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## Protocol Section ### Identification Module **NCT ID:** NCT06426342 **Brief Title:** Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression **Official Title:** Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression: Applying Intervention Mapping #### Organization Study ID Info **ID:** Mindguide_Employee #### Organization **Class:** OTHER **Full Name:** Ewha Womans University ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ewha Womans University #### Responsible Party **Investigator Affiliation:** Ewha Womans University **Investigator Full Name:** Suk-Sun Kim, PhD. MSN. RN **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this feasibility study is to develop a new metaverse-based blended online intervention using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. In addition, this study primarily explores reach and acceptability and secondarily evaluates the preliminary effectiveness of this preventive intervention on Korea's Gen MZ Employees. ### Conditions Module **Conditions:** - Depression and Suicide ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: metaverse-based blended online intervention **Label:** Mindguide_employee **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mindguide_employee **Description:** A new metaverse-based blended online intervention was developed using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. **Name:** metaverse-based blended online intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Recruitment will be assessed by the number of potentially eligible participants enrolled. **Measure:** Recruitment **Time Frame:** Initial (before intervention) **Description:** The retention rate will be calculated as the percentage of completion rates for the entire intervention and questionnaires until the completion of a 5 weeks after intervention. **Measure:** The retention rate **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Acceptability refers to how participants perceive and feel about the intervention and its components (Ayala \& Elder, 2011; Sekhon et al., 2017). A 13- item questionnaire was developed based on the Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979; Sveen et al., 2021) to measure acceptability with three subcategories: helpfulness (three items), suitability (seven items), and satisfaction (three items). Participants responded on a 5- point Likert scale ranging from 1 (not at all) to 5 (very). **Measure:** Acceptability **Time Frame:** at 5 weeks after intervention. #### Secondary Outcomes **Description:** The Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977; Chon et al., 2001) with 20- item will be used to measure depressive symptoms using a 4- point Likert scale. The total score ranges from 0 to 60, with higher scores indicating higher levels of depressive symptoms. **Measure:** Depression scale **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Positive and Negative Affect Schedule (PANAS; Watson et al., 1988; Park \& Lee, 2016) will used to measure positive and negative affect using a 5- point Likert scale. The total score ranges from 10 to 50, with higher scores indicating a greater perception of positive affect or negative affect. **Measure:** Positive and Negative Affect Schedule **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** the Satisfaction with Life Scale (SWLS; Diener et al., 1985; Lim et al., 2010) with 5- items will be used to assess life satisfaction using a 7- point Likert scale. The total score ranges from 5 to 35, with higher scores indicating greater life satisfaction. **Measure:** Satisfaction with Life Scale **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Burnout assessment tool (BAT; Schaufeli et al., 2020; Cho, 2020) with 23 items will be used to measure burnout including four core burnout symptoms: Exhaustion, Mental Distance, Emotional Impairment, and Cognitive Impairment. Exhaustion is the loss of physical and mental energy. Mental distance refers to psychological distancing from work or people at work. Emotional impairment is emotional reactions, such as frustration and irritability, brought on by burnout; and Cognitive impairmentthe is memory problems, attention and concentration deficits and poor cognitive performance. **Measure:** Burnout assessment tool **Time Frame:** Initial(before intervention), at 5 weeks after intervention. **Description:** Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989; Sohn, 2012) with 19 items will be used to evaluate overall sleep quality. 19 self-reported items includes seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep effi ciency, sleep disturbances, use of sleeping medication, and daytime dysfunction **Measure:** Sleep Quality scale **Time Frame:** Initial(before intervention), at 5 weeks after intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Generation MZ Employees of South Korea who are aged between 20 and 42; Millennials were born between 1981 to 1996, and Generation Zs were born between 1997 to 2004 Exclusion Criteria: * 1) being unemployed or having less than 1 year job experience, * 2) having mental disorders such as schizophrenia or substance abuse (as this is a preventive intervention) and currently attending other mental health therapy to avoid mixing effects. **Healthy Volunteers:** True **Maximum Age:** 42 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Suk-Sun Kim, PhD **Phone:** +82-2-3277-2885 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000016728 - Term: Self-Injurious Behavior ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M16191 - Name: Suicide - Relevance: HIGH - As Found: Suicide - 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: M19089 - Name: Self-Injurious Behavior - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000013405 - Term: Suicide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426329 **Brief Title:** The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety **Official Title:** The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety #### Organization Study ID Info **ID:** TR SİVAS 04 #### Organization **Class:** OTHER **Full Name:** Cumhuriyet University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-27 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cumhuriyet University #### Responsible Party **Investigator Affiliation:** Cumhuriyet University **Investigator Full Name:** Sukran Ertekin Pinar **Investigator Title:** Doç. Profesör Doktor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety. **Detailed Description:** Methods: The sample of this randomized controlled experimental research consisted of 66 (intervention group: 33; control group: 33) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Traumatic Childbirth Perception Scale. ### Conditions Module **Conditions:** - Pregnancy - Vaginal Delivery **Keywords:** - Therapeutic Touch - Labor Pain - Birth Duration - Anxiety - Traumatic Birth Perception ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the latent phase of the first stage of labour, and the second was done in the active phase of labour. **Intervention Names:** - Behavioral: Therapeutic Touch **Label:** Therapeutic touch Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group did not receive any treatment. **Label:** Standard of care Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Therapeutic touch Group **Description:** Therapeutic touch, as meaningful touch, is included in complementary medicine in the literature. It provides physical, emotional and spiritual relief, improves physiological health, makes the person feel valuable, gives confidence, peace, calmness and increases self-confidence. **Name:** Therapeutic Touch **Other Names:** - Control Group **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain. **Measure:** Visual Analogue Scale **Time Frame:** Baseline **Description:** It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety". **Measure:** State Anxiety Inventory **Time Frame:** Baseline **Description:** It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth **Measure:** Traumatic Birth Perception Scale **Time Frame:** Baseline #### Secondary Outcomes **Description:** It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain. **Measure:** Visual Analogue Scale **Time Frame:** Postpartum in 2 hour **Description:** It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety". **Measure:** State Anxiety Inventory **Time Frame:** Postpartum in 2 hour **Description:** It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth **Measure:** Traumatic Birth Perception Scale **Time Frame:** Postpartum in 2 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Not having a high-risk pregnancy Having no health problems with the baby or herself Having a single foetus Being about to have a vaginal delivery Not having a chronic physical or psychiatric diagnosis Agreeing to participate in the research Not having communication and perception problems Miad (37W\<) pregnancy Having with induction application Exclusion Criteria: having vacuum, forceps etc. intervention such as **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sukran Ertekin Pinar, Ph.D. **Phone:** 05342831124 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Busra Akkaya **Phone:** 05347880166 **Role:** CONTACT #### Locations **Location 1:** **City:** Sivas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sukran Ertekin Pinar - **Phone:** +905342831124 - **Role:** CONTACT ***Contact 2:*** - **Name:** Busra Akkaya, MSc. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Sukran Ertekin Pinar **Status:** RECRUITING **Zip:** 58140 #### Overall Officials **Official 1:** **Affiliation:** Cumhuriyet University **Name:** Sukran Ertekin Pinar, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** There is not a plan to make IPD available. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M26008 - Name: Labor Pain - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M5002 - Name: Birth Injuries - Relevance: HIGH - As Found: Traumatic Birth - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001720 - Term: Birth Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426316 **Acronym:** SIIM **Brief Title:** The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology. **Official Title:** Immune System, Inflammation, Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology #### Organization Study ID Info **ID:** RBHP 2023 STUCHFIELD #### Organization **Class:** OTHER **Full Name:** University Hospital, Clermont-Ferrand #### Secondary ID Infos **Domain:** ANSM **ID:** 2023-A01503-42 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Clermont-Ferrand #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Migraine is a frequent and debilitating neurologic disorder. It is more frequent in women, and more prevalent in patients with autoimmune and/or inflammatory diseases such as multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn's disease (CD), systemic lupus erythematosus (SLE) and endometriosis, whereas patients with long standing type 1 diabetes mellitus (T1DM) - an autoimmune but non inflammatory disease - seem to be less affected compared to the general population. Despite new migraine prevention treatments, a large number of patients remain unresponsive to currently available anti-migraine therapy and migraine pathophysiology remains unclear. Several peptides (calcitonin gene-related peptide (CGRP), pituitary adenylate cyclase activating peptide-38 (PACAP-38), vasoactive intestinal polypeptide (VIP)) and hormones (estrogens, prolactin) and the immune system play an important role in migraine pathophysiology. Among T lymphocytes, regulatory T (Treg) cells suppress inflammation. Studies have evidenced higher levels of inflammatory molecules (cytokines) in migraine patients and have suggested decreased proportions of Treg cells in migraine, as well as in MS, RA, CD and SLE, whereas inflammation declines and Treg levels seem increased in long-standing T1DM. Inflammation, which participates in migraine pain, seems to be a common factor for migraine and these diseases. However, these studies display conflicting results and further investigation is required to better understand the mechanisms behind migraine. In this study, the investigators will compare Treg levels, as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmune/inflammatory disorder (MS, RA, CD, SLE, T1DM and endometriosis). **Detailed Description:** Migraine is the 6th most frequent disease (14% of the population) and the second leading cause of disability worldwide. From puberty and onward, migraine is 2 to 3 times more frequent in women, which also suffer from more severe attacks. Migraine is also up to twice as prevalent in patients suffering from autoimmune or inflammatory diseases such as multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn disease (CD), systemic lupus erythematosus (SLE) and endometriosis, whereas patients with long standing type 1 diabetes mellitus (T1DM) - an autoimmune but non inflammatory disease - seem to be less affected compared to the general population. Despite the identification of the role of peptides such as CGRP in migraine pathophysiology and the development of targetted anti-CGRP treatments, many patients remain unresponsive and the mechanisms behind migraine are still unclear. The trigemino-vascular system is involved in the perception of migraine pain. Migraine occurs with trigemino-cervical neuron sensitization, leading to peptide secretion (such as CGRP, PACAP-38 and VIP), which induce neurogenic inflammation that is responsible for vasodilation, capillary leakage, oedema and further sensitization of the trigemino-vascular system, leading to amplified perception of migraine pain. CGRP, PACAP-38 and VIP infusions all induce migraine attacks in migraine patients, and only mild or no headache in healthy volunteers. Sex hormones, prolactin and insulin are also involved in migraine pathophysiology, and the immune system, through cytokine production and immune cell dysregulations seems to also play a role in the pathogenesis of migraine. Both are closely related as sex hormone levels may have an influence on the levels of certain immune cell subtypes. Several pro-inflammatory cytokines (tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma and interleukin (IL)-6) were shown to be elevated in migraine patients but also inflammatory diseases such as MS and endometriosis compared to controls and are associated with migraine pathophysiology. Inflammation seems to be a common factor for migraine and these diseases. However, these studies provide conflicting results and further investigation is needed to better understand the role of inflammation in migraine pathophysiology. Among T lymphocytes, regulatory T (Treg) cells regulate inflammation by suppressing effector T cells through several suppressive mechanisms such as IL-10 secretion or the hydrolysis of pro-inflammatory and nociceptive adenosine triphosphate (ATP) into anti-inflammatory and anti-nociceptive adenosine by cluster of differentiation (CD) 39 and 73 enzymes on the Treg cell surface. Recent studies have suggested decreased Treg proportions in migraine patients, particularly CD 39 and CD 73-positive Treg cells, whereas Treg cells were shown to be increased in T1DM patients. This suggests the role of Treg cells in migraine, but further studies are needed. In this study, the investigators aim to compare Treg levels, as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmune/inflammatory disorder (MS, RA, CD, SLE, T1DM and endometriosis). This will provide better understanding of migraine pathophysiology and lead to the development of targeted and personalized treatment strategies, according to the immune pain profile and associated inflammatory diseases of migraine patients. ### Conditions Module **Conditions:** - Migraine Disorders - Pain - Autoimmune Diseases - Multiple Sclerosis - Endometriosis - Rheumatoid Arthritis - Crohn Disease - Lupus Erythematosus **Keywords:** - Migraine Disorders - Pain - Cytokines - Regulatory T cell ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 396 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Migraine - no autoimmune/inflammatory disease group **Intervention Names:** - Biological: Blood test **Label:** Migraine - no autoimmune/inflammatory disease **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No migraine - no autoimmune/inflammatory disease group **Intervention Names:** - Biological: Blood test **Label:** No migraine - no autoimmune/inflammatory disease **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group **Intervention Names:** - Biological: Blood test **Label:** No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group **Intervention Names:** - Biological: Blood test **Label:** Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) - Migraine - no autoimmune/inflammatory disease - No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) - No migraine - no autoimmune/inflammatory disease **Description:** 1 blood test of maximum 40 millilitres per patient **Name:** Blood test **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** To measure Treg cell levels in migraine and migraine-free participants, with and without autoimmune/inflammatory diseases (MS, RA, CD, SLE, endometriosis, T1DM) using flow cytometry **Measure:** Treg cell levels in cell/microliter (cell/µL) **Time Frame:** Once, at inclusion **Description:** To measure Treg cell levels in migraine and migraine-free participants, with and without autoimmune/inflammatory diseases (MS, RA, CD, SLE, endometriosis, T1DM) using flow cytometry **Measure:** Treg cell levels in percentage (%) of white blood cells **Time Frame:** Once, at inclusion **Description:** Age at inclusion **Measure:** Age in years **Time Frame:** Once, at inclusion **Description:** Weight on scales during inclusion visit **Measure:** Weight in kilograms (kg) **Time Frame:** Once, at inclusion **Description:** Score to be answered at inclusion to determine anxiety and depression levels : ranges from 0 to 21 for each (anxiety and depression). A score of 11 and above ascertains anxiety or depression. Licence n° 2403391 with Mapi Research Trust. **Measure:** Score on the Hospital Anxiety and Depression Scale **Time Frame:** Once, at inclusion **Description:** Score to be answered at inclusion to determine the impact of headache on patients' daily life, ranging from 36 to 78. The higher the score, the higher the impact of headache on daily life. Licence to be signed shortly with QualityMetrics **Measure:** Score on the Headache Impact Test **Time Frame:** Once, at inclusion **Description:** To be completed at inclusion to confirm migraine diagnosis. No licence needed **Measure:** Migraine diagnostic criteria from the International Classification of Headache Disorders 3rd edition (ICHD-3) **Time Frame:** Once, at inclusion **Description:** Number of days with a headache to determine whether migraine is episodic or chronic (average during last 3 months) **Measure:** Number of headache days per month in days/month **Time Frame:** Once, at inclusion **Description:** To measure the absolute white blood cell count to determine the percentage of Treg cells **Measure:** White blood cell count in giga/liter (G/L) **Time Frame:** Once, at inclusion **Description:** For sex repartition **Measure:** Sex (female, male) **Time Frame:** Once, at inclusion **Description:** Date of last menstrual period start day to measure the impact of the menstrual cycle on Treg levels **Measure:** Date of last menstrual period as a date in the form: day/month/year **Time Frame:** Once, at inclusion **Description:** To insure exclusion of pregnant women **Measure:** Human chorionic gonadotropin subunit beta level in milli-international units per milliliter (mIU/mL) **Time Frame:** Once, at inclusion **Description:** Measured at inclusion **Measure:** Height in meters (m) **Time Frame:** Once, at inclusion **Description:** Weight in kilograms and height in meters will be combined to determine the body mass index in kilogram per square meter **Measure:** Body mass index (BMI) in kilogram per square meter (kg/m2) **Time Frame:** Once, at inclusion #### Secondary Outcomes **Description:** To measure cytokine levels (interleukin 1b, interleukin 2, interleukin 6, interleukin 10, interleukin 12, interleukin 17, interleukin 18, interleukin 21, interleukin 23, interleukin 35, tumor necrosis factor a, interferon g and transforming growth factor b) using a LUMINEX method **Measure:** Cytokine levels in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To determine correlation with Treg cell levels **Measure:** Progesterone in nanogram per milliliter (ng/mL) **Time Frame:** Once, at inclusion **Description:** To determine correlation with Treg cell levels **Measure:** Estrogen in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between the menstrual cycle period and Treg cell levels **Measure:** Follicle stimulating hormone (FSH) in milli-international units per milliliter (mIU/mL) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between the menstrual cycle period and Treg cell levels **Measure:** Luteinizing hormone in international units per liter (IU/L) **Time Frame:** Once, at inclusion **Description:** To measure the general level of inflammation **Measure:** Levels of C-reactive protein (CRP) in milligram per liter (mg/L) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between sugar levels and Treg cell levels **Measure:** Fasting blood glucose concentration in gram per liter (g/L) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between insulin levels and Treg cell levels **Measure:** Insulin levels in milligram per deciliter (mg/dL) **Time Frame:** Once, at inclusion **Description:** To determine the correlation between the presence of migraine and prolactin levels **Measure:** Prolactin levels in nanogram per milliliter (ng/mL) **Time Frame:** Once, at inclusion **Description:** To study association between CGRP levels and migraine **Measure:** Calcitonin gene-related peptide (CGRP) in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To study association between VIP levels and migraine **Measure:** Vasoactive intestinal polypeptide (VIP) in picogram per milliliter (pg/mL) **Time Frame:** Once, at inclusion **Description:** To study association between PACAP levels and migraine **Measure:** Pituitary adenylate cyclase-activating polypeptide (PACAP) levels in nanogram per milliliter (ng/mL) **Time Frame:** Once, at inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * female * 18 - 50 years of age * at least 50 kg Exclusion Criteria: * menopause * type 2 diabetes * pregnancy (or delivery \< 3 months) * breast feeding * hysterectomy or adnexectomy * characterized immune deficiency * active cancer (or remission \< 1 year) * bone marrow or solid organ transplant * hormone therapy (other than birth control) * migraine attack within 12 hours before or after blood test * person under guardianship **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lise LACLAUTRE **Phone:** 334.73.754.963 **Role:** CONTACT #### Locations **Location 1:** **City:** Clermont-Ferrand **Country:** France **Facility:** CHU de Clermont-Ferrand - Service de Neurologie **State:** Aura **Zip:** 63000 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Clermont-Ferrand **Name:** Xavier MOISSET **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Al-Hassany L, Haas J, Piccininni M, Kurth T, Maassen Van Den Brink A, Rohmann JL. Giving Researchers a Headache - Sex and Gender Differences in Migraine. Front Neurol. 2020 Oct 22;11:549038. doi: 10.3389/fneur.2020.549038. eCollection 2020. **PMID:** 33192977 **Citation:** Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2. **PMID:** 35410119 **Citation:** Ashina M. Migraine. N Engl J Med. 2020 Nov 5;383(19):1866-1876. doi: 10.1056/NEJMra1915327. No abstract available. **PMID:** 33211930 **Citation:** Pellesi L, Al-Karagholi MA, De Icco R, Coskun H, Elbahi FA, Lopez-Lopez C, Snellman J, Hannibal J, Amin FM, Ashina M. Effect of Vasoactive Intestinal Polypeptide on Development of Migraine Headaches: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2118543. doi: 10.1001/jamanetworkopen.2021.18543. **PMID:** 34357396 **Citation:** Al-Karagholi MA, Kalatharan V, Ghanizada H, Gram C, Dussor G, Ashina M. Prolactin in headache and migraine: A systematic review of clinical studies. Cephalalgia. 2023 Feb;43(2):3331024221136286. doi: 10.1177/03331024221136286. **PMID:** 36718026 **Citation:** Bhoi SK, Kalita J, Misra UK. Metabolic syndrome and insulin resistance in migraine. J Headache Pain. 2012 Jun;13(4):321-6. doi: 10.1007/s10194-012-0416-y. Epub 2012 Jan 26. **PMID:** 22278639 **Citation:** Schetters STT, Gomez-Nicola D, Garcia-Vallejo JJ, Van Kooyk Y. Neuroinflammation: Microglia and T Cells Get Ready to Tango. Front Immunol. 2018 Jan 25;8:1905. doi: 10.3389/fimmu.2017.01905. eCollection 2017. **PMID:** 29422891 **Citation:** Watkins LR, Maier SF. Glia: a novel drug discovery target for clinical pain. Nat Rev Drug Discov. 2003 Dec;2(12):973-85. doi: 10.1038/nrd1251. 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Epub 2021 Apr 14. **PMID:** 33853506 **Citation:** Okimura H, Tanaka Y, Fujii M, Shimura K, Maeda E, Ito F, Khan KN, Nakamura Y, Mori T, Kitawaki J. Changes in the proportion of regulatory T cell subpopulations during menstrual cycle and early pregnancy. Am J Reprod Immunol. 2022 Dec;88(6):e13636. doi: 10.1111/aji.13636. Epub 2022 Oct 21. **PMID:** 36217280 **Citation:** Moisset X, Bommelaer G, Boube M, Ouchchane L, Goutte M, Dapoigny M, Dallel R, Guttmann A, Clavelou P, Buisson A. Migraine prevalence in inflammatory bowel disease patients: A tertiary-care centre cross-sectional study. Eur J Pain. 2017 Oct;21(9):1550-1560. doi: 10.1002/ejp.1056. Epub 2017 May 16. **PMID:** 28508514 **Citation:** Moisset X, Giraud P, Dallel R. Migraine in multiple sclerosis and other chronic inflammatory diseases. Rev Neurol (Paris). 2021 Sep;177(7):816-820. doi: 10.1016/j.neurol.2021.07.005. Epub 2021 Jul 27. **PMID:** 34325914 **Citation:** Yang MH, Wang PH, Wang SJ, Sun WZ, Oyang YJ, Fuh JL. Women with endometriosis are more likely to suffer from migraines: a population-based study. PLoS One. 2012;7(3):e33941. doi: 10.1371/journal.pone.0033941. Epub 2012 Mar 19. **PMID:** 22442736 **Citation:** Hagen K, Asvold BO, Midthjell K, Stovner LJ, Zwart JA, Linde M. Inverse relationship between type 1 diabetes mellitus and migraine. Data from the Nord-Trondelag Health Surveys 1995-1997 and 2006-2008. Cephalalgia. 2018 Mar;38(3):417-426. doi: 10.1177/0333102417690488. Epub 2017 Jan 23. **PMID:** 28114807 **Citation:** Malutan AM, Drugan T, Costin N, Ciortea R, Bucuri C, Rada MP, Mihu D. Pro-inflammatory cytokines for evaluation of inflammatory status in endometriosis. Cent Eur J Immunol. 2015;40(1):96-102. doi: 10.5114/ceji.2015.50840. Epub 2015 Apr 22. **PMID:** 26155190 **Citation:** Gobel K, Ruck T, Meuth SG. Cytokine signaling in multiple sclerosis: Lost in translation. Mult Scler. 2018 Apr;24(4):432-439. doi: 10.1177/1352458518763094. 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Front Immunol. 2019 Jan 22;10:19. doi: 10.3389/fimmu.2019.00019. eCollection 2019. **PMID:** 30723474 ## Derived Section ### Condition Browse Module - Ancestors - 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: D000007154 - Term: Immune System Diseases - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000015212 - Term: Inflammatory Bowel Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine Disorders - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M7877 - Name: Endometriosis - Relevance: HIGH - As Found: Endometriosis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Diseases - ID: M13066 - Name: Pain - 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 - ID: M22529 - Name: Headache Disorders - Relevance: LOW - As Found: Unknown - ID: M9351 - Name: Headache - Relevance: LOW - As Found: Unknown - ID: M26657 - Name: Headache Disorders, Primary - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - 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: 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: D000003424 - Term: Crohn Disease - ID: D000009103 - Term: Multiple Sclerosis - ID: D000008881 - Term: Migraine Disorders - ID: D000004715 - Term: Endometriosis - ID: D000001327 - Term: Autoimmune Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426303 **Acronym:** ABSTAIN **Brief Title:** Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder **Official Title:** Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder #### Organization Study ID Info **ID:** 25536 #### Organization **Class:** OTHER **Full Name:** Oregon Health and Science University ### Status Module #### Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-19 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Portland VA Medical Center #### Lead Sponsor **Class:** OTHER **Name:** Milky Kohno #### Responsible Party **Investigator Affiliation:** Oregon Health and Science University **Investigator Full Name:** Milky Kohno **Investigator Title:** Assistant Professor **Type:** SPONSOR_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:** The goal of this clinical trial is to identify sex-specific biomarkers that confer greater susceptibility for Alcohol Use Disorder (AUD) and differentiate how treatment response varies by sex in people with Alcohol Use Disorder. The main questions it aims to answer are: * How does trauma affect emotion regulation, inflammation, and limbic function, and what are the sex-dependent effects of NTX (Naltrexone) on these aspects? * What is the mechanism of Naltrexone (NTX), and how does it potentially moderate reductions in alcohol use through changes in or interactions between emotion regulation, inflammation, or limbic system function? Participants will * Be consented and will undergo comprehensive screening for eligibility criteria * Complete behavioral assessments and neuropsychological assessments, as well as neurocognitive assessments and neuroimaging measures * Provide urine samples for a urine drug screen (UDS) and urine pregnancy test (for women), and have blood and a cheek swab collected and stored in the repository * Take a study drug once daily for 12 weeks and track drug usage and effects in a study journal * Undergo weekly assessment calls and bi-weekly medical follow-up safety exams Researchers will compare naltrexone to placebo in AUD to see if naltrexone is effective in reducing alcohol cravings and promoting abstinence. Researchers will also compare baseline measures between AUD and Healthy Controls. **Detailed Description:** A twelve-week randomized placebo-controlled trial of naltrexone (NTX) will be conducted in one hundred people with alcohol use disorder (AUD), fifty of which will be women. Fifty healthy participants will serve as controls for baseline measures. We will use validated measures to comprehensively assess trauma exposure including: military sexual trauma (MST), physical or sexual assault, combat exposure, intimate partner violence, and other traumatic events. Emotion regulation will be assessed with the Cognitive Emotion Regulation questionnaire and Difficulty in Emotion Regulation scale. Functional magnetic resonance imaging at rest and during an emotion regulation task will assess limbic system connectivity and reactivity. Inflammation will be indexed with a multiplex panel assay of peripheral inflammatory markers. Days of alcohol use and average weekly standard drinks will be assessed at each time-point. ### Conditions Module **Conditions:** - Alcohol Use Disorder **Keywords:** - Naltrexone ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Drug: Naltrexone Half of the study participants with AUD will take an oral tablet of 50 mg naltrexone once daily for one week followed by 11 weeks of 100 mg naltrexone orally, once daily. Drug: Placebo oral tablet The other half of study participants will receive an identical looking placebo in tablet form and take the medication using an identical schedule as the real drug. Drug type will be randomized. **Intervention Names:** - Drug: Naltrexone **Label:** Alcohol Use Disorder (AUD) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Baseline measures will be taken but controls will not continue to the drug trial. **Label:** Healthy Controls **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Alcohol Use Disorder (AUD) **Description:** 12-week randomized double blinded placebo-controlled drug trial titrating drug/placebo dose after 1 week. **Name:** Naltrexone **Other Names:** - Revia **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Drinking days and average number of weekly standard drinks will be measured at baseline and at follow-up **Measure:** Change from baseline in alcohol use (number of drinking days, amount used per day) **Time Frame:** Baseline and Week 12 **Description:** Plasma samples will be analyzed using a customized, high-sensitivity magnetic bead multiplex assay Luminex system. Samples will be prepared and analyzed to measure peripheral immune markers: interleukin (IL)-1-beta, IL-6, IL-10, tumor necrosis factor (TNF)-alpha, brain-derived neurotrophic factor (BDNF), monocyte chemotactic protein (MCP)-1 and neural cell adhesion molecule (NCAM). Intra-and inter-assay coefficients of variation, as indices of within-and between-assay precision, respectively, will be calculated to examine the reliability of cytokine measurements. **Measure:** Changes from baseline in peripheral immune biomarkers associated with inflammation **Time Frame:** Baseline and Week 12 **Description:** Resting-state functional magnetic resonance imaging (rs-fMRI) will be used to assess changes in limbic system connectivity. Correlation coefficients of low-frequency oscillations in the fMRI blood oxygenation level dependent (BOLD) signal between regions and between large-scale resting-state networks in the brain will be z-score transformed. A score of 0 indicates no change while higher or lower scores indicate increased or decreased connectivity, respectively. **Measure:** Changes in limbic functional connectivity **Time Frame:** Baseline and Week 12 **Description:** The task will assess emotional reactivity and regulation to negative and stressful images. Each event (cue, neutral-look, negative-look, negative-reappraise and rating scale of negative affect) will be modeled using a canonical hemodynamic response function with a time derivative. The contrasts of interest will be Negative-look vs Neutral-look and Negative-look vs Negative-reappraise. Amygdala BOLD signal estimates will be extracted to calculate percent-change. **Measure:** Changes from baseline in BOLD signal brain activation during an emotion regulation fMRI task **Time Frame:** Baseline and Week 12 **Description:** DERS is a 36-item self-report questionnaire scored on a 5-point scale from 1 (almost never) to 5 (almost always), with total score ranging from 36 to 180. It measures emotion regulation difficulties across six dimensions: 1. Non-acceptance of emotional responses, 2. Difficulties engaging in goal-directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to effective emotion regulation strategies, 6. Lack of emotional clarity. Higher scores suggest greater difficulties in emotion regulation. **Measure:** Changes from baseline in emotion regulation assessed with the Difficulty in Emotion Regulation Scale (DERS) **Time Frame:** Baseline and Week 12 **Description:** CERQ is a 36-item self-report questionnaire that identifies cognitive emotion regulation or cognitive coping strategies used after having experienced negative events or situations. Scores can identify individual strategies to compare with normed scores from various populations. The nine cognitive emotion regulation strategies are measured on a 5-point Likert scale ranging from 1 to 5, with scores being obtained by calculating the mean scores belonging to a particular subscale. Higher subscale scores indicate greater use of a specific cognitive strategy. **Measure:** Changes from baseline in emotion regulation assessed with the Cognitive Emotion Regulation Questionnaire (CERQ) **Time Frame:** Baseline and Week 12 #### Secondary Outcomes **Description:** The Brief Alcohol Craving Scale, a 10-item self-report assessment of craving, will be used. Participants will be prompted with a statement regarding alcohol cravings and will choose an answer ranging between "strongly disagree" and "strongly agree." **Measure:** Change from baseline in craving (include craving measures/questionnaires) **Time Frame:** Baseline and Week 12 **Description:** Department of Veterans Affairs Military Sexual Trauma Screening consists of two questions used nationally within the Veterans Heath Administration (VHA) to screen for MST. Response options are yes, no, or decline to respond. Trauma Assessment for Adults (TAA) is a 17-item self-report on combat exposure, physical or sexual assault, surviving serious accidents and other threatening life events. Life Stressor Checklist-Revised (LSC-R) includes self-report measures relevant to women such as abortion or caregiver duties, in addition to 30 life events related to natural disasters, physical or sexual assault, death of a relative, incarceration and financial hardships. Childhood Maltreatment questionnaire is 70 items in five dimensions: emotional, physical, and sexual abuse, and physical and emotional neglect. A 7-point scale will be used to indicate level of trauma **Measure:** Differences in baseline trauma exposure (composite score) **Time Frame:** Baseline and Week 12 **Description:** The Standard Neuropsychological Battery will be used **Measure:** Change from baseline in neuropsychological testing scores **Time Frame:** Baseline and Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-60 years old * Veteran enrolled in VHA healthcare Alcohol Group: * must meet diagnosis for recent alcohol-use disorder (DSM-V) * willing to return for follow-up visits and can participate for 12-weeks Control Group: * must not meet DSM-V criteria for a use disorder other than nicotine Exclusion Criteria: * Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes * Left-handedness * Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder * Recreational or prescriptive use of psychotropic medications * Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids * MRI contraindications (e.g. metal in body) * Positive urine drug screen, except for nicotine and marijuana, on test days * Women who are pregnant or breastfeeding * Participants on hormonal therapy or treatments other than pregnancy contraceptives * Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's) * Current participation in an investigational drug study * Alcohol group: \< 5 days and \> 3 weeks of abstinence from alcohol * Alcohol group: Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit of normal, gastrointestinal or renal disease that would significantly impair absorption, metabolism or excretion of study drug, or require medical treatment. * Non-english speaker **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jazryn Nagum **Phone:** 503-721-7964 **Role:** CONTACT #### Locations **Location 1:** **City:** Portland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jazryn Nagum - **Phone:** 503-721-7964 - **Role:** CONTACT **Country:** United States **Facility:** VA Portland Health Care System **State:** Oregon **Status:** RECRUITING **Zip:** 97239 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000004327 - Term: Drinking Behavior - ID: D000019973 - Term: Alcohol-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC25 - Name: Substance Related Disorders ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Use - ID: M3783 - Name: Alcoholism - Relevance: HIGH - As Found: Alcohol Use Disorder - ID: M7502 - Name: Drinking Behavior - Relevance: LOW - As Found: Unknown - ID: M21842 - Name: Alcohol-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced 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: D000007249 - Term: Inflammation - ID: D000000437 - Term: Alcoholism - ID: D000000428 - Term: Alcohol Drinking ### Intervention Browse Module - Ancestors - ID: D000000427 - Term: Alcohol Deterrents - ID: D000009292 - Term: Narcotic Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AlcDet - Name: Alcohol Deterrents - Abbrev: NarcAntag - Name: Narcotic Antagonists - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M12222 - Name: Naltrexone - Relevance: HIGH - As Found: Stretching - ID: M12245 - Name: Narcotics - Relevance: LOW - As Found: Unknown - ID: M12243 - Name: Narcotic Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009271 - Term: Naltrexone ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426290 **Acronym:** PREDI-CHIRBA **Brief Title:** Prediction of Response to Bariatric Surgery in Patients With Severe Obesity **Official Title:** Prediction of Response to Bariatric Surgery Treatment in Patients Suffering From Severe Obesity, Based on the Scales of the MMPI-2-RF Questionnaire Carried Out Preoperatively #### Organization Study ID Info **ID:** CHMY-2021-06 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier de Moulins Yzeure ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier de Moulins Yzeure #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an MMPI-2-RF (Minnesota Multiphasic Personality Inventory-2-Restructured form) questionnaire in the preoperative phase of a bariatric surgery project. The evolution of their BMI will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery. The presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve BMI evolution and bariatric surgery success. **Detailed Description:** A first phase of data collection will concern data from the MMPI-2-RF questionnaire as well as clinical data, collected during preoperative consultations. For the second phase, post-operative data will be collected, during a routine follow-up consultation in the nutrition Department, where specific psychological questionnaires are taken by patients. ### Conditions Module **Conditions:** - Body Weight Changes ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 360 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Following questionnaires will be done : Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder (GAD-7) Three Factor Eating Questionnaire (TFEQ-R21) Quality of life for obesity and dietetic questionnaire (EQVOD) Body Esteem Scale (BES) Figure Rating Scale (auto-questionnaire) **Name:** post-surgery psychological evaluation **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Depressive dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of depressive symptomatology dimension on the evolution of BMI. **Time Frame:** At inclusion psychological consultation #### Secondary Outcomes **Description:** Anxiety dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of anxiety symptomatology dimension on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** Eating behaviour dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of eating behavior dimension on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** Quality of life dimension assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of quality of life dimension on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** satisfaction and body perception dimensions assessed by the preoperative MMPI-2-RF questionnaire and compared to the same dimension from post-surgery psychological questionnaires. **Measure:** Determine the predictive value of satisfaction and body perception dimensions on the evolution of BMI **Time Frame:** At inclusion psychological consultation **Description:** Using the MMPI-2-RF preoperative questionnaire **Measure:** Determine typical profiles of patients who have finally denied surgery apart from medical contraindications **Time Frame:** At inclusion psychological consultation **Description:** Using the MMPI-2-RF preoperative questionnaire **Measure:** Identify the risk factors for abandonment or difficulties after the intervention, in order to establish appropriate preoperative treatments before surgery **Time Frame:** At inclusion psychological consultation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Having been treated in the Nutrition department for severe obesity and considered for bariatric surgery because having met the criteria validating bariatric surgery: * Having passed the MMPI-2-RF questionnaire between January 1, 2014 and December 31, 2023 in the preoperative phase, as part of psychological follow-up * Having benefited from bariatric surgery or patients who have abandoned the surgery plan for a reason other than a medical contraindication. * Informed of the study, having agreed to participate and not having opposed the use of their data Exclusion Criteria: * Subjects who generated an invalid MMPI-2-RF questionnaire, according to the test validity criteria (verified by the principal investigator) * Subjects who expressly objected to the use of their data for this study * Subjects who have not undergone bariatric surgery due to a medical contraindication. * Patient unable to understand the study or complete the post-operative phase visit * Persons under guardianship or curators or under legal protection **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with severe obesity : BMI \> 40 kg/m2 or \> 35 kg/m2 associated with at least one comorbidity likely to be improved after surgery. * Failure of well-conducted medical, nutritional, dietetic and psychotherapeutic monitoring for 6-12 months * Lack of sufficient weight loss or failure to maintain weight loss ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Virginie ALLASSEUR, psychologist **Phone:** 33478357884 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sophie PAGNON, CRA **Phone:** 33470357822 **Role:** CONTACT #### Locations **Location 1:** **City:** Moulins **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** psychologist - **Phone:** 33478357884 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sophie PAGNON, CRA - **Phone:** 33470357822 - **Role:** CONTACT ***Contact 3:*** - **Name:** Virginie ALLASSEUR - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Centre hospitalier Moulins-Yzeure **Status:** RECRUITING **Zip:** 03000 #### Overall Officials **Official 1:** **Affiliation:** Centre Hospitalier de Moulins Yzeure **Name:** Virginie ALLASSEUR, psychologist **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Body Weight - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M12702 - Name: Obesity, Morbid - Relevance: HIGH - As Found: Severe Obesity - ID: M5115 - Name: Body Weight Changes - Relevance: HIGH - As Found: Body Weight Changes - 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: D000009767 - Term: Obesity, Morbid - ID: D000001835 - Term: Body Weight - ID: D000001836 - Term: Body Weight Changes ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426277 **Acronym:** PROVEN-DIA **Brief Title:** Effectiveness of the Brazilian Diabetes Prevention Program **Official Title:** Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study) #### Organization Study ID Info **ID:** PROVEN-DIA ECR #### Organization **Class:** OTHER **Full Name:** Beneficência Portuguesa de São Paulo ### Status Module #### Completion Date **Date:** 2029-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-03-19 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beneficência Portuguesa de São Paulo #### 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 multicenter controlled randomized trial is to assess the effectiveness of Brazilian Diabetes Prevention Program (face-to-face or e-health) in incidence of T2D with, at least, 1590 adults at high risk of developing T2D during 3-yr follow-up. Our primary outcomes are the incidence of T2D, MVPA (min/week), prevalence of physical inactivity, quality of life, BALANCE DI, CDHI, body weight (kg), and biomarkers of glycemia. In addition, social, cultural, educational and geographical factors at community levels will also be analyzed throughout the follow-up to verify their association with the incidence of T2D. **Detailed Description:** This is a multicenter controlled randomized trial coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program). ### Conditions Module **Conditions:** - Prediabetic State - Pre Diabetes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 1590 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Brazilian Diabetes Prevention Program will be delivered face-to-face, including guidance for improving diet and lifestyle (especially physical activity in daily life), as well as stimulating self-care. **Intervention Names:** - Behavioral: Brazilian Diabetes Prevention Program (face-to-face care) **Label:** Brazilian Diabetes Prevention Program (face-to-face care) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Brazilian Diabetes Prevention Program (remote care) will be delivered either through telephone or video calls (using several media and software application), including guidance for improving diet and lifestyle (especially physical activity in daily life), as well as stimulating self-care. **Intervention Names:** - Behavioral: Brazilian Diabetes Prevention Program (remote care) **Label:** Brazilian Diabetes Prevention Program (remote care) **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Diet prescription for weight loss. **Intervention Names:** - Behavioral: Diet **Label:** Diet Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Brazilian Diabetes Prevention Program (face-to-face care) **Description:** A Program structured in 28 visits (in group and individual) and 21 contacts (through phone calls or video calls) to guide the improvement of diet quality, self-care, and regular practice of physical activity **Name:** Brazilian Diabetes Prevention Program (face-to-face care) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Diet Group **Description:** Hypocaloric diet prescription **Name:** Diet **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Brazilian Diabetes Prevention Program (remote care) **Description:** A Program structured in 49 contacts delivered through telehealth (through phone calls or video calls between professional and participant) to guide the improvement of diet quality, self-care, and regular practice of physical activity **Name:** Brazilian Diabetes Prevention Program (remote care) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** to analyze the incidence of type 2 diabetes mellitus **Measure:** Incidence of type 2 diabetes mellitus **Time Frame:** 36 months #### Secondary Outcomes **Description:** to compare mean HbA1c(%) obtained through laboratory exams/tests between groups **Measure:** Mean value of Glycated Hemoglobin level (HbA1c in %) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups **Measure:** Mean value of Fasting Blood Glucose (mg/dL) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals with controlled blood glucose (\<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication **Measure:** Number of Participants with controlled Fasting blood glucose (<126mg/dL) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals with HbA1c (\<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication **Measure:** Number of Participants with controlled Glycated Hemoglobin level (<6.4%) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean weight (kg) between groups **Measure:** body weight **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals who are physically active (\>150 minutes of moderate to vigorous physical activity) and inactive (\<150 minutes of moderate to vigorous physical activity) between groups **Measure:** Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained thourgh International Physical Activity Questionnaire short form **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups **Measure:** Minutes spent on moderate-to-vigorous physical activity **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals engaging in moderate or vigorous physical activity and sedentary behavior **Measure:** Moderate-to-vigorous physical activity and sedentary behavior **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of individuals who engage in 150 minutes or more of physical activity per week **Measure:** Physical activity **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the proportion of sedentary individuals **Measure:** Sedentary behavior **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare mean score of Brazilian Cardioprotective Nutritional Program dietary index (BALANCE DI) between groups Minimum: 0 Maximum: 40 When higher the score, better the quality of diet **Measure:** Quality of diet (Mean score of the Brazilian Cardioprotective Nutritional Program dietary index) **Time Frame:** 6, 12, 24 and 36 months **Description:** to compare the mean caloric intake (kcal) from ultra-processed foods obtained through two 24-hour Dietary Recall applied within a period of fifiteen days **Measure:** Mean of kcal from ultra processed food intake **Time Frame:** 6, 12, 24 and 36 months **Description:** to analyze the quality of life based on delta value of the eight domains (Functional capacity, Physical aspects, Pain, General health status, Vitality, Social aspects, Emotional aspects and Mental health) When higher the score, better the quality of life related to the assessed domain **Measure:** Delta value (Change score from baseline to 6, 12, 24 and 36 months) for each domain of Quality of life obtained through Short Form Health Survey (SF-36) **Time Frame:** 6, 12, 24 and 36 months **Description:** To compare the cost of interventions. To estimate healthcare system costs, we will consider only direct medical costs, which include screening costs, intervention costs, and costs of healthcare service utilization. To estimate social costs, we will consider not only direct medical costs but also non-medical direct costs, such as transportation, food, and accommodation expenses reported by participants when seeking medical assistance, as well as time spent traveling to and participating in group sessions. Additionally, we will include indirect costs, calculated based on the assumption that each necessary hospitalization results in a loss of 9 hours of paid work and each outpatient visit results in a loss of half a day (4.5 hours) of paid work **Measure:** Cost **Time Frame:** 36 months **Description:** To analyze the correlation between years of study and the incidence of type 2 diabetes **Measure:** Scholarity **Time Frame:** 36 months **Description:** T2DM incidence across Brazillian five geographic regions (South, Southeast, Midwest, West, and Northwest) **Measure:** Geo-Stratified Analysis **Time Frame:** 36 months **Description:** Association between T2DM incidence and individual Low or high income (accessed by ABEP - Critério Brasil 2022 questionnaire) **Measure:** Household income **Time Frame:** 36 months **Description:** correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2) **Measure:** Neighbourhood value **Time Frame:** 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Be 18 years or older (no maximum age for being eligible) * Have a body mass index (BMI) between 25 and 34,9kg/m² * Have, at least, one electronic device (includes any of the following devices): * Computer * Laptop/notebook * Tablet * Smartphone * Have access to internet (broadband, 3G, 4G, 5G, among others) * Without previous nutritional counseling (within 6 months prior to the recruitment/randomization/intervention) * Living near the research center (at maximum 60 minutes of walking) * Had a blood test result in the prediabetes range within the last three months prior to the recruitment/randomization/intervention (includes any of these tests and results): * Hemoglobin levels (HbA1c): 5.7-6.4% * Fasting blood glucose: 100-125 mg/dL * Blood glucose 2 hours after an oral glucose tolerance: 140-199 mg/dL Exclusion Criteria * Diagnosis of Diabetes Mellitus * In secondary prevention for Cardiovascular Disease (myocardial infarction, unstable angina or stroke in the past six months) * Exclusion for underlying disease or condition likely to limit life span and/or increase risk of interventions o Cardiovascular disease * Congestive Heart Failure (New York Heart Association Functional Class \> 2) * Uncontrolled hypertension * Lung disease (asthma or Chronic Obstructive Pulmonary Disease) * Gastrointestinal disease * Renal disease * Major psychiatric disorder * Anemia (hematocrit \< 36.0% in men or \< 33.0% in women) * Weight loss of \> 10% in past 6 months for any reason, except post-partum weight loss * Excessive alcohol intake * Medication use (antihypertensives, antibiotics, corticoids, antipsychotic, antineoplastic agents, phenytoin, amphetamines, and prescript weight-loss drugs) * Likely to move away from participating clinics in next 5 years * Another household member is a participant or staff member in the study * Unable or unwilling to give informed consent (subject refused to sign the Free and Informed Consent Form) * Current participation in another Randomized Clinical Trial whose main purpose interferes with any of the interventions and primary outcomes of this study (for instance, food consumption and physical activity level) * Participant of the pilot Randomized Clinical Trial ( Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Prediabetic State - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: LOW - As Found: Unknown - ID: M20295 - Name: Glucose Intolerance - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000011236 - Term: Prediabetic State ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426264 **Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA] **Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA] #### Organization Study ID Info **ID:** ATTN201- CT010b #### Organization **Full Name:** [Redacted] ### Status Module **Delayed Posting:** True #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** WITHHELD #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Name:** [Redacted] #### Responsible Party **Old Name Title:** [Redacted] **Old Organization:** [Redacted] ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426251 **Brief Title:** Photobiomodulation Therapy in Patients Receiving Total Knee Arthroplasty **Official Title:** A Randomized Trial of Photobiomodulation Effect in Patients Receiving Total Knee Arthroplasty #### Organization Study ID Info **ID:** 111-036-F #### Organization **Class:** OTHER **Full Name:** National Taiwan University Hospital Hsin-Chu Branch ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2022-08-02 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Taiwan University Hospital Hsin-Chu Branch #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Photobiomdoulation is the use of near-infrared light to relieve pain, stimulate healing and reduce inflammation. Swelling and inflammation is a common condition after orthopedics surgeries over extremity and spine. This study aim to evaluate the effect of photobiomodulation over patients after Total Knee Arthroplasty. **Detailed Description:** Patients aged over 20 after Total Knee Arthroplasty in our institution would be candidate for recruitment. The patients will be randomized to receive routine post operative care or photobiomodulation therapy. The swelling extent and subjective outcome will be recorded. ### Conditions Module **Conditions:** - Inflammation - Osteoarthritis - Post Operative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group of patient will receive photobiomodulation pads on the part of surgical site and the machine will emit near-infrared light. **Intervention Names:** - Device: Photobiomodulation **Label:** intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This group of patient will have photobiomodulation pads on the body surface as intervention group, but the machine will not emit near-infrared light. **Intervention Names:** - Device: Photobiomodulation **Label:** control group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - control group - intervention group **Description:** Photobiomodulation therapy will be given daily start on the first day after surgery to post operative day 6 **Name:** Photobiomodulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** bioimpedance of the surgical site will be measured for evaluation of swelling change **Measure:** the change of bioimpedance **Time Frame:** the bioimpedance measured once daily since post operative day1 to day6 and at 2 weeks #### Secondary Outcomes **Description:** patient reported pain score, from 0 to 100 points **Measure:** pain score (visual analogue score) **Time Frame:** once daily since post operative day1 to day6 **Description:** active range of motion of knee **Measure:** active range of motion of knee **Time Frame:** once daily since post operative day1 to day6 **Description:** the distance that the patient could walk within 2 minutes **Measure:** 2 minute walk test **Time Frame:** once daily since post operative day1 to day6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * total knee arthroplasty Exclusion Criteria: * open injury * pregnancy * wound without primary closure * infection * previous surgery over surgical site * skin defect **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hsiang-Chieh Hsieh **Phone:** 886972654075 **Role:** CONTACT #### Locations **Location 1:** **City:** Hsinchu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hsiang-Chieh Hsieh - **Phone:** +886972654075 - **Role:** CONTACT **Country:** Taiwan **Facility:** National Taiwan University Hospital, Hsin-Chu Branch **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** National Taiwan University Hospital Hsin-Chu Branch **Name:** Hsiang-Chieh Hsieh **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** de Rezende MU, Varone BB, Martuscelli DF, Ocampos GP, Freire GMG, Pinto NC, de Sousa MVP. Pilot study of the effect of therapeutic photobiomodulation on postoperative pain in knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):159-161. doi: 10.1016/j.bjane.2021.07.040. Epub 2021 Nov 17. **PMID:** 34800495 **Citation:** Vassao PG, Renno AC, Smith BN, Bennett GB, Murphy M, Liebert A, Chow R, Laakso EL. Pre-Conditioning and Post-Operative Photobiomodulation Therapy by a Novel Light Patch System for Knee Arthroplasty: A Protocol for a Phase 1 Study. Photobiomodul Photomed Laser Surg. 2020 Apr;38(4):206-214. doi: 10.1089/photob.2019.4751. Epub 2020 Mar 18. **PMID:** 32186975 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000011183 - Term: Postoperative Complications - 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: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M12926 - Name: Osteoarthritis - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007249 - Term: Inflammation - ID: D000010149 - Term: Pain, Postoperative ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426238 **Brief Title:** Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment **Official Title:** Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment #### Organization Study ID Info **ID:** CIRB_23010 #### Organization **Class:** OTHER **Full Name:** Midwestern University ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Midwestern 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:** Pressure Pain Threshold (PPT) is defined as the minimum force applied to an area that is perceived as pain. PPT is considered an objective measurement tool to assess pain levels. Studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. No study has utilized PPT to evaluate the difference in pain between aligners and fixed braces at different time points. This study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance. ### Conditions Module **Conditions:** - Pain **Keywords:** - Pressure pain threshold - Clear aligners - Orthodontic appliance - Adolescents - Self-reported pain ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 38 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Self-reported pain will be assessed using a Visual Analogue Scale with anchors from 0 (=no pain) to 10 (=worst imaginable pain) **Measure:** Self-reported pain intensity **Time Frame:** At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks **Description:** Pressure Pain Threshold will be measured through an algometer on masseter and temporals muscles **Measure:** Pressure Pain Threshold **Time Frame:** At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks #### Secondary Outcomes **Description:** Self-perceived anxiety and depression measured through the Patient Health Questionnaire, PHQ-4 (from 0 to 12, with higher score identifying higher anxiety and depression) **Measure:** Anxiety and depression symptoms **Time Frame:** At two timepoints through study completion: at baseline, and at 8-12 weeks **Description:** Self-reported pain catastrophizing measured trough Pain Catastrophizing Scale, PCS (from 0 to 52, with values \>30 identifying clinically meaningful pain catastrophizing) **Measure:** Pain catastrophizing **Time Frame:** At two timepoints through study completion: at baseline, and at 8-12 weeks **Description:** Semi-structural interview through questionnaire **Measure:** Past pain experience **Time Frame:** At T0: Baseline (pre-intervention) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * consecutive consented patients (\> 14 years old) beginning an orthodontic treatment on both arches, either with aligners or fixed appliance at the Midwestern University, Multidisciplinary Clinic; * patients in possession of an email address and Internet connection. Exclusion Criteria: * patients with generalized systemic conditions known to affect the overall body pain and pressure pain threshold assessment (e.g., fibromyalgia, autoimmune conditions such as multiple sclerosis, rheumatoid arthritis), * untreated dental caries. **Minimum Age:** 14 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients starting an orthodontic treatment (clear aligners or fixed braces) at the Multispecialty Clinic of Midwestern University ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Linda Sangalli, DDS, MS, PhD **Phone:** 630-515-7369 **Role:** CONTACT #### Locations **Location 1:** **City:** Downers Grove **Contacts:** ***Contact 1:*** - **Name:** Linda Sangalli, DDS, MS, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Linda Sangalli, DDS, MS, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Jahnavi Rao, DDS, MS - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Midwestern University **State:** Illinois **Status:** RECRUITING **Zip:** 60515 ## 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426225 **Brief Title:** Spinal Or General Anesthesia For Umblical Hernia Surgery **Official Title:** Should General Anesthesia or Spinal Aneshtesia With Ketofol Sedation Be Applied in Umblical Hernia Operations ? #### Organization Study ID Info **ID:** 1646 #### Organization **Class:** OTHER **Full Name:** Ankara City Hospital Bilkent ### Status Module #### Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara City Hospital Bilkent #### Responsible Party **Investigator Affiliation:** Ankara City Hospital Bilkent **Investigator Full Name:** Nargiz Mammadova **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In this study, the investigators compared spinal anesthesia under ketofol (ketamine-propofol combination) sedation with general anesthesia in terms of intraoperative and postoperative hemodynamics, respiratory parameters and cost in patients undergoing umbilical hernia operation. the investigator aimed to provide the most appropriate and hemodynamically stable option for the patient, to decrease the complication rates and to reduce the associated costs. **Detailed Description:** This study was carried out at the Ministry of Health Ankara City Hospital Operating Room, after receiving ethics committee approval.Preoperative evaluation was performed before the operation in cases undergoing elective umbilical hernia surgery.Complications and side effects are explained in detail.Verbal and written consents were obtained from the subjects who agreed to participate in the study.In patients undergoing umbilical hernia surgery, general anesthesia and spinal anesthesia under propofol and ketamine (ketamine-propofol combination) sedation were compared in terms of intraoperative and postoperative hemodynamics, aldrete score, pain score, respiratory parameters, and cost. The patients, who had fasted for 8 hours before the operation, were taken to the operating room without premedication. In all cases, a peripheral venous catheter cannulated on the dorsal part of the hand (20G, Plusflon i.v. Cannula, India) .Standard monitoring was applied. Group1. As premedication 0.03mg/kg midazolam was administered . For spinal anesthesia, 15 mg heavy-bupivacaine, sedation was provided with ketofol. ketamine:propofol mixture was prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine 1 mg/kg ketofol administered i.v. Group2 . As premedication 0.03mg/kg midazolam was administered.In general anesthesia to all patients after induction 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl Bispectral index and non-invasive blood pressure was monitored, a urinary catheter was placed. Anesthesia was maintained with sevoflurane and fentanyl to keep BIS values between 40-60. ### Conditions Module **Conditions:** - Umbilical Hernia - Spinal Aneshtesia - General Anesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** As premedication 0.03mg/kg midazolam was administered. During general anesthesia, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl were administered to all patients for induction. **Intervention Names:** - Other: General Anesthesia **Label:** General Anesthesia **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** As premedication 0.03mg/kg midazolam was administered. After premedication Spinal Anesthesia applied. Group will be sedated with ketofol after spinal anesthesia. Ketamine:propofol mixture will be prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine. Surgery will begin when the Ramsey sedation scale reaches 3. **Intervention Names:** - Other: Spinal Aneshtesia **Label:** Spinal Anesthesia **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - General Anesthesia **Description:** General Anesthesia Applied Group 2 Patients. **Name:** General Anesthesia **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Spinal Anesthesia **Description:** Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients. **Name:** Spinal Aneshtesia **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** During Perioperative Period Heart rate was measured **Measure:** Heart Rate **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** non invasive blood pressure measurement **Measure:** systolic blood pressure **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** non invasive blood pressure measurement **Measure:** diastolic blood pressure **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** non invasive blood pressure measurement **Measure:** mean arterial blood pressure **Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute **Description:** Length of hospital stay was recorded. **Measure:** hospital stay **Time Frame:** From hospital admission to discharge **Description:** Bill amount during hospitalization **Measure:** Cost **Time Frame:** From hospital admission to discharge #### Secondary Outcomes **Description:** postoperative numeric rating scale was evaluated, 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable **Measure:** Postoperative NRS **Time Frame:** Postoperative 30.minute, Postoperative 12. hour **Description:** Postoperative Aldrete score was evaluated. **Measure:** Postoperative Aldrete Score **Time Frame:** Postoperative first 1 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I-II patients between the ages of 18 and 65 who would undergo Umbilical hernia surgery were included in the study. Exclusion Criteria: * who do not accept the procedure * serious cardiovasculer disease ,renal, hematological (bleeding diathesis, under anticoagulant therapy, those with hemoglobin value below 10 g/dl) disease, hepatic disease, cerebrovascular, neurological or psychiatric diseases, * those who are contraindicated for spinal anesthesia, * Those who are allergic to one of the local anesthetics to be used, with drug and alcohol addiction, * pregnant or breastfeeding * using drugs and analgesics effective on the central nervous system were excluded from the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nargiz Mammadova **Phone:** +905356570987 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** KROBOT, R. i PREMUŽIĆ, J. (2013). Comparison of general and spinal anaesthesia in patients undergoing open ventral hernia repair. Periodicum biologorum, 115 (2), 225-229. Preuzeto s https://hrcak.srce.hr/105984 **Citation:** Germano P, Siboni S, Milito P, Mautone G, Resta M, Bonavina L. Ventral hernia repair under neuraxial anesthesia. Eur Surg. 2022;54(1):54-58. doi: 10.1007/s10353-021-00731-x. Epub 2021 Jul 20. **PMID:** 34306042 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000006555 - Term: Hernia, Ventral - ID: D000046449 - Term: Hernia, Abdominal ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M9625 - Name: Hernia - Relevance: HIGH - As Found: Hernia - ID: M9632 - Name: Hernia, Umbilical - Relevance: HIGH - As Found: Umbilical Hernia - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M9633 - Name: Hernia, Ventral - Relevance: LOW - As Found: Unknown - ID: M25675 - Name: Hernia, Abdominal - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006554 - Term: Hernia, Umbilical - ID: D000006547 - Term: Hernia ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Analg - Name: Analgesics - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Function - ID: M8418 - Name: Fentanyl - Relevance: LOW - As Found: Unknown - ID: M1666 - Name: Rocuronium - Relevance: LOW - As Found: Unknown - ID: M11845 - Name: Midazolam - Relevance: LOW - As Found: Unknown - ID: M10674 - Name: Ketamine - Relevance: LOW - As Found: Unknown - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426212 **Acronym:** 3-TEICO **Brief Title:** Use of Teicoplanin on a Three-weekly Administration in the Infectious Diseases Unit **Official Title:** Use of Teicoplanin on a Three-weekly Administration in the Complex Outpatient Macroactivity Regimen of Infectious Diseases Unit in the Alessandro Manzoni Hospital (Lecco, Italy) #### Organization Study ID Info **ID:** 3-TEICO #### Organization **Class:** OTHER **Full Name:** Azienda Ospedaliera di Lecco ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Azienda Ospedaliera di Lecco #### Responsible Party **Investigator Affiliation:** Azienda Ospedaliera di Lecco **Investigator Full Name:** Stefania Piconi **Investigator Title:** Director of Infectious Diseases Unit **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Teicoplanin is an antibiotic belonging to the class of glycopeptides, in use since 1986. Like its older "classmate" vancomycin, it inhibits protein synthesis by interfering with the synthesis of peptidoglycan, and is active on Gram-positive bacteria such as Staphilococcus spp (including MRSA), Streptococcus spp and Enterococcus spp (both faecalis and faecium). Teicoplanin is characterized by poor gastrointestinal absorption, which requires intramuscular or intravenous administration; has a binding to plasma proteins greater than 90%; and a high volume of distribution. It reaches high levels in deep tissues (bone, abdomen, lung, kidney, heart) on the contrary it has poor penetration at the central nervous system level; it is approved for the treatment of skin and soft tissue infections, osteo-articular infections, pneumonia, endocarditis, complicated urinary tract infections, peritonitis and bacteremia associated with the aforementioned clinical conditions. Furthermore, teicoplanin has a markedly long half-life (between 30 and 180h) which allows it to be administered even every 48-72h. Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function. The possibility of carrying out therapeutic drug monitoring (TDM) allows maintaining plasma levels adequate for the treatment of deep infections (e.g. \>20 mg/l for endocarditis) and avoiding overdose. Thanks to the possibility of administering teicoplanin on a three-weekly schedule, patient access to hospital is further reduced. The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs). ### Conditions Module **Conditions:** - Comparison of Teicoplanin Used Three Times a Week in DSIs vs NDISs ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Use of teicoplanin three times a week **Label:** patients with deep infections (deep seated infections - DSIs) #### Arm Group 2 **Intervention Names:** - Drug: Use of teicoplanin three times a week **Label:** patients with superficial infections (non deep seated infections - NDSIs). ### Interventions #### Intervention 1 **Arm Group Labels:** - patients with deep infections (deep seated infections - DSIs) - patients with superficial infections (non deep seated infections - NDSIs). **Description:** retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs). **Name:** Use of teicoplanin three times a week **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Describe the clinical characteristics of patients and outcome (recovery vs therapeutic failure intended as death, need for modification of antibiotic therapy or recurrence of infection) of the study population. **Measure:** Describe the clinical characteristics and outcome of the study population. **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \>18 years; * Patients with documented Gram-positive infection sensitive to teicoplanin; * Patients who have received at least 4 doses of teicoplanin on a three-weekly schedule, as monotherapy or associated with other antibiotics Exclusion Criteria: * Hospitalized patients * Patients who have received less than 4 doses of teicoplanin for any cause. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The data of patients with deep seated infections - DSIs or non deep seated infections - NDSIs treated from January 2021 to October 2023 in the Manzoni hospital in Lecco will be collected from the medical records in order to record the clinical outcomes understood as clinical resolution vs therapeutic failure, change of therapy or recurrence of infection. