:** Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma **Official Title:** A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma #### Organization Study ID Info **ID:** OPN6602-C01 #### Organization **Class:** INDUSTRY **Full Name:** Opna Bio LLC ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Opna Bio LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM. ### Conditions Module **Conditions:** - Relapsed Multiple Myeloma - Refractory Multiple Myeloma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: OPN-6602 **Label:** Dose escalation monotherapy **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: OPN-6602 - Drug: Dexamethasone **Label:** Dose escalation in combo with dexamethasone **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: OPN-6602 **Label:** Dose expansion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dose escalation in combo with dexamethasone - Dose escalation monotherapy - Dose expansion **Description:** orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily **Name:** OPN-6602 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Dose escalation in combo with dexamethasone **Description:** Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle **Name:** Dexamethasone **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Number and type of dose-limiting toxicities (DLTs) **Time Frame:** Through up to approximately 30 days following last dose of OPN-6602 **Measure:** Number and type of treatment-emergent adverse events (TEAEs) **Time Frame:** Through up to approximately 30 days following last dose of OPN-6602 **Description:** Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. **Measure:** Number of Participants With Clinical Laboratory Test Abnormalities **Time Frame:** Through up to approximately 30 days following last dose of OPN-6602 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Confirmed diagnosis of multiple myeloma (MM) * Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit * Adequate hematologic, renal, liver, cardiac function Exclusion Criteria: * Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma * Active plasma cell leukemia * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome) * Prior Stevens Johnson syndrome * Localized radiation therapy to disease site(s) within 2 weeks of the first dose * Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug * Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of screening; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded. * Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug * Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma) * Known central nervous system involvement by multiple myeloma * Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score \<7 and a PSA level \<10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years * Ongoing systemic infection requiring parenteral treatment * Poorly controlled Type 2 diabetes **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** kinokuchi@opnabio.com **Name:** Kerry Inokuchi **Phone:** 650-204-4065 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Dana Farber Cancer Institute **State:** Massachusetts **Zip:** 02215 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000020141 - Term: Hemostatic Disorders - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010265 - Term: Paraproteinemias - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12058 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: HIGH - As Found: Multiple Myeloma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3947 - Name: Multiple Myeloma - Relevance: HIGH - As Found: Multiple Myeloma ### Condition Browse Module - Meshes - ID: D000009101 - Term: Multiple Myeloma - ID: D000054219 - Term: Neoplasms, Plasma Cell ### 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 ### 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 ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - 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: 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 ### Intervention Browse Module - Meshes - ID: D000003907 - Term: Dexamethasone ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433934 **Brief Title:** Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery **Official Title:** Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery #### Organization Study ID Info **ID:** Oxymask #### Organization **Class:** OTHER **Full Name:** Northwestern Medicine ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Northwestern Medicine #### Responsible Party **Investigator Affiliation:** Northwestern Medicine **Investigator Full Name:** Patti DeJuilio **Investigator Title:** Director Respiratory Care and Diagnostic Services **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:** The purpose of this study is to determine if the performance of a newly released oxygen mask is the same, better, or worse than previous mask version. We will measure the flow rate necessary to maintain the same oxygen saturation in adult patients using each mask. **Detailed Description:** Southmedic, Inc. has received approval to distribute a newly designed oxygen mask. The current design has been studied and the FiO2 delivered reported to be inconsistent. The purpose of this study is to determine if the performance is the same, better, or worse than current mask. We can evaluate performance by determining Liter flow required to maintain oxygen saturations that are within limits described in NM CDH oxygen protocol. We will measure the flow rate necessary to maintain the same saturation in adult patients using both the OxyMask and Oxy2Mask. The Oxymask has a flow device inside the mask that has been revised since implementation. The mask itself is otherwise unchanged. We intend to determine if the same amount of flow results in the same outcome. This study will include adult patients that require supplemental oxygen and we do not believe the patients will report a difference between each mask. The only variance in care is mask version used, the oxygen protocol will remain the same. ### Conditions Module **Conditions:** - Hypoxia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Each patient will receive mask #1, then receive mask #2. The flowrate to maintain same desired oxygen saturations will be documented. ##### 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:** Change oxymask to oxy2mask **Intervention Names:** - Device: Oxy2mask **Label:** Oxy2mask **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Oxy2mask **Description:** Open design oxygen mask **Name:** Oxy2mask **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Flow (LPM) required to maintain target oxygen saturation **Measure:** Required Flowrate **Time Frame:** 4 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants have oxygen device and are being titrated per NM CDH oxygen protocol (maintained between 90%-96%; or 88% - 92% if CO2 retainer) * Participants to have period of stability; 2 hours at same liter flow on open design mask, 5-15 lpm 02. * All adult patients (\> 18 years old) in med surge units (bed tower) * Post-op patients requiring oxygen on Post-op Day 2. * Patients currently on \>5 LPM via nasal cannula, clinician can recommend the change to OxyMask. If remains on \>5 LPM via OxyMask, patient can be included. * Oxygen protocol will be followed per standards of care. Exclusion Criteria: * Patients receiving home oxygen therapy who do not require additional oxygen during hospital stay. * Patients with a history of Bleomycin therapy. * Patients with a history of Paraquat poisoning * Patients that are pregnant **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** patricia.dejuilio@nm.org **Name:** Patti DeJuilio, MS **Phone:** 6309332432 **Role:** CONTACT **Contact 2:** **Email:** mary.henriksen@nm.org **Name:** Mary Henriksen, MS **Phone:** 6309335875 **Role:** CONTACT #### Locations **Location 1:** **City:** Winfield **Country:** United States **Facility:** Central DuPage Hospital **State:** Illinois **Zip:** 60190 #### Overall Officials **Official 1:** **Affiliation:** Northwestern Medicine IRB **Name:** Megan Carney **Role:** STUDY_DIRECTOR ### 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 ### Condition Browse Module - Meshes - ID: D000000860 - Term: Hypoxia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433921 **Brief Title:** A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive **Official Title:** A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Active Device Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects #### Organization Study ID Info **ID:** 219729 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline #### Secondary ID Infos **Domain:** EU CT number **ID:** 2024-511220-14-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-04 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### 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 primary objectives of the study are: * Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \[PC20\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. * Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. ### Conditions Module **Conditions:** - Asthma - Mild Asthma **Keywords:** - salbutamol - propellant HFA-152a - propellant HFA-134a - metered dose inhalers - mild asthma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** 2-part, 7-way cross-over (Part 1) and up to 7-way cross-over (Part 2). ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 91 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Part 1 will consist of a 7 treatment, 7 period cross-over evaluation with all participants receiving the following treatments once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period. **Intervention Names:** - Drug: Salbutamol HFA-152a - Drug: Salbutamol HFA-134a - Drug: Placebo **Label:** Part 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Part 2 is proposed to consist of up to a 7 treatment, 7-way cross-over pivotal evaluation with the following treatments given once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period. **Intervention Names:** - Drug: Salbutamol HFA-152a - Drug: Salbutamol HFA-134a - Drug: Placebo **Label:** Part 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1 - Part 2 **Description:** A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals. **Name:** Salbutamol HFA-152a **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part 1 - Part 2 **Description:** A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals. **Name:** Salbutamol HFA-134a **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Part 1 - Part 2 **Description:** A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PC of methacholine causing at least a 20% fall in FEV1. **Measure:** PC20 **Time Frame:** Up to 11 weeks #### Secondary Outcomes **Measure:** Peak QTc Interval **Time Frame:** Up to 11 weeks **Measure:** Peak Heart Rate (HR) **Time Frame:** Up to 11 weeks **Measure:** Minimum Serum Potassium **Time Frame:** Up to 11 weeks **Measure:** Maximum Observed Plasma Concentration (Cmax) **Time Frame:** Up to 11 weeks **Measure:** Time to Reach Cmax (Tmax) **Time Frame:** Up to 11 weeks **Measure:** Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) **Time Frame:** Up to 11 weeks **Measure:** Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Up to 11 weeks **Measure:** Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR **Time Frame:** Up to 11 weeks **Description:** Intervals recorded: * PR * QRS * QT * QTc **Measure:** Absolute Values for 12-lead ECGs Recording of Intervals **Time Frame:** Up to 11 weeks **Description:** The 3 predose measures will be recorded and will be averaged for HR to derive 1 baseline value. **Measure:** Change from Baseline for Post-dose 12-lead ECGs Recording of HR **Time Frame:** Baseline and up to 11 weeks **Description:** The 3 predose measures will be recorded and will be averaged for QTc interval to derive 1 baseline value. Intervals recorded: * PR * QRS * QT * QTc **Measure:** Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals **Time Frame:** Baseline and up to 11 weeks **Measure:** Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters **Time Frame:** Up to 11 weeks **Measure:** Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure) **Time Frame:** Up to 11 weeks **Measure:** Absolute Values of Vital Signs (Pulse Rate) **Time Frame:** Up to 11 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal. 2. Participant must be 18 to 65 years of age inclusive, at the time of screening. 3. ≥50 kg, at the time of screening. 4. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study. iii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA \[GINA, 2023\]) plus or minus SABA, which is anticipated to remain stable for the duration of the study. 6. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening. 7. Pre-bronchodilator FEV1 ≥80% of predicted, at screening 8. PC20 to methacholine of ≤8 mg/mL, at screening. 9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective. 10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. 11. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years. Exclusion Criteria: 1. Medical Conditions 1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator. 2. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma. 3. Asymptomatic gallstones. 4. History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study. 5. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful. 6. Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis. 2. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer. 3. Participants who are currently or in the last 15 days have worked nightshifts. 4. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \>21 units for males or \>14 units for females. 5. A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1. 6. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12 months prior to the start of 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:** GSKClinicalSupportHD@gsk.com **Name:** US GSK Clinical Trials Call Center **Phone:** 877-379-3718 **Role:** CONTACT **Contact 2:** **Email:** GSKClinicalSupportHD@gsk.com **Name:** EU GSK Clinical Trials Call Center **Phone:** +44 (0) 20 89904466 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months. **Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications. **URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Ancestors - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000058666 - Term: Adrenergic beta-2 Receptor Agonists - ID: D000000318 - Term: Adrenergic beta-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: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: HIGH - As Found: Residual - ID: M18666 - Name: Methacholine Chloride - Relevance: LOW - As Found: Unknown - ID: M353106 - Name: Norflurane - Relevance: HIGH - As Found: Aldara - 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: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-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 ### Intervention Browse Module - Meshes - ID: C000063006 - Term: Norflurane - ID: D000000420 - Term: Albuterol ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433908 **Brief Title:** A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive **Official Title:** A Phase 1, Randomized, Open-label, Single Dose, 2-treatment Arm (200 μg and 800 μg), 4-way Crossover Study in Healthy Participants Aged 18 to 55 to Compare the Pharmacokinetics of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152A (Test) and HFA-134A (Reference) #### Organization Study ID Info **ID:** 219728 #### Organization **Class:** INDUSTRY **Full Name:** GlaxoSmithKline #### Secondary ID Infos **Domain:** EU CT number **ID:** 2023-508279-36-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-09-27 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-13 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** GlaxoSmithKline #### 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 primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference). ### Conditions Module **Conditions:** - Asthma - Healthy Participants **Keywords:** - salbutamol - propellant HFA-152a - propellant HFA-134a - metered dose inhalers - healthy participants - asthma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** 4-way crossover study. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive single 200 μg doses given as 2x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10. **Intervention Names:** - Drug: Salbutamol HFA-152a - Drug: Salbutamol HFA-134a **Label:** Cohort 1: Salbutamol 200 μg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive single 800 μg doses given as 8x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10. **Intervention Names:** - Drug: Salbutamol HFA-152a - Drug: Salbutamol HFA-134a **Label:** Cohort 2: Salbutamol 800 μg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1: Salbutamol 200 μg - Cohort 2: Salbutamol 800 μg **Description:** 100 µg (ex-valve), given at 20-second intervals. **Name:** Salbutamol HFA-152a **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Cohort 1: Salbutamol 200 μg - Cohort 2: Salbutamol 800 μg **Description:** 100 µg (ex-valve), given at 20-second intervals. **Name:** Salbutamol HFA-134a **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC[0-30min]) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, and 30 minutes post-dose **Measure:** Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose **Measure:** Maximum Observed Plasma Concentration (Cmax) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose #### Secondary Outcomes **Measure:** Time to Reach Cmax (Tmax) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose **Measure:** Apparent Terminal Phase Half-life (t1/2) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose **Measure:** Area Under the Plasma Concentration-time Curve up to Last Time with Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last]) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose **Measure:** Intra-participant Variability of AUC(0-30min) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, and 30 minutes post-dose **Measure:** Intra-participant Variability of AUC(0-∞) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose **Measure:** Intra-participant Variability of AUC(0-last) **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose **Measure:** Intra-participant Variability of Cmax **Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose **Measure:** Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Up to Day 18 **Measure:** Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR) **Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11) **Measure:** Absolute Values for 12 Lead ECGs Recording of QTc Intervals **Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11) **Measure:** Change from Baseline for Post-dose 12 Lead ECGs Recording of HR **Time Frame:** Baseline and on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11) **Measure:** Change from Baseline for Post-dose 12 Lead ECGs Recording of QTc Intervals **Time Frame:** Baseline and on each dosing day (Day 1, 4, 7 and, 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11) **Measure:** Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters **Time Frame:** Day-1 (admission) up to discharge (Day 11) **Measure:** Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure) **Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at the following time points post-dose: 15, 30 minutes, 1, 2, 4 hours, and at discharge (Day 11) **Measure:** Absolute Values of Vital Signs (Pulse Rate) **Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at the following time points post-dose: 15, 30 minutes, 1, 2, 4 hours, and at discharge (Day 11) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal. 2. Age: 18 to 55 years inclusive. 3. Weight: 45 to 110 kg inclusive 4. Status: healthy participants. 5. Females must not be pregnant or lactating. 6. All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center based on investigator judgment. An exception is made for hormonal contraceptives, which may be used throughout the study. 7. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center based on investigator judgment. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center. 8. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, and from 48 hours (2 days) prior to admission until discharge from the clinical research center. 9. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission until discharge from the clinical research center. 10. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator. 11. Serum potassium and serum glucose levels within reference ranges of the clinical research center. 12. Willing and able to sign the informed consent form. 13. Spirometry at screening demonstrating forced expiratory volume ≥80% predicted. Exclusion Criteria: 1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs. 2. History or presence of any form of asthma, including childhood asthma and exercise induced asthma. 3. At screening, systolic blood pressure \<90 mmHg or \>140 mmHg, or diastolic blood pressure \<50 mmHg or \>90 mmHg. 4. History of pathological tachycardia, or a pulse rate \> 85 beats per minute (bpm) at screening or Day-1. 5. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 6. Breast cancer within the past 10 years. 7. A QTcF value of \>450 msec at screening based on a triplicate measurement taken at a single timepoint. 8. Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study. 9. Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants) or more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study. 10. Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study. 11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 12. Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention. 13. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. NOTE: Participants with positive hepatitis C antibody test result due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C RNA test is obtained. 14. Positive pre-study drug/alcohol screen, including tetrahydrocannabinol. 15. Positive HIV antibody test. 16. Cotinine levels indicative of smoking or history or use of tobacco- or nicotine containing products within 6 months prior to screening. Assessment as ineligible by the investigator based on the results of the clinical laboratory tests or other assessments. 17. Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits. 18. Regular use of known drugs of abuse, including tetrahydrocannabinol. 19. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 6 months prior to screening. 20. Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.). 21. Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator/delegate. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** GSKClinicalSupportHD@gsk.com **Name:** US GSK Clinical Trials Call Center **Phone:** 877-379-3718 **Role:** CONTACT **Contact 2:** **Email:** GSKClinicalSupportHD@gsk.com **Name:** EU GSK Clinical Trials Call Center **Phone:** +44 (0) 20 89904466 **Role:** CONTACT #### Locations **Location 1:** **City:** Groningen **Contacts:** ***Contact 1:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** US GSK Clinical Trials Call Center - **Phone:** 877-379-3718 - **Role:** CONTACT ***Contact 2:*** - **Email:** GSKClinicalSupportHD@gsk.com - **Name:** EU GSK Clinical Trials Call Centre - **Phone:** +44 (0) 20 8990 4466 - **Role:** CONTACT ***Contact 3:*** - **Name:** Jeroen van de Wetering - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** GSK Investigational Site **Zip:** 9728 ### IPD Sharing Statement Module **Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months. **Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications. **URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Ancestors - ID: D000001993 - Term: Bronchodilator Agents - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000058666 - Term: Adrenergic beta-2 Receptor Agonists - ID: D000000318 - Term: Adrenergic beta-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: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: CaAg - Name: Cardiotonic Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: HIGH - As Found: Residual - ID: M13031 - Name: Oxymetazoline - Relevance: LOW - As Found: Unknown - ID: M13561 - Name: Phenylephrine - Relevance: LOW - As Found: Unknown - ID: M353106 - Name: Norflurane - Relevance: HIGH - As Found: Aldara - 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: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3670 - Name: Adrenergic beta-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 ### Intervention Browse Module - Meshes - ID: C000063006 - Term: Norflurane - ID: D000000420 - Term: Albuterol ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433895 **Brief Title:** Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus **Official Title:** Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial #### Organization Study ID Info **ID:** E2-21-1003 #### Organization **Class:** OTHER **Full Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital ### Status Module #### Completion Date **Date:** 2024-12-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital #### Responsible Party **Investigator Affiliation:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital **Investigator Full Name:** Tuğba Atan, MD **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:** Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin. **Detailed Description:** Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. It results from complex interactions between the somatosensory and auditory systems, which involve the musculoskeletal system rather than the ear. The temporomandibular joint, craniocervical junction, cervical vertebrae and neck and shoulder muscles, in particular the sternocleidomastoid (SCM) muscle, upper trapezius and levator scapula, are anatomical regions that can cause somatic tinnitus. Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin. ### Conditions Module **Conditions:** - Tinnitus, Subjective ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period. Additionally, patients in the manual therapy group will receive manual therapy on a weekly basis for a total of six sessions. **Intervention Names:** - Other: Manual Therapy - Other: Exercise **Label:** Manual therapy + Exercise group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period. **Intervention Names:** - Other: Exercise **Label:** Exercise group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Manual therapy + Exercise group **Description:** Manual Therapy **Name:** Manual Therapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Exercise group - Manual therapy + Exercise group **Description:** Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation **Name:** Exercise **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The severity of tinnitus will be graded using a 10 cm visual analogue scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely severe tinnitus). **Measure:** Visual Analogue Scale for Tinnitus (VAS-tinnitus) **Time Frame:** baseline- 6 week #### Secondary Outcomes **Description:** Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain. **Measure:** Visual Analogue Scale for cervical pain (VAS-Cervical) **Time Frame:** baseline- 6 week **Description:** The THI contains a total of 25 items with functional (11 items), emotional (9 items) and catastrophic (5 items) subscales. Each item is rated 0 (not affected), 2 (sometimes affected) or 4 (always affected). The total score ranges from 0 to 100, with higher scores indicating higher levels of disability of perceived tinnitus. **Measure:** Tinnitus Handicap Index (THI) **Time Frame:** baseline- 6 week **Description:** The NDI is designed to assess self-reported neck functional status. The questionnaire consists of 10 items related to pain, activities of daily living, weight lifting, reading, headache, concentration, working status, driving, sleep and recreation and is rated on a 6-point Likert scale ranging from 0 (no disability) to 50 (major disability). Higher scores represent greater disability. The NDI has been found to be reliable and valid for cervical disorders. **Measure:** Neck disability index (NDI) **Time Frame:** baseline- 6 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients aged ≥ 18 and ≤ 65 years Patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus 1. Neck pain 2. Cervical joint range of motion limitation (especially rotation) 3. Modulation of tinnitus in relation to head and neck movements and posture 4. Tenderness in the cervico-occipital muscles Patients reporting cervical pain between \>2 and \<7 on a visual analogue scale (VAS) on most days of the last month Patients with stable medical and psychological status Patients willing to participate in the study Exclusion Criteria: Patients with objective tinnitus Patients with subjective tinnitus with hearing loss Patients with Meniere's disease Patients with a history of vertigo Patients with middle ear pathologies Patients with a history of intracranial pathology Patients with a history of whiplash injury Patients with a history of cervical spinal surgery Patients with a history of active infection, malignancy, inflammatory rheumatic disease or fibromyalgia Pregnancy Patients who have undergone any exercise or physiotherapy programme for the cervical region in the last 3 months **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Contacts:** ***Contact 1:*** - **Email:** tubaatan@gmail.com - **Name:** Tuğba Atan - **Phone:** +90 312 2911000 - **Phone Ext:** 1414 - **Role:** CONTACT **Country:** Turkey **Facility:** Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16769 - Name: Tinnitus - Relevance: HIGH - As Found: Tinnitus - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014012 - Term: Tinnitus ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433869 **Brief Title:** The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites **Official Title:** Multi-arm, Phase II Clinical Study of Intraperitoneal Injection of Recombinant Human Tumor Necrosis Factor, Bevacizumab Monoclonal Antibody, and Serplulimab for the Treatment of Malignant Ascites Patients With Standard Therapy Failure #### Organization Study ID Info **ID:** HPPMS-001 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Dong sheng Zhang **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** 1. More than half of peritoneal metastases are from digestive tract. Peritoneal metastasis has poor prognosis, poor treatment response and limited means. 2. rmhTNF-NC or bevacizumab are effective in the treatment of malignant pleuroabdominal effusion. 3, There is increasing evidence that PD-1/PD-L1 inhibitors in combination with vascular endothelial growth factor receptor (VEGFR) inhibitors have a complementary mechanism of action: VEGF pathway inhibitors normalize blood vessels in tumors and promote immune cell maturation and infiltration, thus playing a synergistic role with ICIs. The strategy of systemic immunotherapy combined with antivascular therapy has been confirmed by several large phase III clinical trials such as IMbrave-150. Basic studies have confirmed that uncontrolled tumor vessels in peritoneal metastasis and malignant ascites microenvironment also play an important role in promoting disease progression. Therefore, this project intends to explore the treatment of malignant abdominal effusion by local intraperitoneal injection of bevacizumab and PD-1 on the basis of rmhTNF-NC **Detailed Description:** GROUP A: serplulimab(PD-1 inhibitor)+bevacizumab GROUP B: serplulimab+rmhTNF-NC GROUP C: serplulimab+bevacizumab+rmhTNF-NC serplulimab(100mg,ip,D1、D15) bevacizumab(100mg,ip,D1、D15) rmhTNF-NC(300IU/time,ip,D1、D4、D7、D10) ### Conditions Module **Conditions:** - Malignant Ascites ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor and bevacizumab **Intervention Names:** - Drug: serplulimab - Drug: Bevacizumab **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor and rmhTNF-NC **Intervention Names:** - Drug: serplulimab - Drug: rmhTNF-NC **Label:** Group B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor, rmhTNF-NC and bevacizumab **Intervention Names:** - Drug: serplulimab - Drug: Bevacizumab - Drug: rmhTNF-NC **Label:** Group C **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A - Group B - Group C **Description:** Additional intraperitoneal injection of bevacizumab or rmhTNF-NC is added to the PD-1 inhibitor. **Name:** serplulimab **Other Names:** - PD-1 inhibitor **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group A - Group C **Description:** Intraperitoneal injection of bevacizumab is added to PD-1 inhibitor or rmhTNF-NC. **Name:** Bevacizumab **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Group B - Group C **Description:** Intraperitoneal injection of rmhTNF-NC is added to PD-1 inhibitor or bevacizumab. **Name:** rmhTNF-NC **Other Names:** - recombinant human tumor necrosis factor **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Defined as the percentage of patients achieving CR or PR according to the WHO criteria detected by ultrasound. **Measure:** Objective response rate of ascites **Time Frame:** 2 months #### Secondary Outcomes **Description:** Time since first CR or PR to PD **Measure:** Duration of ascites relief **Time Frame:** 1 years **Description:** percentage of patients achieving CR, PR and SD. **Measure:** Ascites control rate **Time Frame:** 2 months **Description:** Adverse events according to the NCI CTCAE 5.0 **Measure:** Incidence of Treatment-Emergent Adverse Events **Time Frame:** 2 months **Description:** Measured by FACIT-AI,score range 1 to 5, higher scores mean a better **Measure:** The score of chronic abdominal effusion function scale changed **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years old, gender unlimited; * Malignant ascites confirmed by histology or cytology as originating from digestive system tumors (malignant confirmed by ascites cytology or clinically diagnosed as peritoneal metastases by imaging and symptoms); * Patients with more than a moderate amount of abdominal fluid, who have failed initial treatment or have been treated with conventional chemotherapy drugs and/or biological response modulators intravenously. Moderate ascites is defined as: * B ultrasound examination of ascites ≥3cm in lying position; * Accompanied by clinical symptoms (chest tightness, shortness of breath, abdominal distension and discomfort, which were judged by researchers to be related to abdominal fluid accumulation); * ECOG physical status is 0-2; * Expected survival time \>3 months; * Cardiopulmonary function is basically normal; * For adequate organ function, subjects must meet the following laboratory criteria: * Peripheral blood imaging: WBC≥4.0×109/L, PLT≥80×109/L, Hb≥90g/L; * Renal function: serum creatinine ≤2×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min; * Liver function: total bilirubin ≤1.5× upper limit of normal value (ULN); Or total bilirubin \>ULN but direct bilirubin ≤ ULN; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis); * Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; * Thyroid stimulating hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels and clinical manifestations should be investigated, and comprehensive assessment of non-acute activity can be included; * Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 6 months after the end of the study treatment period; Women of reproductive age who were not surgically sterilized had to be negative for serum or urine HCG within 7 days prior to study enrollment. And must be non-lactation period; For men whose partners are women of childbearing age, effective contraception should be used during the trial and within 6 months after the last administration of the study drug; * Voluntarily enrolled in this study, with good compliance, signed written informed consent, and able to cooperate with follow-up observation. Exclusion Criteria: * History of allergy to tumor necrosis factor and its derivatives, bevacizumab analogues, and Serplulimab; * Malignant diseases other than digestive tract neoplasms were diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); * Received any other investigational drug therapy or participated in an interventional clinical investigator within 7 days prior to initial dosing; Or received anti-tumor drug treatment (including Chinese herbal medicine with anti-tumor indication) within 7 days prior to the first use of the study drug; * Pregnant or lactating women, women of childbearing age who did not want to use contraception during the study period; Or the man is unwilling to use effective contraception during treatment and during the following 1 year; * Significant damage to the function of important organs; * Patients with obvious bleeding tendency; * Clinically significant or uncontrolled heart disease, including unstable angina pectoris, acute myocardial infarction within 6 months prior to first dosing, New York Heart Association Class III/IV congestive heart failure, and uncontrolled arrhythmia (in subjects who are allowed to wear a pacemaker or have atrial fibrillation and have a well-controlled heart rate); * Presence of ECG changes or medical history that investigators consider clinically significant; Screening QTcF interval \>480 ms, subjects with indoor block (QRS interval \>120 ms) can use JTc interval instead of QTc interval (if JTc is used instead of QTc, JTc must be ≤340 ms); * Uncontrolled hypertension, systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; * Severe acute infection that is not under control; The patient is having fever (\> 38℃), or has suppurative and chronic infection, and the wound is prolonged and does not heal; * Patients with encapsulated abdominal effusion confirmed by imaging; A definite diagnosis of abdominal infection; * Persons infected with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA\>2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA\> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive. After nucleotide antiviral therapy, those who were lower than the above criteria could be included in the group. A known history of human immunodeficiency virus (HIV) infection or a confirmed positive immunotest result; * Patients with obvious evidence of bleeding tendency or history within 3 months prior to enrollment (hemorrhage \>30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (\>5 mL fresh blood within 4 weeks); People with a history of inherited or acquired bleeding or coagulation disorders. Have clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; Arterial or venous thrombotic disease was present 6 weeks before enrollment; * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; * Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study therapy or expected to require major surgery during study therapy; * Complications of toxicity and/or major surgery have not fully recovered before starting treatment; * Women who are pregnant or nursing, or who are expected to become pregnant or give birth during the study period from screening visits to completion of safety follow-up visits (male subjects to 90 days after the last dosing); * Radiotherapy was received within 4 weeks prior to the first administration of the study drug. Subjects must have fully recovered from radiation-related toxicities without the need for corticosteroid therapy, confirming the rule out of radiation pneumonia. For palliative radiotherapy for non-CNS disease, a 2-week washout period is allowed; * Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, unable to cooperate with and describe the response to treatment; Patients with uncontrolled primary brain tumor or central nervous metastases, with obvious cranial hypertension or neuropsychiatric symptoms; * There are other conditions that researchers consider inappropriate to participate in this experiment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zhangdsh@sysucc.org.cn **Name:** dongsheng zhang, PHD **Phone:** 020-87343533 **Role:** CONTACT **Contact 2:** **Email:** luyx@sysucc.org.cn **Name:** yunxin LU, PHD **Phone:** 020-87343533 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** zhangdsh@sysucc.org.cn - **Name:** Dongsheng Zhang, MD,PhD - **Phone:** 86-2087343795 - **Role:** CONTACT **Country:** China **Facility:** Cancer center of SunYat-sen University **State:** Guangdong **Status:** RECRUITING **Zip:** 510060 **Location 2:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Name:** LU YUNXIN - **Role:** CONTACT **Country:** China **Facility:** Zhang Dongsheng **Status:** RECRUITING **Location 3:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Name:** ZHANG - **Role:** CONTACT **Country:** China **Facility:** Zhang Dongsheng **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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: M4509 - Name: Ascites - Relevance: HIGH - As Found: Ascites - ID: M12284 - Name: Necrosis - Relevance: HIGH - As Found: Necrosis ### Condition Browse Module - Meshes - ID: D000009336 - Term: Necrosis - ID: D000001201 - Term: Ascites ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M246 - Name: Bevacizumab - Relevance: HIGH - As Found: Non- - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: HIGH - As Found: Obstruction - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068258 - Term: Bevacizumab - ID: D000082082 - Term: Immune Checkpoint Inhibitors ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433856 **Brief Title:** Neuromuscular Responses to Recovery Techniques **Official Title:** Effects of Cold Water Immersion and Percussive Gun Massage on Recovery Measures in Soccer Players #### Organization Study ID Info **ID:** Fisioterapia1705 #### Organization **Class:** OTHER **Full Name:** University of Trieste ### Status Module #### Completion Date **Date:** 2023-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Trieste #### Responsible Party **Investigator Affiliation:** University of Trieste **Investigator Full Name:** Alex Buoite Stella **Investigator Title:** RTD-A **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cold water immersion (CWI) and percussive massage therapy (PMT) are commonly used re-covery techniques in team sports. In particular, despite its wide use, PMT has been scarcely investigated in the literature, especially regarding neuromuscular measures and in comparison with other techniques. This study aims to evaluate and compare the acute and short-term ef-fects (24 h) of CWI and PMT on muscle strength, contractile properties, and soreness after exercise. A randomized crossover study will be performed on sixteen male soccer players (22 y, 20-27) who participate in three experimental sessions involving high-intensity training and 12-min recovery including CWI (10 °C water), bilateral PMT on the anterior and posterior thigh, or passive resting. Outcomes will be assessed immediately after the exercise protocol, after the recovery intervention, and at 24 h. Isometric knee extension (IKE) and flexion (IKF), and tensiomyography (TMG) will be assessed.Muscle soreness and fatigue will be scored from 0 to 10. **Detailed Description:** Participants will be invited to participate to a cross-over randomized trial, consisting in 3 experimental sessions at 7 days of distance one from another. During each experimental session, participants will be asked to train for about 45 min at a high-intensity protocol (High-Intensity Intermittent Running, plyometric jumps and isometric chair position). After the exercise, participants will be assessed for neuromuscular function (isometric strength and tensiomyography) as well as perceived soreness and fatigue. Then, in a randomized order, participants will receive three different recovery interventions: cold water immersion, percussive massage, or a passive control condition. After the recovery intervention, outcomes are assessed again, as well as at 24 h. Isometric strength is assessed with a dynamometer during knee extension and knee flexion. Tensiomyography is performed on the thigh muscles, and time to contraction and radial displacement are considered as outcomes. Soreness and fatigue are rated by the participant from 0 to 10. ### Conditions Module **Conditions:** - Muscle Soreness **Keywords:** - recovery - team sport - cryotherapy - massage guns ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 16 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The CWI protocol consists of participants standing, with only their underwear and a t-shirt, in a portable tub for cold water therapy (Qryo, Italy), with the water to their hips being constantly maintained at 10±0.5 °C by a cooling system that pumped and stirred the water inside the tub and around the participant's lower limbs. Water temperature and the duration of the immersion, which is 12 minutes for all the participants considering they were characterized by similar anthropometrics and body composition, were based on previous literature **Intervention Names:** - Other: Cold Water Immersion **Label:** CWI **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The PMT protocol is performed with the application of a percussive therapy gun (Theragun Elite, Therabody, USA). The participants rests with their underwear and a t-shirt on a treatment bed, and the percussive therapy gun with a "standard ball", 16 mm amplitude of percussions, and a frequency of 30 Hz, is applied to the thigh muscles of both lower limbs, 3 min on the anterior and 3 min on the posterior area of each thigh. The protocol is based on previous literature and adapted to the specific aims of this study. **Intervention Names:** - Device: Percussive Massage Therapy **Label:** PMT **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The control condition (PAS) consists of participants resting on a chair for 12 minutes in a quiet room at 25 °C. **Label:** PAS **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - CWI **Description:** Cold water immersion consists in 12 min standing in 10 °C water **Name:** Cold Water Immersion **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - PMT **Description:** Percussive massage therapy is performed with a massage gun on the thigh muscles for 12 min **Name:** Percussive Massage Therapy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Subjective evalutation of muscle soreness from 0 to 10 with a numeric rating scale (NRS), where 0 is no soreness at all, and 10 is unbearable soreness **Measure:** Muscle soreness **Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours) **Description:** Subjective evaluation of muscle fatigue from 0 to 10 with a numeric rating scale (NRS), where 0 is no fatigue at all, and 10 is unbearable fatigue **Measure:** Muscle fatigue **Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours) #### Secondary Outcomes **Description:** Isometric knee extension (IKE) and flexion (IKF) strength assessments performed on a treatment bed, with a digital handheld dynamometer **Measure:** Isometric muscle strength **Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours) **Description:** Tensiomyography (TMG) will be performed on anterior and posterior thigh muscles **Measure:** Tensiomyography **Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * being healthy * training in soccer for more than 3 years and with a training frequency \> 2 times/week Exclusion Criteria: * reported time-loss injuries * using analgesics or other therapies affecting muscle function or pain **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 16 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Trieste **Country:** Italy **Facility:** CdL in Fisioterapia **Zip:** 34100 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000059352 - Term: Musculoskeletal Pain - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M30156 - Name: Myalgia - Relevance: HIGH - As Found: Muscle Soreness - ID: M14978 - Name: Respiratory Tract Infections - 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: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29444 - Name: Musculoskeletal Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000063806 - Term: Myalgia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433843 **Brief Title:** FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome **Official Title:** FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome #### Organization Study ID Info **ID:** 090/2015BO2 #### Organization **Class:** OTHER **Full Name:** University Hospital Tuebingen ### Status Module #### Completion Date **Date:** 2020-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-03 **Type:** ACTUAL #### Start Date **Date:** 2016-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital Tuebingen #### 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 aim of this study is to investigate the role FKBP5 DNA methylation levels in patients suffering from complex posttraumatic stress disorder, who participated in a 12-weeks disorder-specific DBT-PTSD inpatient treatment. DNA methylation levels were measured before and after completing DBT-PTSD. **Detailed Description:** Epigenetic modifications in the FKBP5 gene, which is involved in regulating the stress response, have been found to be associated with trauma-related mental disorders like posttraumatic stress disorder (PTSD). Previous research has suggested that FKBP5 may also be a predictor of therapy outcomes. However, there is limited evidence regarding its relationship with complex PTSD (cPTSD). This pilot study aimed to investigate the association between cPTSD and FKBP5 DNA methylation, as well as its predictive role in therapy outcomes among patients undergoing Dialectical Behavior Therapy for PTSD (DBT-PTSD), a 12-week trauma-focused inpatient treatment program. 29 patients with cPTSD who participated in the DBT-PTSD program were enrolled. FKBP5 DNA methylation levels were measured at two CpG sites before treatment (n=25) and after completing DBT-PTSD (n=15). To assess the predictive value of FKBP5 DNA methylation, we categorized the sample into responders and non-responders based on therapy outcome. ### Conditions Module **Conditions:** - Borderline Personality Disorder - Posttraumatic Stress Disorder ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 29 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study consists of one arm including cPTSD patients, who participated in a 12-weeks dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD) **Intervention Names:** - Behavioral: Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD) **Label:** cPTSD patients participating in 12-weeks DBT-PTSD program **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - cPTSD patients participating in 12-weeks DBT-PTSD program **Description:** 12 weeks inpatient disorder specific psychotherapy **Name:** Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** FK506 binding protein 5 (FKBP5), an immunoregulator modulating glucocorticoid receptor activity, plays a key role in stress reactivity **Measure:** DNA methylation levels of FKBP5 before and following DBT-PTSD **Time Frame:** After 12 weeks of DBT-PTSD treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: complex posttraumatic stress disorder with or wothout comorbid borderline personality disorder Age between 18 and 65 Years Participiation in 12 weeks DBT-PTSD inpatient treatment Exclusion Criteria: Acute suicidality **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tuebingen **Country:** Germany **Facility:** University Hospital Tuebingen **State:** Baden Württemberg **Zip:** 72076 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Stress Disorder - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Posttraumatic Stress Disorder - ID: M13462 - Name: Personality Disorders - Relevance: HIGH - As Found: Personality Disorder - ID: M5161 - Name: Borderline Personality Disorder - Relevance: HIGH - As Found: Borderline Personality Disorder - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000013313 - Term: Stress Disorders, Post-Traumatic - ID: D000010554 - Term: Personality Disorders - ID: D000001883 - Term: Borderline Personality Disorder ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433830 **Brief Title:** Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy **Official Title:** A Single-arm, Phase II Trial of Hetrombopag for the Treatment of Concurrent Chemoradiotherapy-induced Thrombocytopenia in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** 20220125-10 #### Organization **Class:** OTHER **Full Name:** Sir Run Run Shaw Hospital ### Status Module #### Completion Date **Date:** 2025-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-05-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sir Run Run Shaw Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Thrombocytopenia represents one of the main toxicities of concurrent chemoradiotherapy, which may necessitate chemotherapy dose reductions, dose delays, or discontinuation, and even compromise survival. Hetrombopag, a thrombopoietin receptor agonist, has shown efficacy and safety in patients with chemotherapy-induced thrombocytopenia. However, the efficacy of hetrombopag in patients who received concurrent chemoradiotherapy is not clear yet. This study aimed to evaluate the efficacy and safety of hetrombopag in this patient population. **Detailed Description:** Antitumor related therapy is one of the common causes of thrombocytopenia. Chemotherapy regimens based on drugs such as gemcitabine, platinum, anthracycline, and paclitaxel are high-risk options for thrombocytopenia. The degree of thrombocytopenia caused by external radiation therapy mainly depends on the irradiation dose, irradiation site, irradiation field size, and irradiation duration. The synchronous radiotherapy and chemotherapy regimen for head and neck tumors, esophageal cancer, rectal cancer, and other cancers often involves platinum drugs, and the irradiation site often involves flat and irregular bones. Therefore, the incidence of thrombocytopenia in patients during the treatment process is higher than that of chemotherapy or radiotherapy alone. In a phase III clinical study on the combination of carboplatin and paclitaxel in the treatment of esophageal cancer, the incidence of thrombocytopenia was as high as 54%. Once thrombocytopenia occurs, it may lead to a decrease in chemotherapy drug dosage, delay, and cessation of radiotherapy and chemotherapy, and may require platelet infusion. In follow-up studies of various cancer patients, it has been found that reducing the dosage of chemotherapy drugs or delaying the chemotherapy cycle will reduce treatment efficacy and lead to poor prognosis, including shortened disease-free survival (DFS) and overall survival (OS) time. TPO-RA drugs are currently approved for indications in the fields of chronic primary immune thrombocytopenia (ITP), severe aplastic anemia (SAA), and chronic liver disease (CLD). There are also relevant data reports in the CIT field. A phase II clinical study using romiplostim for the treatment of CIT enrolled a total of 60 patients. After treatment with romiplostim, 85% of patients returned to normal platelet count within 3 weeks and resumed chemotherapy. In the subsequent prescribed chemotherapy cycle, only 6.8% of patients experienced a relapse due to another round of chemotherapy. The occurrence of CIT leads to a decrease or delay in chemotherapy dose; In another randomized placebo-controlled phase II study using eltrombopag for the prevention of solid tumor CIT, patients received gemcitabine monotherapy or gemcitabine combined with cisplatin/carboplatin regimen chemotherapy, and treated with eltrombopag or placebo 100mg before and 5 days after chemotherapy. In the 1-6 chemotherapy cycles, the average platelet count on the day before chemotherapy in the eltrombopag group was numerically higher than that in the placebo group, but did not reach statistically significant differences. The incidence of grade 3/4 thrombocytopenia in the eltrombopag group was lower than that in the placebo group. Among patients in the combination chemotherapy group, the average time required for eltrombopag group to recover from the lowest platelet count to normal was 8 days. The placebo group, on the other hand, requires 15 days, and the incidence of delayed/reduced chemotherapy dose or dose loss due to thrombocytopenia is lower in patients in the eltrombopag group, Therefore, in gemcitabine based chemotherapy, treatment with eltrombopag can shorten the time for platelet minimum recovery and reduce the delayed/reduced chemotherapy dose caused by thrombocytopenia. However, there is still a lack of stronger evidence-based medicine for the application of TPO-RA drugs in CIT, and there is no relevant data in the field of concurrent chemoradiotherapy induced thrombocytopenia. ### Conditions Module **Conditions:** - Thrombocytopenia - Radiotherapy Side Effect **Keywords:** - hetrombopag - thrombocytopenia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients receive oral hetrombopag at an initial dose of 7.5 mg QD **Intervention Names:** - Drug: Hetrombopag Olamine **Label:** Hetrombopag **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Hetrombopag **Description:** The administration of hetrombopag as a monotherapy and at an initial dose of 7.5 mg QD.The dose adjusted based on platelet count. **Name:** Hetrombopag Olamine **Other Names:** - thrombopoietin receptor agonist **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The response rate is defined as the proportion of patients who receive treatment with hetrombopag until PLT≥100×10\^9/L **Measure:** The proportion of patients with PLT ≥100×10^9/L **Time Frame:** From admission to discharge, up to 6 weeks #### Secondary Outcomes **Description:** Use Kaplan Meier method to estimate median platelet recovery time. **Measure:** The median time of PLT ≥100×10^9/L **Time Frame:** From admission to discharge, up to 6 weeks **Description:** The number of events in which radiotherapy and chemotherapy were suspended due to thrombocytopenia, as determined by researchers **Measure:** Incidence of delayed radiotherapy cycles due to thrombocytopenia **Time Frame:** From admission to discharge, up to 6 weeks **Description:** Researchers determine the number of platelet transfusion events caused by thrombocytopenia **Measure:** Number and percentage of patients receiving platelets transfusion for thrombocytopenia **Time Frame:** From admission to discharge, up to 6 weeks **Description:** Record the name and frequency of serious adverse events **Measure:** Incidence of serious adverse events according to CTCAE 5.0 criteria **Time Frame:** From admission to the end of the study, up to 9 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years old, regardless of gender; * Malignant tumor patients diagnosed through pathological or cytological examination, regardless of cancer type, may experience thrombocytopenia during radical synchronous radiotherapy and chemotherapy treatment; * Platelet count of patients ≤ 75 × 10\^9/L on the day or 3 days prior to enrollment; * Expected survival time ≥ 12 weeks; * ECOG PS score for physical condition: 0-2 points; * The laboratory inspection indicators meet the following requirements: 1. Renal function: Cr ≤ ULN (upper limit of normal value) x 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min; 2. Liver function: Total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 3; (If it is intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin should not exceed 3 times the normal upper limit, and transaminase should not exceed 5 times the normal upper limit); * Women of childbearing age agree to use contraception during the study period and within 6 months after the end of the study; And not a lactating patient; Male patients who agree to contraception during the study period and within 6 months after the end of the study; * Those who have not participated in clinical trials of other drugs within the 4 weeks prior to enrollment; * It is expected that those with good compliance will be able to follow up on therapeutic effects and adverse reactions according to the protocol requirements; * No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal disorders Obstruction, non cancerous fever\>38 °C; * The subjects are able to understand the situation of this study and voluntarily sign an informed consent form. Exclusion Criteria: * Screening for thrombocytopenia caused by non tumor treatment within the first 6 months, including but not limited to liver cirrhosis, splenic hyper function, infection, and bleeding; * Suffering from other hematopoietic system diseases besides thrombocytopenia caused by concurrent radiotherapy and chemotherapy for malignant tumors, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome; * Combined bone marrow invasion or bone marrow metastasis; * After treatment with infusion of red blood cells or erythropoietin (EPO), hemoglobin remains below 50g/L, or after treatment with granulocyte colony-stimulating factor (G-CSF), the absolute value of neutrophils remains below 1.0 × 10\^9/L; * Have received pelvic and spinal radiation therapy, as well as bone field radiation, within the three months prior to screening; * History of arterial or venous thrombosis within the first 6 months of screening; * Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within the first two weeks of screening; * Received platelet transfusion within 2 days prior to enrollment; * Screening for patients with severe cardiovascular diseases (such as NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, coronary stent implantation, angioplasty, and coronary artery bypass grafting within the first 6 months; * Received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatrombopag) within 14 days prior to screening; * Patients who are known or expected to be allergic or intolerant to the active ingredients or excipients of hetrombopag tablets (excipients include cellulose lactose, low substituted hydroxypropyl cellulose, magnesium stearate, and film coated premixes); * Breastfeeding women; * Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, etc; * The researcher believes that the participants are not suitable for enrollment. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sunxiaonan@zju.edu.cn **Name:** Xiaonan Sun **Phone:** (+86)-0571-86006783 **Role:** CONTACT **Contact 2:** **Email:** 21718403@zju.edu.cn **Name:** Weiwen Zhou **Phone:** (+86)-0571-86006783 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** sunxiaonan@zju.edu.cn - **Name:** Xiaonan Sun - **Phone:** (+86)-0571-86006783 - **Role:** CONTACT ***Contact 2:*** - **Email:** 21718403@zju.edu.cn - **Name:** Weiwen Zhou - **Phone:** (+86)-0571-86006783 - **Role:** CONTACT **Country:** China **Facility:** Sir Run Run Shaw Hospital, Zhejiang University School of Medicine **State:** Zhejiang **Status:** RECRUITING **Zip:** 310016 #### Overall Officials **Official 1:** **Affiliation:** Sir Run Run Shaw Hospital **Name:** Xiaonan Sun **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Sir Run Run Shaw Hospital **Name:** Weiwen Zhou **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000095542 - Term: Cytopenia ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16680 - Name: Thrombocytopenia - Relevance: HIGH - As Found: Thrombocytopenia - 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 ### Condition Browse Module - Meshes - ID: D000013921 - Term: Thrombocytopenia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433817 **Brief Title:** Spectral CT in Radiotherapy for Cervical Cancer **Official Title:** The Clinical Research of Spectral CT in Radiotherapy for Cervical Cancer #### Organization Study ID Info **ID:** SPRTCC-Trial #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-22 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-22 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer. ### Conditions Module **Conditions:** - Cervical Cancer - Radiotherapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Spectral CT scans acquisition performed during the arterial phase and venous phase for cervical cancer **Name:** Spectral computed tomography scan **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the tumor response of using quantitative parameters in spectral CT for cervical cancer patients according to RECIST 1.1 **Measure:** Comparison of spectral CT derived data with response evaluation in cervical cancer **Time Frame:** through study completion, an average of 2 year #### Secondary Outcomes **Description:** To evaluate the diagnostic performances of using spectral CT for identifying metastatic lymph nodes in patients with cervical cancer **Measure:** Identifying metastatic lymph nodes in cervical cancer with spectral CT **Time Frame:** through study completion, an average of 2 year **Description:** The ability to reduce metal artifact and assist in target delineation **Measure:** Application of energy spectrum CT in brachytherapy of cervical cancer **Time Frame:** through study completion, an average of 2 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All patients were confirmed cervical cancer by pathology 2. patients were treated with concurrent chemoradiotherapy 3. Spectral CT scans acquisition performed during the arterial phase and venous phase 4. All the patients underwent a 18F-FDG PET/CT before treatment Exclusion Criteria: 1. CT without spectral scans 2. History of allergy to intravenous contrast 3. Pregnant or potentially pregnant female subjects **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** adult patients with newly stablished diagnosis of cervical cancer complying with selection criteria for cervical cancer. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zhangfq@pumch.cn **Name:** Fuquan Zhang, Porf **Phone:** 86 01069154072 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** zengzheng1206@163.com - **Name:** Zheng Zeng, MD. - **Phone:** 86 01069154073 - **Role:** CONTACT **Country:** China **Facility:** Peking Union Medical College Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 100010 ### 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 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433804 **Brief Title:** Clinicopathological Parameters of HER2 Low Breast Cancers **Official Title:** Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers #### Organization Study ID Info **ID:** CC-229 #### Organization **Class:** OTHER **Full Name:** Vardhman Mahavir Medical College And Safdarjung Hospital ### Status Module #### Completion Date **Date:** 2024-02-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Start Date **Date:** 2022-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vardhman Mahavir Medical College And Safdarjung Hospital #### Responsible Party **Investigator Affiliation:** Vardhman Mahavir Medical College And Safdarjung Hospital **Investigator Full Name:** SANA AHUJA **Investigator Title:** ASSISTANT 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 was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre. This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading. Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers. ### Conditions Module **Conditions:** - HER2 Low Breast Cancers ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 70 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: HER2 IHC **Label:** HER2 low #### Arm Group 2 **Intervention Names:** - Diagnostic Test: HER2 IHC **Label:** HER2 negative ### Interventions #### Intervention 1 **Arm Group Labels:** - HER2 low - HER2 negative **Description:** Immunohistochemistry for HER2 **Name:** HER2 IHC **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** It will be measured for HER2 low breast cancer patients **Measure:** Age (in years) **Time Frame:** JANUARY 2022- DECEMBER 2023 **Description:** This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients **Measure:** Tumor stage (categorised from T1-T4) **Time Frame:** JANUARY 2022- DECEMBER 2023 **Description:** This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients **Measure:** N stage (categorised from N0-N3) **Time Frame:** JANUARY 2022- DECEMBER 2023 **Description:** This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients. **Measure:** Tumor grade (categorised from G1-G3) **Time Frame:** JANUARY 2022- DECEMBER 2023 **Description:** This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression. **Measure:** Surrogate molecular classification (Categorised as luminal/ triple negative) **Time Frame:** JANUARY 2022- DECEMBER 2023 **Description:** This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer **Measure:** Androgen receptor expression (Denoted as present or absent) **Time Frame:** JANUARY 2022- DECEMBER 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 Exclusion Criteria: * Benign breast tumors **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 ### Contacts Locations Module #### Locations **Location 1:** **City:** New Delhi **Country:** India **Facility:** VMMC SJH ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433791 **Brief Title:** Evaluation of Ascorbate-Meglumine Therapeutic for SRS **Official Title:** Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-Guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS) #### Organization Study ID Info **ID:** LadeRX #### Organization **Class:** INDUSTRY **Full Name:** LadeRx LLC ### Status Module #### Completion Date **Date:** 2025-06-17 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-17 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Duke Clinical Research Institute #### Lead Sponsor **Class:** INDUSTRY **Name:** LadeRx LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS) **Detailed Description:** Phase 1, single-center, open-label study in subjects receiving Stereotactic Radiosurgery (SRS) for brain metastases. The study will consist of 4 principal cohorts (n=3 in each cohort). Each cohort will receive an escalating dose of ascorbate-meglumine as an Magnetic Resonance Imaging (MRI)-detectable adjunctive therapeutic to SRS. Subjects will complete a planning MRI for SRS with gadolinium- diethylenetriamine penta-acetic acid (GD-DPTA) per standard of care for SRS. Forty-eight hours after the planning MRI, the subjects will complete the study MRI with ascorbate-meglumine contrast agent. Each cohort will receive an escalating dose of ascorbate-meglumine by intravenous administration over 1 hour during the MRI. The total dose of ascorbate-meglumine will escalate from the first cohort to the next cohort in a sequential manner. During ascorbate-meglumine infusion, MRI scans will be performed to evaluate the contrast effect and PK blood draws will occur at defined time points. Patients will return for the SRS procedure within 1 week following the planning MRI per standard of care. During SRS, subjects will receive a second dose of ascorbate-meglumine as an adjunctive therapeutic. Patients will enter into a follow up phase within 2 weeks after the SRS procedure per standard of care. The primary endpoint is to evaluate the safety of parenteral ascorbate-meglumine as a MRI-detectable adjunctive therapeutic to SRS. ### Conditions Module **Conditions:** - Safety ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** dose escalation ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receiving Stereotactic Radiosurgery (SRS) treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced Magnetic Resonance Imaging (MR) scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases. The first cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.16 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine **Intervention Names:** - Drug: Ascorbate-Meglumine **Label:** Ascorbate Meglumine dose 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases.The second cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.31 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine **Intervention Names:** - Drug: Ascorbate-Meglumine **Label:** Ascorbate Meglumine dose 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, includingpost-operative patients with 1-3 residual metastases. The third cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.63 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine **Intervention Names:** - Drug: Ascorbate-Meglumine **Label:** Ascorbate Meglumine dose 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, includingpost-operative patients with 1-3 residual metastases. The fourth cohort of patients will receive ascorbate-meglumine at a dose administration rate of 1.25 g/min for 60 minutes. Interventions: Drug: Ascorbate-Meglumine **Intervention Names:** - Drug: Ascorbate-Meglumine **Label:** Ascorbate Meglumine dose 4 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Ascorbate Meglumine dose 1 - Ascorbate Meglumine dose 2 - Ascorbate Meglumine dose 3 - Ascorbate Meglumine dose 4 **Description:** Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate,125 mM ascorbic acid and 125 mM meglumine in sterile water for injection **Name:** Ascorbate-Meglumine **Other Names:** - Vitamin C **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Adverse events will be monitored in patients receiving ascorbate-meglumine during Stereotactic Radiosurgery (SRS) **Measure:** Safety as measured by adverse events **Time Frame:** 1 week after receiving study drug with SRS ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Primary cancer diagnosis with newly diagnosed brain metastases * Diagnostic MRI demonstrates the presence of 1 to 3 intact (not previously irradiated or resected) brain metastases. * Maximum tumor diameter ≤ 2.5 cm for the largest lesion determined during the planning MRI * Plan of care must include Stereotactic Radiosurgery (SRS) * SRS treatment plan must be delivered as a single RT fraction * Age 18 years and older * Life expectancy of at least 3 months * GPA score 0.5 or greater * Capable of providing written informed consent to participate in the study Exclusion Criteria: * Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma) * Metastases in the brain stem, pons or medulla or within 3 mm of the optic apparatus (such that some portion of the optic nerve or chiasm would receive a radiation dose \> 10 Gy SRS in one single fraction) * Previous whole-brain radiation (previous SRS to or resection of other brain lesions is permitted if more than 3 months prior to the date of enrollment on this protocol) * Pregnancy * History or manifestation of glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency * History of oxalate kidney stones * History of iron overload or hemochromatosis * History of allergy to ascorbic acid * Anuria, dehydration, serum albumin \<3.0 g/dL, severe pulmonary congestion or pulmonary edema or fixed low cardiac input since all are conditions for which osmotic diuresis are contraindicated . * Subjects who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. * Subjects who are on strong inducers, inhibitors or substrates of CYP within 3 days of planned administration of study ascorbate-meglumine. * Subjects for which MRI is contra-indicated (for example a pacemaker/recent surgery with orthopedic prosthesis) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** christopher.lascola@duke.edu **Name:** Christopher Lascola, MD **Phone:** 9194752607 **Role:** CONTACT **Contact 2:** **Email:** maureen.maughan@duke.edu **Name:** Maureen Maughan, PhD **Phone:** 9195979530 **Role:** CONTACT #### Locations **Location 1:** **City:** Durham **Country:** United States **Facility:** Duke Health **State:** North Carolina **Zip:** 27709 #### Overall Officials **Official 1:** **Affiliation:** Duke Health **Name:** John Kirkpatrick, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M4513 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: T477 - Name: Vitamin C - Relevance: HIGH - As Found: SARS-CoV-2 - ID: T437 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433778 **Brief Title:** A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK) **Official Title:** Vonicog Alfa (Recombinant Von Willebrand Factor) Treatment Outcomes in Von Willebrand Disease in the UK: a Retrospective Chart Review Study #### Organization Study ID Info **ID:** TAK-577-5001 #### Organization **Class:** INDUSTRY **Full Name:** Takeda ### Status Module #### Completion Date **Date:** 2023-10-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-30 **Type:** ACTUAL #### Start Date **Date:** 2021-12-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Takeda #### 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 is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor \[rVWF\]). Von Willebrand disease (VWD) is the most common inherited bleeding disorder. rVWF is approved in Europe and UK to treat bleeding and to treat and prevent bleeding during surgeries in adults in 2018. This study will review and collect information on the treatment and bleed prevention of adult persons with inherited VWD with rVWF in UK. These data were already collected as a part of the routine care. The main aims of this study are to describe the use of rVWF in on-demand treatment of bleeding and the prevention of treatment and treatment of bleeding during surgeries. Other aims are to describe bleedings and their treatment as well as any surgeries before and after first treatment with rVWF and to gather information on the use of healthcare resources (such as hospital visits, emergency room visits, etc.). ### Conditions Module **Conditions:** - Von Willebrand Disease (VWD) **Keywords:** - Drug Therapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 34 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants who have been diagnosed with congenital VWD and prescribed rVWF within the index date range (defined as the first administration of rVWF and must fall between 1st October 2020 and 30th June 2022) will be assessed using data obtained from medical records to evaluate the treatment outcome of rVWF in real-world clinical practice. **Intervention Names:** - Other: No Intervention **Label:** Participants diagnosed With Congenital VWD ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants diagnosed With Congenital VWD **Description:** This is a non-interventional study. **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Bleeding episodes will be assessed based on categories of overall and annualized, type, severity, location, bleed frequency, bleed type/location and bleed severity. **Measure:** Number of Participants With Bleeding Episodes Treated with rVWF Between the Index Date and Following 12 Months **Time Frame:** From index date up to 12 months **Description:** Surgical procedures included surgery type, severity, category (emergency or elective). Data on the participants use of rVWF in the pre-, intra- and post-operative setting during the period between the index date and the following 12 months, will be stratified by VWD type, surgery type, severity, location, or treatment rationale. **Measure:** Number of Surgical Procedures Between the Index Date and Following 12 Months **Time Frame:** From index date up to 12 months **Description:** Surgery outcomes (success, failure, complications) will be reported. **Measure:** Number of Participants with Surgery Outcomes (Success, Failure, Complications) Between the Index Date and Following 12 Months **Time Frame:** From index date up to 12 months #### Secondary Outcomes **Description:** HRU will include bleeding-related hospitalization rates, outpatient visits, accident and emergency visits. **Measure:** Number of Participants With VWD-Related Healthcare Resource Utilization (HRU) **Time Frame:** Up to 24 months **Description:** Surgery related costs by type will include length of stay in intensive care unit (ICU), rVWF consumption, factor VIII (FVIII) consumption, VWD treatment consumption, laboratory tests and examinations. **Measure:** Number of Participants With Surgery Related Costs By Type **Time Frame:** Up to 24 months **Description:** Bleeding episodes will be reported based on type, severity, location, treatment, and outcomes, of all recorded bleeds within 12 months prior to and 12 months following the first administration of rVWF. **Measure:** Number of Participants With Bleeding Episodes Treated With rVWF **Time Frame:** Up to 24 months **Description:** Surgical procedures will be reported based on surgery type (orthopaedic, gastro-intestinal, dental, etc), severity (major, minor), category (emergency or elective) treatment duration and outcomes, of all recorded surgeries within 12 months prior to and 12 months following the first administration of rVWF. **Measure:** Number of Surgical Procedures **Time Frame:** Up to 24 months **Description:** Surgery outcomes (success, failure, complications) based on average number of post-operative bleeds will be reported. **Measure:** Number of Participants with Surgery Outcomes (Success, Failure, Complications) **Time Frame:** Up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Adults (aged 18 or over at time of first administration of rVWF) who have provided informed consent and used rVWF within its licensed indication. * Participants who have been diagnosed with congenital von Willebrand disease. * Confirmed instance of * at least one bleed (either a new bleed or ongoing bleed treated under a treatment switch) treated on-demand with rVWF between 01-Oct-2020 and 30-Jun- 2022 and/or * treatment to prevent and treat surgical bleeds with rVWF between 01-Oct-2020 and 30-Jun-2022 Exclusion criteria: * Participants who were aged 17 years or less at the time of the first administration of rVWF. * Participants who have been diagnosed with any other bleeding disorders or factor deficiencies including acquired von Willebrand disease. * Participants with neutralising antibodies/inhibitors to VWF. * Participants participation in a clinical trial of an investigational medical product during the study period. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants who have been diagnosed with congenital VWD and were prescribed rVWF in UK. ### Contacts Locations Module #### Locations **Location 1:** **City:** Birmingham **Country:** United Kingdom **Facility:** University Hospitals Birmingham **Zip:** B15 2GW **Location 2:** **City:** Leeds **Country:** United Kingdom **Facility:** Leeds Teaching Hospital **Zip:** LS9 7TF **Location 3:** **City:** Liverpool **Country:** United Kingdom **Facility:** Liverpool University Hospital **Zip:** L7 8XP **Location 4:** **City:** London **Country:** United Kingdom **Facility:** Royal Free London **Zip:** NW3 2QG **Location 5:** **City:** London **Country:** United Kingdom **Facility:** Imperial College Healthcare **Zip:** W2 1NY **Location 6:** **City:** Manchester **Country:** United Kingdom **Facility:** Manchester University **Zip:** M13 9WL **Location 7:** **City:** Oxford **Country:** United Kingdom **Facility:** Oxford University Hospital **Zip:** OX3 9DU #### Overall Officials **Official 1:** **Affiliation:** Takeda **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. **Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **URL:** https://vivli.org/ourmember/takeda/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000025861 - Term: Blood Coagulation Disorders, Inherited - ID: D000001778 - Term: Blood Coagulation Disorders - ID: D000006402 - Term: Hematologic Diseases - ID: D000020147 - Term: Coagulation Protein Disorders - ID: D000001791 - Term: Blood Platelet Disorders - ID: D000006474 - Term: Hemorrhagic Disorders - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M17585 - Name: Von Willebrand Diseases - Relevance: HIGH - As Found: Von Willebrand Disease - ID: M21977 - Name: Hemostatic Disorders - Relevance: LOW - As Found: Unknown - ID: M5059 - Name: Blood Coagulation Disorders - Relevance: LOW - As Found: Unknown - ID: M23095 - Name: Blood Coagulation Disorders, Inherited - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M21982 - Name: Coagulation Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M5072 - Name: Blood Platelet Disorders - Relevance: LOW - As Found: Unknown - ID: M9560 - Name: Hemorrhagic Disorders - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014842 - Term: Von Willebrand Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433765 **Brief Title:** A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS) **Official Title:** BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI® #### Organization Study ID Info **ID:** TG1101-RMS403 #### Organization **Class:** INDUSTRY **Full Name:** TG Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2030-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2030-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** TG Therapeutics, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®. ### Conditions Module **Conditions:** - Multiple Sclerosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 728 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception \[DOC\]). **Intervention Names:** - Other: No intervention **Label:** BRIUMVI® Exposed Cohort #### Arm Group 2 **Description:** Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS. **Intervention Names:** - Other: No intervention **Label:** BRIUMVI® Unexposed Cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - BRIUMVI® Exposed Cohort - BRIUMVI® Unexposed Cohort **Description:** No intervention **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of Participants with Major Congenital Malformations (MCMs) **Time Frame:** Up to 52 weeks post-delivery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®. 2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy. 3. Diagnosis of MS. 4. Currently or recently (within 1 year of pregnancy outcome) pregnant. 5. Authorization from healthcare provider to provide data to registry. Exclusion Criteria: 1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy. 2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled). 3. Exposure to known teratogens and/or investigational medications during pregnancy. **Gender Based:** True **Maximum Age:** 50 Years **Minimum Age:** 15 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT **Study Population:** The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** briumvipregnancyregistry@ppd.com **Name:** BRIUMVI® Pregnancy Registry Virtual Research Coordination Center **Phone:** 1-877-411-4605 **Role:** CONTACT **Contact 2:** **Email:** clinicalsupport@tgtxinc.com **Name:** TG Therapeutics Clinical Support Team **Phone:** 1-877-555-8489 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000012598 - Term: Sclerosis ### 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: M4230 - Name: Antibodies, Monoclonal - 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:** NCT06433752 **Acronym:** ENABLE **Brief Title:** A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS) **Official Title:** REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE) #### Organization Study ID Info **ID:** TG1101-RMS406 #### Organization **Class:** INDUSTRY **Full Name:** TG Therapeutics, Inc. ### Status Module #### Completion Date **Date:** 2027-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** TG Therapeutics, Inc. #### 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 safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting ### Conditions Module **Conditions:** - Relapsing Multiple Sclerosis - Multiple Sclerosis ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS. **Intervention Names:** - Other: No Intervention **Label:** BRIUMVI® (Ublituximab-xiiy) ### Interventions #### Intervention 1 **Arm Group Labels:** - BRIUMVI® (Ublituximab-xiiy) **Description:** No Intervention **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Annualized Relapse Rate (ARR) **Time Frame:** Up to Week 96 #### Secondary Outcomes **Measure:** Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Up to Week 96 **Measure:** Number of Participants with Infusion Related Reaction (IRR) at Each Infusion **Time Frame:** Up to Week 96 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Confirmed Multiple Sclerosis (MS) diagnosis. 2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included. Exclusion Criteria: 1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration. 2. Any active infection (e.g., active Hepatitis B virus \[HBV\]) 3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** clinicalsupport@tgtxinc.com **Name:** TG Therapeutics Clinical Support Team **Phone:** 1-877-555-8489 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000012598 - Term: Sclerosis ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11982 - Name: Morphine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433739 **Acronym:** EACEC **Brief Title:** Efficacy of a Clinical Algorithm for the Selection of Peripheral Venous Catheters **Official Title:** Efficacy of a Clinical Algorithm for the Selection of Peripheral Venous Catheters to Reduce the Number of Catheter-Associated Complications in Hospitalized Patients: A Retrospective Cohort Study #### Organization Study ID Info **ID:** CSAPG-47 #### Organization **Class:** OTHER **Full Name:** Consorci Sanitari de l'Alt Penedès i Garraf ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Consorci Sanitari de l'Alt Penedès i Garraf #### 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 observational study is to investigate the complications associated with peripheral venous catheterization based on whether a correct or incorrect catheter was used according to a clinical algorithm in patients admitted to an acute care unit. The main question it seeks to answer is: • Are there fewer complications associated with catheterization when a correct catheter choice is made? Data from patients admitted to the acute care units of the sponsoring study center will be reviewed. ### Conditions Module **Conditions:** - Catheter Related Complication **Keywords:** - Catheterization, Peripheral ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 3314 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group will include all peripheral venous catheterizations for which the appropriate catheter type selection according to the standardized algorithm has been performed **Intervention Names:** - Other: standardized algorithm **Label:** appropriate catheter type selection #### Arm Group 2 **Description:** This group will include all peripheral venous catheterizations for which an inappropriate catheter type selection according to the standardized algorithm has been performed **Intervention Names:** - Other: standardized algorithm **Label:** inappropriate catheter type selection ### Interventions #### Intervention 1 **Arm Group Labels:** - appropriate catheter type selection - inappropriate catheter type selection **Description:** standardized algorithm for the correct selection of peripheral venous catheters **Name:** standardized algorithm **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Percentage of catheters removed due to complications associated with the use of a peripheral venous catheter **Measure:** Catheters removed due to complications associated with the use of a peripheral venous catheter **Time Frame:** Through study completion, an average of 1 year #### Secondary Outcomes **Description:** Correct or incorrect selection of the catheter according to the clinical algorithm. The proportion of correctly selected catheters in relation to the total number of catheters will be calculated. **Measure:** Selection of the peripheral venous catheter **Time Frame:** Through study completion, an average of 1 year **Description:** Number of complications associated with the use of a peripheral venous catheter depending on whether a correct or incorrect selection of the catheter was made according to the clinical algorithm. **Measure:** Complications associated with the use of a peripheral venous catheter **Time Frame:** Through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Admitted to acute care hospital wards. * Carriers of a peripheral venous catheter. * With the study evaluation criteria documented in their medical records. Exclusion Criteria: * Admitted to gynecology, obstetrics, and pediatrics wards. * Admitted to the emergency department and intensive care units **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients admitted to some acute care unit requiring peripheral venous catheterization ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** emoreno@csapg.cat **Name:** Esther Moreno **Phone:** +34 938960025 **Role:** CONTACT **Contact 2:** **Email:** recerca@csapg.cat **Name:** Noemí Casaponsa **Phone:** +34 938960025 **Phone Ext:** 43197 **Role:** CONTACT #### Locations **Location 1:** **City:** Sant Pere De Ribes **Contacts:** ***Contact 1:*** - **Email:** emoreno@csapg.cat - **Name:** Esther Moreno - **Phone:** +34 938960025 - **Role:** CONTACT ***Contact 2:*** - **Email:** recerca@csapg.cat - **Name:** Noemí Casaponsa - **Phone:** +34 938960025 - **Phone Ext:** 43197 - **Role:** CONTACT ***Contact 3:*** - **Name:** Esther Moreno - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Consorci Sanitari Alt Penedes i Garraf **State:** Barcelona **Zip:** 08810 #### Overall Officials **Official 1:** **Affiliation:** CSAPG **Name:** Esther Moreno **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision. **Description:** IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union). **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** After publication of main results of the study. ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433726 **Brief Title:** A Phase l Study of By101921, an Oral PARP7 Inhibitor, in Patients With Advanced Solid Tumors **Official Title:** A Phase Ⅰ, Multi-center, Open-label, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of BY101921 Monotherapy in Patients With Advanced Solid Tumors #### Organization Study ID Info **ID:** BY1921-I-01 #### Organization **Class:** INDUSTRY **Full Name:** Chengdu Baiyu Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chengdu Baiyu Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** BY101921 is a novel small molecule, being developed as a PARP7 inhibitor which acts on the PARP7 catalytic subunit, for the treatment of solid tumors. PARP7 is a member of the monoPARP family and involved in various biological processes such as gene expression, protein degradation, and cellular stress response. The results of non-clinical studies showed BY101921 was a potent inhibitor of PARP7 and had good selectivity. The primary objective is to assess the safety and tolerability and MTD of BY101921 in patients with refractory or metastatic solid tumors. This study will also evaluate pharmacokinetic (PK) profile, preliminary anti-tumor activity, major metabolites and biomarkers in patients with refractory or metastatic solid tumors. ### Conditions Module **Conditions:** - Solid Tumor, Adult ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dose Escalation: Multiple doses of BY101921 for oral administration **Intervention Names:** - Drug: BY101921 tablets **Label:** BY101921 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BY101921 **Description:** An oral PARP7 Inhibitor **Name:** BY101921 tablets **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Grade and frequency of adverse events and serious adverse events **Measure:** To assess the safety and tolerability of BY101921 in patients with advanced solid tumors **Time Frame:** through study completion (an average of 1.5 years) **Description:** Incidence of Dose limiting Toxicities (DLTs) **Measure:** To assess the maximum tolerated dose (MTD) **Time Frame:** through study completion (an average of 1.5 years) #### Secondary Outcomes **Description:** ORR **Measure:** To assess preliminary antitumor activity of BY101921 in patients with advanced solid tumors **Time Frame:** through study completion (an average of 1.5 years) **Description:** AUC **Measure:** To assess pharmacokinetics (PK) parameters of BY101921 in patients with advanced solid tumors **Time Frame:** through study completion (an average of 1.5 years) **Description:** Cmax **Measure:** To assess pharmacokinetics (PK) parameters of BY101921 in patients with advanced solid tumors **Time Frame:** through study completion (an average of 1.5 years) **Description:** T1/2 **Measure:** To assess pharmacokinetics (PK) parameters of BY101921 in patients with advanced solid tumors **Time Frame:** through study completion (an average of 1.5 years) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female patients ≥18 years and ≤75 years of age. 2. patients histologically or cytologically diagnosed advanced malignant solid tumors who have failed, cannot tolerate, or refuse prior standard treatment regimens. At least 1 measurable lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. 3. Have a projected life expectancy of at least 3 months. 4. Eastern Cooperative Oncology Group Performance Status 0 or 1. 5. Adequate organ and bone marrow function. Laboratory tests that meet the following criteria within 7 days prior to the first dose of study treatment (without blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor therapy, renal replacement therapy, etc., within 28 days prior to the screening examination): Routine blood test: Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelets count (PLT) ≥ 100×109/L Hemoglobin (Hb) ≥ 90 g/L Hepatic function: Total bilirubin (TBIL) ≤ 1.5×ULN Aspartate aminotransferase (AST) ≤ 2.5×ULN Alanine aminotransferase (ALT) ≤ 2.5×ULN ALT and AST ≤ 5×ULN and TBIL ≤ 3×ULN for patients with primary liver cancer, liver metastases, or Gilbert 's syndrome. Renal function: Creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula). Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN 6. Females and males of childbearing potential must agree to use appropriate methods of contraception (hormonal/barrier method or abstinence) during the study and for 3 months after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration. 7. Understand and be willing to sign written informed consent and be able to follow the study protocol for treatment, visits, and other study procedures. Exclusion Criteria: 1. Previously treated with PARP-7 inhibitors. 2. Treated with a potent CYP3A4 inhibitor or inducer within 2 weeks prior to the first dose of study treatment. 3. Previous any treatment with of the following: 1. Systemic chemotherapy, other antitumor agents (including endocrine therapy, macromolecular targeted therapy, immunotherapy, or biotherapy) within 4 weeks or 5 half-lives prior to the first dose of study treatment, or who need to continue receiving these agents during the study period; 2. Small molecule targeted therapy within 2 weeks or 5 half-lives prior to the first dose of study treatment; 3. Anti-tumor traditional Chinese medicine or proprietary Chinese medicine preparations prior to the first dose of study treatment; 4. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment; 5. Palliative radiation therapy within 2 weeks prior to the first dose of study treatment; 6. Investigational drug within 4 weeks prior to the first dose of study treatment; g Radical radiation therapy within 4 weeks prior to the first dose of study treatment. 4. Major surgical intervention (excluding needle biopsy) within 28 days before study drug administration, surgical wound has not fully healed or surgery is scheduled during the study period. 5. Brain metastasis (except asymptomatic, stable for more than 4 weeks prior to the first dose and not requiring steroid therapy for at least 4 weeks prior to the first dose, no imaging findings of marked edema around the tumor lesion), presence of meningeal metastasis or brainstem metastasis, or presence of spinal cord compression. 6. History of other malignancy within the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or other carcinomas in situ which have undergone curative treatment and have had no recurrence within 5 years after treatment. 7. Toxicities from prior antitumor therapy that have not recovered to CTCAE version 5.0 Grade 1 or less, except CTCAE (V5.0) Grade 2 peripheral neurotoxicity and alopecia of any grade. 8. Difficult-to-control pleural effusion, ascites, or pericardial effusion.etc, requiring repeated drainage and considered unsuitable for study enrollment by the investigator. 9. Serious or uncontrolled diseases as assessed by the investigator, including but not limited to: Severe or uncontrolled diabetes, poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg under standardized antihypertensive regimens), epilepsy, chronic obstructive pulmonary disease, interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson 's disease, active bleeding, uncontrolled infection. Cognitive dysfunction, history of psychiatric disorders, other uncontrolled concomitant diseases, alcohol dependence, hormone dependence, or drug abuse. History of immunodeficiency, including HIV antibody positive, other acquired or congenital immunodeficiency disease, or history of organ transplantation. HBsAg or HBcAb positive, and peripheral blood HBV DNA titer test ≥ 200 IU/mL or ≥ 1000 copies/mL or above the upper limit of normal value at the study site; HCV antibody test positive, and HCV RNA test above the upper limit of normal value at the study site; treponema pallidum-specific antibody positive. Clinically serious gastrointestinal dysfunction that may compromise drug intake, transport, or absorption. For example, inability to take oral medication, uncontrollable nausea or vomiting, history of massive gastrointestinal resection, history of gastrointestinal ulcer and gastrointestinal bleeding within 6 months prior to the first dose, untreated recurrent diarrhea, untreated stomach disease requiring long-term use of PPI acid suppressants, Crohn 's disease, ulcerative colitis, etc. 10. Cardiac dysfunction, including any of the following: Myocardial infarction in past 6 months, heart failure classified as Class II/III/IV according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, and unstable arrhythmia. Left ventricular ejection fraction LVEF \< 50% shown by echocardiography. QT interval corrected using Fridericia 's formula: QTcF \> 470 msec (females), QTcF \> 450 msec (males). 11. Pregnant (positive pregnancy test prior to dosing) or lactating. 12. History of serious hypersensitivity (e.g., anaphylactic shock) or hypersensitivity to excipients or other ingredients associated with the study drug. 13. Cannot follow the protocol to "avoid ingesting grapefruit , pomegranate, orange or green lemon (juice/sauce made from these fruits as well) within 7 days before study drug administration and throughout the BY101921 treatment period". 14. Other factors considered unsuitable for study enrollment 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:** 13370582181@163.com **Name:** Jinming Yu **Phone:** +8613806406293 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** 13370582181@163.com - **Name:** Jinming professor Yu, MD - **Phone:** +8613806406293 - **Role:** CONTACT ***Contact 2:*** - **Email:** 13370582181@163.com - **Name:** Yuping professor Sun, MD - **Phone:** +86-531-67627158 - **Role:** CONTACT ***Contact 3:*** - **Name:** Jinming professor Yu, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Yuping professor Sun, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Cancer Hospital Affiliated to Shandong First Medical University / Shandong Cancer Research Institute / Shandong Cancer Hospital **State:** Shandong **Status:** RECRUITING **Zip:** 250117 ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433713 **Brief Title:** Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections **Official Title:** Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections, a Double-blinded Randomized Control Study #### Organization Study ID Info **ID:** MS-220 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-01 **Type:** ACTUAL #### Start Date **Date:** 2023-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Amr Fathy Zaky **Investigator Title:** Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Postoperative discomfort is a frequently seen adverse event after to caesarean operation. Early mobilization and bonding of the mother and her infant are typically impacted by this phenomenon. Nevertheless, the current state of postoperative analgesia and recovery remains inadequate in clinical settings. In the context of major abdominal surgery, opioids are often regarded as the preferred postoperative analgesic. Nevertheless, they possess adverse side effects that might impact the process of recuperation after surgery. These symptoms include nausea and vomiting, decreased bowel movement, and shallow breathing. One additional challenging consequence after surgery is the delayed restoration of bowel function, which has the potential to extend the duration of hospitalization and impede the initiation of oral feeding, resulting in gaseous colonic distension. The administration of lidocaine infusion has been shown to possess analgesic, anti-hyperalgesic, and anti-inflammatory characteristics. The use of intravenous lidocaine after surgery is postulated to have the dual effect of mitigating postoperative pain and expediting the resumption of bowel movements. Recent studies have shown that the administration of intravenous lidocaine, either as a single dosage or by continuous infusion, may have potential advantages in maintaining gastrointestinal motility and exerting an impact on biochemical pain mechanisms. However, the literature presents contradictory data about the effectiveness of lidocaine in providing sufficient postoperative pain relief and reducing postoperative ileus. Consequently, this study was conducted and aimed to assess the effect of intravenous intraoperative lidocaine on postoperative pain and early return of bowel function following elective caesarean section. This randomized clinical trial was conducted at Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University Hospitals from August till December 2023. A total of 60 pregnant women underwent elective caesarean section were enrolled and randomized into two groups; experimental group who received IV infusion of lidocaine starting with skin incision, which was maintained until skin closure and control group who received 0.9% normal saline at the same rate as that described in the experimental group. Both groups were compared as regard total operative time, medications given, start-stop time of the study drug infusion, and degree of pain using visual analogue scale, need for analgesics, time for first healing of normal intestinal sounds and time to first flatus and symptoms of lidocaine toxicity were recorded. ### Conditions Module **Conditions:** - Postoperative Pain - Postoperative Return of Bowel Function ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intravenous lidocaine infusion, 2 mg/kg/hour **Intervention Names:** - Drug: Lidocaine IV **Label:** Lidocaine Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Normal saline infusion **Intervention Names:** - Drug: Placebo **Label:** Control Group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Lidocaine Group **Description:** They received IV infusion of 2 mg/kg per hour of lidocaine starting with skin incision, which was maintained until skin closure. This was done using a syringe pump with the calculated amount of lidocaine added to 50 ml of normal saline infused at a rate of 50 ml/hr. **Name:** Lidocaine IV **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control Group **Description:** 0.9% normal saline infusion **Name:** Placebo **Other Names:** - Normal saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The patients are asked to describe how much pain they feel in a scale from 0 to 10. Minimum score 0, maximum score 10 where 10 is worse and means more pain **Measure:** Effect of intraoperative intravenous lidocaine on visual analogue scale pain scores among the two groups. **Time Frame:** 12-24 hours **Description:** Time to hearing of bowel sounds, passing of flatus \& passing of stool **Measure:** Effect of intraoperative intravenous lidocaine on early return of bowel function assessed by the time to first hearing of bowel sounds and the time to first flatus passing. **Time Frame:** 12-24 hours #### Secondary Outcomes **Description:** Nausea, perioral numbness, neurological symptoms or cardiac arrhythmia **Measure:** Occurrence of lidocaine toxicity with the standard dose given. **Time Frame:** 12-24 hours **Measure:** Duration of hospital stay. **Time Frame:** 12-24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age \> 18 years. 2. American society of anesthesiology (ASA) class II (Normal pregnancy, well controlled gestational HTN, controlled preeclampsia without severe features, diet-controlled gestational DM). 3. Singleton term pregnancy. 4. Elective caesarean section. 5. Spinal anesthesia. Exclusion Criteria: 1. Atypical postoperative care e.g. following caesarean hysterectomy. 2. Inflammatory bowel disease. 3. Prolonged surgery \>1.5 hours. 4. Medical disorders e.g. liver or renal affection 5. Previous bowel surgery. 6. History' of allergic reaction to lidocaine. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Cairo University Kasr Al Aini School of Medicine **Zip:** 11562 ### 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: 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: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - 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 - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - 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: D000008012 - Term: Lidocaine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433700 **Brief Title:** Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients **Official Title:** Risk of Revision and Other Complications Following Knee Arthroplasty in Patients Previously Exposed to Bariatric Surgeries: A Nationwide, Register-based Study #### Organization Study ID Info **ID:** p-2023-14433 #### Organization **Class:** OTHER **Full Name:** Bispebjerg Hospital ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2023-09-07 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bispebjerg Hospital #### Responsible Party **Investigator Affiliation:** Bispebjerg Hospital **Investigator Full Name:** Saber Muthanna Saber **Investigator Title:** Principal Investigator, PhD Fellow **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients. The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA. ### Conditions Module **Conditions:** - Arthritis Knee - Bariatric Surgery Candidate - Prosthesis Failure - Prosthesis Survival - Prosthesis-Related Infections **Keywords:** - arthroplasty - revision - bariatric ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 90000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who received bariatric surgery prior to their knee arthroplasty **Intervention Names:** - Other: BAS **Label:** BAS group #### Arm Group 2 **Description:** Patients who did not receive bariatric surgery prior to their knee arthroplasty **Intervention Names:** - Other: Non-BAS **Label:** Non-BAS group ### Interventions #### Intervention 1 **Arm Group Labels:** - BAS group **Description:** NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures (KJDF10 \& KJDF11 \[gastric bypass\]; KJDF20 \& KJDF21 \[gastric banding\]; KJDF40, KJDF41, KJDF96 \& KJDF97 \[gastric sleeve\]). **Name:** BAS **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Non-BAS group **Description:** Patients without BAS codes **Name:** Non-BAS **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Revision surgery is defined as surgery with debridement and/or exchange of at least one component **Measure:** Hazard rate of Revision due to any cause **Time Frame:** within 90 days and within 2 years **Description:** Our definition of infection is adapted from the European Bone and Joint Infection Society (EBJIS) criteria as at least one of the following A. An indication of deep infection is reported to the Danish knee arthroplasty register (DKR) by the surgeon on revision surgery B. At least 2 deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples C. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated. **Measure:** Hazard rate of Revision due to infection **Time Frame:** within 90 days and within 2 years #### Secondary Outcomes **Description:** the use of one of the following oral antibiotics: dicloxacillin, flucloxacillin, phenoxymethylpenicillin, amoxicillin, oral ciprofloxacin, roxithromycin, linezolid, cefuroxime and cefalexin **Measure:** Hazard rate of Knee related antibiotic use within 30- and 90-days following KA **Time Frame:** within 30- and 90-days following KA **Description:** the use of one of oral antibiotics other than those that were mentioned in outcome 3. **Measure:** Hazard rate of Antibiotic use due to other causes **Time Frame:** within 30- and 90-days following KA **Description:** Mortality registered in the Danish Civil Registration System (DCRS) by date **Measure:** Mortality **Time Frame:** 2 years postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Primary knee arthroplasty due to osteoarthritis Exclusion Criteria: * Primary knee arthroplasty due to traumatic osteoarthritis. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The investigators will include patients with primary/idiopathic or secondary (due to meniscus or cruciate ligament lesion) osteoarthritis (OA) who received primary KA in the period from 2011 and 2 years earlier to data-extraction date. Patients will be identified from the DKR. Patients are followed for 2 years, until first revision, death or migration, whichever comes first. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ssab0009@regionh.dk **Name:** Saber M. Saber, MD **Phone:** 004521299265 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Department of orthopedic surgery, Bispebjerg University Hospital, Denmark **Name:** Søren Overgaard, MD,DMSc,Prof **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-27 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 236674 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-27T06:03 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M18866 - Name: Prosthesis-Related Infections - Relevance: HIGH - As Found: Prosthesis-Related Infections - ID: M14338 - Name: Prosthesis Failure - Relevance: HIGH - As Found: Prosthesis Failure - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016459 - Term: Prosthesis-Related Infections - ID: D000011475 - Term: Prosthesis Failure ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433687 **Acronym:** HekaHeart POC **Brief Title:** HekaHeart Phase 1 Proof of Concept **Official Title:** HeakHeart Phase 1 Study: Proof of Concept #### Organization Study ID Info **ID:** 2000037817 #### Organization **Class:** OTHER **Full Name:** Yale University ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Roivant Sciences (HekaHeart) #### Lead Sponsor **Class:** OTHER **Name:** Yale 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 pilot study will test the feasibility of a novel digital health technology-enabled platform, HekaHeart, developed to facilitate comprehensive medical management, including medication initiation, titration, e-prescription eligibility, remote patient monitoring, and communication of care coordination activities, for patients with Heart Failure with Reduced Ejection Fraction (HFrEF) not currently on all four pillars of guideline-directed medical therapy (GDMT). **Detailed Description:** Heart Failure (HF) is a major cause of morbidity, mortality, and healthcare expenditure in the United States (US). The 2022 AHA/ACC/HFSA Guideline for the management of HF strongly recommends quadruple therapy for all patients with HFrEF, which includes: beta-blockers (BB); renin-angiotensin-aldosterone-system (RAAS) inhibitors such as angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) and angiotensin receptor-neprilysin inhibitors (ARNi); mineralocorticoid receptor antagonists (MRA); and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Unfortunately, suboptimal adoption of GDMT persists despite mounting, unambiguous evidence of its substantial benefit on patient outcomes (including mortality) across numerous large-scale studies. Further, following initial prescription of quadruple therapy, augmentation of each pillar to target or highest tolerated dosing is critical to achieve maximum benefit, as shown in a recent multinational randomized controlled trial (STRONG-HF) where rapid uptitration to optimal doses of GDMT reduced the risk of death and hospitalization just 180 days after an acute HF episode. Yet, multiple contemporary registry studies continue to reflect suboptimal uptake and dose escalation of GDMT for patients with HFrEF in real-world clinical practice due to both clinical and patient-based barriers. The HekaHeart platform is a comprehensive remote care and monitoring-based method for GDMT titration and management. The platform uses a virtual team of clinicians with expertise in HF to manage GDMT prescription, dose escalation, and symptom monitoring for patients with HFrEF as a means to both provide personalized patient care and support while alleviating clinician burden. Once a patient is fully optimized with respect to GDMT, they are transitioned back to routine clinical care. The present study will evaluate the usability of the HekaHeart platform to initiate, monitor, and manage GDMT for patients with HFrEF. The study will prospectively recruit eligible patients from ambulatory HF clinics affiliated with Yale New Haven Health System (YNHHS). Consented patients will be onboarded to the HekaHeart platform for GDMT management by HF disease management clinicians, which will include medication adjustment and remote patient monitoring to assess laboratory results, changes in body weight, blood pressure, and heart rate. Throughout the study, patients will engage in short message service (SMS), video and phone check-ins with clinicians, who will leverage standardized titration protocols to guide medication optimization, monitor patient progress and symptoms, and collect, analyze and respond to remote monitoring data. After 45 days, patients will be transitioned back to usual care. The primary outcome is the Net Promoter Score (NPS), collected at study offboarding by each participant, and used to assess patient satisfaction with the HekaHeart platform and experience. The secondary outcome is the increase in proportion of HFrEF patients prescribed four pillars of GDMT. Other secondary endpoints include percent of patients successfully onboarded to the HekaHeart platform, proportion of patients whose GDMT is titrated toward target or maximally tolerated dosing, number scheduled visits attended, and percent of platform GDMT recommendations implemented. ### Conditions Module **Conditions:** - Heart Failure With Reduced Ejection Fraction **Keywords:** - Heart Failure - Guideline-directed medical therapy - Remote monitoring - Medication optimization ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will onboard to the HekaHeart platform, which will recommend a GDMT management plan that has been validated by a Yale-based clinician, with consideration given to eligibility for GDMT, past medical history, and patient preference. Participants will also be provided with an at-home blood pressure cuff, weight scale, and heart rate monitor and be instructed to use these devices on a regular cadence. Measurements will be electronically transmitted in real-time to the HekaHeart platform and uploaded to a web-based portal for review. Weekly/bi-weekly scheduled remote check-ins will be used by clinicians to monitor patient progress with GDMT management, to evaluate whether additional medications or dose adjustments are necessary, monitor symptoms, identify issues, offer medical education, and provide continued assistance with remote patient monitoring (RPM) devices. A final patient offboarding visit will occur once the patient has been on the platform for 45 days. **Intervention Names:** - Device: HekaHeart platform medication management and remote monitoring **Label:** HekaHeart-based medication optimization and remote monitoring ### Interventions #### Intervention 1 **Arm Group Labels:** - HekaHeart-based medication optimization and remote monitoring **Description:** Onboarding to the HekaHeart platform which includes a personalized GDMT management plan along with remote monitoring kits including a scale, blood pressure cuff, and heart rate monitor. Patients engage in video and phone calls with clinicians who will use established standardized clinical protocols to guide medication and vital optimization. Once patients are determined to be maximally titrated on all GDMT, they are transitioned back to standard clinical care. **Name:** HekaHeart platform medication management and remote monitoring **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** A metric used to gauge patient satisfaction with the HekaHeart platform. Patients are asked how likely they are to recommend the platform to a friend on a scale of 1 to 10 (with 1 being not likely to recommend, and 10 being highly likely to recommend). **Measure:** Net Promoter Score **Time Frame:** Assessed at time off patient offboarding (45 days after enrollment) #### Secondary Outcomes **Description:** Patients assessed for number of eligible classes of eligible GDMT medications prescribed. **Measure:** Percent of patients on all eligible guideline-directed medical therapy (GDMT) classes **Time Frame:** Assessed at time off patient offboarding (45 days after enrollment) **Description:** Percent of patients who consented to the study who have successfully onboarded to the HekaHeart plan with an optimized medication management plan. **Measure:** Percent of enrolled patients onboarded to HekaHeart **Time Frame:** Assessed from time of enrollment to 45 days post-enrollment **Description:** Percent of patients who have been prescribed a new medication within the HekaHeart platform after enrollment. **Measure:** Percent of onboarded patients successfully prescribed a new medication **Time Frame:** Assessed from time of enrollment to 45 days post-enrollment **Description:** Percent of patients who attended a scheduled check-in (via SMS, text, email, or phone) **Measure:** Percent of scheduled study check-ins attended by patients **Time Frame:** Assessed from time of enrollment to 45 days post-enrollment **Description:** Percent of HekaHeart-recommended medications prescribed **Measure:** Percent of medication recommendations implemented **Time Frame:** Assessed from time of enrollment to 45 days post-enrollment **Description:** Time in days to optimal titration of all eligible classes of GDMT as determined by clinician judgement and expertise **Measure:** Time to maximum titration **Time Frame:** Assessed from time of enrollment to 45 days post-enrollment **Description:** Time in days to first prescription made in HekaHeart platform **Measure:** Time from patient enrollment to first remote prescription **Time Frame:** Assessed from time of enrollment to 45 days post-enrollment **Description:** Determined via qualitative survey assessment of clinicians which asks how well the HekaHeart platform integrates into existing systems and workflows **Measure:** Ease of implementation of HekaHeart platform **Time Frame:** Assessed up to one month post- study completion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documentation of HFrEF as evidenced by the presence of LVEF ≤40% reading at any time within the last 12 months, 1. with associated symptoms of HF 2. or an elevated NT-proBNP 3. or a hospitalization for HF within the preceding 12 months * Currently receiving care at YNHHS * Currently not on all 4 recommended classes of GDMT (BB, ACEi/ARB/ARNi, MRA, and SGLT2i) Exclusion Criteria: * Currently pregnant or breast feeding * Received or listed for cardiac transplantation * Planned or present durable left ventricular-assist device (LVAD) * Goals of treatment are palliation * Currently has a condition(s) that limit survival to \<1 year * Unable to provide informed consent * Unwilling to use remote monitoring devices **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will come from two outpatient Heart Failure clinics associated with Yale New Haven Hospital. The population will be adults ≥18 years with symptomatic HFrEF who are not on adequate GDMT. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** francis.p.wilson@yale.edu **Name:** Francis P Wilson, MD MSCE **Phone:** 203 7371704 **Role:** CONTACT #### Locations **Location 1:** **City:** Guilford **Contacts:** ***Contact 1:*** - **Email:** marc.samsky@yale.edu - **Name:** Marc Samsky, MD - **Role:** CONTACT **Country:** United States **Facility:** Shoreline Medical Center- 111 Goose Lane location **State:** Connecticut **Zip:** 06437 **Location 2:** **City:** New Haven **Contacts:** ***Contact 1:*** - **Email:** marc.samsky@yale.edu - **Name:** Marc Samsky, MD - **Role:** CONTACT **Country:** United States **Facility:** Yale Physicians Building- 800 Howard Ave location **State:** Connecticut **Zip:** 06519 #### Overall Officials **Official 1:** **Affiliation:** Yale University **Name:** Francis P Wilson, MD MSCE **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** De-identified data for the primary and secondary outcomes will be made available upon publication. **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** Data will become available upon publication and indefinitely. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433674 **Brief Title:** Enteral Zinc Supplementation in VLBW Infants **Official Title:** Enteral Zinc Supplementation in VLBW Infants #### Organization Study ID Info **ID:** 23-09580-FB #### Organization **Class:** OTHER **Full Name:** University of Tennessee ### Status Module #### Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Tennessee #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to observe for changes in rate of weight gain in the VLBW infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer: • Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups * Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive \~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks PMA or hospital discharge, whichever comes first. * The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy. **Detailed Description:** This is a prospective, single center, randomized, double blinded, placebo controlled clinical trial. The goal of this clinical trial is to observe for changes in rate of weight gain in the VLBW infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer: • Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups * Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized using sealed envelopes. The subjects will be randomly selected to one of two groups. The treatment group will receive \~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. Only the pharmacy will know which patient is receiving the Zinc Sulfate and which patient is receiving the placebo. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks PMA or hospital discharge, whichever comes first. * The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy. ### Conditions Module **Conditions:** - Very Low Birth Weight Infant - Nutritional Deficiency ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The experimental group will receive \~1 mg/kg/day of elemental enteral Zinc **Intervention Names:** - Drug: Zinc Sulfate **Label:** Zinc Sulfate **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The placebo group will receive a similar amount of sterile water in a colored syringe **Intervention Names:** - Other: Sterile Water **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Zinc Sulfate **Description:** The pharmacy will be the one preparing the Zinc sulfate. The zinc sulfate comes in 220 mg tablets which are then mixed with 1 ml of Oral plus (a common suspending agent) as well as 9 ml of Sterile water. This then makes a Zinc Sulfate 22 mg/ml oral suspension which will be dispensed in an amber syringe. **Name:** Zinc Sulfate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** The placebo group with will receive a similar amount of sterile water in a colored syringe **Name:** Sterile Water **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome would be the rate of weight gain in grams/kg/day **Measure:** Rate of weight gain **Time Frame:** at hospital discharge or 36 weeks PMA whichever comes first. #### Secondary Outcomes **Description:** This secondary outcome would be the rate of length gain in cm/day **Measure:** Length **Time Frame:** at hospital discharge of 36 weeks PMA whichever comes first **Description:** This secondary outcome would be the rate of head circumference gain in cm/day **Measure:** Head Circumference **Time Frame:** at hospital discharge of 36 weeks PMA whichever comes first **Description:** This secondary outcome would be looking for a statically significant difference in zinc level **Measure:** Zinc level **Time Frame:** Comparing the initial zinc level to the four week zinc level as well as the zinc level at 36 weeks or discharge whichever comes first ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Birth weight \< 1500 grams 2. Infant is tolerating at least 100 ml/kg/day of enteral feeds 3. At least 25wks PMA. Exclusion Criteria: * Major congenital malformations especially anomaly of the GI tract * Major congenital heart disease (i.e.: ductal dependent lesion) * Previously diagnosed NEC (stage 2 or 3), bowel perforation, or bowel resection * Infant who has tolerated ≥100 ml/kg/day prior to admission. **Healthy Volunteers:** True **Maximum Age:** 36 Weeks **Minimum Age:** 25 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** amire@uthsc.edu **Name:** Andrew C Mire, M.D. **Phone:** 2255884831 **Role:** CONTACT **Contact 2:** **Email:** mweems@uthsc.edu **Name:** Mark Weems, M.D. **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** UTHSC **Name:** Andrew C Mire, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Terrin G, Berni Canani R, Passariello A, Messina F, Conti MG, Caoci S, Smaldore A, Bertino E, De Curtis M. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country. Am J Clin Nutr. 2013 Dec;98(6):1468-74. doi: 10.3945/ajcn.112.054478. Epub 2013 Sep 11. **PMID:** 24025633 **Citation:** Brion LP, Heyne R, Lair CS. Role of zinc in neonatal growth and brain growth: review and scoping review. Pediatr Res. 2021 May;89(7):1627-1640. doi: 10.1038/s41390-020-01181-z. Epub 2020 Oct 3. Erratum In: Pediatr Res. 2021 Mar 2;: **PMID:** 33010794 **Citation:** Terrin G, Berni Canani R, Di Chiara M, Pietravalle A, Aleandri V, Conte F, De Curtis M. Zinc in Early Life: A Key Element in the Fetus and Preterm Neonate. Nutrients. 2015 Dec 11;7(12):10427-46. doi: 10.3390/nu7125542. **PMID:** 26690476 **Citation:** Sinha B, Dudeja N, Chowdhury R, Choudhary TS, Upadhyay RP, Rongsen-Chandola T, Mazumder S, Taneja S, Bhandari N. Enteral Zinc Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysis. Pediatrics. 2022 Aug 1;150(Suppl 1):e2022057092J. doi: 10.1542/peds.2022-057092J. **PMID:** 35921675 **Citation:** Shaikhkhalil AK, Curtiss J, Puthoff TD, Valentine CJ. Enteral zinc supplementation and growth in extremely-low-birth-weight infants with chronic lung disease. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):183-7. doi: 10.1097/MPG.0000000000000145. **PMID:** 24121149 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001835 - Term: Body Weight - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Nutritional Deficiency - ID: M5006 - Name: Birth Weight - Relevance: HIGH - As Found: Birth Weight - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition - ID: D000001724 - Term: Birth Weight ### Intervention Browse Module - Ancestors - ID: D000001252 - Term: Astringents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients ### Intervention Browse Module - Browse Leaves - ID: M21269 - Name: Zinc Sulfate - Relevance: HIGH - As Found: Systolic blood pressure - ID: M17768 - Name: Zinc - Relevance: LOW - As Found: Unknown - ID: M4559 - Name: Astringents - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019287 - Term: Zinc Sulfate ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433661 **Brief Title:** A Research Study of the Effect of Food on Etavopivat in Healthy Participants **Official Title:** A Single-centre, Open-label, Randomised, Single-dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Etavopivat in Healthy Participants #### Organization Study ID Info **ID:** NN7535-7702 #### Organization **Class:** INDUSTRY **Full Name:** Novo Nordisk A/S #### Secondary ID Infos **Domain:** World Health Organization (WHO) **ID:** U1111-1289-2544 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novo Nordisk A/S #### 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 effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening). ### Conditions Module **Conditions:** - Healthy Volunteers Sickle Cell Disease, Thalassemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive a single dose of Etavopivat in fed condition in period 1 and a single dose of Etavopivat in fasted condition in period 2. **Intervention Names:** - Drug: Etavopivat **Label:** Sequence 1: Etavopivat: fed-fasted **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive a single dose of Etavopivat in fasted condition in period 1 and a single dose of Etavopivat in fed condition in period 2. **Intervention Names:** - Drug: Etavopivat **Label:** Sequence 2: Etavopivat: fasted-fed **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Sequence 1: Etavopivat: fed-fasted - Sequence 2: Etavopivat: fasted-fed **Description:** Participants will receive single dose of oral Etavopivat in each treatment period. **Name:** Etavopivat **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Measured as hours nanograms per milliliter (h\*ng/mL). **Measure:** AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose **Time Frame:** From 0 to 120 hours after IMP administration (V2/V6) **Description:** Measured as nanograms per milliliter (ng/mL). **Measure:** Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose **Time Frame:** From 0 to 120 hours after IMP administration (V2/V6) #### Secondary Outcomes **Description:** Measured as hours nanograms per milliliter (h\*ng/ml). **Measure:** AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration **Time Frame:** From 0 to 120 hours after IMP administration (V2/V6) **Description:** Measured as hours. **Measure:** tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose **Time Frame:** From 0 to 120 hours after IMP administration (V2/V6) **Description:** Measured as hours. **Measure:** t1/2, etavopivat: Terminal half-life for etavopivat after a single dose **Time Frame:** From 0 to 120 hours after IMP administration (V2/V6) **Description:** Measured as liter per hours (L/h). **Measure:** CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose **Time Frame:** From 0 to 120 hours after IMP administration (V2/V6) **Description:** Measured as liters (L). **Measure:** Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values **Time Frame:** From 0 to 120 hours after IMP administration (V2/V6) **Description:** Measured as count of events. **Measure:** Number of adverse events **Time Frame:** From IMP administration on day 1 to completion of the end of study visit (V10) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 18.5 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. * Body weight greater than or equal to (≥) 40.0 kilogram (kg) at screening. * Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods. * Participation (i.e., signed informed consent) in any other interventional clinical study within 30 days or 5 times the half-life of the previous investigational medicinal product (IMP) (if known), whichever is longer before screening. * Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol. * Use of tobacco and nicotine products, defined as any of the below: * Has used any product containing tobacco or nicotine within 90 days prior to screening, * Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study, * Positive nicotine test at screening. * Participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study. * Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** clinicaltrials@novonordisk.com **Name:** Novo Nordisk **Phone:** (+1) 866-867-7178 **Role:** CONTACT #### Locations **Location 1:** **City:** Salt Lake City **Country:** United States **Facility:** ICON-Salt Lake City **State:** Utah **Zip:** 84124 #### Overall Officials **Official 1:** **Affiliation:** Novo Nordisk A/S **Name:** Clinical Transparency (dept. 2834) **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** According to the Novo Nordisk disclosure commitment on novonordisk-trials.com **IPD Sharing:** YES **URL:** http://novonordisk-trials.com ## 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 ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4085 - Name: Anemia, Sickle Cell - Relevance: HIGH - As Found: Sickle Cell Disease - ID: M16557 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - 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: T5622 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: T5229 - Name: Sickle Cell Anemia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000755 - Term: Anemia, Sickle Cell - ID: D000013789 - Term: Thalassemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433648 **Brief Title:** Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait **Official Title:** Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait #### Organization Study ID Info **ID:** STU00217960 #### Organization **Class:** OTHER **Full Name:** Shirley Ryan AbilityLab ### Status Module #### Completion Date **Date:** 2029-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shirley Ryan AbilityLab #### Responsible Party **Investigator Affiliation:** Shirley Ryan AbilityLab **Investigator Full Name:** Levi Hargrove **Investigator Title:** Scientific Chair, Center for Bionic Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees. Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle. Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only. Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle). Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements. **Detailed Description:** Amputation of the lower limb causes profound disability, significantly limiting mobility, independence, and the ability to pursue employment or leisure activities. Nearly 90% of all lower limb amputations in the United States occur in older persons, mostly due to vascular disease, and this population is expected to triple by 2050. After lower limb loss, individuals walk more slowly and more asymmetrically are less stable, and expend more metabolic energy during walking than persons with intact limbs. Even when using state-of-the-art microprocessor-controlled prostheses (typically a microprocessor knee with a passive ankle), persons with transfemoral amputations expend approximately 60% more energy than able-bodied individuals during ambulation. In addition to the physical limitations caused by the amputation, the increased energy requirements affect performance of everyday activities, including getting up out of a chair or off the toilet, or stepping up or down a curb. Most commercially available prosthetic legs are passive. The movement of a passive prosthetic joint relies on the properties of its mechanical components, such as hydraulic or pneumatic valves or sliding joints, together with compensatory adjustments made by the user. Since these computerized prostheses are passive, the user cannot efficiently negotiate stairs, an incline, or the numerous other functions that require net knee and/or ankle power. Powered prostheses can actively generate joint torque, allowing easy and efficient performance of more demanding activities, such as ascending stairs and hills. Powered knees and ankles, may allow for better outcomes in both older and younger individuals with transfemoral amputation; this powered componentry may enable more energy efficient walking, allow users to stand up from a seated position with ease, and enable them to walk across more challenging terrains-such as up and down hills, ramps, and stairs-safely and with more normal and symmetric gait kinematics and kinetics. This study will demonstrate the functional benefits of adding power at an individual joint. This knowledge will be critical for prioritizing future device development and will provide valuable information for clinicians and individuals on selecting appropriate componentry for transfemoral K2 amputees. ### Conditions Module **Conditions:** - Amputation - Amputation, Traumatic - Amputation of Knee - Amputation; Traumatic, Limb ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for transfemoral amputees with limited community mobility. Aim 1: measure functional performance of transfemoral ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle. Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only. Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle). ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participant is fit with the commercially available device (Ottobock Cleg 4/Ottobock foot), they will receive standard of care clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments. Participant is then fit with the SRALAB Hybrid knee and SRALAB Polycentric Ankle prosthesis, they again will receive clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments. **Intervention Names:** - Device: Ottobock CLeg4 + Ottobock foot - Device: SRALAB Hybrid Knee + Polycentric Ankle **Label:** Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** For this arm, transfemoral amputees will participate in an AB/BA randomized crossover study. Before each arm of the cross-over, baseline data will be taken with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot. Condition A is CLeg + Polycentric Ankle Condition B is SRALab Hybrid knee + Passive Ankle Subjects will participate in 2 sessions over 2 weeks, each lasting 2-3 hours to have the device tuned for the specific condition (A or B). On the third week, they will participate in 2 visits to complete functional outcome measures, biomechanical and metabolic assessments. They will then switch conditions, and repeat the protocol for the second condition. There will not be a washout period between conditions, but subjects will complete outcome measures with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot prior to each arm of the crossover to obtain baseline data. **Intervention Names:** - Device: SRALAB Hybrid Knee + Passive Ankle - Device: Ottobock CLeg 4 + Polycentric Ankle **Label:** Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** During this arm, participants will receive intensive clinical training with the SRALAB Hybrid knee + Polycentric Ankle twice per week over 8 weeks, lasting 2-3 hours. Training will include patient-driven therapy to achieve participants' individual therapy goals, functional mobility and community skills. At the end of the 8-week training period, subjects will complete the same set of functional outcome measures, biomechanical and metabolic assessments in previous arms. To complete this arm, participants will again complete training and outcome measures with the Ottobock Cleg4/Ottobock or their clinically prescribed microprocessor knee unit/foot over 3 visits. **Intervention Names:** - Device: Ottobock CLeg4 + Ottobock foot - Device: SRALAB Hybrid Knee + Polycentric Ankle **Label:** Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle - Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot **Description:** Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot. **Name:** Ottobock CLeg4 + Ottobock foot **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle - Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot **Description:** Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle. **Name:** SRALAB Hybrid Knee + Polycentric Ankle **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle **Description:** Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle. **Name:** SRALAB Hybrid Knee + Passive Ankle **Type:** DEVICE #### Intervention 4 **Arm Group Labels:** - Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle **Description:** Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle. **Name:** Ottobock CLeg 4 + Polycentric Ankle **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The AMPRO measures the ambulatory potential of lower limb amputees. It is used to assess functional mobility through a standardized sequence of mobility tests while using a prosthesis. Individual tasks are scored and combined, resulting in a total assessment score out of a possible 47; the minimum score is zero. Higher scores indicate better mobility. The AMPPRO is a reliable performance measure that has been validated for those with lower limb loss; it measures several functional mobility tasks that are needed during activities of daily living; it has been used to identify limitations in prosthetic mobility, including tasks that require both vertical mobility (sit/stand), horizontal mobility (walking), and balance. The AMPPRO scores have been shown to differentiate between Medicare K-levels and to provide information to guide therapeutic exercise techniques and document change after clinical instruction. **Measure:** Amputee Mobility Predictor with Prosthesis (AMPRO) score **Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. #### Secondary Outcomes **Description:** The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. **Measure:** 6 Minute Walk Test (6MWT) **Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. **Description:** The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. **Measure:** Timed Up and Go (TUG) **Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. **Description:** A test of dynamic balance and coordination that clinically assesses the participant's ability to step over objects forward, sideways, and backwards. **Measure:** Four Square Step Test (FSST) **Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38. **Description:** Subjects will be instrumented with the COSMED® K5 system (COSMED, Rome, Italy). Baseline metabolic data prior to each walking bout will be recorded for 2 minutes of sitting and quiet rest. Metabolic data will then be collected during 6 minutes of walking at a constant self-selected walking velocity on a treadmill. After each walking bout, subjects will rest for 20 minutes to allow their heart rate to return to their baseline level. **Measure:** Metabolic Testing **Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ages 18-95 * A unilateral transfemoral amputation * At least 6 months since definitive prosthesis fitting * Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person. * Medically cleared by physician to participate in study * English speaking Exclusion Criteria: * Weight greater than 250 pounds * Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions. * Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study. * Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers. **Maximum Age:** 95 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sfinucane@sralab.org **Name:** Suzanne Finucane, MS, PTA **Phone:** 312-238-0937 **Role:** CONTACT **Contact 2:** **Email:** lhargrove@sralab.org **Name:** Levi Hargrove, PhD **Phone:** 312-238-2080 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** sfinucane@sralab.org - **Name:** Suzanne Finucane, MS, PTA - **Phone:** 312-238-0937 - **Role:** CONTACT ***Contact 2:*** - **Email:** lhargrove@sralab.org - **Name:** Levi Hargrove, PhD - **Phone:** 312-238-2080 - **Role:** CONTACT ***Contact 3:*** - **Name:** Levi Hargrove, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Shirley Ryan AbilityLab **State:** Illinois **Status:** RECRUITING **Zip:** 60611 ### References Module #### References **Citation:** Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005. **PMID:** 18295618 **Citation:** Gailey RS, Wenger MA, Raya M, Kirk N, Erbs K, Spyropoulos P, Nash MS. Energy expenditure of trans-tibial amputees during ambulation at self-selected pace. Prosthet Orthot Int. 1994 Aug;18(2):84-91. doi: 10.3109/03093649409164389. **PMID:** 7991365 **Citation:** Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol, Avon). 2002 Jun;17(5):325-44. doi: 10.1016/s0268-0033(02)00020-7. **PMID:** 12084537 **Citation:** Burger H, Marincek C. The life style of young persons after lower limb amputation caused by injury. Prosthet Orthot Int. 1997 Apr;21(1):35-9. doi: 10.3109/03093649709164528. **PMID:** 9141124 **Citation:** Fey NP, Simon AM, Young AJ, Hargrove LJ. Controlling Knee Swing Initiation and Ankle Plantarflexion With an Active Prosthesis on Level and Inclined Surfaces at Variable Walking Speeds. IEEE J Transl Eng Health Med. 2014 Jul 25;2:2100412. doi: 10.1109/JTEHM.2014.2343228. eCollection 2014. **PMID:** 27170878 **Citation:** Adamczyk PG, Kuo AD. Mechanisms of Gait Asymmetry Due to Push-Off Deficiency in Unilateral Amputees. IEEE Trans Neural Syst Rehabil Eng. 2015 Sep;23(5):776-85. doi: 10.1109/TNSRE.2014.2356722. Epub 2014 Sep 12. **PMID:** 25222950 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4009 - Name: Amputation, Traumatic - Relevance: HIGH - As Found: Amputation, Traumatic - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000673 - Term: Amputation, Traumatic ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433635 **Acronym:** SMART-BD **Brief Title:** Sequential Multiple Assignment Randomized Trial for Bipolar Depression **Official Title:** Sequential Multiple Assignment Randomized Trial for Bipolar Depression #### Organization Study ID Info **ID:** 2024P000831 #### Organization **Class:** OTHER **Full Name:** Massachusetts General Hospital ### Status Module #### Completion Date **Date:** 2030-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2030-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-04-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Patient-Centered Outcomes Research Institute #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts General Hospital #### Responsible Party **Investigator Affiliation:** Massachusetts General Hospital **Investigator Full Name:** Andrew A. Nierenberg, MD **Investigator Title:** Director, Dauten Family Center for Bipolar Treatment Innovation **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a sequential multiple assignment randomized trial for adults (ages \> 18) with a bipolar disorder type 1 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram). **Detailed Description:** This is a comparative effectiveness study to address the critical questions of how best to treat people with bipolar disorder who have a major depressive episode: how to get them well, provide second-line treatment when they don't initially get well, and keep them well after they get well. This is a multisite Sequential Multiple Assignment Randomized Trial (SMART) comparative effectiveness design. Investigators will recruit 2726 participants who have BD with a current major depressive episode. In Stage 1, investigators will compare four treatment arms, including three FDA approved monotherapies and the most widely used, but understudied, treatment for BD major depressive episode (i.e., a non-FDA approved combination of an antipsychotic and antidepressant). In Stage 2, participants who do not remit will be re-randomized to treatments not used in Stage 1. Investigators will follow all participants for a total of 52 weeks. This study will be conducted in two phases, a feasibility phase and a full study phase. In the feasibility phase, investigators will recruit at 8 of the 19 study sites based on readiness and interest, to ensure the efficacy of the study design before launching the full study phase. Feasibility Aim 1: To ensure that 8 of the 19 selected sites can recruit, randomize, and retain participants. During the feasibility phase, the selected sites will recruit 133 participants, administer baseline assessments, randomize the participants (at baseline and again at 6-weeks for non-remitters), and conduct follow-up assessments at the end of Stage 1 (6-weeks) and the end of Stage 2 (12-weeks) and end of study (52 weeks or end of feasibility phase, whichever is sooner) and all other scheduled visits. Feasibility Aim 2: To refine and finalize all study standard operating procedures for the full-scale study. After Aim 1 is complete, any changes in standard operating procedures will be made as needed to be implemented in the full study phase. Full Scale Study Full-Scale Study Aim 1: To compare the effectiveness, tolerability, and safety of the four treatments for BD major depressive episodes. Hypothesis 1a: There will be significant differences across the Stage 1 treatments in the proportion of remitters at week 6 (primary endpoint, effectiveness) and in the average adverse event burden and suicidal ideation/behavior at week 6 (secondary endpoints, tolerability and safety). Hypothesis 1b: Among non-remitters of a given Stage 1 treatment (i.e., participants who do not remit by week 6), there will be significant differences across the three remaining Stage 2 treatments in the proportion of remitters at week 12 (primary endpoint, effectiveness) and the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety). Full-Scale Study Aim 2: To characterize the effectiveness, tolerability, and safety of the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design. Hypothesis 2: On average, there will be significant differences across the 12 embedded adaptive interventions in the proportion of remitters at week 12 (primary endpoint, effectiveness) and in the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety). Full-Scale Study Aim 3: To determine individual-level characteristics that predict heterogeneity of treatment effect (HTE) across the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design. Hypothesis 3a: Individual-level characteristics and symptoms assessed at baseline as well as symptom changes and side effect profiles at week 6 will predict HTE at weeks 12 and 52. Hypothesis 3b: Investigators hypothesize that an optimal personalized adaptive intervention will perform significantly better than the best aggregate embedded adaptive intervention identified in Aim 2 in terms of the proportion of remitters at week 12 (primary endpoint, effectiveness) and the side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety). ### Conditions Module **Conditions:** - Bipolar I Disorder - Depression **Keywords:** - Bipolar - Depression - Adults - Medication ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2726 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Cariprazine **Label:** Cariprazine **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Aripiprazole/Escitalopram combination **Label:** Aripiprazole /Escitalopram combination **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: Quetiapine **Label:** Quetiapine **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: Lurasidone **Label:** Lurasidone **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cariprazine **Description:** 1. Cariprazine monotherapy outperformed placebo in improving depressive symptoms in most large randomized control trials (RCT). Pooled data showed higher remission rates (30.2%) with cariprazine (1.5 mg and 3 mg/day) compared to placebo (20.9%). Its efficacy extends to bipolar I depression, including mixed features and anxiety. 2. Common adverse effects include nausea (8%) and akathisia (7%). Somnolence and sedation were slightly more common with cariprazine than placebo. 3. Results from a large RCT evaluating cariprazine for bipolar disorder maintenance treatment (NCT03573297) are awaited. An open-label trial reported reduced manic symptoms over 16 weeks. 4. Cariprazine is a D3-preferring partial agonist for D3 and D2 receptors. It antagonizes 5-HT2A and 5-HT2B receptors and partially agonizes 5-HT1A receptors. Affinity for 5-HT1C and histamine 1 receptors is low to moderate. **Name:** Cariprazine **Other Names:** - Vraylar **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Aripiprazole /Escitalopram combination **Description:** 1. 40-70% of bipolar patients use antidepressants, often with antipsychotics or mood stabilizers. Aripiprazole lacks efficacy in bipolar depression but is used for mania. Escitalopram, studied alongside mood stabilizers, showed some efficacy. 2. Aripiprazole in bipolar depression trials led to higher rates of akathisia, insomnia, nausea, fatigue, and impulse control disorders. Escitalopram's is generally safe but adverse effects include nausea, diarrhea, insomnia, dry mouth, ejaculatory dysfunction and dizziness. 3. Aripiprazole monotherapy in bipolar I patients reduced relapse rates and delayed relapse time, but not for depressive episodes. 4. Aripiprazole acts as a partial agonist at D2, D3, 5-HT1A, and 5-HT2C receptors, with antagonistic effects on α1 and possibly H1 receptors. Escitalopram is highly selective for the serotonin transporter, with no significant activity at other receptors. **Name:** Aripiprazole/Escitalopram combination **Other Names:** - Abilify/ Lexapro **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Quetiapine **Description:** 1. Both immediate and extended-release quetiapine monotherapies showed superiority over placebo in acute BD depression across three 8-week randomized trials, confirmed by meta-analysis. Quetiapine exhibited significantly higher remission rates (52.8%) compared to placebo (34.7%) and improved various aspects of life, including quality of life, clinical global impression, sleep, functioning, and anxiety. 2. Common adverse events of quetiapine include sedation, hypotension, increased appetite, weight gain, dyslipidemia, and elevated glucose levels, particularly in a population already at risk. 3. Four studies examined quetiapine's maintenance effects in patients with manic, mixed, or depressive episodes. Overall, quetiapine prolonged the time to recurrence for both depressive and manic episodes. **Name:** Quetiapine **Other Names:** - Seroquel **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Lurasidone **Description:** 1. Lurasidone, either alone or with lithium/valproate, proved more effective than placebo for acute BD depression in two 6-week randomized trials. Remission rates were significantly higher with lurasidone monotherapy (40.9%) and in combination (50.3%) compared to placebo (24.7% and 35.4% respectively). Lurasidone also improved anxiety, quality of life, and disability. 2. Common mild adverse events included nausea, headache, akathisia, somnolence, sedation, dry mouth, and vomiting. Weight gain, dyslipidemia, and increased glucose levels were not observed. 3. In a 6-month double-blind discontinuation study post-acute treatment response, lurasidone combined with lithium/valproate prolonged time to depressive episode recurrence compared to placebo (hazard ratio: 0.68). Although not statistically significant due to low placebo recurrence and shorter follow-up, it hints at maintenance efficacy. **Name:** Lurasidone **Other Names:** - Latuda **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** self-rating mania scale designed to assess the presence and/or severity of manic symptoms in children and adolescents The range is from 5-25, higher scores reflect increased symptoms of of mania **Measure:** Altman Self-Rating Mania Scale **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** A seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The range is from 0-21, higher scores reflect increased symptoms of of anxiety **Measure:** Generalized Anxiety Disorder Assessment **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** The MRTF generates the average number of necessary clinical adjustments per month, which provides a method to compare long-term outcomes in a pragmatic trial. There is no range or scoring necessary for this assessment. **Measure:** Medication Reconciliation Tracking Form **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression The range is from 0-27, higher scores reflect increased symptoms of of depression **Measure:** Patient Health Questionnaire **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** Cognitive deficits will be assessed with the PROMIS- Cognitive Function-Short Form. This 8-item self-report questionnaire has good construct validity and psychometric properties and has been used as an outcome in multiple studies. The range is from 8-40, increased scores are associated with a person's increased perception of cognitive function in areas such as concentration, memory, and mental acuity **Measure:** PROMIS Item Bank v2.0 Cognitive Functioning- Short Form **Time Frame:** Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** This measure is an 8 item self-report questionnaire that assesses the individual's satisfaction with social roles and activities. The measure has clinical validity across a range of chronic conditions, including depression and responds to change in clinical state The range is from 8-40 increased scores are associated with higher feelings of satisfaction with performing one's usual social roles and activities **Measure:** PROMIS Item Bank v2.0 Satisfaction with Social Roles and Activities **Time Frame:** Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** The YMRS is a rating scale used to evaluate manic symptoms at baseline and over time in individuals with mania. The range is from 0-60, higher scores reflect increased risk for Bipolar Disorder. If the participant scores 18 or above on the YMRS, they will be considered manic and not in remission even if they meet criteria for remission with the RDQ **Measure:** Young Mania Rating Scale **Time Frame:** Investigators can administer at any time between weeks 0 to 52. This assessment only applies if patients has a pseudo-remission from depression, indicated if the patient scores a 6 or higher on the self-rated Altman Scale for Rating Mania (ASRM) **Description:** The QoL.BD93,94 measures 12 core domains (physical, sleep, mood, cognition, leisure, social, spirituality, finances, household, self-esteem, independence, identity) and 2 optional (work, education) domains A brief 12-item version represents the core QoL domains and is scored on a five-point range (1: strongly disagree to 5: strongly agree). The range of scoring is 12-60 with higher scores reflecting a greater belief in ones quality of life. **Measure:** Quality of Life Scale **Time Frame:** Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). #### Primary Outcomes **Description:** RDQ is a 41 items self report questionnaire used to assess the seven domains found in extensive previous research to be important to patients: depressive symptoms, anxiety, coping ability, positive mental health, functioning, life satisfaction and a general sense of well-being. Using a score of 27 as the cutoff, the RDQ scale has a sensitivity of 83.7% and specificity of 77.9% in predicting self-reported remission status. The RDQ has excellent internal consistency reliability (Cronbach's alpha of 0.97 for the total scale and above 0.80 for each of the 7 subscales with test-retest reliability of the total scale = 0.85 and \> 0.60 for each subscale). The primary outcome will be remission as defined by a RDQ score \< 27. This test will be administered in all assessment visits. The RDQ scale ranges from 0-27 per domain, with higher scores indicating greater remission rates. **Measure:** The Remission from Depression Questionnaire **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). #### Secondary Outcomes **Description:** CHRT is a 14 item self-report measure of suicidal ideation and behavior in individuals with mood disorders. The CHRT has excellent psychometric properties, with an internal consistency reliability (Cronbach's alpha) of 0.78 and a consistent factor structure with 3 independent factors (current suicidal thoughts and plans, perceived lack of social support, and hopelessness). The range is from 14-70, higher scores reflect an increase in suicidality behaviors. **Measure:** Safety: Concise Health Risk Tracking Scale **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** This subscale of the FIBSER scale is a reliable self-report measure of the intensity of side effects from medications in a population receiving treatment for depression. This scale measures the participants side effects intensity from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response. The range is from 0-6, higher scores reflect an greater intensity in medication side effects. **Measure:** Frequency and Intensity of Side Effects Ratings - Intensity **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** This subscale of the FIBSER scale is a reliable and valid self-report measure on the frequency of medication side effects in a population receiving treatment for depression. This scale measures the participants side effects frequency from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response. The range is from 0-6, higher scores reflect an greater frequency in medication side effects. **Measure:** Frequency and Intensity of Side Effects Ratings - Frequency **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). **Description:** This subscale of the FIBSER scale is a reliable self-report measure of the side effects burden of medications in a population receiving treatment for depression. This scale measures the participants side effects burden from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response. The range is from 0-6, higher scores reflect an greater burden in medication side effects. **Measure:** Frequency and Intensity of Side Effects Ratings - Burden **Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged between 18 years to 75 years 2. Meets criteria for DSM-V Bipolar I disorder with a history of manic episodes and current major depressive episode lasting at least 6 weeks 3. Can be managed as an outpatient and participate in the study 4. Willing to be randomized; able to perform study assessments 5. Women of childbearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence; Depo Provera is acceptable if it is started 3 months prior to enrollment), and inform staff of their plans to conceive. Exclusion Criteria: 1. Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year) 2. History of schizophrenia or other nonaffective psychosis 3. Current substance use disorder that will interfere with participation in the study 4. Currently taking the study medications or a history of serious adverse events to any of the study medications, to the extent that as determined by site PI, another trial would not be clinically indicated 5. A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks 6. Current acute suicidal risk that requires inpatient treatment 7. Pregnancy or breastfeeding **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** anierenberg@mgh.harvard.edu **Name:** Andrew Nierenberg, M.D **Phone:** 617-724-0837 **Role:** CONTACT #### Locations **Location 1:** **City:** Birmingham **Contacts:** ***Contact 1:*** - **Email:** swwhite@uabmc.edu - **Name:** Samanta White - **Role:** CONTACT ***Contact 2:*** - **Name:** Richard Shelton - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Matthew Macaluso - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Alabama Birmingham **State:** Alabama **Zip:** 35294 **Location 2:** **City:** Baltimore **Contacts:** ***Contact 1:*** - **Email:** audrey.shoultz@sheppardpratt.org - **Name:** Audrey Shoultz - **Role:** CONTACT ***Contact 2:*** - **Name:** Scott Aaronson - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Sheppard Pratt Health System **State:** Maryland **Zip:** 21204 **Location 3:** **City:** Baltimore **Contacts:** ***Contact 1:*** - **Email:** hklohr1@jhmi.edu - **Name:** Heather Klohr - **Role:** CONTACT ***Contact 2:*** - **Name:** Fernando Goes - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** John Hopkins **State:** Maryland **Zip:** 21218 **Location 4:** **City:** Belmont **Contacts:** ***Contact 1:*** - **Name:** Jenny Clark - **Role:** CONTACT ***Contact 2:*** - **Name:** Dost Ongur - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** McLean Hospital **State:** Massachusetts **Zip:** 02478 **Location 5:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** ktlaiti@mgh.harvard.edu - **Name:** Khadija Tlaiti - **Phone:** 617-584-3285 - **Role:** CONTACT ***Contact 2:*** - **Name:** Masoud Kamali - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Massachusetts General Hospital **State:** Massachusetts **Zip:** 02114 **Location 6:** **City:** Ann Arbor **Contacts:** ***Contact 1:*** - **Email:** grisdale@umich.edu - **Name:** Jacqui Grisdale - **Role:** CONTACT ***Contact 2:*** - **Name:** Sagar Parikh - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Melvin McInnis - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Michigan **State:** Michigan **Zip:** 48109 **Location 7:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** skime.michelle@mayo.edu - **Name:** Michelle Skime - **Role:** CONTACT ***Contact 2:*** - **Name:** Mark Frye - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mayo Clinic **State:** Minnesota **Zip:** 55902 **Location 8:** **City:** Albuquerque **Contacts:** ***Contact 1:*** - **Email:** joshcorb@salud.unm.edu - **Name:** Josh Corb - **Role:** CONTACT ***Contact 2:*** - **Name:** Mauricio Tohen - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of New Mexico Health Sciences Center Albuquerque **State:** New Mexico **Zip:** 87131-0001 **Location 9:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** xiaotong.song@nyulangone.org - **Name:** Xiaotong Song - **Role:** CONTACT ***Contact 2:*** - **Email:** dan.iosifescu@nyulangone.org - **Name:** Dan Iosifescu - **Role:** CONTACT ***Contact 3:*** - **Name:** Dan Iosifescu - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** New York University Grossman School of Medicine NYU **State:** New York **Zip:** 10016 **Location 10:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** jealexan@montefiore.org - **Name:** Jennifer Alexander - **Role:** CONTACT ***Contact 2:*** - **Name:** Thomas Betzler - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jonathan Alpert - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Montefiore Medical Center and Albert Einstein College of Medicine **State:** New York **Zip:** 10461 **Location 11:** **City:** Chapel Hill **Contacts:** ***Contact 1:*** - **Email:** amanda_teer@med.unc.edu - **Name:** Amanda Teer - **Role:** CONTACT ***Contact 2:*** - **Name:** Bradley Gaynes - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of North Carolina at Chapel Hill **State:** North Carolina **Zip:** 27599 **Location 12:** **City:** Cleveland **Contacts:** ***Contact 1:*** - **Email:** carla.conroy@uhhospitals.org - **Name:** Carla Conroy - **Role:** CONTACT ***Contact 2:*** - **Name:** Keming Gao - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Case Western Reserve University **State:** Ohio **Zip:** 44106-1712 **Location 13:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Email:** anitaag@pennmedicine.upenn.edu - **Name:** Anita Agarwal - **Role:** CONTACT ***Contact 2:*** - **Name:** Michael Thase - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Pennsylvania **State:** Pennsylvania **Zip:** 19104 **Location 14:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** yuteea2@upmc.edu - **Name:** Elizabeth Yute - **Role:** CONTACT ***Contact 2:*** - **Name:** Holly Swartz - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Pittsburgh **State:** Pennsylvania **Zip:** 15260 **Location 15:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** dellmedspa@austin.utexas.edu - **Name:** Lindsey Demeritt - **Role:** CONTACT ***Contact 2:*** - **Name:** Jorge Almeida - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Texas at Austin **State:** Texas **Zip:** 78712 **Location 16:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** lezlie.britton@utsouthwestern.edu - **Name:** Lezlie Britton - **Role:** CONTACT ***Contact 2:*** - **Name:** Madhukar Trivedi - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Manish Jha - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Texas at Southwestern Medical Center **State:** Texas **Zip:** 75390-7208 **Location 17:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** Chelsea.Tran@uth.tmc.edu - **Name:** Chelsea Tran - **Role:** CONTACT ***Contact 2:*** - **Email:** courtney.vecera@uth.tmc.edu - **Name:** Courteny Vecera - **Role:** CONTACT ***Contact 3:*** - **Name:** Giovana Zunta-Soares - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Jair Soares - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Rodrigo MachadoVeira - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** UT Health Houston Texas **State:** Texas **Zip:** 77030 **Location 18:** **City:** Vancouver **Contacts:** ***Contact 1:*** - **Email:** nazlin.walji@ubc.ca - **Name:** Nazlin Walji - **Role:** CONTACT ***Contact 2:*** - **Name:** Lakshmi Yatham - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** University of British Columbia **State:** British Columbia **Zip:** V6T 1Z4 **Location 19:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Email:** lee.phan@mail.utoronto.ca - **Name:** Lee Phan - **Role:** CONTACT ***Contact 2:*** - **Name:** Roger McIntyre - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** University of Toronto **State:** Ontario **Zip:** M5R 0A3 ## 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: 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: D000001714 - Term: Bipolar Disorder ### Intervention Browse Module - Ancestors - ID: D000017367 - Term: Selective Serotonin Reuptake Inhibitors - ID: D000014179 - Term: Neurotransmitter Uptake Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000018490 - Term: Serotonin Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000928 - Term: Antidepressive Agents - ID: D000011619 - Term: Psychotropic Drugs - ID: D000014150 - Term: Antipsychotic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000018491 - Term: Dopamine Agonists - ID: D000015259 - Term: Dopamine Agents - ID: D000058825 - Term: Serotonin 5-HT1 Receptor Agonists - ID: D000017366 - Term: Serotonin Receptor Agonists - ID: D000058830 - Term: Serotonin 5-HT2 Receptor Antagonists - ID: D000012702 - Term: Serotonin Antagonists - ID: D000065127 - Term: Dopamine D2 Receptor Antagonists - ID: D000018492 - Term: Dopamine Antagonists - ID: D000058669 - Term: Adrenergic alpha-2 Receptor Antagonists - ID: D000000317 - Term: Adrenergic alpha-Antagonists - ID: D000018674 - Term: Adrenergic Antagonists - ID: D000018663 - Term: Adrenergic Agents ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: AnDyAg - Name: Anti-Dyskinesia Agents - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M229 - Name: Aripiprazole - Relevance: HIGH - As Found: Safety and Tolerability - ID: M399 - Name: Quetiapine Fumarate - Relevance: HIGH - As Found: Identified - ID: M293041 - Name: Cariprazine - Relevance: HIGH - As Found: New Onset - ID: M2732 - Name: Escitalopram - Relevance: HIGH - As Found: 2D - ID: M19022 - Name: Lithium Carbonate - Relevance: LOW - As Found: Unknown - ID: M17983 - Name: Citalopram - Relevance: LOW - As Found: Unknown - ID: M9708 - Name: Histamine - Relevance: LOW - As Found: Unknown - ID: M17383 - Name: Valproic Acid - Relevance: LOW - As Found: Unknown - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown - ID: M7104 - Name: Dexetimide - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M212144 - Name: Histamine phosphate - Relevance: LOW - As Found: Unknown - ID: M348 - Name: Lurasidone Hydrochloride - Relevance: HIGH - As Found: Treatment plan - ID: M19649 - Name: Selective Serotonin Reuptake Inhibitors - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20595 - Name: Dopamine Agonists - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown - ID: M29240 - Name: Serotonin 5-HT1 Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M19648 - Name: Serotonin Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M20596 - Name: Dopamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M29195 - Name: Adrenergic alpha-2 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M3669 - Name: Adrenergic alpha-Antagonists - Relevance: LOW - As Found: Unknown - ID: M20755 - Name: Adrenergic Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068180 - Term: Aripiprazole - ID: D000069348 - Term: Quetiapine Fumarate - ID: D000069056 - Term: Lurasidone Hydrochloride - ID: C000533287 - Term: Cariprazine - ID: D000089983 - Term: Escitalopram ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433622 **Brief Title:** Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM) **Official Title:** Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping in Patients With Severe Traumatic Brain Injuries on Antiplatelet Therapy #### Organization Study ID Info **ID:** 2023-47 #### Organization **Class:** OTHER **Full Name:** Lancaster General Hospital ### Status Module #### Completion Date **Date:** 2027-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lancaster General Hospital #### Responsible Party **Investigator Affiliation:** Lancaster General Hospital **Investigator Full Name:** Lindsey Perea **Investigator Title:** Trauma and Acute Care Surgeon **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 see if administering platelets (cells in our blood that stop or prevent bleeding) results in improved platelet function and slows/stops the progression of a head bleed for patients who have a traumatic head bleed and are on antiplatelet therapy (medications that stop blood cells from forming a blood clot) prior to admission. **Detailed Description:** This study aims to determine if platelet function has improved following platelet transfusion by prospectively performing repeat thromboeleastography with platelet mapping (TEG-PM) assays on all patients consented and enrolled in the study. This study will also examine the rate of progression or stability of ICH on repeat head CT following platelet administration and will aid in the determination of a potential association between repeat CT head findings and the repeat TEG-PM results. ### Conditions Module **Conditions:** - Traumatic Intracranial Hemorrhage ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 225 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Will receive a repeat TEG-PM after platelet transfusion based on inclusion criteria. **Intervention Names:** - Diagnostic Test: Repeat Thromboelastography with Platelet Mapping **Label:** Repeat TEG-PM #### Arm Group 2 **Description:** Not eligible to be consented; will proceed with normal course of treatment. **Label:** No Repeat TEG-PM ### Interventions #### Intervention 1 **Arm Group Labels:** - Repeat TEG-PM **Description:** Thromboelastography (TEG) is an assay used by many medical professionals to assess coagulopathy, predict outcomes, and guide treatment. Although TEG does not assess platelet function very well, a TEG with platelet mapping (TEG-PM) assay assesses platelet functioning by measuring the percent of arachidonic acid (AA) and adenosine diphosphate (ADP) that are inhibited in the patient's blood. **Name:** Repeat Thromboelastography with Platelet Mapping **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Other Outcomes **Description:** Determine the efficacy of platelet transfusion among this patient cohort by measuring mortality rate. **Measure:** Mortality **Time Frame:** During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an averge of 2 years. #### Primary Outcomes **Description:** Rate of reversed pathway inhibition on repeat thromboelastography with platelet mapping (TEG-PM) when platelets are administered to TICH patients who are on antiplatelet therapy prior to admission. **Measure:** Repeat TEG **Time Frame:** 1 hour after platelets given **Description:** Number of patients with improved platelet function on repeat TEG-PM and stability of TICH on subsequent CT scan. **Measure:** Repeat Head CT **Time Frame:** From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks. #### Secondary Outcomes **Description:** Determine the efficacy of platelet transfusion among this patient cohort by measuring need for neurosurgical intervention after second CT scan (ie: the failure of non-operative management) **Measure:** Need for Neurosurgical Intervention **Time Frame:** During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years. **Description:** Determine the efficacy of platelet transfusion among this patient cohort by reviewing discharge status. **Measure:** Discharge Status **Time Frame:** From the time of interventional platelet administration until the time of patient discharge from their index admission assessed through study completion, an average of 2 years. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria for Interventional Portion of Study: * Patients ≥ 18 years of age who present with isolated TICH meeting BIG 2 or 3 head bleed criteria * Currently on antiplatelet medication on admission * Must have taken this antiplatelet medication within the past 48 hours prior to presentation * Patients who have AA and/or ADP inhibition of 70% or greater and MA \<50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion Exclusion Criteria for Interventional Portion of Study: * Under 18 years of age * Have a known bleeding diatheses * Current therapeutic anticoagulation use * Do not know the time of their last antiplatelet medication dose * Patients or their proxy who are unable to provide consent Inclusion Criteria for Retrospective Portion of Study: • Patients with a TICH who are 18 years of age or older Exclusion Criteria for Retrospective Portion of Study: * AIS \>1 in body regions other than head * Under 18 years of age **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The targeted population includes patients ≥ 18 years of age who present to Penn Medicine Lancaster General Health with isolated TICH. Selection of subjects is based on all adult patients presenting with isolated TICH that are admitted to Lancaster General Health Trauma Center. ### Contacts Locations Module #### Locations **Location 1:** **City:** Lancaster **Country:** United States **Facility:** Penn Medicine Lancaster General Health **State:** Pennsylvania **Zip:** 17602 #### Overall Officials **Official 1:** **Affiliation:** Penn Medicine Lancaster General Health **Name:** Lindsey Perea, DO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Traumatic brain injury: time to end the silence. Lancet Neurol. 2010 Apr;9(4):331. doi: 10.1016/S1474-4422(10)70069-7. No abstract available. **PMID:** 20298955 **Citation:** Li L, Geraghty OC, Mehta Z, Rothwell PM; Oxford Vascular Study. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet. 2017 Jul 29;390(10093):490-499. doi: 10.1016/S0140-6736(17)30770-5. Epub 2017 Jun 13. **PMID:** 28622955 **Citation:** Pace WD. Daily Low-Dose Aspirin, Diabetes, and Age-Still Looking for a Balance. JAMA Netw Open. 2021 Jun 1;4(6):e2112875. doi: 10.1001/jamanetworkopen.2021.12875. No abstract available. **PMID:** 34152422 **Citation:** Alter SM, Mazer BA, Solano JJ, Shih RD, Hughes MJ, Clayton LM, Greaves SW, Trinh NQ, Hughes PG. Antiplatelet therapy is associated with a high rate of intracranial hemorrhage in patients with head injuries. Trauma Surg Acute Care Open. 2020 Nov 25;5(1):e000520. doi: 10.1136/tsaco-2020-000520. eCollection 2020. **PMID:** 33294625 **Citation:** van den Brand CL, Tolido T, Rambach AH, Hunink MG, Patka P, Jellema K. Systematic Review and Meta-Analysis: Is Pre-Injury Antiplatelet Therapy Associated with Traumatic Intracranial Hemorrhage? J Neurotrauma. 2017 Jan 1;34(1):1-7. doi: 10.1089/neu.2015.4393. Epub 2016 May 9. **PMID:** 26979949 **Citation:** Svedung Wettervik T, Lenell S, Enblad P, Lewen A. Pre-injury antithrombotic agents predict intracranial hemorrhagic progression, but not worse clinical outcome in severe traumatic brain injury. Acta Neurochir (Wien). 2021 May;163(5):1403-1413. doi: 10.1007/s00701-021-04816-0. Epub 2021 Mar 26. **PMID:** 33770261 **Citation:** Peck KA, Calvo RY, Schechter MS, Sise CB, Kahl JE, Shackford MC, Shackford SR, Sise MJ, Blaskiewicz DJ. The impact of preinjury anticoagulants and prescription antiplatelet agents on outcomes in older patients with traumatic brain injury. J Trauma Acute Care Surg. 2014 Feb;76(2):431-6. doi: 10.1097/TA.0000000000000107. **PMID:** 24458049 **Citation:** Fabbri A, Servadei F, Marchesini G, Bronzoni C, Montesi D, Arietta L; Societa Italiana di Medicina d'Emergenza Urgenza Study Group. Antiplatelet therapy and the outcome of subjects with intracranial injury: the Italian SIMEU study. Crit Care. 2013 Mar 21;17(2):R53. doi: 10.1186/cc12575. **PMID:** 23514619 **Citation:** Joseph B, Pandit V, Aziz H, Kulvatunyou N, Hashmi A, Tang A, O'Keeffe T, Wynne J, Vercruysse G, Friese RS, Rhee P. Clinical outcomes in traumatic brain injury patients on preinjury clopidogrel: a prospective analysis. J Trauma Acute Care Surg. 2014 Mar;76(3):817-20. doi: 10.1097/TA.0b013e3182aafcf0. **PMID:** 24553554 **Citation:** Van Ornam J, Pruitt P, Borczuk P. Is repeat head CT necessary in patients with mild traumatic intracranial hemorrhage. Am J Emerg Med. 2019 Sep;37(9):1694-1698. doi: 10.1016/j.ajem.2018.12.012. Epub 2018 Dec 10. **PMID:** 30559018 **Citation:** Shammassian BH, Ronald A, Smith A, Sajatovic M, Mangat HS, Kelly ML. Viscoelastic Hemostatic Assays and Outcomes in Traumatic Brain Injury: A Systematic Literature Review. World Neurosurg. 2022 Mar;159:221-236.e4. doi: 10.1016/j.wneu.2021.10.180. Epub 2021 Nov 27. **PMID:** 34844010 **Citation:** Fleming K, Redfern RE, March RL, Bobulski N, Kuehne M, Chen JT, Moront M. TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage. J Extra Corpor Technol. 2017 Dec;49(4):283-290. **PMID:** 29302119 **Citation:** Fan D, Ouyang Z, Ying Y, Huang S, Tao P, Pan X, Lu S, Pan Q. Thromboelastography for the Prevention of Perioperative Venous Thromboembolism in Orthopedics. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221077975. doi: 10.1177/10760296221077975. **PMID:** 35379018 **Citation:** Rao A, Lin A, Hilliard C, Fu R, Lennox T, Barbosa R, Schreiber M, Rowell S. The Utility of Thromboelastography for Predicting The Risk of Progression of Intracranial Hemorrhage in Traumatic Brain Injury Patients. Neurosurgery. 2017 Sep 1;64(CN_suppl_1):182-187. doi: 10.1093/neuros/nyx210. No abstract available. **PMID:** 28899039 **Citation:** Kay AB, Morris DS, Collingridge DS, Majercik S. Platelet dysfunction on thromboelastogram is associated with severity of blunt traumatic brain injury. Am J Surg. 2019 Dec;218(6):1134-1137. doi: 10.1016/j.amjsurg.2019.09.024. Epub 2019 Sep 23. **PMID:** 31575420 **Citation:** Davis PK, Musunuru H, Walsh M, Cassady R, Yount R, Losiniecki A, Moore EE, Wohlauer MV, Howard J, Ploplis VA, Castellino FJ, Thomas SG. Platelet dysfunction is an early marker for traumatic brain injury-induced coagulopathy. Neurocrit Care. 2013 Apr;18(2):201-8. doi: 10.1007/s12028-012-9745-6. **PMID:** 22847397 **Citation:** Nekludov M, Bellander BM, Blomback M, Wallen HN. Platelet dysfunction in patients with severe traumatic brain injury. J Neurotrauma. 2007 Nov;24(11):1699-706. doi: 10.1089/neu.2007.0322. **PMID:** 18001200 **Citation:** Daley MJ, Enright Z, Nguyen J, Ali S, Clark A, Aydelotte JD, Teixeira PG, Coopwood TB, Brown CV. Adenosine diphosphate platelet dysfunction on thromboelastogram is independently associated with increased morality in traumatic brain injury. Eur J Trauma Emerg Surg. 2017 Feb;43(1):105-111. doi: 10.1007/s00068-016-0643-z. Epub 2016 Feb 18. **PMID:** 26888580 **Citation:** Cannon JW, Dias JD, Kumar MA, Walsh M, Thomas SG, Cotton BA, Schuster JM, Evans SL, Schreiber MA, Adam EH, Zacharowski K, Hartmann J, Schochl H, Kaplan LJ. Use of Thromboelastography in the Evaluation and Management of Patients With Traumatic Brain Injury: A Systematic Review and Meta-Analysis. Crit Care Explor. 2021 Sep 14;3(9):e0526. doi: 10.1097/CCE.0000000000000526. eCollection 2021 Sep. **PMID:** 34549189 **Citation:** Lee J, Kim JK, Kim JH, Dunuu T, Park SH, Park SJ, Kang JY, Choi RK, Hyon MS. Recovery time of platelet function after aspirin withdrawal. Curr Ther Res Clin Exp. 2014 Mar 25;76:26-31. doi: 10.1016/j.curtheres.2014.02.002. eCollection 2014 Dec. **PMID:** 25031665 **Citation:** Glass NE, Riccardi J, Horng H, Kacprzynski G, Sifri Z. Platelet dysfunction in patients with traumatic intracranial hemorrhage: Do desmopressin and platelet therapy help or harm? Am J Surg. 2022 Jan;223(1):131-136. doi: 10.1016/j.amjsurg.2021.07.050. Epub 2021 Aug 3. **PMID:** 34446216 **Citation:** Wolff C, Muakkassa F, Marley R, El-Khatib A, Docherty C, Muakkassa L, Stephen H, Salvator A. Routine platelet transfusion in patients with traumatic intracranial hemorrhage taking antiplatelet medication: Is it warranted? Can J Surg. 2022 Mar 15;65(2):E206-E211. doi: 10.1503/cjs.018120. Print 2022 Mar-Apr. **PMID:** 35292527 **Citation:** Miles MVP, Hicks RC, Parmer H, Brown C, Edwards A, Stewart K, Gao L, Maxwell R. Traumatic brain injury patients with platelet inhibition receiving platelet transfusion demonstrate decreased need for neurosurgical intervention and decreased mortality. J Trauma Acute Care Surg. 2022 Apr 1;92(4):701-707. doi: 10.1097/TA.0000000000003516. **PMID:** 35320155 **Citation:** Jehan F, Zeeshan M, Kulvatunyou N, Khan M, O'Keeffe T, Tang A, Gries L, Joseph B. Is There a Need for Platelet Transfusion After Traumatic Brain Injury in Patients on P2Y12 Inhibitors? J Surg Res. 2019 Apr;236:224-229. doi: 10.1016/j.jss.2018.11.050. Epub 2018 Dec 20. **PMID:** 30694760 **Citation:** Lokhandwala AM, Asmar S, Khurrum M, Chehab M, Bible L, Castanon L, Ditillo M, Joseph B. Platelet Transfusion After Traumatic Intracranial Hemorrhage in Patients on Antiplatelet Agents. J Surg Res. 2021 Jan;257:239-245. doi: 10.1016/j.jss.2020.07.076. Epub 2020 Aug 27. **PMID:** 32862051 **Citation:** Spiess BD. Platelet transfusions: the science behind safety, risks and appropriate applications. Best Pract Res Clin Anaesthesiol. 2010 Mar;24(1):65-83. doi: 10.1016/j.bpa.2009.11.001. **PMID:** 20402171 **Citation:** Joseph B, Pandit V, Sadoun M, Larkins CG, Kulvatunyou N, Tang A, Mino M, Friese RS, Rhee P. A prospective evaluation of platelet function in patients on antiplatelet therapy with traumatic intracranial hemorrhage. J Trauma Acute Care Surg. 2013 Dec;75(6):990-4. doi: 10.1097/TA.0b013e3182a96591. **PMID:** 24256671 **Citation:** Holzmacher JL, Reynolds C, Patel M, Maluso P, Holland S, Gamsky N, Moore H, Acquista E, Carrick M, Amdur R, Hancock H, Metzler M, Dunn J, Sarani B. Platelet transfusion does not improve outcomes in patients with brain injury on antiplatelet therapy. Brain Inj. 2018;32(3):325-330. doi: 10.1080/02699052.2018.1425804. Epub 2018 Jan 17. **PMID:** 29341793 #### See Also Links **Label:** United Zion Retirement Community. Why Retire to Lititz in Lancaster County? Retirement Advice. February 11, 2019. **URL:** http://www.uzrc.org/blog/retirement-advice/retire-to-lititz/ **Label:** Word Population Review. Lancaster County, Pennsylvania Population 2022. World Population Review. 2022. **URL:** https://worldpopulationreview.com/us-counties/pa/lancaster-county-population ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - 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: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Hemorrhage - ID: M22113 - Name: Intracranial Hemorrhages - Relevance: HIGH - As Found: Intracranial Hemorrhage - ID: M22025 - Name: Intracranial Hemorrhage, Traumatic - Relevance: HIGH - As Found: Traumatic Intracranial Hemorrhage - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M628 - Name: Brain Injuries, Traumatic - 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 - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020300 - Term: Intracranial Hemorrhages - ID: D000020198 - Term: Intracranial Hemorrhage, Traumatic - ID: D000006470 - Term: Hemorrhage ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M3595 - Name: Adenosine - Relevance: LOW - As Found: Unknown - ID: T362 - Name: Arachidonic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433609 **Brief Title:** Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer **Official Title:** A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer #### Organization Study ID Info **ID:** BJGBYY-IIT-LCYJ-2024-008 #### Organization **Class:** OTHER **Full Name:** Beijing GoBroad Hospital #### Secondary ID Infos **Domain:** Jiangsu Hengrui Pharmaceuticals Co., Ltd. **ID:** BC-MUL-IIT-ADC-SHR1316 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing GoBroad Hospital #### Responsible Party **Investigator Affiliation:** Beijing GoBroad Hospital **Investigator Full Name:** Yang Ke **Investigator Title:** Associate 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:** Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811 and SHR-A1921 combined with adebrelimab in HER2-negative advanced breast cancer. ### Conditions Module **Conditions:** - Advanced Breast Cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 131 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: SHR-A1811 - Drug: Adebrelimab **Label:** SHR-A1811+adebrelimab **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: SHR-A1921 - Drug: Adebrelimab **Label:** SHR-A1921+adebrelimab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SHR-A1811+adebrelimab **Description:** Via intravenous infusion **Name:** SHR-A1811 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - SHR-A1921+adebrelimab **Description:** Via intravenous infusion **Name:** SHR-A1921 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - SHR-A1811+adebrelimab - SHR-A1921+adebrelimab **Description:** Via intravenous infusion **Name:** Adebrelimab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1. **Measure:** ORR (objective response rate) by investigator **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years #### Secondary Outcomes **Description:** DCR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1. **Measure:** DCR (disease control rate) by investigator **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years **Description:** CBR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD lasting≥24 weeks (stable disease) per RECIST v1.1. **Measure:** CBR (clinical benefit rate) by investigator **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years **Description:** DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression. **Measure:** DoR (duration of response) **Time Frame:** up to 3.5 years **Description:** PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression). **Measure:** PFS (progression-free survival) **Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years **Description:** OS is the time from the date of first dose until the date of death by any cause. **Measure:** OS (overall survival) **Time Frame:** up to 3.5 years **Description:** An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE. **Measure:** Safety as assessed by percentage of patients with any Adverse Event (AE) **Time Frame:** up to 3.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. 18 years to 75 years old (including boundary values), female patients with breast cancer; 2. ECOG PS Score: 0\~1; 3. Histologically or cytologically confirmed HER2-negative advanced breast cancer; 4. Disease progression after prior 1-2 lines of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary; 5. Based on RECIST v1.1, at least one measurable lesion; 6. Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible; 7. No prior PD-(L)1 inhibitor; 8. Patients must have a life expectancy ≥ 6 months; 9. Adequate organ function and marrow function (no corrective treatment within 14 days before first dose); 10. Patients of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate; 11. Available blood samples for ctDNA detection in the exploratory study; 12. Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol. Exclusion Criteria: 1. Has known active brain metastasis which needs local therapy immediately; 2. Prior anti-HER2 or anti-TROP-2 treatment; 3. Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload; 4. Existence of third space fluid that is not well controlled by effective methods, e.g. drainage; 5. Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy; 6. Use of other antitumor systemic treatment during the study; 7. Has active autoimmune disease or a history of autoimmune disease; 8. Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation; 9. Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis; 10. Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator); 11. Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at \>10mg/d or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy; 12. Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma; 13. Hypersensitivity to study therapy or any of its excipients; 14. Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis; 15. Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled; 16. Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment; 17. Patients with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception; 18. Other conditions that might influence the study and analysis of results in the opinion of the investigator. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** key3@gobroadhealthcare.com **Name:** Yang Ke **Phone:** +86-13592618724 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** key3@gobroadhealthcare.com - **Name:** Yang Ke - **Phone:** +86-13592618724 - **Role:** CONTACT ***Contact 2:*** - **Name:** Yang Ke - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Beijing GoBroad Hospital **State:** Beijing **Zip:** 102200 #### Overall Officials **Official 1:** **Affiliation:** Beijing GoBroad Hospital **Name:** Yang Ke **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - 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:** NCT06433596 **Brief Title:** Autologous PRP and Focal Shock Waves for Erectile Dysfunction **Official Title:** Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment #### Organization Study ID Info **ID:** PRP-SW-03 #### Organization **Class:** OTHER **Full Name:** Elexial Research Limited #### Secondary ID Infos **ID:** 2022-002985-34 **Type:** EUDRACT_NUMBER ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Boston Medical Group #### Lead Sponsor **Class:** OTHER **Name:** Elexial Research Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if Platelet-rich plasma (PRP) combined with Shock-wave therapy (SWT) works to treat moderate or mild to moderate erectile dysfunction. It will also learn about the safety of this combined therapy. The main questions it aims to answer are: * Does Combined therapy PRP + SWT improve erection in men with moderate or mild to moderate erectile dysfunction? * What medical problems do participants have when receiving Combined therapy PRP + SWT? Researchers will compare Combined therapy PRP + SWT to placebo therapy (a look-alike substance that contains no PRP) to see if Combined therapy PRP + SWT works to treat moderate or mild to moderate erectile dysfunction. Participants will: * Take a lab test to evaluate their platelets * Answer some questionnaires to assess your erectile function * Receive Combined therapy PRP + SWT (3 sessions PRP + 6 sessions SWT) or placebo therapy for 9 weeks * Visit the clinic one month, 3 months, and 6 months after finishing the treatment for checkups and tests **Detailed Description:** The goal of this clinical trial is to evaluate the effectiveness of intracavernosal autologous platelet-rich plasma therapy, compared with placebo, for the treatment of moderate or mild to moderate erectile dysfunction, measured as improvement in the IIEF-EF questionnaire score. Study design: Randomized, double-blind, placebo-controlled clinical trial, phase III. The study will include four groups: * G1 - Autologous PRP: Autologous Platelet Rich Plasma (PRP) + placebo shock waves * G2 - combined therapy: Autologous PRP + focal shock waves * G3 - placebo control: Placebo PRP + placebo shock waves * G4 - shock waves: PRP placebo + shock waves 116 subjects will be included, who will be randomized in a 1:1:1:1 ratio in the four groups described above. The change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) score, the change in the Erection Hardness Score (EHS), and the adverse events will be evaluated at the end of treatment, and 1, 3, and 6 months of follow-up. ### Conditions Module **Conditions:** - Erectile Dysfunction **Keywords:** - Erectile dysfunction - Platelet-rich plasma - Shock wave therapy - Randomized clinical trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 116 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves **Intervention Names:** - Other: Platelet-rich plasma - Other: Sham shock waves therapy **Label:** Autologous PRP **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves. **Intervention Names:** - Other: Platelet-rich plasma - Other: Shock waves therapy **Label:** Combined therapy **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves **Intervention Names:** - Other: Placebo PRP - Other: Sham shock waves therapy **Label:** Placebo control **Type:** PLACEBO_COMPARATOR #### Arm Group 4 **Description:** 3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock. **Intervention Names:** - Other: Shock waves therapy - Other: Placebo PRP **Label:** Shock waves **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Autologous PRP - Combined therapy **Description:** 3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9 **Name:** Platelet-rich plasma **Other Names:** - PRP **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Combined therapy - Shock waves **Description:** 6 sessions of focal shock waves, 1 per week **Name:** Shock waves therapy **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Placebo control - Shock waves **Description:** 3 injections of 10 cc of saline solution, weeks 1, 5 and 9 **Name:** Placebo PRP **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Autologous PRP - Placebo control **Description:** 6 sessions of sham shock waves, 1 per week **Name:** Sham shock waves therapy **Other Names:** - Placebo therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline and week 21 (3 months after completion of treatment) **Measure:** Change in IIEF-EF score **Time Frame:** From enrollment to the third month of follow-up at 21 weeks #### Secondary Outcomes **Description:** Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline measurement and measurement at week 13 **Measure:** Change in IIEF-EF score 1- month follow-up **Time Frame:** From enrollment to the first month of follow-up at 13 weeks **Description:** Change in IIEF-EF score between baseline measurement and measurement at week 33 **Measure:** Change in IIEF-EF score 6 months follow-up **Time Frame:** From enrollment to the sixth month of follow-up at 33 weeks **Description:** Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points) **Measure:** Minimum clinically significant difference **Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks **Description:** Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33 **Measure:** Change in Erection Hardness Score (EHS) **Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks **Description:** Proportion of patients who accomplish to penetrate after treatment, evaluated by the change in the EHS from 1 or 2 at baseline to 3 or 4 in weeks 13, 21 and 33. **Measure:** Ability to penetrate **Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks **Description:** Change in the score of the sexual quality of life questionnaire (SLQQ) between the baseline measurement and the measurement at weeks 13, 21 and 33. **Measure:** Quality of sexual life **Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks **Description:** Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33. **Measure:** Global assessment **Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks **Description:** Incidence of PRP-related adverse events during the study **Measure:** Adverse events incidence **Time Frame:** From the first intervention to end of follow-up at 33 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Men over 18 years of age. 2. Erectile dysfunction present for more than 3 months in more than 50% of intercourse. 3. Baseline score of the IIEF-EF questionnaire between 11 and 21. 4. Stable heterosexual relationship of at least 6 months. 5. Commitment to have at least 3 vaginal sexual relations per month after completing treatment. 6. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion. 7. A patient who agrees to voluntarily enter the study by signing an informed consent. Exclusion Criteria: 1. Score of 4 on the EHS scale. 2. Patients with an international normalized ratio (INR) greater than 3. 3. Patients with sickle cell anemia. 4. Patients with clinical suspicion of hypogonadism (ADAM positive). 5. Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency. 6. Active bladder, prostate, or colon cancer. 7. Radical prostatectomy or other radical pelvic surgery. 8. History of pelvic radiotherapy. 9. Spinal cord injury or other neurological disease associated with erectile dysfunction. 10. Penile anatomical dysfunction, penile implant. 11. Platelet diseases or coagulation disorders. 12. Treatment with oral anticoagulants. 13. Platelet count outside the normal range (150 to 400 × 109/L). 14. Patients with active infections or lesions of the penis or pubic area. 15. Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics). 16. Patients with erectile dysfunction of psychological origin. 17. Abuse of psychoactive substances (including alcohol). 18. Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls. 19. Inability to attend therapies and controls. **Gender Based:** True **Gender Description:** The participant must be male by biological sex and their gender identity must be male **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** csandoval@bostonmedical.com.co **Name:** Carolina Sandoval, Master **Phone:** 0057 31339208916 **Role:** CONTACT **Contact 2:** **Email:** hcorredor@bostonmedical.com.co **Name:** Héctor Corredor, MD **Phone:** 0057 3174317162 **Role:** CONTACT #### Locations **Location 1:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Email:** jbenitez@boston.es - **Name:** Jose Benitez, MD - **Phone:** 0034 607769225 - **Role:** CONTACT ***Contact 2:*** - **Email:** mrodriguez@boston.es - **Name:** Mercedes Rodriguez, Coordinator - **Phone:** 0034 610238191 - **Role:** CONTACT ***Contact 3:*** - **Name:** Jose Aramis Benitez, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Boston Medical Group Spain S.L.U **Status:** RECRUITING **Zip:** 28046 #### Overall Officials **Official 1:** **Affiliation:** Boston Medical Group **Name:** Jose Benitez, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All individual participant data (IPD) collected throughout the trial, except personal identification data of the participants **Info Types:** - STUDY_PROTOCOL - SAP - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** Beginning 1 month after publication with no end date **URL:** https://www.elexialresearch.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000012735 - Term: Sexual Dysfunction, Physiological - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000020018 - Term: Sexual Dysfunctions, Psychological - ID: D000001523 - Term: Mental Disorders ### 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 ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M10217 - Name: Erectile Dysfunction - Relevance: HIGH - As Found: Erectile Dysfunction - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M15546 - Name: Sexual Dysfunction, Physiological - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M21873 - Name: Sexual Dysfunctions, Psychological - 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: D000007172 - Term: Erectile Dysfunction ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433583 **Acronym:** NEUROMUTE **Brief Title:** Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents **Official Title:** Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation for the Prevention of Non-suicidal Self-injury Recurrence in Adolescents #### Organization Study ID Info **ID:** 2023-01-CHRMT #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Régional Metz-Thionville ### Status Module #### Completion Date **Date:** 2026-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Régional Metz-Thionville #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury. Their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the COVID-19 health crisis, with the prevalence of NSSI rising to 40% in adolescents. Access to psychiatrists is declining. Drug solutions, meanwhile, lack scientific proof in this indication. The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion. Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder. Transcutaneous neurostimulation of the atrial vagus nerve (taVNS) has been studied for some ten years. The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals. The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI, and thus reduce the frequency of acting out. Although taVNS is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment. ### Conditions Module **Conditions:** - Psychiatric Disorder **Keywords:** - non-suicidal self-injury - transcutaneous auricular vagal nerve stimulation ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 22 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: transcutaneous auricular vagal nerve stimulation **Label:** transcutaneous auricular vagal nerve stimulation (taVNS) treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - transcutaneous auricular vagal nerve stimulation (taVNS) treatment **Description:** The use of TENS ECO PLUS and the vagus nerve ear electrode medical devices for transcutaneous auricular vagal nerve stimulation (taVNS) everyday for 10 minutes twice a day or 20 minutes for 8 successive weeks. Patients are included at week 0, use taVNS between week 2 and 10, and are followed up until week 22. Patient adherence: percentage of patients performing 20 minutes of daily stimulation on at least 5 days a week for at least 6 cumulative weeks. **Name:** transcutaneous auricular vagal nerve stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** percentage of patients performing 20 minutes of daily stimulation on at least 5 days a week for at least 6 weeks. **Measure:** Patient adherence to treatment **Time Frame:** 10 weeks after inclusion #### Secondary Outcomes **Description:** Cumulative daily duration of stimulation, number of daily taVNS sessions performed, number of days per week with at least one session, number of weeks with at least one session, number of premature study exists and reasons. **Measure:** Other caracteristics for patient adherence to treatment **Time Frame:** 10 weeks after inclusion **Description:** Assessed by the patient on a Likert scale in a logbook. **Measure:** Frequency of weekly non-suicidal self-injury (NSSI) **Time Frame:** weekly, from 2 weeks before treatment and up to 20 weeks after treatment **Description:** Using the Hospital Anxiety Depression (HAD) scale The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case. **Measure:** Anxiety and depression levels **Time Frame:** at week 0, 2, 10 and 22 after inclusion **Description:** assessed through patient logbook and consultations with psychiatrist during taVNS treatment **Measure:** Adverse events **Time Frame:** up to 22 weeks after inclusion **Description:** Semi-structured questionnaire at the end of taVNS. **Measure:** Patient's experience of taVNS **Time Frame:** at week 10 after inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adolescents aged between 13 and 17 years old * Patients with NSSI disorder as defined by DSM-5 * Patient affiliated to a social security scheme * Patient who parents or guardians have signed a free and informed consent form * Patient able to understand neurostimulation instructions Exclusion Criteria: * Contraindication to taVNS: * Malformation, skin pathology of the external ear. (piercings in the area concerned must be removed during the neurostimulation session). * Children with sleep apnea syndrome treated with NIV (non-invasive ventilation) * Presence of epileptic seizures * Proven cardiac pathology on the advice of the attending cardiologist * History of venous or arterial thrombosis * Adolescent with pacemaker or defibrillator * Adolescent with an active implantable device * Pregnancy (based on anamnestic criteria, checked by blood test if necessary) * Patients with psychotic episodes, confusional states or severe neurodevelopmental disorders * Patients with an allergic skin reaction to silicone (component of the ear electrode) * Patients with a cochlear implant on the stimulation side * Pregnant or breast-feeding women * Minor under guardianship * Minor under judicial measure or sanction **Maximum Age:** 18 Years **Minimum Age:** 13 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** justine.grigorcea@chr-metz-thionville.fr **Name:** Justine GRIGORCEA, MD **Phone:** 00333 82 88 15 03 **Role:** CONTACT #### Locations **Location 1:** **City:** Thionville **Contacts:** ***Contact 1:*** - **Email:** projet-recherche-clinique@chr-metz-thionville.fr - **Name:** Arpiné EL NAR, PhD - **Phone:** 0033387557766 - **Role:** CONTACT ***Contact 2:*** - **Name:** Dorin SINDILA, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Centre Médico-Psychologique adolescents - CHR Metz-Thionville #### Overall Officials **Official 1:** **Affiliation:** CHR Metz Thionville **Name:** Dorin SINDILA, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Psychiatric Disorders - ID: M85 - Name: Problem Behavior - Relevance: HIGH - As Found: Psychiatric Disorders - ID: M19089 - Name: Self-Injurious Behavior - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001523 - Term: Mental Disorders - ID: D000066553 - Term: Problem Behavior ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433570 **Brief Title:** Detection of Krupple Like Factor -1(KLF1/ EKLF) DNA Mutations in Beta Thalassemia Patients **Official Title:** Detection of Krupple Like Factor -1(KLF1/ EKLF) DNA Mutations in Beta Thalassemia Patients #### Organization Study ID Info **ID:** EKLFmutation in β thalassemia #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Mohamed Abd Elnasser Mahmoud **Investigator Title:** Assiut **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** * Detection of KLF1 gene mutations in patients with beta thalassemia considering the alpha and beta molecular status of these patients. * Study the relation between genotypic mutational status of KLF1 mutation with the level of Hb F and Hb A2 in the patients of beta thalassemia. **Detailed Description:** Thalassemias are inherited abnormalities in globin chain synthesis of hemoglobin and one of the most common single gene disorders in the world. β-Thalassemia is caused by reduced (β+) or absent (β0) synthesis of the β-globin chains of haemoglobin. Three clinical and hematological conditions of increasing severity are recognized: the β-thalassemia trait, thalassemia intermedia and thalassemia major. The Erythroid Kruppel-like factor (EKLF or KLF1) is a master regulator of terminal erythroid differentiation, controlling expression of many key pathways and structures including cell division, the cell membrane and cytoskeleton, heme and globin synthesis. The KLF1 works as a key regulator of γ-globin to β-globin switch by up-regulation of PUM1 that binds to fetal γ globin mRNA impairing its stability and translation and by Bcl11a expression that represses γ-globin expression. Previous studies reported that KLF1 mutations have been identified in a variety of erythroid conditions like hereditary persistence of fetal hemoglobin, Congenital dyserythropoietic anemia and borderline HbA2. An Indian study on KLF1 gene variations found a marginal significance in the thalassemia intermedia group (14%) as against the thalassemia major group (2.0%). Also, a case report on a Chinese family with twin brothers, both of whom had the same genotype of β0/β0, reported that KLF1 mutations have a role in modulating the phenotypic severity of β-thalassemia. In our study, where there is high incidence of beta thalassemia in Egypt, we try to detect KLF1 mutations and its relation to clinical phenotype of these patients. ### Conditions Module **Conditions:** - EKLF Mutations in Beta Thalassemia Patients ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Genetic: multiplex PCR **Label:** 50 patients with beta thalassemia intermedia #### Arm Group 2 **Intervention Names:** - Genetic: multiplex PCR **Label:** 50 patients with beta thalassemia major ### Interventions #### Intervention 1 **Arm Group Labels:** - 50 patients with beta thalassemia intermedia - 50 patients with beta thalassemia major **Description:** Detection of Krupple Like Factor -1(KLF1/ EKLF) DNA Mutations in Beta Thalassemia Patients using multiplex PCR **Name:** multiplex PCR **Type:** GENETIC ### Outcomes Module #### Primary Outcomes **Description:** Study the relation between genotypic mutational status of KLF1 mutation with the level of Hb F and Hb A2 in the patients of beta thalassemia and with the clinical data (frequency of blood transfusions). **Measure:** Detection of KLF1 gene mutations in patients with beta thalassemia considering the beta molecular status of these patients **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with β-thalassemia (intermedia and major) of both genders at any age Exclusion Criteria: * Patients with any other type of haemolytic anaemias. * Patients on Hydroxyurea therapy **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** cross sectional study ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** doctor4egypt2011@yahoo.com **Name:** mohamed mahmoud **Phone:** 01113225644 **Role:** CONTACT **Contact 2:** **Email:** Somaia2020m@gmail.com **Name:** Somia Mohammed, prof **Phone:** 01118279876 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Assiut University **Name:** Reem Abd Elkhalek Mohamed, lecturer **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Assiut University **Name:** Hebatallah Ahmed, lecturer **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Siatecka M, Bieker JJ. The multifunctional role of EKLF/KLF1 during erythropoiesis. Blood. 2011 Aug 25;118(8):2044-54. doi: 10.1182/blood-2011-03-331371. Epub 2011 May 25. **PMID:** 21613252 **Citation:** Tallack MR, Perkins AC. Three fingers on the switch: Kruppel-like factor 1 regulation of gamma-globin to beta-globin gene switching. Curr Opin Hematol. 2013 May;20(3):193-200. doi: 10.1097/MOH.0b013e32835f59ba. **PMID:** 23474875 **Citation:** Elagooz R, Dhara AR, Gott RM, Adams SE, White RA, Ghosh A, Ganguly S, Man Y, Owusu-Ansah A, Mian OY, Gurkan UA, Komar AA, Ramamoorthy M, Gnanapragasam MN. PUM1 mediates the posttranscriptional regulation of human fetal hemoglobin. Blood Adv. 2022 Dec 13;6(23):6016-6022. doi: 10.1182/bloodadvances.2021006730. **PMID:** 35667093 **Citation:** Borg J, Papadopoulos P, Georgitsi M, Gutierrez L, Grech G, Fanis P, Phylactides M, Verkerk AJ, van der Spek PJ, Scerri CA, Cassar W, Galdies R, van Ijcken W, Ozgur Z, Gillemans N, Hou J, Bugeja M, Grosveld FG, von Lindern M, Felice AE, Patrinos GP, Philipsen S. Haploinsufficiency for the erythroid transcription factor KLF1 causes hereditary persistence of fetal hemoglobin. Nat Genet. 2010 Sep;42(9):801-5. doi: 10.1038/ng.630. Epub 2010 Aug 1. **PMID:** 20676099 **Citation:** Srivorakun H, Thawinan W, Fucharoen G, Sanchaisuriya K, Fucharoen S. Thalassemia and erythroid transcription factor KLF1 mutations associated with borderline hemoglobin A2 in the Thai population. Arch Med Sci. 2020 Aug 11;18(1):112-120. doi: 10.5114/aoms.2020.93392. eCollection 2022. **PMID:** 35154532 **Citation:** Waye JS, Eng B. Kruppel-like factor 1: hematologic phenotypes associated with KLF1 gene mutations. Int J Lab Hematol. 2015 May;37 Suppl 1:78-84. doi: 10.1111/ijlh.12356. **PMID:** 25976964 **Citation:** Hariharan P, Colah R, Ghosh K, Nadkarni A. Differential role of Kruppel like factor 1 (KLF1) gene in red blood cell disorders. Genomics. 2019 Dec;111(6):1771-1776. doi: 10.1016/j.ygeno.2018.11.032. Epub 2018 Dec 5. **PMID:** 30529538 **Citation:** Xie XM, Liu YN, Li J, Jiang F, Li DZ. A Kruppel-Like Factor 1 Gene Mutation Ameliorates the Severity of beta-Thalassemia: A Case Report. Hemoglobin. 2019 Mar;43(2):137-139. doi: 10.1080/03630269.2019.1607373. Epub 2019 May 21. **PMID:** 31111750 **Citation:** El-Beshlawy A, Youssry I. Prevention of hemoglobinopathies in Egypt. Hemoglobin. 2009;33 Suppl 1:S14-20. doi: 10.3109/03630260903346395. **PMID:** 20001619 **Citation:** Origa R. beta-Thalassemia. Genet Med. 2017 Jun;19(6):609-619. doi: 10.1038/gim.2016.173. Epub 2016 Nov 3. **PMID:** 27811859 ## 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 ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16557 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: M19408 - Name: beta-Thalassemia - Relevance: HIGH - As Found: Beta Thalassemia - 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: T5622 - Name: Thalassemia - Relevance: HIGH - As Found: Thalassemia - ID: T737 - Name: Beta-thalassemia - Relevance: HIGH - As Found: Beta Thalassemia ### Condition Browse Module - Meshes - ID: D000013789 - Term: Thalassemia - ID: D000017086 - Term: beta-Thalassemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433557 **Acronym:** COACH **Brief Title:** A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia **Official Title:** A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia #### Organization Study ID Info **ID:** ASND0042 #### Organization **Class:** INDUSTRY **Full Name:** Ascendis Pharma A/S ### Status Module #### Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Ascendis Pharma Growth Disorders A/S #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years. ### Conditions Module **Conditions:** - Achondroplasia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Combination of Navepegritide and Lonapegsomatropin administered as two separate s.c. injections **Label:** Combination of Navepegritide and Lonapegsomatropin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Combination of Navepegritide and Lonapegsomatropin **Description:** For navepegritide, a once weekly s.c. dose of 100 μg CNP/kg. For lonapegsomatropin, a once weekly s.c. dose of lonapegsomatropin 0.30 mg hGH/kg as starting dose. Treatment duration of up to 156 weeks. **Name:** Combination of Navepegritide and Lonapegsomatropin administered as two separate s.c. injections **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** cm per year, compared to navepegritide alone **Measure:** Annualized growth velocity **Time Frame:** Week 52 **Description:** safety profile of navepegritide and lonapegsomatropin **Measure:** Treatment-emergent adverse events (TEAEs). **Time Frame:** Throughout the trial for 156 weeks #### Secondary Outcomes **Description:** cm per year **Measure:** Annualized growth velocity **Time Frame:** From start until 156 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Written, signed informed consent and/or assent (if applicable) by the parent(s) or legal representative(s) of the participant, and as required by the IRB/HREC/IEC. 2. Male or female between 2 to 11 years of age (inclusive) at the time of Visit 1. 3. Clinical diagnosis of ACH with genetic confirmation of heterozygote genotype present at Visit 1. Documentation of historic test results are acceptable for proof of diagnosis. 4. Able to stand without assistance. 5. Parent(s)/caregiver(s)/legal guardian(s) willing and able to administer weekly SC injections of IMP and comply with all protocol requirements. 6. At least 6 months of growth and disease history from TCC-NHS-01 or TCC-201 or comparable growth and disease history available from medical records. 7. No intracranial pathology as confirmed by brain MRI (historical MRI obtained within 2 years prior to screening allowable). Exclusion Criteria: 1. Participation in any interventional clinical trial within three months prior to screening (except TCC-201 or ASND0039). 2. Closed epiphysis at screening. 3. History of or suspected hypersensitivity to the IMP or related products. 4. Findings on fundoscopy at screening consistent with intracranial hypertension, papilledema, or evidence of any other retinal disease for which GH therapy is contraindicated. 5. Have a growth disorder or medical condition other than ACH that results in short stature or abnormal growth such as severe ACH with developmental delay and acanthosis nigricans (SADDAN), hypochondroplasia, GHD, Turner syndrome, pseudoachondroplasia, inflammatory bowel disease, celiac disease, hypothyroidism, hyperthyroidism, pre-diabetes, or diabetes mellitus. 6. Have received any dose of prescription and/or investigational medications or device intended to affect stature, growth, or body proportionality at any time prior to screening. 7. Receiving concurrent treatment with any agent that might influence growth or interfere with GH secretion or action: 1. Inhaled corticosteroid therapy at a dose of \>400 µg/day of inhaled budesonide or equivalent for more than 28 consecutive days total over the course of 12 months prior to screening. 2. Require, or anticipated to require, chronic (\>4 weeks) or repeated treatment (more than twice/year and \>3 weeks/year) with systemic corticosteroids during participation in the trial. 3. Currently using or have used within 12 months prior to screening any sex steroids (for example estrogen), non-steroidal anabolic agents (for example, oxandrolone) or gonadotropin-releasing hormone (GnRH) analogues treatment. 