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Stefania Piconi, MD **Phone:** +390341489890 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Silvia Pontiggia, MS **Phone:** +390341253678 **Role:** CONTACT #### Locations **Location 1:** **City:** Lecco **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stefania Piconi, MD - **Phone:** +390341489890 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Silvia Pontiggia, MS - **Phone:** +390341253678 - **Role:** CONTACT **Country:** Italy **Facility:** Stefania Piconi **Status:** RECRUITING **Zip:** 23900 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - 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: HIGH - As Found: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19621 - Name: Teicoplanin - Relevance: HIGH - As Found: Intracytoplasmic Sperm Injection - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017334 - Term: Teicoplanin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426199 **Acronym:** TMJ **Brief Title:** Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement **Official Title:** Arthroscope-Guided Intra-Articular Injection of Chitosan-Hyaluronate Gel Mixture Versus Hyaluronic Acid in the Treatment of TMJ Internal Derangement: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 12345asdfg #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-17 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Misr International University **Class:** UNKNOWN **Name:** University of Nizwa #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is designed to assess the impact of injecting sodium hyaluronic acid versus a chitosan-hyaluronate hybrid gel into the upper compartment of the temporomandibular joint (TMJ) as a treatment for anterior disc displacement without reduction. The study will include patients diagnosed with Stage III or IV TMJ internal derangement (anterior disc displacement without reduction), as classified by Wilkes, with diagnoses confirmed through clinical symptoms and MRI evaluations. Participants will be randomly divided into two groups, both undergoing TMJ arthroscopy. In the first group, 2 ml of chitosan-hyaluronic acid hybrid gel will be injected into the affected joints, whereas in the second group, 2 ml of hyaluronic acid (HA) will be administered. The study will compare and analyze outcomes in both groups, focusing on pain during TMJ function, clicking sounds, the extent of maximum mouth opening, and maximum lateral jaw movement. **Detailed Description:** This study will be a prospective randomized controlled clinical study on a convenience sample of patients who will be selected from the Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine, Suez University. Patients selected are whom will be diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations. Inclusion criteria will be adults aged between 25 - 50 years old, sufficient clinical and magnetic resonance imaging (MRI) data that could be obtained before and after the treatment. The exclusion criteria will be hematological or neurological diseases, inflammation or connective tissue diseases, head and neck malignancies, history of treatment of TMJ disease or history of craniofacial surgery not related to internal derangement treatment, insufficient clinical and MRI data. Participants will be selected based on established criteria. A total sample size of 20 (10 in each group) was calculated to detect an effect size of about 1.33-1.34, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data \[13\]. All patients will undergo a preoperative clinical evaluation including Pain level on forced mouth opening using visual analogue scale (VAS), assessment of mean lateral jaw movements, assessment of TMJ clicking, assessment of maximum mouth opening (MMO), deviation of mandibular midline during mouth opening and closure. All patients will do a Magnetic resonance imaging (MRI) to evaluate the disc displacement.All patients will undergo conservative treatment as the first line of treatment in all TMJID cases. All patients will be under general anesthesia. For both groups, the operation will be under GA and The skin surface of the pre-auricular region will be disinfected with povidone iodine solution. For both groups, TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. In the first group, the injection of 2 ml of chitosan-hyaluronic acid hybrid gel into affected joints, while 2 ml of HA will be injected in to affected joints in the second group. Needles will be removed after the injection sites and covered its sites with gauze dressing. Postoperative care and instructions: 1. Medications: Brufen\* as a nonsteroidal anti-inflammatory drug (NSAIDs) relieving muscle pain and swelling. Myofen\* as a muscle relaxant especially for people who grind or clench their teeth help to relax tight jaw muscles. 2. Application hot \& cold packs: All patients will be instructed to apply an ice pack to the side of his face and temple area for about 10 minutes. Also, simple stretching exercises for his or her jaw should be done. Application a warm towel or pack to the side of his face for about 5 minutes five times daily for 4 days. 3. Soft diet: Soft food such as yogurt, mashed potatoes, cheese, soup, fish, cooked fruits and vegetables, beans, and grains should be eaten. In addition, food should be cut into small pieces. Avoid hard and crunchy foods like hard rolls, raw carrots, thick and large foods that need your mouth to open wide to fit the foods. Also, chewy sticky foods (like caramels and taffy) avoided too for next 10 days. ### Conditions Module **Conditions:** - TMJ Disc Disorder **Keywords:** - TMD - Hyaluronic acid - Chitosan - Arthroscopy - Intra Articular Injection - TMJ ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Arthroscope-guided intra-articular injection of Hyaluronic Acid in patients with TMJ anterior disc displacement without reduction. **Intervention Names:** - Drug: Hyaluronic Acid **Label:** Intra-Articular Injection of Hyaluronic Acid **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Arthroscope-guided intra-articular injection of chitosan-hyaluronate gel mixture in patients with TMJ anterior disc displacement without reduction **Intervention Names:** - Drug: Chitosan-Hyaluronate Gel Mixture **Label:** Intra-Articular Injection of chitosan-hyaluronate gel mixture **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intra-Articular Injection of chitosan-hyaluronate gel mixture **Description:** The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Chitosan-Hyaluronate Gel Mixture into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing. **Name:** Chitosan-Hyaluronate Gel Mixture **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intra-Articular Injection of Hyaluronic Acid **Description:** The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Hyaluronic acid into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing. **Name:** Hyaluronic Acid **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Self-pain and function of the jaw assessment, with Visual Analogue Scale (VAS), ranging from 0 to 10 scales. This scale will be used for self-evaluation of the patients, to evaluate pain level and jaw dysfunction and compared with preoperative degree. Patients will be asked about the pain severity \& dysfunction according to the VAS. **Measure:** Joint Pain **Time Frame:** 3 months **Description:** Maximum lateral excursion, the distance from midline of upper \& lower jaw will be measured with a digital caliper in mm. **Measure:** lateral excursion **Time Frame:** 3 months **Description:** measured by asking the patients to open and closed his mouth several times and clicking was recorded as present (early clicking, late clicking) or absent. **Measure:** TMJ sounds **Time Frame:** 3 months **Description:** Maximum mouth opening (MMO), between upper \& lower incisors will be measured during maximum opening with a digital caliber in mm. **Measure:** Maximum mouth opening **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients were diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations. 2. Age 25 - 50 years old. Exclusion Criteria: 1. Hematological or neurological diseases. 2. Inflammation or connective tissue diseases. 3. Head and neck malignancies. 4. History of treatment of TMJ disease or history of craniofacial surgery not related to ID treatment. 5. Insufficient clinical and MRI data. **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nehal IA Shobair, PhD **Phone:** 00201063666985 **Phone Ext:** 0 **Role:** CONTACT #### Locations **Location 1:** **City:** Suez **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mahmoud A Elfarmawy, PhD - **Phone:** 01001464971 - **Phone Ext:** 0 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nehal I Shobair, PhD - **Role:** SUB_INVESTIGATOR ***Contact 3:*** - **Name:** Mahmoud A Elfarmawy, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Mayson H Alkhatib, PhD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Ahmed AA Al-Saadi, Msc - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Mohammed A Al-Saadi, PhD - **Role:** SUB_INVESTIGATOR **Country:** Egypt **Facility:** Suez University **Status:** RECRUITING **Zip:** 41522 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000055675 - Term: Viscosupplements - ID: D000020011 - Term: Protective Agents - ID: D000000924 - Term: Anticholesteremic Agents - ID: D000000960 - Term: Hypolipidemic Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000057847 - Term: Lipid Regulating Agents - ID: D000002614 - Term: Chelating Agents - ID: D000064449 - Term: Sequestering Agents - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Coag - Name: Coagulants - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: HIGH - As Found: Users - ID: M25928 - Name: Chitosan - Relevance: HIGH - As Found: Hyperthermia - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M28295 - Name: Viscosupplements - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M4243 - Name: Anticholesteremic Agents - Relevance: LOW - As Found: Unknown - ID: M4278 - Name: Hypolipidemic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M28883 - Name: Lipid Regulating Agents - Relevance: LOW - As Found: Unknown - ID: M5860 - Name: Chelating Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown - ID: T377 - Name: Chitosan - Relevance: HIGH - As Found: Hyperthermia ### Intervention Browse Module - Meshes - ID: D000048271 - Term: Chitosan - ID: D000006820 - Term: Hyaluronic Acid ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426186 **Brief Title:** Effect of Right-stellate Ganglion Block in Preventing on Postoperative Nausea and Vomiting **Official Title:** Effect of Right-stellate Ganglion Block in Preventing Postoperative Nausea and Vomiting in Gynecological Laparoscopic Patients #### Organization Study ID Info **ID:** PONV-Gynecological surgery #### Organization **Class:** OTHER **Full Name:** The Second Affiliated Hospital of Chongqing Medical University ### Status Module #### Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-08 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Second Affiliated Hospital of Chongqing Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Postoperative nausea and vomiting is one of the common postoperative complications. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk operations such as gynecological laparoscopy is higher. Postoperative nausea and vomiting can lead to perioperative complications and seriously affect the prognosis of patients. Although various preventive and therapeutic measures have been adopted in clinic, the incidence of perioperative nausea and vomiting is still high. Therefore, it is of great clinical significance to explore more effective and feasible methods to prevent the occurrence of PONV. Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this project aims to explore the preventive effect of stellate ganglion block on postoperative nausea and vomiting in gynecological laparoscopic surgery patients, and to explore its possible mechanism. **Detailed Description:** Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as gynecologic laparoscopy is higher. The pathogenesis of postoperative nausea and vomiting is very complex, including central, peripheral receptors and multiple nerve pathways. When peripheral receptors are stimulated, the signal passes through the afferent nerve to the vomiting center, causing nausea and vomiting. The emetic chemical receptors are rich in many receptors, which can directly feel various toxins, metabolites or drugs in the blood and cerebrospinal fluid, project signals to the nerve center and then spread to the cerebral cortex, causing nausea and vertigo, or transmit signals along the vagus nerve, glossopharyngeal nerve, spinal nerve, etc. to the digestive tract, diaphragm and abdominal wall muscles, resulting in the opening of the sphincter in the upper esophagus and strong contraction of the diaphragm. Abdominal muscles contract, so that the stomach pressure increases, stomach contents through the digestive tract is expelled from the body, vomiting. There are many factors affecting postoperative nausea and vomiting in gynecological laparoscopic surgery, including patient factors, anesthetic factors and surgical factors. Firstly, gender as an independent risk factor for postoperative nausea and vomiting is widely recognized by researchers, and a large number of studies have confirmed that the incidence of postoperative nausea and vomiting is higher in females, and the possible mechanism is caused by different hormone levels. Secondly, some studies believe that the type of surgery is also a risk factor for postoperative nausea and vomiting, but there is some controversy. In general, laparoscopic surgery patients have a higher incidence of postoperative nausea and vomiting. Finally, the mode of anesthesia and anesthesia-related drugs are also one of the risk factors affecting PONV. Compared with other anesthesia methods, the incidence of PONV was increased under general anesthesia, and the combination of intravenous anesthesia and intraoperative opioid application also increased the incidence of postoperative nausea and vomiting. Stellate ganglion block has been proved to be widely used in clinic and can play a positive role in multiple organs and systems of the whole body. In clinical work, stellate ganglion block is more widely used in the treatment of various pain, autonomic nerve disorders and other diseases. However, there are few clinical studies on whether stellate ganglion block can be used as an effective and feasible means to prevent postoperative nausea and vomiting and the related mechanisms to prevent the possible occurrence of nausea and vomiting. Therefore, this study will explore the preventive effect of stellate ganglion block on postoperative nausea and vomiting in gynecological laparoscopic patients, and hope to explore its possible mechanism, so as to provide more effective and feasible methods for clinical prevention of postoperative nausea and vomiting and improve patients' medical comfort and satisfaction. ### Conditions Module **Conditions:** - Postoperative Nausea and Vomiting ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Right-stellate ganglion block was given 30 minutes before anesthesia induction **Intervention Names:** - Procedure: Right-stellate ganglion block **Label:** Right-stellate ganglion block **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No treatment was given 30 minutes before anesthesia induction **Label:** Blank control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Right-stellate ganglion block **Description:** The experimental group was given right stellate ganglion block 30 minutes before anesthesia **Name:** Right-stellate ganglion block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Postoperative nausea and vomiting is evaluated by follow-up **Measure:** The incidence of postoperative nausea and vomiting **Time Frame:** From end of surgery to 24 hours after surgery #### Secondary Outcomes **Description:** Postoperative nausea and vomiting is evaluated by investigator's follow-up **Measure:** Incidence of nausea and vomiting during preemptive analgesia **Time Frame:** From 0-10 min after preemptive analgesia **Description:** ntensity of nausea and vomiting (the scale is Rhodes index of nausea and vomiting)is evaluated by numerical rating scale (0-10), which higher socre represents more severe the nausea and vomiting **Measure:** Intensity of nausea and vomiting during preemptive analgesia **Time Frame:** From 0-10 min after preemptive analgesia **Description:** Intensity of nausea and vomiting is evaluated by numeric rating scale (0-10), which higher socre represents more uncomfortable **Measure:** Intensity of nausea and vomiting during hospitalization **Time Frame:** From end of surgery to 24 hours after surgery **Description:** Mean arterial pressure in mmHg,heart rate in bpm,oxygen saturation（%） **Measure:** Hemodynamic parameters **Time Frame:** Before stellate ganglion block and From 0-30 min after Satellite Ganglion Blocks **Description:** Postoperative pain intensity is assessed by numeric rating scale (0-10), which higher socre represents more uncomfortable **Measure:** Postoperative pain intensity **Time Frame:** From end of surgery to 24 hours after surgery **Description:** Gastrointestinal function is is assessed by the evacuation time **Measure:** Recovery of gastrointestinal function **Time Frame:** From end of surgery to 24 hours after surgery **Description:** Sleep quality is is assessed by numeric rating scale (0-10), which higher socre represents better sleep quality **Measure:** Sleep quality **Time Frame:** From end of surgery to 1 day after surgery **Description:** Satisfaction score and postoperative analgesia satisfaction score is assessed by numeric rating scale (0-10), which higher socre represents more comfortable **Measure:** Satisfaction score and postoperative analgesia satisfaction score **Time Frame:** From end of surgery to hospital discharge with about 5 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years and ≤ 70 years 2. American Society of Anesthesiologists(ASA) physical status classification I-Ill. 3. Voluntary participation and ability to understand and sign the informed consent form 4. Patients undergoing gynecological laparoscopic surgery elective general anesthesia Exclusion Criteria: 1. Patients with obesity(BMI\>30kg/m2) 2. Contraindicated to stellate ganglion block 3. Patients who cannot cooperate with the study for any reason,or whom the investigator deems unsuitable for inclusion in this trial. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ling Dan, BD **Phone:** 13983072922 **Phone Ext:** 86 **Role:** CONTACT #### Locations **Location 1:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ling Dan, BD - **Phone:** 86 13983072922 - **Role:** CONTACT **Country:** China **Facility:** The Second Affiliated Hospital of Chongqing Medical University **State:** Chongqing **Status:** RECRUITING **Zip:** 400000 #### Overall Officials **Official 1:** **Affiliation:** The Second Affilated Hospital of Chongqing Medical University **Name:** ling Dan, BD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** all IPD that underlie results in a publication **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M17582 - Name: Vomiting - Relevance: HIGH - As Found: Vomiting - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: HIGH - As Found: Postoperative Nausea and Vomiting - ID: M12273 - Name: Nausea - Relevance: HIGH - As Found: Nausea - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009325 - Term: Nausea - ID: D000014839 - Term: Vomiting - ID: D000020250 - Term: Postoperative Nausea and Vomiting ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426173 **Brief Title:** Effect of Resistance Training in Patients on the Waiting List for Heart Transplant **Official Title:** Effect of Resistance Training on Functional Capacity, Quality of Life and Cardiac Biomarkers in Patients on the Waiting List for Heart Transplant: a Randomized and Controlled Clinical Trial #### Organization Study ID Info **ID:** CAAE: 77806024.4.0000.0068 #### Organization **Class:** OTHER **Full Name:** University of Sao Paulo General Hospital ### Status Module #### Completion Date **Date:** 2026-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico #### Lead Sponsor **Class:** OTHER **Name:** University of Sao Paulo General Hospital #### Responsible Party **Investigator Affiliation:** University of Sao Paulo General Hospital **Investigator Full Name:** Rafael M. Ianotti, PT **Investigator Title:** Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor) **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The present longitudinal, randomized, and blinded clinical trial aims to: * Evaluate the effects of resistance training on the functional capacity, quality of life, and cardiac biomarkers of hospitalized patients with heart failure (HF) on the waiting list for heart transplantation (HTx). * Evaluate the associations between Fried's frailty classification and functional capacity responses to resistance training. The protocol will have a total duration of 12 weeks. **Detailed Description:** Heart failure (HF) presents a significant challenge to contemporary healthcare systems. As HF progresses, heart transplantation (HTx) becomes the primary treatment option to enhance survival rates. Patients awaiting HTx often endure extended hospitalizations and rely on continuous inotropic support. This scenario exacerbates bed rest and potentially worsening functional capacity. Resistance training has shown promise in mitigating the detrimental effects of immobility, however, limited research has explored its impact on HF patients on the HTx waiting list. Objectives: * To evaluate the effects of resistance training on functional capacity, quality of life, and cardiac biomarkers in hospitalized patients with HF on the HTx waiting list. * To assess the associations between Fried's frailty phenotype and functional capacity responses to resistance training, hemodynamic behavior during the protocol, and the incidence of adverse events during the protocol implementation. Methods: A total of 50 patients hospitalized on the HTx waiting list will be recruited for this study. Participants will be randomly assigned to one of two groups: the resistance training group (TG) and the control group (CG). Assessments will occur at three time points: baseline (T0), at 6 weeks (T1), and at 12 weeks (T2) of resistance training. Clinical parameters will be evaluated, including the six-minute walk test and the Short Physical Performance Battery. Peripheral muscle strength will be measured using a dynamometer, and inspiratory muscle strength will be assessed through maximum inspiratory pressure. Quality of life will be evaluated using the Kansas City Cardiomyopathy Questionnaire-12. Additionally, cardiac biomarkers, such as exhaled air ketone and brain natriuretic peptide levels in venous blood samples, will be analyzed. ### Conditions Module **Conditions:** - Heart Failure - Heart Transplant **Keywords:** - heart failure - resistance training - cardiac rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized controlled trial ##### Masking Info **Masking:** SINGLE **Masking Description:** The researcher responsible for conducting the functional assessment will be blinded to the randomization and allocation groups. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive the standard treatment provided by the hospital inpatient unit alongside the resistance training program. **Intervention Names:** - Other: Resistance Training Program - Other: Standard Treatment Group **Label:** Resistance Training Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive the standard treatment provided by the hospital inpatient unit. **Intervention Names:** - Other: Standard Treatment Group **Label:** Standard Treatment Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Resistance Training Group **Description:** The resistance training program will be individualized and divided into four stages of increasing complexity. It will be conducted for approximately 40 minutes per day, three times a week, for 12 weeks, under supervision. Each patient will begin the program at the stage corresponding to their functional capacity. The resistance load will be set at 50% of the maximum resistance (1RM) obtained in the initial assessment. Throughout all stages of the exercise program, the target intensity will range from light (≤ 12) to moderate (≤ 15) on the Borg scale. **Name:** Resistance Training Program **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Resistance Training Group - Standard Treatment Group **Description:** Patients will receive the standard treatment provided by the hospital inpatient unit, which includes guidance on reducing sedentary time, encouragement to walk, and performance of active and breathing exercises when necessary. **Name:** Standard Treatment Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible. **Measure:** To investigate changes in physical performance measured by Six-Minute Walk Test. **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** The SPPB consists of three additional tests assessing balance, mobility, and strength. Each test is scored from 0 (indicating a worse outcome) to 4 (indicating a better outcome) points. At the completion of all tests, the total score ranges from 0 to 12 points. **Measure:** To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB). **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Maximum inspiratory pressure (measured in cmH2O) **Measure:** To investigate changes in respiratory muscle strength: **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Handgrip test (measured in KgF) **Measure:** To investigate changes in peripheral muscle strength. **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Kansas City Cardiomyopathy Questionnaire-Short Version. The total score ranges from 0 (indicating a worse outcome) to 100 (indicating a better outcome) points. **Measure:** To investigate changes in quality of life: **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Ketones in exhaled air (measured in μg/L) **Measure:** Enhancing the investigation of changes in cardiac biomarker ketones **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Description:** Brain natriuretic peptide in venous blood sample (picogram per milliliter, pg/ml) **Measure:** Enhancing the investigation of changes in cardiac biomarker brain natriuretic peptide **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). #### Secondary Outcomes **Description:** The Fried's frailty phenotype scale ranges from 0 to 5 points, where: 0 points denote non-frailty, up to 2 points denote pre-frailty, and ≥3 points denote frailty **Measure:** To investigate changes Fried's frailty phenotype **Time Frame:** The data will be collected on the baseline (T0), at 6 weeks (T1), and at 12 weeks (T2). **Measure:** To investigate changes in heart rate( bpm) **Time Frame:** Immediately before and after each session exercise training.(3 times per week, during 12 weeks) **Measure:** To investigate changes in blood pressure (mmHg) **Time Frame:** Immediately before and after each session exercise training (3 times per week, during 12 weeks) **Description:** Borg Rating of Perceived Exertion (0-lower, up to 10- highest) **Measure:** To investigate changes in perceived exertion sensation: **Time Frame:** Immediately before and after each session exercise training.(3 times per week, during 12 weeks) **Description:** Hemodynamic instability ( MAP \< 60 mmHg or \>120 mmHg) **Measure:** To investigate the occurrence of adverse events:Hemodynamic instability **Time Frame:** In each intervention period (3 days a week for 12 weeks) **Description:** Heart rate ( HR \< 50 bpm or \> 120 bpm). **Measure:** To investigate the occurrence of adverse events:Arrhythmia **Time Frame:** In each intervention period (3 times per week for 12 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients included in heart transplant list ≤1 month * hemodynamically stable in the last 48 hours defined as mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg and - Heart rate (HR) ≥ 60 bpm and ≤ 120 mmHg. * dobutamine dose ≤ 10 mcg/kg/min Exclusion Criteria: * heart failure of arrhythmogenic and/or restrictive etiology * presence of uncontrolled acute arrhythmias * cognitive, orthopedic, or neuromotor changes that prevent functional tests from being carried out **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Juliana A Nascimento, PT, PhD **Phone:** +55 11 30618529 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rafael M Ianotti, PT **Phone:** +55 11 26615319 **Role:** CONTACT #### Locations **Location 1:** **City:** Sao Paulo **Country:** Brazil **Facility:** Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo **Zip:** 05403-000 #### Overall Officials **Official 1:** **Affiliation:** University of Sao Paulo **Name:** Juliana A Nascimento, PT, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo **Name:** Rafael M Ianotti, PT **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### 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 - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426160 **Acronym:** TOPAC **Brief Title:** Tocilizumab for Painful Chronic Pancreatitis **Official Title:** Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-Controlled, Double-blinded, Investigator Initiated Trial (TOPAC Trial) #### Organization Study ID Info **ID:** F2024-054 #### Organization **Class:** OTHER **Full Name:** Aalborg University Hospital #### Secondary ID Infos **ID:** 2023-510084-35-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Aarhus University Hospital **Class:** OTHER **Name:** University of Aarhus **Class:** OTHER **Name:** Viborg Regional Hospital **Class:** OTHER **Name:** Stanford University **Class:** OTHER **Name:** Haukeland University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Soren Schou Olesen #### Responsible Party **Investigator Affiliation:** Aalborg University Hospital **Investigator Full Name:** Soren Schou Olesen **Investigator Title:** Professor, MD, Ph.D. **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis. **Detailed Description:** Recent independent research has emphasized the crucial role of immune cell infiltration and its interaction with pancreatic stellate cells in driving the inflammatory process and fibrogenesis in chronic pancreatitis (CP). The cytokine Interleukin 6 (IL-6) has been identified as a key mediator in this process, and preclinical studies have indicated that inhibiting IL-6 signaling can lead to favorable therapeutic outcomes. Consequently, targeting IL-6 signaling therapeutically holds great promise as a disease-modifying treatment for CP. Until now, there have been no placebo-controlled trials in humans to test immune-modulating treatments for CP. However, there have been some promising results in preclinical studies. For example, administering an anti-IL-6 receptor antibody to an animal model of CP reduced pancreatitis-related pain, indicating a potential therapeutic effect. Blocking IL-6 signaling in an in-silico model of CP was also shown to have disease-modifying effects. Recent anecdotal evidence indicates that using tocilizumab to treat patients with COVID-19 and concomitant pancreatitis can decrease inflammation and pain in the pancreas. Additionally, blocking IL-6 signaling has been demonstrated to have anti-fibrotic effects in patients with systemic sclerosis. Taken together, these findings suggest that targeting IL-6 signaling could be a promising approach for reducing inflammation and fibrogenesis in CP. Tocilizumab (RoActemra) is an anti-IL-6 receptor antibody currently used to treat several inflammatory diseases. Objectives: The investigators hypothesize that treatment with tocilizumab, compared with a placebo, will reduce symptom burden (CP-related pain) and improve physical functioning and quality of life in patients with CP. In addition, the investigators hypothesize that the clinical effects will be linked to a decrease in pancreatic inflammation and fibrosis as well as systemic inflammation. The investigators also hypothesize that the pain-relieving effect of tocilizumab will lead to the normalization of pain processing in CP patients. To test these hypotheses, the project is organized into four sub-studies. Sub-study 1 (main study - randomized placebo-controlled trial): The objective of sub-study 1 is to conduct an investigator-initiated phase 2b double-blinded, placebo-controlled, randomized clinical trial to investigate the clinical effect of tocilizumab on patient-reported outcomes. Sub-study 2 (inflammatory biomarkers): The objective of sub-study 2 is to investigate the effects of tocilizumab on systemic inflammation using blood-based immune and fibrosis markers. Sub-study 3 (quantitative imaging biomarkers): The objective of sub-study 3 is to investigate the effect of tocilizumab on pancreatic inflammation and fibrosis using Magnetic Resonance Imaging (MRI) of the pancreas. Sub-study 4 (pain processing): The objective of sub-study 4 is to investigate the effect of tocilizumab on pain processing using Pancreatic Quantitative Sensory Testing (P-QST) and electrophysiological methods (EEG and ECG). ### Conditions Module **Conditions:** - Pancreatitis, Chronic **Keywords:** - Inflammation - Pancreatic diseases - Digestive System Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomised, placebo-controlled, double-blinded investigator-initiated trial ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 8 mg / kg Tocilizumab will be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9 %) **Intervention Names:** - Drug: Tocilizumab 20 MG/ML [Actemra] **Label:** Tocilizumab **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 100 ml sodium chloride 9 mg/mL (0.9 %). **Intervention Names:** - Drug: Sodium Chloride 0.9% Inj **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Tocilizumab **Description:** Tocilizumab 8 mg/kg every four weeks for 24 weeks. **Name:** Tocilizumab 20 MG/ML [Actemra] **Other Names:** - RoActemra - Actemra **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo (Sodium chloride) every four weeks for 24 weeks. **Name:** Sodium Chloride 0.9% Inj **Other Names:** - Natriumchloride 0.9 % Inj **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** The investigators plan to use an O-link multiplex platform to examine changes in soluble inflammatory biomarker levels, including several cytokines and chemokines. **Measure:** Levels of soluble inflammation biomarker **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** The investigators plan to use an O-link multiplex platform to examine changes in soluble fibrosis biomarker levels, from baseline at 24 weeks. **Measure:** Levels of soluble fibrosis biomarker **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** Macrophage activation biomarkers will be analyzed using enzyme-linked immunosorbent assays (ELISAs) levels, from baseline at 24 weeks. **Measure:** Levels of soluble Biomarker of Macrophage Activation **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** For the key inflammatory mediator, found in above mentioned analysis, the investigators will confirm the analyses using ELISAs levels from baseline at 24 weeks. **Measure:** Levels of key Inflammatory Mediator **Time Frame:** The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24) **Description:** The between and within-group difference of diffusion-weighted imaging for inflammation using multiparametric pancreatic MRI at baseline and after 24 weeks. **Measure:** Pancreatic inflammation (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of fibrosis detection using T1 mapping multiparametric pancreatic MRI parameters at baseline and after 24 weeks. **Measure:** Pancreatic fibrosis (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of conventional anatomic imaging using multiparametric pancreatic MRI at baseline and after 24 weeks. **Measure:** Pancreatic morphology (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of pancreatic duct morphology using Magnetic resonance cholangiopancreatography (MRCP) at baseline and after 24 weeks. **Measure:** Pancreatic duct morphology (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The between and within-group difference of biliary duct morphology using MRCP at baseline and after 24 weeks. **Measure:** Biliary duct morphology (imaging) **Time Frame:** The intervention period is 24 weeks (conducted at weeks 0 and 24) **Description:** The pancreatic quantitative sensory testing (P-QST) is used to characterize pain processing and comprises different experimental pain stimuli: PinPrick test: A pinprick stimulator 256 mN (MRC Systems GmbH, Germany) will be used to perform the pinprick test. The patient is asked to rate the pain sensitisation using the VAS score after a single pinprick stimulus and after ten repetitive stimuli (applied with an interstimulus interval of 1 second). Two test areas are assessed: the dominant forearm and the anterior TH10 dermatome. The score is reported on a VAS score from 0 to 10. Higher scores indicate higher pain tolerance. **Measure:** P-QST: PinPrick (Temporal summation) **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** The P-QST is used to characterize pain processing and comprises different experimental pain stimuli: Pain pressure test: Pressure algometry is performed with a handheld pressure algometer (Type2, Somedic production AB, Sweden) and performed in four dermatomes and five locations: C5 (the clavicle), TH10 (the back and abdomen), L1 (the anterior superior iliac spine), and L4 (straight thigh). The probe has a surface area of 1cm2. Pressure will be increased at a rate of 30 kPa/sec until prespecified thresholds (i.e., pain detection threshold (PDT) and pain tolerance threshold (PTT)) are reached. The assessment parameters are the imposed pressure (kPa) at the PDT and PTT. **Measure:** P-QST: Pain Pressure thresholds **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** The P-QST is used to characterize pain processing and comprises different experimental pain stimuli: Cold pressor test: The patient's hand is immersed in cold water (approximately two degrees Celsius) for 120 seconds. At 40, 80, and 120 seconds, the patient is asked to rate the pain sensation using a VAS score. If the patient cannot keep their hand in the water for 120 seconds, the duration is noted, and the VAS score at the time they withdraw their hand is used as the maximum score. The assessment parameters are the cold pressor endurance time (seconds) and the evoked pain responses on a visual analog scale (VAS) score, 0 = no pain and 10 = worst pain imaginable. Lower values indicate higher pain tolerance. **Measure:** P-QST: Cold Pressor **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** The P-QST is used to characterize pain processing and comprises different experimental pain stimuli: Conditioned pain modulation test is conducted using a pain pressure algometer, and the PTT is assessed at 15 cm above the patella in the L4 dermatome on the nondominant side before and after the cold pressor test is performed. The imposed pain pressure tolerance threshold is reported as kPa, with a minimum of 0, and no upper limit. Higher scores indicate higher pain tolerance. **Measure:** P-QST: Conditioned Pain Threshold **Time Frame:** The intervention period is 24 weeks (performed at weeks 0 and 24) **Description:** While performing the P-QST, the investigators measure EEG and ECG before and after the cold pressor test. A standard EEG electrode Cap Kit (EEG Electrode Cap Kit - OpenBCI Online Store) with ten electrodes is employed for these measurements.The Texas Instrument ADS1299 biopotential measurements system will be used for EEG and ECG recordings. This system is already being used in mobile brain-computer interfaces, and its signals are comparable to those of standard systems that can work in hospital settings. The EEG signals are transmitted wirelessly to an Android mobile telephone and stored for further processing. The results will be used to model connectivity between brain centres as well as the dominating centres of the brain. EEG power will be assessed in the Delta, Theta, Alpha, Beta, and Gamma bands between 1 and 70 Hertz. Finally, inverse modelling will be conducted to explore the dominating centres of brain activity. **Measure:** Electroencephalography (EEG) analysis **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) **Description:** Four conventional ECG electrodes (Neurolink 700) is employed for these measurements. The ECG signals are transmitted wirelessly to an Android mobile telephone and stored for further processing. Frequency domains of heart variablity will be assessed using ECG,this involve Fast Fourier transformation of the Blackman Harris window included very low frequency (VLF), low frequency (LF), high frequency (HF), total power (TP), and the ratios LF/HF. **Measure:** Electrocardiographic (ECG) frequency domain **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) **Description:** Four conventional ECG electrodes (Neurolink 700) is employed for these measurements. The ECG signals are transmitted wirelessly to an Android mobile telephone and stored for further processing. Time domains of heart variablity will be assessed using ECG, this involve determining the mean RR interval, standard deviation of RR interval, heartbeat rate (HR), and root mean squared difference of successive normal RR intervals (RMSSD). **Measure:** ECG time domain **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) #### Primary Outcomes **Description:** The between-group difference (tocilizumab vs. placebo) of the change from baseline in the COMPAT-SF score at 24 weeks. The COMPAT-SF score is noramlized on a 0-100 score. Higher scores indicate a higher degree of pain. **Measure:** The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire **Time Frame:** The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization) #### Secondary Outcomes **Description:** The between-group difference in the Global Quality of Life Score from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ-C30) questionnaire at 24 weeks. The global quality of life score range from 0 to 100. A high score on the Global Quality of Life score represents a high level of life quality. **Measure:** Global Quality of Life Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Physical Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The physical functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Physical Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Role Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The role functional score ranges from 0 to 100 A high score on the functional scales represents a high level of daily functioning. **Measure:** Role Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Cognitive Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The cognitive functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Cognitive Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Emotional Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The emotional functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Emotional Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Social Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The social functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning. **Measure:** Social Functional Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Symptom Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The symptom burden score ranges from 0 to 100. A high score for the symptom items represents a high level of symptomatology. **Measure:** Symptom Burden Score (EORTC-QLQ-C30) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Pain severity score from baseline in the modified Brief Pain Inventory at 24 weeks. The pain severity score is rated on a visual analogue scale (VAS), 0 = no pain, 10 = worst pain imaginable), based on four pain severity items. Higher scores reflect more severe pain. **Measure:** Pain severity Score (modified BPI) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Pain Interference score from baseline in the modified Brief Pain Inventory at 24 weeks. The pain interference score is rated on a VAS, 0 = no pain, 10 = worst pain imaginable, based on seven pain interference items. Higher scores reflect more pain interference with daily life. **Measure:** Pain Interference Score (modified BPI) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in Average Daily Pain score from baseline in the modified Brief Pain Inventory at 24 weeks. The average daily pain score ranges is rated on a VAS-scale, 0-10, 0 = no pain, and 10 = worst pain imaginable. **Measure:** Average Daily Pain Score (modified BPI) **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0, 12, and 24) **Description:** The between-group difference in the PGIC questionnaire, a self-reporting seven-point rating scale (points from 1-7) on how the participant experiences treatment change from baseline at 24 weeks. Higher score corresponds to improvement. **Measure:** Patient's Global Impression of Change (PGIC) Questionnaire **Time Frame:** The intervention period is 24 weeks (assessed at week 24) **Description:** The between-group difference in the CP prognosis score from baseline at 24 weeks. The CP prognosis score ranges from 5-15 points. Higher scores indicates higher risk of readmission to hospital. **Measure:** CP Prognosis Score **Time Frame:** The intervention period is 24 weeks (assessed at weeks 0 and 24) **Description:** Opioid use (yes, no, binary answer) continuously through the entire study **Measure:** Number of patient using prescription opioids for pain control **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** The between and within-group difference of opioid dose (continuous variable in mg of moprhine equivalent) in patients, from baseline at 24 weeks. **Measure:** Daily opioid dose for patients using prescription opiods **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** Weak analgesic use (yes, no, binary answer) continuously through the entire study **Measure:** Number of patient using weak analgesics for pain control **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** The between and within-group difference of weak analgesic dose (continuous variable in mg) in patients, from baseline at 24 weeks. **Measure:** Daily weak analgesics dose for patients **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) **Description:** The frequency of adverse events from baseline at 24 weeks. **Measure:** Frequency of adverse events (Patient Diary) **Time Frame:** The intervention period is 24 weeks (continuously throughout the entire study) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed informed consent. * Probable or definitive diagnosis of CP according to the M-ANNHEIM criteria. This entails a typical clinical history of CP, including recurrent pancreatitis or abdominal pain in combination with the following additional criteria: * A definitive diagnosis of CP is established by one or more of the following additional criteria: * i) Pancreatic calcification * ii) Moderate or marked ductal lesions (according to the Cambridge classification) * iii) Exocrine pancreatic insufficiency, defined as pancreatic steatorrhea markedly reduced by enzyme supplementation * iv) Histological verification of CP * A probable diagnosis of CP is established by one or more of the following additional criteria: * i) Mild ductal alterations (according to the Cambridge classification) * ii) Recurrent or persistent pseudocysts * iii) Pathological test of pancreatic exocrine function (such as faecal elastase-1 test, secretin test, secretin-pancreozymin test) * iv) Diabetes mellitus * Abdominal pain of presumed pancreatic origin (i.e., upper abdominal pain radiating to the back). * Evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months. An inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following criteria: * i) Plasma amylase levels elevated 2-fold or more than the participant's usual amylase level. * ii) Elevated plasma levels of CRP 2-fold the upper normal level without suspicion of other sources such as infection. * iii) Signs of pancreatic inflammation on cross-sectional imaging. * ≥ 18 years of age * The participant must be able to read and understand the informed consent forms. * The participant is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures. Exclusion Criteria: * End-stage CP indicated by severe pancreatic atrophy defined as segmented pancreas volume \<20 ml on the latest available cross-sectional imaging examination (Computed Tomography (CT) or MRI). * Pancreatic duct obstruction by a stricture and/or stone amendable to endoscopic or surgical treatment. Patients with previous pancreatic duct decompression procedures are allowed to participate. * Ongoing alcohol or substance abuse. The patient must document abstinence from alcohol and substance abuse for the preceding six months prior to study enrolment. Recreational alcohol consumption within the safety limits recommended by the National Danish Health Authorities (i.e., max. ten units of alcohol per week) is allowed. * Active or recurrent infections. * Untreated ulcers in the gastrointestinal tract (however, those who have undergone proper treatment and one month has elapsed with no recurrence of symptoms will not be excluded). * Known hypersensitivity to Tocilizumab. * Positive test for Tuberculosis during screening * Positive test for Hepatitis during screening * Severe liver disease, indicated by ALT with \>5 upper normal limits. * Thrombocytopenia (platelet count \< 50 x 109/L). * Neutropenia (neutrophil count \<2 x 109/L). * Pregnancy and no contraception use, fertile women (\<55 years) must provide a urine sample for pregnancy test upon inclusion. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rasmus Hagn-Meincke, MD **Phone:** 004597663520 **Role:** CONTACT #### Locations **Location 1:** **City:** Aalborg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rasmus Hagn-Meincke, MD - **Phone:** 004597663520 - **Role:** CONTACT **Country:** Denmark **Facility:** Centre for Pancreatic Diseases and Mech-Sense research laboratory, Aalborg University Hospital **State:** Nordjylland **Zip:** 9000 #### Overall Officials **Official 1:** **Affiliation:** Mech-Sense, Department of Gastroenterology, Aalborg University Hospital **Name:** Søren S Olesen, MD, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Access to the data is available upon reasonable request. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M13115 - Name: Pancreatitis - Relevance: HIGH - As Found: Pancreatitis - ID: M26260 - Name: Pancreatitis, Chronic - Relevance: HIGH - As Found: Pancreatitis, Chronic - ID: M13102 - Name: Pancreatic 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: D000010195 - Term: Pancreatitis - ID: D000050500 - Term: Pancreatitis, Chronic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426147 **Brief Title:** L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients) **Official Title:** A Randomised, Double-blind, Placebo-controlled Trial of L-Citrulline Oral Supplementation to Improve Short and Long-term Outcomes of Admitted Febrile Paediatric Patients With Biomarker-determined High-risk of Adverse Outcomes #### Organization Study ID Info **ID:** EChiLiBRiST CT2 #### Organization **Class:** OTHER **Full Name:** Barcelona Institute for Global Health ### Status Module #### Completion Date **Date:** 2027-04-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-01-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Barcelona Institute for Global Health #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project ("Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival") has the two-fold objective of: 1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the "prognostic" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and 2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-\<60 months identified as "moderate-to-high risk" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo. This second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving \~888 children 1-\<60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg/kg/day depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia. **Detailed Description:** Children admitted to hospital and meeting the study eligibility criteria who are 0-\<60 months of age will be eligible for study inclusion, and for initial biomarker screening using the study-designed rapid triaging PoC test, based on the measurement of sTREM-1. Study participants aged 1m-\<5 years of age with sTREM-1 values classified as moderate (i.e., "yellow") or high-risk (i.e., "red") in the traffic light risk-stratification system will be randomly allocated (1:1) to receive L-Cit intervention or placebo. All study participants will be followed for 6 months, with study visits at the study hospitals or at home or via phone communication after discharge at day 3, day 5, day 7, day 28, and month 6. The study primary outcome will be "adverse disease outcome", defined as a composite of mortality, incident neurological sequelae, major adverse kidney event at discharge, need for organ support, clinical shock, coma, severe respiratory distress or need for readmission within 28 days after recruitment. ### Conditions Module **Conditions:** - Infectious Disease - Infections - Child, Only ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1 or 2 sachets every 12 hours (200-300mg/kg/day depending on weight-band) for 28 days **Intervention Names:** - Dietary Supplement: L-citrulline **Label:** L-citrulline **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 1 or 2 sachets every 12 hours (depending on weight-band) for 28 days **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - L-citrulline **Description:** 1 or 2 sachets every 12 hours (200-300mg/kg/day depending on weight-band) for 28 days **Name:** L-citrulline **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** 1 or 2 sachets every 12 hours (depending on weight-band) for 28 days **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** Concentration of circulating mediators of host immune and endothelial function, inflammation, intestinal barrier function, and neuronal damage at baseline, D3 and D7 **Measure:** Concentration of circulating mediators of host immune and endothelial function, inflammation, intestinal barrier function, and neuronal damage **Time Frame:** Up to day 7 **Description:** Levels of lactate at baseline and D3 **Measure:** Lactate levels **Time Frame:** Up to day 3 **Description:** Levels of markers of kidney function (creatinine, urea, saliva urea nitrogen (SUN), uNGAL etc.) at baseline, D3, D7 and at discharge **Measure:** Levels of markers of kidney function **Time Frame:** Up to day 7 **Description:** Prognostic performance of PoC-RTT measured sTREM-1 values at baseline among children (0-\<60 months of age) with adverse outcomes up to D28. **Measure:** PoC-RTT prognostic performance **Time Frame:** Up to day 28 **Description:** Prognostic performance of a larger panel of prognostic biomarkers (circulating markers of endothelial function, inflammation, intestinal barrier function, and neuronal damage) at baseline. **Measure:** Prognostic performance of a larger panel of biomarkers **Time Frame:** At baseline #### Primary Outcomes **Description:** Proportion of participants with "adverse disease outcome" defined as a composite of (i.e., the occurrence between D0 and D28 after recruitment of at least one -or more- of the following adverse outcomes): * Mortality * Incident neurological sequelae * Major adverse kidney event at discharge (MAKE-DC, defined as a severe AKI event between 2-7 days or a discharge eGFR\<60mL/min per 1.73m2) * Need for organ support * Clinical shock * Coma * Severe respiratory distress * Need for readmission within the first 28 days post-recruitment (after having been discharged) **Measure:** Adverse disease outcome **Time Frame:** Up to day 28 #### Secondary Outcomes **Description:** Proportion of participants with mortality between day 0 and day 28 after recruitment and/or up to hospital discharge. **Measure:** Mortality **Time Frame:** Up to day 28 **Description:** Proportion of participants with incident neurological sequelae between day 0 and day 28 after recruitment and/or up to hospital discharge. **Measure:** Incident neurological sequelae **Time Frame:** Up to day 28 **Description:** Proportion of participants with major adverse kidney event at discharge (MAKE-DC, defined as a severe AKI event between 2-7 days or a discharge eGFR\<60mL/min per 1.73m2) **Measure:** Major adverse kidney event **Time Frame:** Up to day 28 **Description:** Proportion of participants with need for organ support **Measure:** Need for organ support **Time Frame:** Up to day 28 **Description:** Proportion of participants with clinical shock **Measure:** Clinical shock **Time Frame:** Up to day 28 **Description:** Proportion of participants with severe respiratory distress **Measure:** Severe respiratory distress **Time Frame:** Up to day 28 **Description:** Proportion of participants with coma **Measure:** Coma **Time Frame:** Up to day 28 **Description:** Proportion of participants with need for readmission within the first 28 days post-recruitment (after having been discharged) **Measure:** Need for readmission **Time Frame:** Up to day 28 **Description:** Median duration of antibiotic treatment up to day 28 **Measure:** Median duration of antibiotic treatment **Time Frame:** Up to day 28 **Description:** Proportion of participants with oxygen requirement up to D28 and/or up to hospital discharge **Measure:** Oxygen requirement **Time Frame:** Up to day 28 **Description:** Proportion of participants with radiological pneumonia among children with RTI up to D28 and/or up to hospital discharge **Measure:** Radiological pneumonia **Time Frame:** Up to day 28 **Description:** Proportion of participants with hypoxemia (Sat 02\<90% irrespective of supplementary oxygen in absence of cyanotic heart disease) up to D28 and/or up to hospital discharge **Measure:** Hypoxemia (Sp02 <90%) **Time Frame:** Up to day 28 **Description:** Length of hospitalisation up to D28 and/or up to hospital discharge **Measure:** Lenght of hospitalisation **Time Frame:** Up to day 28 **Description:** Proportion of participants with mortality up to M6 **Measure:** Mortality **Time Frame:** Up to month 6 **Description:** Proportion of participants with secondary consultations or hospitalisations up to M6 **Measure:** Secondary consultation or hospitalisations **Time Frame:** Up to month 6 **Description:** Proportion of participants with serious adverse events up to month 6 **Measure:** Proportion of participants with serious adverse events **Time Frame:** Up to month 6 **Description:** Proportion of participants with suspected unexpected serious adverse reactions up to M6. **Measure:** Proportion of participants with suspected unexpected serious adverse reactions **Time Frame:** Up to month 6 **Description:** Proportion of participants with adverse events up to D30. **Measure:** Proportion of participants with adverse events **Time Frame:** Up to day 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Enrolled in the initial prognostic screening component. * Sick children with fever (axillary temperature\>37.5ºC) or a history of fever (within the preceding 72h) or with suspected severe disease. * 1m-\<60 months of age. * With an indication for admission, or having already been admitted to hospital due to their illness. * With an sTREM-1 PoC result classifying their disease as of "moderate-high risk" ("yellow" or "red") upon study recruitment and within D3. * Residents in the study area or willing to be contacted and traced during the study duration. * Willing to sign an informed consent document. * Willing to undergo and adhere to study procedures as explained in the IC document. Exclusion Criteria: * Admission to hospital for social reasons (and not on account of their disease). * Children for which informed consent document has not been signed. * Known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet. * Concurrent participation in any other clinical trial. * Patient under NPO or "nothing by mouth" prescription . * Contraindication for the insertion of a nasogastric tube (NGT) of for the enteral administration of drugs through the NGT in children who cannot tolerate by mouth. * Critically sick patient whose prognosis is considered by the clinical researcher as fatal outcome in the following hours after screening. * Any other condition determined by the investigators that makes it unlikely that the participant would complete the follow up until day 28 of study. **Maximum Age:** 60 Months **Minimum Age:** 0 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Quique Bassat, Prof **Phone:** 93 227 92 12 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Barbara Baro, PhD **Phone:** 93 227 92 12 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Barcelona Institute for Global Health **Name:** Quique Bassat, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** On request to any interested professional **Description:** This clinical trial, as part of the wider EChiLiBRiST project, is committed to EU-funded Horizon 2021 aims to improve and maximize access to and reuse of research data generated by the Project. Biological samples and data will be shared using material and data transfer agreements with the collaborating institutions. The full protocol will be available on request to any interested professional and may be published in peer-reviewed journals or deposited in an online repository. A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the the analysis is completed and no later than five years after the publication of the trial. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the data analysis is completed and no later than five years after the publication of the trial. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M8464 - Name: Fever - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infectious Disease - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infectious Disease - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426134 **Acronym:** KISSeS **Brief Title:** Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS **Official Title:** Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders #### Organization Study ID Info **ID:** NL83836.018.23 #### Organization **Class:** OTHER **Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **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:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Parnassia Groep **Class:** OTHER **Name:** The University of Texas at Dallas **Class:** OTHER **Name:** University of Alberta **Class:** UNKNOWN **Name:** EnLiSense #### Lead Sponsor **Class:** OTHER **Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) #### Responsible Party **Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) **Investigator Full Name:** Karin Huizer **Investigator Title:** Principal Investigator; MD, PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD). The main questions it aims to answer are: Does a ketone drink improve information processing in patients with SSD/BD? Other questions it aims to answer are: Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over'). Participants will: 1. drink a ketone drink and (after a wash-out period) an isocaloric control drink; after each drink: * EEG to determine information-processing parameters (PPI and P300) * cognitive tests * visual analog scale of mood, energy levels, ability to focus * indirect calorimetry to determine use of energy substrate * blood draws 2. for 5 consecutive days: * wear a continuous glucose monitor (CGM) * wear a non-invasive passive sweat biomarker sensor (EnLiSense device) * register a diet and nicotine diary * saliva sampling (max. 4x/day, only on both intervention days) ### Conditions Module **Conditions:** - Schizophrenia and Related Disorders - Psychosis - Bipolar and Related Disorders - Manic Episode - Depressive Episode ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1x50 g dGK ketone drink **Intervention Names:** - Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) **Label:** dGK **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 1x isocaloric carbohydrate control drink **Intervention Names:** - Other: Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride **Label:** isocaloric carb control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - dGK **Description:** 1x50g ingestion of pure dGK **Name:** (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) **Other Names:** - delta G Ketones (dGK) **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - isocaloric carb control **Description:** Isocaloric carbohydrate control (active control) **Name:** Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride **Other Names:** - Maurten Drink Mix 160 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** PPI: an event-related potential (ERP) representing information processing (known to be disrupted in schizophrenia and bipolar disorder). The PPI task is an auditory paradigm featuring a total of 10 trials split evenly into two conditions: prepulse (PP) and non-prepulse (NP) in blocks. Startle pulses are 100dB at 40 ms, which is shown to provide significant startle visible in EEG126. Prepulse stimuli are 70 dB and 50 ms in duration, presented 50ms prior to the startle pulse. There is a 12 to 18 (avg: 15 s) interstimulus interval. All stimuli are white-noise blips. A calibrated apparatus is used to present the stimuli. Total estimated time is 20 min. **Measure:** Prepulse Inhibition (PPI) - change dGK vs isocaloric control **Time Frame:** measured 45 minutes (Tmax) after ingestion of intervention 1 (dGK) and 45 minuts after ingestion of intervention 2 (isocaloric carb control) #### Secondary Outcomes **Description:** The P300 task consists of 160 stimuli in the oddball paradigm and requires the subjects to press a button on detection of the rare target (32/160). The common nontarget stimuli are 500 Hz, 100 ms duration. The rare target stimuli are 700 Hz. Both are 100 ms duration at 80 dB with variable interstimulus interval of 1.2 to 1.5 s. Preceded by 10 practice trials. This task has minimal burden and requires about 10 minutes. **Measure:** P300 Event Related Potential (change dGK vs isocaloric control) **Time Frame:** measured 65-75 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after PPI. **Description:** 15WT is a measure of verbal/episodic memory. The 15WT consists of 15 words, which have to be learned during three trials. After every trial the respondent is asked to recall as many words as possible. After a distraction period of 20 minutes, the respondent is asked to name the words they have learned before, again. Immediate recall after 1 test: maximum 15 words (minimum 0) Immediate recall after 3 test: maximum 45 words (minimum 0). Retention score after 20 minutes: 1. percentage of correctly remembered words in the delayed recall-trial, relative to the number of words correctly remembered in the third immediate recall-trial 2. percentage of correctly remembered words in the delayed recall-trial, relative to the maximum score in the immediate recall-trials Higher 15WT scores indicate better verbal/episodic memory, lower scores the opposite. **Measure:** Cognitive test: 15 Word Test (15WT) - change dGK vs isocaloric control **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300. **Description:** TMT-A is a measure of (visual) attention. TMT-A outcome is the duration of time required to finalize test (including the time needed for the correction of errors prompted by the examiner), with a maximum of 5 minutes. The average TMT-A score in healthy adults is 29 seconds; a deficient score is greater than 78 seconds. Higher scores on TMT-A indicate worse (visual) attention. **Measure:** Cognitive test: Trail Making Test A (TMT-A) - change dGK vs isocaloric control **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after P300. **Description:** TMT-B is a measure of (frontal) executive functioning. TMT-B outcome is the duration of time required to finalize test (including the time needed for the correction of errors prompted by the examiner), with a maximum of 5 minutes. Average TMT-B score is 75 seconds; a deficient score is greater than 273 seconds. Higher scores on TMT-B indicate worse (frontal) executive functioning. **Measure:** Cognitive test: Trail-Making Test B (TMT-B) - (change dGK vs isocaloric control) **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-A. **Description:** DST is a measure for working memory. DST outcome is the maximum number of sequential digits correctly reproduced. In average healthy adults, the digit span is around 7 +/- 2. Minimum score is 0, maximum score is 9. Lower DST score indicate worse working memory. **Measure:** Cognitive test: Digit Span Test (DST) (change dGK vs isocaloric control) **Time Frame:** measured 75-85 minutes after ingestion of intervention 1 (dGK) and 75 minutes after ingestion of intervention 2 (isocaloric carb control); NB: directly after TMT-B. **Description:** visual analog scale (VAS) is used with a scale of 0 to 10 to measure patient-experiences effects of the interventions on their mood (0=extremely depression, 10 = extremely happy/euforic), energy level (0=completely exhauster, 10= extremely energetic) and ability to focus (0=completely unable to focus, 10=perfect focus). **Measure:** Patient experience outcome on Mood, energy level, focus (change dGK vs isocaloric control) **Time Frame:** measured circa 120 minutes after ingestion of intervention 1 (dGK) and circa 120 minutes after ingestion of intervention 2 (isocaloric carb control) **Description:** sequential blood sampling through intravenous line: concentration (pg/ml) of inflammatory biomarkers relevant for immune function: * IL-1b * IL-6 * IL-8 * IL-10 * TNF-a * IFN-g * hsCRP Comparison between dGK and isocaloric control at the same time points (see below). **Measure:** Immune function: blood markers (change dGK vs isocaloric control) **Time Frame:** first blood sample before ingestion (dGK or isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours) **Description:** RNA expression analysis (immune panel nCounter, Nanostring) in whole blood: comparison dGK vs isocaloric control only at T0 plus 90 minutes. **Measure:** Immune function: blood RNA markers (change dGK vs isocaloric control) **Time Frame:** first blood sample before ingestion (dGK or isocaloric control) (T0), next at T0+90 minutes **Description:** continuous measurement of IL-6 (pg/ml) in passive sweat (EnLiSense device) **Measure:** Immune function: passive sweat IL-6 (change dGK vs isocaloric control) **Time Frame:** Full 5 days of the study **Description:** continuous measurement of TNF-a (pg/ml)in passive sweat (EnLiSense device) **Measure:** Immune function: passive sweat TNF-a (change dGK vs isocaloric control) **Time Frame:** Full 5 days of study **Description:** Resting energy expenditure (REE) is measured by gaseous exchange (indirect calorimetry). Oxygen consumption and CO2 production are measured during 20 minutes using a ventilated hood system (Q-NRG, Cosmed). Subjects lie flat on their backs and breathe into a canopy for 20 minutes. REE and Respiratory Quotient (RQ) are calculated with these measurements. The RQ represents the ratio of CO2 exhaled to the amount of 02 consumed by the individual and represents whole body substrate oxidation (glucose, fat and protein oxidation). **Measure:** Metabolic function: Indirect Calorimetry (change dGK vs isocaloric control) **Time Frame:** circa 90-120 minutes after ingestion of intervention 1 (dGK) and intervention 2 (isocaloric control); directly after finalizing cognitive tests. **Description:** Sequential blood sampling through intravenous line, to determine the plasma and serum concentrations of: * Glucose * Ketones * acylcarnitine profile * growth hormone (GH) * superoxide dismutase (SOD) * gluthione S-transferase (GST) * soluble intercellular adhesion molecule 1 (sICAM1) Comparison between dGK and isocaloric control at the same time points (see below). **Measure:** Metabolic function: blood biomarkers - change dGK vs isocaloric control **Time Frame:** first blood sample before ingestion (both dGK and isocaloric control) (T0), then every 20 minutes in first hour after ingestion; afterwards every 30 minutes (max. 3 hours) **Description:** continuous glucose monitor (CGM; Abbott Libre Sense); continuous concentration in mM. **Measure:** Metabolic function: continuous glucose monitor (CGM) - change dGK vs isocaloric control **Time Frame:** Full 5 days of the study. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder) * Age \>= 18 years old * Receiving standard care (including antipsychotic and mood stabilizing medication) * Mentally competent to give informed consent: Exclusion Criteria: * Substance use as cause of psychosis or (hypo)mania * Substance use (other than nicotine) in the week prior to study onset * Intellectual disability * Diabetes mellitus (type 1 or type 2) * Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood) * Liver disease * Kidney disease * Cardiovascular disease * Pregnancy * Breastfeeding **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Karin Huizer, MD/PhD **Phone:** +31683048776 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nico Beveren, van, MD/PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Parnassia Groep **Name:** Karin Huizer, MD/PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019967 - Term: Schizophrenia Spectrum and Other Psychotic Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000019964 - Term: Mood Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M15376 - Name: Schizophrenia - Relevance: HIGH - As Found: Schizophrenia - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M2598 - Name: Mania - Relevance: HIGH - As Found: Manic Episodes - ID: M226 - Name: Bipolar and Related Disorders - Relevance: HIGH - As Found: Bipolar and Related Disorders - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M10687 - Name: Ketosis - Relevance: LOW - As Found: Unknown - ID: M21838 - Name: Schizophrenia Spectrum and Other Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000087122 - Term: Mania - ID: D000012559 - Term: Schizophrenia - ID: D000001714 - Term: Bipolar Disorder - ID: D000068105 - Term: Bipolar and Related Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426121 **Brief Title:** Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product **Official Title:** Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product #### Organization Study ID Info **ID:** IDS-23CNBAC01 #### Organization **Class:** INDUSTRY **Full Name:** Becton, Dickinson and Company ### Status Module #### Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Becton, Dickinson and Company #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a multi-center, randomized clinical validation. Subjects should be fully informed of this protocol and related risks, and can only be enrolled into this study after signing the informed consent form. Blood collection of the subjects at the same puncture point at a single site will be injected into the test vial and the control vial respectively, and the vials will be transferred to the BACTEC system for culture and the results will be observed. After the BACTEC system incubation completion, the vials will be subcultured. Strains grown on plates will be identified using appropriate methods and, if possible, at the species level. ### Conditions Module **Conditions:** - Blood Culture of Microorganisms ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Additional blood sample collected compared to clinical routine care **Intervention Names:** - Diagnostic Test: test Aerobic/F Culture Vials **Label:** BD BACTEC™ Plus Aerobic/F Culture Vials(test) #### Arm Group 2 **Description:** clinical routine care **Intervention Names:** - Diagnostic Test: control Aerobic/F Culture Vials **Label:** BD BACTEC™ Plus Aerobic/F Culture Vials(control) ### Interventions #### Intervention 1 **Arm Group Labels:** - BD BACTEC™ Plus Aerobic/F Culture Vials(test) **Description:** an additional blood sample will be collected compared to clinical routine of blood culture, inoculated into the test culture vial, and compared with the blood culture results of the control vial collected from the same site and the same puncture point **Name:** test Aerobic/F Culture Vials **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - BD BACTEC™ Plus Aerobic/F Culture Vials(control) **Description:** according to the clinical routine of blood culture, this blood sample should be collected and inoculated into the control vial, and its culture result will be collected **Name:** control Aerobic/F Culture Vials **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The consistency rate of the test vials and the control vials BACTEC™ system test results, including the overall consistency rate, positive consistency rate, and negative consistency rate **Measure:** consistency rate **Time Frame:** 8 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subject is willing to provide written informed consent to sponsor. * Blood specimens * Patients with suspected blood infection that have one or more of the following characteristics : a) Body temperature \> 38°C or body temperature \<36°C; b) chills; c) increased peripheral blood leukocyte count (count \> 10.0×109/L, especially if there is a "left shift") or decrease (count \< 3.0×109/L); d) Respiratory rate \> 20 beats/min or arterial partial pressure of carbon dioxide (PaCO2) \<32mmHg; e) Heart rate\> 90 beats/min; f) mucocutaneous hemorrhage; g) coma; h) Multi-organ dysfunction; i) decreased blood pressure; j) Elevated inflammatory response parameters such as C-reactive protein or hypersensitive C-reactive protein, procalcitonin (PCT), 1,3-β-D-glucan (G test), etc. Exclusion Criteria: * Subjects have been enrolled in this study and samples have been collected * Patients with severe and very severe anemia (last hemoglobin \<60g/L within seven days) * Females with known pregnancy **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** patients with suspected blood infection who are at risk of sepsis ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** namei hu **Phone:** +86 15800702757 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426108 **Acronym:** LBIARHMI **Brief Title:** Interventions to Control Hypersensitivity Pain in Teeth With Insisive Molar Hypomineralization **Official Title:** Association of Low-intensity Laser and a Remineralizing Agent in Controlling the Pain of Incisor Molar Hypomineralization in Children: a Randomized, Placebo-controlled, Triple-blind Clinical Trial #### Organization Study ID Info **ID:** 63035222.3.0000.5419 #### Organization **Class:** OTHER **Full Name:** University of Sao Paulo #### Secondary ID Infos **Domain:** UNIVERSITY OF SAO PAULO RIBEIRÃO PRETO FACULTY OF DENTISTRY **ID:** FORP-USP **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-03-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Sao Paulo #### Responsible Party **Investigator Affiliation:** University of Sao Paulo **Investigator Full Name:** Lucas Masaru Marubayashi **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Molar incisor hypomineralization (MIH) manifests as a qualitative, demarcated defect in tooth enamel of systemic origin, predominantly affecting one or more permanent first molars, and potentially extending to the incisors. One significant challenge in managing this enamel anomaly is hypersensitivity, leading to discomfort and pain in affected patients. Low-intensity laser therapy, alone or combined with other modalities, appears promising in alleviating pain associated with MIH. This study aims to assess the efficacy of low-intensity laser therapy using varied parameters, in conjunction with a remineralizing agent, for pain management in children with molar incisor hypomineralization. Participants aged 6 to 12 years will be recruited, with a total of 88 teeth diagnosed with MIH, presenting a sensitivity score ≤3 on the Visual Analog Scale (VAS) and a score ≤1 on the Schiff Cold Air Sensitivity Scale (SCASS). The teeth will be randomly assigned to one of four groups (n=22 each): Group I (GI): L-1J + VF, Group II (GII): L-1J + VP, Group III (GIII): L-2J + VF, and Group IV (GIV): L-2J + VP. Here, 'L' denotes low-intensity laser application at different parameters (1J and 2J), combined with either fluoride varnish (VF) or a placebo varnish (VP). Interventions and assessments will be conducted initially, after 48 hours, and at 1 and 2 weeks post-treatment. Patients will undergo re-evaluation at 2, 4, 8, and 12 weeks following interventions. Statistical analyses will be performed with a 95% confidence level (α = 0.05). **Detailed Description:** A randomized clinical trial will be carried out involving children aged 6 to 12 years, with a total of 88 teeth diagnosed with MIH, presenting a sensitivity score ≤3 on the visual analogue scale (VAS) and a score ≤1 on the Schiff Cold Air Sensitivity Scale (SCASS). ). Inclusion criteria will require the presence of at least one erupted permanent molar with an occlusal surface free of gingival tissue, demonstrating IMH with sensitivity. Additionally, participants must provide informed consent forms signed by parents or guardians, along with consent forms signed by children. Exclusion criteria include decayed teeth, atypical carious lesions, teeth that have other enamel defects such as fluorosis, enamel hypoplasia, amelogenesis imperfecta or enamel malformations associated with syndromes, ongoing orthodontic treatment, cognitive disorders in patients, desensitizing treatments recent use in the last 3 months, previous use of anti-inflammatory and/or analgesic medications, teeth diagnosed with MIH presenting post-eruptive dentin fractures, atypical restorations, atypical caries, sensitivity scores \>3 on the visual analogue scale (VAS) and scores \> 1 on the Schiff Cold Air Sensitivity Scale (SCASS). For the diagnosis of MIH, the investigators will employ the criteria outlined by the European Academy of Pediatric Dentistry, which includes assessment of demarcated opacities, post-eruptive enamel defects, atypical restorations, teeth lost due to MIH, and incompletely erupted teeth. The sample size was determined based on the anticipated outcome of pain reduction following treatment, with an expected 60% reduction. Calculation was conducted with a confidence level of 95% and a power of 80%. Following the application of the inclusion and exclusion criteria, each group will consist of a total of 88 teeth, randomly assigned to one of four groups: GI, GII, GIII, and GIV. The interventions for each group will be as follows: GI: Low-Intensity Laser 1J (10 seconds) + Fluoride Varnish. GII: Low-Intensity Laser 1J (10 seconds) + Placebo. GIII: Low-Intensity Laser 2J (20 seconds) + Fluoride Varnish. GIV: Low-Intensity Laser 2J (20 seconds) + Placebo. To administer laser therapy, the investigators will utilize a low-intensity infrared diode laser (Therapy EC, DMC Equipamentos Ltda., São Carlos, Brazil) operating in continuous mode, emitting at a wavelength of 808 nm with a power output of 100 mW. The dosage will be set at either 1 or 2 Joules, with a fluence of 35 J/cm\^2. Both the operator and the patient will wear personal protective equipment (PPE) during the procedure. The tooth will be irradiated perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion. Activation time will be either 10 or 20 seconds, corresponding to 1 or 2 Joules respectively, depending on the assigned group. To ensure consistency, even if the laser is activated for 1 Joule (equivalent to 10 seconds), the laser tip will be maintained in place for a standardized duration of 20 seconds, the maximum activation time, as confirmed by a stopwatch in all applications to ensure reliability. As an adjunct to LBI, the investigators will use a fluoride varnish (FV) and a placebo varnish (PV) without the active ingredient, ensuring that they are in identical packaging with the same taste and texture. Both will maintain the same method of application. The FV used will be Duraphat® (22,600 ppm F, Colgate). The application of both FV and PV will be conducted according to each respective group. Application will be facilitated using a microbrush, spreading it over the entire lesion area for 30 seconds. After the interventions, patients will be instructed not to consume hard foods and to refrain from brushing their teeth for at least four hours following varnish application, adhering to the manufacturer's recommendations. Following all tests, the data will undergo normality analysis (Shapiro-Wilk test) and homoscedasticity assessment (Levene's test) to determine the suitability of parametric statistics. Therefore, for all variables, one-way ANOVA will be employed, followed by Tukey's post-hoc test for group comparisons. Demographic data will be evaluated using Pearson's chi-square test. Friedman's test may be utilized for multiple comparisons (sensitivity assessments), and the Wilcoxon test for paired comparisons. Analyses will be conducted using the statistical software SPSS 12.0 (SPSS Inc., Chicago, IL, USA). All tests will be performed at a 95% confidence level (α = 0.05). ### Conditions Module **Conditions:** - Molar Incisor Hypomineralization **Keywords:** - Molar Incisor Hypomineralization - low-intensity Laser - Dental hypersensitivity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized placebo controlled triple blind clinical trial ##### Masking Info **Masking:** SINGLE **Masking Description:** Triple blind **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 88 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). In conjunction with the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized as an adjuvant. Application will be facilitated using a microbrush, ensuring coverage over the entire extent of the lesion for 30 seconds. Following the interventions, patients will be advised to refrain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish, adhering to the manufacturer's guidelines. **Intervention Names:** - Drug: Fluoride Varnishes - Radiation: Low-Intensity Laser 1J **Label:** Low-Intensity Laser 1J + Fluoride Varnish **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The tooth will be subjected to low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized. The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish. **Intervention Names:** - Drug: Varnishes placebo - Radiation: Low-Intensity Laser 1J **Label:** Low-Intensity Laser 1J + Placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, utilizing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicularly in contact with the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized. The varnish application will be facilitated using a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be instructed to refrain from consuming hard foods and to postpone tooth brushing for at least four hours after applying the varnish, in accordance with the manufacturer's recommendations. **Intervention Names:** - Drug: Fluoride Varnishes - Radiation: Low-Intensity Laser 2J **Label:** Low-Intensity Laser 2J + Fluoride Varnish **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the third cervical region of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized.The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish. **Intervention Names:** - Drug: Varnishes placebo - Radiation: Low-Intensity Laser 2J **Label:** Low-Intensity Laser 2J + Placebo. **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Low-Intensity Laser 1J + Fluoride Varnish - Low-Intensity Laser 2J + Fluoride Varnish **Description:** the investigators will utilize a fluoride varnish with a concentration of 22,600 ppm F. The application will be facilitated using a microbrush, ensuring thorough coverage over the entire length of the lesion for a duration of 30 seconds. Following application, the varnish will be finished with water to create a film on the tooth surface. After completing the interventions, patients will receive instructions to refrain from consuming hard foods and to postpone tooth brushing for at least four hours, adhering to the manufacturer's recommendations. **Name:** Fluoride Varnishes **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Low-Intensity Laser 1J + Placebo - Low-Intensity Laser 2J + Placebo. **Description:** the investigators will apply a placebo varnish without the active ingredient (fluoride), ensuring that it is packaged identically to the fluoride varnish and has the same taste and texture, thus maintaining consistency in application. The varnish will be applied using a microbrush, spreading it evenly over the entire length of the lesion for a duration of 30 seconds. Following the interventions, patients will receive instructions to avoid consuming hard foods and to delay tooth brushing for at least four hours after applying the varnish. **Name:** Varnishes placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Low-Intensity Laser 1J + Fluoride Varnish - Low-Intensity Laser 1J + Placebo **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion. **Name:** Low-Intensity Laser 1J **Type:** RADIATION #### Intervention 4 **Arm Group Labels:** - Low-Intensity Laser 2J + Fluoride Varnish - Low-Intensity Laser 2J + Placebo. **Description:** The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion. **Name:** Low-Intensity Laser 2J **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Applying the low intensity laser of 1 joule (10 seconds) in infrared light in continuous mode, using a wavelength of 808 nm, power of 100 mW, dose of 1 or 2 Joules and fluence of 35 J/cm2. As an adjuvant to fluoride varnish (22,600 ppm F), we expect an improvement in hypersensitivity assessed by the visual analogue scale, ranging from 0 (no pain) to 10 (worst possible pain), so that applications performed after 48 hours will decrease, and in 1 and 2 weeks post-treatment, remaining stable during follow-ups at 2, 4, 8 and 12 weeks after interventions. This expectation arises from the known mechanisms of laser action in controlling inflammation and providing analgesia. Furthermore, we also anticipate that fluoride varnish will exert its remineralizing effects, contributing to the overall treatment of the disease. **Measure:** Gradual change of hypersensitivity on the visual analogue scale. **Time Frame:** Gradual reduction after 48 hours, and at 1 and 2 weeks post-treatment and remaining stable during follow-ups of 2, 4, 8, and 12 weeks following interventions #### Secondary Outcomes **Description:** Applying the low intensity laser of 1 joule (10 seconds) in infrared light in continuous mode, using a wavelength of 808 nm, power of 100 mW, dose of 1 or 2 Joules and fluence of 35 J/cm2. As an adjuvant to fluoride varnish (22,600 ppm F), we expect improvement in hypersensitivity assessed by the Schiff Cold Air Sensitivity Scale, ranging from 0 (the child does not respond to the stimulus) to 3 (the child responds to the stimulus, moves away and requests immediate suspension of the stimulation), so that it decreases with applications carried out after 48 hours, and at 1 and 2 weeks post-treatment, remaining stable during follow-ups at 2, 4, 8 and 12 weeks after the interventions. This expectation arises from the known mechanisms of laser action in controlling inflammation and providing analgesia. Furthermore, we also anticipate that fluoride varnish will exert its remineralizing effects, contributing to the overall treatment of the disease. **Measure:** Gradual change of hypersensitivity on the Schiff Cold Air Sensitivity Scale **Time Frame:** Gradual reduction after 48 hours, and at 1 and 2 weeks post-treatment and remaining stable during follow-ups of 2, 4, 8, and 12 weeks following interventions ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children aged 6 to 12 years old * Teeth diagnosed with MIH, exhibiting at least one erupted permanent molar with the occlusal surface devoid of gingival tissue and showing sensitivity associated with MIH with sensitivity score ≤3 on the Visual Analogue Scale (VAS) and score ≤1 on the Self-Consensus Assessment scale symptoms and signs (SCASS). * Children who have the cognitive ability to answer the tests. * Children who obtained authorization from their parents or guardians, through a signed free and informed consent form. Exclusion Criteria: * Decayed or restored teeth. * Teeth with other enamel defects, such as fluorosis, enamel hypoplasia, amelogenesis imperfecta or enamel malformations associated with syndromes, as well as those undergoing orthodontic treatment. * Patients with cognitive impairments that prevent responsiveness to the test. * Children who have undergone desensitizing treatment in the last 3 months. * Children who use anti-inflammatory and/or analgesic medications before starting treatment. * Teeth that have a sensitivity score \>3 on the visual analogue scale (VAS) and a score \>1 on the Schiff Cold Air Sensitivity Scale (SCASS). **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lucas M Marubayashi **Phone:** +5544988491230 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23. **PMID:** 31808584 #### See Also Links **Label:** Related Info **URL:** https://pubmed.ncbi.nlm.nih.gov/31808584/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000094603 - Term: Dental Enamel Hypomineralization - ID: D000094602 - Term: Developmental Defects of Enamel - ID: D000014071 - Term: Tooth Abnormalities - ID: D000018640 - Term: Stomatognathic System Abnormalities - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Hypersensitivity - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M3067 - Name: Molar Hypomineralization - Relevance: HIGH - As Found: Molar Incisor Hypomineralization - ID: M16853 - Name: Toothache - Relevance: LOW - As Found: Unknown - ID: M6941 - Name: Dental Enamel Hypoplasia - Relevance: HIGH - As Found: Molar Incisor Hypomineralization - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M3066 - Name: Dental Enamel Hypomineralization - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M16826 - Name: Tooth Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20727 - Name: Stomatognathic System Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000094604 - Term: Molar Hypomineralization - ID: D000003744 - Term: Dental Enamel Hypoplasia - ID: D000006967 - Term: Hypersensitivity ### Intervention Browse Module - Ancestors - ID: D000002327 - Term: Cariostatic Agents - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M8587 - Name: Fluorides - Relevance: HIGH - As Found: Components - ID: M140080 - Name: Listerine - Relevance: LOW - As Found: Unknown - ID: M15771 - Name: Sodium Fluoride - Relevance: LOW - As Found: Unknown - ID: M8588 - Name: Fluorides, Topical - Relevance: HIGH - As Found: Cranial - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005459 - Term: Fluorides - ID: D000005460 - Term: Fluorides, Topical ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426095 **Brief Title:** A Comparative Analysis of the Efficacy of Instructional Videos and Live Demonstrations in Crown Preparation Training for Preclinical Dental Students **Official Title:** Exploring Pedagogical Approaches: A Comparative Analysis of the Efficacy of Instructional Videos and Live Demonstrations in Crown Preparation Training for Preclinical Dental Students #### Organization Study ID Info **ID:** AIDM/ERC/01/2023/02 #### Organization **Class:** OTHER **Full Name:** Altamash Institute of Dental Medicine ### Status Module #### Completion Date **Date:** 2024-01-11 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-11 **Type:** ACTUAL #### Start Date **Date:** 2023-01-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Altamash Institute of Dental Medicine #### Responsible Party **Investigator Affiliation:** Altamash Institute of Dental Medicine **Investigator Full Name:** Dr Maria Shakoor **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:** finding the optimal balance between traditional live demonstrations and instructional videos remains a subject of ongoing discussion in dental education. Moreover, integrating a hybrid model that combines the strengths of both methods may offer a comprehensive approach to crown preparation training. Therefore, this study aims to address this ongoing discussion by investigating the relative effectiveness of traditional live demonstrations, instructional videos, and a hybrid model that merges both approaches. Through an evaluation of dental students' satisfaction and performance with video tutorials and hands-on demonstrations, this research endeavors to shed light on how different instructional methods influence knowledge acquisition within the practical environment. **Detailed Description:** A randomized controlled single-blind trial was conducted at the Department of Prosthodontics, Altamash Institute of Dental Medicine for a duration of 12 months from 12th Jan' 2023 till 11th Jan' 2024. Prior approval was obtained from the Ethical Review Committee of Altamash Institute of Dental Medicine (AIDM/ERC/01/2023/02). written consent was obtained from all participants, A simple random sampling technique was used for the recruitment of participants. . a total of ninety-six final-year BDS students were enrolled in the study. Before allocation, all participants attended a comprehensive lecture on crown preparation principles delivered via a PowerPoint presentation. Following the lecture, participants were randomly assigned to one of three groups: Group A (instructional video), Group B (live demonstrations), or Group C (hybrid) Participants in Group A will view an instructional video, group B will attend live demonstrations. Participants in Group C received a dual approach, combining instructional video guidance with live demonstrations. Before the intervention, all participants across the three groups underwent a pretest consisting of five questions. These questions were designed to gauge participants' readiness and perceptions regarding crown preparation training. Responses were recorded using a Likert scale ranging from 1 to 5, where 1 represented "strongly disagree" and 5 represented "strongly agree". Following the lecture and demonstrations, participants were provided with an assessment questionnaire comprising six questions aimed at evaluating their comprehension and knowledge regarding porcelain-fused-to-metal tooth preparation. ### Conditions Module **Conditions:** - Medical Education - Dental - Dental Crown Preparation - Instructional Methods - Training Effectiveness **Keywords:** - Medical Education - Instruction video - Live Demonstrations ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 96 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in Group A received access to a specially prepared pre-recorded instructional video detailing the step-by-step process of porcelain-fused-to-metal tooth preparation for molars **Intervention Names:** - Behavioral: Group A (instructional video), **Label:** instructional video **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** live demonstrations of the same procedure conducted by the same experienced Prosthodontist to ensure consistency in teaching quality and technique. **Intervention Names:** - Behavioral: Group B (live demonstration) **Label:** live demonstrations **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** both video and live demonstrations will be given **Intervention Names:** - Behavioral: Group C (hybrid) **Label:** hybrid **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - instructional video **Description:** Participants in Group A received access to a specially prepared pre-recorded instructional video detailing the step-by-step process of porcelain-fused-to-metal tooth preparation for molars. **Name:** Group A (instructional video), **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - live demonstrations **Description:** Participants in Group B were provided with live demonstrations of the same procedure conducted by the same experienced Prosthodontist to ensure consistency in teaching quality and technique **Name:** Group B (live demonstration) **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - hybrid **Description:** Group C received a dual approach, combining instructional video guidance with live demonstrations. **Name:** Group C (hybrid) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Proficiency in Crown Preparation: Assessed by a standardized scoring chart evaluating key areas such as preparation axis, axial reduction, anatomic reduction, occlusal convergence, occlusal reduction depth, morphology, quality of axial/occlusal line angles, finish line location, form, continuity, and surface texture. Each area is scored to give a total proficiency score out of 20. Measurements will be taken immediately following the intervention period." **Measure:** Proficiency in Crown Preparation after instructional Videos and Live Demonstrations i **Time Frame:** 12 months **Description:** Before the intervention, all participants across the three groups underwent a pretest consisting of five questions. These questions were designed to gauge participants' readiness and perceptions regarding crown preparation training. Specifically, the questions addressed stress levels during preparation, the duration of preclinical training, the effectiveness of lectures and training, and readiness for clinical practice. Responses were recorded using a Likert scale ranging from 1 to 5, where 1 represented "strongly disagree" and 5 represented "strongly agree". **Measure:** students perception about the demonstration techniques of the three groups **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Fourth-year students of Bachelor of Surgery who voluntarily agreed to participate were included in the study. Exclusion Criteria: * Exclusion criteria include students who do not provide consent, those absent from tutorials, individuals with prior experience in crown preparation, or students with medical conditions affecting participation. **Healthy Volunteers:** True **Maximum Age:** 26 Years **Minimum Age:** 24 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Karachi **Country:** Pakistan **Facility:** Altamash Institute of dental medicine **Zip:** 75500 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426082 **Acronym:** DEBATE **Brief Title:** Deciphering a Novel and Unique Brown Adipose Tissue Depot in Women **Official Title:** Deciphering the Molecular and Secretory Functions of a Novel and Unique Brown Adipose Tissue Depot in Women #### Organization Study ID Info **ID:** PID2022-141442OA-I00 #### Organization **Class:** OTHER **Full Name:** Universidad de Almeria ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2023-10-11 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Leiden University Medical Center **Class:** OTHER **Name:** ETH Zurich (Switzerland) #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Almeria #### Responsible Party **Investigator Affiliation:** Universidad de Almeria **Investigator Full Name:** Borja Martínez Tellez **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:** Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate specific brown and beige fat cells in the dorsocervical area of young, lean adult women. Participant Population/Health Conditions: The study will involve 40 young, lean adult women. Main Questions: The main questions this study aims to answer are: * Are there active brown or beige adipocytes in the subcutaneous fat of the dorsocervical area (i.e., iBAT)? * What is the secretory function of these adipocytes? * How do traditional interventions like cold exposure, as well as new approaches like Beta-2 agonist stimulation and exercise, affect the thermogenesis of these fat cells at the cellular and molecular levels? Participants Will: Be randomized into one of four groups: thermoneutral exposure, cold exposure, aerobic exercise, or Beta-2 agonist treatment. Follow their assigned regimen for 4 weeks. Provide tissue samples from the dorsocervical area and abdomen before and after the 4-week intervention. Undergo analysis of these samples using advanced techniques to understand the presence and activity of brown and beige fat cells. Comparison Group: Researchers will compare the effects of different interventions (thermoneutral exposure, cold exposure, aerobic exercise, Beta-2 agonist treatment) on the presence and thermogenesis of brown and beige fat cells in the dorsocervical area. **Detailed Description:** Cardiometabolic diseases affect almost 50% of the population in the Western World. While lifestyle plus pharmacological interventions may provide short-term benefits, more research is needed to understand the long-term effectiveness and underlying molecular mechanisms. Brown adipose tissue (BAT) is a thermogenic tissue that combusts large amounts of glucose and lipids to generate heat and secretes signalling molecules known as 'batokines' that can influence cardiometabolic health. Previous research has shown that BAT is active in adults, primarily in the supraclavicular region, as demonstrated by the uptake of 18F-Fluorodeoxyglucose. Recently, it has been demonstrated that a rare subpopulation of brown adipocytes increases their abundance at higher temperatures and can regulate the thermogenesis of neighbouring adipocytes. Thus, it is plausible that classical (e.g., cold exposure) and novel interventions (i.e., Beta-2 stimulation and exercise) that can activate BAT, would induce a remodelling in the brown/beige subpopulation adipocytes that govern whole tissue thermogenesis. These unstudied changes in human BAT physiology could potentially explain how BAT activation could enhance cardiometabolic health. However, despite over a decade of research, our understanding of the role of BAT in human physiology in humans is limited. This lack of knowledge may be mainly explained because i) obtaining biological samples of human BAT is very difficult and ii) the seasonal variation strongly influences the current gold standard (PET-CT scan). Given the pilot data found in this proposal, young, lean adult women may have a novel and undescribed thermogenic active BAT depot at the dorsocervical area (i.e., interscapular BAT=iBAT). Based on that, the main hypothesis is that there are brown and/or beige adipocytes present within the subcutaneous adipose tissue of the dorsocervical area (i.e., iBAT) that have a unique composition of adipocyte subpopulations and specific secretory functions. Additionally, the specific subpopulations of brown and/or beige adipocytes related to thermogenesis in iBAT can be increased through exposure to cold temperatures, Beta-2 agonist stimulation, and exercise in young, lean women. Thus, the main objective of this study is to investigate whether the subcutaneous fat in the dorsocervical area contains active brown and/or beige adipocytes (i.e., iBAT), understand its secretory function, and study the impact of traditional (e.g. cold exposure) and new interventions (e.g. Beta-2 agonist and exercise) on iBAT thermogenesis at the cellular and molecular levels. Thus, the DEBATE project will carry out a randomized controlled trial where 40 young, lean adult women will be randomized into a thermoneutral exposure group (2 hours/day at 32ºC; 5 days/week) or a cold exposure group (2 hours/day at 18ºC; 5 days/week) or an aerobic exercise group (5 days/week at 65% heart rate reserve for 60 minutes) or a Beta-2 agonist group (salbutamol 12 mg/day. 7 days week). Before and after the 4-week intervention, iBAT tissue samples from the dorsocervical area and subcutaneous white adipose tissue (scWAT) from the abdomen will be collected. In these biological samples, the investigators will apply a set of cutting-edge omics (e.g., single nucleus RNA-seq) that will allow us to investigate whether iBAT is present and metabolically active in adults. The investigators will also conduct a set of in vitro experiments to discover the secretory function of this novel depot. ### Conditions Module **Conditions:** - Cardiometabolic Diseases **Keywords:** - brown adipose tissue - cold exposure - hot exposure - dorsocervical fat - exercise ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study will consist of a randomized controlled trial in which forty young, lean women will be assigned to a control group (n=10; receiving a thermoneutral exposure 2 hours/day at 32ºC; 5 days/week) or a cold exposure group (n=10; receiving 2 hours/day at 18ºC; 5 days/week) or aerobic exercise group (n=10; receiving 5 days/week at 65% heart rate reserve for 60 minutes each training session) or an ADBR2 agonist ingestion (n=10; salbutamol 12 mg/day. 7 days week). ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** n=10; receiving a thermoneutral exposure 2 hours/day at 32ºC; 5 days/week; Total 4 weeks **Intervention Names:** - Behavioral: Thermoneutral condition **Label:** Thermoneutral condition **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** n=10; receiving 2 hours/day at 18ºC; 5 days/week; Total 4 weeks **Intervention Names:** - Behavioral: Cold condition **Label:** Cold condition **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** n=10; salbutamol 12 mg/day. 7 days week. Total 4 weeks **Intervention Names:** - Drug: Salbutamol **Label:** Salbutamol **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** n=10; receiving 5 days/week at 65% heart rate reserve for 60 minutes each training session. Total 4 weeks **Intervention Names:** - Behavioral: Aerobic exercise condition **Label:** Aerobic exercise **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Thermoneutral condition **Description:** Participants will be exposed 2 hours/day at 32ºC for 5 days/week **Name:** Thermoneutral condition **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Cold condition **Description:** Participants will be exposed 2 hours/day at 18ºC for 5 days/week **Name:** Cold condition **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Aerobic exercise **Description:** Participants will perform aerobic exercise training 5 days/week at 65% heart rate reserve for 60 minutes each training session **Name:** Aerobic exercise condition **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Salbutamol **Description:** Participants will take salbutamol 12 mg/day. 7 days week **Name:** Salbutamol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Investigators will quantify the level UCP1 expression by qPCR in white adipose tissue biopsies obtained before and after the intervention **Measure:** Change in UCP1 expression in the dorsocervical area **Time Frame:** 2 years #### Secondary Outcomes **Description:** Change in fat percentage (% of fat) **Measure:** Body composition (BIA, Tanita) **Time Frame:** 2 years **Description:** Change in VO2max (ml/kg/min) **Measure:** Cardiorespiratory fitness test (indirect calorimetry and monarch bike) **Time Frame:** 2 years **Description:** Change in LDL-C (mg/dL) **Measure:** LDL quantification in blood **Time Frame:** 2 years **Description:** Change in HDL-C (mg/dL) **Measure:** HDL quantification in blood **Time Frame:** 2 years **Description:** Change in Glucose (mg/dL) **Measure:** Glucose quantification in blood **Time Frame:** 2 years **Description:** Change in Insulin (µIU/mL) **Measure:** Insulin quantification in blood **Time Frame:** 2 years **Description:** Change in Triglycerides (mg/dL) **Measure:** Triglycerides quantification in blood **Time Frame:** 2 years **Description:** Change in CRP (mg/L) **Measure:** C-reactive protein quantification in blood **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-22 years of age women. * BMI between ≥18 and \<25 kg/m2 * Are willing to be randomized to either of these 4 groups. * Must be sedentary (i.e., do not perform exercise or go to the gym). * Participants should have regular menstrual cycles. * Must be willing to adhere to all study procedures, including attendance at all study visits. * Must be willing to have biological samples stored for future research. * Must accept the use of the Period Calendar and Google Fit Apps on their mobile phones. Exclusion Criteria: * Diabetes mellitus (determined based on fasting glucose levels defined by ADA criteria). * Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia). * Any cardiac disease (i.e., ischemic cardiac disease, arrhythmias, severe heart failure). * Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g., beta-blockers, antidepressants, corticosteroids). * Use of medication shown to increase risk of hypokalemia after salbutamol administration (e.g., xanthine derivatives, steroids and diuretics). * Clinically relevant abnormalities in clinical chemistry or electrocardiogram (ECG) at screening (to be judged by the study physician). * A first-degree family member with sudden cardiac death. * Any chronic renal or hepatic disease. * Any other contra-indications for the use of salbutamol or propranolol. * Abuse of alcohol or other substances. * Smoking. * Current participation in another research projects that may influence the current research project. * Use of beta-adrenergic receptor agonists (e.g., asthma). * Polycystic ovary syndrome. * Diagnosed psychotic conditions. **Healthy Volunteers:** True **Maximum Age:** 22 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Borja Martinez Tellez, PhD **Phone:** +34 950215334 **Phone Ext:** +34 **Role:** CONTACT #### Locations **Location 1:** **City:** Almería **Country:** Spain **Facility:** Universidad de Almería **Zip:** 04131 ### IPD Sharing Statement Module **Access Criteria:** Everybody **Info Types:** - STUDY_PROTOCOL - ICF - CSR **IPD Sharing:** YES **Time Frame:** 5 years after publishing the data **URL:** https://www.sportresearchgroup.es/ ### References Module #### References **Citation:** Martinez-Tellez B, Sanchez-Delgado G, Alcantara JMA, Acosta FM, Amaro-Gahete FJ, Osuna-Prieto FJ, Perez-Bey A, Jimenez-Pavon D, Llamas-Elvira JM, Gil A, Aguilera CM, Rensen PCN, Ruiz JR. Evidence of high 18 F-fluorodeoxyglucose uptake in the subcutaneous adipose tissue of the dorsocervical area in young adults. Exp Physiol. 2019 Feb;104(2):168-173. doi: 10.1113/EP087428. Epub 2018 Dec 18. **PMID:** 30468689 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown ### 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 ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3767 - Name: Albuterol - Relevance: HIGH - As Found: Finger - 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 ### Intervention Browse Module - Meshes - ID: D000000420 - Term: Albuterol ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426069 **Brief Title:** Assessment of Masticatory Performance in Periodontitis **Official Title:** Assessment of Masticatory Performance in Various Stages of Periodontitis #### Organization Study ID Info **ID:** JANVIPERIO2024 #### Organization **Class:** OTHER **Full Name:** Postgraduate Institute of Dental Sciences Rohtak ### Status Module #### Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **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:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### 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:** The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium. **Detailed Description:** Periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. Loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. Thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. Even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. Since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations. This clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice. ### Conditions Module **Conditions:** - Periodontitis, Chronic - Chewing Problem - Inflammation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 555 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Periodontally Healthy #### Arm Group 2 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage I Periodontitis #### Arm Group 3 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage II Periodontitis #### Arm Group 4 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage III Periodontitis #### Arm Group 5 **Description:** Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. **Intervention Names:** - Other: Masticatory efficiency assessment **Label:** Stage IV Periodontitis ### Interventions #### Intervention 1 **Arm Group Labels:** - Periodontally Healthy - Stage I Periodontitis - Stage II Periodontitis - Stage III Periodontitis - Stage IV Periodontitis **Description:** Masticatory efficiency will be assessed for each group. **Name:** Masticatory efficiency assessment **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. **Measure:** Objective masticatory performance **Time Frame:** Baseline #### Secondary Outcomes **Description:** Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks. **Measure:** Subjective masticatory performance **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adult patients with age group 30-50 years diagnosed with generalized periodontitis 2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars. Exclusion Criteria: * Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) * Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis) * Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria) * Smoking or substance abuse * Pregnant and lactating women **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 30 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** A total of 555 patients will be recruited from the out patient department of periodontics, PGIDS, Rohtak based on the inclusion and exclusion criteria. The study design will be explained to eligible candidates and all study participants will be required to provide informed consent. Subjects will be grouped based on stage of periodontitis and a healthy control group. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rajinder K Sharma, MDS **Phone:** 09416358222 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Janvi Janvi, BDS **Phone:** 09416183623 **Role:** CONTACT #### Locations **Location 1:** **City:** Rohtak **Country:** India **Facility:** Post Graduate Institute of Dental Sciences **State:** Haryana **Zip:** 124001 #### Overall Officials **Official 1:** **Affiliation:** PGIDS Rohtak **Name:** Janvi Janvi, BDS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic 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: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M28044 - Name: Chronic Periodontitis - Relevance: HIGH - As Found: Periodontitis, Chronic - 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: 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: D000010518 - Term: Periodontitis - ID: D000055113 - Term: Chronic Periodontitis - ID: D000007249 - Term: Inflammation ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426056 **Brief Title:** Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial. **Official Title:** Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial. #### Organization Study ID Info **ID:** M2024240 #### Organization **Class:** OTHER **Full Name:** Peking University Third Hospital ### Status Module #### Completion Date **Date:** 2028-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Jilin Provincial Tumor Hospital **Class:** OTHER **Name:** Affiliated Hospital of Hebei University **Class:** OTHER **Name:** Hebei Medical University Fourth Hospital #### Lead Sponsor **Class:** OTHER **Name:** Peking University Third Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer. ### Conditions Module **Conditions:** - Cervical Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Radiation Therapy Concurrently With Nab-Paclitaxel Plus Cisplatin ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 64 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week). **Intervention Names:** - Radiation: radiotherapy - Drug: Nab paclitaxel - Drug: Cisplatin **Label:** Experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week. **Name:** radiotherapy **Other Names:** - RT **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Experimental group **Description:** Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week). **Name:** Nab paclitaxel **Other Names:** - paclitaxel for injection (albumin bound) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Experimental group **Description:** Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week). **Name:** Cisplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** ORR(objective response rate)=CR (complete response)+PR(partial response)/all participants **Measure:** ORR (objective response rate) **Time Frame:** the 1, 3, 6, 9, 12 months after the end of the treatment #### Secondary Outcomes **Description:** adverse events **Measure:** AE **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment **Description:** objective response rate **Measure:** OS **Time Frame:** the 1, 2, and 3 years after the end of the treatment **Description:** progression-free survival **Measure:** PFS **Time Frame:** the 1, 2, and 3 years after the end of the treatment **Description:** duration of response **Measure:** DOR **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment **Description:** disease control rate **Measure:** DCR **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment **Description:** clinical benefit rate **Measure:** CBR **Time Frame:** the 1, 3, 6, 9, 12 months, and 2, 3 years after the end of the treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * (1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system; * (2) Eastern Cooperative Oncology Group at 2 or less; * (3) Life expectancy of greater than 3 months; * (4) Left ventricular ejection fraction at ≥55%; * (5) Neutrophil count at ≥1500/mm\^3, platelet count at ≥100,000/mm\^3 or hemoglobin at ≥9.0 g/dL; * (6) Serum creatinine at \<1.5 times the upper limit of the normal reference range; * (7) Alanine transaminase or aspartate aminotransferase at \>2.5 times the upper limit of the normal reference range; * (8) Non pregnant or lactating women; * (9) Women of childbearing age willing to adopt reliable contraceptive measures; * (10) Sign informed consent form. Exclusion Criteria: * (1) Individuals who have previously received chemotherapy with albumin bound paclitaxel; * (2) Individuals who have previously received abdominal or pelvic radiation therapy; * (3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy; * (4) Individuals with central nervous system diseases or brain metastases； * (5) Other malignant tumors other than cervical cancer have appeared within the past 5 years; * (6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ; * (7) The researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc; * (8) known to be allergic to paclitaxel; * (9) Received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration; * (10) Serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia; * (11) Human immunodeficiency virus (HIV) positive individuals; * (12) Uncontrolled or active viral hepatitis or infection with human immunodeficiency virus; * (13) Researchers determine that it is not suitable to participate in this study. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ping Jiang, doctor **Phone:** 86010-82266699 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Peking University Third Hospital **Name:** Ping Jiang, Doctor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - 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: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000068196 - Term: Albumin-Bound Paclitaxel ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426043 **Brief Title:** A Prospective Study on the Treatment of Recurrent/Refractory/Intolerable NSAA With Lusutrombopag **Official Title:** An Exploratory Study on the Efficacy and Safety of Lusutrombopag in the Treatment of Recurrent/Refractory/Intolerable NSAA #### Organization Study ID Info **ID:** LNA-2024 #### Organization **Class:** OTHER **Full Name:** Peking Union Medical College Hospital ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **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:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking Union Medical College Hospital #### Responsible Party **Investigator Affiliation:** Peking Union Medical College Hospital **Investigator Full Name:** Bing Han **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:** In a prospective, single-arm study, the efficacy and safety of Lusutrombopag in the treatment of relapsed/refractory/intolerable non-severe aplastic anemia (NSAA) were explored. **Detailed Description:** The enrolled patients: were given Lusutrombopag at 3mg/qd orally for 12 weeks (the starting dose of lusutrombopag was 3mg, taken once daily. After 2 weeks of continuous administration, the dose was increased by 3mg every 2 weeks based on the platelet count and safety of the subjects. The dose was gradually increased to 9mg/d over a total of 12 weeks). The treatment duration was at least 3 months. When the platelet increase was \<20×10\^9/L, the daily dose was increased by 3mg, up to a maximum of 9mg/day. When the platelet increase was ≥50×109/L and ≤200×10\^9/L, the dose was maintained at the previous level. When the platelet count was ≥200×10\^9/L and ≤400×10\^9/L, the daily dose was reduced by 3mg. When the platelet count was \>400×10\^9/L, the drug could be suspended, and the dose was reduced by 3mg when the platelet count decreased to \<200×10\^9/L. In this case, if the lowest dose of 3mg/day was used, the drug could be suspended. Responders continued treatment for 6 months. Other TPO-RA therapies were not allowed during the study period. ### Conditions Module **Conditions:** - Aplastic Anemia **Keywords:** - Non-severe aplastic anemia - Lusutrombopag - Refractory - Recurrent ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Administer lusutrombopag at 3mg/qd orally for 12 weeks (lusutrombopag starting dose is 3mg, once daily. After 2 weeks of continuous administration, the dose can be increased by 3mg every 2 weeks based on the platelet count and safety of the subject. The dose can be gradually increased to 9mg/d over a total of 12 weeks). The course should be at least 3 months. When the platelet increase is \<20×10\^9/L, the daily dose can be increased by 3mg up to a maximum of 9mg/day; when the platelet increase is ≥50×10\^9/L and ≤200×10\^9/L, the dose can be maintained; when the platelet count is ≥200×10\^9/L and ≤400×10\^9/L, the daily dose can be reduced by 3mg; when the platelet count is \>400×10\^9/L, the drug can be suspended and resumed when the platelet count decreases to \<200×10\^9/L, with the daily dose reduced by 3mg. In this case, if the lowest dose of 3mg/day is used, the drug can be suspended. Responders continue treatment until 6 months. **Intervention Names:** - Drug: Lusutrombopag **Label:** Lusutrombopag **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lusutrombopag **Description:** Administer lusutrombopag at 3mg/qd orally for 12 weeks (lusutrombopag starting dose is 3mg, once daily. After 2 weeks of continuous administration, the dose can be increased by 3mg every 2 weeks based on the platelet count and safety of the subject. The dose can be gradually increased to 9mg/d over a total of 12 weeks). The course should be at least 3 months. When the platelet increase is \<20×109/L, the daily dose can be increased by 3mg up to a maximum of 9mg/day; when the platelet increase is ≥50×10\^9/L and ≤200×10\^9/L, the dose can be maintained; when the platelet count is ≥200×10\^9/L and ≤400×10\^9/L, the daily dose can be reduced by 3mg; when the platelet count is \>400×10\^9/L, the drug can be suspended and resumed when the platelet count decreases to \<200×10\^9/L, with the daily dose reduced by 3mg. In this case, if the lowest dose of 3mg/day is used, the drug can be suspended. Responders continue treatment until 6 months. **Name:** Lusutrombopag **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Proportion of patients who achieved complete response, partial response and hematological response **Measure:** Overall response rate at 3 months **Time Frame:** 3 month **Description:** Proportion of patients who achieved complete response, partial response and hematological response **Measure:** Overall response rate at 6 months **Time Frame:** 6 month #### Secondary Outcomes **Description:** Proportion of patients with adverse eventsProportion of patients with adverse events **Measure:** adverse event rate at 3 months **Time Frame:** 3 month **Description:** Proportion of patients with adverse events **Measure:** adverse event rate at 6 months **Time Frame:** 6 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participants must be at least 18 years old, male or female. 2. Participants must be diagnosed with NSAA and have a refractory/relapsed/intolerable response to standard-dose cyclosporine (CsA). The definition of refractory/relapsed is patients who have been treated with sufficient doses of cyclosporine (3-5mg/kg) for at least 6 months without response or relapse. The definition of intolerable is patients who cannot tolerate CsA and have stopped treatment due to significant side effects. 3. Participants must meet the following criteria at enrollment: platelets \<30×109/L. 4. Baseline liver and kidney function must be within 2 times of normal range. 5. No active infection; no pregnancy or breastfeeding. 6. Participants must agree to sign the informed consent form. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Exclusion Criteria: 1. Other causes of pancytopenia, such as myelodysplastic syndrome (MDS). 2. Evidence of clonal hematopoietic system bone marrow disease (MDS, AML) with cytogenetics. 3. PNH clone ≥50%. 4. Received hematopoietic stem cell transplant (HSCT) prior to enrollment. 5. Received ATG treatment within 6 months prior to enrollment. 6. Infection or bleeding that cannot be controlled with standard therapy. 7. Allergic to ruxolitinib. 8. Active HIV, HCV, or HBV infection, cirrhosis, or portal hypertension. 9. Any malignant tumor within 5 years, or local basal cell carcinoma of the skin. 10. History of thromboembolic events, myocardial infarction, or stroke (including antiphospholipid syndrome) and current use of anticoagulants. 11. Pregnant or breastfeeding (lactating) women. 12. Participated in another clinical trial within 3 months. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bing Bing, PhD **Phone:** 13601059938 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** QLin Hu, PhD **Phone:** 15810785167 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** QLin Hu, PhD - **Phone:** 15810785167 - **Role:** CONTACT ***Contact 2:*** - **Name:** Bing Bing, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Peking Union Medical College Hospital **State:** Beijing **Zip:** 100730 #### Overall Officials **Official 1:** **Affiliation:** Peking Union Medical College Hospital **Name:** Bing Bing, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Young NS. Aplastic Anemia. N Engl J Med. 2018 Oct 25;379(17):1643-1656. doi: 10.1056/NEJMra1413485. No abstract available. **PMID:** 30354958 **Citation:** Ruan J, Zuo W, Chen M, Yang C, Han B. Eltrombopag is effective in patients with relapse/refractory aplastic anemia-report from a single center in China. Ann Hematol. 2020 Dec;99(12):2755-2761. doi: 10.1007/s00277-020-04266-1. Epub 2020 Sep 17. Erratum In: Ann Hematol. 2020 Nov 2;: **PMID:** 32944791 **Citation:** Katsube T, Wajima T, Fukuhara T, Kano T. Effects of Food and Calcium Carbonate on the Pharmacokinetics of Lusutrombopag, a Novel Thrombopoietin Receptor Agonist. Clin Ther. 2019 Sep;41(9):1747-1754.e2. doi: 10.1016/j.clinthera.2019.06.004. Epub 2019 Jul 11. **PMID:** 31303281 **Citation:** Hidaka H, Kurosaki M, Tanaka H, Kudo M, Abiru S, Igura T, Ishikawa T, Seike M, Katsube T, Ochiai T, Kimura K, Fukuhara T, Kano T, Nagata T, Tanaka K, Kurokawa M, Yamamoto K, Osaki Y, Izumi N, Imawari M. Lusutrombopag Reduces Need for Platelet Transfusion in Patients With Thrombocytopenia Undergoing Invasive Procedures. Clin Gastroenterol Hepatol. 2019 May;17(6):1192-1200. doi: 10.1016/j.cgh.2018.11.047. Epub 2018 Nov 28. **PMID:** 30502505 **Citation:** Wan Z, Chen M, Han B. Avatrombopag, a promising novel thrombopoietin receptor agonist for refractory/relapsed/intolerant non-severe aplastic anemia: a phase 2 single-arm clinical trial. Ann Med. 2023 Dec;55(1):2224044. doi: 10.1080/07853890.2023.2224044. **PMID:** 37318085 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000740 - Term: Anemia - ID: D000006402 - Term: Hematologic Diseases - ID: D000080983 - Term: Bone Marrow Failure Disorders - ID: D000001855 - Term: Bone Marrow Diseases ### 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M4070 - Name: Anemia - Relevance: LOW - As Found: Unknown - ID: M4071 - Name: Anemia, Aplastic - Relevance: HIGH - As Found: Aplastic Anemia - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2241 - Name: Bone Marrow Failure Disorders - Relevance: LOW - As Found: Unknown - ID: M13118 - Name: Pancytopenia - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: T460 - Name: Aplastic Anemia - Relevance: HIGH - As Found: Aplastic Anemia ### Condition Browse Module - Meshes - ID: D000000741 - Term: Anemia, Aplastic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426030 **Brief Title:** Validation of Czech Language Versions of Questionnaires for ALS Patients' Functional Status and Biomarker Long-term Follow-up **Official Title:** Validation of Czech Language Versions of Questionnaires Most Frequently Used for Functional Status Monitoring in Patients With Amyotrophic Lateral Sclerosis and the Long-term Follow-up of Biomarkers of the Disease in These Patients. #### Organization Study ID Info **ID:** VALID-ALS-QUEST-CZ #### Organization **Class:** OTHER **Full Name:** Masaryk University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Brno University Hospital **Class:** OTHER **Name:** University Hospital, Motol **Class:** OTHER **Name:** University Hospital, Martin **Class:** OTHER **Name:** University Hospital Bratislava #### Lead Sponsor **Class:** OTHER **Name:** Masaryk 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:** Questionnaires and scales used to assess the clinical status and quality of life of patients with amyotrophic lateral sclerosis (ALS) are an important tool to monitor the disease progression and current needs of patients. The use of these tools (and in particular their combination) allows to cover the whole spectrum of potential patient difficulties and thus significantly facilitates the process of individualisation and optimisation of care. The aim of the study was to create and validate the Czech language versions of the following questionnaires or scales: (1) ALSFRS-R (ALS Functional Rating Scale - Revised Version) and (2) ALSFRS-EX (EXtended, i.e. extended, version of the same scale), both in the self-assessment version (incl. (3) the ALSAQ-40 (ALS Assessment Questionnaire including 40 questions), (4) the DYALS (Dysphagia in ALS), and (5) the Borg Dyspnoea Rating Scale. All questionnaires were translated using the forward-backward translation method. The scales and questionnaires were administered to ALS patients repeatedly at one-week intervals, first in writing during routine patient follow-up at the Neuromuscular Centre of the University Hospital Brno, and during repeated administrations by telephone. **Detailed Description:** The first step of the study (before patient recruitment began) was the linguistic validation of all the scales and questionnaires used. Initially, Czech language versions were created using the forward-backward translation method. These created versions were then discussed by an expert panel consisting of 2 amyotrophic lateral sclerosis experts and 2 translators (one native speaker bilingual for both Czech and English, one professional translator specialized in medical English). Patients potentially meeting the entry criteria will be informed about the purpose and conduct of the study and will sign an informed consent if they agree to participate in the study. The first administration of all questionnaires (including the self-assessment version of the ALSFRS-R, ALSFRS-Ex, ALSAQ-40, DYALS and Borg Scale for lying, standing and moving positions) will be performed as part of the patient's routine clinical follow-up at the neuromuscular centre. The other two administrations of the questionnaires will be done by telephone one and two weeks after inclusion, respectively. The one-week interval was chosen in line with the approach of similar foreign validation studies of other languages, so that there is a high probability of no significant change in the patient's clinical condition between repeated administrations and, on the other hand, that the patient no longer remembers in detail the answers from the previous administration. At the first telephone readministration (after one week), patients will complete the full range of questionnaires as they did at the first administration of the questionnaires at the centre. The second telephone readministration (after an additional week) will involve completion of the ALSFRS-R and -EX questionnaires only and will use the standard version of both questionnaires administered by an assessor certified to use this scale. For patients with significantly limited verbal communication skills, it is acceptable to have the patient's caregiver mediate the responses during the telephone administration and/or to send the completed questionnaires during the follow-up administrations by mail or electronically (e-mail). In these cases, patients will be invited to complete the readministration questionnaires by email or telephone (depending on their preference) at a time that would be consistent with normal telephone readministrations for other patients (to maintain an identical time interval between readministrations). Similarly, for patients with limited ability to grasp writing instruments, it will be permissible to complete questionnaires in collaboration with the caregiver, but always on the basis of patient-reported data. At the first administration of all questionnaires (including the self-assessment version of the ALSFRS-R questionnaire) at the centre, the patient will be asked to complete the questionnaires without further clarification from the investigator. Similarly, during the first telephone readministration involving only the self-assessment questionnaires, the individual questions and the options included in them will be read to the patient only, with no opportunity for the patient to ask additional questions, in order to maintain the self-assessment nature of all tests used. The standard (non-self-assessment) version of the ALSFRS-R questionnaire will be administered at the second telephone follow-up by TRICALS (Treatment Research Initiative to Cure ALS, an organisation authorised to use the questionnaire in a certified manner) certified assessors and will be administered in accordance with the training provided by this initiative. Initial and repeat administrations will be conducted by different raters. Evaluators conducting telephone readministrations will not be aware of patients' initial test results at the first administration or their clinical status. The procedures for working with human subjects were approved by the Ethics Committee of the Brno University Hospital on 11.05.2023, reference number 06-110522/EK, project number 85/22. Statistical data processing will be performed using SPSS 29 statistical software (IBM Corporation, 2020, Armonk, New York, USA). ### Conditions Module **Conditions:** - Amyotrophic Lateral Sclerosis **Keywords:** - Amyotrophic lateral sclerosis - ALS - ALSFRS-R - ALSFRS-EX - ALSAQ-40 - Borg scale - Frontal assessment battery - Scale - Questionnaire ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Content Validity: Ensures the questionnaire comprehensively covers the construct it intends to measure. **Measure:** Questionnaire validity (ALSFRS-R(-EX), ALSAQ-40, DYALS) **Time Frame:** 01.09.2024 **Description:** Test-Retest Reliability: Intraclass Correlation Coefficient (ICC) Pearson or Spearman Correlation Coefficient Cohen's Kappa (κ) Bland-Altman Plot **Measure:** Questionnaire reproducibility (Czech versions of ALSFRS-R(-EX), ALSAQ-40, DYALS) **Time Frame:** 01.09.2024 **Description:** Test-Retest Reliability: Intraclass Correlation Coefficient (ICC) Pearson or Spearman Correlation Coefficient Cohen's Kappa (κ) Bland-Altman Plot **Measure:** Agreement between self reported and non-self reported version of ALSFRS-R **Time Frame:** 01.09.2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. diagnosed amyotrophic lateral sclerosis (ALS) meeting the EMG (electromyographic) criteria: * Gold Coast criteria or * at least clinically probable ALS according to Awaji-Shima criteria 2. willing and able to comply with all protocol procedures Exclusion Criteria: * none **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** ALS patients in colaborating Centres - University Hospital Brno (CZ), Motol University Hospital (CZ), Martin University Hospital (SK), University Hospital Bratislava (SK) - who are willing to participate in study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Adam Betik, MD **Phone:** +420532232503 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Eva Vlckova, doc,MD,PhD **Phone:** +420532233221 **Role:** CONTACT #### Locations **Location 1:** **City:** Brno **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Adam Betik, MD - **Phone:** +420532232503 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Eva Vlckova, doc,MD,PhD - **Phone:** +420532233221 - **Role:** CONTACT **Country:** Czechia **Facility:** University Hospital Brno **State:** Czech Republic **Status:** RECRUITING **Zip:** 62500 #### Overall Officials **Official 1:** **Affiliation:** Masaryk University, University Hospital Brno. **Name:** Eva Vlckova, doc,MD,PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000057177 - Term: TDP-43 Proteinopathies - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M18879 - Name: Motor Neuron Disease - Relevance: HIGH - As Found: Lateral Sclerosis - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M28759 - Name: TDP-43 Proteinopathies - Relevance: LOW - As Found: Unknown - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T4699 - Name: Primary Lateral Sclerosis - Relevance: HIGH - As Found: Lateral Sclerosis - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: HIGH - As Found: Amyotrophic Lateral Sclerosis ### Condition Browse Module - Meshes - ID: D000016472 - Term: Motor Neuron Disease - ID: D000000690 - Term: Amyotrophic Lateral Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426017 **Brief Title:** Impact of FTO Gene Variation on Body Composition, Lipid Profile, Insulin Resistance, Advanced Glycation End-Products and Ghrelin Levels in Response to Hypocaloric, Protein Rich-Diet **Official Title:** Impact of FTO Gene Variation on Body Composition, Lipid Profile, Insulin Resistance, Advanced Glycation End-Products and Ghrelin Levels in Response to Hypocaloric, Protein Rich-Diet #### Organization Study ID Info **ID:** ASRB001624/IF/IBMS #### Organization **Class:** OTHER **Full Name:** Khyber Medical University Peshawar ### Status Module #### Completion Date **Date:** 2024-07-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Khyber Medical University Peshawar #### Responsible Party **Investigator Affiliation:** Khyber Medical University Peshawar **Investigator Full Name:** Bibi Hajira **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:** Obesity is a widespread disease that basically develops from unhealthy lifestyle and genetics. The Fat-mass and obesity associated (FTO) gene affects appetite and energy intake of the body, thus elevating fat mass and body weight. The single nucleotide polymorphism (SNP) rs9939609 of the FTO gene is a common variant in different ethnic groups, and its A allele is associated with increased body mass and waist circumference. Hence, the carriers of rs9939609 SNP are prone to weight gain if a healthy diet and lifestyle are not maintained. Similarly, high levels of serum cholesterol and triglycerides, while low levels of high-density lipoproteins are observed in carriers of rs9939609 AA genotype. For individuals having FTO rs9939609 A allele, consumption of hypocaloric diets (1500 kcal/day) consisting of high protein foods up to 25-30% of total daily energy intake might help reduce body weight. However, weight loss tends to vary in individuals after consuming the same diet under similar environmental conditions, so it is important to know the effect of different genotypes that might cause this variation. The study aimed to genotype overweight and obese adults for FTO rs9939609 polymorphism and to determine the effect of this polymorphism on body weight, BMI, waist and hip circumferences, lipid profile, insulin sensitivity, ghrelin levels, inflammatory markers and advanced glycation end-products in these individuals after consumption of a hypocaloric, high-protein diet for 4 weeks. ### Conditions Module **Conditions:** - Obesity - Insulin Resistance - Dyslipidemias - Advance Glycation - Inflammation **Keywords:** - Satiety - Food Intake - High protein diet - Obesity - FTO rs9939609 - Ghrelin - Carboxymethyl lysine - Interleukin-6 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** It will be a quasi-experimental study, where 110 individuals with obesity will be allocated into three allele groups i.e. TT, AT and AA based on minor allele frequency. Each participant in the study will go through intervention of high protein, low calorie diet for four weeks. BMI, waist to hip ratio, body composition, lipid profile, fasting glucose level, insulin resistance, advanced glycation end-products will measure at the start and end of the study while hunger hormone will be measured at the start, mid and end of the study. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 3 meals/day consumed by the participants with daily caloric intake of 800 kcal. 40-60% of the total calories added from both animal and plant proteins. 30% of the total calories added from fats. 20% of the total calories added from carbohydrates. **Intervention Names:** - Other: High Protein Low Calorie Dietary Intervention **Label:** High Protein Low Calorie Diet **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - High Protein Low Calorie Diet **Description:** High Protein Diet: Diet consisting of 40-60% total energy from proteins, \<20% total energy from carbohydrates and \<30% total energy from fats. **Name:** High Protein Low Calorie Dietary Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Body Weight **Time Frame:** Day 0 and day 29 **Measure:** Body Composition **Time Frame:** Day 0 and day 29 **Measure:** Lipid Profile **Time Frame:** Day 0 and day 29 **Measure:** Waist Circumference **Time Frame:** Day 0 and day 29 **Measure:** Hip Circumference **Time Frame:** Day 0 and day 29 **Measure:** HOMA-IR **Time Frame:** Day 0 and day 29 **Measure:** Carboxymethyl lysine levels (CML **Time Frame:** Day 0 and day 29 **Measure:** Interleukinin-6 **Time Frame:** Day 0 and day 29 **Measure:** Hunger Hormone- Ghrelin **Time Frame:** Day 1(Fasting and postprandial), Day 7(Fasting and postprandial) and Day 28(Fasting and postprandial). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1Overweight (BMI ≥ 25kg/m2) and obese (BMI ≥ 30kg/m2) individuals. * Both genders. * Age 18-50 years. Exclusion Criteria: * Children, pregnant and lactating women * Individuals taking medication for weight loss or undergoing any other weight loss dietary intervention. * Individuals having lost more than 5 pounds in the past three-month period. * Patients with any psychiatric disorders, heart, liver, kidney disease, diabetes or abnormal thyroid function. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Dr Bibi Hajira, PhD **Phone:** 03015287833 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Dr Muhammad Omar Malik, PhD **Phone:** 03335196243 **Role:** CONTACT #### Locations **Location 1:** **City:** Peshawar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bibi Hajira, PhD - **Phone:** 0301-5287833 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Omar Malik, PhD - **Phone:** 0333-5196243 - **Role:** CONTACT ***Contact 3:*** - **Name:** Bibi Hajira, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Omar Malik, PhD - **Role:** SUB_INVESTIGATOR **Country:** Pakistan **Facility:** Khyber Medical University **State:** KPK **Status:** RECRUITING **Zip:** 25100 **Location 2:** **City:** Peshawar **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dr Bibi Hajira, PhD - **Phone:** 03015287833 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Dr Muhammad Omar Malik, PhD - **Phone:** 03335196243 - **Role:** CONTACT ***Contact 3:*** - **Name:** Dr Bibi Hajira, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Dr Muhammad Omar, PhD - **Role:** SUB_INVESTIGATOR **Country:** Pakistan **Facility:** Trial Room Institute of Basic Medical Sciences **State:** KPK **Status:** RECRUITING **Zip:** 25100 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Rexrode KM, Carey VJ, Hennekens CH, Walters EE, Colditz GA, Stampfer MJ, Willett WC, Manson JE. Abdominal adiposity and coronary heart disease in women. JAMA. 1998 Dec 2;280(21):1843-8. doi: 10.1001/jama.280.21.1843. **PMID:** 9846779 **Citation:** McMillan DC, Sattar N, McArdle CS. ABC of obesity. Obesity and cancer. BMJ. 2006 Nov 25;333(7578):1109-11. doi: 10.1136/bmj.39042.565035.BE1. No abstract available. **PMID:** 17124223 **Citation:** Karra E, O'Daly OG, Choudhury AI, Yousseif A, Millership S, Neary MT, Scott WR, Chandarana K, Manning S, Hess ME, Iwakura H, Akamizu T, Millet Q, Gelegen C, Drew ME, Rahman S, Emmanuel JJ, Williams SC, Ruther UU, Bruning JC, Withers DJ, Zelaya FO, Batterham RL. A link between FTO, ghrelin, and impaired brain food-cue responsivity. J Clin Invest. 2013 Aug;123(8):3539-51. doi: 10.1172/JCI44403. Epub 2013 Jul 15. **PMID:** 23867619 **Citation:** Zou ZC, -J Mao L, Shi YY, Chen JH, Wang LS, Cai W. Effect of exercise combined with dietary intervention on obese children and adolescents associated with the FTO rs9939609 polymorphism. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4569-75. **PMID:** 26698254 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000052439 - Term: Lipid Metabolism Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M26181 - Name: Dyslipidemias - Relevance: HIGH - As Found: Dyslipidemia - ID: M10370 - Name: Insulin Resistance - Relevance: HIGH - As Found: Insulin Resistance - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007333 - Term: Insulin Resistance - ID: D000050171 - Term: Dyslipidemias - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: T11 - Name: Lysine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06426004 **Acronym:** NPH **Brief Title:** Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland **Official Title:** Community Interventions to Address Health Disparities in the Care of Normal Pressure Hydrocephalus (NPH) in Maryland #### Organization Study ID Info **ID:** IRB00028028 #### Organization **Class:** OTHER **Full Name:** Johns Hopkins Bloomberg School of Public Health ### Status Module #### Completion Date **Date:** 2030-03-30 **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:** 2027-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2025-04-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Johns Hopkins Bloomberg School of Public Health #### 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 study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race, with a focus on the Black community. Interventions will include educational elements about NPH and three layers targeting patients, Primary Care Providers, and community health workers to enhance care access. Short-term outcomes will measure referrals to specialists, while long-term outcomes will assess healthcare utilization. The study aims to identify and reduce racial disparities in NPH care access, informing intervention strategies for NPH and other surgical areas. **Detailed Description:** This proposal responds to an established need for developing an evidence-based and community-informed approach to address health disparities in specialty surgical clinics where barriers to accessing care are multiplied along each level of the referral pathway. The study will focus on Normal Pressure Hydrocephalus (NPH) related care - a clinical syndrome characterized excess cerebrospinal fluid (CSF) in the brain resulting in symptoms of falls, dementia, and urinary incontinence, that is treated surgically by shunting to remove excess fluid from the brain. This disorder afflicts an estimated about 750,000 Americans, and prevalence increases with age. Limited information regarding racial and socioeconomic contributing factors associated with diagnosis and treatment is available. Studies show NPH goes underdiagnosed in the USA. In the first part of the study the investigators will estimate NPH prevalence, the health equity gap in Baltimore and greater Maryland (MD), the health equity gap based on Zip Code as a marker of sociodemographic community status, and the health equity gap based on race, looking at the Black community, which comprises over 60% of the Baltimore and 30% in MD population. In the second part of the study, the investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care. The success of these interventions will be evaluated by short-term outcomes such as referrals to specialists including neurologists and neurosurgeons every 6 months, and long-term outcomes such as healthcare utilization including screening for shunt surgery within 12 months. This study aims to identify racial disparities in access to NPH care and intervention outcomes will evaluate the effect of different interventions on reducing racial disparities and to help developing a referral system to address the needs of most vulnerable population and Zip Codes in Baltimore and greater MD. Using the results of this study will help to identify gaps, understand the best intervention, and develop intervention strategies not only for NPH but potentially other surgical areas. ### Conditions Module **Conditions:** - Normal Pressure Hydrocephalus - Hakim Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL **Intervention Model Description:** The investigators will develop three layers of interventions that involve educational elements about NPH and evaluate which provides the most benefit including referrals to NPH related care. 1) Patients identified from the first part of the study with possible NPH symptoms will receive intervention 2) Patients, and the Primary Care Providers (PCPs) receive intervention, and 3) patients, and PCP receive intervention and with additional community health workers (CHWs) assisting providers with managing the patient care including referrals, addressing socioeconomic barriers, transportation to receive care. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 660 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients and the patient's family will receive NPH-related education. **Intervention Names:** - Other: patients will receive NPH education - Other: primary care physicians (PCPs) will receive professional NPH education - Other: A community health worker will assist PCP **Label:** Patients and the patient's family **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Primary Care Provider (PCP) will receive NPH education. **Intervention Names:** - Other: primary care physicians (PCPs) will receive professional NPH education - Other: A community health worker will assist PCP **Label:** PCPs Training **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** A community health worker (CHW) will assist PCP. **Intervention Names:** - Other: A community health worker will assist PCP **Label:** CHWs assist PCPs **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients and the patient's family **Description:** Patients will benefit from the Hydrocephalus Association's (HA) educational strategy for idiopathic normal pressure hydrocephalus (iNPH) emphasizes patient collaboration in the development of educational materials specifically for this condition. HA has a library of assets that include PowerPoint presentations, videos, and online and print educational materials. There will be also in-person outreach resulting recruitment, website (the study website and HA website), webform (with a symptom of gait, dementia, and bladder symptoms), YouTube videos. The investigators will also go to the communities like senior centers, health fair, and churches, then we will give a talk about iNPH. These resources will be carefully adjusted to suit low-income demographics, guided by feedback from Baltimore audiences and HA's iNPH volunteers. **Name:** patients will receive NPH education **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - PCPs Training - Patients and the patient's family **Description:** A comprehensive professional development program for PCPs and CHWs, featuring presentations, educational videos, webinars, and tools on iNPH diagnosis, treatment, and care management. Provider Continuing Medical Education (CME) credits will be offered for in-person lectures, aiming to equip PCPs with the skills needed to address iNPH in low-income settings effectively **Name:** primary care physicians (PCPs) will receive professional NPH education **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - CHWs assist PCPs - PCPs Training - Patients and the patient's family **Description:** A community health worker will assist PCP to identify barriers and help overcome these barriers in order for patient to access iNPH care. **Name:** A community health worker will assist PCP **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** referrals for physical therapy, occupational therapy, psychiatry, neurology - movement disorder specialist, neurology neuropathy specialist, orthopedic surgery, neurosurgery- spine specialist, neuropsychologist **Measure:** number of referrals **Time Frame:** 12 months and 24 months #### Primary Outcomes **Description:** number of referrals for suspicion of NPH to neurologists or neurosurgeons **Measure:** number of referrals **Time Frame:** 6 months **Description:** number of screenings for shunt surgery **Measure:** number of screenings **Time Frame:** 12 months **Description:** number of screenings for shunt surgery **Measure:** number of screenings **Time Frame:** 24 months #### Secondary Outcomes **Description:** number of patients who have received a consultation **Measure:** number of NPH's consultations **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * People over 65 years old who have completed the Annual Wellness Survey (AWV) survey * have a clinical profile in the Hopkins Epic data sets * live in Maryland Exclusion Criteria: * People under 65 years old will be excluded if they have not completed the AWV survey * do not live in Maryland Community Health Worker (CHW) Inclusion Criteria: * certified Community Health Workers from Maryland * completed accredited training by the Maryland Department of Health Primary Care Physician inclusion criteria: * must have patients in Johns Hopkins University AWV **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hossein Zare, MS, PhD **Phone:** 4106147246 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mark G Luciano, PhD, FACS **Role:** CONTACT #### Locations **Location 1:** **City:** Baltimore **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hossein Zare, MS, PhD - **Phone:** 410-614-7246 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mark G Luciano, PhD, FACS - **Role:** CONTACT ***Contact 3:*** - **Name:** Hossein Zare, MS, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Mark G Luciano, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Sevil Yasar, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 6:*** - **Name:** Darrell Gaskin, MS, PhD - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Taiwo Akindahunsi, MD - **Role:** SUB_INVESTIGATOR ***Contact 8:*** - **Name:** Michelle Spencer, MS - **Role:** SUB_INVESTIGATOR ***Contact 9:*** - **Name:** Jiangxia Wang, MA, MS - **Role:** SUB_INVESTIGATOR ***Contact 10:*** - **Name:** Amanda Garzon, MIA - **Role:** SUB_INVESTIGATOR ***Contact 11:*** - **Name:** Roger Clark - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Johns Hopkins University and Hospital **State:** Maryland **Zip:** 21205 **Location 2:** **City:** Baltimore **Country:** United States **Facility:** Johns Hopkins University **State:** Maryland **Zip:** 21205 #### Overall Officials **Official 1:** **Affiliation:** Johns Hopkins Bloomberg School of Public Health **Name:** Hossein Zare, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The study protocol and analytic plan will be freely available. In addition to analytical files, the Stata, Statistical Analysis System (SAS), R codes and programs and data dictionary will be available to researchers approved by one of the study's Principal Investigators to receive data. All papers must include an acknowledgment section that includes the funding source. **Info Types:** - SAP - CSR **IPD Sharing:** YES **Time Frame:** The investigators will release the data 2 years after finishing up the study on April 2030. ## Derived Section ### Condition Browse Module - Ancestors - 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 ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M9907 - Name: Hydrocephalus - Relevance: HIGH - As Found: Hydrocephalus - ID: M9908 - Name: Hydrocephalus, Normal Pressure - Relevance: HIGH - As Found: Normal Pressure Hydrocephalus - 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: D000006849 - Term: Hydrocephalus - ID: D000006850 - Term: Hydrocephalus, Normal Pressure ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425991 **Acronym:** MajesTEC-10 **Brief Title:** A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma **Official Title:** A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma #### Organization Study ID Info **ID:** 64007957MMY1008 #### Organization **Class:** INDUSTRY **Full Name:** Janssen Research & Development, LLC #### Secondary ID Infos **Domain:** Janssen Research & Development, LLC **ID:** 64007957MMY1008 **Type:** OTHER **Domain:** EUCT number **ID:** 2023-508426-10-00 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2027-01-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Janssen Research & Development, LLC #### 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:** The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change). ### Conditions Module **Conditions:** - Relapsed or Refractory Multiple Myeloma **Keywords:** - 1-3 prior lines ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. **Intervention Names:** - Drug: Teclistamab **Label:** Arm A: Pre-change Teclistamab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. **Intervention Names:** - Drug: Teclistamab **Label:** Arm B: Post-change Teclistamab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A: Pre-change Teclistamab - Arm B: Post-change Teclistamab **Description:** Teclistamab will be administered subcutaneously. **Name:** Teclistamab **Other Names:** - JNJ-64007957 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose). **Measure:** Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab **Time Frame:** Cycle 1 (28 days cycle): Predose to Day 7 postdose **Description:** AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose). **Measure:** Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose **Time Frame:** Cycle 1 (28 days cycle): Predose to Day 7 postdose **Description:** Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration. **Measure:** Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1 **Time Frame:** Cycle 3 (28 days cycle): Day 1 #### Secondary Outcomes **Description:** Number of participants with ADAs to teclistamab will be reported. **Measure:** Number of Participants with Anti-drug Antibodies (ADAs) **Time Frame:** Up to approximately 3 years **Description:** Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. **Measure:** Percentage of Participants With Complete Response (CR) or Better Response **Time Frame:** Up to approximately 3 years **Description:** An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event. **Measure:** Number of Participants with Adverse Events (AEs) by Severity **Time Frame:** Up to approximately 3 years **Description:** SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important. **Measure:** Number of Participants with Serious Adverse Events (SAEs) **Time Frame:** Up to approximately 3 years **Description:** Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported. **Measure:** Number of Participants with Abnormal Laboratory Results **Time Frame:** Up to approximately 3 years **Description:** Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria. **Measure:** Percentage of Participants With Overall Response (Partial Response [PR] or Better) **Time Frame:** Up to approximately 3 years **Description:** Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. **Measure:** Percentage of Participants With Very Good Partial Response (VGPR) or Better Response **Time Frame:** Up to approximately 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line * Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria * Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2 * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study Exclusion Criteria: * Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients * Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed * Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required * Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Study Contact **Phone:** 844-434-4210 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Janssen Research & Development, LLC **Name:** Janssen Research & Development, LLC Clinical Trial **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu **IPD Sharing:** YES **URL:** https://www.janssen.com/clinical-trials/transparency ## 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425978 **Acronym:** CellularMatrix **Brief Title:** Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit **Official Title:** The Efficacy of the Use of Cellular Matrix / A-CP-HA Kit (Combination of Autologous Platelet-rich Plasma and Non-cross-linked Hyaluronic Acid) Compared to Local Estrogen Therapy (Blissel, Estriol 50 Micrograms/g Vaginal Gel) in Women With Genitourinary Syndrome of Menopause. A Randomized Controlled Trial, With a Second Blind Observer. #### Organization Study ID Info **ID:** FSD-CEL-2023-11 #### Organization **Class:** OTHER **Full Name:** Institut Universitari Dexeus #### Secondary ID Infos **ID:** 2023-507200-31-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Regen Lab SA #### Lead Sponsor **Class:** OTHER **Name:** Fundación Santiago Dexeus Font #### 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 randomized, controlled, non-inferiority trial, that will be performed on 192 women on Menopause (absence of menstruation for at least 12 months), with diagnostic of genitourinary syndrome of menopause (SGM) and a vaginal health index \<15 points, that are sexually active. Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel). Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence. **Detailed Description:** This study is a randomized, controlled, non-inferiority trial, with a second blind observer, comparing effectiveness of the use of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) to the standard line of treatment, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) in women with genitourinary syndrome of menopause (SGM). Duration of the study estimated is 24 months. A total of 192 menopausal women, with absence of menstruation for at least 12 months, ≤70 years old, that are sexually active and who report symptoms and signs of SGM, with a vaginal health index \<15 points. Patients will be excluded if are in treatment with systemic or local hormonal treatment in the last 3 months, Tamoxifen or Aromatase inhibitor treatments. Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida). Contraindication for vaginal estrogen therapy. Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases. Women who have had pelvic surgery within 6 months. Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid), separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel). Patients will interviewed about their medical history, age of menopause, symptoms related and history of treatments. Evaluation of the Vaginal Health Index (VHIS), Vulvar Health Index (VHI), vaginal pH, and vaginal maturation index (vaginal cytology). The intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria) will be measured using a 5-cm visual analog scale (VAS), and a valuation of Female Sexual Distress (FSD) score. Photographic monitoring during all phases of the procedure. Routine laboratory test serology will requested for both groups (valid up to 3 months). Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence. ### Conditions Module **Conditions:** - Genitourinary Syndrome of Menopause ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 192 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) is a sterile tube designed for use in the preparation of a mixture of PRP and hyaluronic acid, tube is under vacuum allowing the withdrawal of 6 ml of blood and contains: 2 ml of hyaluronic acid gel (20mg/ml, 40 mg per tube) in phosphate buffer. Not crosslinked, hyaluronic acid is obtained from bacterial fermentation, 3 g of inert cell-selector gel, and 0.6 ml of anticoagulant (sodium citrate 4%). Centrifuged at 1,500 g, 3,000 rpm for 5 min. Platelet recovery of more than 70%, granulocyte depletion of 94.3% and red blood cells of 99.5% are achieved. **Intervention Names:** - Drug: Cellular Matrix / A-CP-HA Kit **Label:** Cellular Matrix / A-CP-HA Kit **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Blissel, estriol 50 micrograms/g vaginal gel **Intervention Names:** - Drug: Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) **Label:** Local estrogen therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cellular Matrix / A-CP-HA Kit **Description:** For infiltration, a prior preparation of the region with anesthetic cream is performed, procaine 25 mg/g + lidocaine 25 mg/g (Emla 5% cream) in the vulvar area and vaginal introitus. Occlusion of the area with plastic film is performed for 20 minutes. After asepsis and antisepsis, infiltration is performed with mesotherapy needles 31G 4mm, using the technique of superficial "point-to-point" mesotherapy microinjections, in the vestibule and the first 3 cm of the posterior wall of the vagina. **Name:** Cellular Matrix / A-CP-HA Kit **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Local estrogen therapy **Description:** Blissel®, Estriol vaginal gel 50 micrograms/g, daily application for 15-21 days in a row, then two times a week for 24 weeks (6 months). Application instructions will be explained to the patients. The gel should be applied in the vagina using an applicator with the marked dose, the full applicator should be inserted into the vagina and emptied, preferably at night. **Name:** Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS) **Measure:** Percentage of patients with improved symptomatology. **Time Frame:** at 6 months after treatment #### Secondary Outcomes **Description:** defined as percentage of patients scoring ≥ 15 in the VHIS **Measure:** Healing percentage **Time Frame:** at 6 months after treatment **Measure:** Evolution of Vaginal Health Index **Time Frame:** at 3-months and 6-months follow-up **Measure:** Evolution of Vulvar Health Index **Time Frame:** at 3-months and 6-months follow-up **Measure:** Evolution of vaginal pH **Time Frame:** at 3-months and 6-months follow-up **Measure:** Evolution of Vaginal maturation index (vaginal cytology) **Time Frame:** at 3-months and 6-months follow-up **Description:** measured using a 5-cm visual analog scale (VAS) **Measure:** Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) **Time Frame:** at 3-months and 6-months follow-up **Measure:** Incidence of adverse events and serious adverse events **Time Frame:** at 3-months and 6-months follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women ≤70 years old * Women that are sexually active * Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) \< 15 points. * Women who understand the Spanish language * Willing to participate in the study and sign informed consent. Exclusion Criteria: * Systemic or local hormonal treatment in the last 3 months * Tamoxifen or Aromatase inhibitor treatments * Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida) Contraindication for vaginal estrogen therapy * Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases. * Women who have had pelvic surgery within 6 months. * Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Antonella de Ponte Davi, MD **Phone:** 0034932274700 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ignacio Rodríguez, MSc **Phone:** 0034932274700 **Phone Ext:** 22029 **Role:** CONTACT #### Locations **Location 1:** **City:** Barcelona **Country:** Spain **Facility:** Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus **Zip:** 08037 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### See Also Links **Label:** Related Info **URL:** http://www.dexeus.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - 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: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: T6036 - Name: Menopause - Relevance: HIGH - As Found: Menopause ### Condition Browse Module - Meshes - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Ancestors - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### 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 - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M8116 - Name: Estrogens - Relevance: HIGH - As Found: Interviewing - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown - ID: M21320 - Name: Citric Acid - Relevance: LOW - As Found: Unknown - ID: M1837 - Name: Sodium Citrate - Relevance: LOW - As Found: Unknown - ID: M14216 - Name: Procaine - Relevance: LOW - As Found: Unknown - ID: M1801 - Name: Lidocaine, Prilocaine Drug Combination - 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: T382 - Name: Citrate - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004967 - Term: Estrogens ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425965 **Brief Title:** Effect of Hybrid Simulation Method on Advanced Life Support Application of Nursing Students **Official Title:** Effect of Hybrid Simulation Method on Advanced Life Support Application of Nursing Students #### Organization Study ID Info **ID:** 641752 #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul University - Cerrahpasa (IUC) #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Yagmur Sen **Investigator Title:** Research Assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The use of simulation in nursing education is an effective way to provide professional skills and enrich learning experiences while protecting patient safety. When the literature is examined, it is seen that simulation is frequently used in advanced life support training. The aim of the study is to examine the effects of advanced life support training in adults, which will be carried out with high-reality simulator/model simulation, web-based simulation and hybrid simulation methods, on the knowledge and skills of nursing students. It has been determined that training provided with hybrid simulation contributes to the professional development of students by creating individualized and interactive learning environments, and that students can more easily transfer the knowledge they have acquired in the educational environment to clinical practice. As a hybrid simulation method in the study; It is planned to use a combination of high-reality simulator/model, which has been proven to be effective in the development of psychomotor skills, and the web-based simulation method, which is effective in creating permanent learning by allowing students to repeat more. In the literature; It has been stated that the level of knowledge and skills gradually decreases after 6-10 weeks of advanced/basic life training. It is anticipated that the web-based simulation method will be effective in providing permanent learning as it gives learners the opportunity to repeat during/after the training. Based on these assumptions, it is planned to develop an adult advanced life support training program consisting of theory and practice, in which the development of students' professional skills is supported through hybrid simulation applications, and the students are provided with the opportunity to repeat. Since the study tests 3 different interventions, it is anticipated that it will lay the groundwork for subsequent studies and provide comprehensive information about simulation-based education practices. ### Conditions Module **Conditions:** - Advanced Life Support - Simulation Training - Nursing Education **Keywords:** - simulation - Advanced life support - Nursing education - Nursing student - Web-based simulation - High fadility ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first group will receive advanced life support training with a high reality simulator. **Intervention Names:** - Other: Advanced life support training with high reality simulator **Label:** Intervention Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The second group will receive advanced life support training with web-based simulation method. **Intervention Names:** - Other: Advanced life support training with web-based simulation **Label:** Intervention Group 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The third group will receive advanced life support training with a hybrid simulation method using both high reality simulator and web-based simulation. **Intervention Names:** - Other: Advanced life support training with hybrid simulation **Label:** Intervention Group 3 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention Group 1 **Description:** The training consists of theoretical and practical training and lasts 3 hours a day, 5 days, for a total of 15 hours. The first 3 days of the training are theoretical, 1 day is laboratory practice and 1 day is evaluation. Theoretical courses start with introductions and sharing the content of the training and aim to provide the basic professional knowledge and skills required for advanced life support practice (diagnosis of cardiac arrest, ensuring airway patency, monitoring, cardiac rhythm diagnosis, drugs used during advanced life support and advanced life support algorithm). The laboratory application of the training is carried out with a high reality simulator in line with the information (15 min), scenario implementation (15 min) and debriefing sessions (30 min), respectively. **Name:** Advanced life support training with high reality simulator **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Intervention Group 2 **Description:** The training consists of theoretical and practical training and lasts 3 hours a day, 5 days, for a total of 15 hours. The first 3 days of the training are theoretical, 1 day is laboratory practice and 1 day is evaluation. Theoretical courses start with introductions and sharing the content of the training and aim to provide the basic professional knowledge and skills required for advanced life support practice (diagnosis of cardiac arrest, ensuring airway patency, monitoring, cardiac rhythm diagnosis, drugs used during advanced life support and advanced life support algorithm). The laboratory application of the training is carried out by web-based simulation method. Students participate in the web-based simulation application developed by the researcher. **Name:** Advanced life support training with web-based simulation **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Intervention Group 3 **Description:** The training consists of theoretical and practical training and lasts 3 hours a day, 5 days, for a total of 15 hours. The first 3 days of the training are theoretical, 1 day is laboratory practice and 1 day is evaluation. Theoretical courses start with introductions and sharing the content of the training and aim to provide the basic professional knowledge and skills required for advanced life support practice (diagnosis of cardiac arrest, ensuring airway patency, monitoring, cardiac rhythm diagnosis, drugs used during advanced life support and advanced life support algorithm). The laboratory application of the training is carried out with the hybrid simulation method in which high reality simulator and web-based simulation method are applied together. Students first apply the web-based simulation developed by the researcher. Then they perform the practice on the high reality simulator. **Name:** Advanced life support training with hybrid simulation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It was developed by the researchers in line with the literature to determine the level of knowledge of the participants about advanced life support practice. **Measure:** Advanced Life Support Knowledge Test **Time Frame:** before training, immediately after training, 1 month after training, 3 months after training **Description:** It was developed by the researcher based on the European Resuscitation Council 2021 Advanced Life Support Algorithm. **Measure:** Advanced Life Support Skill Checklist **Time Frame:** before training, immediately after training, 1 month after training, 3 months after training #### Secondary Outcomes **Description:** The scale was developed by Jeffries and Rizzolo in 2006. The Turkish validity and reliability study of the scale was conducted by Ünver et al. in 2015. The scale aims to determine students' satisfaction and self-confidence towards learning in simulation environment. The scale consists of two sub-dimensions, "Satisfaction with Current Learning" and "Confidence in Learning", and a total of 12 items. The scale is a 5-point Likert scale (1: Strongly disagree, 2: Disagree, 3: Undecided, 4: Agree, 5: Strongly Agree) and each item is scored as 1 being the lowest and 5 being the highest. The higher the total score obtained from the scale, the higher the student satisfaction and self-confidence in learning. **Measure:** Student Satisfaction and Self-confidence in Learning Scale **Time Frame:** immediately after training **Description:** The scale was developed by Jeffries and Rizzolo in 2006 and the Turkish validity and reliability study was conducted by Ünver et al. in 2015. The scale consists of 20 items and 2 sections. The first part measures simulation design elements, and the second part measures how important the simulation application is for students. An increase in the total score obtained in the first part of the scale indicates that the best simulation design elements are applied in the simulation application; an increase in the total score obtained from the second part indicates that the importance given by the student to the simulation experience is high. **Measure:** Simulation Design Scale **Time Frame:** immediately after training **Description:** In this study, a semi-structured interview form developed by the researchers in line with the literature was used to determine the opinions of the students participating in the Advanced Life Support in Adults Training Program about the training program. The form consists of questions aimed at determining the theoretical content of the training program, the effectiveness of teaching methods (web-based simulation, simulation with high reality simulator, hybrid simulation), the effects of the training on learning retention, and suggestions for improving the training program. **Measure:** Semi-structured Interview Form **Time Frame:** immediately after training ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * To complete first aid, internal medicine nursing, surgical nursing courses, * Volunteering to participate in the research. * Having experienced the simulation application before Exclusion Criteria: * Fail the specified courses (taking FF) * Not having taken first aid course/training before * Not having experienced the simulation application before. Disqualification criteria: * Being absent for more than 20% of the theoretical part of the planned advanced life support training * Not participating in the laboratory applications of the planned advanced life support training * Not having completed the planned web-based simulation application **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yagmur Sen **Phone:** +905061258462 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yagmur Sen - **Phone:** +905061258462 - **Role:** CONTACT **Country:** Turkey **Facility:** Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing **State:** Şişli **Status:** RECRUITING **Zip:** 34381 ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425952 **Acronym:** EquiCMT **Brief Title:** Impact of Sensory, Motor and Vestibular Deficit on the Postural Stability of CMT Patients **Official Title:** Impact of Sensory, Motor and Vestibular Deficit on the Postural Stability of CMT Patients #### Organization Study ID Info **ID:** OSRSCP-EquiCMT #### Organization **Class:** OTHER **Full Name:** IRCCS San Raffaele ### Status Module #### Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** IRCCS San Raffaele #### Responsible Party **Investigator Affiliation:** IRCCS San Raffaele **Investigator Full Name:** Stefano Previtali **Investigator Title:** Head Neuromuscular Repair Unit **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Charcot-Marie-Tooth (CMT), a therapeutically orphan neuromuscular disease affecting one in 2,500 people, represents a challenge to the medical and scientific communities. Physiotherapeutic-rehabilitative strategies play a crucial role in the management of CMT, particularly addressing balance impairment, a key disabling symptom. However, clinical studies in this field are limited. Our study aims to investigate the impact of strengh and somatosensory deficits on static and dynamic balance in CMT patients. The Investigators also aim to explore the involvement of the vestibular system and its correlation with postural instability. Furthermore, the Investigators seek to evaluate relationships between neurochemical biomarkers offering valuable insights for future targeted clinical studies. **Detailed Description:** A total of 60 patients will be recruited. To ensure adequate representation of the subgroups of interest, 10 patients with CMT1A (PMP22 gene duplication) and 10 patients with CMT2, regardless of their genotype, will be included. Additionally, three control groups, each comprising 10 subjects, will be included. The first group will consist of patients with motor symptoms, including those with hereditary motor neuropathy (HMN, 10 patients) or distal myopathy (MD, 10 patients). The second group will include patients with solely sensory symptoms, genetic neuropathies, or purely sensory acquired neuropathies such as HSN and neuropathies from anti-MAG antibodies. Finally, the third group will be composed of 10 healthy subjects. Each control subject will have comparable level of disability (motor or somatosensory), age, and gender to the enrolled CMT patients. All participants must meet the following inclusion criteria to take part in the study: * Age 18 years or older * Subject has documented diagnosis of one of the following diseases (except from healthy controls): * Hereditary sensory-motor neuropathy (CMT) confirmed by genetic analysis * Hereditary motor neuropathy (HMN) confirmed by genetic analysis * Hereditary sensory neuropathy (HSN) confirmed by genetic analysis * Hereditary distal myopathy (MD) confirmed by genetic analysis * Acquired sensory neuropathy: anti-MAG antibody neuropathy confirmed by neurophysiological, clinical and serological assessment. The presence of any one of the following exclusion criteria will lead to the exclusion of the subject: * Inability to maintain an upright position without assistance * Presence of systemic, neurological (except for the neuropathies and hereditary myopathies under study), psychiatric, orthopedic or rheumatological diseases that may affect evaluation * Mini Mental State Examination (MMSE)14 score less than 28 * History of alcohol or substance abuse * Partecipation in intensive motor rehabilitation programs in the last three months. ### Conditions Module **Conditions:** - Hereditary Neuropathy **Keywords:** - CMT neuropathy - equilibrium ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with sensory-motor genetic neuropathy **Label:** CMT patients #### Arm Group 2 **Description:** Patients with motor genetic neuropathy **Label:** Motor patients #### Arm Group 3 **Description:** Patients with sensory neuropathy **Label:** Sensory patients #### Arm Group 4 **Description:** Patients with distal myopathy **Label:** Myopathic patients ### Outcomes Module #### Primary Outcomes **Description:** How sensory and motor deficit influence the postural equilibrium **Measure:** Postural equilibrium **Time Frame:** 12 months #### Secondary Outcomes **Description:** how vestibular system influence the postural equilibrium **Measure:** Vestibular equilibrium **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * CMT or HMN or sensory neuropathy or distal myopathy Exclusion Criteria: * unable to stand * other neurological, psychiatric, or orthopedic disorders * MMSE \<28 * alcohol abuse * intensive rehabilitation program **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 10 CMT1A patient, 10 CMT2, 10 HMN, 10 sensory neuropathies, 10 distal myopathies, 10 healthy controls. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Stefano C Previtali, MD **Phone:** 00390226433036 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Benedetta Sorrenti, MD **Phone:** 00390226433036 **Role:** CONTACT #### Locations **Location 1:** **City:** Milano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stefano C Previtali, MD - **Phone:** 00390226433036 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Benedetta Sorrenti, MD - **Phone:** 00390226433036 - **Role:** CONTACT **Country:** Italy **Facility:** Dept. of Neurology, IRCCS Ospedale San Raffaele **Status:** RECRUITING **Zip:** 20132 #### Overall Officials **Official 1:** **Affiliation:** IRCCS Ospedale San Raffaele **Name:** Stefano C Previtali, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425939 **Brief Title:** Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance **Official Title:** Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance #### Organization Study ID Info **ID:** PEP-2401 #### Organization **Class:** INDUSTRY **Full Name:** PepsiCo Global R&D ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** PepsiCo Global R&D #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Heart rate variability (HRV) is a measure of the variation in time between each heartbeat. It is an indirect and ubiquitous biomarker of performance readiness and recovery measured by most consumer-grade wearable fitness trackers. However, there is little documented on the relationship between HRV, training load, and performance measures in the Real-World. Whoop wrist-worn activity trackers have been validated against the gold-standard Electrocardiography (ECG) for HRV and HR measurements. Whoop leverages photoplethysmography (PPG) technology to continuously track (HR, HRV, respiratory rate, energy expenditure) and provides, daily, individual insights, trends, and coaching to improve strain, sleep, and recovery. Research has demonstrated that heart rate variability (HRV) guided training may be more optimal compared to predetermined training for aerobic exercise improvements. The purpose of this study is to assess the feasibility of providing personalized training recommendations based on HRV measured by a consumer-grade wearable (Whoop) in a real-world setting to better understand the HRV relationship with performance. **Detailed Description:** The purpose of this study is to determine if Training Intensity (%HRmax in min.) during Low HRV periods acutely (below HRV baseline next day and consecutive days) and chronically (weeks below previous weeks HRV baseline) will have a negative relationship with Post-Test Performance Metrics as measured by Force Plates, which could lead to personalized training recommendations using HRV. The Investigators conducted a pilot study using Whoop devices to monitor 50 subjects for 3 months and observed that individuals had High Training Load (above their baseline) on Low HRV days (below their baseline) on over 200 days. The Investigators hypothesize seeing similar High Training Load on Low HRV days during this study and would like to understand that relationship with Performance Primary objective: To determine if Training Intensity (%HRmax in min.) during Low HRV periods acutely (below HRV baseline next day and consecutive days) and chronically (weeks below previous weeks HRV baseline) will have a negative relationship with Post-Test Performance Metrics as measured by Force Plates. Secondary Objective : Measure and determine if subjective journal entries (mood, anxiety, recovery, etc.) are related to HRV, RHR, Sleep Quantity, and Sleep Efficiency. ### Conditions Module **Conditions:** - Heart Rate Variability - Exercise **Keywords:** - exercise performance - HRV - training load - Whoop - wrist worn tracker - exercise recovery ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Healthy adults moderately trained in resistance exercises **Intervention Names:** - Other: Force plate assessment - Device: Whoop wrist band **Label:** Single group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Single group **Description:** On Day 1, Day 45 and Day 90: 3x drop jumps, 2 min rest, 3x counter movement jumps, 2 min rest, 3x dynamic push-ups **Name:** Force plate assessment **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Single group **Description:** Whoop wrist worn activity tracker (not a medical device) collects continuous data via smartphone app. This is a marketed device. This is not a device study. **Name:** Whoop wrist band **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** % HRmax (in minutes) measured by force plates **Measure:** Training Intensity **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) **Description:** Reactive Strength Index in cm/s using force plates **Measure:** Performance **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) **Description:** W/kg using force plates **Measure:** Peak Power Output **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) **Description:** (cm) using force plates **Measure:** Jump Height **Time Frame:** Change from baseline (Day1) to mid-study (Day 45) and end of study (Day 90) **Description:** (N)) using force plates **Measure:** Dynamic Push Ups Peak Force **Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90) #### Secondary Outcomes **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to Heart Rate Variability (HRV) **Time Frame:** Daily for 90 days **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to resting heart rate (RHR) **Time Frame:** Daily for 90 days **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to sleep quantity **Time Frame:** Daily for 90 days **Description:** True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin **Measure:** Correlation of subjective measures to sleep efficiency **Time Frame:** Daily for 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Actively participating in resistance training 2-4 times per week. 2. Age 21-50 years, male and female. 3. Subject is willing to refrain from vigorous exercise (light physical activity only) 24 hours prior to visit(s). 4. Subject is willing to avoid alcohol consumption 24 hours prior to visit(s). 5. Subject is willing to provide consent. 6. Subject is able to continuously wear a wrist-worn device, including during sleep, except when submerged underwater (i.e., swimming, bathing). Exclusion Criteria: 1. Individual has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the project/study protocol, which might confound the interpretation of the project/study results or put the person at undue risk. 2. Those with a medical history that would interfere with the results of this study. 3. Under the care of a physician. 4. Skin sensitivities. 5. Sleep disorders. 6. Using prescription medications that would impact sleep. 7. If female, you are not pregnant, planning to get pregnant or currently breast feeding. 8. Smoker. 9. Not able to wear wrist-worn device continuously. 10. Lack of proficiency in English. 11. Lack of proficiency or access to the internet and email address. 12. Participation in another clinical trial within the past 30 days. 13. Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Corey Ungaro, PhD **Phone:** 815-382-3213 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Eric Freese, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Corey Ungaro, PhD - **Phone:** 815-382-3213 - **Role:** CONTACT **Country:** United States **Facility:** PepsiCo R&D, Gatorade Sports Science Institute **State:** Illinois **Status:** RECRUITING **Zip:** 60607 **Location 2:** **City:** Frisco **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anthony Wolfe, M.S. - **Phone:** 469-920-2862 - **Role:** CONTACT **Country:** United States **Facility:** PepsiCo R&D, Gatorade Sports Science Institute **State:** Texas **Status:** RECRUITING **Zip:** 75034 #### Overall Officials **Official 1:** **Affiliation:** PepsiCo, Inc. Sports Science **Name:** Corey Ungaro, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425926 **Brief Title:** Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors **Official Title:** A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors #### Organization Study ID Info **ID:** GIM531-CT01 #### Organization **Class:** INDUSTRY **Full Name:** Georgiamune Inc ### Status Module #### Completion Date **Date:** 2026-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** 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:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Georgiamune Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs). **Detailed Description:** GIM531-CT01 is a Phase 1/2 open label, first-in-human, multicenter study. The Phase 1 portion will include a dose escalation with GIM-531 administered as a single agent. Additionally, there will be a dose expansion portion at the safety-cleared dose levels with participants allocated 1:1 within the proposed therapeutic range to accrue additional data for determining the safety profile, pharmacokinetics (PK) profile, pharmacodynamic (PD) effects and early anti-tumor activity of GIM-531. In Phase 2, GIM-531will be administered to participants with advanced/metastatic cutaneous melanoma who have progressed following treatment with an anti-PD-1 therapy. ### Conditions Module **Conditions:** - Melanoma Stage IV - Solid Tumor **Keywords:** - PD-1 resistance - PD-1 resistant/refractory ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** GIM-531 administered orally daily **Intervention Names:** - Drug: GIM-531 **Label:** Phase 1 Single Agent **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** GIM-531 administered orally daily in combination with anti-PD-1 therapy **Intervention Names:** - Drug: GIM-531 - Drug: Anti-PD-1 monoclonal antibody **Label:** Phase 2 Combination Treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Phase 1 Single Agent - Phase 2 Combination Treatment **Description:** GIM-531 administered orally daily **Name:** GIM-531 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Phase 2 Combination Treatment **Description:** Continued treatment with anti-PD-1 therapy **Name:** Anti-PD-1 monoclonal antibody **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading **Measure:** Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability **Time Frame:** Through study completion, an average of 1 year **Description:** To identify dose limiting toxicities with GIM-531 **Measure:** Dose limiting toxicities (DLT) with GIM-531 **Time Frame:** 21 days #### Secondary Outcomes **Description:** To preliminarily evaluate the Cmax in patients with advanced solid tumors **Measure:** Maximum plasma concentration (Cmax) **Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose **Description:** To preliminarily evaluate Tmax in patients with advanced solid tumors **Measure:** Time to maximum plasma concentration (Tmax) **Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose **Description:** To preliminarily evaluate the AUC in patients with advanced solid tumors **Measure:** Area under the plasma concentration versus time curve (AUC) **Time Frame:** Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose **Description:** To identify objective response rate in patients with advanced solid tumors **Measure:** Objective response rate (ORR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate BOR in patients with advanced solid tumors **Measure:** Best overall response (BOR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate DOR in patients with advanced solid tumors **Measure:** Duration of response (DOR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate DCR in patients with advanced solid tumors **Measure:** Disease control rate (DCR) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate PFS in patients with advanced solid tumors **Measure:** Progression-free survival (PFS) **Time Frame:** From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) **Description:** To preliminarily evaluate OS in patients with advanced solid tumors, including 12 month OS **Measure:** Overall survival (OS) rates **Time Frame:** From study enrollment until death from any cause (OS rate assessed at 12 months) **Description:** To analyze tumor expression of immunological markers **Measure:** Tumor expression of immunological markers **Time Frame:** Cycle 1 Days 1, 2 and 8; Cycle 2 Days 1 and 8; Cycle 3 Day 1 (each Cycle is 14 days) ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Written informed consent * Cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard therapy exist; or be intolerant of standard therapy * Have not received an experimental drug within 4 weeks or 5 half-lives (whichever is shorter) of Screening or already be enrolled in a clinical study * ECOG performance status 0-1 * Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions * Agree to baseline core needle biopsy or archival (within 12 months of screening) tumor submission; Note: Participants whose only site(s) of disease are in areas considered moderate or high risk for biopsy complications may be enrolled without a fresh biopsy upon Sponsor approval. * Non pregnant participants; female participants of child bearing potential with non-sterile partners agree to use an effective form of contraception from the time of first dose of study drug (or 14 days prior to first dose for oral contraception) until 7 months after the last dose of study drug. Effective forms of contraception include hormonal (injection or oral), double barrier method, or intrauterine device. Non-sterile male participants with sexual partners of childbearing potential agree to use a barrier contraception method and agree to not donate sperm from the time of first dose of study drug until 4 months after the last dose of study drug. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 Phase 2 Specific Inclusion Criteria (in addition to above inclusion criteria): * Have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma that has radiographically progressed (as confirmed by imaging assessed by the Investigator) on an approved first-line single-agent or combination anti-PD-1 therapy * Receiving anti-PD-1 therapy as their first line of treatment at the time of enrollment and amenable to continuing anti-PD-1 therapy during the study Key Exclusion Criteria: * Ongoing \>Grade 1 toxicity from prior therapy according to Common Terminology Criteria for Adverse Events v5.0 (Note: Grade 2 alopecia and Grade 2 sensory neuropathy are not exclusionary) * Has melanoma with documented BRAF mutation (Phase 2 only) * Has known brain metastases, except participants with the following: * Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the first administration of study drug; Note: Participants receiving steroids for brain metastases must be either off steroids or on a stable, or decreasing dose, of \<10 mg daily of prednisone (or equivalent) in order to be eligible for enrollment; and * No ongoing neurological symptoms related to the anatomic location of the brain metastases. Note: Neurological symptoms that are considered sequelae to treatment for brain metastases are allowed. * Has known structural cardiac disease * Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities * Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * At time of screening, is receiving systemic steroid therapy (greater than or equal to 10 mg/day of prednisone or equivalent) or is taking any immunosuppressive therapy; Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed. * Has active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Has a history of, or currently has, an acquired or primary (congenital) immunodeficiency; * Has had prior anti-cancer treatment with chemotherapeutic agents or immune modulating agents within \<4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study drug. * Has received a live vaccine within 30 days of first dose of study drug; * Has had or has planned major surgery within 2 weeks of the first dose of study drug; * Inability to swallow an oral dose of a medication (eg, oral capsules) * Is taking medications that are considered strong inducers or inhibitors of CYP2C8 or CYP3A4/5, P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), or sensitive substrates of P-gp and BCRP (Appendix C) that cannot be discontinued at least 1 week prior to first dose of study drug and for the duration of the study. * Is taking drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids such as calcium carbonate or aluminum hydroxide-based products are permitted. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jayadev Sureddi, CBCC CRO **Phone:** (661) 616-6453 **Role:** CONTACT #### Locations **Location 1:** **City:** Bakersfield **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nicole Ward - **Phone:** 661-862-8548 - **Role:** CONTACT **Country:** United States **Facility:** Comprehensive Blood and Cancer Center **State:** California **Status:** RECRUITING **Zip:** 93309 **Location 2:** **City:** Billings **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Matt Adler - **Phone:** 406-238-6894 - **Role:** CONTACT **Country:** United States **Facility:** Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana **State:** Montana **Status:** RECRUITING **Zip:** 59102 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000018326 - Term: Nevi and Melanomas - ID: D000012878 - Term: Skin Neoplasms - ID: D000009371 - Term: Neoplasms by Site - 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11528 - Name: Melanoma - Relevance: HIGH - As Found: Melanoma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: M12448 - Name: Nevus, Pigmented - Relevance: LOW - As Found: Unknown - ID: M12446 - Name: Nevus - Relevance: LOW - As Found: Unknown - ID: M20470 - Name: Nevi and Melanomas - Relevance: LOW - As Found: Unknown - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000008545 - Term: Melanoma ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: HIGH - As Found: Chemotherapy - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Given - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000906 - Term: Antibodies - ID: D000000911 - Term: Antibodies, Monoclonal ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425913 **Brief Title:** Effects of Cold and Kinesio Taping in Individuals With Rotator Cuff Tendonitis **Official Title:** Short-Term Effects of Cold Therapy and Kinesio Taping on Pain and Upper Extremity Functionality in Individuals With Rotator Cuff Tendonitis: A Randomized Study #### Organization Study ID Info **ID:** 71306642 #### Organization **Class:** OTHER **Full Name:** Bezmialem Vakif University ### Status Module #### Completion Date **Date:** 2023-02-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-02-26 **Type:** ACTUAL #### Start Date **Date:** 2021-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Bezmialem Vakif University #### Responsible Party **Investigator Affiliation:** Bezmialem Vakif University **Investigator Full Name:** Elif Durgut **Investigator Title:** Asst. Prof **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Rotator cuff tendonitis (RCT) is one of the most common shoulder pathologies, causing pain, limitation of shoulder joint movements, and impaired function. Patient education, medical treatment, corticosteroid injections, physiotherapy rehabilitation approaches are the most common treatment options applied to alleviate the symptoms of RCT. Despite these various treatment methods, there are currently no specific guidelines regarding the most appropriate and effective intervention for RCT treatment. This is mainly because adequate, high-quality studies are lacking in RCT management. To the best of our knowledge, no studies have evaluated the effects of Kinesio Taping (KT), which has become a popular approach in recent years, and Cold Therapy (CT), which has often been used as a therapeutic agent since immemorial, on individuals with RCT. In this regard, this study aimed to investigate and compare the short-term effects of KT and CT on pain and upper extremity functionality in individuals with RCT. ### Conditions Module **Conditions:** - Rotator Cuff Tendinitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Participants were unaware of their group assignments. A therapist who was unaware of the intervention protocol and assigned groups performed the assessment procedures **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** KT was applied to the symptomatic shoulder of participants. **Intervention Names:** - Other: Kinesio Taping (KT) - Other: standardized home exercise program **Label:** Kinesio Taping **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Ice packs were applied to the symptomatic shoulder of participants. **Intervention Names:** - Other: Cold Therapy (CT) - Other: standardized home exercise program **Label:** Cold Therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Kinesio Taping **Description:** KT was applied to the symptomatic shoulder at the end of the baseline assessment by a certificated physiotherapist with over ten years of experience in Kinesio taping. After three days, participants were re-evaluated. KT application has been made according to the protocol for rotator cuff impingement or tendonitis including inhibition and correction techniques. **Name:** Kinesio Taping (KT) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Cold Therapy **Description:** The initial application was administered by the physiotherapist. In a sitting position, a pack was wrapped in a thin towel and placed on the affected shoulder joint, including the painful locations. During the application, the participant was closely observed for discomfort or adverse reactions (redness, burning, numbness, itching, ...). The cold application was continued for 20 minutes.After the first application, participants were instructed to apply ice for 20 minutes five times a day for three days at home or work. **Name:** Cold Therapy (CT) **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Cold Therapy - Kinesio Taping **Description:** All participants performed standardized home exercise program, including shoulder isometric and stretching exercises were . A physiotherapist taught the exercise program until the participants were able to exercise accurately on their own. All participants were instructed to perform the exercises three times a day for three days. **Name:** standardized home exercise program **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Numerical Rating Scale (NRS): The pain severity was assessed using the NRS, for which a subject was asked to rate his/her perceived pain. A 11-point NRS from 0 to 10 which 0 means no pain and 10 means the worst possible pain was scored during night, rest, and activity. **Measure:** Pain intensity **Time Frame:** At baseline and after three days of the applications **Description:** Disability of the Arm, Shoulder and Hand (DASH) Questionnaire): DASH is a self-reported questionnaire designed for evaluating the functional level of upper extremity. It is a 30-item scale that addresses difficulty in performing various physical activities that require upper extremity function (physical function, 21 items); symptoms of pain, activity-related pain, tingling, weakness, and stiffness (pain symptoms, 5 items); or impact of disability and symptoms on social activities, work, sleep, and psychological well-being (emotional and social function, 4 items). Each item is scored between 1 and 5. A score of 1 indicates no strain, and a score of 5 indicates inability to perform the specified activity. **Measure:** Function **Time Frame:** At baseline and after three days of the applications **Description:** Shoulder Pain and Disability Index (SPADI): The SPADI is a self-administered questionnaire developed to measure the pain and disability associated with shoulder pathology in people with shoulder pain of musculoskeletal, neurogenic, or undetermined origin. It consists of 13 items that assess two domains: a 5-item subscale that measures pain and an 8-item subscale that measures disability. The items of both domains were scored on a numerical rating scale ranging from 0 to 10, where 0=no pain/no disability and 10= worst pain imaginable/so difficult required help. **Measure:** Function **Time Frame:** At baseline and after three days of the applications #### Secondary Outcomes **Description:** Range of Motion (ROM): The active range of motion (ROM) of the affected shoulder, including flexion, abduction, external rotation, and internal rotation, was assessed using a universal goniometer following the protocol reported by the American Academy of Orthopaedic Surgeons (AAOS) **Measure:** Range of Motion **Time Frame:** At baseline and after three days of the applications **Description:** Jamar® hydraulic hand dynamometer were used to assess hand-grip strength of the affected side. **Measure:** Grip strength **Time Frame:** At baseline and after three days of the applications ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * RCT diagnosis * Excluding other shoulder pathologies by magnetic resonance imaging (MRI) and specific tests Exclusion Criteria: * Glenohumeral joint dislocation/subluxation; * Acromioclavicular sprain; * Rotator cuff tear; * Glenohumeral joint instability; * Calcific tendinitis of the shoulder; * Acromioclavicular joint pathologies, * Hyperlaxity; * Any fracture in the shoulder; * Diabetes, thyroid and any vascular or rheumatologic disease; * Glenohumeral joint deformities; * Superior labrum anteroposterior (SLAP) lesion; * Shoulder pain lasting more than six months; * History of shoulder surgery; * Intra-articular steroid injection **Maximum Age:** 60 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Bezmialem Vakıf University **Zip:** 34060 ### IPD Sharing Statement Module **Description:** IPD will not be shared **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000013708 - Term: Tendon Injuries - ID: D000014947 - Term: Wounds and Injuries - ID: D000012421 - Term: Rupture - ID: D000070599 - Term: Shoulder Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M27013 - Name: Tendinopathy - Relevance: HIGH - As Found: Tendinitis - ID: M624 - Name: Rotator Cuff Injuries - Relevance: HIGH - As Found: Rotator Cuff Tendinitis - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000052256 - Term: Tendinopathy - ID: D000070636 - Term: Rotator Cuff Injuries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425900 **Brief Title:** A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients **Official Title:** Histologic and LCMS Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1% #### Organization Study ID Info **ID:** DCS-115-22 #### Organization **Class:** INDUSTRY **Full Name:** Sun Pharmaceutical Industries Limited ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sun Pharmaceutical Industries Limited #### 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:** to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment ### Conditions Module **Conditions:** - Acne Vulgaris ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Winlevi (Clascoterone) cream 1% **Label:** Winlevi (Clascoterone ) cream 1% **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Winlevi (Clascoterone ) cream 1% **Description:** Dosed twice daily (BID) **Name:** Winlevi (Clascoterone) cream 1% **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment. **Time Frame:** Week 12 #### Secondary Outcomes **Measure:** The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment. **Time Frame:** Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Female or male subjects age 18-35 years. 2. Subjects of all Fitzpatrick skin types. 3. Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity. 4. Subjects with oily facial skin. 5. Subjects who agree to use only the study product and nothing else to the face. 6. Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face. 7. Subjects agree not to introduce any new skin care products during the study. 8. No known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects." 10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits. 11. Subjects in generally good physical and mental health. Exclusion Criteria: 1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics. 2. Subjects who are not willing to use the assigned study product to their face as instructed. 3. Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry. 4. Subjects who have used any OTC products on the face for 2 weeks. 5. Subjects with clinically significant unstable medical disorders. 6. Subjects who are unwilling or unable to comply with the requirements of the protocol. 7. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 8. Subjects currently participating in any other clinical trial. **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Head Clinical development **Phone:** 9122 66455645 **Role:** CONTACT #### Locations **Location 1:** **City:** High Point **Country:** United States **Facility:** Dermatology Consulting Services, PLLC **State:** North Carolina **Zip:** 27262 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017486 - Term: Acneiform Eruptions - ID: D000012871 - Term: Skin Diseases - ID: D000012625 - Term: Sebaceous Gland Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3512 - Name: Acne Vulgaris - Relevance: HIGH - As Found: Acne Vulgaris - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M19751 - Name: Acneiform Eruptions - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15439 - Name: Sebaceous Gland Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000152 - Term: Acne Vulgaris ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425887 **Brief Title:** Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter **Official Title:** Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter #### Organization Study ID Info **ID:** Smartwatch vs Holter study #### Organization **Class:** OTHER **Full Name:** Chinese University of Hong Kong ### Status Module #### Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-17 ### 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:** Tam Tsz Kin **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 lifetime risk for development of atrial fibrillation, the commonest sustained arrhythmia in adults, is estimated to be 24%-27% for individuals of 40 years or older. Previous work showed that annual new diagnosis of AF is 11000-26000 in Hong Kong. Other arrhythmia such as supraventricular arrhythmia or premature beats were also common and of clinical significance. 12-lead ECG is a first line investigation for patients with suspected paroxysmal arrhythmia, but it has a low diagnostic yield with its 10-30 seconds recordings. 24-hour Holter exam is the usual next step of diagnosis. The diagnostic yield of Holter varies according to indication but is generally low at 1%-12%. This is because paroxysmal arrhythmia may not happen every day. In addition, even if arrhythmia is picked up in Holter, patient may not register the symptom, making the symptom arrhythmia correlation problematic. Despite limitations, the demand for Holter exam is still high. In Prince of Wales Hospital, a tertiary referral centre with a catchment of about 1 million populations, the waiting time for a routine Holter exam is 3 years. Smartwatch has gained popularity over past years as an adjunct to smartphone. Latest generations of smartwatch were equipped with wearer-initiated ECG rhythm strip recording capabilities. Smartwatch has evolved to become a health tracker with arrhythmia detection capabilities. It was found to be a useful tool for atrial fibrillation screening in general population. Other arrhythmias, such as supraventricular tachycardia, premature beats, and abnormal ECG patterns associated with sudden cardiac death could also be detected with smartwatch ECG recordings. Apple Heart study was the largest study utilizing smartwatch for arrhythmia detection. The general population was screened for atrial fibrillation using irregular pulse algorithm. The study found a 84% concordance rate between irregular pulse notification and ECG patches. Therefore, investigators propose to conduct a study to compare its diagnostic yield with Holter, in patients with suspected arrhythmia and see if smartwatch recording following a systematic protocol for four-weeks will have better arrhythmia diagnosis yield than a 24-hour Holter exam. ### Conditions Module **Conditions:** - Arrythmia ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 185 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** not interventional **Name:** Smart watch **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Compare the percentage of patients with significant arrhythmia diagnosed, between smartwatch rhythm recording and 24-hour Holter arm Significant arrhythmia is defined as the presence of any one of the following * Sustained supraventricular tachycardia (\>=30 seconds) * Atrial fibrillation (\>=30 seconds) * Ventricular tachycardia of more than 3 consecutive beats * Significant AV block (defined as 2nd degree Mobitz type II or 3rd degree heart block) * HR less than 40 while awake. * Pause \> 2 seconds while awake (for both smartwatch and Holter), or \>3 seconds while asleep (for Holter only) * Premature ventricular complex with an overall burden of more than 10% **Measure:** Comparison **Time Frame:** through study completion, an average of 1 month #### Secondary Outcomes **Description:** describe the detection rate of smartwatch for various arrhythmia **Measure:** Detection rate **Time Frame:** through study completion, an average of 1 month **Description:** describe patients' preference on using which modality (smartwatch or Holter) to record their arrhythmia, by means of a questionnaire **Measure:** Preference **Time Frame:** through study completion, an average of 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All patients referred for out-patient Holter exam from age 18 - 80 years old 2. The following indications for Holter exam will be allowed for recruitment * Palpitation * Pre-syncope * Dizziness Exclusion Criteria: 1. Patients with a prior ECG diagnosis to explain the symptom 2. Primary symptom is syncope 3. Patient who has no clear indication for Holter exam 4. Pregnant ladies 5. Patients who failed to make a successful recording despite teaching attempts. 6. Patients who cannot read English or Chinese version of consent. 7. Anticipation of non-compliance with recording protocol. 8. Patients who do not have a compatible smart phone (Android 9.0 or newer, or iOS15 or newer) 9. Patients under custody **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients being referred for out-patient Holter exam will be reviewed for eligibility. Individuals aged 18 to 80 with indications for Holter including palpitation, pre-syncope \& dizziness without meeting any exclusions will be invited to participate in this study. ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4453 - Name: Arrhythmias, Cardiac - Relevance: HIGH - As Found: Arrhythmia - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001145 - Term: Arrhythmias, Cardiac ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425874 **Brief Title:** The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery **Official Title:** The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery: an Observational Cohort Study #### Organization Study ID Info **ID:** SYSKY-2024-147-01 #### Organization **Class:** OTHER **Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2035-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2035-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University **Investigator Full Name:** Chen Kai **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Breast-conserving surgery is the standard treatment for young breast cancer patients, while mastectomy with breast reconstruction is an alternative for those who are not eligible for Breast-conserving surgery. Several studies have compared the quality of life and patient satisfaction among individuals receiving different types of surgery (Breast-conserving surgery, mastectomy alone, or mastectomy with reconstruction). For example, Meghan R. demonstrated that patients undergoing Breast-conserving surgery experience a higher quality of life compared to those undergoing mastectomy with breast reconstruction, whereas J. Dauplat's study showed that patients who undergo mastectomy with breast reconstruction report a higher quality of life than those who undergo mastectomy alone. However, the investigators hypothesize that the advantages of a specific type of surgery over another, such as Breast-conserving surgery versus breast reconstruction, may vary among patients with different socioeconomic factors. For instance, the benefits of breast reconstruction over Breast-conserving surgery might be more pronounced in young patients who require a more socially active lifestyle. Additionally, the benefits of one type of surgery over another may also vary at different time points during post-operative follow-up. Furthermore, it is worth noting that most current studies have been conducted in Caucasian populations. In contrast to Caucasians, Asians typically have smaller breast volumes, potentially leading to more significant defects after Breast-conserving surgery and possibly poorer aesthetic outcomes. Therefore, a study focusing on Asian young breast cancer populations is necessary. **Detailed Description:** This study is a prospective, observational cohort study aiming to enroll 1000 young Chinese breast cancer patients and assign them to three arms: Breast-conserving surgery, mastectomy alone, and mastectomy with breast reconstruction, based on their clinical decisions and preferences. Clinicopathological features (age,Tumor, Node, Metastasis stages, pathological features, etc.), socioeconomic determinants (education level, income, insurance status, marital status, occupational status, personality, etc.), treatment information (neoadjuvant chemotherapy or not, post-operative complications), and survival (local recurrence, metastasis) will be recorded. All patients will be followed at 6 and 12 months for the first year after diagnosis, then yearly thereafter for an additional 9 years (for a total follow-up of at least 10 years following diagnosis). During the post-operative follow-up, quality of life, psychological well-being, decision regret, surgical information, treatment costs, and surveillance-follow-up will be recorded. The primary endpoint of this study is the quality of life, assessed using the Breast-Q and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary endpoints include decisional conflict scale, decision regret scales, and the Hospital Anxiety and Depression Scale (HADS). The primary and secondary endpoints will be compared among the three arms, and the impact of socioeconomic determinants at baseline on these endpoints will also be investigated. Additionally, the investigators aim to explore the potential of a novel subtyping method for young breast cancer patients using selected socioeconomic determinants. ### Conditions Module **Conditions:** - Breast Cancer - Surgery - Quality of Life ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Breast-conserving surgery **Label:** Breast-conserving surgery #### Arm Group 2 **Intervention Names:** - Procedure: Mastectomy **Label:** Mastectomy #### Arm Group 3 **Intervention Names:** - Procedure: Mastectomy with reconstruction **Label:** Mastectomy with reconstruction ### Interventions #### Intervention 1 **Arm Group Labels:** - Breast-conserving surgery **Description:** Breast-conserving surgery **Name:** Breast-conserving surgery **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Mastectomy **Description:** Mastectomy without reconstruction **Name:** Mastectomy **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Mastectomy with reconstruction **Description:** Any type of reconstruction(include implant and autologous) **Name:** Mastectomy with reconstruction **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Exploring the Influence of Socioeconomic, Psychological, and Clinicopathological Features on Primary and Secondary Outcomes. **Measure:** Influence of Socioeconomic, Psychological, and Clinicopathological Factors on Outcomes **Time Frame:** Pre-operation and 10 years #### Primary Outcomes **Description:** Utilizing the BREAST-Q questionnaire, this measure assesses women's self-reported satisfaction with their breasts and associated quality of life, encompassing psychosocial, sexual, and physical well-being. Scores range from 0 (worst) to 100 (best), with higher scores indicating a more favorable outcome.Assessment is conducted preoperatively and 10 years postoperatively. **Measure:** Participant's breast satisfaction assessed by BREAST-Q questionnaire version 2.0 **Time Frame:** Pre-operation and 10 years **Description:** Assessed through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), this self-administered questionnaire consists of 30 items designed to evaluate the health-related quality of life among cancer patients. For questions 1 to 28, a 4-point scale is used, ranging from 1 ("Not at all") to 4 ("Very much"), with lower scores indicating a more positive outcome. Questions 29 and 30 employ a 7-point scale, with scores ranging from 1 ("Very poor") to 7 ("Excellent"), where higher scores signify a better outcome.Assessment is conducted 10 years postoperatively. **Measure:** Participant's health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) **Time Frame:** 10 years #### Secondary Outcomes **Description:** Administered pre-operation, this tool evaluates the patient's conflict regarding the decision for surgery. Each item is rated on a Likert Scale with five responses, ranging from 0 ("Not at All") to 4 ("Extremely"), resulting in a total score ranging from 0 (Less conflicted) to 100 (Highly conflicted).Assessment is conducted preoperatively. **Measure:** Participant's decisional conflict assessed by Decisional Conflict Scale questionnaire **Time Frame:** Pre-Operative **Description:** Conducted during follow-up sessions, this assessment captures the patient's sentiments and remorse regarding the treatment-related decision to undergo surgery. Five items specifically inquire about feelings of regret. Scores range from 0 to 100, with a higher score indicating a greater level of decision-related regret.Assessment is conducted 10 years postoperatively. **Measure:** Participant's decision regret assessed by Decision Regret Scale questionnaire **Time Frame:** 10 years **Description:** Administered during follow-ups, this scale measures the patient's psychological change. The HADS comprises two 7-item subscales assessing depression and anxiety symptoms separately. Higher scores indicate greater levels of depression and/or anxiety.Assessment is conducted preoperatively and 10 years postoperatively. **Measure:** Participant's anxiety and depression assessed by Hospital Anxiety and Depression Scale questionnaire **Time Frame:** Pre-operation and 10 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age between 18 and 50 years old. * The surgery time and procedure have been confirmed, and the surgical informed consent and research informed consent forms have been signed. * Informed consent obtained from patient. * Unilateral Breast Cancer. * Good health,the patient is able to tolerate general anesthesia and surgery, with an ECOG performance status of ≤2 points. * No history of breast/axillary radiation therapy. * Willing and capable of complying with the study protocol visits, treatment plans, and other research procedures. Exclusion Criteria: * Bilateral breast cancer. * Inflammatory breast cancer. * Stage IV breast cancer. * Physical examination and imaging suggest tumor infiltration into the skin, pectoralis major muscle, and other adjacent tissues. * Patients unable to tolerate surgery due to coagulation abnormalities. * In patients without evidence of breast cancer in the contralateral breast, requesting contralateral prophylactic mastectomy. * In patients who have undergone surgical treatment for breast cancer (including mastectomy, breast-conserving surgery, and mastectomy with implant reconstruction), requesting secondary breast surgery. * Patients with a history or current diagnosis of other malignancies, excluding thyroid cancer. * The conditions considered unsuitable for inclusion by researchers. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Young breast cancer women. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kai Chen, MD **Phone:** 15920164730 **Phone Ext:** 86 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Name:** Kai Chen, MD - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-sen Memorial Hospital,Sun Yat-sen University **State:** Guangdong **Status:** RECRUITING ### IPD Sharing Statement Module **Description:** The study protocol and the raw and clean data for analysis will be shared among the participated researchers. Non-researchers could obtain relevant informations from the researchers upon reasonable requests. **IPD Sharing:** NO ### References Module #### References **Citation:** Dominici L, Hu J, Zheng Y, Kim HJ, King TA, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Wong JS, Partridge AH, Rosenberg SM. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. 