4. Treatment for attention-deficit hyperactive disorder (ADHD) such as methylphenidate. 8. Known history or presence of injury or disease of the growth plate(s), other than ACH, that affects growth potential of long bones. 9. Known history of any bone-related surgery affecting growth potential of long bones, such as Orthopaedic reconstructive surgery for bone lengthening (procedures for leg bowing such as 8-plate are not exclusionary). 10. Cervicomedullary decompression surgery within 6 months prior to Screening or with anticipated need for repeat decompression surgery during the time of the trial. 11. Evidence at screening consistent with severe cervicomedullary junction compression based on clinical and/or radiologic findings that indicate immediate surgical intervention is required. 12. Ventriculoperitoneal shunt and laminectomy with full recovery within 6 months prior to Screening. 13. Salter-Harris fracture within 6 months prior to screening (within 2 months for fracture of digits and buckle fractures). 14. Clinically significant musculoskeletal disease, such as Salter-Harris fractures or clinical and/or radiographic evidence of severe hip pathology. 15. Planned or expected surgical intervention during trial participation that may significantly affect trial parameters (confounding of safety events) or would prevent the participant from performing trial procedures. Minimally invasive surgeries such as insertion of grommets, adenoidectomy, tonsillectomy, or myringotomy tube placement, are permitted during the trial. 16. Severe untreated sleep apnoea or newly initiated sleep apnoea treatment (e.g., Continuous Positive Airway Pressure \[CPAP\] in the previous 2 months prior to screening). 17. Clinically significant finding or arrhythmia as determined by the investigator that indicates abnormal cardiac function or conduction that includes, but is not exclusive to: 1. Repaired or unrepaired coarctation. 2. Moderate or greater complexity congenital heart disease including tetralogy of Fallot, Atrioventricular septal defects, truncus arteriosus, total anomalous pulmonary venous return, double outlet right ventricle, or single ventricle heart disease. 18. QT corrected using Fridericia's correction (QTcF) ≥ 450 msec at screening. 19. Known history or presence of condition that impacts haemodynamic stability (such as autonomic dysfunction and orthostatic intolerance). 20. Known history or presence at screening of the following: 1. Chronic anaemia (iron deficiency anaemia that is resolved or considered adequately treated in the Investigator's opinion is allowed). 2. Chronic renal insufficiency defined as estimated glomerular filtration rate (eGFR) according to the revised bedside Schwartz equation less than \<60 mL/min/1.73 m2 for \>3 months. 3. Chronic or recurrent illness that can affect hydration or volume status, including conditions associated with decreased nutritional intake or increased volume loss. 21. Known history or presence of malignant disease. 22. Hepatic transaminases (aspartate aminotransferase (AST) or alanine transferase (ALT)) greater than 3x upper limit of normal (ULN) at screening. 23. Serum 25-hydroxy-vitamin D (25OHD) level of \<30 nmol/L (\<12 ng/mL) at screening. Participants with 25OHD levels between 30-50 nmol/L (12-20 ng/mL) may be enrolled provided treatment with Vitamin D supplementation is initiated. 24. Any disease or condition that, in the opinion of the Investigator, may make the participant unlikely to fully complete the trial, may confound interpretation of trial results, or may present undue risk from receiving trial treatment. This could include family situations, complications or manifestations, or medications that might impact safety or be considered confounding. 25. Sexually active male and female participants who are unwilling or unable to use a highly effective form of contraception for the entire trial period and for 90 days after last dose of trial treatment. 26. Female participants who are pregnant, lactating or breastfeeding. **Maximum Age:** 11 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** vib@ascendispharma.com **Name:** Vibeke Breinholt **Phone:** +4561242484 **Role:** CONTACT #### Locations **Location 1:** **City:** Copenhagen **Country:** Denmark **Facility:** Ascendis Pharma Investigational Site **Zip:** 2100 **Location 2:** **City:** Dublin **Country:** Ireland **Facility:** Ascendis Pharma Investigational Site **Zip:** D01 YC76 **Location 3:** **City:** London **Country:** United Kingdom **Facility:** Ascendis Pharma Investigational Site **Zip:** W1W 5AH ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004392 - Term: Dwarfism - ID: D000001848 - Term: Bone Diseases, Developmental - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000010009 - Term: Osteochondrodysplasias - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3494 - Name: Achondroplasia - Relevance: HIGH - As Found: Achondroplasia - ID: M7566 - Name: Dwarfism - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5127 - Name: Bone Diseases, Developmental - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12932 - Name: Osteochondrodysplasias - Relevance: LOW - As Found: Unknown - ID: M12043 - Name: Mucopolysaccharidosis IV - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T102 - Name: Achondroplasia - Relevance: HIGH - As Found: Achondroplasia - ID: T3909 - Name: Mucopolysaccharidosis Type IV - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000130 - Term: Achondroplasia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433544 **Brief Title:** Online Mindfulness Therapy for Pandemic Fatigue and Resilience in COVID-19 Nurses **Official Title:** Evaluating the Effects of Online Mindfulness Therapy on Pandemic Fatigue and Resilience Among Nurses in COVID-19 Quarantine Wards #### Organization Study ID Info **ID:** 11112-001 #### Organization **Class:** OTHER **Full Name:** Chimei Medical Center ### Status Module #### Completion Date **Date:** 2023-05-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-31 **Type:** ACTUAL #### Start Date **Date:** 2022-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chimei Medical Center #### 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 evaluates online mindfulness therapy's impact on pandemic fatigue and resilience in COVID-19 quarantine ward nurses. Sixty nurses were divided into experimental and control groups, with the experimental group receiving a 6-week online mindfulness course. **Detailed Description:** This study evaluates the effectiveness of online mindfulness therapy on reducing pandemic fatigue and enhancing resilience among nurses in COVID-19 quarantine wards. Using a repeated-measures quasi-experimental design, 60 nurses were divided into experimental and control groups. The experimental group participated in a 6-week online mindfulness course. Outcomes were measured using pandemic fatigue and resilience questionnaires at the pre-test , three weeks and after six weeks. ### Conditions Module **Conditions:** - Mindfulness - Nurses in COVID-19 - Pandemic Fatigue - Resilience **Keywords:** - Online mindfulness - COVID-19 quarantine ward nurses - Pandemic fatigue - Resilience ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The experimental group received a 6-week online mindfulness course, once a week for 90 minutes each session. Participants completed questionnaires before the course, at week 3, and at week 6. **Intervention Names:** - Other: 6-week online mindfulness course **Label:** Experimental group will undergo a 6-week online mindfulness course **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** General routine care **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group will undergo a 6-week online mindfulness course **Description:** The experimental group received a 6-week online mindfulness course, once a week for 90 minutes each session. **Name:** 6-week online mindfulness course **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Use Lockdown/Pandemic Fatigue Scale (LFS) measure pandemic fatigue. The scale with a total of 10 items measures pandemic fatigue. The range of total scores of the scale is 10-50. It shows that pandemic fatigue increases as total points of the scale increase. **Measure:** Pandemic Fatigue **Time Frame:** 6 weeks #### Secondary Outcomes **Description:** Use Connor-Davidson Resilience Scale (CD-RISC) measure individual resilience. The scale with a total of 25 items measures resilience. The range of total scores of the scale is 0-100. It shows that resilience increases as total points of the scale increase. **Measure:** Resilience **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Over 20 years old. * Nurses of COVID-19 dedicated wards and dedicated intensive care units. Exclusion Criteria: * Difficulty in attending * less than 80% of the total number of online mindfulness therapy sessions **Gender Based:** True **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tainan City **Country:** Taiwan **Facility:** Chi Mei Medical Center **State:** 其他（非美國） **Zip:** 71004 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Afshari D, Nourollahi-Darabad M, Chinisaz N. Demographic predictors of resilience among nurses during the COVID-19 pandemic. Work. 2021;68(2):297-303. doi: 10.3233/WOR-203376. **PMID:** 33492260 **Citation:** Amutio A, Martinez-Taboada C, Delgado LC, Hermosilla D, Mozaz MJ. Acceptability and Effectiveness of a Long-Term Educational Intervention to Reduce Physicians' Stress-Related Conditions. J Contin Educ Health Prof. 2015 Fall;35(4):255-60. doi: 10.1097/CEH.0000000000000002. **PMID:** 26953856 **Citation:** Asuero AM, Queralto JM, Pujol-Ribera E, Berenguera A, Rodriguez-Blanco T, Epstein RM. Effectiveness of a mindfulness education program in primary health care professionals: a pragmatic controlled trial. J Contin Educ Health Prof. 2014 Winter;34(1):4-12. doi: 10.1002/chp.21211. **PMID:** 24648359 **Citation:** Barnett P, Barnett M, Borgueta E, Moreno JV, Watson J. COVID-19: An Organizational-theory-guided Holistic Self-caring and Resilience Project. J Holist Nurs. 2021 Dec;39(4):325-335. doi: 10.1177/08980101211007007. Epub 2021 Apr 16. Erratum In: J Holist Nurs. 2022 Sep;40(3):NP1-NP5. **PMID:** 33861185 **Citation:** Barry KM, Woods M, Martin A, Stirling C, Warnecke E. A randomized controlled trial of the effects of mindfulness practice on doctoral candidate psychological status. J Am Coll Health. 2019 May-Jun;67(4):299-307. doi: 10.1080/07448481.2018.1515760. Epub 2018 Nov 2. **PMID:** 30388950 **Citation:** Baskin RG, Bartlett R. Healthcare worker resilience during the COVID-19 pandemic: An integrative review. J Nurs Manag. 2021 Nov;29(8):2329-2342. doi: 10.1111/jonm.13395. Epub 2021 Jul 9. **PMID:** 34182609 **Citation:** Bazarko D, Cate RA, Azocar F, Kreitzer MJ. The Impact of an Innovative Mindfulness-Based Stress Reduction Program on the Health and Well-Being of Nurses Employed in a Corporate Setting. J Workplace Behav Health. 2013 Apr;28(2):107-133. doi: 10.1080/15555240.2013.779518. **PMID:** 23667348 **Citation:** Buleon C, Minehart RD, Fischer MO. Protecting healthcare providers from COVID-19 through a large simulation training programme. Br J Anaesth. 2020 Nov;125(5):e418-e420. doi: 10.1016/j.bja.2020.07.044. Epub 2020 Aug 5. No abstract available. **PMID:** 32828493 **Citation:** Cai Z, Cui Q, Liu Z, Li J, Gong X, Liu J, Wan Z, Yuan X, Li X, Chen C, Wang G. Nurses endured high risks of psychological problems under the epidemic of COVID-19 in a longitudinal study in Wuhan China. J Psychiatr Res. 2020 Dec;131:132-137. doi: 10.1016/j.jpsychires.2020.09.007. Epub 2020 Sep 14. **PMID:** 32971356 **Citation:** Catania G, Zanini M, Hayter M, Timmins F, Dasso N, Ottonello G, Aleo G, Sasso L, Bagnasco A. Lessons from Italian front-line nurses' experiences during the COVID-19 pandemic: A qualitative descriptive study. J Nurs Manag. 2021 Apr;29(3):404-411. doi: 10.1111/jonm.13194. Epub 2020 Nov 15. **PMID:** 33107657 **Citation:** Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. **PMID:** 12964174 **Citation:** Creswell JD, Lindsay EK, Villalba DK, Chin B. Mindfulness Training and Physical Health: Mechanisms and Outcomes. Psychosom Med. 2019 Apr;81(3):224-232. doi: 10.1097/PSY.0000000000000675. **PMID:** 30806634 **Citation:** Croghan IT, Chesak SS, Adusumalli J, Fischer KM, Beck EW, Patel SR, Ghosh K, Schroeder DR, Bhagra A. Stress, Resilience, and Coping of Healthcare Workers during the COVID-19 Pandemic. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211008448. doi: 10.1177/21501327211008448. **PMID:** 33834900 **Citation:** Cuadrado E, Maldonado MA, Tabernero C, Arenas A, Castillo-Mayen R, Luque B. Construction and Validation of a Brief Pandemic Fatigue Scale in the Context of the Coronavirus-19 Public Health Crisis. Int J Public Health. 2021 Aug 30;66:1604260. doi: 10.3389/ijph.2021.1604260. eCollection 2021. **PMID:** 34566554 **Citation:** de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Bjorndal A. Mindfulness training for stress management: a randomised controlled study of medical and psychology students. BMC Med Educ. 2013 Aug 13;13:107. doi: 10.1186/1472-6920-13-107. **PMID:** 23941053 **Citation:** Dharra S, Kumar R. Promoting Mental Health of Nurses During the Coronavirus Pandemic: Will the Rapid Deployment of Nurses' Training Programs During COVID-19 Improve Self-Efficacy and Reduce Anxiety? Cureus. 2021 May 24;13(5):e15213. doi: 10.7759/cureus.15213. **PMID:** 34178532 **Citation:** Dincer B, Inangil D. The effect of Emotional Freedom Techniques on nurses' stress, anxiety, and burnout levels during the COVID-19 pandemic: A randomized controlled trial. Explore (NY). 2021 Mar-Apr;17(2):109-114. doi: 10.1016/j.explore.2020.11.012. Epub 2020 Dec 3. **PMID:** 33293201 **Citation:** Duarte J, Pinto-Gouveia J. Effectiveness of a mindfulness-based intervention on oncology nurses' burnout and compassion fatigue symptoms: A non-randomized study. Int J Nurs Stud. 2016 Dec;64:98-107. doi: 10.1016/j.ijnurstu.2016.10.002. Epub 2016 Oct 8. **PMID:** 27744228 **Citation:** Ducar DM, Penberthy JK, Schorling JB, Leavell VA, Calland JF. Mindfulness for healthcare providers fosters professional quality of life and mindful attention among emergency medical technicians. Explore (NY). 2020 Jan-Feb;16(1):61-68. doi: 10.1016/j.explore.2019.07.015. Epub 2019 Aug 6. **PMID:** 31471216 **Citation:** Duchemin AM, Steinberg BA, Marks DR, Vanover K, Klatt M. A small randomized pilot study of a workplace mindfulness-based intervention for surgical intensive care unit personnel: effects on salivary alpha-amylase levels. J Occup Environ Med. 2015 Apr;57(4):393-9. doi: 10.1097/JOM.0000000000000371. **PMID:** 25629803 **Citation:** Elliott M, Khallouf C, Hirsch J, de Camps Meschino D, Zamir O, Ravitz P. Novel Web-Based Drop-In Mindfulness Sessions (Pause-4-Providers) to Enhance Well-Being Among Health Care Workers During the COVID-19 Pandemic: Descriptive and Qualitative Study. JMIR Form Res. 2024 Mar 14;8:e43875. doi: 10.2196/43875. **PMID:** 38180869 **Citation:** Fernandez-Castillo RJ, Gonzalez-Caro MD, Fernandez-Garcia E, Porcel-Galvez AM, Garnacho-Montero J. Intensive care nurses' experiences during the COVID-19 pandemic: A qualitative study. Nurs Crit Care. 2021 Sep;26(5):397-406. doi: 10.1111/nicc.12589. Epub 2021 Jan 5. **PMID:** 33401340 **Citation:** Ferrara M, Funaro MC, Vacca F, Kusmann F, Tedeschini E, Galeazzi GM, Scattoni ML, Starace F. The cost of caring during recent epidemics: a rapid review of risk factors, psychological manifestations, and strategies for its treatment. Ann Ist Super Sanita. 2021 Jan-Mar;57(1):7-17. doi: 10.4415/ANN_21_01_02. **PMID:** 33797399 **Citation:** Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. **PMID:** 35244208 **Citation:** Fox KC, Dixon ML, Nijeboer S, Girn M, Floman JL, Lifshitz M, Ellamil M, Sedlmeier P, Christoff K. Functional neuroanatomy of meditation: A review and meta-analysis of 78 functional neuroimaging investigations. Neurosci Biobehav Rev. 2016 Jun;65:208-28. doi: 10.1016/j.neubiorev.2016.03.021. Epub 2016 Mar 28. **PMID:** 27032724 **Citation:** Friborg O, Hjemdal O, Rosenvinge JH, Martinussen M. A new rating scale for adult resilience: what are the central protective resources behind healthy adjustment? Int J Methods Psychiatr Res. 2003;12(2):65-76. doi: 10.1002/mpr.143. **PMID:** 12830300 **Citation:** Gomez-Salgado J, Arias-Ulloa CA, Ortega-Moreno M, Garcia-Iglesias JJ, Escobar-Segovia K, Ruiz-Frutos C. Sense of Coherence in Healthcare Workers During the COVID-19 Pandemic in Ecuador: Association With Work Engagement, Work Environment and Psychological Distress Factors. Int J Public Health. 2022 Dec 5;67:1605428. doi: 10.3389/ijph.2022.1605428. eCollection 2022. **PMID:** 36545403 **Citation:** Garcia CL, Abreu LC, Ramos JLS, Castro CFD, Smiderle FRN, Santos JAD, Bezerra IMP. Influence of Burnout on Patient Safety: Systematic Review and Meta-Analysis. Medicina (Kaunas). 2019 Aug 30;55(9):553. doi: 10.3390/medicina55090553. **PMID:** 31480365 **Citation:** Goh YS, Ow Yong QYJ, Chen TH, Ho SHC, Chee YIC, Chee TT. The Impact of COVID-19 on nurses working in a University Health System in Singapore: A qualitative descriptive study. Int J Ment Health Nurs. 2021 Jun;30(3):643-652. doi: 10.1111/inm.12826. Epub 2020 Dec 5. **PMID:** 33280242 **Citation:** Gonzalez-Gil MT, Gonzalez-Blazquez C, Parro-Moreno AI, Pedraz-Marcos A, Palmar-Santos A, Otero-Garcia L, Navarta-Sanchez MV, Alcolea-Cosin MT, Arguello-Lopez MT, Canalejas-Perez C, Carrillo-Camacho ME, Casillas-Santana ML, Diaz-Martinez ML, Garcia-Gonzalez A, Garcia-Perea E, Martinez-Marcos M, Martinez-Martin ML, Palazuelos-Puerta MDP, Sellan-Soto C, Oter-Quintana C. Nurses' perceptions and demands regarding COVID-19 care delivery in critical care units and hospital emergency services. Intensive Crit Care Nurs. 2021 Feb;62:102966. doi: 10.1016/j.iccn.2020.102966. Epub 2020 Oct 28. **PMID:** 33172732 **Citation:** Gordon JM, Magbee T, Yoder LH. The experiences of critical care nurses caring for patients with COVID-19 during the 2020 pandemic: A qualitative study. Appl Nurs Res. 2021 Jun;59:151418. doi: 10.1016/j.apnr.2021.151418. Epub 2021 Mar 11. **PMID:** 33947512 **Citation:** Guo YF, Cross W, Plummer V, Lam L, Luo YH, Zhang JP. Exploring resilience in Chinese nurses: a cross-sectional study. J Nurs Manag. 2017 Apr;25(3):223-230. doi: 10.1111/jonm.12457. Epub 2017 Feb 6. **PMID:** 28164403 **Citation:** Harper CA, Satchell LP, Fido D, Latzman RD. Functional Fear Predicts Public Health Compliance in the COVID-19 Pandemic. Int J Ment Health Addict. 2021;19(5):1875-1888. doi: 10.1007/s11469-020-00281-5. Epub 2020 Apr 27. **PMID:** 32346359 **Citation:** Hart PL, Brannan JD, De Chesnay M. Resilience in nurses: an integrative review. J Nurs Manag. 2014 Sep;22(6):720-34. doi: 10.1111/j.1365-2834.2012.01485.x. Epub 2012 Nov 2. **PMID:** 25208943 **Citation:** Hoedl M, Bauer S, Eglseer D. Influence of nursing staff working hours on stress levels during the COVID-19 pandemic: A cross-sectional online survey. HeilberufeScience. 2021;12(3-4):92-98. doi: 10.1007/s16024-021-00354-y. Epub 2021 Sep 10. **PMID:** 34522573 **Citation:** Hoge EA, Bui E, Goetter E, Robinaugh DJ, Ojserkis RA, Fresco DM, Simon NM. Change in Decentering Mediates Improvement in Anxiety in Mindfulness-Based Stress Reduction for Generalized Anxiety Disorder. Cognit Ther Res. 2015 Apr;39(2):228-235. doi: 10.1007/s10608-014-9646-4. Epub 2014 Oct 14. **PMID:** 28316355 **Citation:** Hummel S, Oetjen N, Du J, Posenato E, Resende de Almeida RM, Losada R, Ribeiro O, Frisardi V, Hopper L, Rashid A, Nasser H, Konig A, Rudofsky G, Weidt S, Zafar A, Gronewold N, Mayer G, Schultz JH. Mental Health Among Medical Professionals During the COVID-19 Pandemic in Eight European Countries: Cross-sectional Survey Study. J Med Internet Res. 2021 Jan 18;23(1):e24983. doi: 10.2196/24983. **PMID:** 33411670 **Citation:** Jorgensen F, Bor A, Rasmussen MS, Lindholt MF, Petersen MB. Pandemic fatigue fueled political discontent during the COVID-19 pandemic. Proc Natl Acad Sci U S A. 2022 Nov 29;119(48):e2201266119. doi: 10.1073/pnas.2201266119. Epub 2022 Nov 21. **PMID:** 36413499 **Citation:** Karimi Khordeh N, Dehvan F, Dalvand S, Repisti S, Ghanei Gheshlagh R. The COVID-19 fear, anxiety, and resilience among emergency nurses. Front Psychol. 2022 Sep 2;13:999111. doi: 10.3389/fpsyg.2022.999111. eCollection 2022. **PMID:** 36118421 **Citation:** Kriakous SA, Elliott KA, Lamers C, Owen R. The Effectiveness of Mindfulness-Based Stress Reduction on the Psychological Functioning of Healthcare Professionals: a Systematic Review. Mindfulness (N Y). 2021;12(1):1-28. doi: 10.1007/s12671-020-01500-9. Epub 2020 Sep 24. **PMID:** 32989406 **Citation:** Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022. **PMID:** 2803071 **Citation:** Labrague LJ. Pandemic fatigue and clinical nurses' mental health, sleep quality and job contentment during the covid-19 pandemic: The mediating role of resilience. J Nurs Manag. 2021 Oct;29(7):1992-2001. doi: 10.1111/jonm.13383. Epub 2021 Jun 9. **PMID:** 34018270 **Citation:** Labrague LJ. Psychological resilience, coping behaviours and social support among health care workers during the COVID-19 pandemic: A systematic review of quantitative studies. J Nurs Manag. 2021 Oct;29(7):1893-1905. doi: 10.1111/jonm.13336. Epub 2021 Apr 28. **PMID:** 33843087 **Citation:** Labrague LJ, Ballad CA. Lockdown fatigue among college students during the COVID-19 pandemic: Predictive role of personal resilience, coping behaviors, and health. Perspect Psychiatr Care. 2021 Oct;57(4):1905-1912. doi: 10.1111/ppc.12765. Epub 2021 Mar 17. **PMID:** 33728666 **Citation:** Labrague LJ, De Los Santos JAA. Prevalence and predictors of coronaphobia among frontline hospital and public health nurses. Public Health Nurs. 2021 May;38(3):382-389. doi: 10.1111/phn.12841. Epub 2020 Nov 23. **PMID:** 33226158 **Citation:** Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976. **PMID:** 32202646 **Citation:** Leng M, Wei L, Shi X, Cao G, Wei Y, Xu H, Zhang X, Zhang W, Xing S, Wei H. Mental distress and influencing factors in nurses caring for patients with COVID-19. Nurs Crit Care. 2021 Mar;26(2):94-101. doi: 10.1111/nicc.12528. Epub 2020 Jul 27. **PMID:** 33448567 **Citation:** Liu Q, Luo D, Haase JE, Guo Q, Wang XQ, Liu S, Xia L, Liu Z, Yang J, Yang BX. The experiences of health-care providers during the COVID-19 crisis in China: a qualitative study. Lancet Glob Health. 2020 Jun;8(6):e790-e798. doi: 10.1016/S2214-109X(20)30204-7. Epub 2020 Apr 29. **PMID:** 32573443 **Citation:** Lin L, He G, Yan J, Gu C, Xie J. The Effects of a Modified Mindfulness-Based Stress Reduction Program for Nurses: A Randomized Controlled Trial. Workplace Health Saf. 2019 Mar;67(3):111-122. doi: 10.1177/2165079918801633. Epub 2018 Oct 29. **PMID:** 30370837 **Citation:** Liu Y, Xian JS, Wang R, Ma K, Li F, Wang FL, Yang X, Mu N, Xu K, Quan YL, Wang S, Lai Y, Yang CY, Li T, Zhang Y, Tan B, Feng H, Chen TN, Wang LH. Factoring and correlation in sleep, fatigue and mental workload of clinical first-line nurses in the post-pandemic era of COVID-19: A multi-center cross-sectional study. Front Psychiatry. 2022 Aug 25;13:963419. doi: 10.3389/fpsyt.2022.963419. eCollection 2022. **PMID:** 36090368 **Citation:** Lazaro-Perez C, Martinez-Lopez JA, Gomez-Galan J, Lopez-Meneses E. Anxiety About the Risk of Death of Their Patients in Health Professionals in Spain: Analysis at the Peak of the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Aug 15;17(16):5938. doi: 10.3390/ijerph17165938. **PMID:** 32824258 **Citation:** Luthar SS, Cicchetti D, Becker B. The construct of resilience: a critical evaluation and guidelines for future work. Child Dev. 2000 May-Jun;71(3):543-62. doi: 10.1111/1467-8624.00164. **PMID:** 10953923 **Citation:** Lutz A, Jha AP, Dunne JD, Saron CD. Investigating the phenomenological matrix of mindfulness-related practices from a neurocognitive perspective. Am Psychol. 2015 Oct;70(7):632-58. doi: 10.1037/a0039585. **PMID:** 26436313 **Citation:** Majumdar P, Biswas A, Sahu S. COVID-19 pandemic and lockdown: cause of sleep disruption, depression, somatic pain, and increased screen exposure of office workers and students of India. Chronobiol Int. 2020 Aug;37(8):1191-1200. doi: 10.1080/07420528.2020.1786107. Epub 2020 Jul 13. **PMID:** 32660352 **Citation:** Marotta M, Gorini F, Parlanti A, Berti S, Vassalle C. Effect of Mindfulness-Based Stress Reduction on the Well-Being, Burnout and Stress of Italian Healthcare Professionals during the COVID-19 Pandemic. J Clin Med. 2022 May 31;11(11):3136. doi: 10.3390/jcm11113136. **PMID:** 35683520 **Citation:** Mealer M, Jones J, Moss M. A qualitative study of resilience and posttraumatic stress disorder in United States ICU nurses. Intensive Care Med. 2012 Sep;38(9):1445-51. doi: 10.1007/s00134-012-2600-6. Epub 2012 May 23. **PMID:** 22618093 **Citation:** Mealer M, Jones J, Newman J, McFann KK, Rothbaum B, Moss M. The presence of resilience is associated with a healthier psychological profile in intensive care unit (ICU) nurses: results of a national survey. Int J Nurs Stud. 2012 Mar;49(3):292-9. doi: 10.1016/j.ijnurstu.2011.09.015. Epub 2011 Oct 5. **PMID:** 21974793 **Citation:** Mealer M, Conrad D, Evans J, Jooste K, Solyntjes J, Rothbaum B, Moss M. Feasibility and acceptability of a resilience training program for intensive care unit nurses. Am J Crit Care. 2014 Nov;23(6):e97-105. doi: 10.4037/ajcc2014747. Erratum In: Am J Crit Care. 2016 Mar;25(2):172. **PMID:** 25362680 **Citation:** Mehta DH, Perez GK, Traeger L, Park ER, Goldman RE, Haime V, Chittenden EH, Denninger JW, Jackson VA. Building Resiliency in a Palliative Care Team: A Pilot Study. J Pain Symptom Manage. 2016 Mar;51(3):604-8. doi: 10.1016/j.jpainsymman.2015.10.013. Epub 2015 Nov 6. **PMID:** 26550936 **Citation:** Melnyk BM, Kelly SA, Stephens J, Dhakal K, McGovern C, Tucker S, Hoying J, McRae K, Ault S, Spurlock E, Bird SB. Interventions to Improve Mental Health, Well-Being, Physical Health, and Lifestyle Behaviors in Physicians and Nurses: A Systematic Review. Am J Health Promot. 2020 Nov;34(8):929-941. doi: 10.1177/0890117120920451. Epub 2020 Apr 27. **PMID:** 32338522 **Citation:** Murphy JFA. Pandemic Fatigue. Ir Med J. 2020 Jun 11;113(6):90. No abstract available. **PMID:** 32816425 **Citation:** Nasirizad Moghadam K, Chehrzad MM, Reza Masouleh S, Maleki M, Mardani A, Atharyan S, Harding C. Nursing physical workload and mental workload in intensive care units: Are they related? Nurs Open. 2021 Jul;8(4):1625-1633. doi: 10.1002/nop2.785. Epub 2021 Feb 17. **PMID:** 33596333 **Citation:** Othman SY, Hassan NI, Mohamed AM. Effectiveness of mindfulness-based interventions on burnout and self-compassion among critical care nurses caring for patients with COVID-19: a quasi-experimental study. BMC Nurs. 2023 Sep 6;22(1):305. doi: 10.1186/s12912-023-01466-8. **PMID:** 37674145 **Citation:** Perez V, Menendez-Crispin EJ, Sarabia-Cobo C, de Lorena P, Fernandez-Rodriguez A, Gonzalez-Vaca J. Mindfulness-Based Intervention for the Reduction of Compassion Fatigue and Burnout in Nurse Caregivers of Institutionalized Older Persons with Dementia: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 11;19(18):11441. doi: 10.3390/ijerph191811441. **PMID:** 36141714 **Citation:** Placzek M, Friede T. Clinical trials with nested subgroups: Analysis, sample size determination and internal pilot studies. Stat Methods Med Res. 2018 Nov;27(11):3286-3303. doi: 10.1177/0962280217696116. Epub 2017 Mar 14. **PMID:** 29298604 **Citation:** Reger MA, Piccirillo ML, Buchman-Schmitt JM. COVID-19, Mental Health, and Suicide Risk Among Health Care Workers: Looking Beyond the Crisis. J Clin Psychiatry. 2020 Aug 4;81(5):20com13381. doi: 10.4088/JCP.20com13381. No abstract available. **PMID:** 32757506 **Citation:** Ren HF, Chen FJ, He LX, Liu CQ, Liu YY, Huang YJ, Han H, Fu S, Zhang MG, Jiang Y. Nursing allocation in isolation wards of COVID-19 designated hospitals: a nationwide study in China. BMC Nurs. 2022 Jan 19;21(1):23. doi: 10.1186/s12912-021-00795-w. **PMID:** 35042486 **Citation:** Resnick B. Covid-19 lessons learned from the voices of our geriatric nurses: Leadership, resilience, and heroism. Geriatr Nurs. 2020 Jul-Aug;41(4):357-359. doi: 10.1016/j.gerinurse.2020.06.008. Epub 2020 Jun 18. No abstract available. **PMID:** 32680676 **Citation:** Sallon S, Katz-Eisner D, Yaffe H, Bdolah-Abram T. Caring for the Caregivers: Results of an Extended, Five-component Stress-reduction Intervention for Hospital Staff. Behav Med. 2017 Jan-Mar;43(1):47-60. doi: 10.1080/08964289.2015.1053426. Epub 2015 Nov 7. **PMID:** 26548543 **Citation:** Salzberger B, Buder F, Lampl B, Ehrenstein B, Hitzenbichler F, Holzmann T, Schmidt B, Hanses F. Epidemiology of SARS-CoV-2. Infection. 2021 Apr;49(2):233-239. doi: 10.1007/s15010-020-01531-3. Epub 2020 Oct 8. **PMID:** 33034020 **Citation:** Schroeder DA, Stephens E, Colgan D, Hunsinger M, Rubin D, Christopher MS. A Brief Mindfulness-Based Intervention for Primary Care Physicians: A Pilot Randomized Controlled Trial. Am J Lifestyle Med. 2016 Feb 4;12(1):83-91. doi: 10.1177/1559827616629121. eCollection 2018 Jan-Feb. **PMID:** 30202383 **Citation:** Senders A, Hanes D, Bourdette D, Carson K, Marshall LM, Shinto L. Impact of mindfulness-based stress reduction for people with multiple sclerosis at 8 weeks and 12 months: A randomized clinical trial. Mult Scler. 2019 Jul;25(8):1178-1188. doi: 10.1177/1352458518786650. Epub 2018 Jul 9. **PMID:** 29985095 **Citation:** Serrano-Ripoll MJ, Meneses-Echavez JF, Ricci-Cabello I, Fraile-Navarro D, Fiol-deRoque MA, Pastor-Moreno G, Castro A, Ruiz-Perez I, Zamanillo Campos R, Goncalves-Bradley DC. Impact of viral epidemic outbreaks on mental health of healthcare workers: a rapid systematic review and meta-analysis. J Affect Disord. 2020 Dec 1;277:347-357. doi: 10.1016/j.jad.2020.08.034. Epub 2020 Aug 23. **PMID:** 32861835 **Citation:** Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972. **PMID:** 18696313 **Citation:** Sun N, Wei L, Shi S, Jiao D, Song R, Ma L, Wang H, Wang C, Wang Z, You Y, Liu S, Wang H. A qualitative study on the psychological experience of caregivers of COVID-19 patients. Am J Infect Control. 2020 Jun;48(6):592-598. doi: 10.1016/j.ajic.2020.03.018. Epub 2020 Apr 8. **PMID:** 32334904 **Citation:** Tang X, Pei Y, Wang X, Jiang L, Liu P, Chen Y, Meng Z. Mental health and fatigue status of the medical workforce during the COVID-19 outbreak in the Yangzhou city, China. Front Psychiatry. 2022 Oct 17;13:1018069. doi: 10.3389/fpsyt.2022.1018069. eCollection 2022. **PMID:** 36325526 **Citation:** Tang YY, Holzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci. 2015 Apr;16(4):213-25. doi: 10.1038/nrn3916. Epub 2015 Mar 18. **PMID:** 25783612 **Citation:** Umbetkulova S, Kanderzhanova A, Foster F, Stolyarova V, Cobb-Zygadlo D. Mental Health Changes in Healthcare Workers During COVID-19 Pandemic: A Systematic Review of Longitudinal Studies. Eval Health Prof. 2024 Mar;47(1):11-20. doi: 10.1177/01632787231165076. Epub 2023 May 4. **PMID:** 37143216 **Citation:** Usher K, Jackson D, Durkin J, Gyamfi N, Bhullar N. Pandemic-related behaviours and psychological outcomes; A rapid literature review to explain COVID-19 behaviours. Int J Ment Health Nurs. 2020 Dec;29(6):1018-1034. doi: 10.1111/inm.12790. Epub 2020 Oct 13. **PMID:** 32860475 **Citation:** Wang Y, Tang L, Li L. Work engagement and associated factors among healthcare professionals in the post-pandemic era: a cross-sectional study. Front Public Health. 2023 Jul 27;11:1173117. doi: 10.3389/fpubh.2023.1173117. eCollection 2023. Erratum In: Front Public Health. 2023 Nov 20;11:1332486. **PMID:** 37575106 **Citation:** Wax RS, Christian MD. Practical recommendations for critical care and anesthesiology teams caring for novel coronavirus (2019-nCoV) patients. Can J Anaesth. 2020 May;67(5):568-576. doi: 10.1007/s12630-020-01591-x. Epub 2020 Feb 12. **PMID:** 32052373 **Citation:** White L. Mindfulness in nursing: an evolutionary concept analysis. J Adv Nurs. 2014 Feb;70(2):282-94. doi: 10.1111/jan.12182. Epub 2013 Jun 16. **PMID:** 23772683 **Citation:** Wielgosz J, Goldberg SB, Kral TRA, Dunne JD, Davidson RJ. Mindfulness Meditation and Psychopathology. Annu Rev Clin Psychol. 2019 May 7;15:285-316. doi: 10.1146/annurev-clinpsy-021815-093423. Epub 2018 Dec 10. **PMID:** 30525995 **Citation:** Windle G, Bennett KM, Noyes J. A methodological review of resilience measurement scales. Health Qual Life Outcomes. 2011 Feb 4;9:8. doi: 10.1186/1477-7525-9-8. **PMID:** 21294858 **Citation:** Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. **PMID:** 32091533 **Citation:** Zhan YX, Zhao SY, Yuan J, Liu H, Liu YF, Gui LL, Zheng H, Zhou YM, Qiu LH, Chen JH, Yu JH, Li SY. Prevalence and Influencing Factors on Fatigue of First-line Nurses Combating with COVID-19 in China: A Descriptive Cross-Sectional Study. Curr Med Sci. 2020 Aug;40(4):625-635. doi: 10.1007/s11596-020-2226-9. Epub 2020 Aug 29. **PMID:** 32767264 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M8364 - Name: Fatigue - Relevance: HIGH - As Found: Fatigue - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - 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 ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000005221 - Term: Fatigue ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433531 **Brief Title:** A Clinical Study of TQH2929 Injection in Treatment With Generalized Pustular Psoriasis (GPP) **Official Title:** Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects and Psoriasis Subjects #### Organization Study ID Info **ID:** TQH2929-I-01 (Ib) #### Organization **Class:** INDUSTRY **Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy. ### Conditions Module **Conditions:** - Generalized Pustular Psoriasis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** TQH2929 Injection is administered as a single dose. **Intervention Names:** - Drug: TQH2929 Injection **Label:** TQH2929 Injection (900 mg) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - TQH2929 Injection (900 mg) **Description:** TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade. **Name:** TQH2929 Injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The occurrence of all adverse events (AE). **Measure:** Adverse events (AE) **Time Frame:** From the first dose to 113 days after the last dose **Description:** The occurrence of all serious adverse events (SAE). **Measure:** Serious adverse events (SAE) **Time Frame:** From the first dose to 113 days after the last dose **Description:** The occurrence of all treatment-related adverse events(TRAE). **Measure:** Treatment-related adverse events(TRAE) **Time Frame:** From the first dose to 113 days after the last dose **Description:** Incidence of participants with clinical laboratory abnormalities **Measure:** Clinical laboratory abnormalities **Time Frame:** From the first dose to 113 days after the last dose #### Secondary Outcomes **Description:** Time to reach maximum (peak) serum concentration following drug administration. **Measure:** Time to reach maximum observed serum concentration (Tmax) **Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose **Description:** The Cmax is the maximum observed serum concentration of study drug. **Measure:** Maximum serum concentration (Cmax) **Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose **Description:** Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to infinity. **Measure:** Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) **Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose **Description:** Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point. **Measure:** Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t]) **Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose **Description:** Apparent volume of distribution of the TQH2929 Injection in serum. **Measure:** Apparent volume of distribution (Vd/F) **Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose **Description:** Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. **Measure:** Apparent clearance (CL/F) **Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose **Description:** Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. **Measure:** Half-life (t1/2) **Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose **Description:** A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study. **Measure:** Anti-drug antibodies (ADA) **Time Frame:** Single dose: within 1 hour (pre-dose), Days 15, 57, 85, and 113 post-dose **Description:** The Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) relies on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The investigator (or qualified site personnel) scored the erythema, pustules, and scaling of all GPP lesions from 0 to 4. A lower GPPGA pustulation subscore indicates a better outcome. A GPPGA pustulation subscore of 0 means no visible pustules. The proportion of patients who achieved a GPPGA pustulation subscore of 0/1 at Week 1,2,4 is reported. **Measure:** Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) pustulation subscore of 0/1 at Weeks 1,2,4 **Time Frame:** 1, 2 and 4 weeks post-dose **Description:** GPPASI provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 (no disease) to 72 (worse disease state). It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs). **Measure:** Percent change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at weeks 1,2,4 **Time Frame:** Baseline and 1,2,4 weeks post-dose **Description:** GPPGA relied on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The GPPGA total score was calculated by taking the mean of the erythema subscore, pustules subscore and scaling/crusting subscore. The severity of each subscore was assessed using a 5 point scale score ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). A lower GPPGA score indicates a better outcome, with 0 being clear and 1 being almost clear. The proportion of patients with a GPPGA score of 0 or 1 at Week 1,2,4 is reported. **Measure:** Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) score of 0 or 1 at week 1 **Time Frame:** Baseline and 1,2,4 weeks post-dose **Description:** Generalized Pustular Psoriasis Area and Severity Index (GPPASI) provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs). A higher score indicates a worse disease state, while a score of 0 indicates no disease. **Measure:** Change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at week 1,2,4. **Time Frame:** Baseline and 1,2,4 weeks post-dose **Description:** PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in moderate to severe psoriasis patients. The symptoms included are: pain, redness, itching, and burning. The symptom severity was assessed using a 5 point scale ranging from 0 to 4 where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The symptom scores are added to an unweighted total score (range: 0 to 16). A lower PSS score indicates a better outcome. **Measure:** Change from baseline in psoriasis symptom scale (PSS) score at week 1,2,4 **Time Frame:** Baseline and 1,2,4 weeks post-dose **Description:** PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in moderate to severe psoriasis patients. The symptoms included are: pain, redness, itching, and burning. The symptom severity was assessed using a 5 point scale ranging from 0 to 4 where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. **Measure:** Proportion of patients with psoriasis symptom scale (PSS) score of 0 at week 1,2,4. **Time Frame:** 1,2,4 weeks post-dose **Description:** The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement. **Measure:** Change from baseline in dermatology life quality index (DLQI) score at weeks 1,2,4 **Time Frame:** Baseline and 1,2,4 weeks post-dose. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults aged between 18 and 75 years (inclusive)，both male and female； * A known and documented history of Generalized Pustular Psoriasis diagnosed with European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria in 2017； * Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP) * Body mass index (BMI) within 18\~36 kg/m2； * Major organ function is good; * Patients must be able to understand and sign a written informed consent document; * Patients must be able to complete study-related procedures and questionnaires; * Female and male subjects of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Female subjects need to serum pregnancy pregnancy test within 7 days before study enrollment. Exclusion Criteria: * Patients with primary plaque psoriasis vulgaris with pustules that are restricted to psoriatic plaques； * Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator； * Computed Tomography of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. Subjects positive for tuber closes spot(T-SPOT) (or other tuberculosis diagnostic test) result; * Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg)； * History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening during screening； * Positive antibodies to treponema pallidum during screening； * History of serious infection leading to hospitalization or intravenous infusion of antibiotics or antiviral therapy within 3 months prior to baseline; * Active systemic infections requiring systemic antibiotics or systemic antiviral therapy within 4 weeks prior to baseline; * History of opportunistic infection and parasitic infection within 6 months prior to the screening period； * History of herpes zoster infection within 2 months prior to baseline； * Subject has known or suspected autoimmune disease; * Receive major surgery within 4 weeks prior to the first dose; * Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period; * Subjects have history of significant drug allergies； * Use of the following medications within the prescribed time: 1. Receive topical drugs for the treatment of skin diseases within 1 weeks prior to baseline; 2. Receive systemic therapy within 4 weeks prior to baseline; 3. Receive regular phototherapy within 4 weeks prior to baseline; 4. Within 12 weeks prior to baseline, receive live (attenuated) vaccine; 5. Receive antibiotics and antivirals within 4 weeks prior to baseline. * People who are alcoholic, drug addicts, and known drug dependents; * Pregnant or Breasting feeding subject; * Received a blood transfusion within 4 weeks prior to the first dose; * Subject is unable to tolerate intravenous infusion administration; * During the period of participation in this study, participants had planned surgical procedures; * Have participated in clinical trials of other drugs or medical devices within 4 weeks prior to baseline; * In the judgment of the investigator or sponsoring medical auditor, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drlihang@126.com **Name:** Hang Li, Doctor **Phone:** 13693058190 **Role:** CONTACT **Contact 2:** **Email:** zxyjk@126.com **Name:** Xia Zhao, Master **Phone:** 13621020878 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** drlihang@126.com - **Name:** Hang Li, Doctor - **Phone:** 13693058190 - **Role:** CONTACT **Country:** China **Facility:** Peking University First Hospital **State:** Beijing **Zip:** 100871 **Location 2:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** yangbin101@hotmail.com - **Name:** Bin Yang, Doctor - **Phone:** 13922207231 - **Role:** CONTACT **Country:** China **Facility:** Dermatology Hospital of Southern Medical Universitye **State:** Guangdong **Zip:** 510091 **Location 3:** **City:** Shijiazhuang **Contacts:** ***Contact 1:*** - **Email:** zgq810328@sina.com - **Name:** Guoqiang Zhang, Doctor - **Phone:** 18633888122 - **Role:** CONTACT **Country:** China **Facility:** The First Hospital of Hebei Medical University **State:** Hebei **Zip:** 050000 **Location 4:** **City:** Shijiazhuang **Contacts:** ***Contact 1:*** - **Email:** lyldoctor@sina.com - **Name:** Yanling Li, Doctor - **Phone:** 15803212590 - **Role:** CONTACT **Country:** China **Facility:** The Second Hospital of Hebei Medical University **State:** Hebei **Zip:** 050000 **Location 5:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Email:** gaobarry@hotmail.com - **Name:** Xinghua Gao, Doctor - **Phone:** 13940152467 - **Role:** CONTACT **Country:** China **Facility:** The First Hospital of China Medical University **State:** Liaoning **Zip:** 110000 **Location 6:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Email:** boyct1217@163.com - **Name:** Tao Chen, Doctor - **Phone:** 13980427003 - **Role:** CONTACT **Country:** China **Facility:** Second People's Hospital of Chengdu **State:** Sichuan **Zip:** 610052 **Location 7:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** manxy@zju.edu.cn - **Name:** Xiaoyong Man, Doctor - **Phone:** 13600516219 - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital Zhejiang University School of Medicine **State:** Zhejiang **Zip:** 310000 ## 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 - Abbrev: Rare - Name: Rare Diseases ### 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 - ID: T4835 - Name: Pustular Psoriasis - Relevance: HIGH - As Found: Pustular Psoriasis - ID: T2462 - Name: Generalized Pustular Psoriasis - Relevance: HIGH - As Found: Generalized Pustular Psoriasis ### Condition Browse Module - Meshes - ID: D000011565 - Term: Psoriasis ### 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: M4230 - Name: Antibodies, Monoclonal - 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:** NCT06433518 **Acronym:** BEST **Brief Title:** BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study) **Official Title:** What Should Be The Optimal Ovulation Triggering Size in Poseidon Group 4 Patients Undergoing Ovarian Stimulation? #### Organization Study ID Info **ID:** 2024-3-1 #### Organization **Class:** OTHER **Full Name:** Centrum Clinic IVF Center ### Status Module #### Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centrum Clinic IVF Center #### Responsible Party **Investigator Affiliation:** Centrum Clinic IVF Center **Investigator Full Name:** Emre Göksan Pabuçcu **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This observational clinical study aims to determine the optimal timing of ovulation triggering in women aged 35 and above with poor ovarian reserve. For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups: 1. \*\*Experimental Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm. 2. \*\*Control Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm. All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections. The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates. Primary and secondary outcomes will be compared between the two groups. **Detailed Description:** The timing of final oocyte maturation in assisted reproductive techniques is critically important. If serum steroid hormone levels are appropriate during the late follicular phase, ovulation triggering can be performed using various agents. There are numerous comparative studies in the literature on this topic. However, a key issue is determining the most optimal timing for this trigger. In standard practice, the final triggering is performed when the follicle size reaches 17 mm or more. The purpose of this is to obtain mature eggs from these follicles during the oocyte aspiration process. However, in some special cases, to maximize the desired yield, this size threshold may be adjusted. A prime example of this is in older patients with poor ovarian reserve, as the expected egg yield may not be achieved with standard practices. During the oocyte collection process, fewer mature oocytes (M2) may be retrieved, or no oocytes may be retrieved at all, despite proper ovarian stimulation. Therefore, the optimal follicle size for these cases has not been definitively established in the literature. Thus, there is a need to determine other follicular thresholds specifically for older women with poor ovarian reserves to enhance egg and mature egg yields. For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups: 1. \*\*Experimental Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm. 2. \*\*Control Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm. All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections. The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates. Primary and secondary outcomes will be compared between the two groups. ### Conditions Module **Conditions:** - Fertilization - Fertilization in Vitro **Keywords:** - oocyte - IVF - poor responder - ovarian stimulation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Arms Interventions Module #### Arm Group 1 **Description:** This group of women, who have low serum AMH levels and low antral follicle count obviusly reveal unfavorable ovarian stimulation and reproductive outcomes in daily practice. Since the most important outcome measure is the live birth rate in assisted reproduction, rates have been reportedly very low for this cohort. Depending from the reports, live birth rates particularly cumulative rates directly correlated with collected numbers of oocytes. Therefore, studies should focus on this entity. **Intervention Names:** - Drug: recombinant hCG **Label:** Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF ### Interventions #### Intervention 1 **Arm Group Labels:** - Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF **Description:** Experimental Group: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm. Control Group: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm. All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections. The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates. Primary and secondary outcomes will be compared between the two groups. **Name:** recombinant hCG **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Mean numbers of oocytes, mature oocytes, fertilization rates, embryos and pregnancy rates will be compared between two different triggering sizes. **Measure:** Change in the Mean Mature Oocytes between two triggering strategies **Time Frame:** From enrollment to the end of treatment at 6-8 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Women age \&gt;35 years Women with low serum AMH (\&lt;1,2 ng/ml), low AFC (\&lt;5) Undergoing assisted reproduction with Short antagonist protocol Max daily gonadotropin dose of 300 IU Exclusion Criteria: * women with uterine and/or endometrial abnormality, women with endometrioma(s), short or long GnRH-agonist ovarian stimulation protocols, severe male infertiliy, genetic conditions, with normal ovarian reserve markers, \&lt;35 years old, women with prior ovarian surgeries, PGT-a cycles **Gender Based:** True **Gender Description:** Women with diminished ovarian reserve undergoing assisted reproduction. **Maximum Age:** 44 Years **Minimum Age:** 35 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** A group of women defined as Poseidon Group 4, who will apply to the infertility clinic to be scheduled for ovarian stimulation and assisted conception treatments during the study period. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** emregpabuccu@gmail.com **Name:** Emre G Pabuccu, Professor **Phone:** +90 532 4147844 **Role:** CONTACT **Contact 2:** **Email:** pabuccu@hotmail.com **Name:** Recai Pabuccu, Professor **Phone:** +90 532 6160086 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Ufuk University **Name:** Emre Pabuccu, Prof. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19618 - Name: Triptorelin Pamoate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433505 **Brief Title:** A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants **Official Title:** A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants #### Organization Study ID Info **ID:** CA071-1005 #### Organization **Class:** INDUSTRY **Full Name:** Celgene ### Status Module #### Completion Date **Date:** 2024-09-23 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### 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 objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365. ### Conditions Module **Conditions:** - Healthy Volunteers **Keywords:** - BMS-986365 - Pharmacokinetics - Absolute Bioavailability - Healthy Male Volunteers - CC-94676 - ADME ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BMS-986365 - Drug: [14C] BMS-986365 **Label:** Part A **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: [14C] BMS-986409 + BMS-986410 **Label:** Part B - Arm 1 **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: [14C] BMS-986410 + BMS-986409 **Label:** Part B - Arm 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part A **Description:** Specified dose on specified days **Name:** BMS-986365 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part A **Description:** Specified dose on specified days. **Name:** [14C] BMS-986365 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Part B - Arm 1 **Description:** Specified dose on specified days **Name:** [14C] BMS-986409 + BMS-986410 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Part B - Arm 2 **Description:** Specified dose on specified days **Name:** [14C] BMS-986410 + BMS-986409 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Part A and B **Measure:** Maximum observed concentration (Cmax) **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Time of maximum observed concentration (Tmax) **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF)) **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Apparent terminal plasma half-life (T-HALF) **Time Frame:** Up to Day 60 **Description:** Part A **Measure:** Total body clearance (CLT) **Time Frame:** Up to Day 15 **Description:** Part A and B **Measure:** Apparent total body clearance (CLT/F) **Time Frame:** Up to Day 60 **Description:** Part A **Measure:** Mean residence time (MRT) **Time Frame:** Up to Day 15 **Description:** Part A **Measure:** Apparent volume of distribution (Vz) **Time Frame:** Up to Day 15 **Description:** Part A and B **Measure:** Apparent volume of distribution (Vz/F) **Time Frame:** Up to Day 60 **Description:** Part A **Measure:** Absolute bioavailability (F) **Time Frame:** Up to Day 15 #### Secondary Outcomes **Description:** Part A and B **Measure:** Number of participants with Adverse Events **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Number of participants with Serious Adverse Events **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Number of participants with AEs leading to discontinuation **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Number of participants with Vital sign abnormalities **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Number of participants with electrocardiogram (ECG) abnormalities **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Number of participants with physical examination abnormalities **Time Frame:** Up to Day 60 **Description:** Part A and B **Measure:** Number of participants with clinical laboratory abnormalities **Time Frame:** Up to Day 60 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator * Participants will require a left ventricular ejection fraction of \> 50% at screening. * Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2. Exclusion Criteria: * Any current or recent significant acute or chronic illness. * Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\> 450 ms) at screening. * Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary. * History of allergy to BMS-986365 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 the NCT# and Site #. **Role:** CONTACT #### Locations **Location 1:** **City:** Madison **Contacts:** ***Contact 1:*** - **Name:** Site 0001 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0001 **State:** Wisconsin **Zip:** 53704 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### 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 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433492 **Brief Title:** Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint. **Official Title:** Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Liposomes in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint. #### Organization Study ID Info **ID:** 2.0 06.10.2020 #### Organization **Class:** INDUSTRY **Full Name:** Biovico Sp. z o.o. ### Status Module #### Completion Date **Date:** 2022-12-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-12-21 **Type:** ACTUAL #### Start Date **Date:** 2020-12-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Biovico Sp. z o.o. #### 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 main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms. ### Conditions Module **Conditions:** - Osteoarthritis, Knee ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 50 patients age 38-70 with OA confirmed by ACR criteria and radiologically verified OA (Kellgren-Lawrence grade 2 or 3) suffering from knee joint pain for at least 3 months and VAS pain score minimum 4 in one knee, and \< 2 in the contralateral knee were subjected to the administration of Lipotris™. The product was administered as a course of three injections weekly. **Intervention Names:** - Device: Intra-articular injection **Label:** Study group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Study group **Description:** Three doses of intra-articular injection administered in weekely intervals. **Name:** Intra-articular injection **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The visual analog scale (VAS) measures the severity of pain. The patient assesses the level of pain by marking a point on a line 10 cm long, where a value of 0 is assigned the complete absence of pain, and a value of 10 is assigned the most severe pain the patient can imagine. **Measure:** The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment. **Time Frame:** 3 months #### Secondary Outcomes **Description:** The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment. **Measure:** The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment **Time Frame:** baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment **Description:** The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items.The patient assesses his condition using a scale by marking one of 5 options (scoring 0 - 4, where 0 - no complaints, 1 - mild, 2 - moderate, 3 - severe, 4 - extreme). The scores for each subscale are summed up to give a total subscale score, with higher scores indicating greater severity of symptoms. **Measure:** The score of WOMAC at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment **Time Frame:** baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment **Description:** The TUG test measures the time it takes for a person to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down. **Measure:** Functional status of knee joint according to time to perform the The Timed Up and Go Test. **Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment **Description:** To perform "The Five Time Sit to Stand Test" (FTSST, 5xSTS), patient was asked to take a sitting position on a standard 45 cm high chair with arms crossed over the chest. At the command "START," the patient must stand up as quickly as possible five times and completely straighten up and sit back in the chair without supporting himself with his arms. **Measure:** Functional status of knee joint according to time to perform the Five Time Sit to Stand Test. **Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment **Description:** The 10 Meter Walk Test (10MWT) is a clinical assessment tool used to evaluate a patient's walking speed and mobility. The test involves measuring the time it takes for a patient to walk 10 meters (33 feet) at normal, self-selected pace. **Measure:** Functional status of knee joint according to time to perform the to 10 Meter Walk Test. **Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment **Description:** Maximal voluntary isometric contraction (MVIC) of extensor/flexor muscles of knee joint measurement was performed with Forcemeter FB 500 (AXIS, Gdansk, Poland). To measure the maximum isometric force of the knee joint extensors/flexors, a person sits on a bench with the belt around waist and legs placed freely beyond the table. The measuring belt is placed parallel to the floor just above the ankle joint with knee flexed to 90 degrees. The length of the measuring belt is specified 160 cm for extensors and 60 cm for flexors. The procedure starts with the measuring belt pretension, then the patient is asked to extend/flex the knee as hard as patient can and hold it for 6 s. **Measure:** Maximum isometric force of flexor muscles of knee joint. **Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment **Measure:** Maximum isometric force of extensor muscles of the knee joint. **Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment **Description:** Number of patients with adverse events -type, duration and severity of every adverse event for each patient will be reported **Measure:** Safety assesment **Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 38 and 70 years, * OA diagnosed by the American College of Rheumatology (ACR) criteria, * OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale), * Pain in the knee joint for at least 3 months, * Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee. Exclusion Criteria: * Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment, * Present joint infection, * Previous knee arthroscopy up to 1 year prior to examination, * Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.), * Total arthroplasty and osteotomy, * Ankylosis of the study joint, * Dermatitis or dermatological disease at the intended injection site, * Known hypersensitivity to the components of the preparation, * Coexistence of the degenerative changes in other limb joints (hip, foot), * Cancer, * Oral corticosteroid therapy, * Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs), * Pregnancy or breast-feeding. * History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease. * Participation in other clinical trials. **Maximum Age:** 70 Years **Minimum Age:** 38 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Poznań **Country:** Poland **Facility:** Rehasport **Zip:** 60-201 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthrosis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Osteoarthritis, Knee - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown - ID: T404 - Name: Lecithin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433479 **Acronym:** DARE-AF **Brief Title:** Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation **Official Title:** Efficacy of DApagliflozin on REcurrence After Catheter Ablation for Atrial Fibrillation #### Organization Study ID Info **ID:** 2024-4-20610 #### Organization **Class:** OTHER **Full Name:** Beijing Anzhen Hospital ### Status Module #### Completion Date **Date:** 2026-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Anzhen Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a single-center, parallel-group, randomized, open-label trial evaluating the effect of 3-month treatment with dapagliflozin 10mg once daily on the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation in patients without diabetes, heart failure, or chronic kidney disease. **Detailed Description:** Atrial fibrillation (AF) is one of the most common arrhythmias. Catheter ablation of atrial fibrillation, as the main means of rhythm control, can effectively maintain sinus rhythm, reduce the recurrence of AF burden, and improve the patient's quality of life and prognosis. However, AF recurrence still occurs in 30-50% of patients after atrial fibrillation catheter ablation, and there is currently no effective strategy to reduce the recurrence rate after atrial fibrillation ablation. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. Several studies demonstrated that SGLT2i might reduce AF/atrial flutter events among patients with diabetes. Our cohort study and meta-analysis demonstrated a lower risk of AF recurrence with the use of SGLT2i among patients with diabetes after AF ablation. However, the beneficial effects of SGLT2i in patients after AF catheter ablation without current indications for SGLT2i were uncertain. In this study, we aim to evaluate the effect of dapagliflozin on AF burden. Patients with persistent AF undergoing initial catheter ablation without diabetes at high cardiovascular risk, heart failure, or chronic kidney disease will be enrolled. Patients will be randomly assigned to either the dapagliflozin group (10mg/d) for 3 months or the control group stratified according to body mass index (\<24, ≥24kg/m2) or left atrial diameter (\<45，≥45mm). The primary outcome is atrial fibrillation burden calculated as the percentage of of all atrial arrhythmia episodes detected by 7-day single-lead ECG patches at 3 months after ablation. Quality of life and echocardiography changes of left atrial structure will also be evaluated at 3 months. Our central hypothesis is that SGLT2i will reduce the AF burden after catheter ablation. ### Conditions Module **Conditions:** - Atrial Fibrillation **Keywords:** - Catheter ablation - Atrial fibrillation - Recurrence - Dapagliflozin - AF Burden ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation **Intervention Names:** - Drug: Dapagliflozin 10 mg per day for 3 months after initial catheter ablation **Label:** Dapagliflozin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No intervention **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Dapagliflozin **Description:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation **Name:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 3 months after ablation. **Measure:** Atrial fibrillation burden at 3 months after ablation **Time Frame:** 3 months #### Secondary Outcomes **Description:** Atrial fibrillation recurrence is defined as the recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by 7-day single-lead ECG patches at 3 months after ablation. **Measure:** Atrial fibrillation recurrence at 3 months after ablation **Time Frame:** 3 months **Description:** Changes of quality of life from baseline to 3 months after ablation evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. **Measure:** Changes of quality of life at 3 months **Time Frame:** 3 months **Description:** Changes in the echocardiography parameter of anteroposterior atrial diameter from baseline to 3 months after ablation. **Measure:** Echocardiography changes of left atrial structure at 3 months **Time Frame:** 3 months **Description:** Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 1 year after ablation. **Measure:** Atrial fibrillation burden at 1 year after ablation **Time Frame:** 1 year **Description:** Atrial fibrillation recurrence is defined as the first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by ECG during 1 year after ablation. In-person or telephonic follow-up visits will be scheduled at 3-, 6-, and 12-month post-procedure. At each time of follow-up, the following data will be collected: (1)7-day single-lead patch ECG and (2) symptom-triggered ECG since the last follow-up. **Measure:** Atrial fibrillation recurrence during 1 year after ablation **Time Frame:** 1 year **Description:** The composite endpoint of cardiovascular death or cardiovascular hospitalization during 1-year follow-up. **Measure:** Cardiovascular outcomes during 1-year follow-up **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age between 18-80 years diagnosed with atrial fibrillation based on ECG or Holter 2. persistent atrial fibrillation 3. prepare to undergo initial catheter ablation for atrial fibrillation 4. agree to enrollment, randomization, treatment, and follow-up Exclusion Criteria: 1. diagnosed with persistent atrial fibrillation longer than 5 years or left atrial anterior-posterior diameter ≥ 50mm 2. diagnosed with atrial fibrillation secondary to reversible causes (such as hyperthyroidism, acute infection, etc.) 3. severe structural heart disease (hypertrophic cardiomyopathy, rheumatic heart disease, dilated cardiomyopathy, etc.) 4. currently take sodium-glucose co-transporter 2 inhibitors 5. complicated with the following Class I indications for sodium-glucose co-transporter 2 inhibitors: i. patients with type 2 diabetes with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD ii. patients with a history of heart failure (HF), including HF with reduced ejection fraction, mildly reduced ejection fraction, and preserved ejection fraction iii. patients with chronic kidney disease with eGFR=20-60 ml/min/1.73m2 6. complicated with the following contraindication of sodium-glucose co-transporter 2 inhibitors: i. with previous allergic reactions to dapagliflozin ii. with end-stage renal failure or dialysis 7. type 1 diabetes, or previous diabetic ketoacidosis 8. severe hypoglycemia or genitourinary infection in the past 12 months 9. hypovolemia or hypotension 10. currently enrolled in another clinical study. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** superj@zju.edu.cn **Name:** Chao Jiang, MD **Phone:** +86 (010) 84005361 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** superj@zju.edu.cn - **Name:** Chao Jiang - **Phone:** 86+15001251357 - **Role:** CONTACT ***Contact 2:*** - **Name:** Zixu Zhao - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Zejun Yang - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Beijing Anzhen Hospital **State:** Beijing **Zip:** 100029 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes ### 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: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation - ID: D000012008 - Term: Recurrence ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M348449 - Name: Dapagliflozin - Relevance: HIGH - As Found: COPD - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000529054 - Term: Dapagliflozin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433466 **Brief Title:** Influencer Marketing: a Survey-based Experiment **Official Title:** The Impact of Instagram and TikTok Influencer Marketing on Perceptions of E-cigarettes in Young Adults: a Survey-based Experiment #### Organization Study ID Info **ID:** unidentified #### Organization **Class:** OTHER **Full Name:** University of Southern California ### Status Module #### Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Southern California #### Responsible Party **Investigator Affiliation:** University of Southern California **Investigator Full Name:** Jennifer Unger **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Young adults (N = 1,500) will participate in the online survey-based experiment. They will be randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group), or a healthy lifestyle activity alone (control). After watching each video, participants will rate perceptions of influencer credibility (i.e., honesty, trustworthiness, knowledge, attractiveness, intelligence, and popularity) on the scale of 0 (e.g., dishonest) to 100 (honest). Among all participants, harm perceptions of e-cigarettes will be assessed. Susceptibility to use e-cigarettes will be assessed among never users. These outcomes will then be compared among participants who perceived influencers as credible and those who perceived influencers as non-credible. **Detailed Description:** Young adults (18-24 years of age) living in California were recruited by YouGov marketing research panel to participate in a survey on tobacco-related attitudes and behaviors. YouGov, a research panel agency, has been used in prior research to survey young adults about their tobacco-related attitudes and behaviors. Respondents (N=1,500) were matched to a sampling frame based on gender, age, race, and education. The sampling frame was a politically representative modeled frame of United States (U.S.) adults based on the American Community Survey. The matched cases were weighted to the sampling frame using a propensity score matching procedure. Participants were provided with a survey URL link. After completing informed consent, participants completed the survey online. The study was approved by the University of Southern California Institutional Review Board (UP-21-00135). Respondents were randomly assigned to watch 10 10-second long TikTok videos in either experimental (influencers promoting e-cigarettes alongside healthy lifestyle activities ) or control group (influencers showing healthy lifestyle activity alone). ### Conditions Module **Conditions:** - Vaping ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 1500 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Young adults were randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group). **Intervention Names:** - Other: Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities **Label:** Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Young adults were randomly shown 10 videos, featuring influencers promoting healthy lifestyle activity alone (control). **Intervention Names:** - Other: Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities **Label:** Videos featuring influencers showing healthy lifestyle activities **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities - Videos featuring influencers showing healthy lifestyle activities **Description:** Young adults were randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group), or a healthy lifestyle activity alone (control). **Name:** Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Responses to the question, "Do you think vaping e-cigarettes is harmful to your health?" were measured on a Likert scale, ranging from "definitely yes" (1), "probably yes" (2), to "probably not (3)," "definitely not (4)." The measure represents one validated item from the Population Assessment of Tobacco and Health (PATH). **Measure:** harm perceptions of e-cigarettes **Time Frame:** one-time assessment after the experimental exposure (immediately post-treatment) **Description:** Susceptibility to use e-cigarettes was measured (among never-users of e-cigarettes), using the validated three-item scale adapted from PATH, and combined into one variable (α=0.93). Consistent with prior research, the measure was dichotomized with responses "definitely not" to all items being coded as "not susceptible" and responses "probably not," "probably yes", or "definitely yes" being coded as "susceptible." **Measure:** Susceptibility to use e-cigarettes **Time Frame:** one-time assessment after the experimental exposure (immediately post-treatment) **Description:** Perceptions of influencer credibility (i.e., honesty, trustworthiness, knowledge, intelligence, attractiveness, and popularity) were assessed using a 0 (e.g., dishonest) -100 (e.g., honest) scale that has been validated in prior research. **Measure:** Perceptions of influencer credibility **Time Frame:** assessed 10 times after each video (during treatment, immediately after each video) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-24 years of age, * English fluency, * Current California resident. The survey was sampled to be representative by age group (18 to 24) and gender, and was weighted to be representative by age, gender, race, and educational attainment using propensity score weighting. Exclusion Criteria: Not meeting these criteria: * 18-24 years of age, * English fluency, * Current California resident. **Maximum Age:** 24 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** YouGov, online **State:** California **Zip:** 94102 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433453 **Brief Title:** Three Dimensional Ultrasonographic Detection of Human Ovulation **Official Title:** Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation #### Organization Study ID Info **ID:** Bio 2757 #### Organization **Class:** OTHER **Full Name:** University of Saskatchewan ### Status Module #### Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Saskatchewan #### Responsible Party **Investigator Affiliation:** University of Saskatchewan **Investigator Full Name:** Angela Baerwald **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:** The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography. **Detailed Description:** Thirty healthy participants will be enrolled. When their dominant ovarian follicle has a diameter of 16 mm or more, an anti-prostaglandin medication, indomethacin 30 mg, will be administered three times daily for 1-7 days. Anti-prostaglandins are known to cause anovulation. Daily 2D and 3D ultrasound scans, and urine and finger prick blood tests for reproductive hormonal assays will be performed. The medication will be discontinued once ultrasound features of anovulation are observed. These study procedures will also be carried out on days 1, 3 and 7 after anovulation. A second cohort of 30 participants who had 2D and 3D ultrasound scans and hormonal assays in a natural cycle in a previous study (Bio 2080; NCT05531357) will also be evaluated. These two groups represent the anovulatory and ovulatory groups, respectively, and their 2D and 3D ultrasound features will be compared. With 2D ultrasonography as a gold standard, the study aims to determine if 3D ultrasonography improves ovulation assessment and improves the recognition of anovulatory follicles in infertility treatment ### Conditions Module **Conditions:** - Ovulation Disorder **Keywords:** - ovulation - 3D ultrasonography ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed. **Intervention Names:** - Drug: Indomethacin 50 MG - Procedure: Transvaginal ultrasound scans - Diagnostic Test: Finger prick blood test - Diagnostic Test: Urine test **Label:** Indomethacin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Indomethacin **Description:** The medication is commenced when a preovulatory follicle is observed. It will be administered for a minimum of one day, up to a maximum of 7 days. It will be discontinued when anovulation is observed. **Name:** Indomethacin 50 MG **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Indomethacin **Description:** Ultrasound scans done intermittently before and after an ovulatory or anovulatory event **Name:** Transvaginal ultrasound scans **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Indomethacin **Description:** Capillary blood extracted from a finger prick. Blood spots are collected on a specialized card, dried and frozen before reproductive hormones are assayed from them. **Name:** Finger prick blood test **Other Names:** - Dried blood spots **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Indomethacin **Description:** Early morning urine tests to assay reproductive hormones **Name:** Urine test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Daily ultrasound scans to demonstrate the disappearance of a preovulatory follicle and replacement with a corpus luteum **Measure:** Daily measures of follicle diameters in each ovary (mm) **Time Frame:** 8-16 days **Description:** Daily ultrasound scans to demonstrate the preovulatory follicle transforming into a corpus luteum vs anovulatory follicle **Measure:** Presence of corpus luteum (Y/N) **Time Frame:** 8-16 days **Description:** FSH assay from dried blood spots and urine samples **Measure:** Follicle stimulating hormone (FSH) level **Time Frame:** 8-16 days **Description:** LH assay from dried blood spots and urine samples **Measure:** Luteinizing hormone (LH) level **Time Frame:** 8-16 days **Description:** Estradiol assay from dried blood spots and urine samples **Measure:** Estradiol level **Time Frame:** 8-16 days **Description:** Progesterone assay from dried blood spots and urine samples **Measure:** Progesterone level **Time Frame:** 8-16 days #### Secondary Outcomes **Description:** A point system based on changes in follicle size, antrum size, follicle wall thickness, follicular vascularity, visualization of a rupture site, presence of irregular wall-antral borders, presence of internal echoes, visualization of a cumulus-oocyte complex, rise in serum LH, and rise in serum progesterone. **Measure:** Ovulation score **Time Frame:** 1 day **Description:** Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure. **Measure:** Endometrial thickness **Time Frame:** 8-16 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy biological females * Regular menstrual cycles (21-35 days) Exclusion Criteria: * BMI \<18 or \>30 * Pregnancy * Breastfeeding mothers * History of infertility * History of hysterectomy or oophorectomy * Reproductive health issues that can interfere with study outcomes * Smoking * Not on any hormonal medication that affects reproduction (including hormonal contraception) * History of metabolic syndrome or untreated thyroid disease * Contra-indication to non-steroidal anti-inflammatory drug (NSAID) use. These include: * Gastric ulcers or gastro-intestinal bleeding * History of myocardial infarction or a coronary artery bypass * Cerebrovascular disease * Hypertension * Chronic or acute renal failure * Severe liver disease * Nasal polyp syndrome **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** angela.baerwald@usask.ca **Name:** Angela R Baerwald, PhD,MD,CCFP **Phone:** 306-555-4200 **Role:** CONTACT **Contact 2:** **Email:** nike.bello@usask.ca **Name:** Folasade A Bello, MBBS, FWACS **Role:** CONTACT #### Locations **Location 1:** **City:** Saskatoon **Contacts:** ***Contact 1:*** - **Email:** nike.bello@usask.ca - **Name:** Nike Bello, PhD Candidate - **Role:** CONTACT ***Contact 2:*** - **Email:** angela.baerwald@usask.ca - **Name:** Angela Baerwald, PhD MD - **Role:** CONTACT ***Contact 3:*** - **Name:** Angela R Baerwald, PhD CCRP - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Nike Bello, MD MBBS MPH - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Roger PIERSON, PHD - **Role:** SUB_INVESTIGATOR **Country:** Canada **Facility:** Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan **State:** Saskatchewan **Status:** RECRUITING **Zip:** S7N0W8 #### Overall Officials **Official 1:** **Affiliation:** University of Saskatchewan **Name:** Angela R Baerwald, PhD,MD,CCFP **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4184 - Name: Anovulation - Relevance: LOW - As Found: Unknown ### 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: D000006074 - Term: Gout Suppressants - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10257 - Name: Indomethacin - Relevance: HIGH - As Found: Predicting - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - 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: M17869 - Name: Tocolytic Agents - 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 ### Intervention Browse Module - Meshes - ID: D000007213 - Term: Indomethacin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433440 **Brief Title:** Safety and Immunogenicity of Purified Verocell Rabies Vaccine PVRV Administered Intramuscularly and Intradermally **Official Title:** An Open-label, Randomized Study Evaluating the Safety and Immunogenicity of the Purified Vero Cell Rabies Vaccine PVRV Administered Intradermally and Intramuscularly as Post-exposure Prophylaxis #### Organization Study ID Info **ID:** PVRV-ID #### Organization **Class:** OTHER **Full Name:** University of Peshawar ### Status Module #### Completion Date **Date:** 2021-08-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-08-30 **Type:** ACTUAL #### Start Date **Date:** 2020-07-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Hayatabad Medical Complex #### Lead Sponsor **Class:** OTHER **Name:** University of Peshawar #### Responsible Party **Investigator Affiliation:** University of Peshawar **Investigator Full Name:** Mohammad Ismail **Investigator Title:** Dr. Mohammad Ismail Associate Professor of Clinical Pharmacy **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:** Rabies is fatal disease but preventable with rabies vaccines and immunoglobulins, conventionally involves intramuscular (IM) administration of the vaccine. However, switching the intradermal (ID) route offers potential advantages in dosing, time and cost without compromising efficacy and safety. Therefore, this study aims to compare the safety and immunogenicity of a short-term three-doses intradermal regimen (3D-ID) with a conventional five-doses intramuscular regimen (5D-IM) of the purified Vero cell rabies vaccine (PVRV), administered via both intramuscular (IM) and intradermal (ID) routes as post-exposure prophylaxis (PEP). **Detailed Description:** Rabies vaccines can be used ID for PEP, according to a WHO Expert Committee recommendation. The administration of short-term PEP through ID (3-doses) offers a safe, immunogenic, dose-sparing, and cost-effective alternative to the conventional protocol (IM, 5-dose regimen) while reducing the volume by up to 60 to 80% and vaccination schedules by 3 weeks. This strategy has the potential to reduce the overall requirement and cost of such vaccines, along with minimizing the burden on healthcare professionals and facilities. Furthermore, this strategy is more likely to improve vaccination compliance compared to conventional protocol, and will certainly improve treatment outcomes. ### Conditions Module **Conditions:** - Rabies ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 0.2 ml of PVRV Intradermally (ID) on the following days: Day0, Day3, and Day7 Biological: PVRV PEP regimen **Intervention Names:** - Biological: PVRV **Label:** Group-1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 0.5 ml of PVRV Intramuscularly (IM) on the following days: Day0, Day3, and Day7, Day14 and Day28 Biological: PVRV PEP regimen **Intervention Names:** - Biological: PVRV **Label:** Group-2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group-1 - Group-2 **Description:** Group-1 will receive PVRV ID on on the following days: Day0, Day3, Day7, while group-2 will receive PVRV IM on Day0, Day3, Day7, Day14, and Day28. **Name:** PVRV **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Patients were assigned into two groups each consisting of n=50 patients: Group-1 and Group-2. Group-1 were administered PVRV intradermally in a dose of 0.2ml on day 0, day 3, and day 7 as post exposure prophylaxis. While, patients in the group-2 received PVRV intramuscularly in a dose of 0.5ml on day 0, day 3, day 7, day 14 and day 28. Efficacy of PVRV in both groups were measured by the presence of rabies virus neutralizing antibodies (RVNA). Patients with an RVNA titer of ≥ 0.5 IU/mL were considered immunized. **Measure:** To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response. **Time Frame:** 56 days #### Secondary Outcomes **Description:** Monitoring of both local and systemic adverse events occurring during the study period The safety of the PVRV was determined by reviewing ADEs obtained during physical examinations following vaccine administration and during follow-up visits in both the groups (group-1 and group-2). The ADEs were recorded after completion of the full vaccination schedule by following-up the patient until day 42. Adverse drug events were characterized in terms of local and systemic effects. A reaction was considered local when it occurred at the site of injection within a few hours of administration, while systemic effects were defined as those occurring in tissues distant from the site of contact between the body and vaccines. **Measure:** To evaluate the safety of PVRV administered intradermally and intramuscularly based on the frequency of adverse drug events **Time Frame:** 42 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants aged 2 year or older * Both male and female * Dog-bite cases only * Informed consent form signed by the individual participant and/or their parents or guardian in case of minor age or major Trauma Exclusion Criteria: * Subject is participating in any other clinical trial. * Pregnant and lactating women * Have a plan to donate blood while participating in the study * Received any other vaccine except rabies vaccines in last 6 months **Maximum Age:** 76 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Peshawar **Country:** Pakistan **Facility:** Mohammad Ismail **State:** KPK **Zip:** 25000 #### Overall Officials **Official 1:** **Affiliation:** Department of Pharmacy, University of Peshawar **Name:** Mohammad Ismail, PhD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Department of Pharmacy University of Peshawar **Name:** Waqar Ali, MPhil **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Will be shared on reasonable request from the PI **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018353 - Term: Rhabdoviridae Infections - ID: D000018701 - Term: Mononegavirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14667 - Name: Rabies - Relevance: HIGH - As Found: Rabies - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M20491 - Name: Rhabdoviridae Infections - Relevance: LOW - As Found: Unknown - ID: M20778 - Name: Mononegavirales Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: T4859 - Name: Rabies - Relevance: HIGH - As Found: Rabies ### Condition Browse Module - Meshes - ID: D000011818 - Term: Rabies ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433427 **Acronym:** FRAMITO **Brief Title:** Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction **Official Title:** Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction #### Organization Study ID Info **ID:** 653/2023/Oss/AOUFe #### Organization **Class:** OTHER **Full Name:** University Hospital of Ferrara ### Status Module #### Completion Date **Date:** 2026-02-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ESTIMATED **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-03-14 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Milano Bicocca #### Lead Sponsor **Class:** OTHER **Name:** University Hospital of Ferrara #### 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 evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. The main questions it aims to answer are: * What is the role of oxidative stress-related mitochondrial dysfunction in frailty, taking into account the interaction with multimorbidity. * What could be the specific biomarkers associated with mitochondrial dysfunction in the assessment of frailty. In order to reach the study goals, we will enroll three categories of older adults: * Non-Frail without Multimorbidity (NFWoM); * Frail with Multimorbidity (FWM); * Frail without Multimorbidity (FWoM). Each individual will undergo an assessment of frailty phenotype and multimorbidity, and the collection of blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). The identification of frailty biomarkers in each group of participants will be performed by combining untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and their subpopulations. Multivariate statistical and machine learning techniques will characterize the three clinical phenotype groups based on molecular data. **Detailed Description:** Study type: observational prospective study. Primary aim: is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity. Primary endpoint: mitochondrial dysfunction in frailty. Secondary aims: to combine untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and PBMC subpopulations (B lymphocytes, T lymphocytes and monocytes). The research activities are organized in the following tasks: * Task 1, Patient Enrollment: We will enroll individuals aged 65 years or older from geriatric outpatient clinics or geriatric wards. For each individual, we will perform an assessment of frailty and multimorbidity, and collect blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). Three categories of individuals will be enrolled: 25 non-frail individuals without multimorbidity (NFWoM), 25 frail individuals with multimorbidity (FWM), and 25 frail individuals without multimorbidity (FWoM). * Task 2, Separation of PBMC Subpopulations: T lymphocytes, B lymphocytes, and monocytes will be separated from frozen PBMCs using the Cell Sorting Facility for Fluorescence-Activated Cell Sorting (FACS) separation and the MoFlo Astrios cell sorter. The analyses on CD45+/CD3+/CD19-/CD14- T lymphocytes, CD45+/CD3-/CD19+/CD14- B lymphocytes, CD45+/CD3-/CD19-/CD14+ monocytes. * Task 3, Mitochondrial Dysfunction Analysis on PBMCs and PBMC Subpopulations: For each individual, mitochondrial dysfunction will be evaluated by analyzing mtDNA damage (by Real-Time PCR), mitochondrial mass alteration (by Mitotracker staining), and intracellular and mitochondrial Reactive Oxygen Species (by DCF and MitoSOX staining). Moreover, we will evaluate alteration of glycolytic and mitochondrial metabolism using Agilent Seahorse Extracellular Flux Analyzer XFe96. * Task 4, Untargeted Metabolomics on PBMCs and PBMC Subpopulations: To assess metabolic signature of PBMCs and subpopulations and highlight metabolic dysregulations linked to frailty, we will perform untargeted LC-MS-based metabolomics on PBMCs, T lymphocytes, B lymphocytes, and monocytes. The analysis on the polar metabolome will allow us to understand better the metabolic alterations associated with mitochondrial dysregulation. * Task 5, Characterization of Biomarkers and Molecular Mechanism of Frailty: The potential biomarkers of frailty and the molecular mechanisms involved in mitochondrial dysfunction will be studied using statistical and machine learning techniques on molecular, metabolic and clinical data. This step will help characterize clinical phenotypes based on molecular measurements. ### Conditions Module **Conditions:** - Aging - Frailty - Mitochondrial Dysfunction - Chronic Disease **Keywords:** - Metabolic dysregulation ### Design Module #### Bio Spec **Description:** The laboratory of Oncology and Molecular Pathology of the University of Milano Bicocca will perform DNA extraction and the mtDNA damage evaluation by Real Time PCR analysis on PBMCs and sorted T and B lymphocytes and monocytes, obtained from each participant. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals aged 65 years or older without frailty and without multimorbidity. This group will serve as a reference for participants who are not frail and do not have multiple chronic conditions. **Label:** Non-Frail without Multimorbidity (NFWoM) #### Arm Group 2 **Description:** Frail individuals aged 65 years or older who have multimorbidity. This group will include participants who exhibit frailty and have two or more chronic diseases. **Label:** Frail with Multimorbidity (FWM) #### Arm Group 3 **Description:** Frail individuals aged 65 years or older without multimorbidity. This group will help assess frailty in the absence of multiple chronic conditions. **Label:** Frail without Multimorbidity (FWoM) ### Outcomes Module #### Primary Outcomes **Description:** mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels. The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases. **Measure:** Difference in the mtDNA copy number between frail individuals with vs without multimorbidity **Time Frame:** Baseline **Description:** mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels. The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases. **Measure:** Difference in the mtDNA copy number between non-frail vs frail individuals without multimorbidity **Time Frame:** Baseline #### Secondary Outcomes **Description:** 500,000 PBMCs obtained from the study participants will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 100 nM Mitotracker Deep Red (Thermo Fisher Scientific) for 30 minutes at 30°C. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry with MoFLO Astrios cell sorter. Mitochondrial mass, evaluated as the median fluorescence intensity (MFI) of Mitotracker Deep Red, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software. **Measure:** Variation in the mean intensity of mitochondrial fluorescence between non-frail vs frail individuals without multimorbidity **Time Frame:** Baseline **Description:** 500,000 PBMCs obtained from the study participants will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 100 nM Mitotracker Deep Red (Thermo Fisher Scientific) for 30 minutes at 30°C. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry with MoFLO Astrios cell sorter. Mitochondrial mass, evaluated as the median fluorescence intensity (MFI) of Mitotracker Deep Red, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software. **Measure:** Variation in the mean intensity of mitochondrial fluorescence between frail individuals with vs without multimorbidity **Time Frame:** Baseline **Description:** The fluorescent cell-permeable indicator 2',7'-dichlorofluorescin diacetate (DCFH-DA) will be used for detecting intracellular ROS. DCFH-DA is deacetylated by cellular esterases to a non-fluorescent compound, which is later oxidised by ROS into fluorescent 2',7'-dichlorofluorescein (DCF). The intensity of the generated fluorescent signal correlates with the intracellular level of ROS. 500,000 PBMCs obtained from 25 NFWoM, 25 FWM and 25 FWoM subjects will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 10 μM 2',7'-dichlorofluorescin diacetate (DCFH-DA) at 37°C for 30 minutes. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry. Intracellular ROS, evaluated as the median fluorescence intensity (MFI) of DCF, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software. **Measure:** Difference of intracellular Reactive Oxygen Species (ROS) between non-frail vs frail individuals without multimorbidity **Time Frame:** Baseline **Description:** The fluorescent cell-permeable indicator 2',7'-dichlorofluorescin diacetate (DCFH-DA) will be used for detecting intracellular ROS. DCFH-DA is deacetylated by cellular esterases to a non-fluorescent compound, which is later oxidised by ROS into fluorescent 2',7'-dichlorofluorescein (DCF). The intensity of the generated fluorescent signal correlates with the intracellular level of ROS. 500,000 PBMCs obtained from 25 NFWoM, 25 FWM and 25 FWoM subjects will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 10 μM 2',7'-dichlorofluorescin diacetate (DCFH-DA) at 37°C for 30 minutes. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry. Intracellular ROS, evaluated as the median fluorescence intensity (MFI) of DCF, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software. **Measure:** Difference of intracellular Reactive Oxygen Species (ROS) between frail individuals with vs without multimorbidity **Time Frame:** Baseline **Description:** Untargeted LC-MS-based metabolomics will be performed on PBMCs and on T and B lymphocytes and monocytes, obtained as described in Task 2. Cell samples will be quenched using cold methanol. After protein precipitation, metabolites will be extracted and analysed by liquid chromatography mass spectrometry (LC-MS). Hydrophilic interaction chromatography (HILIC) will be used to resolve the polar metabolome before MS detection using an Agilent 6546 lc/q-tof instrument (Agilent).The whole protein content will be quantified with NanoDrop™ (Thermofisher) and used to normalize the metabolic profile of each sample. **Measure:** Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between non-frail vs frail individuals without multimorbidity **Time Frame:** Baseline **Description:** Untargeted LC-MS-based metabolomics will be performed on PBMCs and on T and B lymphocytes and monocytes, obtained as described in Task 2. Cell samples will be quenched using cold methanol. After protein precipitation, metabolites will be extracted and analysed by liquid chromatography mass spectrometry (LC-MS). Hydrophilic interaction chromatography (HILIC) will be used to resolve the polar metabolome before MS detection using an Agilent 6546 lc/q-tof instrument (Agilent).The whole protein content will be quantified with NanoDrop™ (Thermofisher) and used to normalize the metabolic profile of each sample. **Measure:** Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between frail individuals with vs without multimorbidity **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 65 years * Stable clinical conditions * Willingness to participate in the study (provision of informed consent) * Proficiency in the Italian language Exclusion Criteria: - Acute or unstable clinical conditions **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** The study will enroll individuals aged 65 years or older. The enrollment will take place among patients accessing geriatric outpatient clinics or being discharged from geriatric wards in clinically stable conditions. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** caterina.trevisan@unife.it **Name:** Caterina Trevisan, PhD **Phone:** 00393896743650 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Università degli Studi di Ferrara **Name:** Caterina Trevisan, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Frailty - ID: M6147 - Name: Chronic Disease - Relevance: HIGH - As Found: Chronic Disease - ID: M23341 - Name: Mitochondrial Diseases - Relevance: HIGH - As Found: Mitochondrial Dysfunction - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000028361 - Term: Mitochondrial Diseases - ID: D000073496 - Term: Frailty - ID: D000002908 - Term: Chronic Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433414 **Acronym:** PAUSE **Brief Title:** PAUSE: Sick Day Medication Management Mobile App Study **Official Title:** Preventing Medication Complications During AcUte Illness Through Symptom Evaluation and Sick Day Guidance Mobile Application (PAUSE) #### Organization Study ID Info **ID:** Pro000140652 #### Organization **Class:** OTHER **Full Name:** University of Alberta ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Calgary #### Lead Sponsor **Class:** OTHER **Name:** University of Alberta #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Diabetes, heart disease and kidney disease have high morbidity and costs of care. Medications used to treat these conditions are effective. Yet, some have the risk of preventable adverse events when people are sick with the flu or stomach bug. These events include low blood sugar and acute kidney injury which can lead to extended hospital stays or death. Sick day medication guidance (SDMG) recommends stopping these medications temporarily when sick and restarted after symptoms subside. Unfortunately, many patients are not aware of these recommendations or find them hard to follow. The investigator's previous research has shown that there is a lack of SDMG education and patient resources. Research on the development, implementation, usability and efficacy of these resources is also limited. In developing a SDMG tool, the investigators surveyed patients who expressed interest in an electronic health (eHealth) tool. As a result, the PAUSE App provides a timely and innovative way to provide continuity of care to patients that is linked to each patients' unique pharmacy record. In the present pilot randomized control trial, the investigators will examine the outcomes of the PAUSE Initiative consisting of the PAUSE App and a SDMG educational handout. Approximately 16 Loblaw/Shoppers Drug Mart pharmacies across Alberta will take part. Patients of these pharmacies who take high-risk medications will be invited to participate. Each pharmacy will be randomized to provide their patients usual care (i.e. SDMG handout) or the intervention (i.e., PAUSE App + handout). Approximately 320 participants (20 per pharmacy) are expected to be recruited. The expected trial length is 9 months from recruitment to analysis. A simulated 'sick day' survey will be used to assess the fidelity and efficacy of the PAUSE Initiative. Feasibility of the study processes (i.e., recruitment, onboarding) will be assessed to inform a full-scale trial. The usability and acceptability of the PAUSE App will also be investigated. Pharmacists and participants will complete questionnaires and qualitative interviews to assess these outcomes. Additionally, PAUSE App user metrics will be collected. All participants will receive an honorarium for their time. **Detailed Description:** Our previous research surveyed healthcare providers from Alberta on "factors affecting clinician's decision to provide sick day medication guidance to patients with diabetes and CKD to prevent adverse events." Our results identified 75% of primary health providers were aware of sick day medication guidance, but just 56% knew where to find guidelines and resources. An overwhelming majority of respondents (97%) were supportive of enrolling patients in a study evaluating alternative innovations for providing sick day medication guidance. In a recent scoping review summarizing existing interventions, our research team found the majority of published SDMG documents were aimed towards healthcare providers, with few patient-targeted documents. These were mainly in the form of handouts, wallet-sized cards, webpages, or telephone support. There is limited primary research on the development, implementation, or evaluation of current SDMG interventions. Most were reported to be challenging to follow and identification of sick days or qualifying medication without error was low. This survey and review highlight the need to develop and to evaluate new solutions for providing SDMG to patients. Our previous work also found that seniors in Canada were receptive to the use of electronic means of communication and several patients have expressed interest in using electronic health (eHealth) tools for sick day self-management. Participants receiving the intervention will receive access to the PAUSE App, a self-management tool for SDMG intended for patients to use during an acute illness. Users' Loblaw/Shoppers Drug Mart pharmacy records are electronically linked to the PAUSE App within the President's Choice (PC) Health app allowing for up-to-date recommendations based on current prescribed medications. The app asks users a series of questions regarding signs and symptoms that identify a qualifying sick day illness, and screens for 'red flags' that would require emergency, or healthcare provider or urgent care referral, and help patients identify which of their medications they should temporarily withhold or adjusted, tailored to a patients' current medication list. This aims to provide patients with interactive support for managing medication during a sick day event. As part of the intervention, patients will also receive a SDMG patient handout. The intervention addresses the previously identified challenges of identifying qualifying signs and symptoms that warrant SDMG and which medications qualify via an interactive and individualized electronic application designed to facilitate provision of SDMG. The usual care group will receive a SDMG patient handout which outlines SDMG and addresses which medications qualify for SDMG. Based on preliminary data, the investigators assume an absolute difference of 30% (50% with the PAUSE app vs. 20% without the PAUSE app) in the proportion of participants who complete a simulated sick day without error. Using a two-sided alpha of 0.05, 80% power, and an interclass correlation coefficient of 0.1 between pharmacy clusters, a sample size of 280 participants will be required. To account for a 10% loss to follow-up, the investigators will aim to recruit a total of 320 participants in the trial. The investigators plan to recruit 16 pharmacies that will recruit 20 participants each. Data Analysis Participant baseline data, including sociodemographics, comorbidities, and active prescriptions will be analyzed using descriptive statistics. Feasibility and fidelity outcomes will be reported using descriptive statistics with numbers and percentages. Comparisons of outcomes between groups (e.g., PAUSE App vs. usual care) will be reported using unadjusted and adjusted generalized estimating equations to determine mean differences and risk differences between groups. Descriptive statistics will be used as appropriate to evaluate group differences following the follow-up period. Associations between key variables and study outcomes will be analyzed using appropriate univariate, multivariate, and mixed model analyses. Exploratory analyses of Google Analytics data will be performed to report user behaviour insights. Analyses of routinely collected health data over a 5-year extended follow-up period will be used to determine the effect, if any, of the intervention on health outcomes. The simulated sick day evaluations will be scored and analyzed according to predefined scorecards based on scenarios used by Doerfler et al. measuring correct usage of SDMG during acute illness. Log-binomial regression models will be used to directly estimate the risk ratios (RRs) and 95% confidence intervals for the outcome of error free completion of the simulated sick day, as well as for correct completion of each of the 3 individual components of the sick day simulation. Random effects will be used to account for clustering by pharmacies. Unadjusted and adjusted models will be fit, including fixed effects for individual participant characteristics including age, sex, demographics, diabetes, other comorbidities, number of qualifying medications and any other significant confounding variables from univariate analyses. Additionally, data collected from participants on the usefulness of the PAUSE App and/or SDMG patient handout in managing a simulated sick day and overall acceptability of the interventions will be used to further assess the fidelity of the intervention. All statistical analysis will be completed in R. Selected participants (patients and pharmacists) will be invited to be interviewed following their simulated sick day scenario evaluation based on the purposive sampling strategy. One-on-one semi-structured interviews will be conducted with participants and pharmacists ranging from 30-60 minutes in duration. Interview questions and analysis will be iterative throughout the study to allow for emerging or irregular themes to be examined in later interviews. Qualitative interviews will be audio-recorded, transcribed verbatim and examined using multiple phases of inductive thematic analysis. Collected field notes and transcriptions from interviews will be analyzed using NVIVO qualitative analysis software. Analysis of data will begin immediately following the conclusion of the first participant interview. Data will be coded by two researchers independently and then codes will be compared after the first interview to draft the coding manual for subsequent interviews. ### Conditions Module **Conditions:** - Chronic Condition - Adverse Event **Keywords:** - chronic condition - medication safety - sick day medication guidance ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Cluster randomized controlled trial ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 320 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receiving usual care will only receive the SDMG patient handout from their community pharmacist. This handout has been adapted from the Diabetes Canada "How to Stay Safe When You Are Sick" SDMG patient resource as well as the results of a modified Delphi study conducted by the research team to achieve consensus among 25 international clinicians on recommendations for SDMG for people with diabetes, kidney, or cardiovascular disease. This handout will be reviewed and refined with input from people with lived experience with the chronic conditions of interest prior to the study and is intended to provide guidance on how to self-manage medications during a sick day event. **Label:** Usual Care **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants will receive enhanced care through onboarding and accessing the PAUSE App via the PC Health app to provide continuity of care electronically through a personalized eHealth mobile application, as well as the SDMG patient resource handout. The PAUSE App provides the same guidance as the SDMG handout, but uses algorithms tailored to identify and provide guidance specific to users' symptoms and current medications. **Intervention Names:** - Other: PAUSE App **Label:** PAUSE App Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PAUSE App Intervention **Description:** Participants receiving the intervention will receive access to the PAUSE App, a self-management tool for SDMG intended for patients to use during an acute illness. The app asks users a series of questions regarding signs and symptoms that identify a qualifying sick day illness, and screens for 'red flags' that would require emergency, or HCP or urgent care referral, and help patients identify which of their medications they should temporarily withhold or adjusted, tailored to a patients' current medication list. This aims to provide patients with interactive support for managing medication during a sick day event. As part of the intervention, patients will also receive a SDMG patient handout. The intervention addresses the previously identified challenges described above via an interactive and individualized electronic application designed to facilitate provision of SDMG. **Name:** PAUSE App **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Utilization of future health summary and administrative data to determine the difference, if any, of the intervention on all-cause health outcomes. Proposed collected summary data may include: * Increases in serum creatinine (mg/dl) based on the 2012 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for AKI and AKD (i.e., \>/= 0.3 mg/dl increase or 1.5-1.9x baseline serum creatinine) * Hospital admissions and emergency department data related to AKI and/or SDMG-related health outcomes * Vital statistics (e.g., death records) summary data related to AKI * Prescription medication history summary data related to AKI, worsening chronic conditions and/or SDMG **Measure:** Exploration of future health outcomes summary data resultant of adverse drug-related events **Time Frame:** Over an extended follow-up period of 5 years, or death (whichever comes first) #### Primary Outcomes **Description:** Two to three patient participants on average per pharmacy per week can be recruited (320 patients from 16 pharmacies over 8 weeks) **Measure:** Recruitment rate **Time Frame:** 3-month follow up **Description:** ≥90% of study participants receive the intervention (SDMG handout, PAUSE App onboarding) to which they are randomized within 1 week of giving informed consent **Measure:** Time to randomization **Time Frame:** 3-month follow up **Description:** ≥50% of study participants randomized to pharmacies using the PAUSE app follow SDMG error-free during the simulated sick day evaluation. **Measure:** Adherence to SDMG **Time Frame:** 3-month follow up #### Secondary Outcomes **Description:** Semi-structured participant interviews will be undertaken to explore themes related to study design elements, such as pharmacist onboarding and education, and barriers and facilitators to understanding and usability of the PAUSE App intervention/SDMG tools. Coded concepts will be synthesized into overall themes inductively to form a comprehensive description of the data. **Measure:** Exploration of participant experiences of study design and intervention acceptability **Time Frame:** 3-month follow-up **Description:** Semi-structured pharmacist interviews will be undertaken to explore themes related to study design elements, such as onboarding procedures and education components, and experiences interacting with patients regarding the PAUSE App intervention and SDMG education. Coded concepts will be synthesized into overall themes inductively to form a comprehensive description of the data. **Measure:** Exploration of pharmacist experiences of study design and intervention acceptability **Time Frame:** 3-month follow-up **Description:** Routinely collected, app-generated Google Analytics data will be captured over the data collection period to explore summary data trends, including but not limited to: total number of app visits, session duration, clicks on various pages within the app, time of day most frequently used, PDF (e.g., sick day guidance resources) downloads, and in-app engagement. **Measure:** Exploration of PAUSE App-generated user behaviours and usage patterns **Time Frame:** Throughout the 3-month data collection period **Description:** Pre- and post-intervention evaluation of paraticipant medication self-management using a 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS-13) survey. **Measure:** Exploration of the efficacy of the intervention in managing a simulated sick day event **Time Frame:** At baseline and 3-month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥18 years of age and able to provide informed consent * be able to communicate (read, write, and speak) in English * have access to a smartphone/tablet with an Internet connection * be willing and able to download and use the PC Health app for the duration of the study * currently be taking 2 or more medications from the following classes: renin-angiotensin-aldosterone system (RAAS) antagonists, diuretics, oral NSAIDs, metformin, or 1 or more medications from the following classes: insulin, sulfonylureas, meglitinides, SGLT2 inhibitors. Exclusion Criteria: * fail to meet the inclusion criteria * have kidney failure requiring maintenance dialysis * have had an organ transplant * are pregnant * receive qualifying medications in a blister pack or sachet * do not primarily manage their own medications and condition (i.e., receive home care, in a rehabilitation or medical respite facility) * cannot use the PC Health app independently * previously participated in studies that led to the development of the PAUSE App (including the PAUSE study usability testing or needs assessment focus groups) **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** shania.liu@ualberta.ca **Name:** Shania Liu, PhD **Phone:** 825-965-3258 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Alberta **Name:** Ross T Tsuyuki, PharmD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Calgary **Name:** David JT Campbell, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** IPD will not be shared with other researchers. **IPD Sharing:** NO ### References Module #### References **Citation:** Watson KE, Dhaliwal K, McMurtry E, Donald T, Lamont N, Benterud E, Kung JY, Robertshaw S, Verdin N, Drall KM, Donald M, Campbell DJT, McBrien K, Tsuyuki RT, Pannu N, James MT. Sick Day Medication Guidance for People With Diabetes, Kidney Disease, or Cardiovascular Disease: A Systematic Scoping Review. Kidney Med. 2022 May 28;4(9):100491. doi: 10.1016/j.xkme.2022.100491. eCollection 2022 Sep. **PMID:** 36046611 **Citation:** Watson KE, Dhaliwal K, Robertshaw S, Verdin N, Benterud E, Lamont N, Drall KM, McBrien K, Donald M, Tsuyuki RT, Campbell DJT, Pannu N, James MT; PAUSE (Preventing Medication Complications During Acute Illness Through Symptom Evaluation and Sick Day Guidance) Medication Safety Advisory Panel. Consensus Recommendations for Sick Day Medication Guidance for People With Diabetes, Kidney, or Cardiovascular Disease: A Modified Delphi Process. Am J Kidney Dis. 2023 May;81(5):564-574. doi: 10.1053/j.ajkd.2022.10.012. Epub 2022 Dec 5. **PMID:** 36470530 **Citation:** Dhaliwal KK, Watson KE, Lamont NC, Drall KM, Donald M, James MT, Robertshaw S, Verdin N, Benterud E, McBrien K, Gil S, Tsuyuki RT, Pannu N, Campbell DJT. Managing 'sick days' in patients with chronic conditions: An exploration of patient and healthcare provider experiences. Health Expect. 