2021 Oct 1;156(10):e213758. doi: 10.1001/jamasurg.2021.3758. Epub 2021 Oct 13. Erratum In: JAMA Surg. 2021 Oct 1;156(10):989-990. **PMID:** 34468718 **Citation:** Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8. **PMID:** 35416926 **Citation:** Diao K, Lei X, He W, Jagsi R, Giordano SH, Smith GL, Caudle A, Shen Y, Peterson SK, Smith BD. Patient-reported Quality of Life After Breast-conserving Surgery With Radiotherapy Versus Mastectomy and Reconstruction. Ann Surg. 2023 Nov 1;278(5):e1096-e1102. doi: 10.1097/SLA.0000000000005920. Epub 2023 May 26. **PMID:** 37232937 **Citation:** Rosenberg SM, Dominici LS, Gelber S, Poorvu PD, Ruddy KJ, Wong JS, Tamimi RM, Schapira L, Come S, Peppercorn JM, Borges VF, Partridge AH. Association of Breast Cancer Surgery With Quality of Life and Psychosocial Well-being in Young Breast Cancer Survivors. JAMA Surg. 2020 Nov 1;155(11):1035-1042. doi: 10.1001/jamasurg.2020.3325. **PMID:** 32936216 **Citation:** Riba LA, Gruner RA, Alapati A, James TA. Association between socioeconomic factors and outcomes in breast cancer. Breast J. 2019 May;25(3):488-492. doi: 10.1111/tbj.13250. Epub 2019 Apr 15. **PMID:** 30983100 **Citation:** Flanagan MR, Zabor EC, Romanoff A, Fuzesi S, Stempel M, Mehrara BJ, Morrow M, Pusic AL, Gemignani ML. A Comparison of Patient-Reported Outcomes After Breast-Conserving Surgery and Mastectomy with Implant Breast Reconstruction. Ann Surg Oncol. 2019 Oct;26(10):3133-3140. doi: 10.1245/s10434-019-07548-9. Epub 2019 Jul 24. **PMID:** 31342397 **Citation:** Dauplat J, Kwiatkowski F, Rouanet P, Delay E, Clough K, Verhaeghe JL, Raoust I, Houvenaeghel G, Lemasurier P, Thivat E, Pomel C; STIC-RMI working group. Quality of life after mastectomy with or without immediate breast reconstruction. Br J Surg. 2017 Aug;104(9):1197-1206. doi: 10.1002/bjs.10537. Epub 2017 Apr 12. **PMID:** 28401542 ## 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: BXM - Name: Behaviors and Mental Disorders ### 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 - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425861 **Brief Title:** A First in Human Trial Evaluating THB335 in Healthy Participants **Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB335 in Healthy Participants #### Organization Study ID Info **ID:** THB335-101 #### Organization **Class:** INDUSTRY **Full Name:** Third Harmonic Bio, Inc. ### Status Module #### Completion Date **Date:** 2025-03-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Third Harmonic Bio, 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:** This study is a double blind, randomized, placebo-controlled, Phase 1 study in two parts: single ascending doses and food effect (Part 1) and multiple ascending doses (Part 2). **Detailed Description:** THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells. The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single dose of THB335 fasted **Intervention Names:** - Drug: THB335 single dose **Label:** THB335 single dose **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Single dose of THB335 fasted and then fed **Intervention Names:** - Drug: THB335 fasted/fed **Label:** THB335 fasted and fed **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 14 days of multiple ascending doses of THB335 **Intervention Names:** - Drug: THB335 multiple dose **Label:** THB335 multiple dose **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Single dose of placebo capsule, fasted **Intervention Names:** - Drug: Single dose placebo **Label:** Single dose placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** Single dose of placebo capsule fasted and then fed **Intervention Names:** - Drug: Placebo fasted/fed **Label:** Fasted and fed placebo **Type:** PLACEBO_COMPARATOR #### Arm Group 6 **Description:** 14 days of multiple doses of placebo capsule **Intervention Names:** - Drug: Multiple dose placebo **Label:** Multiple dose placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - THB335 single dose **Description:** Single dose as oral capsule **Name:** THB335 single dose **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Single dose placebo **Description:** Single dose as oral capsule **Name:** Single dose placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - THB335 fasted and fed **Description:** Single dose fasted and fed as oral capsule **Name:** THB335 fasted/fed **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Fasted and fed placebo **Description:** Single dose fasted and fed as oral capsule **Name:** Placebo fasted/fed **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - THB335 multiple dose **Description:** Multiple ascending doses oral capsule **Name:** THB335 multiple dose **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Multiple dose placebo **Description:** Multiple doses oral capsule **Name:** Multiple dose placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Number of Participants with Treatment-Related Adverse Events **Time Frame:** Part 1 Day 1 through Day 9 (end of study), and Part 2 Day 1 through Day 29 (end of study) #### Secondary Outcomes **Measure:** Maximum observed plasma concentration (Cmax) **Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14 **Measure:** Time to Cmax (Tmax) **Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14 **Measure:** Area under the plasma concentration-time curve (AUC) **Time Frame:** Part 1, and Part 2 on Day 1. Part 2 on Day 14 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations * Males or females, of any race, between 18 and 65 years of age, inclusive. * Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures * Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening Exclusion Criteria: * Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study * A positive urine drug screen/alcohol breath test * The participant currently smokes, vapes, or uses nicotine-containing products. **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:** [email protected] **Name:** Third Harmonic Bio **Phone:** 617-915-6680 **Role:** CONTACT #### Locations **Location 1:** **City:** Miami **Contacts:** ***Contact 1:*** - **Name:** Principle Investigator - **Role:** CONTACT **Country:** United States **Facility:** QPS Miami **State:** Florida **Status:** RECRUITING **Zip:** 33143 #### Overall Officials **Official 1:** **Affiliation:** QPS Holdings LLC **Name:** Principal Investigator **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425848 **Acronym:** HF2 Registry **Brief Title:** HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry **Official Title:** Hemodynamic Frontiers in Heart Failure Registry #### Organization Study ID Info **ID:** STUDY00147383 #### Organization **Class:** OTHER **Full Name:** University of Kansas Medical Center ### Status Module #### Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2030-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-10-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-02-29 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Kansas Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research. **Detailed Description:** Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional. ### Conditions Module **Conditions:** - Heart Failure **Keywords:** - Pulmonary Artery (PA) pressure monitor ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** OTHER #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who underwent PA pressure implantation from January 1, 2019 will be identified for registry participation. Patients who were implanted before November 8, 2022 will be considered enrolled in the retrospective arm of the registry and may not need to consent if consent waiver is granted by the institutional IRB (Institutional Review Board). **Intervention Names:** - Device: Observational **Label:** Retrospective arm #### Arm Group 2 **Description:** Patients will be identified as eligible for PA pressure sensor implant by a heart failure cardiologist. Patients will consent for device implant and procedure (right heart catheterization) as per standard of care. Patients may also consent to registry participation as per local institutional guidelines and requirements. **Intervention Names:** - Device: Observational **Label:** Prospective arm ### Interventions #### Intervention 1 **Arm Group Labels:** - Prospective arm - Retrospective arm **Description:** We are collecting information for both retrospective and prospective arm to further understand the utility of PA pressure sensors. **Name:** Observational **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Hemodynamic data such as mean PA pressure in mmHg, PA systolic pressure in mmHg, PA diastolic pressures in mmHg, will be collected at the time of implant of PA pressure sensor and at 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Measure:** Change in hemodynamics **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Description:** Echo data such as Left Ventricular Ejection Fraction (LVEF) percentage will be collected at implant and at 3 months, 6 months, 12 months, 24 months and 36 months if available. **Measure:** Changes in Echocardiogram (ECHO) **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Medications changes such as type of diuretics, will be collected after implant and at 3 months, 6 months, 12 month, 24 months and 36 months. We are not collecting any doses or frequencies. **Measure:** Medication changes **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Sodium levels, reported as millimoles per liter (mmol/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Measure:** Sodium **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Potassium level, reported as milliequivalents per liter (mEq/L), will be collected at implant and 3 months, 6 months, 12 months, 24 months and 36 months post implant. **Measure:** Potassium **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** Hemoglobin concentration (Hb) reported as grams of hemoglobin per deciliter of blood (g/dL). Labs will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Measure:** Hemoglobin **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** BNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Measure:** B-type natriuretic peptide (BNP) **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Description:** NT-proBNP level, reported as 100 picograms per milliliter (pg/mL), will be collected at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant **Measure:** aminoterminal pro B-type natriuretic peptide (NT-proBNP) **Time Frame:** at implant, 3 months, 6 months, 12 months, 24 months and 36 months post implant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization. 2. Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II). Exclusion Criteria: 1. Patients less than 18 years of age. 2. Pregnant women at the scheduled time of PA pressure sensor implant. 3. Patients unable or unwilling to have continuity of care in the heart failure clinic. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All patients who have been or will be implanted with PA pressure sensor. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kartik Munshi, MPH **Phone:** 913-945-6445 **Role:** CONTACT #### Locations **Location 1:** **City:** La Jolla **Contacts:** ***Contact 1:*** - **Name:** Timothy Jordan, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Thomas Heywood, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Scripps Health **State:** California **Status:** RECRUITING **Zip:** 92037 **Location 2:** **City:** Bloomington **Contacts:** ***Contact 1:*** - **Name:** Maya Guglin, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Maya Guglin, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Indiana University **State:** Indiana **Status:** RECRUITING **Zip:** 47401 **Location 3:** **City:** Kansas City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kartik Munshi, MPH - **Role:** CONTACT ***Contact 2:*** - **Name:** Hirak Shah, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Kansas Medical Center **State:** Kansas **Status:** RECRUITING **Zip:** 66160 **Location 4:** **City:** Maplewood **Contacts:** ***Contact 1:*** - **Name:** Terrie-Ann Benjamin, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Terrie-Ann Benjamin, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Fairview Health **State:** Minnesota **Status:** NOT_YET_RECRUITING **Zip:** 55109 **Location 5:** **City:** Minneapolis **Contacts:** ***Contact 1:*** - **Name:** Sarah Schwager, RN - **Role:** CONTACT ***Contact 2:*** - **Name:** Mosi Bennett, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Minneapolis Heart Institute Foundation/ Allina Health **State:** Minnesota **Status:** RECRUITING **Zip:** 55407 **Location 6:** **City:** Kansas City **Contacts:** ***Contact 1:*** - **Name:** Timothy Fendler, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Timothy Fendler, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Saint Luke's Health System **State:** Missouri **Status:** RECRUITING **Zip:** 64131 **Location 7:** **City:** Raleigh **Contacts:** ***Contact 1:*** - **Name:** Elizabeth Volz, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Elizabeth Volz, MS - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of North Carolina/ Rex Hospital, Inc. **State:** North Carolina **Status:** RECRUITING **Zip:** 27607 **Location 8:** **City:** Portland **Contacts:** ***Contact 1:*** - **Name:** Christy Lenhart, RN - **Role:** CONTACT ***Contact 2:*** - **Name:** Jacob Abraham, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Providence Heart Institute **State:** Oregon **Status:** RECRUITING **Zip:** 97225 **Location 9:** **City:** Columbia **Contacts:** ***Contact 1:*** - **Name:** Suzanne Amaker - **Role:** CONTACT ***Contact 2:*** - **Name:** Patrick McCann, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Prisma Health **State:** South Carolina **Status:** RECRUITING **Zip:** 29203 **Location 10:** **City:** Sioux Falls **Contacts:** ***Contact 1:*** - **Name:** Orvaar Jonsson, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Orvaar Jonsson, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Sanford Health **State:** South Dakota **Status:** RECRUITING **Zip:** 57104 **Location 11:** **City:** Austin **Contacts:** ***Contact 1:*** - **Name:** Kunjan Bhatt, MS - **Role:** CONTACT ***Contact 2:*** - **Name:** Kunjan Bhatt, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Austin Heart **State:** Texas **Status:** RECRUITING **Zip:** 78756 **Location 12:** **City:** Houston **Contacts:** ***Contact 1:*** - **Name:** Saba Khan - **Role:** CONTACT ***Contact 2:*** - **Name:** Ashrith Guha, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Arvind Bhimaraj, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Houston Methodist DeBakey Heart and Vascular Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** University of Kansas Medical Center **Name:** Hirak Shah, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425835 **Acronym:** VR **Brief Title:** Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments **Official Title:** Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study) #### Organization Study ID Info **ID:** UMonastir2024 #### Organization **Class:** OTHER **Full Name:** University of Monastir ### Status Module #### Completion Date **Date:** 2026-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-03-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Monastir #### Responsible Party **Investigator Affiliation:** University of Monastir **Investigator Full Name:** Pr. Semir Nouira **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:** Study and evaluate the effectiveness of virtual reality in pain management. **Detailed Description:** Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir. For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned. * If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study. * If initial VAS \<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic. If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician). The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol. The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care. The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted. ### Conditions Module **Conditions:** - Pain and Anxiety - Dislocation - Suture ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol. The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care. The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted. **Name:** VR device **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** occurrence of adverse events, tolerance to glasses, patient satisfaction (Likert Satisfaction Scale) and max VAS during the procedure. **Measure:** occurrence of adverse events and patient satisfaction **Time Frame:** 3 hours #### Primary Outcomes **Description:** frequency of success (%) (use of emergency analgesics) **Measure:** frequency of success **Time Frame:** 30 minutes #### Secondary Outcomes **Description:** reduction in pain assessed by the visual analog scale (mm) **Measure:** reduction of pain **Time Frame:** 30 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 09 and 24 years * suturing a wound * changing a dressing * lumbar puncture, * peripheral venous line * blood test * intramuscular injection * reduction of a fracture * casting or plastering. Exclusion Criteria: * impaired consciousness * epilepsy * wound/infection covering the helmet area * headache * intellectual/mental retardation * nausea, vomiting * patient already included in the protocol * pain requiring immediate medical attention. analgesic (VAS \>5 and described as intolerable). **Maximum Age:** 24 Years **Minimum Age:** 9 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned. * If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study. * If initial VAS\<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** NOUIRA Semir, PR **Phone:** 73106000 **Phone Ext:** 216 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** GANNOUN IMEN, ARC **Phone:** 73106000 **Phone Ext:** 216 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M7385 - Name: Joint Dislocations - 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: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425822 **Acronym:** CLASS-VA **Brief Title:** Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias **Official Title:** Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias #### Organization Study ID Info **ID:** EC-2023-281 #### Organization **Class:** OTHER **Full Name:** Universitair Ziekenhuis Brussel ### Status Module #### Completion Date **Date:** 2027-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universitair Ziekenhuis Brussel #### Responsible Party **Investigator Affiliation:** Universitair Ziekenhuis Brussel **Investigator Full Name:** Andrea Sarkozy **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion. The main questions it aims to answer are: * Are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation? * Are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it? * What is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes? ### Conditions Module **Conditions:** - Atrial Remodeling ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Inclusion criteria: * Age ≥ 18 years old. * Absence of a prior history of atrial fibrillation or flutter. * Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2. Exclusion criteria: * Presence of thrombus in the left atrial appendage. * Complications related to the index procedure. * Insufficient quality of the left atrial electroanatomical map. **Intervention Names:** - Diagnostic Test: Left atrial electroanatomical mapping **Label:** Left atrial mapping group in patients without atrial fibrillation ### Interventions #### Intervention 1 **Arm Group Labels:** - Left atrial mapping group in patients without atrial fibrillation **Description:** Left atrial electroanatomical mapping (substrate and functional mapping) **Name:** Left atrial electroanatomical mapping **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Other Outcomes **Description:** Episodes diagnosed via a single-lead ECG tracing or a complete 12-lead ECG lasting at least 30 seconds, or AHRE episodes detected by any cardiac implantable electronic device (CIED), lasting at least 5 minutes. **Measure:** Incidence of atrial fibrillation during follow-up. **Time Frame:** 12 months **Description:** Only type 1 myocardial infarctions, those related to acute coronary obstruction, will be considered. **Measure:** Incidence of myocardial infarction during follow-up **Time Frame:** 12 months **Description:** Stroke will be defined as any objective evidence of permanent brain, spinal cord, or retinal cell death resulting from a vascular cause, substantiated by pathological or imaging evidence, with or without accompanying clinical symptoms. **Measure:** Incidence of stroke during follow-up **Time Frame:** 12 months **Description:** Transient ischemic attack will be defined as a sudden, focal neurological deficit of presumed vascular origin lasting less than 24 hours. **Measure:** Incidence of transient ischemic attack incidence during follow-up **Time Frame:** 12 months #### Primary Outcomes **Description:** Substrate characterization will involve measuring Low Voltage (LV) and Transition Voltage (TV) Zones (LV zone voltage cut-off of \<0.5mV; TV zone voltage limits within 0.5 and 1mV). These zones will be considered if they encompass an area of at least 1cm², containing ≥3 neighboring points within ≤10mm distance. The total LVZ and TVZ surfaces will be expressed as a percentage relative to the total surface area of the left atrium (excluding the pulmonary veins and the mitral annulus). A comparative analysis of substrate characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation). **Measure:** Substrate characterization of the left atrium. **Time Frame:** 18 months **Description:** Functional analysis will rely on identifying deceleration zones characterized by isochronal crowding, defined as having ≥3 isochrones within a 1cm radius, using an 8-color scale of left atrial isochronal activation mapping. A comparative analysis of functional characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation). **Measure:** Functional characterization of the left atrium. **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Absence of a prior history of atrial fibrillation or flutter. * Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2. Exclusion criteria: * Presence of thrombus in the left atrial appendage. * Complications related to the index procedure. * Insufficient quality of the left atrial electroanatomical map. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Consecutive patients undergoing ventricular arrhythmias ablations in whom transeptal access is needed for the ablation of the targeted arrhythmia. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Andrea Sarkozy, MD, PhD **Phone:** 0032 02476 3657 **Role:** CONTACT #### Locations **Location 1:** **City:** Jette **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Andrea Sarkozy, MD, PhD - **Phone:** 0032 02476 3657 - **Role:** CONTACT **Country:** Belgium **Facility:** Universitair Ziekenhuis Brussel **State:** Brussels **Status:** RECRUITING **Zip:** 1090 #### Overall Officials **Official 1:** **Affiliation:** Universitair Ziekenhuis Brussel **Name:** Andrea Sarkozy, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020763 - Term: Pathological Conditions, Anatomical ### 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: M4453 - Name: Arrhythmias, Cardiac - Relevance: LOW - As Found: Unknown - ID: M30384 - Name: Atrial Remodeling - Relevance: HIGH - As Found: Atrial Remodeling - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000064752 - Term: Atrial Remodeling ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425809 **Brief Title:** Predictors of Muscle Injury Risk in Non-professional Football Players **Official Title:** Predictors of Muscle Injury Risk in Non-professional Football Players From the Principality of Asturias. An Ambispective Cohort Study. #### Organization Study ID Info **ID:** Pred-Fut #### Organization **Class:** OTHER **Full Name:** University of Oviedo ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Oviedo #### Responsible Party **Investigator Affiliation:** University of Oviedo **Investigator Full Name:** Ruben Cuesta Barriuso **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:** Background. Football accounts for 30% of all sports injuries. Muscle injuries in football are the most common non-traumatic and non-contact injuries. A comprehensive approach to injury prevention must consider the design of the footwear and the environmental conditions in which the match is played. Objective. To assess the risk of injury as a function of footwear and field of play in non-professional football players and to identify the best predictive model of muscle injury in these athletes. Method. Ambispective cohort study. Ninety-seven players will be recruited. The primary variable will be the number of lower limb muscle injuries in the last 3 seasons. Secondary and modifying variables will be: age, body mass index, boot type, pitch turf, training load and field position. Potential confounding variables will be motivation for choice of footwear, date of muscle injuries, time playing in the category and presence in the starting team. The analysis will calculate the risk of adverse effects in these patients and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders. Expected outcomes. To calculate the risk of muscle injury as a function of anthropometric variables, and footwear and turf type. To identify the predictive model of muscle injuries in football players. ### Conditions Module **Conditions:** - Sport Injury **Keywords:** - Muscular Diseases - Football - Risk - Secondary Prevention - Physiotherapy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 97 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Data collection will take place between May and June 2024. This will be done through a self-questionnaire format with closed questions where no data will be collected that allow the identification of the subject (name, surname, or national identity document). The coding of the data collected and its analysis will be carried out under the supervision of the principal investigator, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the patients whose data are collected. **Intervention Names:** - Other: Observation **Label:** Observational group ### Interventions #### Intervention 1 **Arm Group Labels:** - Observational group **Description:** The data collection will be carried out by the two researchers, in accordance with current data protection regulations, scrupulously complying with the anonymous collection of clinical data, and without collecting any data that could allow the identification of the athletes whose data are collected. The members of the research group will not have access to personal data that could facilitate the identity of any person on the basis of the data collected. The data collected in this study, anonymised from the outset, will be exported to an Excel file. Access to the Excel file will require password access and will be managed from a computer of the University of Oviedo (Department of Surgery and Medical-Surgical Specialities). **Name:** Observation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary variable, the number of lower limb muscle injuries in the last 3 seasons, will be assessed as a quantitative variable. **Measure:** Asses the number of lower limb muscle injuries in the last 3 competition seasons **Time Frame:** Screening visit #### Secondary Outcomes **Description:** The secondary variable, age (in years completed), will be assessed as a quantitative variable. **Measure:** Assess the age **Time Frame:** Screening visit **Description:** The secondary variable, body mass index (in kg/m2), will be assessed as a quantitative variable. **Measure:** Assess the body mass index **Time Frame:** Screening visit **Description:** The secondary variable, type of training and competition boot (rubber cleat/metal cleat), will be assessed as a nominal qualitative variable. **Measure:** Assess the type of training and competition boot in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, type of training and competition pitch (sand pitch / artificial turf pitch / natural grass pitch), will be assessed as a nominal qualitative variable. **Measure:** Assess the type of training and competition pitch in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, type of muscle injury (fibrillar / musculotendinous / strain), will be assessed as an ordinal qualitative variable. **Measure:** Assess the type of muscle injury in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, weekly training load (hours/week), will be assessed as a quantitative variable. **Measure:** Assess the weekly training load in the last 3 competition seasons **Time Frame:** Screening visit **Description:** The secondary variable, position on the field (goalkeeper / defender / midfielder / striker), will be assessed as an ordinal qualitative variable. **Measure:** Assess the position on the field in the last 3 competition seasons **Time Frame:** Screening visit ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Federated, non-professional football players. * Competing in category 3 RFEF (group 2). * Who compete in the territorial delimitation of the Principality of Asturias. * Subjects who have not undergone previous musculoskeletal surgery in the seasons under study. * Who were federated at least one year before the study period. Exclusion Criteria: * Players who have not participated in competition, during the seasons under study, for a period of more than 6 months due to a musculoskeletal injury. **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** MALE **Standard Ages:** - ADULT **Study Population:** Population: Non-professional football players from the Principality of Asturias, where the aim is to identify the risk of muscle injuries in these players and to identify the predictive model of muscle injuries based on anthropometric and sporting variables. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rubén Cuesta-Barriuso, PhD **Phone:** 607547274 **Role:** CONTACT #### Locations **Location 1:** **City:** Oviedo **Country:** Spain **Facility:** University of Oviedo **State:** Asturias **Zip:** 33006 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M4570 - Name: Athletic Injuries - Relevance: HIGH - As Found: Sport Injury - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries - ID: D000001265 - Term: Athletic Injuries ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M5953 - Name: Chlorhexidine - Relevance: LOW - As Found: Unknown - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425796 **Acronym:** ADIPREG **Brief Title:** Adiposity and Iron Requirements in Pregnancy **Official Title:** Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study #### Organization Study ID Info **ID:** FCBMS-23-259 #### Organization **Class:** OTHER **Full Name:** University of Ulster ### Status Module #### Completion Date **Date:** 2026-01-19 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-19 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Northern Health & Social Care Trust (NHSCT) **Class:** UNKNOWN **Name:** Solvotrin Therapeutics - Active Iron #### Lead Sponsor **Class:** OTHER **Name:** University of Ulster #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to explore how body fat influences the response to either 25 or 50 mg of daily iron supplements during pregnancy. We will conduct a double-blind randomized controlled intervention study involving 312 pregnant women recruited from antenatal clinics in the Northern Trust Area. Participants will be randomly assigned to receive either 25 or 50 mg of iron per day from 12 weeks of pregnancy until delivery, using the Active Iron supplement brand. Blood samples will be collected at 12, 28 and 36 weeks gestation and umbilical cord blood will be collected at delivery. Anthropometric measurements will be taken at each visit, and participants will complete questionnaires on various aspects of health and lifestyle, mental health, gastrointestinal symptoms, and compliance. **Detailed Description:** The main aim of this study is to investigate the influence of adiposity on the difference in response to 25 or 50 mg of daily iron supplementation during pregnancy. The primary aim is to determine the influence of maternal adiposity on adjusted maternal ferritin concentrations in response to 25 mg or 50 mg iron supplementation in pregnancy. The secondary outcomes of this study include: investigating the impact of maternal body fat on various maternal iron biomarkers (such as haemoglobin, soluble transferrin receptor, hepcidin, transferrin saturation, and other haematological markers) in response to either 25 mg or 50 mg iron supplementation during pregnancy, evaluating changes in adjusted ferritin concentrations and other iron markers throughout pregnancy relative to the dosage of iron supplementation received, determining the effect of maternal body fat on neonatal iron biomarkers in response to maternal iron supplementation, assessing changes in markers of inflammation in response to iron supplementation during pregnancy, and examine changes in mental health scores in response to iron supplementation during pregnancy. This is a double-blind randomised controlled intervention study, in which 312 pregnant women with singleton pregnancy, without current complications, aged ≥ 18 years and BMI ≥ 18.5 kg/m2 will be recruited. Participants who are taking multivitamins will be included. They will be asked to discontinue any current supplementation. Pregnant women with anaemia, iron deficiency, high risk of iron overload, history of bariatric surgery, who are planning home birth, are currently involved in another research study, and those who cannot speak or understand English language will be excluded. Blood samples and anthropometric and body composition measurements will be taken at different points in the pregnancy (12, 28, 36 gestational weeks) and an umbilical cord blood sample at the time of birth. Blood concentrations of iron and inflammation markers will be analysed. General, dietary intake and lifestyle information will be collected, through a Health and Lifestyle questionnaire and a 4-day diary. Additionally, participants will complete a questionnaire about their mental health and gastrointestinal symptoms. The compliance of the supplementation will be evaluated at each timepoint. Additionally, participants will receive a telephone call to evaluate possible adverse effects and compliance of the supplementation between the timepoints (18, 24 and 32 weeks of gestation). In the event that a participant has been prescribed iron treatment, anaemia diagnosis at any time during pregnancy or the occurrence of any adverse outcome such as miscarriage, the participant will be withdrawn from the study. Electronic forms prepared in RedCap will be used to collect data. ### Conditions Module **Conditions:** - Iron Deficiency Anemia of Pregnancy **Keywords:** - Iron status - Iron Supplements - Pregnancy - Anaemia - Maternal obesity - Maternal Overweight - Body composition - Ferritin - Inflammation - Mental Health - Neonatal anaemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double Blind: two or more parties are unaware of the intervention assignment **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 312 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Iron 25 (total 25 mg/d of iron): 2 supplements of 12.5 mg of elemental iron + 1 multivitamin supplement; **Intervention Names:** - Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG) **Label:** Iron 25 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Iron 50 (total 50 mg/d of iron): 2 supplements of 25 mg of elemental iron + 1 multivitamin supplement). **Intervention Names:** - Dietary Supplement: Adiposity and Iron Requirements in Pregnancy (ADIPREG) **Label:** IRON 50 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - IRON 50 - Iron 25 **Description:** Iron 25 arm will receive: two iron supplements containing 12.5 mg of elemental iron + 1 multivitamin supplement (they will receive a total of 3 supplements per day). Iron 50 arm will receive: two 25 mg elemental iron supplements + 1 multivitamin supplement (they will receive a total of 3 supplements per day). The multivitamin supplement will contain folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, vitamin C and vitamin D. In summary, each participant will receive 3 supplements per day and instructed to take the 3 supplements together, in the morning, with breakfast. Supplements will be given to the participants when they attend for their clinic appointment. The intervention will begin at 12 gestational weeks and continue until the baby is delivered. **Name:** Adiposity and Iron Requirements in Pregnancy (ADIPREG) **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Assessed via ELISA analyses for ferritin concentration **Measure:** Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL) **Time Frame:** 16, 24 and 28 weeks after baseline #### Secondary Outcomes **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Hemoglobin (g/L) **Time Frame:** 16, 24 and 28 weeks after baseline **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Red blood cell count (RBC) (10^12/L) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Mean cell haemoglobin (MCH) (pg **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Mean cell volume (MCV) (fl) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Mean cell haemoglobin concentrations (MCHC) (g/dL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via Direct Current sheat flow method (Sysmex) **Measure:** Red cell distribution width (RDW) (%) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via immunoturbidimety assay **Measure:** Transferrin (g/L) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via colorimetic assay **Measure:** Serum iron (umol/L) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via ELISA **Measure:** sTfR (ug/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via ELISA **Measure:** Hepcidin (pg/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via ELISA **Measure:** C-reactive protein (mg/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via sandwich immunoassay **Measure:** Pro- anti- inflammatory biomarkers: IL-1 β, IL-6, IL-10, IL-22, IL-17, TNF- α, IFN- γ (fg/mL) **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** Assessed via methylation analyses **Measure:** Genetic variants of interest in relation to obesity and iron metabolism in response to iron supplementation. **Time Frame:** 16, 24 and 28 weeks after baseline. **Description:** CORE 10 questionnaire will be completed by each participant at each timepoint: CORE stands for "Clinical Outcomes in Routine Evaluation." The CORE-10 is a 10-item assesses psychological distress over the past week. The resulting score can be divided into categories with increasing severity: Healthy (0-5), low (6-10), mild (11-14), moderate (15-19), moderate-to-severe (20-24), and severe (25 and above). The score of this questionnaire will be collected as a numeric variable. **Measure:** Mental health score in response to iron supplementation **Time Frame:** 16, 24 and 28 weeks after baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:- Pregnant women * Age ≥ 18 years * BMI ≥18.5 kg/m2 * Without current pregnancy complications (for example, severe bleeding, Diabetes Mellitus, hyperemesis gravidarum, ectopic and molar pregnancies) * At least 12 Gestational Week * Singleton pregnancy confirmed with the first ultrasound scan * Participants who are currently taking multivitamins will be included. They will be asked to discontinue any current supplementation. Exclusion Criteria: * Hb \<110 g/L * SF \<30 μg/L * High risk of iron overload (Hb \>150 g/L, transferrin saturation \>45% or SF\> 150 μg/L) * Participants with history of haematological, renal, liver, autoimmune disorders, malabsorptive syndromes * Participants with history of bariatric surgery * Participants who take steroids or anti-inflammatory treatments or drugs that affect gut absorption (proton-pump inhibitors) * Planned home births * Participants currently involved in another research study * Multiple pregnancy * Participants who do not speak English **Gender Based:** True **Gender Description:** only female participants are being studied **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mary T McCann, PhD **Phone:** +4402870123969 **Role:** CONTACT #### Locations **Location 1:** **City:** Coleraine **Country:** United Kingdom **Facility:** Ulster University,Human Intervention Studies Unit, **State:** Co. Londonderry **Zip:** BT521SA #### Overall Officials **Official 1:** **Affiliation:** University of Ulster **Name:** Mary McCann, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases - ID: D000019189 - Term: Iron Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000000747 - Term: Anemia, Hypochromic ### 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: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M2040 - Name: Obesity, Maternal - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M20857 - Name: Anemia, Iron-Deficiency - Relevance: HIGH - As Found: Iron Deficiency Anemia - ID: M2781 - Name: Iron Deficiencies - Relevance: HIGH - As Found: Iron Deficiency - ID: M4070 - Name: Anemia - Relevance: HIGH - As Found: Anemia - ID: M4081 - Name: Anemia, Neonatal - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic 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 ### Condition Browse Module - Meshes - ID: D000000740 - Term: Anemia - ID: D000018798 - Term: Anemia, Iron-Deficiency - ID: D000090463 - Term: Iron Deficiencies ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: Hemat - Name: Hematinics - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Vi - Name: Vitamins - Abbrev: Mi - Name: Mineral ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M23026 - Name: Vitamin B 6 - Relevance: LOW - As Found: Unknown - ID: M14583 - Name: Pyridoxal - Relevance: LOW - As Found: Unknown - ID: M14589 - Name: Pyridoxine - Relevance: LOW - As Found: Unknown - ID: M12465 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: M9934 - Name: Hydroxocobalamin - Relevance: LOW - As Found: Unknown - ID: M17548 - Name: Vitamin B 12 - Relevance: LOW - As Found: Unknown - ID: M4513 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M12476 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: M12479 - Name: Nicotinic Acids - Relevance: LOW - As Found: Unknown - ID: M17550 - Name: Vitamin D - Relevance: LOW - As Found: Unknown - ID: M6003 - Name: Cholecalciferol - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M13124 - Name: Pantothenic Acid - Relevance: LOW - As Found: Unknown - ID: M16595 - Name: Thiamine - Relevance: LOW - As Found: Unknown - ID: M15085 - Name: Riboflavin - Relevance: LOW - As Found: Unknown - ID: T474 - Name: Vitamin B6 - Relevance: LOW - As Found: Unknown - ID: T459 - Name: Pyridoxal - Relevance: LOW - As Found: Unknown - ID: T461 - Name: Pyridoxine - Relevance: LOW - As Found: Unknown - ID: T453 - Name: Niacin - Relevance: LOW - As Found: Unknown - ID: T441 - Name: Cobalamin - Relevance: LOW - As Found: Unknown - ID: T444 - Name: Cyanocobalamin - Relevance: LOW - As Found: Unknown - ID: T476 - Name: Vitamin B12 - Relevance: LOW - As Found: Unknown - ID: T451 - Name: Methylcobalamin - Relevance: LOW - As Found: Unknown - ID: T437 - Name: Ascorbic Acid - Relevance: LOW - As Found: Unknown - ID: T477 - Name: Vitamin C - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T455 - Name: Nicotinamide - Relevance: LOW - As Found: Unknown - ID: T454 - Name: Niacinamide - Relevance: LOW - As Found: Unknown - ID: T456 - Name: Nicotinic Acid - Relevance: LOW - As Found: Unknown - ID: T471 - Name: Vitamin B3 - Relevance: LOW - As Found: Unknown - ID: T442 - Name: Cholecalciferol - Relevance: LOW - As Found: Unknown - ID: T479 - Name: Vitamin D3 - Relevance: LOW - As Found: Unknown - ID: T440 - Name: Calciferol - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown - ID: T472 - Name: Vitamin B5 - Relevance: LOW - As Found: Unknown - ID: T341 - Name: Iron Supplement - Relevance: LOW - As Found: Unknown - ID: T464 - Name: Thiamin - Relevance: LOW - As Found: Unknown - ID: T465 - Name: Thiamine - Relevance: LOW - As Found: Unknown - ID: T469 - Name: Vitamin B1 - Relevance: LOW - As Found: Unknown - ID: T463 - Name: Riboflavin - Relevance: LOW - As Found: Unknown - ID: T470 - Name: Vitamin B2 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425783 **Brief Title:** Warmed Blood Transfusion in Premature Infants **Official Title:** Warmed Blood Transfusion in Premature Babies Less Than 34 Weeks of Gestational Age: a Randomized Controlled Trial #### Organization Study ID Info **ID:** SYNEO-03 #### Organization **Class:** OTHER **Full Name:** Goztepe Prof Dr Suleyman Yalcın City Hospital ### Status Module #### Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Goztepe Prof Dr Suleyman Yalcın City Hospital #### Responsible Party **Investigator Affiliation:** Goztepe Prof Dr Suleyman Yalcın City Hospital **Investigator Full Name:** Sibel Sevuk Ozumut **Investigator Title:** pediatric clinic chief assistant, MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Premature babies have to deal with many problems from the moment they are born due to the immature of their organs. Their clinical condition is unstable, especially in the first few weeks, and they are greatly affected by environmental factors. During this period, blood transfusion may be needed for many reasons such as intraventricular hemorrhage and necrotizing enterocolitis. In addition, multiple blood draws to evaluate irregular metabolic, hematological and biochemical findings result in anemia and the need for blood transfusion. There are many algorithms regarding blood transfusion indications and transfusion limits in premature babies. However, there are no strict rules regarding the application of warming before blood transfusion, but it is recommended by some guidelines. Especially in unstable babies such as advanced premature babies, it is recommended to give blood by heating it at physiological temperature to avoid important complications such as hypothermia, coagulopathy and rhythm disturbances. Premature babies, whose hemodynamic and metabolic balance is very sensitive, may go into hypothermia when blood and products stored at +4C⁰ are given without heating. In routine practice, blood transfusion is performed without heating. The concern here is that hemolysis may develop by heating the blood. Studies have shown that hemolysis occurs when blood is heated above 46C⁰. In this study, physiological heating is planned. In vitro neonatal experimental modeling has shown that there is no hemolysis with physiological heating. The aim of the researchers is; While protecting fragile, extremely premature babies from the complications of cold transfusion, the aim is to compare the transfusion groups with and without physiological heating in terms of hemolysis, metabolic balance and cerebral tissue oxygenation. **Detailed Description:** This trial is planned to be randomized and controlled. Erythrocyte transfusion (ET) will be applied to premature babies born below the 34th gestational week, based on the limit values specified by TND, during Level 3 routine intensive care treatment and follow-up. They will be divided into two groups of 20 babies each: control and study groups. The control group will receive erythrocyte transfusion without heating, which is routinely applied. Heated ET will be performed on the study group by physiological warming between 34-36C⁰. Procedures to be applied for the working group: 1. ET requirement will be determined in line with the TND guide. It will be transfused at a standard dose of 20 ml/kg. Before ET is performed, blood gas and HTC, K and blood temperature before entering the heater will be measured and recorded. 2. The erythrocyte suspension will be heated between 34-36 C⁰, which is the determined physiological temperature. 3. Before giving it to the baby, 2 ml of blood will be taken through a triple tap and its hematocrit and K value (blood gas) will be checked. It will be given to the baby after the temperature is checked with a body fluid thermometer and determined to be within the appropriate range and if hemolysis is not observed. 4. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. As standard for all babies during transfusion; Heart rate, blood pressure, saturation and body temperatures will be monitored. It was planned to investigate whether there was a difference in terms of hypothermia and hemolysis between the groups with and without Physiological Heating. It will be examined whether heated blood has an effect on cerebral tissue perfusion by NIRS monitoring ### Conditions Module **Conditions:** - Transfusion Related Complication - Premature **Keywords:** - premature infants - warmed blood transfusion - hypothermia - hemolysis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** randomized controlled, parallel group. A single center ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double blind **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** It was planned to transfuse the blood at +4C temperature brought from the blood bank center in 3 hours. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. **Label:** Blood Transfusion **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Blood will be warmed before transfusion. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. **Intervention Names:** - Procedure: Warmed Blood Transfusion **Label:** Blood transfusıon **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Blood transfusıon **Description:** The erythrocyte suspension will be heated between 34-36 C⁰, which is the determined physiological temperature. Before giving it to the baby, 2 ml of blood will be taken through a triple tap and its hematocrit and K value (blood gas) will be checked. It will be given to the baby after the temperature is checked with a body fluid thermometer and determined to be within the appropriate range and if hemolysis is not observed. At the end of the standard transfusion period of 3 hours, all babies will be routinely checked for blood gases, HTC and K. **Name:** Warmed Blood Transfusion **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The baby's body temperature will be measured and recorded before, during and after heated and unheated blood transfusions. It will be determined whether transfusion of unwarmed blood causes lower body temperature. **Measure:** Effect of heated blood transfusion on body temperature in premature babies **Time Frame:** 6 hours **Description:** Cerebral tissue oxygenation will be measured with Near infrared spectroscopy (NIRS) monitoring in both transfusion applications. The data recorded on the NIRS device will be transferred to the computer and compared. The effect of warming the blood on cerebral tissue oxygenation will be demonstrated. **Measure:** Effects of warming blood in blood transfusion on cerebral tissue oxygenation **Time Frame:** 8 hours **Description:** After the heated and unheated blood transfusion ends, the hematocrit levels of the babies will be compared to determine which model is more effective. **Measure:** Effect of heated and unheated blood transfusion on hematocrit level **Time Frame:** 8 hours #### Secondary Outcomes **Description:** After the blood is brought to physiological body temperature, a sample will be taken before giving it to the baby. The presence of hemolysis will be evaluated by measuring the potassium level in blood heated at 34-36 C. At the end of the blood transfusion, potassium will be measured in the blood taken from the baby. **Measure:** Effect of warming blood on potassium level **Time Frame:** 6 hours **Description:** After blood transfusion, LDH will be measured by taking blood samples from the babies in both groups. A measurement of LDH above 700 will be defined as hemolysis. **Measure:** Effect of warming blood on LDH level **Time Frame:** 6 hours **Description:** At the end of heated and unheated blood transfusion, blood gas and blood lactate levels will be measured. It will be compared which transfusion application increases the lactate level more. **Measure:** Effect of heated blood on blood lactate level **Time Frame:** 8 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Premature babies less than 34 weeks of gestation Babies requiring ES transfusions while receiving treatment in the NICU Exclusion Criteria: * babies with severe congenital anomalies **Maximum Age:** 3 Months **Minimum Age:** 1 Hour **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Goztepe Prof Dr. Suleyman Yalcın City Hospital **State:** N/A (n/a) **Zip:** 34730 #### Overall Officials **Official 1:** **Affiliation:** Istanbul Medeniyet University **Name:** Fahri Ovalı, Prof **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bailey SM, Mally PV. Near-Infrared Spectroscopy to Guide and Understand Effects of Red Blood Cell Transfusion. Clin Perinatol. 2023 Dec;50(4):895-910. doi: 10.1016/j.clp.2023.07.006. Epub 2023 Aug 17. **PMID:** 37866855 **Citation:** Poder TG, Nonkani WG, Tsakeu Leponkouo E. Blood Warming and Hemolysis: A Systematic Review With Meta-Analysis. Transfus Med Rev. 2015 Jul;29(3):172-80. doi: 10.1016/j.tmrv.2015.03.002. Epub 2015 Mar 24. **PMID:** 25840802 **Citation:** Hulse W, Bahr TM, Fredrickson L, Canfield CM, Friddle K, Pysher TJ, Ilstrup SJ, Ohls RK, Christensen RD. Warming blood products for transfusion to neonates: In vitro assessments. Transfusion. 2020 Sep;60(9):1924-1928. doi: 10.1111/trf.16007. Epub 2020 Aug 10. **PMID:** 32776545 **Citation:** Dani C, Pratesi S, Fontanelli G, Barp J, Bertini G. Blood transfusions increase cerebral, splanchnic, and renal oxygenation in anemic preterm infants. Transfusion. 2010 Jun;50(6):1220-6. doi: 10.1111/j.1537-2995.2009.02575.x. Epub 2010 Jan 22. **PMID:** 20113454 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature - ID: M10085 - Name: Hypothermia - Relevance: LOW - As Found: Unknown - ID: M9547 - Name: Hemolysis - Relevance: LOW - As Found: Unknown - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425770 **Brief Title:** Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns **Official Title:** Investigating the Accuracy of Conventional vs Digital Impressions and Conventional vs 3D Fabricated Casts in Capturing the Emergence Profile Around Maxillary Anterior Single Implant-supported Crowns #### Organization Study ID Info **ID:** 129/2023 #### Organization **Class:** OTHER **Full Name:** Semmelweis University ### Status Module #### Completion Date **Date:** 2026-02-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-05 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Semmelweis University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25). **Detailed Description:** Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking. Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype: 1. the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position 2. the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position 3. the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning ### Conditions Module **Conditions:** - Dental Implants, Single-Tooth - Dental Impression Technique **Keywords:** - Peri-Implant Emergence Profile - Dental Impression Technique - Dental Implants, Single-Tooth - Esthetics, Dental - Crowns - Denture, Partial, Fixed - Computer-Aided Design ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created **Intervention Names:** - Procedure: conventional impresion and cast **Label:** conventional cast **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration **Intervention Names:** - Procedure: indirect digital impression and 3D printed cast **Label:** indirect digital impression and 3D printed cast **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration **Intervention Names:** - Procedure: direct digital impression **Label:** direct digital impression **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - indirect digital impression and 3D printed cast **Description:** the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration **Name:** indirect digital impression and 3D printed cast **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - direct digital impression **Description:** the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration **Name:** direct digital impression **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - conventional cast **Description:** conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created **Name:** conventional impresion and cast **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** pink esthetic score of the definitive restoration **Measure:** Pink esthetic score/PES **Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up **Description:** white esthetic score of the definitive restoration **Measure:** White esthetic score/WES **Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up **Description:** functional implant prosthodontic score of the definitive restoration **Measure:** functional implant prosthodontic score/FIPS **Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up #### Primary Outcomes **Description:** The absolute mean deviation between the emergence profiles replicated with different impression techniques along the whole surface of the EP **Measure:** 3D RMS - root mean square difference **Time Frame:** at impression taking, 0,2,10,20 mins #### Secondary Outcomes **Description:** Vertical height change of the buccal gingiva marginal level measured at the mesial and distal papilae and mid-facial levels **Measure:** Linear vertical soft tissue change **Time Frame:** at impression taking, 0,2,10,20 mins **Description:** Horizontal thickness change of the buccal and palatal gingiva at three levels at each third of the distance between the implant platform and the marginal gingiva. **Measure:** Linear horizontal soft tissue change **Time Frame:** at impression taking, 0,2,10,20 mins **Description:** The absolute mean deviation between the emergence profiles replicated with different impression techniques along vertical and horizontal cross-sections. **Measure:** 2D RMS - root mean square difference **Time Frame:** at impression taking, 0,2,10,20 mins **Description:** Patient evaluation of the different types of impression methods on a visual analoge scale based questionnaire **Measure:** Patient reported outome measures - evaluation of the impression method **Time Frame:** at the end of each session of the digital and conventional impression taking ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult above 18 yo * No systematic deseases * Good oral hygene (FMPS \< 25%) * Stable occlusion * Thick phenotype * Single missing maxilary anterior (FDI #15-25 position) tooth replaced with osseointegrated bone level impant * Correctly formed soft tissue with CAD/CAM temporary abutment for min. 3 months * Neighbouring teeth in place and in good condition * Patient voluntarily accepts and signs the patient leaflets for the trial Exclusion Criteria: * Active periodontitis * Peri-implant inflammation **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Krisztina Mikulás, PhD **Phone:** +3614591500 **Phone Ext:** 59115 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Xinyi Qian **Phone:** +3614591500 **Phone Ext:** 59313 **Role:** CONTACT #### Locations **Location 1:** **City:** Budapest **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Krisztina Mikulás, PhD - **Phone:** 3614591500 - **Phone Ext:** 59115 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Xinyi Qian - **Phone:** 3614591500 - **Phone Ext:** 59313 - **Role:** CONTACT **Country:** Hungary **Facility:** Semmelweis University, Department of Prosthodontics **State:** Pest **Status:** RECRUITING **Zip:** 1088 #### Overall Officials **Official 1:** **Affiliation:** Department of Prosthodontics, Semmelweis University **Name:** Krisztina Mikulás, PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Li J, Chen Z, Wang M, Wang HL, Yu H. Dynamic changes of peri-implant soft tissue after interim restoration removal during a digital intraoral scan. J Prosthet Dent. 2019 Sep;122(3):288-294. doi: 10.1016/j.prosdent.2018.07.020. Epub 2019 Mar 15. **PMID:** 30885583 **Citation:** Xiong J, Sun W, Huang B, Ji W, Shi B. Effect of the implant-supported provisional restoration on the accuracy of digital peri-implant mucosa replication-A clinical study. Clin Oral Implants Res. 2022 Jun;33(6):598-606. doi: 10.1111/clr.13921. Epub 2022 Mar 26. **PMID:** 35290685 **Citation:** Monaco C, Scheda L, Baldissara P, Zucchelli G. Implant Digital Impression in the Esthetic Area. J Prosthodont. 2019 Jun;28(5):536-540. doi: 10.1111/jopr.12991. Epub 2018 Dec 3. **PMID:** 30357992 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000015853 - Term: Cysteine Proteinase Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M15630 - Name: Silicon - Relevance: LOW - As Found: Unknown - ID: M40889 - Name: Calpastatin - Relevance: HIGH - As Found: Blood draw - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T4 - Name: Cysteine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000033668 - Term: Calpastatin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425757 **Brief Title:** Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia **Official Title:** Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia #### Organization Study ID Info **ID:** IRB-2024-315(IIT) #### Organization **Class:** OTHER **Full Name:** Zhejiang Cancer Hospital ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Xie Kangjie #### Responsible Party **Investigator Affiliation:** Zhejiang Cancer Hospital **Investigator Full Name:** Xie Kangjie **Investigator Title:** Clinical Professor **Type:** SPONSOR_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:** Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia **Detailed Description:** This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood. ### Conditions Module **Conditions:** - Hypoproteinemia - Pharmacokinetics - Ciprofol ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Blood albumin concentration≤30g/L **Intervention Names:** - Drug: ciprofol **Label:** Severe Hypoproteinemia **Type:** OTHER #### Arm Group 2 **Description:** Blood albumin concentration 30g/L-40g/L **Intervention Names:** - Drug: ciprofol **Label:** Moderate Hypoproteinemia **Type:** OTHER #### Arm Group 3 **Description:** Blood albumin concentration \>40g/L **Intervention Names:** - Drug: ciprofol **Label:** Normal plasma albumin **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Moderate Hypoproteinemia - Normal plasma albumin - Severe Hypoproteinemia **Description:** Patients who intended to undergo elective surgery under general anesthesia were induced by a single intravenous injection of 0.3mg/kg and ciprofol, and the experimental drug was manually injected by CVC within 30s. 2ml of venous blood was collected before and after administration 0.5min, 1min, 2min, 3min, 5min, 8min, 15min 30min, 1h, 2h and 4h respectively. The concentration of cyclopofol in blood was measured **Name:** ciprofol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Blood concentration of ciprofol **Measure:** Blood concentrations at different time points after a single injection **Time Frame:** Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours #### Secondary Outcomes **Description:** The time it takes for the blood concentration of a drug to reach the clinically active concentration level from zero **Measure:** Onset time of ciprofol in patients with hypoproteinemia **Time Frame:** Day 1 **Description:** From the time the drug was administered to the time the patient lost consciousness **Measure:** Effect time of ciprofol in patients with hypoproteinemia **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with moderate to severe hypoproteinemia (albumin \< 30g/L, protein detection time uniformly within three days before surgery） * Weight greater than 45kg, BMI20-24 * The ASA rating is Class I or Class II Exclusion Criteria: * Severe liver dysfunction * Severe renal dysfunction * Patients with ASA grade III and above * Known allergy to eggs, soy products, opioids and their relief drugs, propofol * Emergency surgery **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** XIE Kangjie, doctoral **Phone:** 13516721870 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** XIE Kangjie, MD - **Phone:** 13516721870 - **Role:** CONTACT **Country:** China **Facility:** Zhejiang Cancer Hospital **State:** Zhejang **Status:** RECRUITING **Zip:** 310000 #### Overall Officials **Official 1:** **Affiliation:** Zhejiang Cancer Hospital **Name:** XIE Kangjie, doctoral **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001796 - Term: Blood Protein Disorders - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10069 - Name: Hypoproteinemia - Relevance: HIGH - As Found: Hypoproteinemia - ID: M5077 - Name: Blood Protein Disorders - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007019 - Term: Hypoproteinemia ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425744 **Brief Title:** Impact of Pilates and Myofascial Release on Women's Chronic Low Back Pain **Official Title:** The Effect of Self-Myofascial Release and Pilates Reformer Exercise on Pain, Muscle Function and Quality of Life in Women With Chronic Low Back Pain #### Organization Study ID Info **ID:** SYU 2022-07-014 #### Organization **Class:** OTHER **Full Name:** Sahmyook University ### Status Module #### Completion Date **Date:** 2022-11-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-10-30 **Type:** ACTUAL #### Start Date **Date:** 2022-08-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sahmyook University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this study is to find out if Reformer Pilates and self-myofascial release are effective for pain and muscle function in women with chronic low back pain. Investigators will also look at changes in quality of life. The main questions for the study are Can Reformer Pilates and self-myofascial release reduce pain in participants? Can Reformer Pilates and self-myofascial release change muscle function in participants? The researchers want to compare the effects of Reformer Pilates and self-myofascial release in women with chronic low back pain. Participants will be Group 1 Perform Reformer Pilates and self-myofascial release exercises twice a week for 6 weeks, for a total of 12 sessions. Group 2 Perform Reformer Pilates exercises twice a week for 6 weeks, for a total of 12 sessions. Participants will visit the Pilates Centre for an examination before and once after starting the programme. All groups perform a home exercise training programme for 15 minutes three times a week. ### Conditions Module **Conditions:** - Low Back Pain **Keywords:** - low back pain - Pilates - Myofasical Release - Pain - Flexibility ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The experimental 1 group perform self-myofascial release and Pilates exercises. **Intervention Names:** - Other: self-myofascial release combined reformer Pilates **Label:** experimental 1 group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The experimental 2 group perform pilates exercise using reformer. **Intervention Names:** - Other: Reformer Pilates **Label:** experimental 2 group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - experimental 1 group **Description:** The self-myofascial release combined reformer Pilates group performs 10 minutes of self-myofascial release using the BALLance© method before beginning 20 minutes of Reformer Pilates. The 6-week program includes warm-up and breathing, main supine exercises 1 and 2, and movements targeting the sacroiliac and hip joints. All Pilates exercises are designed in a variety of positions including supine, prone, sitting and standing. All participants attend twice a week for 6 weeks, for a total of 12 sessions. And all participants performed home exercise program follows the guidelines of Geroge et al (2021) and includes myofascial release and Pilates Reformer exercises, as well as stretching exercises beneficial for chronic low back pain. The home exercises are performed three times a week for 15 minutes, and exercise materials are distributed. **Name:** self-myofascial release combined reformer Pilates **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - experimental 2 group **Description:** The reformer Pilates group will do 30 minutes of Pilates on the Reformer. All Pilates exercises are designed in a variety of positions including supine, prone, sitting and standing. All participants also attend twice a week for 6 weeks, for a total of 12 sessions. The home exercise program follows the guidelines of Geroge et al (2021) as well as stretching exercises beneficial for chronic low back pain. The home exercises are performed three times a week for 15 minutes, and exercise materials are distributed. **Name:** Reformer Pilates **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Pain severity is measured using a visual analogue scale, where participants mark the level of back pain they feel on a line between 0 mm and 100 mm(0: no pain, 10: worst pain imaginable). Measurement unit is in mm, with higher scores considered more painful **Measure:** Pain severity **Time Frame:** From enrollment to the end of treatment at 6 weeks **Description:** The Korean version of the Oswestry Disability Index (KODI) is used to assess functional impairment due to low back pain. This assessment consists of 10 items, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel, with each item scored on a scale of 0 to 5 for a total of 50 points. The KODI score is given as a percentage (%) of the total score. Scores are categorised as mild disability (0-20%), moderate disability (21-40%), severe disability (40-60%) and disability affecting all aspects of life (\>60%), with high test-retest reliability (r=0.92). **Measure:** Functional disability caused by low back pain **Time Frame:** From enrollment to the end of treatment at 6 weeks #### Secondary Outcomes **Description:** Flexibility is measured using the sit-to-stand reach test (SRT), which assesses the flexibility of the lower back and hamstrings. The score is the most distant point (cm) reached with the fingertips. The best of three trials should be recorded. Participants sit with their feet on a box, knees straight, and reach as far forward as possible. The posture is maintained for five seconds and the reach distance is recorded over three trials and averaged. The longer the distance in centimeters, the more flexible it is. **Measure:** Flexibility of lower back and hamstring **Time Frame:** From enrollment to the end of treatment at 6 weeks **Description:** Muscular endurance is assessed using the supine bridge test (SBT), which requires participants to raise their pelvis to form a straight line from shoulder to knee. The time taken to hold the position is recorded in seconds (sec) and averaged over three trials. The longer time hold is the higher muscular endurance. **Measure:** Muscular endurance **Time Frame:** From enrollment to the end of treatment at 6 weeks **Description:** The European Quality of Life 5-Dimensional 5-Level Version (EQ-5D-5L) questionnaire is used to assess quality of life. This standardised tool assesses five dimensions: mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression. General health status is measured using a visual analogue scale (EQ-5D VAS). Scores on the EQ-5D index range from -0.59 to 1, with 1 being the best health. In the absence of a scoring algorithm, a summed scale score was also calculated for both versions to provide additional information about the contribution of the two additional 5L response categories. **Measure:** Quality of life questionnaire **Time Frame:** From enrollment to the end of treatment at 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * People who have had chronic low back pain for 12 weeks or more * Have a Korean Oswestry Disability Index (KODI) score of 17% or higher Exclusion Criteria: * Patients with low back pain due to trauma, neurological lesions of the lower extremities, herniated disc lesions, hip, pelvic or abdominal surgery * Patients who have received radiation or injections within the last 3 months, * Pregnant women or patients who have given birth within the last year **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Goyang-si **Country:** Korea, Republic of **Facility:** Pilates Dasom **State:** Gyeonggi-do **Zip:** 10592 ### IPD Sharing Statement Module **Description:** only IPD used in the results publication **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425731 **Brief Title:** Dance and Energy Expenditure Among Adults With Parkinson's **Official Title:** Characterizing Dance-related Physical Activity Behaviors Among Adults Living With Parkinson's Disease for Automated Analyses of Energy Expenditure #### Organization Study ID Info **ID:** 23-10-30 #### Organization **Class:** OTHER **Full Name:** Northeastern University ### Status Module #### Completion Date **Date:** 2025-07-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Mark Morris Dance Group #### Lead Sponsor **Class:** OTHER **Name:** Northeastern 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 first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. The second reason we are conducting the study is to better understand the relationship between the intensity of dance classes specifically designed for adults with Parkinson's and individual-level factors like the kinds of routine activities one does beyond dancing and one's health status. Participants in the study may be asked to engage in any of the following activities: * complete a small number of assessments on their physical and cognitive functioning * complete their routine group-based dance classes, specifically designed for adults with a diagnosis of Parkinson's, while being recorded Depending upon the group that a participant joins, one may also be asked to: * wear an activity monitor on their waist while engaged in their daily business as usual for nine (9) days * complete an iDXA scan * describe their perceptions on how the use of technology can integrated into their dancing **Detailed Description:** Parkinson's Disease (PD) is a neurodegenerative disorder that affects an estimated 1 million people in the United States, with the onset of symptoms typically occurring after the age of 50 years old. Adults living with PD experience motor impairments such as postural and gait instability, resting tremor, bradykinesia, and muscular rigidity; cognitive impairment, with an estimated 40% of individuals with PD presenting symptoms of at least mild cognitive impairment; and depression. Furthermore, PD symptom severity is known to increase with age.5 Research has shown that exposures to physical activity (PA) may delay the symptomatic progression of PD, and a recent meta-analysis revealed that engaging in dance, when compared to other modes of PA behavior, confers especial protective benefits across motor and cognitive outcomes. Surprisingly, the PA dose administered across some studies of dance has gone unmeasured and is therefore unknown. This is because various modes of dance are known to elicit different PA intensities, and PA intensity is further influenced by intra-individual factors. Because accurate measures of PA intensity are essential for determining an optimal PA dose within dose-response research, additional research that accurately quantifies the absolute and relative intensities of dance behaviors is needed to advance research on dance and health among adults living with PD. Of the PD sequela that appear sensitive to dance exposures, studies have demonstrated protective benefits across motor symptoms, in addition to cognitive and mental health outcomes, after 3 - 12 months of participation in dance. However, little is known about the PA intensities of the dance behaviors that led to these reported outcomes, which therefore limits present understanding of the dose of dance required to yield reproducible results. Dance for PD (Collaborator: Leventhal), a codified dance program for adults living with PD, has been well-studied. During a Dance for PD class, participants dance, with music, while in a chair, standing, and while ambulatory. With wide acceptability, Dance for PD offers an ideal experimental paradigm in which to systematically monitor and quantify the intensity of dance behaviors among adults with PD. Wearable sensors and cameras can be used to estimate PA intensities at individual and group levels. Building upon our prior work, our group is currently collecting camera, wearable sensor, and cardiopulmonary data in an ongoing clinical trial (PI: McCullough) to train algorithms that predict PA intensity during solo, free-form dance behavior. Preliminary results show healthy adults ages 18 to 75, with and without prior dance training, who intend to dance free-form at light-to-moderate intensities engage in dance at an average 4.4-6.0 metabolic equivalent (METs) (i.e., moderate-to-vigorous PA intensities). Age and body mass index are inversely associated with METs, and dancing with music is positively associated with METs. Dance for PD sessions include a range of structured and free-form activities performed with music; their codified framework affords participants multiple opportunities to modulate their PA behavior and intensity in community- and home-based settings. In view of our preliminary results that show multiple factors may impact the PA intensity of dance behavior, additional research is needed to better understand the dose of PA received during Dance for PD sessions. Therefore, we aim to: 1a) Train PA classifiers to detect the absolute and relative PA intensities of Dance for PD sessions within a cohort of N=30 Dance for PD participants in a community-based setting. To test this aim, 2D/3D cameras and triaxial accelerometers will be used to continuously record behavioral and kinematic data during group-based Dance for PD sessions. Indirect calorimeters and wireless heart rate sensors will be used to continuously monitor oxygen uptake and heart rate during multiple Dance for PD sessions. Oxygen uptake and heart rate data will serve as the ground truth, with signal features derived from the camera and wearable sensor data as key predictors. Hypothesis: Sensor-derived signal features can respectively be used to train algorithms to accurately classify the PA intensity of dance during Dance for PD sessions at both individual and group levels. 1b) Estimate associations between PA intensities observed during Dance for PD sessions and respective individual-level factors. To test this aim, estimates of the absolute and relative intensities of Dance for PD (aim 1) exposures will be respectively adjusted for body fat percentage, PD motor symptom severity, years since PD diagnosis, free-living activity, cognitive function, sex, and age. Hypothesis: Adjusting for clinical, demographic, anthropometric, and behavioral covariates will improve the accuracy of PA intensity classifiers. 2) Characterize the relative intensity of Dance for PD sessions within home-based settings. To test this aim, N=30 adults will wear heart rate monitors while engaged in Dance for PD sessions at home. Heart rate data will be used to calculate the relative intensity of home-based Dance for PD sessions. Hypothesis: Engaging in Dance for PD at home will elicit light to moderate intensity physical activity bouts. ### Conditions Module **Conditions:** - Parkinson Disease ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants are prospectively assigned to participate in one of two study conditions that respectively seek to test different interventions and outcomes. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will engage in Dance for PD classes in-person in their usual fashion, and within a group-based setting, for a total of three sessions. Oxygen uptake, heart rate and perceived exertion will be measured throughout specific Dance for PD classes. **Intervention Names:** - Other: Fasting **Label:** Dance for PD (in-person) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will engage in Dance for PD classes online in their usual fashion, and within a group-based setting, for a total of two sessions. Heart rate and perceived exertion will be measured throughout the Dance for PD classes. **Intervention Names:** - Other: No Intervention **Label:** Dance for PD (virtual/remote) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dance for PD (in-person) **Description:** Participants (Dance for PD, in-person only) will engage in one of their routine weekly dance sessions while a portable indirect calorimeter is used for energy expenditure analysis. Before this session, participants will be asked to fast for at least 4-hours. In this way, participants in this study arm will engage in a self-controlled study design wherein they complete a 4-hour fast before engaging in an oxygen uptake assessment during their routine dance classes. During the 4-hour fasting period, participants will be asked to refrain from eating any food and drinking any beverages except for water. **Name:** Fasting **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Dance for PD (virtual/remote) **Description:** No Intervention **Name:** No Intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The rate of oxygen uptake during a 60-min dance session **Measure:** Oxygen uptake **Time Frame:** The outcome measure will be assessed after the intervention (i.e., after fasting: no food for at least 4 hours prior to a single dance session) and during the intervention (i.e., participants will continue to fast during the 60-minute dance session). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults (18-85 years old) * Diagnosis of idiopathic PD (as confirmed by a neurologist), who are at a Hoehn and Yahr stage \<=3 (i.e., physically independent, some postural instability, mild to moderate bilateral involvement or less severe symptoms; Bhidayasiri et al., 2012), and who are * enrolled in Dance for PD® classes at the time of recruitment as a participant Exclusion Criteria: * Adults with a score of \>3 on the Hoehn \& Yahr scale (i.e., those presenting with severely disabling disease, but still able to walk or stand unassisted or those who are confined to a bed or wheelchair unless aided; Bhidayasiri et al., 2012) * history of a prior neurological condition that is not PD, including epilepsy * pregnant or trying to become pregnant * those with contraindications to exercise as determined by the Physical Activity Readiness Questionnaire for Everyone (PARQ+) * currently smoke cigarettes or use tobacco products * have a pacemaker or other implanted medical device * have been hospitalized due to a psychological disorder within the last 5 years * have a respiratory disease (including chronic obstructive pulmonary disease- COPD, asthma, pulmonary high blood pressure) * have a metabolic condition (including type 1 diabetes, type 2 diabetes, pre-diabetes, chronic kidney disease, or liver problems) * have a kidney condition, a heart condition, history of stroke or cancer * experienced a blackout, fainted, or lost consciousness as a result of a head injury or had diagnosed concussion within the last 12 months * take a medication that affects cardiovascular responses to exercise * prospective participants with a diagnosis of PD who score \< 17 on the Telephone Interview for Cognitive Status (TICS-30) * currently residing outside of the United States **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Aston K McCullough, PhD, MS, MA **Phone:** 6173738893 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gregory Cloutier - **Phone:** 617-373-8009 - **Role:** CONTACT ***Contact 2:*** - **Name:** Aston K McCullough, PhD, MS, MA - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Northeastern University **State:** Massachusetts **Zip:** 02115 ### IPD Sharing Statement Module **Description:** The data set that will be generated in this study will contain identifiable information in the form of video data, which will be instrumental to the primary and secondary aims of the study. Though we do not plan to share any of the raw video or audio data, we may share signal features extracted from human activity detected in the video data; and we may share audio transcripts. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: LOW - As Found: Unknown - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425718 **Brief Title:** Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries **Official Title:** Comparison of Transversalis Fascia Plane Block and Surgical Site Local Anesthetic Infiltration in Elective Cesarean Section Surgeries #### Organization Study ID Info **ID:** MarmaraClinical #### 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:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-21 ### 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:** Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, multimodal analgesia strategies with peripheral nerve blocks are preffered with greater safety in elective Cesarean section surgeries. The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis fascia plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia. **Detailed Description:** After Cesarean sections, several factors play a role in the formation of postoperative pain, including parietal stimulation originating from the surgical incision, visceral stimulation originating from the peritoneum, and manipulation of intra-abdominal structures. To enhance patients' rehabilitation during the postoperative period, promote lactation and infant care, and reduce hospital stays, the most appropriate postoperative analgesia method should be selected. Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, regional anesthesia techniques are preferred with greater safety in elective Cesarean section surgeries. In the postoperative period, multimodal analgesia strategies can be used for pain control, and one of these strategies is postoperative peripheral nerve blocks. Ultrasound guided transversalis fascia plane block is one of the preferred methods for postoperative analgesia in cesarean section patients. The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia. ### Conditions Module **Conditions:** - Opioid Use - Postoperative Pain **Keywords:** - opioid use - postoperative pain - transversalis plane block ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Bilateral Transversalis Fascia Plane Block (with %0.25 bupivacaine, 20 ml for each side) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes) **Intervention Names:** - Procedure: Postoperative pain management technique **Label:** Transversalis Fascia Plane Block **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Local anesthetic infiltration will be applied to the surgical incision area with 0.25% 20 ml bupivacaine and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes) **Intervention Names:** - Procedure: Postoperative pain management technique **Label:** Surgical Site Local Anesthetic Infiltration **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Surgical Site Local Anesthetic Infiltration - Transversalis Fascia Plane Block **Description:** Patients who will undergo cesarean section under spinal anesthesia will be included. Comparing postoperative pain and opioid consumption in groups **Name:** Postoperative pain management technique **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous tramadol consumption will be recorded via PCA device, then it will be documented in mg/kg units. **Measure:** Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device **Time Frame:** 48 hours #### Secondary Outcomes **Description:** In a Numerical Rating Scale (NRS), patients are asked to choose from 1 to 10. 1: no pain 10: worst pain experienced **Measure:** Postoperative pain assessment with Numeric Rating Scale (NRS) **Time Frame:** 48 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over 18 years old * ASA II-III patients undergoing elective cesarean section Exclusion Criteria: * ASA IV patients * Patients with known neurologic or psychiatric disorders * Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease * Patients with alcohol or drug addiction * Mentally disabled patients * Patients with BMI\>30 * Patients who develop massive bleeding or coagulopathy **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Beliz Bilgili **Phone:** +905362187927 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Marmara University **Name:** Beliz Bilgili **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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 - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M16901 - Name: Tramadol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425705 **Brief Title:** Impact of Silymarin Adjunct Therapy on Proteinuria in Type 2 Diabetic Patients on RAS Inhibitors **Official Title:** Evaluating the Outcome of Silymarin as an Adjunct Therapy to Renin-Angiotensin System Inhibitors in Proteinuric Type 2 Diabetic Patients #### Organization Study ID Info **ID:** LahoreGeneralH1 #### Organization **Class:** OTHER_GOV **Full Name:** Lahore General Hospital ### Status Module #### Completion Date **Date:** 2023-07-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-10 **Type:** ACTUAL #### Start Date **Date:** 2022-02-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Lahore General Hospital #### Responsible Party **Investigator Affiliation:** Lahore General Hospital **Investigator Full Name:** Muhammad Irfan Jamil **Investigator Title:** Principal Investigator **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:** Given the inadequacies of existing pharmacological interventions for diabetic nephropathy, this study is predicated on the hypothesis that silymarin, having shown promise in mitigating hyperglycemia in diabetic patients without nephropathy and displaying renal protective effects in animal models, merits a thorough and systematic investigation. The current body of research on silymarin, particularly human trials, is limited by small cohorts and the preliminary nature of its outcomes. This research aims to evaluate the efficacy of silymarin as an adjunctive treatment in patients with Type 2 diabetes mellitus (T2DM) already on renin-angiotensin system inhibitors, focusing on its potential to reduce proteinuria and improve renal function. The ultimate objective is to amass more definitive evidence that could potentially inform a new therapeutic approach in the management of diabetic nephropathy. **Detailed Description:** After securing the approval from the Ethical Review Board of hospital, this study was conducted in the Nephrology Department, Lahore General Hospital, Lahore. All patients diagnosed with Type 2 Diabetes Mellitus was assessed based on the previously defined inclusion and exclusion criteria. Informed consent was obtained from all eligible participants who agreed to participate in the study. Baseline Data Collection: Upon enrollment, demographic and clinical information including age, gender, duration of diabetes, baseline renal function tests, current medication use, and baseline measures of HBA1c, FBS, RBS and proteinuria were collected. This information was provided a comprehensive profile of each participant at the start of the study. Treatment Allocation: Patients was randomly assigned into two groups using a lottery method: * Group A: received 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors. * Group B: received placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors. Monitoring and Follow-up Assessments: Participants was assessed for outcomes after at one month and 3 months to monitor changes in proteinuria and renal function. Specific tests were included: * Measurement of Urinary Albumin-Creatinine Ratio (UACR): Participants were required to provide 24-hour urine specimens at one month and three months into the study. To ensure that the urine samples are not affected by external factors, patients was instructed to maintain their usual physical activities and avoid strenuous exercises the evening before the assessment days. Proteinuria was quantified using immunoturbidimetry. * Assessment of Serum Creatinine and Calculation of eGFR to Monitor Renal Function: The estimated glomerular filtration rate (eGFR) was calculated using the CKD-EPI formula at one month and three months. These assessments were help to monitor any changes in renal function over the course of the study. * Measurement of HbA1c levels after 3 months. The data was recorded meticulously using standardized data collection forms. Data was analyzed using SPSS version 26.0. Baseline characteristics of participants (age, gender, duration of diabetes, baseline renal function tests, HbA1c, FBS, RBS) were summarized using means and standard deviations for continuous variables, and frequencies and percentages for categorical variables. Changes in UACR, eGFR, and HbA1c from baseline to one month and three months were compared between Group A (silymarin) and Group B (placebo) using independent t-tests or Mann-Whitney U tests, depending on the normality of the data. Analysis of Covariance (ANCOVA) was used to adjust for any baseline imbalances and potential confounders between the two groups. Repeated measures ANOVA were employed to analyze changes over time within and between treatment groups for UACR, eGFR, and HbA1c levels, accounting for within-subject correlation over the assessment periods. All statistical tests were two-sided, and a p-value of less than 0.05 was considered statistically significant. ### Conditions Module **Conditions:** - Type 2 Diabetes Mellitus **Keywords:** - Proteinuria - Type 2 Diabetes Mellitus - Renin-Angiotensin System ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Received 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors. **Intervention Names:** - Drug: Silymarin **Label:** Group Silymarin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Received placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors. **Intervention Names:** - Drug: Placebo **Label:** Group Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group Silymarin **Description:** 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors. **Name:** Silymarin **Other Names:** - Milk thistle extract **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group Placebo **Description:** placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** It was measured quantitatively by comparing the urinary albumin-creatinine ratio (UACR) in mg/g between initial recruitment and subsequent follow-up visits at one and three months. **Measure:** Change in the urinary albumin-creatinine ratio (UACR) from baseline **Time Frame:** Outcomes monitored at one and three-month intervals **Description:** eGFR was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula, which incorporates serum creatinine, age, sex, and race. The outcome measure was the change in eGFR in mL/min/1.73 m² at one month and three months compared to the baseline value. **Measure:** Change in estimated glomerular filtration rate (eGFR) from baseline **Time Frame:** Outcomes monitored at one and three-month intervals **Description:** It was measured quantitatively by comparing the HbA1c levels in percentage (%) between initial recruitment and subsequent follow-up visit after three months. **Measure:** Change in HbA1c levels from baseline **Time Frame:** Outcomes monitored after three-month. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 35-70 years. * Both male and female with Type II diabetes. * Overt proteinuria defined by urinary albumin excretion \> 300 mg/24 hr. in 2 consecutive determinations despite treatment with highest FDA recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months. * Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (If a SGLT2 inhibitors is used, stable dose for at least 3 months). * Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins. * Patients using stable dose of Non-Dihydropyridine Calcium Channel Blockers for at least 6 months as antihypertensive. * Presence of diabetic retinopathy. * Signing informed consent. Exclusion Criteria: * Type I diabetes. * Advanced chronic kidney disease defined by estimated GFR \< 30 ml/min/1.73 m2 * Severely uncontrolled diabetes defined by HbA1C \> 10%. * Uncontrolled hypertension defined by SBP \>140 mmHg or DBP \>90 mmHg despite antihypertensive therapy. * Patients with organ transplant history. * Secondary forms of hypertension with defined etiology other than diabetes mellitus. * Other renal diseases. * Chronic Heart Failure with NYHA class III or IV. * Active infection. * Pregnancy. Use of one of the following medications within 2 months prior to enrollment in the study: * Non-steroidal anti-inflammatory agents. * Antioxidants supplements including vitamin E, vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts. * Active malignancy. * History of drug or alcohol dependency. * Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol. **Maximum Age:** 70 Years **Minimum Age:** 35 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Lahore General Hospital, Lahore **State:** Punjab **Zip:** 54000 #### Overall Officials **Official 1:** **Affiliation:** Lahore General Hospital, Lahore **Name:** Muhammad Irfan Jamil, MBBS, FCPS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** will be shared on special request **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000014555 - Term: Urination Disorders - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000020924 - Term: Urological Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Type 2 Diabetes Mellitus - ID: M14368 - Name: Proteinuria - Relevance: HIGH - As Found: Proteinuria - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M17305 - Name: Urination Disorders - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011507 - Term: Proteinuria - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Fl - Name: Flavonoid - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M15643 - Name: Silymarin - Relevance: HIGH - As Found: Pegylated Liposomal Doxorubicin - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T43 - Name: Silymarin - Relevance: HIGH - As Found: Pegylated Liposomal Doxorubicin - ID: T229 - Name: Milk Thistle - Relevance: HIGH - As Found: Eastern ### Intervention Browse Module - Meshes - ID: D000012838 - Term: Silymarin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425692 **Brief Title:** Work Package 3 Education for ICU Clinicians in Basic Palliative Care **Official Title:** Enhancing Palliative Care in ICU (EPIC) - Work Package 3 #### Organization Study ID Info **ID:** 2023-2676 #### Organization **Class:** OTHER **Full Name:** Heinrich-Heine University, Duesseldorf ### Status Module #### Completion Date **Date:** 2029-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-01 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Heinrich-Heine University, Duesseldorf #### 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 EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems- based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff. EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach to care. The development of blended learning for intensive care staff is the task of Work Package (WP) 3. The aim is to improve the attitude, understanding and self-confidence of ICU staff. Blended learning is to be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors will be conducted. **Detailed Description:** Background Around 10% of all deceased people in the population die after being admitted to an intensive care unit (ICU). These patients may have distressing symptoms and may receive more intensive life-prolonging treatment than they would have chosen themselves. This can lead to family stress, but also to mental distress among intensive care staff. The EPIC project aims at sustainably improving palliative care for seriously ill patients and their families in ICUs. To this aim, an interdisciplinary consortium is working together to provide a new practical palliative care model using telemedicine. The project is the first European intervention study on palliative care in the ICU using a systems-based approach with proactive patient identification, checklist and blended learning designed to meet the specific needs of ICU staff. EPIC's vision is to contribute to a change in awareness from a narrow focus on prolonging life to a more holistic approach of care. Objectives of Work Package (WP) 3 The aim is to improve the attitude, understanding and self-confidence of ICU-staff. Blended learning will be developed and implemented for this purpose. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. Due to the international character of the project, it is to be developed in English with subtitles in the local languages. In addition a workshop with patient and family advisors should conducted. Development and implementation of blended learning The blended learning program is to be completed by all ICU staff participating in the study during the crossover period of 4 weeks prior to the intervention. The curriculum will be developed in close collaboration with another work package. The main aim is to teach the standardized EPIC procedures using the following questions: 1. Why is palliative care necessary? 2. When to call for a specialist palliative care consultation? 3. How to message palliative care? 4. What are the critical elements of palliative care in the ICU? Participants first complete the eLearning programme. This is made available to them via the data-secured open-source platform: BeST, Charite. Participants will then take part in interactive online workshops moderated by the investigators involved in the study. The workshop curriculum also focuses on communication skills training and open questions after the eLearning. Two workshops of 90 minutes each will be offered to allow all ICU staff to participate. In addition, a pocket card for symptom assessment, communication and care planning will be developed and handed out at each workshop. Evaluation of the impact of the training The evaluation of blended learning takes place at different times. On one hand, the validated CPD Response Questionnaire, a 12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioral intentions, will be used. CPD activities can be used as a way of indicating that new knowledge can lead to changes in practice. Which changes the investigators want to measure will become apparent during the development of the curriculum. The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using German school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as CSA Gain \[%\] = ((MWpre-MWpost)/(Mwpre-1)) x 100. The learning objectives will be based on the curriculum to be developed, so the questionnaire will also be submitted as an amendment. Both questionnaires will be made available to participants via a link and/or QR code using SoSci Survey tool. The CPD is to be surveyed before and after blended learning and after six months, and the CSA gain after blended learning and also after six months. The questionnaires are available in English and will be translated back and forth according to the state of the art. Reminders for the follow-up questionnaires will be sent to the participants by e-mail. Results will be communicated to the investigators at other sites and used to update the curriculum after the intervention study has ended. Conducting and evaluation of the patients and family workshop A co-workshop will be held with patients and relatives to integrate their perspectives and needs in terms of skills and knowledge of professional caregivers. This will then also be evaluated, whereby the content to be developed will provide the items of the evaluation. The evaluation is also collected as an online questionnaire via SoSci. ### Conditions Module **Conditions:** - ICU - Staff Attitude - Learning - Palliative Care, Patient Care **Keywords:** - multi-center study - ICU staff - EU-Horizon ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Blended learning for ICU staff and online webinars. The aim is to teach the basics of palliative care on a cognitive, affective and psychomotor level. **Intervention Names:** - Behavioral: Education **Label:** Education on basic palliative care **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Education on basic palliative care **Description:** Education on basic palliative care via e-learning + webinar to deepen knowledge. **Name:** Education **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The comparative self-assessment (CSA) gain is used to evaluate the specific learning effects in relation to the increase in knowledge, attitudes and skills \[2\]. Here, the participants assess their own increase in knowledge in the post/this assessment. The information is assessed using german school grades (1 = very good, 6 = unsatisfactory). Subsequently, the learning gain on the levels of attitude and knowledge can be calculated as "Comparative Self-Assessment Gain" (CSA Gain \[%\] = ((MWpre- MWpost)/(Mwpre-1)) x 100) using specific outcome evaluation. **Measure:** CSA-gain **Time Frame:** e-Learning: 45 minutes, CSA-gain immediately after e-learning and 6 months post e-learning. **Description:** 12-item questionnaire to assess the impact of CPD activities on changes in clinical behavioural intentions **Measure:** CPD Response Questionnaire ("Continuing professional development") **Time Frame:** Right before starting the 45-minute e-learning session + immediately after the completion of one of the offered online workshops (to be held on two Thursdays per month for 5 years) + 6 months post blended learning. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥18 years * ICU staff and participants of the EPIC intervention study (physician, nurse) * participants of patients and family workshops * agreement to participate in the study Exclusion Criteria: * \&lt;18 years * rejection of study participation. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Martin Neukirchen, MD **Phone:** GER 0049-211-08700 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Raupach T, Munscher C, Beissbarth T, Burckhardt G, Pukrop T. Towards outcome-based programme evaluation: using student comparative self-assessments to determine teaching effectiveness. Med Teach. 2011;33(8):e446-53. doi: 10.3109/0142159X.2011.586751. **PMID:** 21774642 **Citation:** Legare F, Freitas A, Turcotte S, Borduas F, Jacques A, Luconi F, Godin G, Boucher A, Sargeant J, Labrecque M. Responsiveness of a simple tool for assessing change in behavioral intention after continuing professional development activities. PLoS One. 2017 May 1;12(5):e0176678. doi: 10.1371/journal.pone.0176678. eCollection 2017. **PMID:** 28459836 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425679 **Acronym:** ExerMOT4Health **Brief Title:** Cost-effectiveness and Efficacy of Different Physical Exercise Interventions (ExerMOT4Health) **Official Title:** Cost-effectiveness and Efficacy of Physical Exercise on Mental and Physical Health in Older Adults: Role of Motivational Strategies and Digital Technology #### Organization Study ID Info **ID:** PID2021-123688OB-C31 #### Organization **Class:** OTHER **Full Name:** University of Cadiz ### Status Module #### Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Institute of Biomedical research and innovation of Cádiz (INIBICA) **Class:** OTHER **Name:** Universidad de Almeria **Class:** OTHER_GOV **Name:** Ministerio de Ciencia e Innovación, Spain **Class:** UNKNOWN **Name:** Agencia Estatal de Investigación, Spain **Class:** OTHER **Name:** European Regional Development Fund #### Lead Sponsor **Class:** OTHER **Name:** University of Cadiz #### Responsible Party **Investigator Affiliation:** University of Cadiz **Investigator Full Name:** Ana Carbonell Baeza **Investigator Title:** PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people and the influence of motivational strategies. The main aims of this project are: i) To analyze the influence of applying or not motivational strategies during different physical exercise interventions (face-to-face and online) on the effect on mental health, physical health and adherence, according to sex/gender; ii) To analyze and compare the cost-effectiveness and efficacy of face-to-face and online exercise interventions on mental health, physical health and adherence, according to sex/gender. Participants will be 104 community-dwelling older adults (60-75 years) who will be randomized assigned to control, supervised face to face, supervised face to face plus motivation, synchronous online supervised exercise or synchronous online supervised exercise groups. The control group will carry out the usual activities they have been doing, and the intervention groups will participate for 24 weeks in multicomponent exercise intervention. Study assessments will be made before starting the intervention, at the end and after 24 weeks of follow-up. Primary variables will be changes in mental and physical health, assessed by the Trail Making Test, the Yesavage Geriatric Depression Scale, and lower extremity power measured by the sit to stand test. Secondary outcomes will include other parameters of mental and physical health, blood markers, physical activity, and cost-effectiveness analysis. The dropout rate, the attendance at the sessions, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will also be recorded. The results of this project will provide insight into the mental and physical health effects and feasibility of face-to-face and synchronous online supervised physical exercise interventions, and identify older adults' perceptions of the safety, barriers and facilitators of these interventions for future application and transfer to community settings. **Detailed Description:** Scientific evidence has demonstrated the effects of multicomponent physical exercise on the mental and physical health of community-dwelling older people. Despite this, the interest of some older people in exercise is low and even a low percentage of older people practice it with sufficient frequency and intensity to obtain benefits in their mental and physical health. Recent studies have demonstrated the importance of using motivational strategies to generate adherence to exercise, but there are still no studies with community-dwelling older adults. Furthermore, the Covid-19 pandemic has shown that face-to-face physical exercise is not always possible, so it is necessary to have alternatives in case situations of social isolation and mobility restrictions return. It is also important to note that many older people have difficulty traveling to a sports center or living in rural environments, which makes it difficult to practice exercise regularly. Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people. The specific aims of this study are: 1. To analyze the influence of applying or not motivational strategies during supervised face-to-face and synchronous online physical exercise interventions on the effect on mental health, physical health and adherence, according to sex/gender in the community setting. 2. To analyze and compare the cost-effectiveness and efficacy of supervised face-to-face and synchronous online exercise interventions vs usual lifestyle on mental health, physical health and adherence, according to sex/gender in the community setting, in short and long term (follow up). 3. To design and evaluate the feasibility of supervised face-to-face and synchronous online exercise interventions and to identify older adults' perceptions of safety, barriers and facilitators of supervised face-to-face and synchronous online physical exercise interventions for future application and transfer to the community setting. 4. To create audio-visual resources that explain how to implement safe face-to-face and synchronous online supervised physical exercise interventions in older men and women that promote adherence, based on scientific evidence, in the community setting. Participants (N=104 community-dwelling older adults aged 60-75 years) will be randomized assigned to: 1) control, 2)supervised face to face, 3) supervised face to face plus motivation, 4) synchronous online supervised exercise or 5) synchronous online supervised exercise groups. The control group will carry out the usual activities they have been doing, and the intervention groups will participate for 24 weeks in 3 sessions/week of multicomponent exercise intervention, being performed from home (online groups) or at a sport center, according to the assigned group. Each session will last 60 minutes and will include 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. Study assessments will be made before starting the intervention, at the end and after 24 weeks of follow-up. Primary variables will be changes in mental and physical health, assessed by the Trail Making Test, the Yesavage Geriatric Depression Scale, and lower extremity power measured by the sit-to-stand test. Secondary outcomes will include other parameters of mental and physical health, blood markers, physical activity, and cost-effectiveness analysis. We will also record the dropout rate, the attendance at the sessions, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality. ### Conditions Module **Conditions:** - Physical Inactivity - Healthy Aging - Older Adult **Keywords:** - Aging - Exercise - Physical activity - Supervised - Home-based - Multidomain training - Multicomponent training - Physical health - Mental health - Quality of life - Physical function - Cost-effectiveness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Supervised synchronous online exercise intervention without motivational strategies **Label:** Supervised synchronous online exercise intervention without motivational strategies **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Supervised synchronous online exercise intervention with motivational strategies **Label:** Supervised synchronous online exercise intervention with motivational strategies **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Behavioral: Supervised face to face exercise intervention without motivational strategies **Label:** Supervised face to face exercise intervention without motivational strategies **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Behavioral: Supervised face to face exercise intervention with motivational strategies **Label:** Supervised face to face exercise intervention with motivational strategies **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Participants will be advised to maintain their usual lifestyle. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Supervised synchronous online exercise intervention without motivational strategies **Description:** Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks.. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks **Name:** Supervised synchronous online exercise intervention without motivational strategies **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Supervised synchronous online exercise intervention with motivational strategies **Description:** Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online and will also apply motivational strategies based on self-determination theory. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. **Name:** Supervised synchronous online exercise intervention with motivational strategies **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Supervised face to face exercise intervention without motivational strategies **Description:** Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. **Name:** Supervised face to face exercise intervention without motivational strategies **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Supervised face to face exercise intervention with motivational strategies **Description:** Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional who will also apply motivational strategies. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. **Name:** Supervised face to face exercise intervention with motivational strategies **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Trail-Making Test Part A and B will be administered. Part A is based on number sequencing, participants link numbers from 1 to 25 in ascending order. Part B focuses on alternating numbers and letters in ascending order. The completion time will be registered in seconds (the lower duration, the best performance). **Measure:** Neuropsychological Performance **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The short 15-item version of the Yesavage Geriatric Depression Scale will be used. This is a questionnaire used to screen for depression in older people. This scale consists of 15 items with a yes/no answer pattern, being the minimum score 0 and the maximum 15. The cut-off point for Depression is 5 or more. **Measure:** Depression **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Lower limb muscle performance will be assessed using the 30-seconds Chair Sit to Stand (30-s CST) test. The number of standing up in 30 seconds will be counted. A higher score, better performance. **Measure:** Lower-body muscular function **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) #### Secondary Outcomes **Description:** Grip strength will be measured with a digital hand-held dynamometer on both arms (Takei TKK5401, Tokyo, Japan). The test was performed in both standing and sitting positions, in both cases with the arm fully extended. A higher score, better performance. **Measure:** Upper-body muscular function **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Maximum gait speed will be evaluated by measuring the time used to walk 3, 4, 6 and 10 meters linear distance at maximum pace without running. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance. **Measure:** Maximum walking speed (3, 4, 6 and 10-m) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Usual gait speed will be evaluated by measuring the time used to walk 3, 6 and 10 meters linear distance at usual pace. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance. **Measure:** Usual walking speed (3, 6 and 10-m) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** It consists of three parts: the ability to stand with feet together in side-to-side, semi-tandem, and tandem positions (balance), 4-meters walk test (speed), and 5 times sit-to-stand (muscle power). Each part is scored from 0 to 4, with a total SPPB score of 12 points, a higher score, better performance. **Measure:** Short Physical Performance Battery (SPPB) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** SFT battery includes 30-second chair stand test (lower-body strength), 30-second arm curl test (upper-body strength), 6-minute walk test (aerobic endurance), Chair sit-and-reach test (lower-body flexibility), Back scratch test (upper-body flexibility) and 8-foot up-and-go test (agility and dynamic balance). **Measure:** Senior Fitness Test (SFT) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Systolic and diastolic blood pressure will be assessed in a seated position, twice, 2 minutes apart, after 5 minutes at rest, using a digital upper arm blood pressure monitor (OMRON M6, Spain). Blood pressure will be assessed at the level of the right atrium, with the participant's back supported and uncrossed legs with both feet on the floor. **Measure:** Resting blood pressure **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Heart rate will be assessed in a seated position twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute), using a digital upper arm blood pressure monitor (OMRON M6, Spain). **Measure:** Resting heart rate **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Height will be measured with a stadiometer (Seca 213, Hamburg, Germany). Body mass will be measured using a body composition analyzer (InBody 770, Biospace, California, USA). The participant will be barefoot and wearing as minimally clothed as possible. Body mass index will be calculated as body mass (kg) divided by height (m) squared (kg·m-2). **Measure:** Anthropometry **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Waist and hip perimeters will be measured in upright position in accordance with the ISAK guidelines with a circumference tape (Lukfin, W606PM) following the standardized protocol, as well as calf perimeter in a sitting position. **Measure:** Body perimeters **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Body Composition will be measured using a body composition analyzer (InBody 770, Biospace, California, USA), following the standardized protocol. Fat mass (kg and %), fat free mass (kg and %) and skeletal muscle mass (kg and %) will be obtained. **Measure:** Body composition **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The EuroQol-5D questionnaire will be used for assessing the health-related quality of live of the participants, including five dimensions and a visual analogue scale. The 5 dimensions included in the descriptive system are (1) mobility, (2) self-care, (3) usual activities, (4) pain/discomfort, and (5) anxiety/depression. Responses will be coded according to the three-level scale for each dimension. A utility value will be assigned to each combination of responses. This index provides a quantitative measure of each individual's health-related quality of life, where 0 represents the worst possible health and 1 represents the best possible health.The EQ-VAS scale consists of asking participants to indicate their current health status from 0 ("worst imaginable health status") to 100 ("best imaginable health status"). **Measure:** Health-related quality of life **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score ranged from 0 to 30, and the highest score indicates better performance. **Measure:** Cognitive Performance- The Montreal Cognitive Assessment **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Stroop Color and Word Test (SCWT) is divided into three conditions, the first condition consists of reading color names printed in black ink, in the second condition the participant will read colors printed in an "X", and the third condition consists of naming the ink color instead of reading the word. All conditions contain 100 words, and time is limited to 45 seconds for each condition. The total number of correct words for each condition will be recorded, indicating that the higher the number of correct words, the better the performance. **Measure:** Cognitive Performance-The Stroop Color and Word Test (SCWT) **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Digit Span test of the Wechsler Adult Intelligence Scale III (WAIS III). Participants will be asked to recall a list of numbers in the order given (forward or backwards). The test is finished when for the same item, the participant fails two attempts. A total number of correct answers will be registered for each condition, ranging from 0 to 30, with the highest scores being the best performance. **Measure:** Cognitive Performance- Digit Span test of the Wechsler Adult Intelligence Scale III **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The test consists of drawing a clock with a given time (11:10). The total score is the sum of the scores given to dial, numbers and clock faces, ranging from 0 to 10 with the highest scores being the best performance. **Measure:** Cognitive Performance-Clock Drawing Test (CDT). **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Digit Symbol Substitution Test. The participant will fill in a series of coded symbols for 90 and 120 seconds. The total number of responses as well as errors are recorded. In this test, the higher the score, the better the performance. **Measure:** Cognitive Performance- Digit Symbol Substitution Test **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Zung Anxiety Self-Assessment Scale will be used to assess anxiety symptoms. It consists of 20 items with a 4-point response scale ranging from 1 (not at all or hardly ever) to 4 (most or all of the time), obtaining a maximum score of 80. The higher the score, the higher anxiety. **Measure:** Anxiety **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Physical activity and sedentary behavior will be assessed by accelerometry ((Actigraph GT3X, MTI, USA). The devices will be placed on the subject's non-dominant wrist using a watch strap for 8 days. **Measure:** Physical activity and sedentary behavior patterns assessed by accelerometry. **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Physical activity and sedentary behavior will be assessed by the International Physical Activity Questionnaire-Short form (IPAQ). This questionnaire ask about the time spent on vigorous, moderate, walking and sitting activities in the last 7 days. **Measure:** Physical activity and sedentary behavior patterns by questionnaire **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The number of hours of sleep will be assessed by accelerometry ((Actigraph GT3X, MTI, USA). The devices will be placed on the subject's non-dominant wrist using a watch strap for 8 days. **Measure:** Sleep assessed by accelerometry **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Pittsburgh Sleep Quality Index consists of 19 self-assessed questions and 5 partner-assessed questions. The 19 items are combined to form seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), each with a range of 0 to 3 points. The total score ranges from 0 to 21, where 0 points represents no difficulties and 21 points represents severe difficulties and worse sleep quality. **Measure:** Sleep assessed by questionnaire **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Blood samples will be collected in the morning after an overnight fast and at least 24 h after the last exercise session. After collection, tubes will be centrifuged at 3500 rpm for 10 min. Serum obtained for each participant will be stored in aliquots at -80 °C until analysis. Serum BDNF (ng/mL) will be quantified using a sandwich enzyme-linked immunosorbent assay (ELISA). Human BDNF Quantikine Immunoassay (R\&D Systems, Minneapolis, MN) will be performed according to the manufacturer's instructions. **Measure:** Serum BDNF **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Blood samples will be collected in the morning after an overnight fast and at least 24 h after the last exercise session. After collection, tubes will be centrifuged at 3500 rpm for 10 min. Serum obtained for each participant will be stored in aliquots at -80 °C until analysis. A commercial enzyme-linked immunosorbent assay (ELISA) will be performed to measure α-klotho serum concentration (pg/ml) according to the manufacturer's protocol (Human soluble α-Klotho Assay Kit JP27998, Immuno-Biological Laboratories Co., Ltd., Gunma, Japan). The quantification will be performed spectrophotometrically using a FLUOstar OPTIMA Microplate Reader (ThermoFisher Scientific, Waltham, MA, USA) and Optima Control software version 2.20. **Measure:** Serum α-Klotho **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Glucose, uric acid, urea, creatinine, bilirubin, sodium, potassium, chloride, calcium, phosphorus, total proteins, albumin, cholesterol, cholesterol-HDL, cholesterol-LDL (calculated), triglycerides, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyltransferase (GGT),alkaline phosphatase, lactate dehydrogenase (LDH), creatine kinase (CK,) will be measured using routinary clinical techniques. **Measure:** Routinary blood serum analysis **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** It consists of the analysis following parameters: red blood cell count, hemoglobin concentration, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, white blood cell count, differential white blood cell count, platelet count and mean platelet volume **Measure:** Hemogram **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** Motivators and barriers to exercise will be measured using the Exercise Benefits/Barriers Scale. It is a 43-item instrument with a four-response Likert-type scale; Twenty-nine items are related to the benefits, while the remaining 14 are barriers. - The total score of the instrument can range from 43 to 172 points, with higher scores indicating a more positive perception of exercise. **Measure:** Motivators and barriers to exercise **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48). **Description:** The Behavioral Regulation during Exercise Questionnaire (BREQ-3) comprises 23 items (4 for intrinsic regulation, 4 for integrated regulation, 3 for identified regulation, 4 for introjected regulation, 4 for external regulation and 4 for amotivation) that measure the stages of the self-determination theory with respect to motivation to exercise. Participants will answer each item on a 5-point scale ranging from 0 (not true for me) to 4 (very true for me). Higher scores on identified regulation, integrated regulation and intrinsic motivation are generally considered indicative of a more self-determined and healthy motivation towards exercise. On the other hand, higher scores on amotivation, external regulation and introjected regulation generally indicate less self-determined motivation. **Measure:** Motivation to exercise according to self-determination theory **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** The Basic Psychological Needs in Exercise Scale (BPNES) is composed of 12 items assessing the satisfaction of the three basic psychological needs in physical exercise contexts: competence, autonomy and relationship with others. A 5-point likert scale is used: (1) Do not agree at all, (2) Somewhat agree, (3) Somewhat agree, (4) Strongly agree, and (5) Strongly agree.using : (1) I don't agree at all, (2) I agree a little bit, (3) I somewhat agree, (4) I agree a lot, and (5) I completely agree. For each need, a minimum score of 4 points and a maximum of 20 points can be obtained. The score for the total questionnaire would be a minimum of 12 points and a maximum of 60 points. A higher score reflects a better satisfaction of basic psychological needs. **Measure:** Basic Psychological Needs in Exercise **Time Frame:** Baseline (week 0), Post-intervention (week 25) and follow-up (week 48) **Description:** The Satisfaction with Life Scale is a 5-item instrument with a Likert-type scale ranging from 1 to 5 points, and measures overall subjective happiness through statements in which participants rate themselves. The higher the score, the higher the satisfaction with life. **Measure:** Satisfaction with Life **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** Age, sex, marital status, educational level, socioeconomic status, employment status, self-rated health, family history of Alzheimer, pathologies diagnosed, number of falls during the previous year, consumption of medicines, and tobacco and alcohol consumption will be determined by this questionnaire **Measure:** Sociodemographic characteristics questionnaire **Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48) **Description:** A cost-effectiveness analysis will be performed to assess the expenses associated with each intervention group, utilizing the EQ-5D questionnaire to evaluate changes in health states.The analysis will focus on the following key metrics, the Quality-Adjusted Life-Year (QALY) and the Incremental Cost-Effectiveness Ratio (ICER). The Cost-Utility analysis examines an intervention's cost-effectiveness by considering expenses and the impact on patients' quality of life. QALYs provide a comprehensive measure of both the quantity and quality of life, calculated by multiplying the utility weights assigned to each health state by the time spent in that state. The cost per QALY gained is determined by dividing the total intervention costs by the total QALYs gained. The ICER compares the cost-effectiveness of two interventions by evaluating the difference in costs and effects (QALYs gained). A positive ICER indicates that Intervention A is more expensive and less effective than Intervention B **Measure:** Cost-Effectiveness Analysis **Time Frame:** Through intervention completion (24 weeks) **Description:** Adherence to physical training program will be recorded by the trainers. It will be calculated as a percentage (\[sessions completed/total sessions expected\] x 100), where 0 % indicates total non-adherence and 100 % indicates full adherence to the exercise intervention. **Measure:** Adherence to physical training program **Time Frame:** Through intervention completion (week 24) **Description:** During the 24-week follow-up, the investigators will assess through an ad-hoc self-reported questionnaire whether or not participants exercised during the follow up period (24 weeks), the exercise modality performed, if the exercise was supervised center-based and/or unsupervised/supervised home-based, the number of weekly exercise sessions performed, the average time and the subjective intensity perceived (light, moderate or vigorous). **Measure:** Exercise during follow-up period **Time Frame:** Follow-up (week 48) **Description:** Participants in the supervised synchronous online exercise and control groups will record in a diary their falls and adverse events during and outside exercise sessions. In the supervised face to face groups, supervisors will register the incidence of falls during exercise sessions an participants will register them outside the exercise sessions using the diary. **Measure:** Falls and adverse events **Time Frame:** Through intervention completion (24 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * People from both sexes aged 60-75 years. * Not to have diseases and disabilities that limit to be part of exercise interventions or avoid measurements. * Not perform supervised moderate to vigorous physical activity \>30 minutes and \>3 days/week. * To be able to communicate without problems. * To be able to read and understand the aim of the project and informed consent form. * To have a smartphone, tablet or computer with internet connection. Exclusion Criteria: * Acute or terminal illness. * Myocardial infarction, coronary artery bypass grafting, angioplasty, angina, or other cardiac conditions in the past year. * Uncontrolled medical problems that the general practitioner considers would preclude patients from undertaking the exercise program (e.g., acute systemic illness such as pneumonia, acute rheumatoid arthritis, and acute or unstable heart failure). * Conditions requiring a specialized physical exercise program (e.g., uncontrolled epilepsy, significant neurological disease or impairment, inability to maintain an upright seated position or unable to move independently, multiple sclerosis, cancer, Parkinson's, Alzheimer's, or chronic obstructive pulmonary disease). * General practitioner-diagnosed hypertension that has not been controlled. * Uncontrolled Type I or Type II Diabetes. * History of major psychiatric illness including schizophrenia, generalized anxiety disorder, or depression according to the DSM-5. * Three or more self-reported falls in the last year. * Not wanting to complete the study or be assigned to the control group; * Be participating in another research study that may influence this project. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Almería **Country:** Spain **Facility:** Universidad de Almeria **State:** Almeria **Zip:** 04120 **Location 2:** **City:** Puerto Real **Country:** Spain **Facility:** University of Cadiz **State:** Cadiz **Zip:** 11519 #### Overall Officials **Official 1:** **Affiliation:** University of Cadiz **Name:** Ana Carbonell Baeza, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Universidad de Almeria **Name:** Pablo Jorge Marcos Pardo, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425666 **Brief Title:** Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy **Official Title:** European Prospective Multicentre, Open Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy (ETCF-trial) #### Organization Study ID Info **ID:** Uni-Koeln-5135 #### Organization **Class:** OTHER **Full Name:** University of Cologne #### Secondary ID Infos **Domain:** ESCRS (European society of Cataract and Refractive Surgeons) **ID:** ORG-100006227 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Clinical Trials Centre Cologne **Class:** UNKNOWN **Name:** ESCRS (European Society of Cataract and Refractive Surgeons) #### Lead Sponsor **Class:** OTHER **Name:** University of Cologne #### Responsible Party **Investigator Affiliation:** University of Cologne **Investigator Full Name:** Björn Bachmann **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients treated with one of the following two surgeries: (1) cataract surgery with preservation of the diseased endothelial cells ("cataract surgery only experimental intervention, investigational therapy/ arm 1); (2) cataract surgery combined with removal of the diseased endothelial cells and the attached Descemet's membrane followed by transplantation of a healthy endothelial cell layer with attached Descemet's membrane ("triple-DMEK"(""cataract surgery only", control intervention comparator therapy/ arm 2) **Detailed Description:** After signing the informed consent, patients are screened for eligibility for the trial regarding in- and exclusion criteria. Different tests will be performed like ocular examination including slit lamp examination, fundus examination, IOP measurement, BSCVA, Pentacam imaging, contrast sensivity test and Macula-OCT, vital signs. Once all inclusion criteria and none of the exclusion criteria are met, the patient will be enrolled into the trial and will receive a subject-ID. If Screening and Baseline assessments cannot be performed on the same day, a Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial. At the Baseline Visit different tests will be performed like a Fluorescein stain test. In addition, subjects have to complete vision related quality of life questionnaires. After all investigations are completed, the subject will be randomised and distributed to the respective treatment groups. Patients who are enroled in arm 1 undergo exclusively a cataract surgery, in the comparator therapy (arm 2) patients undergo triple-DMEK (cataract surgery and DMEK) The post-operative Visit will take place 22 weeks ± 14 days after the surgical intervention where different test have to be performed. The duration of the clinical trial for every individual subject will be up to 24 weeks. ### Conditions Module **Conditions:** - Cataract Surgery - Cataract and Fuchs Endothelial Corneal Dystrophy **Keywords:** - Fuchs´ Endothelial Corneal Dystrophy Krachmer grade 3 and 4 - nuclear cataract - Nuclear opalescence (NO) grades 2 - Nuclear opalescence (NO) grades 3 - Central corneal thickness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Masking Description:** After screening and enrollement subjects will be randomly allocated to the trial groups (cataract surgery versus triple-DMEK, allocation rate 1:1) **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After randomisation the investigational therapy (arm 1), patients undergo a cataract surgery (cataract surgery with preservation of the diseased endothelial cells). The cataract surgery will take approximately 10-20 minutes. The follow-up period after surgery will be 22 weeks ± 14 days. **Intervention Names:** - Procedure: Intervention group /arm 1 (Cataract surgery alone) **Label:** Experimental intervention /arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After randomisation, patients in the comparator therapy (arm 2) undergo triple-DMEK which is a cataract surgery combined with DMEK (removal of the diseased endothelial cells followed by transplantation of a healthy endothelial cell layer). Triple-DMEK takes approximately 5-10 minutes longer than cataract surgery. The follow-up period after surgery will be 22 weeks ± 14 days. **Intervention Names:** - Procedure: Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK) **Label:** Control intervention /arm2 **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental intervention /arm 1 **Description:** Cataract surgery (experimental intervention / arm 1) is performed using a small incision technique. The main incision will be localized between 11 and 12 o'clock and will have a width of 2.4 to 2.8 mm. A tunnel suture will only be placed if there is leakage from the incisions. A thin dispersive viscoelastic is applied to the endothelium for protection before phacoemulsification. A hydrophobic acrylic monofocal IOL will be implanted into the bag. **Name:** Intervention group /arm 1 (Cataract surgery alone) **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control intervention /arm2 **Description:** After cataract surgery DMEK is continued using the surgeon's standard technique for graft implantation and unfolding in triple-DMEK. In all cases the graft will be implanted using the same main incision as for IOL implantation. Once the DMEK graft is unrolled and attached to the posterior corneal stroma the complete anterior chamber will be filled with SF6 20%. **Name:** Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Best spectacle corrected visual acuity (BSCVA) is messured with EDTRS-charts (transformed to logMAR) **Measure:** The primary objective of the study is to investigate whether there is a difference in best spectacle corrected visual acuity (BSCVA) in patients who receive one of the following two surgeries: (arm 1) cataract surgery alone and (arm 2) triple-DMEK **Time Frame:** 22 weeks +/- 14 days after surgery #### Secondary Outcomes **Description:** Specific measurement variable: ETDRS charts (transformed to logMAR); Analysis metric (participant level): Difference BSCVA at follow-up - BSCVA at baseline \[logMAR - no dimension\]; Method of aggregation (summary measure for each study group): Mean difference **Measure:** Change in visual acuity (BSCVA) **Time Frame:** Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of Freiburg Vision Test "FrACT"; Analysis metric (participant level): Value \[logCS (Weber)\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Contrast sensitivity **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of objective scattering index (OSI); Analysis metric (participant level): Value \[OSI - no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Optical quality measured by HD-analyzer **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of Modulation transfer function (MTF) cut-off; Analysis metric (participant level): Value \[c/deg\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Optical quality measured by HD-analyzer **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Total score of Strehl ratio; Analysis metric (participant level): Value \[no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Optical quality measured by HD-analyzer **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Deviation from target refraction \[D\], mean error \[ME\], mean absolute error \[MAE\]; Analysis metric (participant level): Value (D, ME and/or MAE) \[D\]); Method of aggregation (summary measure for each study group): Mean **Measure:** Refractive accuracy:spherical equivalent **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Corneal densitometr (grayscale unit GSU) (Anterior, central, posterior and total layer); Analysis metric (participant level): Value \[GSU\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Corneal topography/ tomography **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Corneal densitometry (grayscale unit GSU) (Anterior, central, posterior and total layer); Analysis metric (participant level): Difference value at follow-up - baseline value \[GSU\]; Method of aggregation (summary measure for each study group): Mean difference **Measure:** Change in Corneal topography/tomography parameters **Time Frame:** At baseline and 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: CCT measured by Pentacam \[μm\]; Analysis metric (participant level): Difference CCT at follow up - CCT baseline \[µm\]; Method of aggregation (summary measure for each study group): Mean difference **Measure:** Change in central corneal thickness (CCT) **Time Frame:** At baseline and 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: CME visualized by SD-OCT; Analysis metric (participant level): Value \[yes/no\]; Method of aggregation (summary measure for each study group): Proportion **Measure:** Cystoid macular edema **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Measured by SD-OCT; Analysis metric (participant level): Difference value at follow-up - baseline value \[µm\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Change in central retinal thickness **Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Total score \[no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Quality of life after surgery **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Specific measurement variable: Catquest-9SF (all centers) and V-Fuchs (Germany only); Analysis metric (participant level): Difference in total score \[no dimension\] (follow-up-- baseline) \[no dimension\]; Method of aggregation (summary measure for each study group): Mean **Measure:** Change in quality of life **Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery **Description:** Analysis metric (participant level): Value \[mmHg\] **Measure:** Change in intraocular pressure (IOP) from baseline **Time Frame:** At baseline and at 22 weeks +/- 14 days after initial surgery **Description:** Analysis metric (participant level): Value \[yes/no\] **Measure:** Postoperative endothelial decompensation **Time Frame:** 22 weeks +/- 14 days after initial surgery **Description:** Analysis metric (participant level): Value \[yes/no\] **Measure:** Additional ocular surgeries **Time Frame:** 22 weeks +/- 14 days after initial surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with FECD and nuclear cataract in study eye 2. Male and female patients ≥18 years of age 3. Subject must be able to understand and read the national language. 4. Written informed consent prior to any study-related procedures 5. Nuclear opalescence (NO) grades 2 and 3 according to the lens opacities classification system III (LOCS III) 6. Krachmer grade (3 \[2-5 mm diameter area with confluent guttae\]; 4 \[ \> 5 mm diameter area with confluent guttae\] without edema identified by slit lamp examination) 7. Central corneal thickness (CCT) measured with Pentacam below 620 µm between 8:00 am and 01:00 pm 8. BSCVA logMAR \< 0,7 and \> 0,1 9. No previous cataract surgery or triple-DMEK on the opposite side 10. Pentacam Quality specification: "OK" 11. For women below age of 60 negative urine pregnancy test Exclusion Criteria: 1. Patients with ocular and/or systemic comorbidity affecting vision or clinically proven anterior and/or posterior segment disease other than FECD and cataract (exclusion of macular disease or edema by OCT) 2. Iris synechiae, pupil diameter \<6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or inflammatory disease 3. Subjective diurnal changes in visual acuity with worse visual acuity in the morning 4. Corneal (epithelial) edema visible at slit lamp examination 5. Preoperative anterior chamber depth below 2 mm 6. Participation in other interventional trials parallel or within the last 4 weeks 7. Systemic use of Alpha-1-Adrenozeptor-Antagonists, immunosuppressive therapy or chemotherapy) 8. Pregnant women and nursing mothers 9. Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator 10. Legally incapacitated persons 11. Persons held in an institution by legal or official order **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Björn Bachmann, Prof. **Phone:** 0049-221 478-87476 **Role:** CONTACT #### Locations **Location 1:** **City:** Aarhus N **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jesper Hjortdal, Prof. - **Phone:** 78 45 46 44, 23346770 - **Phone Ext:** 0045 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jesper Hjortdal, Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Denmark **Facility:** Department of Ophthalmology, Aarhus University Hospital **State:** Midtjylland **Zip:** DK- 8200 **Location 2:** **City:** Köln **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Björn Bachmann, Prof. - **Phone:** 0049-2214784308 - **Role:** CONTACT ***Contact 2:*** - **Name:** Björn Bachmann, Prof. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Germany **Facility:** Klinik für Ophthalmologie des Universitätsklinikums Köln **State:** NRW **Zip:** 50937 **Location 3:** **City:** Nijmegen **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Siamak Nobacht, Dr. - **Phone:** 653613048 - **Phone Ext:** 0031 - **Role:** CONTACT ***Contact 2:*** - **Name:** Siamak Nobacht, Dr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Netherlands **Facility:** Radboud-Universität Nijmegen **State:** Gelderland **Zip:** GA 6525 **Location 4:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** José Luis Güell, Dr. - **Phone:** 934 000 700 - **Phone Ext:** 0034 - **Role:** CONTACT ***Contact 2:*** - **Name:** José Luis Güell, Dr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Instituto de microcirugía ocular; Departamento de Cornea y Cirugia Refractiva **Zip:** 08035 #### Overall Officials **Official 1:** **Affiliation:** University Hospital Cologne **Name:** Björn Bachmann, Prof. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007905 - Term: Lens Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003316 - Term: Corneal Diseases - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M5638 - Name: Cataract - Relevance: HIGH - As Found: Cataract - ID: M6540 - Name: Corneal Dystrophies, Hereditary - Relevance: HIGH - As Found: Corneal Dystrophy - ID: M8761 - Name: Fuchs' Endothelial Dystrophy - Relevance: HIGH - As Found: Fuchs Endothelial Corneal Dystrophy - ID: M10917 - Name: Lens Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002386 - Term: Cataract - ID: D000003317 - Term: Corneal Dystrophies, Hereditary - ID: D000005642 - Term: Fuchs' Endothelial Dystrophy ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425653 **Brief Title:** Exercise With Scleroderma Functional Outcomes **Official Title:** The Effect of Exercise Program Applied to Patients With Scleroderma on Functional Outcomes: A Randomized Controlled Trial #### Organization Study ID Info **ID:** 20-9T/25 #### Organization **Class:** OTHER **Full Name:** Trakya University ### Status Module #### Completion Date **Date:** 2021-12-05 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-02-05 **Type:** ACTUAL #### Start Date **Date:** 2021-02-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Scientific and Technological Research Council of Turkey #### Lead Sponsor **Class:** OTHER **Name:** Trakya University #### Responsible Party **Investigator Affiliation:** Trakya University **Investigator Full Name:** Gizem Özbudak **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 study aims to investigate the effects of an exercise program applied to patients with scleroderma on functional outcomes (hand and mouth functional results and quality of life). **Detailed Description:** Systemic sclerosis (scleroderma) is a significant, rare autoimmune connective tissue disease characterized by autoantibodies, fibrosis of the skin and internal organs, microvascular injury and vascular damage due to endothelial cell activation (Sepulveda et al., 2019; Rosendahl et al., 2022). The term "scleroderma" is derived from two Greek words "sklero" and "derma" meaning hard skin (Bielacka et al., 2017; Singh et al., 2019). The global prevalence of scleroderma is estimated to be between 0.3 and 40 per 100,000 population (Alhendi et al., 2020; Benz et al., 2021; Sierakowska et al., 2019). The occurrence of systemic sclerosis in women is three to five times and in some literature up to eight times higher than in men. The disease incidence peaks between the ages of 30 and 65 (Sierakowska et al., 2019; Hughes et al., 2020; Alhendi et al., 2020). Impairment of hand functions is one of the most significant disabilities in patients with scleroderma and is commonly observed (Gregory et al., 2019; Mugii et al., 2019). The skin of the hand thickens with manifestations including fingertip ulcers, swelling of the fingers, raynaud's phenomenon and subcutaneous calcium deposition (Abreu et al., 2023). Deformities such as loss of flexion in the metacarpophalangeal joints, loss of extension in the proximal and distal interphalangeal joints, loss of abduction, flexion of the thumb and wrist movement can occur, leading to contractures and severe impairment of hand functions (Bongi \& Rosso, 2016; Vannajak et al., 2014). Besides hand function impairment, another significant issue in scleroderma is the fibrotic involvement of the connective tissue of the face and mouth. Patients tend to lose facial expression. Sclerosis of the skin around the lips and mouth area causes a reduction in mouth opening (microstomia) and width (microcheilia) in 43% to 80% of cases (Puzio et al., 2019; Uras et al., 2019). Rehabilitation strategies which play a crucial role in the management of scleroderma, include psychoeducational interventions, exercise therapy, application of physical methods, assistive devices and orthoses; joint protection and energy conservation approaches, dietary interventions and comprehensive multidisciplinary team care programs (Schouffoer et al., 2011). Among these interventions daily hand exercises are specifically mentioned to improve hand movement and function, and also mouth and facial exercises positively affect mouth opening function (Gregory et al., 2019). Hand rehabilitation enhances hand movement, functionality and strength, as well as participation in daily life activities such as self-care, housework, work and recreational activities, thereby improving quality of life (Bongi \& Rosso, 2016). Exercises that stretch the mouth and increase mouth opening are reported to prevent the progression of microstomia and reduce limitations in mouth opening (Puzio et al., 2019; Yuen et al., 2012). Some approaches and techniques involving active exercises for managing microstomia are suggested, indicating success with the performance of mandibular movements (Puzio et al., 2019). Programs that include hand and oral rehabilitation interventions are needed to prevent hand deformities and oral dysfunctions, ensure positive body perception, provide coping strategies and maintain quality of life (Schouffoer et al., 2011; Vannajak et al., 2014). However, individuals with a rare disease such as scleroderma face many challenges, including lack of knowledge about the disease, difficulties in accurate diagnosis and limited treatment and support options. Professional support services that are usually provided to individuals with more common diseases are not available for scleroderma patients (Delisle et al., 2019). Scleroderma is a chronic disease that affects multiple systems and can present numerous symptoms and complications, impacting individuals physically, psychologically and socially. Therefore, the care of patients with scleroderma requires an interdisciplinary holistic health approach that encompasses both physical and emotional support. The rarity of scleroderma, the fact that many patients live far from physical therapy and rehabilitation clinics or the necessity of continuous participation in a program necessitates the implementation of nurse-led home programs (Murphy et al., 2018). ### Conditions Module **Conditions:** - Scleroderma, Systemic - Scleroderma, Diffuse - Scleroderma, Limited - Hand Rheumatism - Mouth Movement Impaired **Keywords:** - exercise - hand and mouth functional outcomes - nursing - scleroderma - quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 44 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the control group the standard protocol was applied. The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization **Intervention Names:** - Other: Exercise Program **Label:** Exercise Program **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The standard protocol included routine care and treatment practices conducted by the same physician at the same institution. **Label:** Standart Protocol **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise Program **Description:** In the intervention group in addition to the standard protocol, an exercise program intervention was applied and after the initial interview the "Exercise Program DVD" was provided through mobile phone. All patients were evaluated 4 times: at baseline, at the 4th week (first visit), at the 8th week (second visit) and at the 12th week (final visit) after randomization **Name:** Exercise Program **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** The mouth opening measurements at the final follow-up of the intervention and control group patients included in the study are compared in Table 3. A statistically significant difference was found between the final follow-up mouth opening measurement values of the groups (p\<0.05) **Measure:** Oral functional results of the participants **Time Frame:** After 12 weeks **Description:** The final follow-up scores of the World Health Organization Quality of Life (WHOQOL) Scale averages for the patients in the intervention and control groups who participated in the study were compared. When all subdomains of the scale were evaluated, it was determined that there was a statistically significant difference between the final follow-up total score averages for the physical, psychological, social and environmental domains of the patients in both the intervention and control groups (p\<0.05) **Measure:** Quality of life results of the participants **Time Frame:** After 12 weeks #### Primary Outcomes **Description:** Of the patients included in the study, 50.0% (22 patients) were in the intervention group and 50.0% (22 patients) were in the control group. 