2023 Aug;26(4):1746-1756. doi: 10.1111/hex.13789. Epub 2023 Jun 8. **PMID:** 37291977 **Citation:** Watson KE, Dhaliwal K, Benterud E, Robertshaw S, Verdin N, McMurtry E, Lamont N, Drall KM, Gill S, Campbell DJT, McBrien K, Tsuyuki RT, Pannu N, James MT, Donald M. Managing Medications During "Sick Days" in Patients With Diabetes, Kidney, and Cardiovascular Conditions: A Theory-informed Approach to Intervention Design and Implementation. Can J Diabetes. 2024 Feb 21:S1499-2671(24)00045-5. doi: 10.1016/j.jcjd.2024.02.003. Online ahead of print. **PMID:** 38395301 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6147 - Name: Chronic Disease - Relevance: HIGH - As Found: Chronic Conditions - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002908 - Term: Chronic Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433401 **Brief Title:** The Effect of Structured Transition Care Model Applied to Adolescents With Congenital Heart Disease **Official Title:** The Effect of Structured Transition Care Model Applied to Adolescents With Congenital Heart Disease on Transition Readiness, Self-Management Skills and Care Satisfaction #### Organization Study ID Info **ID:** AnkaraYBU-SBF-TKT-01 #### Organization **Class:** OTHER **Full Name:** Ankara Yildirim Beyazıt University ### Status Module #### Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara Yildirim Beyazıt University #### Responsible Party **Investigator Affiliation:** Ankara Yildirim Beyazıt University **Investigator Full Name:** tutkukırçı **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:** Congenital heart disease is one of the most common congenital defects with a high mortality and morbidity rate. Children with congenital heart disease step from pediatric care to adult care during adolescence. This situation has brought up transitional care, which is defined as "the purposeful and planned movement of adolescents and young adults with chronic physical and medical conditions from pediatric to adult-oriented health systems". Since adolescents with congenital heart disease are at high risk for complications in adulthood, it is very important to raise awareness, increase the level of readiness for adult care and gain self-management skills during the transition phase. This study was planned as a randomized controlled experimental study to evaluate the effect of the developmental transition care model applied to adolescents with congenital heart disease during the transition from pediatric care to adult care on the transition readiness level, self-management skills and care satisfaction of adolescents. Studies have shown that both adolescents with congenital heart disease and their caregivers need professional support, appropriate transition education and care before transition to adult care in order to increase adaptation to adult care, to gain self-management skills and to reduce their concerns. Studies in which adolescents are followed up after transition to adult care show that when the transition process is not successfully completed, there is excessive time between the last pediatric control and the first adult control or there are losses in further follow-up. Although there are studies in our country in which transition care is applied, this study is planned because there is no intervention study in which developmental transition care model is applied to adolescents with congenital heart disease. It is thought that this study will increase the transition readiness levels, self-management skills and care satisfaction of adolescents with congenital heart disease and guide the nurses working with them. **Detailed Description:** Congenital heart disease is one of the most common congenital defects with high mortality and morbidity rates. The American Heart Association reports that at least eight out of every 1000 babies born are born with heart disease. In Turkey, an average of 11,000-17,000 babies are born with congenital heart disease each year. Congenital heart diseases are a very large group of diseases and the level and prognosis of defects in this group vary. While severe defects result in neonatal and infant mortality, almost all children with mild defects survive. With the adolescent period, children step from pediatric care to adult care. While the transition to adulthood causes psychological and social changes for a healthy adolescent and his/her family, the need for additional care for adolescents with chronic diseases and the change in access to health services make the transition period even more challenging. This situation has brought transition care, defined as "the purposeful and planned movement of adolescents and young adults with chronic physical and medical conditions from pediatric health systems to adult-oriented health systems" to the agenda. Since adolescents with congenital heart disease are at high risk for complications in adulthood, raising awareness of the need for regular medical follow-up and preparing them for changes in the health care environment are very important for a successful transition. The aim of transitional care is to maintain the control and well-being of the disease in adulthood and maximize its potential by providing the quality care practices needed by the adolescent without interruption. Studies have shown that both adolescents with congenital heart disease and their caregivers need professional support, appropriate transition education and care before transition to adult care in order to increase their adaptation to adult care, gain self-management skills and reduce their concerns. The American Academy of Pediatrics (APA) recommends that the transition process should begin with transition planning between the ages of 12-14. However, since physiological and psychological development and needs are not related to the chronological age of the individual, the essence of timing in the transition process is flexibility. The timing of transition varies depending on many individual and environmental variables such as age, gender, physical and psychological maturation, current medical condition, compliance and adherence to treatment, readiness of the adolescent for transition, finding an appropriate adult care provider, and insurance policies. In studies in which adolescents with congenital heart disease were followed up after transition to adult care, when the transition process was not successfully completed, there was a gap between the last pediatric control and the first adult control. In conclusion, there is no intervention study in our country in which the developmental transition care model was applied to adolescents with congenital heart disease and the results were evaluated. In addition, based on clinical experiences and observations, it was determined that adolescents and their parents had difficulties in the transition from pediatric care to adult care and this negatively affected self-management related to the disease. The aim of this study was to evaluate the effect of the developmental transition care model applied to adolescents with congenital heart disease during the transition from pediatric care to adult care on the transition readiness level, self-management skills and care satisfaction of adolescents. ### Conditions Module **Conditions:** - Congenital Heart Disease in Adolescence **Keywords:** - Congenital heart disease - Adolescent - Transition care - Nurses ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The study included two groups, an intervention group and a control group. Intervention group receiving transitional care training and control group receiving routine care. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants will not know which group they are in. They will be assigned to groups by simple simple random randomization method. Since the researcher was the one who provided the training, researcher blinding could not be performed. **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The transitional care group is a group that will receive a transitional care training consisting of a total of 3 modules in which the content is arranged for individualized needs with expert opinion from 10 faculty members working in the field of Child Health and Diseases Nursing.The education sessions will be conducted every 3 months in sessions of approximately 35-40 minutes face-to-face in the training room allocated to the individual researcher. **Intervention Names:** - Behavioral: Transitional care training with brochures, posters and slide training materials **Label:** Transition care group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group is the group receiving routine care that continues the normal follow-up of the clinic without any intervention. However, in terms of compliance with ethical principles, the same training will be given to them upon their request after the research is completely completed. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Transition care group **Description:** Education at 3 and 6 months after the first interview **Name:** Transitional care training with brochures, posters and slide training materials **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** It addresses the readiness of adolescents/young adults with chronic diseases to transition from pediatric care to adult care with the sub-dimensions of management of treatment, management of appointments, monitoring of health status, communication with health personnel and management of daily activities. The Cronbach alpha internal consistency coefficient of the Turkish scale was .88. The readiness for transition assessment scale is a 5-point Likert-type self-assessment scale to assess the skills and behaviors required for disease management in five sub-dimensions. Each item is evaluated between 1 point (no, I do not know how to do it) and 5 points (yes, I can do it when I need to). Adolescents score a minimum of 20 and a maximum of 100 points. The higher the score obtained from the scale, the higher the level of readiness of the adolescent to transition from pediatric care to adult care. **Measure:** Transition Readiness Assessment Scale **Time Frame:** at certain intervals for 1 year #### Secondary Outcomes **Description:** This form was prepared by the researchers as a result of the literature review and will be used to obtain information on the age, gender, contact information, information on parents interested in health checks, initial diagnosis characteristics (date of diagnosis and complaints of hospital admission), degree of congenital heart disease, information on regularly used medication, body mass index, physical activity status, nutritional status, vital signs, cardiac examination and imaging information of adolescents. **Measure:** Data Collection Form on Sociodemographic and Medical Characteristics **Time Frame:** at certain intervals for 1 year **Description:** This scale to determine the disease management skills of individuals with chronic diseases The scale consists of 21 items and 4 sub-dimensions. These sub-dimensions are self-stigmatization, coping with stigmatization, health care effectiveness and treatment compliance. It was stated that the scale is suitable for use in all individuals with chronic diseases. The scale score is calculated by arithmetic mean. Each item in the scale is scored between 1 and 5. Scores obtained from the scale indicate that self-management increases as it approaches 5, and self-management decreases as it decreases towards 1. **Measure:** Chronic Disease Self-Management Scale **Time Frame:** at certain intervals for 1 year **Description:** The scale allows adolescents with chronic diseases to self-assess the care they receive and to determine their expectations; it is a scale that addresses the care provided with the dimensions of "Management of the Physical Environment (PME)", "Health Personnel Characteristics (HCP)" and "Care Process (CP)". The form of the scale used for adolescents consists of two separate questionnaires (ideal care/existing care) with 21 questions in which the adolescent's expected care and current care are evaluated. The scale forms are 7-point Likert-type with 1=strongly disagree and 7=strongly agree. Participants are asked to rate their current care based on the best care they expect for themselves. Scoring is based on the difference between the individual's expectations and what they actually perceive. **Measure:** Transitional Care Satisfaction Rating Scale **Time Frame:** at certain intervals for 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Voluntarily agree to participate in the research * To be between the ages of 16-20, * Having a diagnosis of congenital heart disease, * Being followed up with a diagnosis of congenital heart disease for at least one year in the polyclinics where the study was conducted, * To be able to communicate in Turkish, * Not having any mental deficiency that may prevent communication Exclusion Criteria: * Refusing to participate in the research, * Not being able to communicate in Turkish, * Not showing up regularly for follow-ups, * Having any mental disability that may prevent communication **Maximum Age:** 20 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tutkukrc29095@gmail.com **Name:** Tutku KIRÇI TEMİZ, PhD s. **Phone:** +905064278982 **Role:** CONTACT **Contact 2:** **Email:** utkuarman.orun@sbu.edu.tr **Name:** Utku ARMAN ÖRÜN, Prof.Dr. **Phone:** +905322933072 **Role:** CONTACT #### Locations **Location 1:** **City:** Ankara **Contacts:** ***Contact 1:*** - **Email:** etliksh.iletisim@saglik.gov.tr - **Name:** Ankara Etlik City Hospital - **Phone:** 0312 797 00 00 - **Role:** CONTACT **Country:** Turkey **Facility:** Republic of Turkey Ministry of Health Ankara Etlik City Hospital **State:** Ankara Yenimahalle **Zip:** 06170 #### Overall Officials **Official 1:** **Affiliation:** Ankara Yildirim Beyazıt University **Name:** Tutku KIRÇI TEMİZ, PhD s. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ankara Yildirim Beyazıt University **Name:** Evrim KIZILER, Asst.Prof. **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Republic of Turkey Ministry of Health Ankara Etlik City Hospital **Name:** Utku ARMAN ÖRÜN, Prof.Dr. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Disease - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases - ID: D000006330 - Term: Heart Defects, Congenital ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433388 **Brief Title:** Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease. **Official Title:** Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease. #### Organization Study ID Info **ID:** perirenal fats of ckd #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **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:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Aml Ahmed Ramadan Mohamed **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Exploring the association of perirenal fat thickness assessed by MRI in CKD patients with FLD. **Detailed Description:** Fatty liver disease (FLD) is caused by an accumulation of excessive fat in the liver that leads to liver damage. It has been noticed that fatty liver disease affects not only liver diseases but also extra-hepatic organ systems such as the cardiovascular and renal systems. Increasing the prevalence of FLD has a great association with increasing the risk of cardiovascular diseases, chronic kidney diseases, and Type 2 diabetes mellitus. Hypertension, insulin resistance, and abdominal obesity are risk factors that are shared by FLD and CKD. Moreover, patients with CKD have a great prevalence of developing FLD, and CKD incidence is increased by the presence of FLD. Obesity is one of the most comorbidities over the world, it is related and increase the risk of cardio metabolic disease, as well as it is a strong risk factor for chronic kidney disease (CKD), and the prevalence of both conditions is rising worldwide, Several recent epidemiologic studies have shown that obesity and the metabolic syndrome are independent predictors of CKD. The most common method for defining obesity is based on BMI(weight \[kilograms\] divided by the square of height \[meters\]). previously abdominal fat distribution have been measured by BMI, waist to hip ratio (WHR), OR Waist circumference. Although waist circumference was noted to be a reliable predictor of visceral fat, many interfering factors may also reduce the reliability of WC in estimating abdominal fat deposition, as well as the associated risk for CKD like ageing and normal difference in fat distribution between the two genders. Based on these considerations, we presume that per renal fat thickness measurement by MRI may better reflect the risks commonly associated with increased visceral fat accumulation and particularly those related to renal function impairment. Chronic kidney disease is defined as impairment or structural damage to kidney or kidney function. It manifested by reduction in estimated glomerular rate (eGFR) for at least 3 months. It presented with proteinuria or albuminuria, hematuria. The best diagnosis by biopsy showing renal impairment, or by imaging ultrasound. CKD associated with morbidity and mortality condition especially in developing countries, so it has been necessary to early detection to prevent CKD progression and associated complications, thus improving patient outcomes and reducing the impact of CKD on health-care resources. FLD begins with liver lipid accumulation, and marked hepatic fat accumulation is a risk factor for disease progression. Liver biopsy is the golden for diagnosis and assessment of the severity of steatosis and grading of fibrosis, although being invasive and difficult method. Ultrasound and magnetic resonance imaging (MRI) biomarkers of liver fat Gives the advantage diagnose FLD as it is non-invasive imaging biomarkers to diagnose FLD, steatosis , and fibrosis. Therefore the aim of this study is to determine the independent association of Perirenal fat assessment by MRI with the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria as well as with serum urate values on one side, and grading of fibrosis and steatosis in FLD patients on the other side. ### Conditions Module **Conditions:** - Chronic Kidney Diseases - Fatty Liver ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Magnetic Resonance Imaging (MRI) is a non-invasive imaging technology that produces three dimensional detailed anatomical images. Patients will be subjected to MRI scans and imaging of the kidneys and liver **Name:** MRI **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Association between perirenal fat thickness measured by MRI and PAUS and the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria and serum urate in CKD patient with FLD. **Measure:** Perirenal fat thickness, as measured by MRI and PAUS and its relation to poor renal outcomes in chronic kidney diseased patient with Fatty liver disease. **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age more than 18 years old regardless of gender Exclusion Criteria: * Other causes of chronic liver diseases (HCV, HBV...). * End stage renal diseases (GFR\<15 ml/min). * A history of significant alcohol intake (\>20 g/day in females and 30 g/day in males). * Those using medications that can cause fatty liver. * Pregnant patients. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients will be recruited from the out-patient clinics of the Internal Medicine Department, Assiut university ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aml375090@gmail.com **Name:** Aml Ahmed Ramadan, Master **Phone:** +201024485855 **Role:** CONTACT **Contact 2:** **Email:** samirkotb45@yahoo.com **Name:** Samir Kamal Abdul_Hamid **Phone:** +201062949199 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** professor **Name:** Samir Kamal Abdul_Hamid, prof **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Targher G, Byrne CD. Non-alcoholic fatty liver disease: an emerging driving force in chronic kidney disease. Nat Rev Nephrol. 2017 May;13(5):297-310. doi: 10.1038/nrneph.2017.16. Epub 2017 Feb 20. **PMID:** 28218263 **Citation:** Zhang QH, Xie LH, Zhang HN, Liu JH, Zhao Y, Chen LH, Ju Y, Chen AL, Wang N, Song QW, Xie LZ, Liu AL. Magnetic Resonance Imaging Assessment of Abdominal Ectopic Fat Deposition in Correlation With Cardiometabolic Risk Factors. Front Endocrinol (Lausanne). 2022 Mar 30;13:820023. doi: 10.3389/fendo.2022.820023. eCollection 2022. **PMID:** 35432188 **Citation:** Wahba IM, Mak RH. Obesity and obesity-initiated metabolic syndrome: mechanistic links to chronic kidney disease. Clin J Am Soc Nephrol. 2007 May;2(3):550-62. doi: 10.2215/CJN.04071206. Epub 2007 Mar 14. **PMID:** 17699463 **Citation:** Stenvinkel P, Zoccali C, Ikizler TA. Obesity in CKD--what should nephrologists know? J Am Soc Nephrol. 2013 Nov;24(11):1727-36. doi: 10.1681/ASN.2013040330. Epub 2013 Oct 10. **PMID:** 24115475 **Citation:** Chen J, Muntner P, Hamm LL, Jones DW, Batuman V, Fonseca V, Whelton PK, He J. The metabolic syndrome and chronic kidney disease in U.S. adults. Ann Intern Med. 2004 Feb 3;140(3):167-74. doi: 10.7326/0003-4819-140-3-200402030-00007. **PMID:** 14757614 **Citation:** Sanches FM, Avesani CM, Kamimura MA, Lemos MM, Axelsson J, Vasselai P, Draibe SA, Cuppari L. Waist circumference and visceral fat in CKD: a cross-sectional study. Am J Kidney Dis. 2008 Jul;52(1):66-73. doi: 10.1053/j.ajkd.2008.02.004. Epub 2008 Apr 28. **PMID:** 18440683 **Citation:** Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86. **PMID:** 21712852 **Citation:** Tonelli M, Dickinson JA. Early Detection of CKD: Implications for Low-Income, Middle-Income, and High-Income Countries. J Am Soc Nephrol. 2020 Sep;31(9):1931-1940. doi: 10.1681/ASN.2020030277. Epub 2020 Aug 24. **PMID:** 32839279 **Citation:** Ajmera V, Loomba R. Imaging biomarkers of NAFLD, NASH, and fibrosis. Mol Metab. 2021 Aug;50:101167. doi: 10.1016/j.molmet.2021.101167. Epub 2021 Jan 15. **PMID:** 33460786 **Citation:** Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012. **PMID:** 25920090 ## Derived Section ### Condition Browse Module - Ancestors - 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: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M11107 - Name: Liver Diseases - Relevance: HIGH - As Found: Liver Disease - ID: M8375 - Name: Fatty Liver - Relevance: HIGH - As Found: Fatty Liver - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - 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: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T5868 - Name: Visceral Steatosis - Relevance: HIGH - As Found: Fatty Liver ### Condition Browse Module - Meshes - ID: D000008107 - Term: Liver Diseases - ID: D000005234 - Term: Fatty Liver - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433375 **Brief Title:** Evaluation of the Efficacy of Growth Hormone on Healing of Periapical Pathosis **Official Title:** Evaluation of the Efficacy of Growth Hormone and Non-Surgical Debulking of Periapical Tissues on Healing of Periapical Pathosis #### Organization Study ID Info **ID:** 27/4/2023 #### Organization **Class:** OTHER **Full Name:** Al-Azhar University ### Status Module #### Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Al-Azhar University #### Responsible Party **Investigator Affiliation:** Al-Azhar University **Investigator Full Name:** Mohamed Zakaria Abd El Aziz **Investigator Title:** Principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aimed to evaluate the effect of growth hormone and non-surgical debulking of periapical tissues on healing of periapical pathosis **Detailed Description:** Out of ninety patients, forty-eight healthy male patients aged 18 to 40 years old were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University Boys, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Maxillary permanent incisor teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients. ### Conditions Module **Conditions:** - Periapical Diseases - Growth Hormone - Non Surgical Debulking ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Teeth undergo non-surgical debulking of periapical tissues. **Intervention Names:** - Procedure: Non surgical debulking of periapical tissues - Procedure: Non surgical debulking of periapical tissues with growth hormone application **Label:** Non surgical debulking group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Teeth undergoes Growth Hormone application. **Intervention Names:** - Procedure: Growth hormone application - Procedure: Non surgical debulking of periapical tissues with growth hormone application **Label:** Growth hormone group **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Teeth undergo non-surgical debulking of periapical tissues with Growth Hormone application. **Intervention Names:** - Procedure: Non surgical debulking of periapical tissues with growth hormone application **Label:** Non surgical Debulking & Growth hormone group **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Teeth undergo conventional root canal treatment without any additional intervention **Intervention Names:** - Procedure: Root canal treatment **Label:** Control group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Non surgical debulking group **Description:** Non surgical debulking of periapical tissues **Name:** Non surgical debulking of periapical tissues **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Growth hormone group **Description:** Growth hormone application during non-surgical root canal treatment **Name:** Growth hormone application **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Growth hormone group - Non surgical Debulking & Growth hormone group - Non surgical debulking group **Description:** Non-surgical debulking of periapical tissues with growth hormone application during non-surgical root canal treatment **Name:** Non surgical debulking of periapical tissues with growth hormone application **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Control group **Description:** Teeth undergo conventional root canal treatment without any additional intervention **Name:** Root canal treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of non surgical root canal tratment healing according to CBCTPAI **Measure:** Post operative CBCT scan **Time Frame:** 6 months **Description:** Evaluation of non surgical root canal tratment healing according to CBCTPAI **Measure:** Post operative CBCT scan **Time Frame:** 12 months #### Secondary Outcomes **Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10). **Measure:** Post operative pain assesment **Time Frame:** 24 hours **Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10). **Measure:** Post operative pain assesment **Time Frame:** 48 hours **Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10). **Measure:** Post operative pain assesment **Time Frame:** 72 hours **Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10). **Measure:** Post operative pain assesment **Time Frame:** 96 hours **Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10). **Measure:** Post operative pain assesment **Time Frame:** 120 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:- Necrotic teeth with apical periodontitis. * Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility. * Teeth with mature apices, root canal curvature between (0-10º) according to Schneider(9) and radii of curvature between 2 to 5 mm according to Pruett would be included in the study(10). * Teeth with estimated working length of 20mm(±2mm) from the incisal edge as a reference point provided that the crown/root ratio was not compromised. * Non-critical sized periapical lesion related only to one tooth of a 2 to 4mm diameter and score 3 when evaluated using the Cone Beam Computed Tomography Periapical Index Score (CBCTPAI)(11) , Table (1) presents the scoring scale of CBCT-PAI. * Teeth located in anatomic areas in which enucleation of the periapical tissues may jeopardize nearby structures, such as the incisive foramen or nasal cavity should be at least 2 mm away from these structures. Exclusion Criteria: * Necrotic teeth with related periapical swelling or sinus tract. * Teeth with previous root canal fillings and /or indirect coronal restoration. * Teeth with abnormal root canal anatomy. * Non-restorable teeth due to insufficient coronal tooth structure. * Teeth with periodontal disease. * Teeth with grade III mobility. * Teeth with clinical evidence of a missing buccal bony plate over the periapical defect. * Traumatized teeth with suspected root cracks, fractures, intrusive and extrusive injuries, previously avulsed or lateral luxation injuries. **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Al Azhar University **State:** Nasr City **Zip:** 4450113 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007571 - Term: Jaw Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M13393 - Name: Periapical Diseases - Relevance: HIGH - As Found: Periapical Diseases - ID: M10601 - Name: Jaw Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010483 - Term: Periapical Diseases ### Intervention Browse Module - Ancestors - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: HIGH - As Found: Loss - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006728 - Term: Hormones ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433362 **Brief Title:** CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma **Official Title:** A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Treatment-Naive Patients With Peripheral T-Cell Lymphoma #### Organization Study ID Info **ID:** CSPC-DED-PTCL-K07 #### Organization **Class:** OTHER **Full Name:** Tianjin Medical University Cancer Institute and Hospital ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-26 ### 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 **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOEP in patients with untreated peripheral T-cell lymphoma. **Detailed Description:** This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone(CMOEP) in patients with untreated Peripheral T-cell Lymphoma.Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, etoposide and prednisone.Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned. ### Conditions Module **Conditions:** - Peripheral T Cell Lymphoma **Keywords:** - Untreated Peripheral T-cell Lymphoma - Mitoxantrone hydrochloride liposome ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 115 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Mitoxantrone Hydrochloride Liposome with Cyclophosphamide, Vincristine, Etoposide and Prednisone **Intervention Names:** - Drug: CMOEP **Label:** CMOEP **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CMOEP **Description:** Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 3 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1,every 3 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 3 mg/m2, the maximum dose of 4mg),every 3 weeks; Drug: Etoposide Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3,every 3 weeks; **Name:** CMOEP **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Response is assessed according to the lugano criteria. **Measure:** Complete Response Rate (CRR) **Time Frame:** 2 year #### Secondary Outcomes **Description:** Response is assessed according to the lugano criteria. **Measure:** Overall Response Rate (ORR) **Time Frame:** 2 year **Description:** From the date of the first dose of therapy is given until disease progression, death or last follow-up. **Measure:** Progression-Free-Survival (PFS) **Time Frame:** 2 year **Description:** From the date of inclusion to date of death, irrespective of cause. **Measure:** Overall survival (OS) **Time Frame:** 2 year **Description:** The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity. **Measure:** Safety and Tolerability **Time Frame:** From the first day of medication to 28 days after the last dose **Description:** such as LVEF% change from baseline, cardiac injury indicators, etc. **Measure:** Changes in cardiac safety indicators **Time Frame:** 2 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1.Subjects fully understand and voluntarily participate in this study and sign informed consent. 2. Age ≥18, ≤70years(for 65-70 years old, researchers need to comprehensively evaluate the physical fitness and tolerance of patients), no gender limitation. 3. Expected survival ≥ 3 months. 4.Histologically confirmed diagnosis of Peripheral T-cell lymphoma： 1) Peripheral T-cell lymphoma unspecified (ptcl-NOS) 2) Angioimmunoblastic T-cell lymphoma (AITL) 3) Anaplastic large T-cell lymphoma (ALCL), ALK+ 4) Anaplastic large T-cell lymphoma (ALCL), ALK- 5) Other subtypes of PTCL that the investigator think can be included in the group. 5.No previous treatment for PTCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except for local radiotherapy to alleviate tumor related symptoms), surgical treatment. 6.Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length and diameter should be \>1.5cm; For non-lymph node lesions, the length and diameter should be \>1.0cm. 7.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. 8.The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 90 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelet count (PLT) ≥50×10\^9/L, Hemoglobin(HB)≥ 75g/L). 9.Total Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN(For patients with liver invasion ≤5X ULN), bilirubin (TBIL)≤1.5X ULN(For patients with liver invasion ≤3X ULN ). Exclusion Criteria: * 1.Subjects with a history of prior antitumor therapy. 2.Hypersensitivity to any study drug or its components. 3.Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.) 4.Heart function and disease meet one of the following conditions:1）Long QTc syndrome or QTc interval \>480 ms;2）Complete left bundle branch block, grade II or III atrioventricular block;3）Serious and uncontrolled arrhythmias requiring drug treatment;4）New York Heart Association grade ≥ II;5）Cardiac ejection fraction (LVEF)\<50%;6）A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. 5.Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x10\^3 copy/mL; hepatitis C virus RNA high than 1x10\^3 copy/mL). 6.Human immunodeficiency virus (HIV) infection (HIV antibody positive). 7.Patients with other malignant tumors, except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ and other tumor during the past 5 years. 8.Patients with primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma. 9.Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures. 10.Unsuitable subjects for this study determined by the investigator. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jingweiyu@pku.org.cn **Name:** Jingwei Yu **Phone:** 86-15022015208 **Role:** CONTACT #### Locations **Location 1:** **City:** Tianjin **Contacts:** ***Contact 1:*** - **Email:** huilaizhangtz@163.com - **Name:** Huilai Zhang, MD - **Phone:** +86-18622221228 - **Role:** CONTACT **Country:** China **Facility:** Tianjin Cancer Hospital **Status:** RECRUITING **Zip:** 300060 #### Overall Officials **Official 1:** **Affiliation:** Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital **Name:** Huilai Zhang **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** The Second Affiliated Hospital of Harbin Medical University **Name:** Qingyuan Zhang **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000008228 - Term: Lymphoma, Non-Hodgkin ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18829 - Name: Lymphoma, T-Cell - Relevance: HIGH - As Found: T-cell Lymphoma - ID: M18833 - Name: Lymphoma, T-Cell, Peripheral - Relevance: HIGH - As Found: Peripheral T-cell Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T4496 - Name: Peripheral T-cell Lymphoma - Relevance: HIGH - As Found: Peripheral T-cell Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000016399 - Term: Lymphoma, T-Cell - ID: D000016411 - Term: Lymphoma, T-Cell, Peripheral ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: Infl - Name: Anti-Inflammatory Agents ### Intervention Browse Module - Browse Leaves - ID: M8191 - Name: Etoposide - Relevance: LOW - As Found: Unknown - ID: M11908 - Name: Mitoxantrone - Relevance: LOW - As Found: Unknown - ID: M6727 - Name: Cyclophosphamide - Relevance: LOW - As Found: Unknown - ID: M14121 - Name: Prednisone - Relevance: LOW - As Found: Unknown - ID: M17495 - Name: Vincristine - Relevance: LOW - As Found: Unknown - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown - ID: M17492 - Name: Vinblastine - Relevance: LOW - As Found: Unknown - ID: M17496 - Name: Vindesine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433349 **Brief Title:** A Multi-center Investigation of Family Health. **Official Title:** A Multi-center Investigation of Family Health, Needs, Perceived Support, Self-efficacy and Quality of Life During the Cancer Trajectory: A Longitudinal Mixed Methods Study Among Danish Cancer Patients and Their Caregivers #### Organization Study ID Info **ID:** FaCe Cancer #### Organization **Class:** OTHER **Full Name:** Odense University Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-02-23 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Sygehus Lillebaelt **Class:** OTHER **Name:** Zealand University Hospital **Class:** OTHER **Name:** Rigshospitalet, Denmark #### Lead Sponsor **Class:** OTHER **Name:** Odense University Hospital #### Responsible Party **Investigator Affiliation:** Odense University Hospital **Investigator Full Name:** Laerke Kjaer Tolstrup **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 current healthcare system is unable to identify burdened and vulnerable families affected by cancer, partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship. Recent reviews have documented a general lack of cancer studies including both the patient and the family, and a particular deficiency in studies including more than the spouse. The principal aim of this study is to investigate family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience in both patients with cancer and their families across the cancer trajectory. Additionally, the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability. **Detailed Description:** Background Around 45,000 Danes are diagnosed with cancer each year with an increasing incidence and more than 350,000 people are living with cancer. Depending on the specific diagnosis, the 5-year survival rates range between 67% for men and 69% for women. Approximately 15,000 die of cancer each year. Receiving a cancer diagnosis not only affects patients; it also affects family members, making cancer disorders a family affair. However, adult cancer research rarely focuses on the well-being and health of the whole family, which is worrying as one-third of the Danish population gets a cancer diagnosis before the age of 75, suggesting that most Danes will become caregivers to a cancer patient at some time during their lives. Adding to this, the Danish Cancer Society recently documented that patients who receive support from caregivers perform better on all parameters, i.e. patients are more aware of signs of relapse and get more frequent help when needed. Thus, caregiver support is a significant component for getting well through the course of cancer without unnecessary discomfort. In addition, there is an increasing political focus on the efficient utilization of resources, which has resulted in fast-track treatments (Danish: Kræftpakker) and an increasing number of patients in outpatient clinics. This change of treatment setting from hospital to outpatient settings or even hospitalization in the homes of patients directly involves family caregivers in the care of the individual patient, i.e. with treatment, physical care, or emotional support. Thus, the future healthcare system will increasingly depend on the patient´s family and social network when supporting patients with cancer, ensuring, and supporting the health of individuals and communities in multiple inter-connected ways. This evident shift in responsibility from the public to the private sphere has a direct and substantial effect on family function, with a greater burden on the family members involved, which may eventually lead to deteriorated overall family health. Adding to this, there is growing evidence that the health and well-being of family caregivers are affected by higher expectations of active involvement in the care of their ill family member. Families confronted with health problems are at risk of stress and disturbance of family functioning that could cause other health problems and additional harm within the family system. Similarly and highly concerning, is evidence suggesting caregivers have high rates (42%) of depression, a disorder that in itself is associated with multiple concerning outcomes including premature death, chronic disease courses, self-harm, and suicides. The current healthcare system is unable to identify burdened and vulnerable families affected by cancer, partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship. Recent reviews have documented a general lack of cancer studies including both the patient and the family, and a particular deficiency in studies including more than the spouse. The principal aim of this study is to investigate family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience in both patients with cancer and their families across the cancer trajectory. Additionally, the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability. Methods and material Setting The study will recruit patients and caregivers from six different Danish hospital departments. Participants In total, 240 patients and their appointed caregivers will be included. Inclusion criteria: curative intended patients and their eventual appointed caregivers \>18 years affected by breast-, prostate-, colorectal cancer or lymphoma. Exclusion criteria: Not able to understand or give written informed consent. Design The Face Cancer study is a multi-center investigation of family health, needs, perceived support, self-efficacy, stress, resilience, and quality of life during the cancer trajectory among Danish cancer patients and their adult family caregivers. The study will use mixed methods including patient-reported outcomes in a longitudinal, prospective multicenter survey combined with family interviews conducted in a subset of participants included in the survey. A sequential explanatory design will be applied involving two phases, wherein the quantitative data collection (survey) and analysis will be followed by qualitative follow-up (interviews). Thus, the qualitative data from the family interviews will help to explain and interpret the context and depth of the mechanisms underlying the survey results. The rationale for applying a mixed-methods approach is to gain a deeper and more comprehensive understanding of the impact of cancer on patients and their families. For data presentation purposes, it will be depicted, by the use of a joint display, how the quantitative data is used to inform the qualitative data collection. Quantitative data A prospective longitudinal multicenter survey including curatively intended cancer patients from the target group and their appointed adult family member(s) at entry of treatment (baseline), during treatment (3 months), and at 6, 12, and 18 months after baseline. The survey includes the following questionnaires. Family-reported outcomes will be assessed by the translated and validated Family Health Scale (Long-form) including family social and emotional health processes, family healthy lifestyle, family health resources, and family external social supports. Perceived support will be assessed by the ICE Family Perceived Support Questionnaires. HRQoL is assessed by the short generic EQ-5D-5L (EuroQol-5 dimensions). Self-efficacy is measured by the Danish version of the ten-item validated general self-efficacy scale (GSE) questionnaire to investigate the ability to act towards problems in everyday life. The GSE covers a broad range of the sense of personal competence to deal effectively with stressful situations. The scale has been found to have high validity and reliability in various populations across contexts and cultures To assess the degree of depression, the Patient Health Questionnaire-9 (PHQ-9) will be used. The Level of distress was measured with the Danish version of the National Comprehensive Cancer Network Distress thermometer (NCCN DT), and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale (CD-RISC2). The survey will also assess real-time family needs \& preferences in free text. In total, 240 patients (60 patients per patient group) plus appointed family members will be included based on a power calculation of SD applied sqrt(2)\*22 = 31 in the Family Health Scale. This would require 44 patients per patient group plus dropouts with 90% power to detect a minimal clinically important difference change two-time any pair of two-time points in the longitudinal design. Data are collected from six confirmed sites (Danish cancer departments) and questionnaires are distributed via the national mailbox e-Boks. Qualitative data Family interviews will be conducted to illuminate how patients and caregivers experience (perceive) vulnerable situations, their family supportive care needs, and family support during and after cancer treatment. The groups (n=12-15) will consist of families (one patient and either one or two caregivers) identified in the survey. The interviews will take place longitudinally at two time points at three months (during treatment) and 12 months (during follow-up) after the completion of baseline questionnaires. The interviews can take place either at the hospital, in the patients´ homes or online depending on the preferences of patients and relatives, and are expected to last approximately one hour. We plan to use an integrated approach combining phenomenology with hermeneutics to gain a more complete understanding of the families' experiences, recognizing both their subjective perceptions and the broader cultural and social significance. We will try to carry out the interviews inductively, letting the respondents reflect on their own experiences without imposing preconceived notions. An interview guide will be prepared in alignment with this and the family systems theory. Purposive sampling will be used to ensure the inclusion of families with maximal variation in age, gender, and family life situation will be invited. Thematic analysis by Braun and Clarke is chosen to extract data, identify patterns, and analyze data and themes. NVivo will be used for coding interview data. ### Conditions Module **Conditions:** - Breast Cancer - Prostate Cancer - Colorectal Cancer - Hematologic Neoplasms - Caregivers ### Design Module #### Design Info **Observational Model:** FAMILY_BASED **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will complete the following questionnaires at baseline, 3, 6, 12, and 18 months: Family Health Scale (Long-form), the ICE Family Perceived Support Questionnaires, EQ-5D-5L, The general self-efficacy scale (GSE), the Patient Health Questionnaire-9 (PHQ-9), the National Comprehensive Cancer Network Distress thermometer (NCCN DT) and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale (CD-RISC2). A subset of the patients will also participate in family interviews (n=12-15). **Intervention Names:** - Other: Survey and interviews **Label:** Patients with breast-, prostate- colorectal cancer or lymphoma #### Arm Group 2 **Description:** Caregivers will complete the following questionnaires at baseline, 3, 6, 12, and 18 months: Family Health Scale (Long-form), the ICE Family Perceived Support Questionnaires, EQ-5D-5L, The general self-efficacy scale (GSE), the Patient Health Questionnaire-9 (PHQ-9), the National Comprehensive Cancer Network Distress thermometer (NCCN DT) and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale (CD-RISC2). A subset of the caregivers will also participate in family interviews (n=12-15). **Intervention Names:** - Other: Survey and interviews **Label:** Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma. ### Interventions #### Intervention 1 **Arm Group Labels:** - Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma. - Patients with breast-, prostate- colorectal cancer or lymphoma **Description:** Questionnaires and interviews **Name:** Survey and interviews **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Family Health Scale: For each dimension, sum the scores to get a total score. Higher scores indicate better health. The ICE Family Perceived Support Questionnaires: Sum the scores for each item to get a total score. Higher scores indicate higher perceived support. The EQ-5D-5L: Digits for the five dimensions can be combined into a number that describes the patient's health from 11111 (full health) to 55555 (worst health). The General self-efficacy scale: Ranges between 10 and 40, a higher score indicating more self-efficacy. The Patient Health Questionnaire-9: Score ranges from 0 to 27 (5-9 are mild depression; 10-14 as moderate; 15-19 as moderately severe; ≥ 20 as severe). The National Comprehensive Cancer Network Distress thermometer, a single-item tool using a 0 (no distress) to 10 (extreme distress). The 2-item Connor-Davidson-Resilience Scale: Each item has a score between 0 and 4. Total scores are calculated by the two items. A higher score indicates higher resilience. **Measure:** To investigate family health during the cancer trajectory. **Time Frame:** 1 year #### Secondary Outcomes **Description:** To identify vulnerable families for the interviews, data from the survey will be used in accordance with the explanatory sequential design. To identify vulnerable patients and caregivers from the PRO-results, 10 items from the Family Health Scale long-form (items 4, 11, 16, 17, 18, 23, 26, 27, 31, 32), which corresponds to the Family Health short form, will be used. Each participant can have a final family health score between 0 and 10 points. Poor family health = 0-5 points; moderate family health = 6-8 points; excellent family health = 9-10 points \[30\]. If either the patient or the caregiver has a score indicating poor or moderate family health, the family will be considered a candidate for the interviews. Following this identification, interviews will be carried out to elucidate determinant factors for their vulnerability. **Measure:** to identify vulnerable families and examine determinants for their vulnerability at identifying vulnerable families. To identify vulnerable families **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * curative intended patients and their eventual appointed caregivers \>18 * breast-, prostate- colorectal cancer or lymphoma. Exclusion Criteria: * Not able to understand or give written informed consent * Not able to speak Danish or complete questionnaires in Danish **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with breast, prostate, colorectal cancer, or lymphoma and their appointed caregivers. The patients are to receive anti-neoplastic treatment with curative intent at one of the six hospitals included sites. ### Contacts Locations Module #### Locations **Location 1:** **City:** Odense C **Contacts:** ***Contact 1:*** - **Email:** laerke.tolstrup@rsyd.dk - **Name:** Lærke K. Tolstrup, PhD - **Phone:** +4540295129 - **Role:** CONTACT ***Contact 2:*** - **Email:** Karin.Dieperink@rsyd.dk - **Name:** Karin B. Dieperink, Professor - **Role:** CONTACT **Country:** Denmark **Facility:** Odense University Hospital **Status:** RECRUITING **Zip:** 5000 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Coyne E, Heynsbergh N, Dieperink KB. Acknowledging cancer as a family disease: A systematic review of family care in the cancer setting. Eur J Oncol Nurs. 2020 Dec;49:101841. doi: 10.1016/j.ejon.2020.101841. Epub 2020 Oct 14. **PMID:** 33130424 **Citation:** Adashek JJ, Subbiah IM. Caring for the caregiver: a systematic review characterising the experience of caregivers of older adults with advanced cancers. ESMO Open. 2020 Sep;5(5):e000862. doi: 10.1136/esmoopen-2020-000862. **PMID:** 32963088 **Citation:** Weiss-Laxer NS, Crandall A, Okano L, Riley AW. Building a Foundation for Family Health Measurement in National Surveys: A Modified Delphi Expert Process. Matern Child Health J. 2020 Mar;24(3):259-266. doi: 10.1007/s10995-019-02870-w. **PMID:** 31912378 **Citation:** Jansen L, Dauphin S, van den Akker M, De Burghgraeve T, Schoenmakers B, Buntinx F. Prevalence and predictors of psychosocial problems in informal caregivers of older cancer survivors - A systematic review: Still major gaps in current research. Eur J Cancer Care (Engl). 2018 Nov;27(6):e12899. doi: 10.1111/ecc.12899. Epub 2018 Aug 31. **PMID:** 30168877 **Citation:** Gray TF, Azizoddin DR, Nersesian PV. Loneliness among cancer caregivers: A narrative review. Palliat Support Care. 2020 Jun;18(3):359-367. doi: 10.1017/S1478951519000804. **PMID:** 31581964 **Citation:** Ochoa CY, Buchanan Lunsford N, Lee Smith J. Impact of informal cancer caregiving across the cancer experience: A systematic literature review of quality of life. Palliat Support Care. 2020 Apr;18(2):220-240. doi: 10.1017/S1478951519000622. **PMID:** 31588882 **Citation:** Cochrane A, Reid O, Woods S, Gallagher P, Dunne S. Variables associated with distress amongst informal caregivers of people with lung cancer: A systematic review of the literature. Psychooncology. 2021 Aug;30(8):1246-1261. doi: 10.1002/pon.5694. Epub 2021 May 4. **PMID:** 33945184 **Citation:** Northouse L, Williams AL, Given B, McCorkle R. Psychosocial care for family caregivers of patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1227-34. doi: 10.1200/JCO.2011.39.5798. Epub 2012 Mar 12. **PMID:** 22412124 **Citation:** Geng HM, Chuang DM, Yang F, Yang Y, Liu WM, Liu LH, Tian HM. Prevalence and determinants of depression in caregivers of cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(39):e11863. doi: 10.1097/MD.0000000000011863. **PMID:** 30278483 **Citation:** GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9. Erratum In: Lancet. 2020 Nov 14;396(10262):1562. **PMID:** 33069326 **Citation:** Konradsen H, Brodsgaard A, Ostergaard B, Svavarsdottir E, Dieperink KB, Imhof L, Luttik ML, Mahrer-Imhof R, Garcia-Vivar C. Health practices in Europe towards families of older patients with cancer: a scoping review. Scand J Caring Sci. 2021 Jun;35(2):375-389. doi: 10.1111/scs.12855. Epub 2020 Apr 14. **PMID:** 32291782 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14335 - Name: Prostatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M21314 - Name: Hematologic Neoplasms - Relevance: HIGH - As Found: Hematologic Neoplasms - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019337 - Term: Hematologic Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433336 **Acronym:** AF BP **Brief Title:** Effect of Blood Pressure on Cardiovascular Outcomes and Recurrence After Catheter Ablation in Patients With Atrial Fibrillation **Official Title:** Effect of Blood Pressure on Cardiovascular Outcomes and Recurrence After Catheter Ablation in Patients With Atrial Fibrillation #### Organization Study ID Info **ID:** lanzhou university second hosp #### Organization **Class:** OTHER **Full Name:** The Second Hospital of Lanzhou University #### Secondary ID Infos **Domain:** lanzhou university second hospital **ID:** lanzhou university **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-05-21 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-21 **Type:** ACTUAL #### Start Date **Date:** 2019-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Second Hospital of Lanzhou University #### Responsible Party **Investigator Affiliation:** The Second Hospital of Lanzhou University **Investigator Full Name:** Xiaowei Zhang **Investigator Title:** lanzhou university second hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Effect of blood pressure on cardiovascular outcomes and recurrence after catheter ablation in patients with atrial fibrillation ### Conditions Module **Conditions:** - Atrial Fibrillation, Persistent - Blood Pressure ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 800 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Year ### Arms Interventions Module #### Arm Group 1 **Description:** Atrial Fibrillation Recurrence Pulmonary Vein Isolation **Label:** Effect of blood pressure on cardiovascular outcomes and recurrence after catheter ablation in patien ### Outcomes Module #### Primary Outcomes **Description:** death AMI stroke **Measure:** cardiovascular events **Time Frame:** 1 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The inclusion criteria were age \&gt;18 years and a diagnosis of AF by electrocardiogram during the preceding six months or on admission Exclusion Criteria: No follow-up **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Between February 2019 and December 2024, 800 consecutive patients who had been referred to lanzhou University second Hospital for treatment of AF and underwent successful ablation were assessed ### Contacts Locations Module #### Locations **Location 1:** **City:** Lanzhou **Country:** China **Facility:** Lanzhou University Second Hospital **State:** Gansu **Zip:** 730030 #### Overall Officials **Official 1:** **Affiliation:** The Second Hospital of Lanzhou University **Name:** xiao wei xiaowei zhang, PHD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001145 - Term: Arrhythmias, Cardiac - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes ### 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: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001281 - Term: Atrial Fibrillation - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433323 **Brief Title:** Biological Anti-aging Efficacy of a Cosmetic Night Cream **Official Title:** Evaluation of Biological Anti-aging Efficacy of the Cosmetic Night Cream RV4983A- LA3365 in Women After 2 Months of Daily Use #### Organization Study ID Info **ID:** RV4983A20240122 #### Organization **Class:** INDUSTRY **Full Name:** Pierre Fabre Dermo Cosmetique ### Status Module #### Completion Date **Date:** 2024-07-26 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-19 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-28 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** SpinControl #### Lead Sponsor **Class:** INDUSTRY **Name:** Pierre Fabre Dermo Cosmetique #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In a previous study, the cosmetic night cream RV4983A- LA3365 has proven a great efficacy in reducing the clinical signs of skin aging, as well as a great tolerance. The skin structure and composition greatly evolve over the time, and deciphering the biological mechanisms by which the cosmetic night cream RV4983A- LA3365 reduces the signs of skin aging is therefore of great interest to deepen our efficacy evaluation and knowledge on skin aging biology. **Detailed Description:** An intra-individual, comparative study randomized will be conducted as monocentric trial in female adult 46 subjects are included 4 visits are planned: * Visit 1 (D1): Inclusion and 1st product application * Visit 2 (D28): Phone call follow-up * Visit 3 (D57): End of application and biopsies * Visit 4 (7 days after V3): Biopsies control and end-of-study For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum. The maximal duration of participation for a subject is 68 days. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Anti-aging cosmetic care product **Label:** Treated group : Healthy female adults ### Interventions #### Intervention 1 **Arm Group Labels:** - Treated group : Healthy female adults **Description:** This is an intra-individual comparison study. * frequency of application: Once a day (in the evening) * modalities of application: Apply the cream on the tested area determined by the randomization * duration of investigational product application: 56 days (a window of + 72 hours is allowed) **Name:** Anti-aging cosmetic care product **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Will be determined from skin biopsies. **Measure:** Biological efficacy assessed by the analysis of proteins expression related to aging. **Time Frame:** Day 57 **Description:** The occurrence of Adverse Events will be determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation. **Measure:** General safety assessed by the occurence of Adverse Events. **Time Frame:** Day 1 to Day 68 **Measure:** Compliance calculated from data reported by the subject in her diary. **Time Frame:** Day 1 to Day 57 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject with phototype I, II or III according to the Fitzpatrick scale Non-inclusion Criteria: * Criteria related to the subject's health / skin : * Subject having any dermatologic condition or characteristics (like tattoo) on any of the target areas liable to interfere with the study assessments * Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements * Subject having received on any of target areas artificial UV exposure, excessive or prolonged exposure to natural sunlight within 2 weeks before the inclusion visit or planning to be exposed to artificial UV, excessive or prolonged natural sunlight during the study and up to 3 months after completion of study participation * Subject hirsute on the target areas * Subject having contraindication to the local anaesthetic used for biopsies * Subject with known immune deficiency * Subject with a recognised addiction to alcohol or drug * Subject with a scar pathology or pathology with consequences for healing such as diabetes * Subject with known history of hepatitis B or C or known HIV positive status * Subject with hereditary or acquired haemostasis disorder * Smoker \> 10 cigarettes/day with nicotine (or equivalent in electronic cigarettes) * Criteria related to treatments and/or products: * Surgical, chemical or significant invasive treatment on any of the target areas within 6 months before the inclusion or planned during the study * Techniques with aesthetic aim on any of the target areas (laser, pulsed flash lamp etc.) or injections of reshaping products (collagen, hyaluronic acid, botulinic toxin etc.) within 6 months before the inclusion or planned during the study * Oral isotretinoin taken within 6 months before the inclusion or planned during the study * Phototherapy treatment on any of the target areas within 2 months before the inclusion or planned during the study * Systemic treatment likely to affect haemostasis (anticoagulants, platelet antiaggregants, etc.) taken within the weeks before the inclusion or planned during the study * Systemic treatment may interfere with the healing process (non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants) taken within the weeks before the inclusion or planned during the study * Systemic treatment or topical treatment applied on any target areas likely to interfere with the local anesthetic (anti-arhythmic, beta blockers etc.) within the weeks before the inclusion or planned during the study * Topical non-steroidal anti-inflammatory, dermocorticoids, immunomodulators applied on any of the target areas within the 2 weeks before the inclusion or planned during the study * Topical skincare product (e.g. exfoliation, scrub, body mask) applied on any of the target areas within 7 days before the inclusion or planned during the study **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 40 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Healthy female volunteers. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** adeline.bacquey@pierre-fabre.com **Name:** Adeline BACQUEY **Phone:** +335.34.50.65.33 **Role:** CONTACT **Contact 2:** **Email:** christophe.chamard@pierre-fabre.com **Name:** Christophe CHAMARD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** SpinControl **Name:** Elisabeth GUITTON-OUDET, Dr **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:** NCT06433310 **Brief Title:** Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study **Official Title:** Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study #### Organization Study ID Info **ID:** 23-09026469 #### Organization **Class:** OTHER **Full Name:** Weill Medical College of Cornell University ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Weill Medical College of Cornell University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes in fungal populations in the gut microbiome. **Detailed Description:** The human gastrointestinal tract hosts a diverse microbial community that has a role in influencing the host's pathophysiological responses. Although there is an abundance of metagenomic data available, the functional dynamics of the gut microbiota still need exploration in different conditions. The microbiota produces various metabolites from dietary products, impacting both host health and pathophysiological functions. The metabolites produced by different microbiota may selectively suppress or stimulate the growth of some components of the gut microbiome, ultimately influencing the dynamic of gut bacterial and fungal populations. Our lab is specifically interested in a metabolite, known as phenylpropionic acid (PPA) produced by a human gut resident bacteria known as Clostridium sporogenes. C.sporogenes produces PPA by metabolizing the amino acid, L-phenylalanine, which is sourced from human diet. Many studies have observed the antimicrobial and antifungal effects of PPA. Our lab determined the antifungal activity of PPA through decreased levels of Candida albicans in the mouse gut. We are interested in investigating how diversity in mycobiota populations, which focuses on the fungi species in the human gut, are related to changes in PPA levels. Therefore, this study will assess whether additional oral supplementation of L-Phenylalanine has any effect on the way C. sporogenes metabolizes phenylalanine. Healthy subjects will receive a 14-day supply of L-phenylalanine supplements and will provide stool and blood samples to the study team. ### Conditions Module **Conditions:** - Gut Microbiome - Gut Health - Dietary Supplement - L-Phenylalanine - Phenylpropionic Acid ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive one bottle of L-Phenylalanine 500 mg Veg Capsule product on Day 0. All subjects will be asked to start taking the supplement on Day 1 continuing until Day 14. They will be asked to take 2x 500 mg capsules in the morning and 1x 500 mg capsule in the evening daily for 14 days. **Intervention Names:** - Dietary Supplement: L-Phenylalanine 500 mg Veg Capsule product **Label:** Healthy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy **Description:** 500 mg Veg Capsule product **Name:** L-Phenylalanine 500 mg Veg Capsule product **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention **Measure:** Change in phenylpropionic acid levels from baseline in subject fecal material **Time Frame:** Baseline, Week 2 (Day 14) **Description:** Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis. **Measure:** Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material **Time Frame:** Baseline, Week 2 (Day 14) **Description:** Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens **Measure:** Change in the number of T cells that react to fungal antigens from baseline in subject blood samples **Time Frame:** Baseline, Week 2 (Day 14) #### Secondary Outcomes **Description:** Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention **Measure:** Change in phenylpropionic acid levels from baseline in subject fecal material **Time Frame:** Baseline, Week 4 (Day 28) **Description:** Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis. **Measure:** Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material **Time Frame:** Baseline, Week 4 (Day 28) **Description:** Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens **Measure:** Change in the number of T cells that react to fungal antigens from baseline in subject blood samples **Time Frame:** Baseline, Week 4 (Day 28) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female adults over the age of 18 years Exclusion Criteria: * History of a diagnosis of any gastrointestinal condition, such as inflammatory bowel syndrome or disease * Antibiotic usage within the past two weeks * Antifungal usage within the past month * Allergy to L-Phenylalanine or individuals with phenylketonuria (PKU) * Adults taking medications known to interact with L-phenylalanine supplements, such as Monoamine Oxidase Inhibitors (MOAI), L-DOPA, and some antipsychotic drugs (complete and extensive drug list will be provided to interested participants during screening) * Pregnant or nursing women **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tss4002@med.cornell.edu **Name:** Tsering D Sherpa-Ngima, BSc **Phone:** 929-328-9571 **Role:** CONTACT #### Locations **Location 1:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** tss4002@med.cornell.edu - **Name:** Tsering D Sherpa-Ngima, BSc - **Phone:** 929-328-9571 - **Role:** CONTACT ***Contact 2:*** - **Name:** Iliyan D Iliev, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Belfer Research Building **State:** New York **Zip:** 10022 #### Overall Officials **Official 1:** **Affiliation:** Weill Medical College of Cornell University **Name:** Iliyan D Iliev, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: AA - Name: Amino Acids - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T14 - Name: Phenylalanine - Relevance: HIGH - As Found: Glass ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433297 **Brief Title:** Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars **Official Title:** Comparative Evaluation of Indirect and Direct Pulp Capping After Partial or Complete Caries Removal in Deeply Carious Mature Permanent Mandibular Molars With Moderate Pulpitis: A Randomized Clinical Trial #### Organization Study ID Info **ID:** Soma Chanakya #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-12-23 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Postgraduate Institute of Dental Sciences Rohtak #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. Objectives: 1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. 2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. 3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis. **Detailed Description:** Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristics, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which corresponds to irreversible pulpitis. Vital pulp therapy is suggested to be the choice of treatment for such cases. It has been suggested that infection is often a cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Partial caries removal, which involves complete removal of carious dentine from the surrounding cavity walls, followed by the partial removal of infected dentin at the pulpal wall which reduce chances of pulp exposure followed by placement of medicament for Indirect pulp capping. Whereas during Complete caries removal, caries is completely removed from surrounding walls as well as on pulpal wall which increase the chances of pulp exposure followed by placement of medicament for Direct pulp capping procedure. Based on this premise, IPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of direct pulp capping, partial pulpotomy or full pulpotomy in adults. Research Question Does Indirect Pulp Capping have comparable outcome with Direct pulp capping after partial caries removal in deeply carious mature permanent molars with clinical signs indicative of moderate pulpitis? P (Population) - Deeply carious mature Permanent Mandibular molars with clinical signs indicative of moderate pulpitis I (Intervention) - Partial caries removal followed by Indirect pulp capping C (Comparison) - Complete caries removal followed by Direct pulp capping O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up. * To assess incidence and reduction in pain post operatively at every 24 hours till 1 week. ### Conditions Module **Conditions:** - Indirect Pulp Capping - Reversible Pulpitis **Keywords:** - indirect pulp capping - selective caries removal - moderate pulpitis - direct pulp capping - deep caries - complete caries removal - mature permanent mandibular molars ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** Considering the nature of intervention, masking of the operator will not be possible once he begins the caries removal. Patients will be unaware of the groups in which their allocation will take place. At the time of assessing data masking will be done by masking the entire crown of the tooth before evaluation by endodontist using Adobe Photoshop CS6. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 106 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS **Label:** Partial caries removal followed by Indirect pulp capping. **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS **Label:** Complete caries removal followed by Direct Pulp Capping **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Complete caries removal followed by Direct Pulp Capping - Partial caries removal followed by Indirect pulp capping. **Description:** After partial caries removal the cavity is disinfected, dried, and capped with a 2-3mm layer of MTA followed by a light-cured resin layer. The tooth is then definitively restored with composite. Following complete caries removal, any bleeding pulp will be controlled with sodium hypochlorite for up to 5 minutes. Exposed pulp will then be directly capped with a 2-3mm layer of MTA, followed by a light-cured resin layer and definitive composite restoration using an etch-and-rinse technique. **Name:** INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. **Measure:** Clinical Success Rate **Time Frame:** Base line to 12 months **Description:** No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. **Measure:** Radiographic success **Time Frame:** Base line to 12 months #### Secondary Outcomes **Description:** Post operative pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to100 millimeter line. **Measure:** Pain incidence and reduction **Time Frame:** Baseline to seven days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The patient should be ≥18 years of age. 2. Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit). 7. Pulp exposure after complete caries excavation. 8. No pulp exposure after incomplete caries excavation Exclusion Criteria: 1. Teeth with immature roots. 2. Pulp exposure after incomplete caries excavation. 3. No pulp exposure after complete caries excavation. 4. Bleeding could not be controlled in 5 minutes. 5. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure. 6. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month. 7. Internal/external resorption. 8. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine) **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 29vinaykr@gmail.com **Name:** Dr. Vinay Kumar, MDS **Phone:** 8901149107 **Role:** CONTACT **Contact 2:** **Email:** Chanakyasoma5@gmail.com **Name:** Dr. Soma Chanakya, MDS **Phone:** 7396287866 **Role:** CONTACT #### Locations **Location 1:** **City:** Rohtak **Country:** India **Facility:** PGIDS, Rohtak **State:** Haryana #### Overall Officials **Official 1:** **Affiliation:** PGIDS, Rohtak, Haryana, 124001 **Name:** Dr, Sanjay Tewari, MDS **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003788 - Term: Dental Pulp Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14525 - Name: Pulpitis - Relevance: HIGH - As Found: Pulpitis - ID: M6984 - Name: Dental Pulp Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011671 - Term: Pulpitis ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M15775 - Name: Sodium Hypochlorite - Relevance: LOW - As Found: Unknown - ID: M44557 - Name: Eusol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433284 **Acronym:** MACROHOLE **Brief Title:** Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes **Official Title:** Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes (MACROHOLE): a Randomized-control Trial #### Organization Study ID Info **ID:** WU999 #### Organization **Class:** OTHER **Full Name:** Walailak University ### Status Module #### Completion Date **Date:** 2027-01-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01-30 **Type:** ESTIMATED #### Start Date **Date:** 2025-01-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Walailak University #### Responsible Party **Investigator Affiliation:** Walailak University **Investigator Full Name:** Jakkrit Juhong **Investigator Title:** Jakkrit Juhong, 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 human amniotic membrane (hAM) patch, introduced by Rizzo et al. in 2018, showed a 100% anatomical success rate for large or failed macular holes over a 6-month follow-up. Despite its regenerative properties like promoting angiogenesis and having low immunogenicity, its clinical use is limited by challenges such as trimming to fit small holes and complications during insertion. To overcome these issues, decellularized amniotic membrane (dAM) has been processed into a hydrogel form, enhancing its applicability and allowing it to be used as an injectable hydrogel for minimally invasive therapies. While dAM hydrogels have been used in various medical fields, their application in intraocular surgery is new. This study proposes using dAM hydrogel for large macular hole closure, comparing its effectiveness to the inverted ILM flap technique in a randomized controlled trial. **Detailed Description:** A macular hole (MH) is a neuroepithelial defect in the macular area of the retina. The estimation of macular hole incidence about 33 of every 10,000 person in individuals older than 55 years old1. The female-to-male ratio is 2 to 3:1. Idiopathic macular hole (IMH) is MHs occurring independently of primary ocular diseases such as trauma and vitreoretinopathy2 and represents the predominant subtype of MH, constituting approximately 83%1. There is a 5% to 15% risk of developing macular hole in the other eye if a macular hole develops in one eye.1 In 1988, Gass proposed a classification system for idiopathic macular holes, as well as a new hypothesis for its pathogenesis, which emphasizes the role of the vitreo-macular tangential traction in the formation of macular holes3. Macular hole closure can occurred spontaneously in approximately 5-10% cases in early stages. Pars plana vitrectomy with internal limiting membrane (ILM) peeling and gas tamponade has been the standard of care of small size macular hole treatment with success rate more than 90%4. However, in large macular hole more than 400 um, the success rate is lower. Previous study showed closure rate of large macular hole \> 400 μm is 56% with poor visual outcome.4,5 Several new techniques have been described to improve anatomical and functional outcomes in cases of large macular holes by inserting alternative tissues into the macular hole, such as the ILM flap, human amniotic membrane patch6, or retinal tissue implantation, to promote anatomical closure and improve visual acuity. The utilization of ILM flap coverage has emerged as an effective surgical approach for treating large, full-thickness idiopathic MH and myopic MH. This technique was initially introduced in 1999, showing promising results in enhancing macular hole closure rates through ILM peeling. Several subsequent studies 7-9 have further substantiated the efficacy of ILM flap coverage, making it the standard surgical treatment for large macular hole cases. However, this technique is often hindered by limitations related to the technical complexity of surgery and the risk of retinal trauma. The human amniotic membrane (hAM) patch, proposed by Rizzo et al. in 20186, serves as another alternative technique for large or failed macular hole cases. The anatomical success rate was 100% during the 6 months follow-up. The exceptional biological properties of hAM, including its promote angiogenesis10, low immunogenicity11, and anti-inflammatory11,12, anti-fibrotic13, and antibacterial characteristics14, make it highly suitable for regenerative medicine and intraocular implantation. However, the clinical application of thin hAM sheets is limited by several challenges, such as the difficulty of trimming it to fit very small hole sizes (\< 0.2 cm), tissue loss after insertion into the PPV port, and complications during the insertion of the hAM patch into the hole. To address these limitations, processing decellularized amniotic membrane (dAM) tissue into a hydrogel form has enhanced its processability and applicability15. This transformation allows it to be used as an injectable hydrogel for minimally invasive therapies and facilitates its manipulation into the macular hole. dAM hydrogels have been applied in various fields, including skin repair, cardiac treatment, cartilage regeneration, endometrial regeneration, vascular grafts, dental pulp regeneration, and as cell culture/carrier platforms. However, their use in intraocular surgery has not yet been established. Additionally, the benefits of dAM hydrogel over hAM tissue include lower immunogenicity due to the decellularization processs since the resident cells may cause intense host immunologic reactions after transplantation and transplant rejection and the homogeneous distribution of biochemical substances within the hydrogel structure.15 In this study, we will be the first to propose a new technique and invention for closing large macular holes using human amniotic membrane hydrogel filling in the hole after standard ILM peeling. We conducted a randomized controlled trial to compare the anatomical and visual outcomes of the inverted ILM flap technique (IFT) with the dHM hydrogel technique in idiopathic large macular holes with a minimum diameter (MD) greater than 400 μm. ### Conditions Module **Conditions:** - Macular Holes **Keywords:** - macular holes, decellularized amniotic membrane ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 26 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who will undergo 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade. **Intervention Names:** - Procedure: 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade **Label:** Inverted flap **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients who will undergo 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling, amniotic membrane hydrogel filling and SF6 tamponade. **Intervention Names:** - Procedure: 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade **Label:** Amniotic membrane hydrogel **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Inverted flap **Description:** Standard 3 port 25-gauge pars plana vitrectomy with inverted flap technique after brilliant blue dye staining and SF6 tamponade. "Flower petal" type of inverted flap will be performed - multiple small ILM flaps will be created around the macular hole and placed over the macular hole **Name:** 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Amniotic membrane hydrogel **Description:** Standard 3 port 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling around the macular hole after brilliant blue dye staining then filling the hole with amniotic membrane hydrogel and sulfur hexafluoride (SF6) tamponade **Name:** 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique **Measure:** Best corrected visual acuity (BCVA) **Time Frame:** 6 months **Description:** Closure rate after primary vitrectomy for idiopathic full thickness macular holes with decellularized amniotic membrane hydrogel versus inverted flap technique **Measure:** Closure rate **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \>18 years old * idiopathic full thickness macular hole \> 400 micron of diameter * phakic or pseudophakic * absence of systemic adverse conditions Exclusion Criteria: * idiopathic full thickness macular hole \> 1,500 micron of diameter * traumatic macular holes * myopic macular holes, * concomitant retinal and other ocular disease * previous ocular surgery except cataract surgery **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jakkrit.ju@wu.ac.th **Name:** Jakkrit Juhong, MD. **Phone:** +66816773406 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** School of Medicine, Walailak university **Name:** Jakkrit Juhong, MD. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15002 - Name: Retinal Perforations - Relevance: HIGH - As Found: Macular Hole - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012167 - Term: Retinal Perforations ### 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: D000014151 - Term: Anti-Anxiety Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018757 - Term: GABA Modulators - ID: D000018682 - Term: GABA Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16465 - Name: Temazepam - Relevance: HIGH - As Found: Boston - ID: M10043 - Name: Hypnotics and Sedatives - 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: M20827 - Name: GABA Modulators - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000013693 - Term: Temazepam ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433271 **Brief Title:** Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure **Official Title:** Comparative Effectiveness of Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure #### Organization Study ID Info **ID:** Pro00134707 #### Organization **Class:** OTHER **Full Name:** The University of Texas Health Science Center, Houston #### Secondary ID Infos **Domain:** United States Army Medical Research and Development Command **ID:** PR230007 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2029-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Ralph H. Johnson VA Medical Center **Class:** FED **Name:** U.S. Army Medical Research and Development Command #### Lead Sponsor **Class:** OTHER **Name:** The University of Texas Health Science Center, Houston #### Responsible Party **Investigator Affiliation:** The University of Texas Health Science Center, Houston **Investigator Full Name:** Ronald E. Acierno **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:** Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition. We will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. We hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST. **Detailed Description:** Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. Currently, the VA suggests a problem solving cognitive behavioral therapy, but this recommendation is not based on replicated, randomized controlled trials. Transdiagnostic Behavior Therapy (TBT), is based on key 'active components' of existing evidence based treatments such as Prolonged Exposure and Behavioral Activation, has been designed by this research team to be easily trained and inexpensively disseminated, and has been evaluated in a series of pilots with anxiety and depression disorders that, importantly, represent the key symptom classes of adjustment disorder. Thus, the rationale for the proposed trial is that the research team has done preliminary efficacy testing of an easily exportable intervention that has impact on the key symptoms of adjustment disorder, and the standard of evidence demands replicated, randomized controlled trials to determine if initial signals of positive effect are sustained. The study will use a 2 group repeated measures randomized controlled design to evaluate effectiveness of TBT for AjD compared to treatment as usual (TAU-PST). Participants will be randomly assigned in equal numbers (n = 75; N = 150) to one of two treatment arms: (1) TBT or (2) TAU-PST. Participants assigned to TBT will receive 10-14, 45-60-minute, manualized, individual therapy sessions. Participants assigned to TAU-PST will receive 10-14, 45-60-minute sessions of Problem-Solving Therapy. Dependent measures will include Department of Defense (DoD) specified common data elements and specific measures of AjD, PTSD, anxiety, depression, and functioning collected by blinded assessors at baseline, post-treatment, 3-month, and 6-month follow-up. ### Conditions Module **Conditions:** - Adjustment Disorders - Mental Disorder **Keywords:** - Veterans - Military Personnel ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive 10-14, 45-60-minute, manualized, individual therapy sessions. **Intervention Names:** - Behavioral: Transdiagnostic Behavior Therapy (TBT) **Label:** Transdiagnostic Behavior Therapy (TBT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive 10-14, 45-60-minute individual therapy sessions. **Intervention Names:** - Behavioral: Treatment as Usual-Problem Solving Therapy (TAU-PST) **Label:** Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Transdiagnostic Behavior Therapy (TBT) **Description:** TBT manualized treatment incorporates daily exposure exercises from up to four categories of avoidance that are most characteristic of the emotional disorders (i.e., situational, interoceptive, imaginal, and positive emotional). **Name:** Transdiagnostic Behavior Therapy (TBT) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST) **Description:** PST is an evidence- based psychotherapy implemented in VA Primary Care - Mental Health Integration (PC-MHI), with hundreds of VA providers trained in the intervention nationally. The primary aim of PST is to improve a patient's ability to cope with stressful events by adopting an adaptive perspective to stressors and using goal-focused, problem-solving behaviors to manage the problems associated with the stressors. **Name:** Treatment as Usual-Problem Solving Therapy (TAU-PST) **Other Names:** - Moving Forward Problem Solving Therapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Adjustment Disorder New Module (ADNM) is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with International Classification of Diseases 11th Revision (ICD-11) criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder. **Measure:** Adjustment Disorder New Module Self Report **Time Frame:** Baseline **Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder. **Measure:** Adjustment Disorder New Module Self Report **Time Frame:** 1 week post treatment **Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder. **Measure:** Adjustment Disorder New Module Self Report **Time Frame:** 3 months post treatment **Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder. **Measure:** Adjustment Disorder New Module Self Report **Time Frame:** 6 months post treatment **Description:** The Post-traumatic stress disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity. **Measure:** PTSD Checklist-5 **Time Frame:** Baseline **Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity. **Measure:** PTSD Checklist-5 **Time Frame:** 1 week post treatment **Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity. **Measure:** PTSD Checklist-5 **Time Frame:** 3 months post treatment **Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity. **Measure:** PTSD Checklist-5 **Time Frame:** 6 months post treatment **Description:** The Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for major depressive disorder (MDD). This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression). **Measure:** Patient Health Questionnaire-9 **Time Frame:** Baseline **Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression). **Measure:** Patient Health Questionnaire-9 **Time Frame:** 1 week post treatment **Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression). **Measure:** Patient Health Questionnaire-9 **Time Frame:** 3 months post treatment **Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression). **Measure:** Patient Health Questionnaire-9 **Time Frame:** 6 months post treatment #### Secondary Outcomes **Description:** The Insomnia Severity Index (ISI) self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia. **Measure:** Insomnia Severity Index **Time Frame:** Baseline **Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia. **Measure:** Insomnia Severity Index **Time Frame:** 1 week post treatment **Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia. **Measure:** Insomnia Severity Index **Time Frame:** 3 months post treatment **Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia. **Measure:** Insomnia Severity Index **Time Frame:** 6 months post treatment **Description:** The Short Form-36 (SF-36) (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status. **Measure:** Medical Outcome Study Short Form-36 Health Survey **Time Frame:** Baseline **Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status. **Measure:** Medical Outcome Study Short Form-36 Health Survey **Time Frame:** 1 week post treatment **Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status. **Measure:** Medical Outcome Study Short Form-36 Health Survey **Time Frame:** 3 months post treatment **Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status. **Measure:** Medical Outcome Study Short Form-36 Health Survey **Time Frame:** 6 months post treatment **Description:** Number of treatment sessions completed. **Measure:** Dose Received **Time Frame:** 14 weeks after treatment starts ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult male or female over the age of 18 that has served, or is currently serving, in the military. * Stable psychotropic medication for at least 4 weeks if applicable * Current DSM-5 diagnosis of Adjustment Disorder Exclusion Criteria: * Active psychosis * Suicidal ideation with clear intent * Severe substance use **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** stephanie.hart4@va.gov **Name:** Stephanie M Hart, MPH **Phone:** 8435775011 **Phone Ext:** 205103 **Role:** CONTACT #### Locations **Location 1:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** stephanie.hart4@va.gov - **Name:** Stephanie M Hart, MPH - **Phone:** 843-577-5011 - **Phone Ext:** 205103 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ron Acierno, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Daniel Gros, PhD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Ralph H. Johnson VA Health Care System **State:** South Carolina **Zip:** 29401 #### Overall Officials **Official 1:** **Affiliation:** McGovern Medical School at UTHealth Houston **Name:** Ron Acierno, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Gros DF. Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. Psychiatry Res. 2014 Dec 15;220(1-2):275-82. doi: 10.1016/j.psychres.2014.08.018. Epub 2014 Aug 15. **PMID:** 25193379 **Citation:** Gros DF, Allan NP. A randomized controlled trial comparing Transdiagnostic Behavior Therapy (TBT) and behavioral activation in veterans with affective disorders. Psychiatry Res. 2019 Nov;281:112541. doi: 10.1016/j.psychres.2019.112541. Epub 2019 Aug 29. **PMID:** 31514043 **Citation:** Gros DF, Merrifield C, Rowa K, Szafranski DD, Young L, McCabe RE. A Naturalistic Comparison of Group Transdiagnostic Behaviour Therapy (TBT) and Disorder-Specific Cognitive Behavioural Therapy Groups for the Affective Disorders. Behav Cogn Psychother. 2019 Jan;47(1):39-51. doi: 10.1017/S1352465818000309. Epub 2018 May 29. **PMID:** 29807553 **Citation:** Gros DF, Szafranski DD, Shead SD. A real world dissemination and implementation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. J Anxiety Disord. 2017 Mar;46:72-77. doi: 10.1016/j.janxdis.2016.04.010. Epub 2016 Apr 27. **PMID:** 27158076 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M4815 - Name: Mental Disorders - Relevance: HIGH - As Found: Mental Disorders - ID: M3627 - Name: Adjustment Disorders - Relevance: HIGH - As Found: Adjustment Disorders - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001523 - Term: Mental Disorders - ID: D000000275 - Term: Adjustment Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433258 **Brief Title:** Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas **Official Title:** Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas: Tu Salud ¡Si Cuenta (TSSC)! #### Organization Study ID Info **ID:** HSC-SPH-23-1025 #### Organization **Class:** OTHER **Full Name:** The University of Texas Health Science Center, Houston ### Status Module #### Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Cancer Prevention Research Institute of Texas #### Lead Sponsor **Class:** OTHER **Name:** The University of Texas Health Science Center, Houston #### Responsible Party **Investigator Affiliation:** The University of Texas Health Science Center, Houston **Investigator Full Name:** Belinda Reininger **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to enhance the current TSSC multilevel intervention delivered in Cameron and Hidalgo counties by adding additional components including an educational module on the risks of alcohol intake and its connection to cancer, as well as developing training and referral systems to address social determinants of health (SDOH) that negatively impact uptake of cancer prevention behaviors. ### Conditions Module **Conditions:** - Cancer Prevention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Enhanced TSSC curriculum **Label:** Enhanced TSSC curriculum **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Original TSSC curriculum **Label:** Original TSSC curriculum **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Enhanced TSSC curriculum **Description:** In addition to the original TSSC curriculum participants will also be educated with the enhanced curriculum which includes components related to alcohol and social determinants of health needs) to promote cancer prevention through healthy lifestyles. **Name:** Enhanced TSSC curriculum **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Original TSSC curriculum **Description:** Participants will be educated with evidence-based modules focused on topics such as introduction to TSSC, physical activity, fruit and vegetable consumption, reduce sugar intake, diabetes, portion control, cancer, and high blood pressure.These modules are provided by community health workers who have been trained in the contents of the modules, as well as motivational interviewing techniques for delivering the modules. **Name:** Original TSSC curriculum **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** Change in percentage of participants that show an increase in moderate and vigorous physical activity minutes as assessed by the Physical Activity Questionnaire **Time Frame:** Baseline , 6 month follow up , 9 month month follow up **Measure:** Change in percentage of participants that report increase in fruit and vegetable intake as assessed by the Nutritious Eating Questionnaire **Time Frame:** Baseline , 6 month follow up , 9 month month follow up **Measure:** Change in percentage of participants that report a reduced quantity of alcohol intake as assessed by a questionnaire **Time Frame:** Baseline , 6 month follow up , 9 month month follow up **Measure:** Change in percentage of participants that report a reduced frequency of alcohol intake as assessed by a questionnaire **Time Frame:** Baseline , 6 month follow up , 9 month month follow up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * residents of partnering municipalities throughout Cameron and Hidalgo Exclusion Criteria: * participated in TSSC before **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Belinda.M.Reininger@uth.tmc.edu **Name:** Belinda Reininger, DrPH **Phone:** (956) 755-0600 **Role:** CONTACT **Contact 2:** **Email:** Maria.E.Zolezzi@uth.tmc.edu **Name:** Maria Zolezzi **Phone:** (956) 755-0600 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** Belinda.M.Reininger@uth.tmc.edu - **Name:** Belinda Reininger, DrPH - **Phone:** 956-755-0600 - **Role:** CONTACT ***Contact 2:*** - **Email:** Maria.E.Zolezzi@uth.tmc.edu - **Name:** Maria Zolezzi - **Phone:** (956) 755-0600 - **Role:** CONTACT **Country:** United States **Facility:** The University of Texas Health Science Center at Houston **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** The University of Texas Health Science Center, Houston **Name:** Belinda Reininger, DrPH **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06433245 **Brief Title:** Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy **Official Title:** Outcome Following Use of Different Concentrations of Sodium Hypochlorite as Wound Lavage and Hemostatic Agent in Partial Pulpotomy: A Randomised Control Trial #### Organization Study ID Info **ID:** Ridhi Karwal #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-12-23 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Postgraduate Institute of Dental Sciences Rohtak #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. The main question it aims to answer are: 1. clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis. 2. OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. **Detailed Description:** TITLE :- Outcome following use of different concentrations of NaOCl as wound lavage and hemostatic agent in partial pulpotomy: A Randomised control trial. Question it aims to answer: Does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? P (Population) -Mature permanent mandibular molars with signs of irreversible pulpitis. I (Intervention) - 5% NaOCl C (Comparison) - 3% NaOCl O (Outcome) - 1. Assessment of clinical and radiographic success at 12 months of follow up. 2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months. In literature pertaining to vital pulp therapy procedures, there is often a focus on comparing various materials or treatment methodologies. However, the use of sodium hypochlorite, holds significant importance in ensuring the successful outcome of the procedure. The previous studies indicate that the use of NaOCl presents as a confounding factor, compounded by variations among operators in their choice of high and low concentrations of NaOCl.So, there is a pressing need for a direct comparative analysis to assess the influence of varying sodium hypochlorite concentrations on the overall efficacy and success rates of vital pulp therapy procedures. ### Conditions Module **Conditions:** - Irreversible Pulpitis - Extremely Deep Caries - Partial Pulpotomy **Keywords:** - partial pulpotomy - sodium hypochlorite - mature permanent mandibular molars - hemostatic agent ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The operator, patient and the outcome assessor will be masked to the group allocation **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 116 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After partial pulpotomy procedure, pulp wound will be irrigated with 3% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 3% sodium hypochlorite on the amputated pulp. **Intervention Names:** - Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. **Label:** Control: 3% sodium hypochlorite **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** After partial pulpotomy procedure, pulp wound will be irrigated with 5% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 5% sodium hypochlorite on the amputated pulp. **Intervention Names:** - Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. **Label:** Test: 5% sodium hypochlorite **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control: 3% sodium hypochlorite - Test: 5% sodium hypochlorite **Description:** After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin. **Name:** effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Clinical criteria of success:- 1. No pain or discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Healthy soft tissues around teeth with no swelling, sinus tract. **Measure:** Clinical success rate **Time Frame:** baseline to 12 months **Description:** Radiographic success criteria:- 1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2. Complete radiographic healing **Measure:** Radiographic success rate **Time Frame:** Baseline to 12 months #### Secondary Outcomes **Description:** To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain **Measure:** Post Operative Pain **Time Frame:** Baseline to 7 days **Description:** OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL **Measure:** OHRQoL assessment **Time Frame:** baseline and at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, and then at 6 and 12 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Mature permanent mandibular molars. 2. Teeth with clinical diagnosis of symptomatic irreversible pulpitis 3. Patients having normal periapical status with periapical index (PAI) score ≤ 2 4. Periodontally healthy teeth 5. Patients having physical status of class 1 or 2 according to ASA classification 6. Pulpal bleeding can be controlled within 6 minutes. 7. Presence of extremely deep carious lesion on radiograph - Exclusion Criteria: 1) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women - **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drps_1@yahoo.co.in **Name:** Dr. Pankaj Sangwan, MDS **Phone:** 9996112202 **Role:** CONTACT **Contact 2:** **Email:** ridhikarwal56@mail.com **Name:** Ridhi Karwal, MDS **Phone:** 9958430414 **Role:** CONTACT #### Locations **Location 1:** **City:** Rohtak **Contacts:** ***Contact 1:*** - **Email:** drps_1@yahoo.co.in - **Name:** DR. Pankaj Sangwan, MDS - **Phone:** 9996112202 - **Role:** CONTACT ***Contact 2:*** - **Email:** principalpgids@yahoo.in - **Name:** : DR. Sanjay TewarI, MDS - **Phone:** 9416259534 - **Role:** CONTACT **Country:** India **Facility:** PIGDS **State:** Haryana **Status:** RECRUITING **Zip:** 124001 #### Overall Officials **Official 1:** **Affiliation:** PGIDS, Rohtak, Haryana 124001 **Name:** Dr. Sanjay Tewari, MDS **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003788 - Term: Dental Pulp Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M14525 - Name: Pulpitis - Relevance: HIGH - As Found: Pulpitis - ID: M6984 - Name: Dental Pulp Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011671 - Term: Pulpitis ### Intervention Browse Module - Ancestors - ID: D000004202 - Term: Disinfectants - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Coag - Name: Coagulants ### Intervention Browse Module - Browse Leaves - ID: M15775 - Name: Sodium Hypochlorite - Relevance: HIGH - As Found: Cash - ID: M44557 - Name: Eusol - Relevance: HIGH - As Found: Cash - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M7383 - Name: Disinfectants - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000012973 - Term: Sodium Hypochlorite - ID: C000024611 - Term: Eusol ### Misc Info Module - Version Holder: 2024-05-31