95.5% of the intervention group were women and 4.5% were men, with the control group also comprising 95.5% women and 4.5% men patients. The mean age of the all patients was 51.70 ± 11.11 years. 63.6% of patients in the intervention group and 59.1% of patients in the control group were diagnosed with diffuse cutaneous scleroderma. The mean duration of scleroderma diagnosis of all the patients was 9.54 ± 6.73 years for the intervention group and 9.4 ± 6.20 years for the control group. The majority in both groups (63.6% in the intervention group / 95.5% in the control group) were nonsmokers. Table 1 compares the demographic and disease characteristics of the groups. Groups were similar with regard to the demographic and disease characteristics. **Measure:** Demographic and disease characteristics of the participants **Time Frame:** After 12 weeks #### Secondary Outcomes **Description:** Upon examining the final follow-up hand functional outcomes of the intervention and control group patients, it has been observed that there is a statistically significant difference between the groups in terms of the average total score of the Duruöz Hand Scale for all sub-dimensions including kitchen, dressing, cleaning, workplace and other activities, as well as the overall average total score (p\<0.05) **Measure:** Hand functional outcomes of the participants **Time Frame:** After 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The inclusion criteria were being aged between 18 to 70 years, having no communication problems, being able to speak Turkish and agreeing to participate in the study. Exclusion Criteria: * . The exclusion criteria were not having the ability to regularly perform hand and mouth exercises, having undergone hand surgery in the last six months, having open wounds or contractures on the hand, having hand and mouth functional disorders due to reasons other than scleroderma, having no teeth, having all upper and lower teeth as dentures and being included in a rehabilitation program in the last three months. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Edirne **Country:** Turkey **Facility:** Gizem Özbudak #### Overall Officials **Official 1:** **Affiliation:** Trakya University **Name:** Gizem Özbudak, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ege University **Name:** Serap Özer, PhD **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Ege University **Name:** Figen Yargucu Zihni, MD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Sierra-Sepulveda A, Esquinca-Gonzalez A, Benavides-Suarez SA, Sordo-Lima DE, Caballero-Islas AE, Cabral-Castaneda AR, Rodriguez-Reyna TS. Systemic Sclerosis Pathogenesis and Emerging Therapies, beyond the Fibroblast. Biomed Res Int. 2019 Jan 23;2019:4569826. doi: 10.1155/2019/4569826. eCollection 2019. **PMID:** 30809542 **Citation:** Rosendahl AH, Schonborn K, Krieg T. Pathophysiology of systemic sclerosis (scleroderma). Kaohsiung J Med Sci. 2022 Mar;38(3):187-195. doi: 10.1002/kjm2.12505. Epub 2022 Mar 2. **PMID:** 35234358 **Citation:** Kowal-Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, Distler O, Clements P, Cutolo M, Czirjak L, Damjanov N, Del Galdo F, Denton CP, Distler JHW, Foeldvari I, Figelstone K, Frerix M, Furst DE, Guiducci S, Hunzelmann N, Khanna D, Matucci-Cerinic M, Herrick AL, van den Hoogen F, van Laar JM, Riemekasten G, Silver R, Smith V, Sulli A, Tarner I, Tyndall A, Welling J, Wigley F, Valentini G, Walker UA, Zulian F, Muller-Ladner U; EUSTAR Coauthors. Update of EULAR recommendations for the treatment of systemic sclerosis. 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Physiotherapy. 2019 Sep;105(3):370-377. doi: 10.1016/j.physio.2018.08.008. Epub 2018 Sep 5. **PMID:** 30318128 **Citation:** Mugii N, Matsushita T, Oohata S, Okita H, Yahata T, Someya F, Hasegawa M, Fujimoto M, Takehara K, Hamaguchi Y. Long-term follow-up of finger passive range of motion in Japanese systemic sclerosis patients treated with self-administered stretching. Mod Rheumatol. 2019 May;29(3):484-490. doi: 10.1080/14397595.2018.1466635. Epub 2018 May 15. **PMID:** 29667474 **Citation:** Marcatto de Abreu MF, Landim S, Yuamoto FY, Lins C, Magalhaes EP, Etchebehere M. Screening tool development for hand surgery referrals in systemic sclerosis. Clinics (Sao Paulo). 2023 Aug 17;78:100270. doi: 10.1016/j.clinsp.2023.100270. eCollection 2023. **PMID:** 37597472 **Citation:** Maddali-Bongi S, Del Rosso A. Systemic sclerosis: rehabilitation as a tool to cope with disability. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):162-169. Epub 2016 Jul 4. **PMID:** 27384349 **Citation:** Vannajak K, Boonprakob Y, Eungpinichpong W, Ungpansattawong S, Nanagara R. The short-term effect of gloving in combination with Traditional Thai Massage, heat, and stretching exercise to improve hand mobility in scleroderma patients. J Ayurveda Integr Med. 2014 Jan;5(1):50-5. doi: 10.4103/0975-9476.128859. **PMID:** 24812476 **Citation:** Puzio A, Przywara-Chowaniec B, Postek-Stefanska L, Mrowka-Kata K, Trzaska K. Systemic sclerosis and its oral health implications. Adv Clin Exp Med. 2019 Apr;28(4):547-554. doi: 10.17219/acem/76847. **PMID:** 30079996 **Citation:** Uras C, Mastroeni S, Tabolli S, Masini C, Pallotta S, Teofoli P, Rocco G, Mazzanti C, Abeni D. A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial. Clin Rehabil. 2019 Nov;33(11):1747-1756. doi: 10.1177/0269215519858395. Epub 2019 Jun 19. **PMID:** 31216880 **Citation:** Schouffoer AA, Ninaber MK, Beaart-van de Voorde LJ, van der Giesen FJ, de Jong Z, Stolk J, Voskuyl AE, Scherptong RW, van Laar JM, Schuerwegh AJ, Huizinga TW, Vlieland TP. Randomized comparison of a multidisciplinary team care program with usual care in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2011 Jun;63(6):909-17. doi: 10.1002/acr.20448. **PMID:** 21312348 **Citation:** Yuen HK, Marlow NM, Reed SG, Mahoney S, Summerlin LM, Leite R, Slate E, Silver RM. Effect of orofacial exercises on oral aperture in adults with systemic sclerosis. Disabil Rehabil. 2012;34(1):84-9. doi: 10.3109/09638288.2011.587589. Epub 2011 Sep 27. **PMID:** 21951278 **Citation:** Delisle VC, Gumuchian ST, El-Baalbaki G, Korner A, Malcarne VL, Pelaez S, Carrier ME, Pepin M, Thombs BD; Scleroderma Support Group Project Advisory Team. Training and support needs of scleroderma support group facilitators: the North American Scleroderma Support Group Facilitators Survey. Disabil Rehabil. 2019 Oct;41(20):2477-2482. doi: 10.1080/09638288.2018.1467970. Epub 2018 Apr 26. **PMID:** 29696997 **Citation:** Murphy SL, Barber MW, Homer K, Dodge C, Cutter GR, Khanna D. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1653-1660. doi: 10.1002/acr.23522. **PMID:** 29381834 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Scleroderma - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: HIGH - As Found: Scleroderma - ID: M15045 - Name: Rheumatic Diseases - Relevance: HIGH - As Found: Rheumatism - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M25562 - Name: Scleroderma, Limited - Relevance: HIGH - As Found: Scleroderma, Limited - ID: M15411 - Name: Scleroderma, Localized - Relevance: HIGH - As Found: Scleroderma - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: HIGH - As Found: Scleroderma - ID: T3490 - Name: Localized Scleroderma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012216 - Term: Rheumatic Diseases - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000045743 - Term: Scleroderma, Diffuse - ID: D000012594 - Term: Scleroderma, Localized - ID: D000045745 - Term: Scleroderma, Limited ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425640 **Acronym:** 24h-MBs_T1D **Brief Title:** 24-hour Movement Behaviors in Adults With Type 1 Diabetes **Official Title:** INTERPLAY WITHIN THE DAY: Optimizing Intra-day Glucose Control by Intervening on the Day-to-day 24-hour Movement Behavior Patterns in Adults With Type 1 Diabetes Mellitus. #### Organization Study ID Info **ID:** ONZ-2023-0611 #### Organization **Class:** OTHER **Full Name:** University Hospital, Ghent ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-01 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Ghent #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Ghent #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Only 24.9% of the Belgian adults (25-50 years) with type 1 diabetes mellitus (T1DM) achieve a good glucose control. This can be explained by the challenging day-to-day diabetes management which places a substantial burden on this population. However, a tight glycemic control is fundamental in order to prevent the development of acute and chronic complications. Despite the added value of continue glucose monitors to glucose control, optimizing daily glucose levels is still problematic in adults with T1DM. In addition to self-monitoring of blood glucose, a healthy lifestyle with sufficient physical activity (PA), limited sedentary behavior (SB) and sufficient sleep time and quality is crucial for a good glucose control. A recent shift in health promotion stresses the importance of considering all these behaviors (i.e. PA, SB and sleep) in one 24-hour day instead of focusing on one behavior in isolation. The aim of this study is to investigate the association between the day-by-day 24h-MB patterns of adults (25-50 years) with T1DM and their intra-day glucose control (i.e. time in range and coefficient of variation) on the one hand. On the other hand, associations between he 24-h MB patterns and explanatory variables and cardiometabolic health markers will be investigated. To gain insight into the 24-hour behavior of adults with type 1 diabetes, 150 adults with type 1 diabetes will wear an Actigraph accelerometer, for 14 consecutive days. Daily glucose control will be measured using the participant's continuous glucose meter. Information about the explanatory variables and cardiometabolic health will be obtained by means of a questionnaire, diary and a few measurements (blood pressure, weight, length, Advanced Glycation Endproducts, hip-and waist circumference) during a one-off visit to one of the recruitment- and testing centers namely University hospital of Ghent or University hospital of Antwerp. The results of this cross-sectional study will inform future interventions focusing on the 24-hour movement behaviors in adults with T1DM. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 1 **Keywords:** - 24-hour movement behaviors - Glycemic control ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adults with type 1 diabetes (25-50 years) will wear an accelerometer to objectively measure their 24-hour movement behaviors. An online questionnaire and food diary will be completed to gain insight into the explanatory variables of 24-hour movement behaviors. Information on glucose control will be collect through the continuous glucose monitor of the participant. **Intervention Names:** - Behavioral: 24-hour movement behavior **Label:** Adults with type 1 diabetes ### Interventions #### Intervention 1 **Arm Group Labels:** - Adults with type 1 diabetes **Description:** Cross-sectional observational study investigating the 24-hour movement behaviors and glucose control **Name:** 24-hour movement behavior **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Following demographics will be questioned in a self-developed questionnaire: age, sex, ethnicity, smoking status, educational level, profession, family situation. **Measure:** Demographics **Time Frame:** Through study completion, an average 1 year **Description:** Health-related variables that will be questioned are height, weight, timing of T1DM diagnosis, insulin delivery system (CSII versus multiple daily injections), insulin and other medication. **Measure:** Health-related variables **Time Frame:** Through study completion, an average 1 year **Description:** Two questionnaires will be used to measure HRQOL: the Short Form 36 health survey questionnaire (SF-36) and the Diabetes Quality of life questionnaire-brief (DQOLQ-brief). The SF-36 will measure the general HLQOL. The DQOLQ-brief will assesses diabetes-related QOL. **Measure:** Health-related quality of life **Time Frame:** Through study completion, an average 1 year **Description:** The Hospital Anxiety and Depression Scale is a short (14-item) and easy to use questionnaire. The questionnaire consists of two subscales: one evaluates anxiety (7 items) and the other depression (7 items). **Measure:** Depression an anxiety **Time Frame:** Through study completion, an average 1 year **Description:** The patient education and knowledge (PEAK) questionnaire will be used to assess diabetes knowledge. Diabetes knowledge is determined based on 10-items (i.e. knowledge about insulin titration, correction factor, carbohydrate counting, PA and interpretation of glucose trends) with scores ranging from 0 (no diabetes knowledge) to 10 (excellent diabetes knowledge). **Measure:** Diabetes knowledge **Time Frame:** Through study completion, an average 1 year **Description:** Health literacy will be assessed using the validated Newest-Vital Sign-D (NVS-D) questionnaire. The NVS-D is a six items questionnaire which assesses an individual ability to find, understand and apply information. **Measure:** Health literacy **Time Frame:** Through study completion, an average 1 year **Description:** Diabetes self-management will be assessed using the diabetes self-management questionnaire revised (DSMQ-R). The DSMQ-R is a multidimensional validated questionnaire with 27-items regarding essential self-management practices (e.g. glucose monitoring, physical activity, cooperation with diabetes team) for T1DM. **Measure:** Diabetes self-management **Time Frame:** Through study completion, an average 1 year **Description:** newly developed and reliable questionnaire to assess explanatory variables 24h-MBs in adults will collect information on behavioral factors. The behavioral factors are based on the integrated behavior change (IBC) model. This model combines different behavioral change theories, i.e. the theory of planned behavior, the self-determination theory, and the dual system theory. The following behaviors will be questioned: autonomous motivation, attitude, internal behavioral control (i.e. habits, skills), external behavioral control (i.e. barriers) and self-efficacy. The validated barriers to physical activity in T1DM (BAPD-1) questionnaire will assess external behavioral control factors for physical activity. **Measure:** Behavioral factors **Time Frame:** Through study completion, an average 1 year **Description:** A newly developed and reliable questionnaire to assess explanatory variables of 24-h movement behaviors in adults will collect information on socio-environmental factors and physical environmental factors. The socio-environmental factors are subjective norm, social modelling and social support. The physical environmental factors are electronic devices at home, sleep environment, neighbourhood and work environment. **Measure:** Environmental factors **Time Frame:** Through study completion, an average 1 year **Description:** Each accelerometer will be supplemented by a diary in which the participant will be asked to give context-related information about PA (e.g. type of sport, active transportation) and sleep (e.g. sleep quality). **Measure:** Context-related information about physical activity **Time Frame:** Through study completion, an average 1 year **Description:** Dietary intake, an important and indispensable component of diabetes management, will be measured with a 14-day food diary completed during the same period of wearing the ActiGraph. Since a written food diary is time consuming and can result in reporting errors (i.e. underreporting due to difficulties in estimating portion sizes), the Digitaal Dagboek application (https://digitaaldagboek.be/) will be used to register daily food intake. **Measure:** Food intake **Time Frame:** Through study completion, an average 1 year #### Primary Outcomes **Description:** All the movement behaviors performed within one day (i.e. PA, SB and sleep) will be objectively measured using an Actigraph wGT3X-BT accelerometer. The participants will wear the accelerometer for 14 consecutive days. At daytime, the accelerometer will be worn at the right hip, at night the accelerometer will be switched to the non-dominant wrist. **Measure:** 24-hour movement behaviors **Time Frame:** Through study completion, an average 1 year **Description:** Coefficient of variation is a measure for intra-day glucose control and will be measured by the continuous glucose monitor of the participants. Raw CGM data of 14 consecutive days will be downloaded from the receiver of the participants with the programme compatible with their CGM (i.e. Libreview, Dexcom studio, Glooko). **Measure:** Coefficient of variation (in %) **Time Frame:** Through study completion, an average 1 year **Description:** Time in range is a measure for intra-day glucose control and will be measured by the continuous glucose monitor of the participants. Raw CGM data of 14 consecutive days will be downloaded from the receiver of the participants with the programme compatible with their CGM (i.e. Libreview, Dexcom studio, Glooko). **Measure:** Time in range **Time Frame:** Through study completion, an average 1 year #### Secondary Outcomes **Description:** Waist circumference will be measured twice with a measuring tape (Seca 201). **Measure:** Waist circumference (in cm) **Time Frame:** Through study completion, an average 1 year **Description:** Hip circumference will be measured twice with a measuring tape (Seca 201). **Measure:** Hip circumference (in cm) **Time Frame:** Through study completion, an average 1 year **Description:** Blood pressure will be measured twice with an interval of one minute with an automatic OMRON M6 Comfort device after 10 minutes of rest. **Measure:** Blood pressure (in mmHg) **Time Frame:** Through study completion, an average 1 year **Description:** AGE's, a predictive value for the development of diabetic and cardiovascular complications, will be measured with a skin AGE-reader (Diagnoptics Technologies, Groningen, the Netherlands). **Measure:** Advanced glycation endproducts **Time Frame:** Through study completion, an average 1 year **Description:** LDL-cholesterol will be obtained through the participants' most recent blood results. **Measure:** LDL-cholesterol (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** HDL-cholesterol will be obtained through the participants' most recent blood results. **Measure:** HDL-cholesterol (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** Triglycerides will be obtained through the participants' most recent blood results. **Measure:** Triglycerides (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** Total cholesterol will be obtained through the participants' most recent blood results. **Measure:** Total cholesterol (in mg/dl) **Time Frame:** Through study completion, an average 1 year **Description:** Average HbA1c over the last 10 years (or from diagnosis if diagnosis was less than 10 years ago) will be collected through the patient file. **Measure:** Long-term glucose regulation (in % or mmol/mol) **Time Frame:** Through study completion, an average 1 year **Description:** Information about medication intake will be collected through the patient file. **Measure:** Medication intake **Time Frame:** Through study completion, an average 1 year **Description:** Information about C-peptide level will be collected through the patient file. **Measure:** C-peptide level **Time Frame:** Through study completion, an average 1 year **Description:** Information about comorbidities will be collected through the patient file. **Measure:** Co-morbidities **Time Frame:** Through study completion, an average 1 year **Description:** Weight will be collected through the patient file. **Measure:** Weight (in kg) **Time Frame:** Through study completion, an average 1 year **Description:** The mean glucose of 14 consecutive days will be derived from the participant's raw CGM data. **Measure:** Mean glucose **Time Frame:** Through study completion, an average 1 year **Description:** The standard deviation of glucose, a measure of the spread in glucose readings around the average glucose, will be derived from the participant's raw CGM data. **Measure:** Standard deviation **Time Frame:** Through study completion, an average 1 year **Description:** Mean amplitude of glycemic excursions, a glucose variability metric, will be derived from the participant's raw CGM data. **Measure:** Mean amplitude of glycemic excursions **Time Frame:** Through study completion, an average 1 year **Description:** Continuous overall net glycemic action, a measure of glycemic variability, will be derived from the participant's raw CGM data. **Measure:** Continuous overall net glycemic action **Time Frame:** Through study completion, an average 1 year **Description:** Percent of measurements below 70 mg/dl, a measure that gives insight in the time in hypoglycemia, will be derived from the participant's raw CGM data. **Measure:** Percent of measurements below 70 mg/dl (in %) **Time Frame:** Through study completion, an average 1 year **Description:** Percent of measurements above 180 mg/dl, a measure that gives insight in the time in hyperglycemia, will be derived from the participant's raw CGM data. **Measure:** Percent of measurements above 180 mg/dl (in %) **Time Frame:** Through study completion, an average 1 year **Description:** Mean of daily differences, a measure that gives insight in the between-days glycemic variability, will be derived from the participant's raw CGM data. **Measure:** Mean of daily differences **Time Frame:** Through study completion, an average 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults between 25 and 50 years * Diagnosed with T1DM for a minimum of two years * Minimal daily insulin dose of 10 units * Using a continuous glucose monitor * Most recent HbA1c between 6% and 9.5% Exclusion Criteria: * Using a hybrid closed loop insulin pump * Shift workers * Known cardiovascular disease (e.g. peripheral arterial disease causing intermittent claudication reducing walking distance to \<500 meters, history of cerebrovascular accidents with residual impact on motoric function or heart failure NYHA class 3 and 4) * Physical disabilities that disturb daily functioning (e.g. amputations, paralysis) * Other conditions affecting normal movement behaviors (e.g. active treatment for malignancies, diabetic nephropathy stage 4 or 5, chronic obstructive pulmonary disease stage 3 or 4 or asthma stage 3 or 4) * Visual impairment (e.g. retinopathy with loss of vision or blindness) * Hypoglycemia unawareness (i.e. self-reporting of biochemical hypoglycemia unaccompanied by symptoms, loss of autonomic symptoms (e.g. hunger, sweating) as initial sign of hypoglycemia) * Symptomatic peripheral neuropathy(i.e. loss of sensations, pain, exaggerated sensitivity to painless stimuli, paresthesia, ulceration injuries or amputations) * Professional or semi-professional top athletes * Participating in another supervised healthy lifestyle or drug intervention **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** A total of 150 adults (25-50 years) with T1DM will be recruited in this study. Participants will be recruited through visits at diabetologists at University hospital of Ghent and Antwerp, diabetes educators, dieticians, general practitioners and community health centres. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lotte Bogaert, PhD **Phone:** 093323638 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Marieke De Craemer, Professor **Phone:** 09 332 52 08 **Role:** CONTACT #### Locations **Location 1:** **City:** Ghent **Contacts:** ***Contact 1:*** - **Name:** Bruno Lapauw, Professor - **Role:** CONTACT **Country:** Belgium **Facility:** University Hospital Ghent **State:** East Flanders **Status:** RECRUITING **Zip:** 9000 **Location 2:** **City:** Antwerp **Contacts:** ***Contact 1:*** - **Name:** Eveline Dirinck, Professor - **Role:** CONTACT **Country:** Belgium **Facility:** University Hospital Antwerp **Status:** RECRUITING **Zip:** 2650 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Ghent **Name:** Bruno Lapauw, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University Hospital, Antwerp **Name:** Eveline Dirinck, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 3:** **Affiliation:** University Ghent **Name:** Marieke De Craemer, Professor **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 1 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425627 **Brief Title:** Spinal Versus General Anesthesia on Postoperative Pulmonary Complications **Official Title:** Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture #### Organization Study ID Info **ID:** TongjiHospital102114 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2026-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tongji Hospital #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Tianzhu Liu **Investigator Title:** M.D. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this study was to investigate the difference in postoperative pulmonary complications (PPCs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery. **Detailed Description:** In this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. By means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared. ### Conditions Module **Conditions:** - Pulmonary Complication - Anesthesia - Hip Fractures **Keywords:** - Hip fracture - delayed surgery - pulmonary complication - spinal anesthesia - general anesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients underwent real-time ultrasound guided spinal anesthesia. The maximum attempts of skin piercings are 3, and the total redirections of each skin piercings should not exceed 6 times. General anesthesia was considered if three skin piercings were unsuccessful. **Intervention Names:** - Procedure: spinal anesthesia **Label:** spinal anesthesia **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Rapid sequential induction was performed with sufentanil 0.5 ug /kg, etomidate 0.3 mg /kg, cisatracurium 0.15 mg /kg, and then laryngeal mask was applyed. Parameter settings: tidal volume: 6-10 mL/kg, 1.5 \~ 2.0% sevoflurane inhalation, remifentanil 0.1 \~ 0.2 ug/ kg.min-1. Mechanical driving pressure was applyed by PEEP titration method. **Intervention Names:** - Procedure: general anesthesia **Label:** general anesthesia **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - spinal anesthesia **Description:** An intrathecal anesthetic technique. **Name:** spinal anesthesia **Other Names:** - lumbar anesthesia **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - general anesthesia **Description:** An intravenous (combined with inhalation) anesthetic technique. **Name:** general anesthesia **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Documented side effects associated with the intervention by an unwitting third party **Measure:** Adverse outcomes **Time Frame:** up to one month #### Primary Outcomes **Description:** PaO2 was measured by arterial blood gas analysis **Measure:** Arterial partial pressure of oxygen, PaO2 **Time Frame:** 30 minutes after surgery #### Secondary Outcomes **Description:** PaO2 was measured by arterial blood gas analysis **Measure:** Arterial partial pressure of oxygen, PaO2 **Time Frame:** 30 minutes before surgery **Description:** FVC was measured by Spirometer (SP70B) **Measure:** Forced vital capacity, FVC **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** FEV1 was measured by Spirometer (SP70B) **Measure:** Forced expiratory volume in 1 second, FEV1 **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** PEF was measured by Spirometer (SP70B) **Measure:** Peak expiratory flow, PEF **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** PEF 25, 75, and 25-75 were measured by Spirometer (SP70B) **Measure:** PEF 25, 75, and 25-75 **Time Frame:** 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery **Description:** Bedside measurements using portable ultrasound **Measure:** Lung Ultrasound Score (LUS) **Time Frame:** 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery **Description:** Pulmonary complications (PPCs) include: (1) Evidence of pneumonia, pneumothorax, atelectasis and pleural effusion indicated by postoperative pulmonary ultrasound, chest film or chest CT; ② After surgery, the patient developed bronchospasm, ARDS, O2 requirement (nasal catheter or mask), non-invasive ventilation requirement, or unplanned endotracheal intubation/mechanical ventilation for more than 1 day; ③ The increase of inflammatory biochemical indexes 24 h after surgery suggested systemic inflammatory response (blood routine, C-reactive protein CRP, procalcitonin PCT and IL-6, IL-1β, TNF-α). **Measure:** Postoperative pulmonary complications **Time Frame:** up to one month **Description:** The Harris scale was used to score. Range:0-100. A total Harris hip score below 70 points was considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent. **Measure:** Hip mobility (Harris hip score, HHS) **Time Frame:** up to one month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients ≥ 65 years old * ASA Class I \~ III * Surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures * The time from diagnosis to surgery is more than 48 hours Exclusion Criteria: * Unable to walk about 3 meters or across a room without assistance before the fracture * Emergency surgery * Chronic obstructive pulmonary disease (COPD), congestive heart failure, asthma, anemia (Hb \< 90 g/L), hypoalbuminemia (ALB \< 35g/L) * Abnormal coagulation function * Severe aortic stenosis * Injection site infection or increased intracranial pressure * Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization * The written informed consent of the patient or his/her representative cannot be obtained **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tianzhu Liu, M.D. **Phone:** 13098866448 **Role:** CONTACT #### Locations **Location 1:** **City:** Wuhan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tianzhu Liu, M.D. - **Phone:** 13098866448 - **Role:** CONTACT ***Contact 2:*** - **Name:** Tianzhu Liu, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Tianzhu Liu **State:** Hubei **Status:** RECRUITING **Zip:** 430000 #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospital **Name:** Tianzhu Liu, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000005264 - Term: Femoral Fractures - ID: D000025981 - Term: Hip Injuries - ID: D000007869 - Term: Leg Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fracture - ID: M9696 - Name: Hip Fractures - Relevance: HIGH - As Found: Hip Fracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M8402 - Name: Femoral Fractures - Relevance: LOW - As Found: Unknown - ID: M23105 - Name: Hip Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000050723 - Term: Fractures, Bone - ID: D000006620 - Term: Hip Fractures ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors ### Intervention Browse Module - Browse Leaves - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M19684 - Name: Sufentanil - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Function - ID: M1673 - Name: Sevoflurane - Relevance: LOW - As Found: Unknown - ID: M237638 - Name: Cisatracurium - Relevance: LOW - As Found: Unknown - ID: M8190 - Name: Etomidate - Relevance: LOW - As Found: Unknown - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425614 **Acronym:** COLTRANE **Brief Title:** COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial **Official Title:** Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial #### Organization Study ID Info **ID:** CHUBX 2022/22 #### Organization **Class:** OTHER **Full Name:** University Hospital, Bordeaux ### Status Module #### Completion Date **Date:** 2026-02-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-02-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-01-12 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Bordeaux #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device. Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. **Detailed Description:** The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets. A multicentre single-arm clinical feasibility and safety trial conducted by our group, using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89%, post-treatment hematocrit of 43% with an excellent washing performance. In addition, the device recovered 52% of platelets, that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry. By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC, this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products. It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality. Consequently, an improvement of postoperative outcomes and a decrease in intensive care unit (ICU) and hospital length of stay may be expected. The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. Consequently, a reduction of infectious complication may be also expected. The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding (moderate to massive bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification). ### Conditions Module **Conditions:** - On-pump Cardiac Surgery - High Risk for Bleeding - Autotransfusion **Keywords:** - cardiac surgery - bleeding - autotransfusion - cardiopulmonary bypass - perioperative haemostasis - Universal Definition of Perioperative Bleeding - filtration-based autotransfusion - centrifugation-based autotransfusion ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Multicentre clinical trial, Randomized, Comparative, controlled, single blinded, superiority design, two groups. ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 570 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** new filtration-based autotransfusion (SAME I-SEP device) **Intervention Names:** - Procedure: Autotransfusion **Label:** Autotransfusion by filtration **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** centrifugation-based autotransfusion (routinely used in cardiac surgery centers) **Intervention Names:** - Procedure: Autotransfusion **Label:** Autotransfusion by centrifugation **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Autotransfusion by centrifugation - Autotransfusion by filtration **Description:** ANTIFIBRINOLYTIC THERAPY : tranexamic acid as antifibrinolytic therapy : dose after anaesthesia induction followed by continuous intravenous infusion until end INTRAOPERATIVE MANAGEMENT : * Routine monitoring : five lead-ECG, pulse oximeter, non-invasive arterial pressure will be instituted. A peripheral venous catheter and an arterial catheter * The general anaesthesia : * propofol and Remifentanil or sufentanil both simultaneously administered . * monitoring of the bispectral index * Triple lumen central venous catheter * Heparinization (300 UI/kg) * Aortic and right auricular cannulations TRANSFUSION PROTOCOL : * During CPB, PRBC transfusion if necessary * In the postoperative period if necessary In bleeding patients: The perioperative use of blood products will be managed according to results of conventional haemostasis tests or viscoelastic point of care tests when available in the center. **Name:** Autotransfusion **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** * Hospital incomes will correspond to the Groupe Homogène de Séjour (GHS) of each patient * Hospital expenditure (in-hospital stay, operating room occupancy, transfusions, treatment of infections) valued in the perspective of hospital centers, using data from the national cost studies with common methodology and from analytical accounting. * The difference between hospital incomes and hospital expenditures for each patient will be used to estimate the cost-benefit of the filtration-based autotransfusion SAME device as compared to centrifugation-based autotransfusion devices. **Measure:** COST-BENEFIT **Time Frame:** Day 30 /+2 days **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: haemoglobin level and plasma free haemoglobin will be performed Blood samples will be also collected from the patient just before surgery as well as 6+/-2 hours after surgery to measure plasma free haemoglobin level. **Measure:** Haemoglobin and plasma free haemoglobin **Time Frame:** just before surgery as well as 6+/-2 hours after surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: hematocrit level will be performed. **Measure:** Hematocrit **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: complete blood count will be performed **Measure:** Complete blood count **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: unfractionated heparin anti-Xa level will be performed **Measure:** Unfractionated heparin anti-Xa **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: fibrinogen level will be performed **Measure:** Fibrinogen **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: triglycerides level will be performed **Measure:** Triglycerides **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: total proteins level will be performed **Measure:** Total proteins **Time Frame:** During the surgery **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles. - Laboratory analyses: potassium level will be performed **Measure:** Potassium **Time Frame:** During the surgery **Description:** Patients in whom the salvaged blood from mediastinal shed and residual cardiopulmonary bypass circuit volume will be processed and not reinfused before protamine infusion will be included in this ancillary study. Blood samples will be collected from the patient just before and immediately after re-infusion of the processed blood and sent to the haematology laboratory to perform viscoelasticity assessment Quantra QPlus™ **Measure:** Blood viscoelasticity assessment **Time Frame:** just before and immediately after re-infusion, pré-treatment and just after traitement by the autotransfusion device **Description:** Patients in whom the salvaged blood from mediastinal shed and residual cardiopulmonary bypass circuit volume will be processed and not reinfused before protamine infusion will be included in this ancillary study. Blood samples will be collected from the patient just before and immediately after re-infusion of the processed blood and sent to the haematology laboratory to complete blood count. **Measure:** Complete bloof count **Time Frame:** just before and immediately after re-infusion, pré-treatment and just after traitement by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for INF-γ assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** INF-γ profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for IL-1β assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** IL-1β-γ profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for Il-6 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** Il-6 profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for IL-8 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** IL-8 profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for IL-10 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** IL-10 profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device **Description:** Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF). Blood samples will be also collected from the patient for TNFα assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery **Measure:** TNFα profiling by mass cytometry CyTOF **Time Frame:** just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device #### Primary Outcomes **Description:** The proportion of patients with clinically significant (moderate to massive) perioperative bleeding according to the Universal Definition for Perioperative Bleeding. **Measure:** Perioperative bleeding **Time Frame:** At the end of Day 1 #### Secondary Outcomes **Description:** Total blood loss from chest tubes within 12 and 24 postoperative hours and up to chest tubes removal (maximum 5 postoperative days) **Measure:** total blood loss **Time Frame:** Hours 12, Hours 24, up to 5 after operatives days **Description:** Surgical re-exploration for excessive bleeding within 5 postoperative days **Measure:** surgical re-exploration **Time Frame:** Day 0-Day 5, **Description:** Delayed sternal closure **Measure:** Sternal closure **Time Frame:** Hours 12 **Description:** Perioperative use of blood products and/or plasma derivatives within 2 postoperative days including PRBC, PLT, FFP, fibrinogen concentrate, PCCs, rFVIIa **Measure:** Overall quality of perioperative haemostasis : Use of blood **Time Frame:** Day 0-Day 2, **Description:** Coagulation tests (PT, aPTT, fibrinogen level) preoperatively, at the end of the surgery (+ thrombin time or ACT ), at arrival in ICU and at POD1, 3 and 5 **Measure:** Perioperative biological hemostasis **Time Frame:** Pre-inclusion - Day 5 **Description:** Complete blood count preoperatively, at the end of the surgery, at arrival in ICU and at POD1, 3 and 5. **Measure:** Complete blood count **Time Frame:** Pre-inclusion - Day 5 **Description:** calculated ICU and hospital free days **Measure:** ICU and hospital length of stay **Time Frame:** End of study or early termination- Day 30 **Description:** Cardiovascular: need for inotropes and/or vasopressors intravenous infusion \>24 hours, need for short-term mechanical circulatory support, occurrence of atrial fibrillation and/or ventricular fibrillation/tachycardia, high grade atrioventricular bloc, myocardial infarction, tamponade, symptomatic thromboembolic events. Respiratory: duration of mechanical ventilation, re-intubation, ARDS according the Berlin criteria, need for VV ECMO Renal: Kidney Disease Improving Global Outcomes stage (KDIGO) ≥2; need for renal replacement therapy. Serum electrolytes and renal function preoperatively, at arrival in ICU and at POD1, 3 and 5. Neurology: transient and permanent stroke, epilepsy, confusion Infectious: mediastinitis, septic shock, pneumopathy and bacteremia Abdominal: mesenteric ischemia, upper and/or lower gastrointestinal bleeding. Liver function tests preoperatively, at arrival in ICU and at POD1, 3 and 5. 30-day all-cause mortality **Measure:** Early postoperative morbidity within 30 postoperative days **Time Frame:** Day 30 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Adult patients (≥18 yr) affiliated or beneficiary of a social security scheme and undergoing on-pump cardiac surgery at high risk for bleeding with autotranfusion indication defined as: * Primary or redo combined cardiac procedures (2 valves or more, valve(s) and coronary artery bypass grafting(s)) * Primary or redo ascending aorta surgery * Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or more grafts using the internal mammary artery * Free, informed and written consent signed by the participant and the investigator Exclusion Criteria: * Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days for prasugrel, and within one preoperative hour for cangrelor) * Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours for therapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylactic LMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparin Sepsis * Malignant tumor * Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency disorders, AIDS) * Emergency cardiac surgery * Heart transplantation * Implantation or patients under ventricular assist device (VAD) * Patients with two or more previous sternotomy * Surgery procedure requiring circulatory arrest and/or profound hypothermia (\<32°C) * Active infective endocarditis * Cardiac surgical procedure for benign or malignant cardiac tumors * Patients with known acquired or constitutional coagulopathy requiring specialist management * End stage renal disease * Preoperative haemoglobin level less than 10 g/dL * Preoperative platelet count \< 100 G/L * Persons participating in another interventional research including a period of exclusion that is still ongoing * Pregnant or breastfeeding women * Persons placed under judicial protection * Patients deprived of liberty **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexandre Ouattara, MD, PhD **Phone:** 0557656866 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Antoine Beurton, MD **Phone:** 0557677147 **Role:** CONTACT #### Locations **Location 1:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexandre Ouattara, MD, PhD - **Phone:** 0557656866 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Antoine BEURTON - **Phone:** 0557656866 - **Phone Ext:** +33 - **Role:** CONTACT **Country:** France **Facility:** CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire **Zip:** 33076 **Location 2:** **City:** Bron **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jean-Luc FELLAHI, MD, PhD - **Phone:** 0472118933 - **Role:** CONTACT **Country:** France **Facility:** HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation **Zip:** 69677 **Location 3:** **City:** Montpellier **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Philippe GAUDARD, MD - **Phone:** 0467336733 - **Role:** CONTACT **Country:** France **Facility:** CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve **Zip:** 34295 **Location 4:** **City:** Nantes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bertrand ROZEC, MD, PhD - **Phone:** 0240165304 - **Role:** CONTACT **Country:** France **Facility:** CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque **Zip:** 44093 **Location 5:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aude Carillion, MD - **Phone:** 0184827387 - **Role:** CONTACT **Country:** France **Facility:** Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale **Zip:** 75651 **Location 6:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sophie Provenchere, MD - **Phone:** 0140258355 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation **Zip:** 75877 **Location 7:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Bernard Cholley, MD, PhD - **Phone:** 0156092515 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation **Zip:** 75908 **Location 8:** **City:** Rennes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexandre Mansour, MD - **Phone:** 0299289153 - **Role:** CONTACT **Country:** France **Facility:** CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV **Zip:** 35033 **Location 9:** **City:** Strasbourg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Paul-Michel MERTES, MD, PhD - **Phone:** 0369550444 - **Role:** CONTACT **Country:** France **Facility:** CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale **Zip:** 67091 **Location 10:** **City:** Toulouse **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** François Labaste, MD - **Phone:** 0561322822 - **Role:** CONTACT **Country:** France **Facility:** CHU Toulouse, Hôpital Rangueil, Service Anesthésie **Zip:** 31400 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Bordeaux **Name:** Alexandre Ouattara, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ## 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: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Bleeding ### Condition Browse Module - Meshes - ID: D000006470 - Term: Hemorrhage ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: Coag - Name: Coagulants ### Intervention Browse Module - Browse Leaves - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M19684 - Name: Sufentanil - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M16902 - Name: Tranexamic Acid - Relevance: LOW - As Found: Unknown - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M117729 - Name: Dsuvia - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425601 **Brief Title:** A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy **Official Title:** The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains #### Organization Study ID Info **ID:** 0120-445/2019/8 #### Organization **Class:** OTHER **Full Name:** University Medical Centre Ljubljana ### Status Module #### Completion Date **Date:** 2023-08-10 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-10 **Type:** ACTUAL #### Start Date **Date:** 2020-09-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Medical Centre Ljubljana #### Responsible Party **Investigator Affiliation:** University Medical Centre Ljubljana **Investigator Full Name:** Boris Greif, MD **Investigator Title:** Head of Thoracic Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer. The main questions it aims to answer are: * silicone chest drains are less painful compared to standard PVC drains? * is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome. ### Conditions Module **Conditions:** - Postoperative Pain - Postoperative Complications **Keywords:** - VATS - lung lobectomy - postoperative pain - chest drain - analgesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used **Intervention Names:** - Device: SIL drain **Label:** Silicone (SIL) group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used **Intervention Names:** - Device: PVC drain **Label:** PVC group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Silicone (SIL) group **Description:** Silicone chest tube used for pleural space drainage after VATS lobectomy **Name:** SIL drain **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - PVC group **Description:** Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy **Name:** PVC drain **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome. **Measure:** Analgesics consumption **Time Frame:** 2 days **Description:** Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome. **Measure:** Need for peroral analgesia after the chest tube removal **Time Frame:** 2 days **Description:** Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome. **Measure:** Maximal inspiratory pressure **Time Frame:** 2 days **Description:** Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome. **Measure:** Maximal expiratory pressure **Time Frame:** 2 days **Description:** Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome. **Measure:** Visual analogue scale **Time Frame:** 2 days #### Secondary Outcomes **Description:** The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome. **Measure:** Duration of chest drainage **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome. **Measure:** Pneumothorax rate on the day of surgery **Time Frame:** First day **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. **Measure:** Pneumothorax rate after chest tube removal **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome. **Measure:** Pleural effusion rate on the day of surgery **Time Frame:** First day **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. **Measure:** Pleural effusion rate after chest tube removal **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome. **Measure:** Subcutaneous emphysema rate **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome. **Measure:** Prolonged air leak rate **Time Frame:** 1 month **Description:** The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome. **Measure:** Reintervention rate **Time Frame:** 1 month **Description:** Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome. **Measure:** Duration of hospital stay **Time Frame:** 1 month **Description:** Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome. **Measure:** Respiratory complication rate **Time Frame:** 1 month **Description:** Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome. **Measure:** Readmission rate **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * primary lung cancer eligible for VATS lobectomy by tumor board meeting Exclusion Criteria: * age under 18 years * high risk of post-operative complications (ASA \> 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) \< 15 ml/kg/min) * tumors growing in parietal pleura * extended lung resection diffuse * previous surgery in the same hemithorax * chronic pain * chronic use of analgesics or sedatives * surgical revision * inability to participate in the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ljubljana **Country:** Slovenia **Facility:** University Medical Centre Ljubljana **Zip:** 1000 #### Overall Officials **Official 1:** **Affiliation:** UMC Ljubljana **Name:** Boris Greif **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - 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: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: HIGH - As Found: Postoperative Complications - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative - ID: D000011183 - Term: Postoperative Complications ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425588 **Brief Title:** Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0) **Official Title:** Craniofacial Dimensions as Determinants of the Fitted Performance of Common Face Masks (FACEFIT 2.0) #### Organization Study ID Info **ID:** 24-0349 #### Organization **Class:** OTHER **Full Name:** University of North Carolina, Chapel Hill #### Secondary ID Infos **Domain:** EPA **ID:** FACEFIT 2.0 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** Environmental Protection Agency (EPA) #### Lead Sponsor **Class:** OTHER **Name:** University of North Carolina, Chapel Hill #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study examines the role of craniofacial dimensions and self-evaluation thereof in the protection afforded by masks commonly worn by the public as protection against aerosol contaminants. The effectiveness of instructions for self-evaluation of craniofacial dimensions will be tested against standard digital and manual craniometric methods. Approximately 500 (18-70 year old) subjects of any gender. After consenting to participate in the study, subjects will use a short self-assessment questionnaire to measure their craniofacial dimensions, and have their face measured using standard anthropological techniques and a 3D camera. They will then enter a chamber containing an atmosphere of aerosolized salt particles where the fitted filtering efficiency of 2 types of face masks will be measured briefly. Participation time is approximately 60 minutes. **Detailed Description:** Wearing a face mask is a primary protection strategy against airborne infectious agents as well as toxic aerosols such as wildfire smoke. Despite the ubiquitous presence of masks in public life in recent years, the average person has a poor understanding of factors that influence the fitted performance of the face coverings that they wear. This problem is exacerbated by the lack of mask fit testing available to the public outside of occupational settings subject to regulation. As a result, the vast majority of the population currently wears masks with limited knowledge of their efficacy or the means to acquire it. A simple, validated method to quantitatively self-assess individual craniofacial dimensions relative to that of the general population will permit members of the public to make informed decisions about the types of mask that they wear in specific risk situations, and whether to use fit enhancements to optimize their fitted performance. In addition to limiting the morbidity associated with exposure to poor air quality, an individualized improvement in the efficacy of mask will have a multiplicative effect in the prevention of the transmission of infectious vectors. Subjects who are not excluded from the initial screening will be scheduled for consenting at the EPA Human Studies Facility (HSF). At the start of the visit, the study protocol will be outlined, and informed consent obtained to initiate enrollment into the study. There will be one session in this study. Consenting subjects will proceed immediately to the participation phase. Consenting: There will be one (1) study consent form (form FF2.0 1). This consent form must be signed by the participant and the study team member obtaining informed consent. The subjects may ask any questions they have regarding their participation in the study at any time prior to or during their participation. Persons with child-bearing potential will be required to self-administer a pregnancy test in a private bathroom. Those who self-administer a pregnancy test will have to confirm the results on the consent form in order to proceed to the study phase. Behavioral questionnaire: Subjects will complete a short questionnaire (Form FF2.0 2) that asks about their predisposition to wear a face mask under a variety of scenarios. This information will be used to guide public health communications during air quality emergencies. Assessment of self-evaluation instructions for craniofacial measurements: Subjects will use instructions presented in a self-evaluation form (Form FF2.0 3) to measure their own craniofacial dimensions using the rulers provided and a mirror. Subjects will receive no assistance with completing the self-assessment form. At intervals of approximately, 10-40 subjects, measurements obtained in the self-evaluation will be compared to the craniofacial measurements obtained by a study team member. The results of the comparison will be used to guide revisions of the instruction in the self-evaluation form in an iterative manner. The protocol will be amended accordingly to update changes to the self-evaluation instructions. Craniofacial measurements: A 3 D scan of the subjects' face and head will be obtained by aligning the head inside of an oval shown on a tablet screen. The image takes about 3 seconds to generate and subjects will be asked to move their head slightly. In addition, manual measurement of 4-8 craniofacial dimensions will be taken by a study team member using calipers and a tape measure. Lung Function Test. Participants will complete a breathing test (peak flow meter) before and after the facemask testing. Study personnel will coach the participant to take a full breath in and then blow it out as hard and fast as they can. They may be asked to do this up to five times. This test measures the volume of air they can blow out (exhale) quickly after taking a very deep breath. This is a method to measure lung function before and after the testing procedure for safety purposes. The investigators will stop the study and not complete the mask fit testing if the participant's peak expiratory flow (as measured with the peak flow meter) is not ≥ 80.0% of their predicted value based on their age, height, and weight. Assessment of filtering face piece (FFP) use: The range of variability that exists in the subject population while wearing two different types of face coverings will be assessed. Masks will consist of a KN95 mask and a surgical/procedure mask. The fitted filtration efficiency of each mask will be measured using aerosolized sodium chloride particles (mean aerodynamic diameter 0.040 microns) emitted by a particle generator. During the fit testing, the concentration of aerosolized saline particles emitted by a TSI Particle Generator will be approximately 5000-30000 particles/cc of air. The temperature in the chamber will vary between 20 and 30 oC, the relative humidity will be maintained at approximately 50 %. The subject will remain seated in the chamber and complete a modified version the Occupational Safety and Health Administration Quantitative Fit Testing Protocol (Modified Ambient Aerosol CNC Quantitative Fit Testing Protocol for Filtering Facepiece TableA-2-RESPIRATORS). The subject will then move their head from left to right, taking two breaths at each extreme for 30 seconds. This will be followed by moving the head up and down, taking two beaths at each extreme for 30 seconds. The procedure will be repeated after the addition of a clip to the ear-loops of the mask behind the neck of the subject. In total, the testing time for the 2 masks with and without clip will be approximately 6 minutes. ### Conditions Module **Conditions:** - Healthy **Keywords:** - Healthy subjects - Mask - Mask fit - Fitted Filtration Efficiency - Self-Evaluation - Craniofacial Morphology - 3D imaging ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will be fit tested while completing a modified version of the OSHA fit test. **Intervention Names:** - Other: Surgical/Procedure Mask Fit Testing - Other: KN95 Mask Fit testing **Label:** Mask Testing **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mask Testing **Description:** All participants will wear a surgical/procedure mask and be fit tested using a modified version of the OSHA quantitative fit testing procedure. **Name:** Surgical/Procedure Mask Fit Testing **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Mask Testing **Description:** All participants will wear a KN95 mask and be fit tested using a modified version of the OSHA quantitative fit testing procedure. **Name:** KN95 Mask Fit testing **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A mask fit procedure will be performed based on an OSHA (Occupational Safety and Health Administration)- approved protocol during the baseline visit. The efficiency of masks will be determined by a percentage of particle number measured behind the facemask over the particle number in the ambient air. Mask fit efficiency values from different levels of mask fit instructions will be compared. **Measure:** Fitted Filtration Efficiency **Time Frame:** During fitting procedure (90 seconds for each condition) **Description:** Cranial morphology will be assessed using a self-evaluation that guides participants on how to measure five dimensions of their head/face including: nose length, nose arc, face width, neck circumference, and ear breadth. Participants will record their measurement for each cranial/facial features using the instructions provided on the self-evaluation form. Investigators will then use the five recorded values to cluster each participant into one of four categories of overall face and head shape/size. **Measure:** Cranial Morphology- Self Evaluation **Time Frame:** The self-evaluation will take approximately ten minutes and be filled out once during the study visit (Day 1). #### Secondary Outcomes **Description:** Calipers will be used to measure craniofacial features of each subject. Trained personnel (wearing gloves) will need to touch areas of the subject's face and scalp to ensure proper caliper measurements are collected. Measurements to be collected include: nose length, face width, neck circumference, and ear breadth. All measurements have a common unit (cm). **Measure:** Cranial Morphology- Caliper Measurement **Time Frame:** The craniometric assessment will take approximately 5 minutes and be completed before the fit testing procedure. **Description:** Subjects will self-administer a 3D scan of their face by aligning their head inside of an oval shown on the camera screen, triggering the camera shutter. The image takes about 3 seconds to generate and subjects will be asked to remain still during this time. The acquired facial images will be analyzed using digital image analysis software. The images will be analyzed to measure the participant's nose gap area. **Measure:** Cranial Morphology- 3D Imaging **Time Frame:** The 3D imaging will take approximately 5 minutes and be completed before the fit testing procedure. **Description:** Subjects will take a brief questionnaire regarding their masking behavior and perceptions of masks. The questionnaire will also ask participants to rate how big/small they think their head length, width, and size is compared to adults of the same age/gender. The survey is comprised of 34 questions that fall into the following sections: sociodemographic information, mask perception, experience with mask usage, knowledge of particulate matter vs. volatile organic compounds, and perception of face shape and size. All questions consist of four or five point likert scales corresponding to ordinal scores (No Impact to Significant Impact, 1-5)(Most Likely to Least Likely, 1-4). All questions correspond to the participant's knowledge or perception and are recorded on an ordinal scale and thus the survey has no "directionality". **Measure:** FaceFit 2.0 Face Filtering PIece Usage Survey **Time Frame:** This survey will take about five minutes and be completed before the mask fit testing. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-70 years old healthy of any gender and ethnicity. 2. Subjects must be ambulatory and tolerate enclosed spaces. 3. Subjects must report being in good health 4. Subjects must pass COVID-19 screening questions and have had at least a primary COVID-19 vaccination series. 5. Individuals with a BMI (kg/m2) that is greater than 16.0 and less than 50.0 Exclusion Criteria: 1. Persons who are pregnant, attempting to become pregnant or breastfeeding 2. Persons who are unable to read English well enough to follow written instructions or a questionnaire. 3. Persons who have facial hair. 4. Individuals who have had an acute respiratory illness within 6 weeks. 5. Individuals who have active allergies. 6. Those who are not feeling well. 7. Anyone who is unable to walk unassisted, stand or sit still for 15 minutes at a time. 8. Anyone who suffered a heart attack, cardiac arrest or stroke in the past 6 months. 9. Anyone who has been hospitalized overnight or sought urgent medical care in the last 30 days. 10. Anyone who has an unspecified illness, which in the judgment of the medical staff, might increase the risk associated with this study will be a basis for exclusion. 11. Those who are pregnant, attempting to become pregnant or breastfeeding. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Robin Kaminski **Phone:** (919) 966-0604 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Patrice Ratliffe **Phone:** (919)-966-0607 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapel Hill **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Patrice Ratliffe - **Phone:** 919-966-0607 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** James Samet, PhD - **Phone:** 919-966-0665 - **Role:** CONTACT ***Contact 3:*** - **Name:** James Samet, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** U.S. Environmental Protection Agency Human Studies Facility **State:** North Carolina **Zip:** 27514 #### Overall Officials **Official 1:** **Affiliation:** U.S. Environmental Protection Agency **Name:** James Samet, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data will be available at the U.S. EPA Science Hub. **Description:** Deidentified individual data will be shared through the U.S. EPA's ScienceHub database. ScienceHub is used to upload and store datasets associated with journal articles. Non-sensitive datasets are then made publicly accessible via the Environmental Dataset Gateway in fulfillment of the EPA's requirement to adhere to the Office of Management and Budget's Open Data Policy. **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** The data will be available to the public after the conclusion of the study and the publication of the manuscripts. **URL:** http://catalog.data.gov/dataset/epa-sciencehub ## 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: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425575 **Brief Title:** Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy **Official Title:** Resolution of Pudendal Neuralgia in Chronic Pelvic Pain Using a Novel Biologic Therapy #### Organization Study ID Info **ID:** 18D.719 #### Organization **Class:** OTHER **Full Name:** Thomas Jefferson University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-10-31 **Type:** ACTUAL #### Start Date **Date:** 2019-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-02-21 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Cooper Health System #### Lead Sponsor **Class:** OTHER **Name:** Thomas Jefferson University #### Responsible Party **Investigator Affiliation:** Thomas Jefferson University **Investigator Full Name:** Thomas N. Tulenko **Investigator Title:** Adjunct Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This goal of this study is to determine whether a novel biologic, i.e., an "amniotic suspension allograft" (ASA) will reduce pain and improve quality of life (QoL) in women stricken with chronic pelvic pain (CPP). The main questions it aims to answer are: * Weather pain in the genitalia is reduced with treatment * Weather bladder or urination pain is reduced with treatment * Weather any adverse events occur following treatment Patient responses to pain and QoL will be collected before and 6-12 months after treatment. **Detailed Description:** This is an observational study and is driven by the hypothesis that novel biologic, i.e., an "amniotic suspension allograft" (ASA) will reduce pain and improve quality of life in women stricken with chronic pelvic pain (CPP). This clinical trial is performed in a hospital-based practice at Thomas Jefferson University in which all patients over the age of 18 presenting with clinically defined CPP will be accepted into the study and therefore all patients will be treated with the ASA; no patients with CPP will be excluded from the study. This small study is not funded so the patients will not be randomized and there will not be any "control" subjects receiving placebo instead of the ASA product. Upon arriving to the hospital, but just prior to treatment, all patients will be asked to fill out a consent form and a pre-procedure questionnaire regarding pain, discomfort and quality of life issues they've been experiencing prior to treatment. They will then be brought into the operating room, placed in the lithotomy position, and briefly anesthetized (15-30 min). Once anesthetized, the urogynecologist will feel for an opening in the pelvic bone (ischium) by inserting her fingers into the vagina. The opening (Alcock's canal) in the ischium exposes the pudendal nerve which carries pain signals from the vagina and nearby tissues to the brain's pain centers. Once the medial aspect of Alcock's canal is clearly identified by the doctor's fingers, a 6 inch pudendal trumpet needle will be advanced through the vaginal wall and guided and placed near the pudendal nerve in Alcock's canal. A solution of the ASA along with sterile saline and the anesthetic marcaine (5 cc total) will be injected so as to infiltrate the pudendal nerve with this mixture. Marcaine is used to help suppress any acute pain that may occur in the few hours after treatment. Both the left and right pudendal nerves will be thusly treated. When the patients awaken, they will receive a drink of choice and light snack like gram crackers or biscuits. When fully awake the patients will be allowed to leave the hospital accompanied with a companion, but not allowed to drive until the full effects of the anesthesia has worn off several hours later. From beginning to end, this procedure takes approximately one hour. To determine the extent to which any pain relief and quality of life have improved, or not, answers to a follow-up questionnaire will be solicited from each participating patient by telephone approximately 6 to 12 months after treatment. The questionnaire contains 14 questions addressing pain and discomfort, urination and impact of symptoms and takes about 10 minutes to compete. To protect patient privacy the data will be entered into an Excel spreadsheet with the patients' names replaced by a number and date of birth replaced with just their age. The data will be digitized, analyzed and statistical significance will be evaluated buy a biostatistician. This study has been approved by the institutional review board (protocol number: 18D.719) prior to beginning. ### Conditions Module **Conditions:** - Chronic Pelvic Pain Syndrome **Keywords:** - pudendal neuralgia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** the amniotic suspension allograft consists of fresh amniotic fluid into which micronized amniotic membrane has been added as a suspension. **Name:** Amniotic suspension allograft **Other Names:** - Rheo, Flowgraft **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Pain in structures of the genitalia, rectum and pain during sexual activity **Measure:** Overall Pain and overall quality of life **Time Frame:** Between 6 and 12 months after treatment #### Secondary Outcomes **Description:** Symptoms relating to interstitial cystitis **Measure:** Bladder pain and urination frequency **Time Frame:** Between 6 and 12 months after treatment **Description:** Zero pain relief **Measure:** Adverse events **Time Frame:** Between 6 and 12 months after treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: All patients 18 years of age or older who present with chronic pelvic pain - Exclusion Criteria: 1. Under 18 years of age 2. Malignancy defined as terminal - **Gender Based:** True **Gender Description:** All patients with clinically demonstrable chronic pelvic pain who are 18 years or older.. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All women presenting with chronic pelvic pain who are over 18 and without terminal disease ### Contacts Locations Module #### Locations **Location 1:** **City:** Philadelphia **Country:** United States **Facility:** Thomas Jefferwson University Hospital **State:** Pennsylvania **Zip:** 19107 #### Overall Officials **Official 1:** **Affiliation:** Thomas Jefferson University **Name:** Thomas N Tulenko, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009408 - Term: Nerve Compression Syndromes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M19918 - Name: Pelvic Pain - Relevance: HIGH - As Found: Pelvic Pain - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuralgia - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29660 - Name: Pudendal Neuralgia - Relevance: HIGH - As Found: Pudendal Neuralgia - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12352 - Name: Nerve Compression Syndromes - Relevance: LOW - As Found: Unknown - ID: M5853 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: M18092 - Name: Hereditary Sensory and Motor Neuropathy - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T4805 - Name: Pudendal Neuralgia - Relevance: HIGH - As Found: Pudendal Neuralgia - ID: T1081 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: T2761 - Name: Hereditary Motor and Sensory Neuropathy - Relevance: LOW - As Found: Unknown - ID: T2766 - Name: Hereditary Neuropathy With Liability to Pressure Palsies - Relevance: LOW - As Found: Unknown - ID: T5067 - Name: Roussy Levy Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia - ID: D000060545 - Term: Pudendal Neuralgia - ID: D000017699 - Term: Pelvic Pain ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425562 **Acronym:** AM-IOS **Brief Title:** The Potential Added Value of Impulse Oscillometry in Asthma Monitoring **Official Title:** The Potential Added Value of Impulse Oscillometry in Asthma Monitoring #### Organization Study ID Info **ID:** 24151_AM-IOS #### Organization **Class:** OTHER **Full Name:** Universitair Ziekenhuis Brussel ### Status Module #### Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Vrije Universiteit Brussel #### Lead Sponsor **Class:** OTHER **Name:** Universitair Ziekenhuis Brussel #### 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 longitudinal observational study is to learn if impulse oscillometry (IOS) has an added value in asthma monitoring in adult asthma patients who are prescribed a change in asthma maintenance therapy. The main questions it aims to answer are: * Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in asthma control test? * Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in other questionnaire such as the asthma control questionnaire and the asthma quality of life questionnaire. * Are the proposed minimal clinically important differences (MCIDs) valid for short follow-up periods (3 - 6 months)? Participants will undergo lung function testing (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionnaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire), once during the baseline visit and once during the follow-up visit three to six months later. ### Conditions Module **Conditions:** - Asthma **Keywords:** - impulse oscillometry - asthma monitoring ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Lung function tests (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire) will be conducted, once at baseline and once 3 - 6 months later during follow-up. **Intervention Names:** - Other: Full lung function - Other: Multiple breath nitrogen washout - Other: Impulse oscillometry **Label:** Adult asthma patients **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Adult asthma patients **Description:** This includes spirometry, body plethysmography and single breath gas transfer test. These are all non-invasive physiological measurements / lung function tests. Measures flow volumes, lung volumes and gas transfer respectively. **Name:** Full lung function **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Adult asthma patients **Description:** Non-invasive physiological measurement / lung function test. 100% oxygen is inhaled and the nitrogen concentration in the lungs is measured. This test gives information on the ventilation distribution in the lungs. **Name:** Multiple breath nitrogen washout **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Adult asthma patients **Description:** Non-invasive physiological measurement / lung function test. This technique superimposes sound waves on tidal breathing. The patient can breathe normally trough the device, no forced respiratory maneuvers are required. It gives information on the reactance and resistance of the lung. **Name:** Impulse oscillometry **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score. **Measure:** Change in frequency dependance of resistance (FDR) stratified according to change in asthma control test (ACT) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score. **Measure:** Change in area of reactance (AX) stratified according to change in asthma control test (ACT) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score. **Measure:** Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control test (ACT) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up #### Secondary Outcomes **Description:** Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score. **Measure:** Change in frequency dependence of resistance (FDR) stratified according to change in asthma control questionnaire (ACQ-6) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score. **Measure:** Change in area of reactance (AX) stratified according to change in asthma control questionnaire (ACQ-6) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score. **Measure:** Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control questionnaire (ACQ-6) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score. **Measure:** Change in frequency dependence of resistance (FDR) stratified according to change in asthma quality of life questionnaire (AQLQ) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome.The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score. **Measure:** Change in area of reactance (AX) stratified according to change in asthma quality of life questionnaire (AQLQ) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome.The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score. **Measure:** Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma quality of life questionnaire (AQLQ) **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** MCIDs over 1 year have been published for IOS parameters. For frequency dependence of resistance (FDR) the MCID is defined as a decline of FDR greater or equal to 0.06 kPa/(L.s). Change of FDR ≥ 0.06 kPa/(L.s) or not **Measure:** Change in frequency dependence of resistance (FDR) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for FDR. **Time Frame:** Once at baseline and 3 - 6 months later during follow-up **Description:** MCIDs over 1 year have been published for IOS parameters. For area of reactance (AX) the MCID is defined as a decline of AX greater or equal to 0.65 kPa/L. Change of AX ≥ 0.65 kPa/L or not **Measure:** Change in area of reactance (AX) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for AX. **Time Frame:** Once at baseline and 3 - 6 months later during follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult asthma patients with a scheduled consultation at the outpatient hospital to whom a step-up or step-down of their pharmacological asthma treatment is prescribed Exclusion Criteria: * Unstable asthma (defined as need for oral corticosteroids or (respiratory) antibiotic course in the 4 weeks before inclusion or any major medical issue in the 4 weeks before inclusion) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shane Hanon, Prof. Dr. MD. **Phone:** 02 477 6841 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### 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 ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425549 **Acronym:** BE TOGETHER **Brief Title:** A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis **Official Title:** A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis #### Organization Study ID Info **ID:** PS0021 #### Organization **Class:** INDUSTRY **Full Name:** UCB Pharma #### Secondary ID Infos **Domain:** WHO universal trial number (UTN) **ID:** U1111-1293-2383 **Type:** OTHER **Domain:** CTIS (EU CT) **ID:** 2023-503859-10-00 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2030-11-08 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-05 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-08-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-07 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** UCB Biopharma SRL #### 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 primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO). ### Conditions Module **Conditions:** - Moderate to Severe Plaque Psoriasis **Keywords:** - bimekizumab - BKZ - ustekinumab - paediatric study participants - children - adolescents - Psoriasis - PSO - Plaque Psoriasis - Paediatric Psoriasis - Pediatric Psoriasis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 168 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks). **Intervention Names:** - Drug: bimekizumab - Drug: placebo **Label:** bimekizumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2. **Intervention Names:** - Drug: bimekizumab - Drug: ustekinumab - Drug: placebo **Label:** ustekinumab **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - bimekizumab - ustekinumab **Description:** Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study. **Name:** bimekizumab **Other Names:** - BKZ - UCB4940 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ustekinumab **Description:** Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study. **Name:** ustekinumab **Other Names:** - USTE **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - bimekizumab - ustekinumab **Description:** Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding. **Name:** placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** Psoriasis Area Severity Index 90 (PASI90) response at Week 16 **Time Frame:** Week 16 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline. **Measure:** Investigator´s Global Assessment (IGA) 0/1 response at Week 16 **Time Frame:** Week 16 #### Secondary Outcomes **Description:** The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI75 response at Week 4 **Time Frame:** Week 4 **Description:** A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI100 response at Week 16 **Time Frame:** Week 16 **Description:** The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI90 response at Week 48 **Time Frame:** Week 48 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline. **Measure:** IGA 0/1 response at Week 48 **Time Frame:** Week 48 **Description:** A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. **Measure:** PASI100 response at Week 48 **Time Frame:** Week 48 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear \[0\] with at least a two-category improvement from Baseline. **Measure:** IGA 0 response at Week 16 **Time Frame:** Week 16 **Description:** The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear \[0\] with at least a two-category improvement from Baseline. **Measure:** IGA 0 response at Week 48 **Time Frame:** Week 48 **Description:** An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. **Measure:** Incidence of treatment-emergent adverse events (TEAE)s **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** An serious adverse event (SAE) must meet 1 or more of the following criteria: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. **Measure:** Incidence of serious TEAEs **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. **Measure:** Incidence of TEAEs leading to discontinuation of Investigational Medicinal Product (IMP) **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent withdrawal from study. **Measure:** Incidence of TEAEs leading to withdrawal from the study **Time Frame:** From Baseline (Week 0) to End of Safety Follow-up (up to Week 164) **Description:** Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions. **Measure:** Incidence of TEAEs predefined as safety topics of interest **Time Frame:** From Baseline (Week 0) to Week 48 and to End of Safety Follow-up (up to Week 164) **Description:** Blood pressure will be measured in millimeters of mercury (mmHg). **Measure:** Change from Baseline in vital signs (systolic blood pressure) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Blood pressure will be measured in millimeters of mercury (mmHg). **Measure:** Change from Baseline in vital signs (diastolic blood pressure) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Pulse rate will be measured in beats per minute (beats/min). **Measure:** Change from Baseline in vital signs (pulse rate) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Clinically significant findings or worsening of previous findings since the physical examination at Baseline will be reported as TEAEs. **Measure:** Incidence of clinically significant physical examination findings reported as TEAEs **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Growth assessment, as assessed by the change from Baseline in height. **Measure:** Change from Baseline in height (growth assessment) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Growth assessment, as assessed by the change from Baseline in weight. **Measure:** Change from Baseline in weight (growth assessment) **Time Frame:** From Baseline (Week 0) up to Week 48. **Description:** Platelets will be measured in number of platelets per liter (10\^9/L). **Measure:** Change from Baseline in hematology parameters (platelet count) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Erythrocytes will be measured in number of red blood cells per liter (10\^12/L). **Measure:** Change from Baseline in hematology parameters (erythrocytes) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Hemoglobin will be measured in grams per liter (g/L). **Measure:** Change from Baseline in hematology parameters (hemoglobin) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Hematocrit will be measured in volume percentage (%) of red blood cells in blood. **Measure:** Change from Baseline in hematology parameters (hematocrit) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase will be measured in units per liter (U/L). **Measure:** Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes will be measured in number of white blood cells per liter (10\^9/L). **Measure:** Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L). **Measure:** Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** Clinical chemistry parameters will be measured in micromols per liter (μmol/L). **Measure:** Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) **Time Frame:** From Baseline (Week 0) up to Week 48 **Description:** The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol). **Measure:** Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 16 **Time Frame:** Week 16, compared to Baseline **Description:** The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol). **Measure:** Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48 **Time Frame:** Week 48, compared to Baseline **Description:** The CHAQ is a questionnaire designed to capture physical function in children and adolescents with juvenile rheumatoid arthritis. The CHAQ comprises 2 indices, Disability and Discomfort. The Disability Index assesses the degree of difficulty experienced over the past week across 30 items in the following 8 categories of the daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The Disability Index ranges from 0 (no disability) to 3 (maximum disability). Discomfort is determined by the presence of pain, as measured by a 100-mm visual analogue scale (VAS). In addition, a final global assessment item asks study participants to rate how they are doing by placing a mark on a 100 mm VAS. **Measure:** Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline **Time Frame:** Week 16, compared to Baseline **Description:** The Peak Pruritus NRS measures the worst level of itching in the past 24 hours on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). **Measure:** Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16 **Time Frame:** Week 16, compared to Baseline **Description:** Plasma bimekizumab concentrations prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration **Measure:** Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period **Time Frame:** From Baseline to End of OLE Period (up to 144 weeks) **Description:** Anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration **Measure:** Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period **Time Frame:** From Baseline to End of OLE Period (up to 144 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation * Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit * Study participant meets the following at both the Screening and Baseline Visits: 1. Body surface area (BSA) affected by PSO ≥10% 2. . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) 3. . Psoriasis Area and Severity Index (PASI) score ≥12 OR PASI score ≥10 plus at least 1 of the following: i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement * Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling * Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening Exclusion Criteria: * Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17 * Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO * Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD * History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated * Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * Study participant has previously received bimekizumab * Study participant has previously received ustekinumab * Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments * Study participant has the presence of active suicidal ideation, or positive suicide behavior * Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded * Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study **Maximum Age:** 17 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** UCB Cares **Phone:** 1-844-599-2273 (USA) **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** UCB Cares **Phone:** 001 844 599 2273 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** Ps0021 50161 **State:** California **Status:** RECRUITING **Zip:** 90045 **Location 2:** **City:** Northridge **Country:** United States **Facility:** Ps0021 50196 **State:** California **Status:** RECRUITING **Zip:** 91325 **Location 3:** **City:** Indianapolis **Country:** United States **Facility:** Ps0021 50344 **State:** Indiana **Status:** RECRUITING **Zip:** 46250 #### Overall Officials **Official 1:** **Affiliation:** 001 844 599 2273 **Name:** UCB Cares **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. **Description:** Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion. **URL:** https://Vivli.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14422 - Name: Psoriasis - Relevance: HIGH - As Found: Psoriasis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011565 - Term: Psoriasis ### Intervention Browse Module - Ancestors - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M460 - Name: Ustekinumab - Relevance: HIGH - As Found: Vital - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069549 - Term: Ustekinumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425536 **Brief Title:** Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam **Official Title:** Efficacy of Remineralizing Products Used in Molar Grooves: RCT With Evaluation With Diagnodent Pen and Diagnocam #### Organization Study ID Info **ID:** 2024-MOLARGROOVES #### Organization **Class:** OTHER **Full Name:** University of Pavia ### Status Module #### Completion Date **Date:** 2025-01-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pavia #### Responsible Party **Investigator Affiliation:** University of Pavia **Investigator Full Name:** Andrea Scribante **Investigator Title:** Associate Professor, Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the efficacy of enamel remineralization by biomimetic hydroxyapatite contained in microRepair-based Biorepair Total Protection toothpaste compared to the use of Bio Enamel Caries and Erosion toothpaste based on Fluoro-Hydroxyapatite and BioActive Complex, evaluated with Diagnodent Pen and Diagnocam. **Detailed Description:** The recruited patients will be divided into: Group 1: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Biorepair Total Protection toothpaste 2 times/day Gruppo 2: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Curasept Biosmalto Caries and Erosion toothpaste 2 times/day For both groups, Diagnodent Pen will be used to evaluate the degree of demineralization, while Diagnocam will be used as qualitative evaluation. Other clinical indices to be collected are: plaque index (PI), bleeding index (BOP), basic erosive wear examination (BEWE), Schiff Air Index (SAI). The time frames of the study are: * T0: baseline * T1: after 1 month * T2: after 3 months * T3: after 6 months ### Conditions Module **Conditions:** - Enamel Caries ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Home use **Label:** Biorepair Total protection toothpaste **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Home use **Label:** Biosmalto Caries and Erosion **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Biorepair Total protection toothpaste - Biosmalto Caries and Erosion **Description:** Home use twice a day **Name:** Home use **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Scores (according to the manufacturer): 0 - 12: Normal prophylaxis (such as fluoride toothpaste) 13 - 24: Intensive prophylaxis (e.g. fluoridation, remineralisation) \> 25: Minimally invasive restorative procedures, composite filling materials and intensive prophylaxis (e.g. remineralisation, Air Abrasion, SONICflex micro), conventional restoration with large lesions, depending on risk assessment and findings. **Measure:** Change in Diagnodent Pen value **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Qualitative evaluation. **Measure:** Change in Diagnocam value **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** 0: the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful. **Measure:** Change in Schiff Air Index **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%. **Measure:** Change in Bleeding on Probing **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100 **Measure:** Change in Plaque Index **Time Frame:** Study begin, 1, 3 and 6 months after the baseline **Description:** Scoring criteria (Barlet et al., 2008): 0: no erosive tooth wear; 1. initial loss of surface texture; 2. distinct defect, hard tissue loss \< 50% of the surface area; 3. hard tissue loss ≥ 50% of the surface area. **Measure:** Change in Basic Erosive Wear Examination **Time Frame:** Study begin, 1, 3 and 6 months after the baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * First permanent molars erupted and completely healthy * Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen Exclusion Criteria: * Patients with Diagnodent-stimulated value \> 25 * Patients with groove sealings of sealed permanent first molars or composite restorations * First molars with extensive demineralizations (Molar Incisor Hypomineralization, fluorosis, white/brown spots) **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Andrea Scribante, DDS, PhD **Phone:** +39 0382516223 **Role:** CONTACT #### Locations **Location 1:** **City:** Pavia **Country:** Italy **Facility:** Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia **State:** Lombardy **Zip:** 27100 #### Overall Officials **Official 1:** **Affiliation:** University of Pavia **Name:** Andrea Scribante, DDS, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Data will be available upon motivated request to the Principal Investigator. **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425523 **Acronym:** THRIVE **Brief Title:** Transforming Health and Resilience In Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale **Official Title:** Strengthening Resilience to Climate Change by Improving Mental Health: Evidence From a Randomized Intervention in Southwestern Uganda #### Organization Study ID Info **ID:** NAK-SH/HGI-2024 #### Organization **Class:** OTHER **Full Name:** Uppsala University #### Secondary ID Infos **Domain:** Formas - a Swedish Research Council for Sustainable Development **ID:** 2022-01573_Formas **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) **Class:** INDUSTRY **Name:** Vivo international e.V. **Class:** OTHER **Name:** Bielefeld University **Class:** OTHER **Name:** Kabale University **Class:** OTHER **Name:** University of Turku **Class:** UNKNOWN **Name:** Max Planck Institute for Research on Collective Goods **Class:** UNKNOWN **Name:** University of North Carolina at Charlotte #### Lead Sponsor **Class:** OTHER **Name:** Uppsala 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 study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups: * Control group: Mothers will receive Enhanced Usual Care (EUC). * HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening. * HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention. The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention. Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups. The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess childrens' wellbeing and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development. ### Conditions Module **Conditions:** - Psychological Distress - Malnutrition, Child - Dietary Deficiency - Mental Health - Malnutrition **Keywords:** - Self-Help Plus - Home Gardening Intervention - Uganda - Refugee - Nakivale - Mental health - Child develpment - Food security - Climate change adaptation - Climate smart agriculture - Farming intervention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Three-arm, parallel-group, 1:1:1 allocation, superiority, cluster-randomized controlled trial (cRCT) ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 900 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Enhanced Usual Care **Intervention Names:** - Behavioral: Enhanced Usual Care (EUC) **Label:** EUC **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Home Gardening Intervention **Intervention Names:** - Behavioral: Home Gardening Intervention (HGI) - Behavioral: Enhanced Usual Care (EUC) **Label:** HGI **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Self-Help Plus in combination with Home Gardening Intervention **Intervention Names:** - Behavioral: Home Gardening Intervention (HGI) - Behavioral: Self-Help Plus (SH+) - Behavioral: Enhanced Usual Care (EUC) **Label:** SH+/HGI **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HGI - SH+/HGI **Description:** The Home Gardening Intervention (HGI) provides refugee participants with agricultural inputs and training (field prep., sowing, water management, pest control, weeding, etc.) through a participatory field school approach with a curriculum derived from best practices in agro-ecology. The program includes active monitoring during a 12-month period. The training involves nutrition education on cooking methods and the importance of dietary diversity using garden produce as well as guidance on surplus management and market support. The overall goal of the intervention is to enable climate-resilient farming for improved food security and dietary diversity that is sustainable long-term. **Name:** Home Gardening Intervention (HGI) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - SH+/HGI **Description:** Self-Help Plus (SH+) is a 5-session group intervention developed by the WHO and based on Acceptance and Commitment Therapy, delivered by trained local facilitators. It provides tools to manage stress and adversity through pre-recorded audio lessons and a self-help book. Sessions include individual exercises and group discussions. SH+ aims to decrease psychological distress. It has shown effectiveness among refugees in Uganda and elsewhere. **Name:** Self-Help Plus (SH+) **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - EUC - HGI - SH+/HGI **Description:** The Enhanced Usual Care (EUC) control condition involves a single 15-minute psychoeducation session providing information on managing overthinking and utilizing available mental health services in the settlement. These services include psychosocial support from community health workers and clinical mental health services (counseling and medications) provided weekly at local primary care centers by a visiting team. **Name:** Enhanced Usual Care (EUC) **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Both mothers and their children will play a set of incentivized economic games to measure economic preferences. Risk-taking will be measured using a "bomb-task." Time preferences will be measured using an investment task. Prosociality will be assessed using a series of dictator games. **Measure:** Economic preferences **Time Frame:** 12 months **Description:** Children's cognitive skills will be assessed using a battery of gamified tasks. Spatial cognition will be measured using 3d blocks and 2d shapes. Mathematics ability will be assessed using free counting, give-n, number comparison, and addition/subtraction tasks. Theory of mind will be measured using surprise content and surprise outcome tasks. Gaze following will be measured using TANGO. Language skills will be assessed using TIFALDI. **Measure:** Cognitive skills **Time Frame:** 12 months **Description:** Social capital will be measured using survey items asking about group membership, involvement in citizenship activities, and trust. **Measure:** Social capital **Time Frame:** 12 months **Description:** Positive parenting will be assessed using the 6-item Positive Parenting Subscale of the Alabama Parenting Questionnaire (APQ). This subscale focuses on the frequency of positive interactions between parents and children. Each item is rated on a scale from 1 (never) to 5 (always), with higher scores indicating more frequent use of positive parenting practices. **Measure:** Positive parenting **Time Frame:** 12 months **Description:** Child maltreatment will be measured using the 11-Item Discipline Module of the Multiple Indicator Cluster Survey (MICS). MICS is a household survey developed by UNICEF. It consists of eleven Yes/No questions that inquire about the different disciplinary actions taken by the caregiver in the past month. The total score can range from 0 to 11, with higher scores indicating the use of more types of disciplinary actions. **Measure:** Maltreatment **Time Frame:** 12 months **Description:** Posttraumatic stress will be measured using the Post-Traumatic Checklist 6-item Civilian Version (PCL-C). It has 6 items rated from 1 to 5, measuring key PTSD symptoms. Total score ranges from 6 to 30, with scores above 14 indicating potential PTSD. **Measure:** Posttraumatic stress **Time Frame:** 12 months **Description:** Stress will be assessed with the Perceived Stress Scale 4-item version (PSS-4). The PSS-4 is a brief self-report measure of perceived stress. It consists of four questions that ask about feelings and thoughts during the last month. Each item is rated on a scale from 0 (Never) to 4 (Very often), with items 2 and 3 reverse scored. The total score, ranging from 0 to 16, is obtained by adding the scores of all items. Higher scores indicate higher perceived stress. **Measure:** Stress **Time Frame:** 12 months **Description:** Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a widely-utilized questionnaire that gauges the severity of depression in individuals. It consists of nine items, each corresponding to a symptom of depression. The responses are scored on a scale ranging from 0 (not at all) to 3 (nearly every day), with the total score indicating the depression level. The scale's range is 0-27, reflecting varying degrees of depression severity from mild to severe. **Measure:** Depression **Time Frame:** 12 months **Description:** Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a brief measure designed to assess the severity of generalized anxiety disorder symptoms. It includes seven items that evaluate key symptoms such as nervousness, excessive worry, and fear. Respondents rate how often they have been bothered by each symptom over the past two weeks on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating more severe anxiety. **Measure:** Anxiety **Time Frame:** 12 months **Description:** Psychological flexibility will be measured using the Acceptance and Action Questionnaire - version 2 (AAQ-2). The AAQ-2 consists of seven items scored on a 7-point Likert scale ranging from 1 (never true) to 7 (always true). The total score can range from 7 to 49, with higher scores indicating greater psychological inflexibility. **Measure:** Psychological flexibility **Time Frame:** 12 months **Description:** Functional impairment will be assessed using a 15-item verion of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS-II). The WHODAS-II is a standardized instrument for measuring health and disability across various domains of functioning. It covers six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is rated for difficulty over the past 30 days on a 5-point scale from 0 (none) to 4 (extreme or cannot do). The scores can be summed to provide a profile of functioning and disability. **Measure:** Functional impairment **Time Frame:** 12 months **Description:** Subjective wellbeing will be measured using the WHO-5 Well-Being Index. the WHO-5 is a concise self-report tool that measures an individual's subjective well-being. It contains five questions that assess positive mood, vitality, and general interests. The responses are scored on a scale from 0 (at no time) to 5 (all of the time), and the total score is then multiplied by 4 to give a final score ranging from 0 to 100. A score of 0 indicates very poor well-being, while 100 represents excellent well-being. **Measure:** Subjective wellbeing **Time Frame:** 12 months **Description:** Child wellbeing and functioning will be assessed using one of two versions of the Kiddy-KINDL questionnaire, depending on the child's age. For children aged 3 to 4 years, the parent version consists of 24 items that cover six subscales: physical well-being, psychological well-being, self-worth, family, friends, and functioning in everyday life (school or preschool/kindergarten). The items are scored on a 5-point Likert scale from 1 (never) to 5 (all the time), and a total score is calculated to reflect overall health-related quality of life. For children aged 4 years and above, there is a self-report version of the Kiddy-KINDL which contains 12 items. This version also uses a 5-point Likert scale for responses, and it similarly assesses various dimensions of a child's well-being. **Measure:** Child wellbeing and functioning **Time Frame:** 12 months #### Primary Outcomes **Description:** Food insecurity will be assessed using the Food Insecurity Experience Scale (FIES). The FIES was developed by the FAO, and consists of 8 questions regarding the availability of sufficient food in the past thirty days. The questions form a scale calibrated against a global reference from the 2014-2016 Gallup World Poll for comparability across countries. Responses are analyzed as a scale using Item Response Theory (IRT) models, ensuring comparability of food insecurity prevalence rates. **Measure:** Food insecurity **Time Frame:** 12 months #### Secondary Outcomes **Description:** Dietary diversity will be assessed using the Household Dietary Diversity Score (HDDS). The HDDS is a measure of food consumption that reflects a household's access to a variety of foods. It's based on households' self-reporting of the 12 food groups consumed in the previous 24 hours. **Measure:** Dietary diversity **Time Frame:** 12 months **Description:** Child malnutrition will be assessed using the Height-for-Age Z-score (HAZ). The HAZ is a standard statistical measurement that represents how a child's height compares to a reference population of the same age and sex. It's used to assess long-term nutritional status and can indicate chronic malnutrition or stunting. A HAZ score below -2 is considered stunted, indicating that the child is significantly shorter than the average height for their age. A score above +2 would suggest the child is taller than the average height for their age. **Measure:** Child malnutrition **Time Frame:** 12 months **Description:** Psychological distress will be measured using the Kessler Psychological Distress Scale (K6). The K6 is a concise tool used to screen for psychological distress. It assesses general psychological distress through six questions that inquire about symptoms of depression and anxiety experienced in the past month. Each of the six questions is scored from 0 (none of the time) to 4 (all of the time), providing a total score range from 0 to 24. Higher scores indicate greater psychological distress. **Measure:** Psychological distress **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria (mothers): * Psychological distress (score 5 or above on K-6) * Ability to speak and understand Kiswahili * Have a child aged 36-59 months * Availability of plot of land for farming * Access of water for farming * Written informed consent to enter the study Exclusion Criteria (mothers): * Imminent risk of suicide * Observable signs of psychosis * Manic behaviors * Intellectual disability Inclusion criteria (children): * Age 36-59 months * Written parental consent to enter the study * Assent to enter the study Exclusion criteria (children): * Intellectual disability * Not living with mother **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jonathan Hall, PhD **Phone:** +46709948737 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Phaidon Vassiliou, M.A. **Phone:** +46703726681 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Uppsala University **Name:** Jonathan Hall, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2. **PMID:** 31981556 **Citation:** Al Daccache M, Abi Zeid B, Hojeij L, Baliki G, Bruck T, Ghattas H. Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings. BMC Nutr. 2024 Apr 19;10(1):60. doi: 10.1186/s40795-024-00864-8. **PMID:** 38641632 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Malnutrition - ID: M18049 - Name: Child Nutrition Disorders - Relevance: HIGH - As Found: Malnutrition, Child - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition - ID: D000015362 - Term: Child Nutrition Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425510 **Brief Title:** Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas **Official Title:** Tech Enabled Functional Health: Bridging Primary Care Gaps for Older Latinos With Functional Disabilities in Underserved Communities #### Organization Study ID Info **ID:** 2405230330 #### Organization **Class:** OTHER **Full Name:** University of Puerto Rico ### Status Module #### Completion Date **Date:** 2027-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2025-02-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Puerto Rico #### 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 project aims to test a culturally appropriate assistive technology (AT) intervention called VIVE-AT to help older Latinos with disabilities improve their function and quality of life. The researchers will first refine the VIVE-AT program based on feedback from a Community Advisory Board and focus groups with older Latinos with disabilities. Then, 76 older Latinos with disabilities will be recruited from a primary care clinic serving low-income communities in Puerto Rico. They will be randomly assigned to either receive the VIVE-AT intervention in the primary care clinic or be placed on a waitlist with regular phone calls. All participants will continue to receive standard care at the clinic. **Detailed Description:** Functional disabilities (FDs), defined as difficulties in performing daily activities, constitute a significant public health problem associated with increased dependency, poor health outcomes, diminished quality of life, institutionalization, and premature death. Older Latinos residing in Puerto Rico (PR) are disproportionately affected by FDs, with one of the highest rates of FDs (58%) in the US and its territories. Research has demonstrated positive outcomes from employing assistive technology (AT) devices, such as jar openers, sock aids, and canes, among older adults with FDs, thereby enhancing their functioning, participation, and capacity to remain at home or in the community for a longer period. However, Latinos are among the least likely to utilize AT. Given the dearth of culturally competent assistive technology interventions for Latinos, along with the scarcity of rehabilitation professionals and assistive technology services in primary healthcare facilities, this project leverages preliminary data from a prior study that assessed the feasibility of the Viviendo las Ventajas de la Asistencia Tecnológica; (VIVE-AT for short; Living the Advantages of Assistive Technologies) intervention. The specific aims of this project are to: 1. refine the protocol of the VIVE-AT to align with the unique needs of the primary health care clinic; 2. assess the efficacy of the VIVE-AT in comparison to a waitlist control arm, in decreasing FDs and improving the quality of life among Latinos aged ≥65 years post-intervention and at six months; 3. evaluate whether proposed mechanisms of change in FDs, specifically knowledge of AT, motivation for using AT, self-efficacy for using AT, and use of AT, account for the reduction in FDs post-intervention. To achieve these aims, the interdisciplinary team of this project will first refine the intervention based on recommendations from participants in the feasibility study, as well as input from the Community Advisory Board and older Latinos with FDs through iterative focus groups (Aim 1). Subsequently, 76 older Latinos with physical FDs recruited from a primary health care facility serving low-income communities in PR will be randomly assigned to either the VIVE-AT intervention group (n=38) or a waitlist + attention calls controlled condition group (n=38) to assess its efficacy and mechanisms of change (Aims 2 and; 3). All participants will receive standard usual care at the primary health care center. Participants in the intervention group will attend a weekly, two-hour group session for 6 weeks, facilitated by trained healthcare workers, focusing on self-management of FDs through the use of AT. Additionally, participants will receive up to five AT devices tailored to their specific FI needs, along with training on their usage. All participants will be assessed at baseline, post-intervention, and six months after intervention. The goals of the VIVE-AT are to encourage participants to use AT devices to self-manage their FDs and improve their quality of life. Our approach will contribute to scientific knowledge and inform a subsequent scalable multisite Hybrid Type I RCT, designed to evaluate its effectiveness in reducing physical FDs among older Latinos in primary healthcare settings in the U.S. and P.R. ### Conditions Module **Conditions:** - Aging - Disability Physical **Keywords:** - self help devices - behavioral intervention - assistive technology - primary health care - community health workers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Social Cognitive Theory ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 76 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The VIVE-AT program consists of a six-week, once-a-week, 2-hour group educational intervention guided by the social cognitive model. It is facilitated by primary care and community health workers in a primary healthcare clinic. The intervention aims to teach older Latinos self-management strategies to increase the adoption and use of assistive technology devices that enhance their function in daily activities. VIVE-AT is designed to support behavioral change by providing up to five assistive technology devices to participants, along with information, instruction, demonstration, action planning, and guided practice in using the devices. **Intervention Names:** - Behavioral: Viviendo las Ventajas de la Asistencia Tecnológica **Label:** Viviendo las ventajas de la Asistencia Tecnológica (VIVE-AT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the waitlist control group will receive weekly attention calls providing general health advice during the 6-week intervention period. They will also receive usual care for the initial 6 months post-randomization, followed by crossover to the VIVE-AT intervention. **Intervention Names:** - Other: Attention calls **Label:** Waitlist Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Viviendo las ventajas de la Asistencia Tecnológica (VIVE-AT) **Description:** It comprises 2-hours small group sessions of 8-10 participants, once a week, for six weeks of participatory discussions, experiential learning, multimodal instructions, and demonstration and practice with selected ATDs. The content of the VIVE-AT weekly sessions is as follows: Week 1 - Introduction to ATDs, funding and resources; Week 2 - ATDs for self-care and toilet use; Week 3 - ATDs for mobility; Week 4 - ATDs for dressing; Week 6 - ATDs for cooking and home tasks. Each session is designed with the following components: monitoring of participants\&#39; weekly goals, providing information on ATDs, resources, and services, reflection on the advantages and disadvantages of using these ATDs, hands-on practice with selected ATDs, goal setting, and addressing barriers to using ATDs. Group sessions will incorporate visual aids, including modeling and videos of older individuals using ATDs accessed through an AT web app in a tablet provided by this project. **Name:** Viviendo las Ventajas de la Asistencia Tecnológica **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Waitlist Control **Description:** Ten minutes attention calls, once a week for six weeks to the waitlist control participants will offer general health advice on topics like nutrition, exercise, sleep, stress, and social connections. These calls emphasize participant well-being without touching upon the specific VIVE-AT content, maintaining a clear distinction from the intervention group. **Name:** Attention calls **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** The percent of eligible OL who were enrolled (goal: ≥ 80%) **Measure:** Participation rates **Time Frame:** At the end of the intervention (6 weeks) **Description:** The percent of OL who complete the study measures at the end of the intervention and at 6 months post intervention (goal: ≥ 80%). **Measure:** Retention rates **Time Frame:** At the end of the intervention (6weeks) and at 6 months post-intervention **Description:** The percent of participants who drop out or are lost to follow-up at the end of the intervention and at 6 months post-intervention, with reasons recorded when known (goal: ≤ 20%). **Measure:** Attrition rates **Time Frame:** At the end of the intervention (6 weeks) and 6 months post-intervention **Description:** The percent of participants completing at least 4 of 6 group sessions (goal: ≥ 80%). **Measure:** Completion rates **Time Frame:** At 6 months post-intervention **Description:** This questionnaire is based on the key dimensions outlined in the Theoretical Framework of Acceptability, which include affect, burden, perceived effectiveness, ethicality, coherence, opportunity costs, and self-efficacy. It features open-ended questions to further explore suggested improvements, identify successful components, and understand contextual issues that influenced the implementation of the intervention in primary care clinic, all based on the Practical Robust Implementation and Sustainability Model (PRISM). The goal is to achieve a mean satisfaction level of ≥ 80%. **Measure:** Acceptability as Assessed by Acceptability: Assessment will be conducted using the Intervention Acceptability and Implementation Questionnaire **Time Frame:** At the end of the intervention (6 weeks) **Description:** We will document the total intervention costs, costs per participant, and marginal costs per incremental change in physical functional disabilites PROMIS-HAQ T-score. Resource use associated with the programs will be valued at competitive market rates. Costs will be estimated and evaluated in constant dollars using the Prospective Payment System Index. Major resource categories will be examined, including costs of identifying and recruiting participants and intervention preparation, direct interventionist labor costs, interventionist training and supervision costs, and program materials, supplies, office space, and storage space costs. We will separate research-based costs from intervention costs. Emergency room visit frequency, costs, and reasons, as well as institutional costs, including hospitalizations and institutionalization will be tracked. The number, direct costs, and type of visits to primary care physicians, both internal and external to the primary care clinic, will be doc **Measure:** Cost **Time Frame:** Baseline, during the intervention, at the end of the intervention (6 weeks), and at 6 months post-intervention #### Primary Outcomes **Description:** This is a patient-reported outcome measure design to assess physical FDs in adults across the categories of dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, errands, and chores. It comprises 20 items on a 5-point Likert-type scale, ranging from 5 "without difficulty" to 1 "unable to do". **Measure:** Physical Function as Assessed by the PROMIS Short Form v2.0 - Physical Function 24a (PROMIS-HAQ) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** This is a 10 items health-related quality of life measure with five domains: physical health, pain, fatigue, mental health, and social health, along with an overall health assessment. It also includes two subscales: Global Mental Health (GMH) and Global Physical Health (GPH). **Measure:** Quality of Life as Assessed by PROMIS Scale v1.2 - Global Health **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention #### Secondary Outcomes **Description:** The ATUAS assess participants knowledge of 44 assistive technology devices. Participants are presented with photographs and names of the devices and asked if they possess each item. If the answer is 'No,' further questions will determine whether they use it (code 2) or not (code 1), are aware of its existence (code 3), or neither (code 4). Responses will be recoded into two categories: used (code 2) and not used (codes 1, 3, and 4) to calculate ATD usage. **Measure:** Use of Assistive Technology Devices as Assessed by Assistive Technology Awareness Scale (ATUAS) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** The ATUAS assess participants knowledge of 44 assistive technology devices. Participants are presented with photographs and names of the devices and asked if they possess each item. If the answer is 'No,' further questions will determine whether they use it (code 2) or not (code 1), are aware of its existence (code 3), or neither (code 4). Assistive technology knowledge is assessed by recoding the answer for each assistive technology into two categories: aware (codes 1, 2, 3) versus not aware (code 4). **Measure:** Assistive Technology Knowledge as Assessed by Assistive Technology Use and Awareness Scale (ATUAS) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** The AADS consists of 12 items designed to measure older adults' attitudes (motivation) including the substitution of care, the financial aspect of care, and the effect on privacy. It utilizes a Likert scale with 5 points, ranging from 5 (totally agree) to 1 (totally disagree), with interval scores ranging from 12 to 60. A high score indicates a positive attitude. **Measure:** Motivation to Use Assistive Technology as Assessed by Attitudes Towards Assistive Device Scale (AADS) **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** This measure consists of three items presenting increasing levels of intention (motivation) to use assistive technology devices. It employs a 5-point Likert scale, ranging from 1 (I do not have the intention to do this at all) to 5 (I certainly have the intention to do this). The total score ranges from 3 to 15; higher scores indicating a strong intention to use asssitive technology devices. **Measure:** Intention to Use Assistive Technology as Assessed by Intention to Use Assistive Device Scale **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention **Description:** This measure measures assesses self-efficacy for using assistive technology devices with three items, each representing increasing barriers. The interval scale ranges from 3 to 15; higher score indicates higher self-efficacy. **Measure:** Self-efficacy as Assessed by Self-efficacy Regarding Assistive Device Use **Time Frame:** Baseline, at the end of the intervention (6 weeks), and at 6 months post-intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Spanish speaking Latino adults ≥65 years * With a physical function impairment (PROMIS-HAQ T-Score ≤45) * Living independently in the community (not requiring supervision to perform their daily living activities) * Self-reported ability to participate in a 6 weeks of group intervention * Having no plans to move for the next 12 months Exclusion Criteria: * Currently residing in a nursing or group home * Receiving home healthcare services * Having a significant cognitive impairment as evidenced by a score ≤23 in the Mini Mental State Examination (MMSE) **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Elsa M Orellano-Colón, Ph.D. **Phone:** 787-758-2525 **Phone Ext:** 4200 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Milagros I Figueroa-Ramos, Ph.D. **Phone:** 787-758-2525 **Phone Ext:** 1986 **Role:** CONTACT #### Locations **Location 1:** **City:** San Juan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Elsa M Orellano-Colón, Ph.D. - **Phone:** 787-758-2525 - **Phone Ext:** 4200 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Milagros I Figueroa-Ramos, Ph.D. - **Phone:** 787-758-2525 - **Phone Ext:** 1986 - **Role:** CONTACT ***Contact 3:*** - **Name:** Elsa M Orellano-Colón, Ph.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Puerto Rico **Facility:** University of Puerto Rico Medical Sciences Campus **Zip:** 00936-5067 ### IPD Sharing Statement Module **Access Criteria:** The study's IPD would be accessible to the academic community and the public. This repository serves as a digital storage site for the scientific and creative work produced by the University of Puerto Rico. They will be able to access all shared study materials, data, and metadata. To access the repository, users can visit the DIRe.UPR website at https://repositorio.upr.edu. The repository allows searching and browsing of the content, which includes faculty research works. **Description:** De-identified quantitative data which can be publicly shared will be formatted for widely available statistical packages such as R, SPSS, STATA, and SAS. All shared study materials, data, and metadata will be made publicly available through the University of Puerto Rico Institutional Repository available at the Repositorio Digital Institucional de la Universidad de Puerto Rico (DIRe.UPR) website at https://repositorio.upr.edu. Data will be assigned a Digital Object Identifier (DOI) and will be searchable via the University of Puerto Rico Institutional Repository and other search engines. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Data and metadata will be deposited into the repository at the time of publication or by the end of the project period, whichever comes first. Data will be preserved for three years following the end of the grant period. **URL:** https://repositorio.upr.edu/ ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M251802 - Name: Imidacloprid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425497 **Acronym:** PTV-DSAaKT **Brief Title:** DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY **Official Title:** DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY #### Organization Study ID Info **ID:** sperimentazioni PTV 92.24 #### Organization **Class:** OTHER **Full Name:** University of Rome Tor Vergata ### Status Module #### Completion Date **Date:** 2024-05-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-07-31 **Type:** ACTUAL #### Start Date **Date:** 2010-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Rome Tor Vergata #### Responsible Party **Investigator Affiliation:** University of Rome Tor Vergata **Investigator Full Name:** Roberta Angelico **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels. **Detailed Description:** Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic. For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level. The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method "Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000)". The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival. ### Conditions Module **Conditions:** - Kidney Transplant; Complications - Immunosuppression ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 600 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up. **Intervention Names:** - Other: The dosage of dnDSA **Label:** Kidney transplant patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Kidney transplant patients **Description:** Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000) **Name:** The dosage of dnDSA **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Define the incidence of development of dnDSA in patients undergoing kidney transplantation. **Measure:** Development of dnDSA in kidney transplant patients **Time Frame:** • Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old #### Secondary Outcomes **Description:** Graft survival At 5 and 10 years **Measure:** Graft survival **Time Frame:** 5 and 10 years **Description:** Patient survival at 5 and 10 years **Measure:** Patient survival **Time Frame:** 5 and 10 years **Description:** Blood dosage levels of post-transplant immunosuppressive drugs (tacrolemia, ciclosporinemia, everolemia, sirolemia); **Measure:** Blood dosage levels of post-transplant immunosuppressive drugs **Time Frame:** • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old **Description:** Donor-recipient HLA mismatch **Measure:** Donor-recipient HLA mismatch **Time Frame:** Pre-transplant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients,both male and female over the age of 18 * Patients with at least one year of follow-up Exclusion Criteria: * Combined liver-kidney or pancreas-kidney transplants * Re-transplants * Patients with follow-up less than one year **Minimum Age:** 19 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Università degli Studi di Roma "Tor Vergata" **Name:** Roberta Angelico, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425484 **Brief Title:** The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation. **Official Title:** The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation. #### Organization Study ID Info **ID:** USM/JEPeM/kk/23010129 #### Organization **Class:** OTHER **Full Name:** Universiti Sains Malaysia ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universiti Sains Malaysia #### Responsible Party **Investigator Affiliation:** Universiti Sains Malaysia **Investigator Full Name:** Rhendra Hardy Mohamad Zaini **Investigator Title:** Prof Madya **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to compare effectiveness between epidural combined with TAP block versus epidural alone in gynaecology operation participant .The main question\[s\] it aims to answer are: * what is the pain score for both groups * what is the requirement of epidural infusion between the 2 groups Participants will be given general anesthesia for the operation with the epidural insertion prior to induction. Patient will be randomized into epidural plus TAP block or epidural alone for the study. The US TAP block will be given at the end of operation prior to extubation. Researchers will compare pain score, epidural infusion requirment between the two groups. **Detailed Description:** The research is a prospective randomized control study. It is blinded study as accessor is blinded whereby the acute pain service (APS) team will be reviewing patient postoperatively. Study size of 46 subjects based on repeated measure ANOVA between factor , alpha value 0.05% with 80% power study, a dropout 10%. Divided into 2 groups ; Group E - epidural alone, Group T - epidural plus bilateral US TAP block. Perioperatively, epidural catheter will be inserted then induction for general anesthesia given. Intraoperatively anesthesia maintain with inhalation agent. Prior to extubation, bilateral TAP block is provided using portable US guidance. At this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. Post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs. The APS team will review patient post operatively in ward and all data will be recorded. Participation of patient's during study is approximately 2 days duration. ### Conditions Module **Conditions:** - Gynecologic Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Total sample size of 46 subjects, divided into 2 groups epidural alone (Group E) and epidural with bilateral US TAP block (Group T) ##### Masking Info **Masking:** SINGLE **Masking Description:** APS team will be assessing participants pain score in the ward and documented the data. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group epidural with bilateral US TAP block **Intervention Names:** - Other: Bilateral US TAP block **Label:** Group T **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Group epidural alone **Intervention Names:** - Other: Bilateral US TAP block **Label:** Group E **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group E - Group T **Description:** epidural plus bilateral US guided TAP block **Name:** Bilateral US TAP block **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To compare the pain score between 2 groups (epidural with bilateral TAP block) and epidural alone for gynaecology operation. **Measure:** Pain score between epidural plus bilateral TAP block and epidural alone **Time Frame:** Post operatively, until day 2 post operation. #### Secondary Outcomes **Description:** To compare the postoperative epidural infusion requirement between bilateral US guided TAP block plus epidural versus epidural alone. **Measure:** To compare the epidural infusion requirement between the 2 groups ( Group T and Group E) **Time Frame:** Post operatively, until day 2 post operation. **Description:** To evaluate time taken for early mobilization between group Epidural with TAP block and epidural alone after the operation . **Measure:** To evaluate time of early mobilization between 2 groups ( Group T and Group E) **Time Frame:** Post operatively, until day 2 post operation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Elective major laparotomy gynaecology procedure. * Age 18 years and above * ASA I, II, III Exclusion Criteria: * Prolonged INR * Allergic to LA * History of chronic pain * Psychological disorder/addict to opioid or benzodiazepine * Any contraindication for epidural or TAP block procedure * Pregnancy **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rhendra Hardy Mohd Zain **Phone:** +6097676104 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Suki Ismet **Phone:** +6097676105 **Role:** CONTACT #### Locations **Location 1:** **City:** Kubang Kerian **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Munirah Abdul Majid - **Phone:** +6097673000 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Suki Ismet - **Phone:** +6097676105 - **Role:** CONTACT **Country:** Malaysia **Facility:** Universiti Sains Malaysia **State:** Kelantan **Status:** RECRUITING **Zip:** 16150 #### Overall Officials **Official 1:** **Affiliation:** University Sains Malaysia **Name:** Munirah Abdul Majid **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University Sains Malaysia **Name:** W.Mohd Nazaruddin W. Hassan **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345. **PMID:** 26426576 **Citation:** Yoshida T, Furutani K, Watanabe Y, Ohashi N, Baba H. Analgesic efficacy of bilateral continuous transversus abdominis plane blocks using an oblique subcostal approach in patients undergoing laparotomy for gynaecological cancer: a prospective, randomized, triple-blind, placebo-controlled study. Br J Anaesth. 2016 Dec;117(6):812-820. doi: 10.1093/bja/aew339. **PMID:** 27956680 **Citation:** Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31. **PMID:** 29226150 **Citation:** Iyer SS, Bavishi H, Mohan CV, Kaur N. Comparison of Epidural Analgesia with Transversus Abdominis Plane Analgesia for Postoperative Pain Relief in Patients Undergoing Lower Abdominal Surgery: A Prospective Randomized Study. Anesth Essays Res. 2017 Jul-Sep;11(3):670-675. doi: 10.4103/0259-1162.206856. **PMID:** 28928569 **Citation:** Wu Y, Liu F, Tang H, Wang Q, Chen L, Wu H, Zhang X, Miao J, Zhu M, Hu C, Goldsworthy M, You J, Xu X. The analgesic efficacy of subcostal transversus abdominis plane block compared with thoracic epidural analgesia and intravenous opioid analgesia after radical gastrectomy. Anesth Analg. 2013 Aug;117(2):507-13. doi: 10.1213/ANE.0b013e318297fcee. Epub 2013 Jun 6. **PMID:** 23744953 **Citation:** Huepenbecker SP, Cusworth SE, Kuroki LM, Lu P, Samen CDK, Woolfolk C, Deterding R, Wan L, Helsten DL, Bottros M, Mutch DG, Powell MA, Massad LS, Thaker PH. Continuous epidural infusion in gynecologic oncology patients undergoing exploratory laparotomy: The new standard for decreased postoperative pain and opioid use. Gynecol Oncol. 2019 May;153(2):356-361. doi: 10.1016/j.ygyno.2019.02.017. Epub 2019 Feb 22. **PMID:** 30798950 ## Derived Section ### Condition Browse Module - Ancestors - 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: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8943 - Name: Genital Diseases, Female - Relevance: HIGH - As Found: Gynecologic Disease - 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: D000005831 - Term: Genital Diseases, Female ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425471 **Brief Title:** A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery **Official Title:** A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery #### Organization Study ID Info **ID:** HSC-MS-22-1019 #### Organization **Class:** OTHER **Full Name:** The University of Texas Health Science Center, Houston ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### 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:** Jimmy Espinoza **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery **Detailed Description:** Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes ### Conditions Module **Conditions:** - In Utero Procedure Affecting Fetus or Newborn ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: KARL STORZ fetoscope arm **Label:** KARL STORZ fetoscope arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - KARL STORZ fetoscope arm **Description:** The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS) **Name:** KARL STORZ fetoscope arm **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Gestational age at delivery in patients requiring percutaneous in-utero surgery **Time Frame:** at time of delivery (about 10 weeks after in utero surgery) #### Secondary Outcomes **Measure:** Number of successful procedures with completion of laser ablation of the abnormal vessels. **Time Frame:** within 24 hours of in utero surgery **Description:** This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes. **Measure:** Improved visualization as assessed by the Likert scale **Time Frame:** within 24 hours of in utero surgery **Description:** This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree **Measure:** Improved angle for laser visualization as assessed by the Likert scale **Time Frame:** within 24 hours of in utero surgery **Description:** This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome **Measure:** Improved ease of use of the new fetoscope as assessed by a questionnaire **Time Frame:** within 24 hours of in utero surgery **Description:** Time from from operative cannula insertion until it is removed **Measure:** Operative time in minutes **Time Frame:** end of surgery ( about 1 hour form start of surgery) **Measure:** Number of fetuses alive prior to hospital discharge **Time Frame:** time of discharge (about 48 hours after surgery) **Description:** Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption **Measure:** Total number of maternal patients that present with short term morbidity **Time Frame:** from end of surgery to within 10 weeks after surgery **Measure:** Total number of patients that have maternal and/or fetal perioperative complications **Time Frame:** from end of surgery to within 10 weeks after surgery **Measure:** The number of participants that develop twin-anemia-polycythemia sequence (TAPS) **Time Frame:** from end of surgery to within 10 weeks after surgery **Measure:** Total number of live births **Time Frame:** from time of in utero surgery till delivery (about 10 weeks after surgery) **Description:** Short-term morbidities include, but are not limited to, premature delivery (\<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis. **Measure:** Total number of short-term morbidities **Time Frame:** from time of in utero surgery till delivery (about 10 weeks after surgery) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant woman * The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition * Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure Exclusion Criteria: * Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia * Allergy or previous adverse reaction to a study medication specified in this protocol * Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy * Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation * Suspicion of a major recognized syndrome by ultrasound or MRI * Maternal BMI \>40 kg/m2 * High risk for fetal hemophilia **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jimmy Espinoza, MD, MSc,FACOG **Phone:** (713) 500-5859 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Elisa Garcia **Phone:** 713-500-6347 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jimmy Espinoza, MD, MSc,FACOG - **Phone:** (713) 500-5859 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Elisa Garcia - **Phone:** 713-500-6347 - **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:** Jimmy Espinoza, MD, MSc,FACOG **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425458 **Brief Title:** Transitioning Youth Out of Homelessness 2.5 (TYOH 2.5) **Official Title:** Transitioning Youth Out of Homelessness 2.5: A Co-Designed Strengths-Based Leadership Program for Young People Transitioning Out of Homelessness #### Organization Study ID Info **ID:** 24-072 #### Organization **Class:** OTHER **Full Name:** Unity Health Toronto ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Covenant House Toronto **Class:** UNKNOWN **Name:** StepStones for Youth **Class:** UNKNOWN **Name:** The Resource Association for Teens (RAFT) #### Lead Sponsor **Class:** OTHER **Name:** Unity Health Toronto #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The idea for this study came from the research team's current study called Transitioning Youth Out of Homelessness (TYOH) 2.0, which provides coaching and a leadership guide to youth transitioning out of homelessness. Based on feedback from youth and coaches involved in that study, the research team plans to make small changes to the leadership guide and see if it works better as an in-person, four-week leadership program. All participants in this study will be invited to attend an in-person, four-week leadership program. There will be two programs running at the same time: one in St. Catharines and one in Toronto. The goal is to have 15 participants in each program. The main purpose of the study is to learn what participants think of the program. The second purpose is to see if there are changes in identity capital (feeling a sense of purpose and confidence in achieving goals) and knowledge about things that are covered in the program, when the research team compares participants' answers at the beginning and at the end of the program. **Detailed Description:** This project builds on the research team's current community-based randomized clinical trial (Transitioning Youth Out of Homelessness 2.0) utilizing coaching and a co-designed leadership guide to target identity capital (purpose, control, self-efficacy, and self-esteem) for youth transitioning out of homelessness (all participants are also receiving rent subsidies). Based on preliminary feedback from study youth and coaches involved in the intervention arm, the research team will modify the leadership guide and pilot it in the form of an in-person, four-week leadership program (vs. independent learning in the current study). The overarching objective of this mixed methods pilot project is to co-develop and test a strengths-based leadership program targeting identity capital for youth (16-24 years of age) transitioning out of homelessness. Specifically, the objectives are to: 1. Modify the leadership guide being used in the research team's current study so it can be delivered as an in-person leadership program. 2. Co-develop and pilot a four-week, strengths-based leadership program for young people transitioning out of homelessness. 3. Determine the feasibility and acceptability of the leadership guide when delivered as a four-week, in-person program (as opposed to independent learning in the current study). 4. Examine whether self-reported measures of identity capital and knowledge of program material show improvement immediately post-program compared to baseline. 5. Explore whether there are differences in outcomes by sub-groups (e.g., gender, age, identification as 2SLGBTQ+, child welfare involvement) and/or program participation levels. If this modified delivery of the leadership guide shows promise, the research team plans to incorporate it into a national scale-up alongside rent subsidies and coaching. ### Conditions Module **Conditions:** - Homelessness - Youth **Keywords:** - Identity Capital - Youth - Coach - Self-Efficacy - Self-Esteem - Control - Purpose - Socioeconomic Inclusion - Homelessness - Transition ### 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:** Young people transitioning out of homelessness will attend a four-week, strengths-based leadership program. Two four-week leadership programs (15 youth per program) will be led by coaches from the research team's current TYOH 2.0 study with youth advisors participating as paid leadership interns. **Intervention Names:** - Behavioral: Co-Designed Strengths-Based Leadership Program **Label:** Co-Designed Strengths-Based Leadership Program **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Co-Designed Strengths-Based Leadership Program **Description:** Please see arm description. **Name:** Co-Designed Strengths-Based Leadership Program **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** A baseline demographic questionnaire will be utilized (T1), session attendance will be tracked throughout the intervention (T1-T2), and focus group findings will be examined (T2). The baseline demographic questionnaire is a 18-item self-report measure that was developed for this study and explores domains related to: age; gender; race/ethnicity; sexual orientation; immigration status; child welfare involvement; homelessness entrenchment; education; social support; financial support; and food security. **Measure:** Explore whether there are differences in outcomes by sub-groups (e.g., gender, age, identification as 2SLGBTQ+, child welfare involvement) and/or program participation levels. **Time Frame:** Assessed at T1 (first day of intervention) and T2 (last day of intervention). #### Primary Outcomes **Description:** Quantitative measures consisting of recruitment/enrolment/attendance/dropout metrics will be utilized. The recruitment rate will be estimated as the proportion of contacted individuals who express interest in participating in the study (T0). The enrolment rate will be calculated as the proportion of recruited individuals who are eligible and consent to participate in the study (T0). Session attendance and dropout rates will be tracked throughout the intervention (T1-T2). **Measure:** Intervention feasibility and acceptability as assessed by recruitment/enrolment/attendance/dropout metrics. **Time Frame:** Assessed at T0 (pre-intervention), T1 (first day of intervention) and T2 (last day of intervention). **Description:** This 4-item anonymous questionnaire will be used to collect information about participants' view of the leadership program, the impact of the program on them, and their view of the individuals running the program. **Measure:** Intervention feasibility and acceptability as assessed by a composite program feedback questionnaire. **Time Frame:** Assessed at T2 (last day of intervention). **Description:** Focus group discussions will explore intervention feasibility and acceptability (T2). **Measure:** Intervention feasibility and acceptability as informed by focus groups. **Time Frame:** Assessed at T2 (last day of intervention). #### Secondary Outcomes **Description:** The MAPS20 is a 20-item validated self-report measure that explores domains related to identity capital: self-esteem; purpose in life; internal locus of control; self-efficacy/ego strength. Score range: 20-120; score of less than 71 indicates risk/vulnerability of being overwhelmed by any adverse circumstances (internal consistency of four sub-scales α = .61-.75; T1/T2). **Measure:** Change in self-reported measures of identity capital as assessed by the Multi-Measure Agentic Personality Scale (MAPS20). **Time Frame:** Assessed at T1 (first day of intervention) and T2 (last day of intervention). **Description:** The composite knowledge assessment scale is 16-item self-report measure that was developed for this study and explores domains related to self-leadership, such as: mindfulness; core values; purpose; goal setting; growth mindset; identity; and courage (T1/T2). **Measure:** Change in self-reported knowledge of program material as assessed by a composite knowledge assessment scale. **Time Frame:** Assessed at T1 (first day of intervention) and T2 (last day of intervention). ### Eligibility Module **Eligibility Criteria:** Eligible young people aged 16-24 years who have transitioned out of homelessness (e.g., no longer living in a shelter or couch surfing), defined as 3 consecutive months within the past 12 months, will be identified by community partners (note: for the purpose of this study, youth living in foster care will be considered homeless). This age mandate was chosen because this is the age group served by the community partners. The research team has chosen to target the first year of exiting homelessness because collective experience has shown that this can be a particularly precarious time for youth in terms of mental health challenges and risk of (re)experiencing homelessness (even if youth have attempted exits in the past). Inclusion Criteria: * Be able to provide free and informed consent. * Be able to understand English (leadership program and data collection will be conducted in English). * Have experienced homelessness (e.g., unstable housing arrangements including shelter stays, foster care, and couch surfing) for 3 consecutive months in the past 12 months. * Be able to consistently attend the four-week leadership program. Exclusion Criteria: * Enrolled in a program or study with similar features to the TYOH 2.5 leadership program. **Healthy Volunteers:** True **Maximum Age:** 24 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Naomi S Thulien, NP-PHC, PhD **Phone:** 416-360-4000 **Role:** CONTACT #### Locations **Location 1:** **City:** Toronto **Country:** Canada **Facility:** Unity Health Toronto **State:** Ontario ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Côté, J. (2016). The identity capital model: A handbook of theory, methods, and findings. #### See Also Links **Label:** Describes the Multi-Measure Agentic Personality Scale (MAPS20), which is being utilized in the current study. **URL:** https://ir.lib.uwo.ca/sociologypub/38/ ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425445 **Brief Title:** Quantitative Assessment of Orofacial Muscle Function in FSHD **Official Title:** Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study. #### Organization Study ID Info **ID:** P2024/031 #### Organization **Class:** OTHER **Full Name:** University of Mons ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Mons #### Responsible Party **Investigator Affiliation:** University of Mons **Investigator Full Name:** Alexandre Legrand **Investigator Title:** Professor and Dean of the Faculty of Medicine and Pharmacy **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 validate a new method for the assessment of orofacial muscles in FSHD affected individuals, using maximal expiratory pressures (MEPs). Our hypothesis is the following: - The pressure drop observed when using circular mouthpieces (versus ovoid mouthpieces) is a reflection of orofacial dysfunction in FSHD affected individuals ### Conditions Module **Conditions:** - Facioscapulohumeral Muscular Dystrophy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds **Label:** Affected participants **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds **Label:** Healthy participants **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Affected participants - Healthy participants **Description:** Participants perform forced static expiratory maneuvers sustained over a five second period **Name:** Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The pressure drop (PD) is defined as the pressure difference between a reference ovoid-shaped mouthpiece and variously-sized circular mouthpieces, divided by the reference pressure. It is a relative value that is expected to reflect the magnitude of orofacial muscle dysfunction in FSHD affected individuals. **Measure:** The pressure drop **Time Frame:** The pressure drop will be assessed for each study participant at visit 1 and subsequently at visit 2 (3 months later). The measurements as such, should take about 30 minutes for each participant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Genetic diagnosis of FSHD type 1 and/or type 2 Exclusion Criteria: * Pregnant women * Presence of other associated neuromuscular conditions * Any unstable interfering clinical situation **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Eliot Rudy Mbolo Ebubu (PhD candidate, MD, study investigator) **Phone:** 0032485114738 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Alexandre Legrand (PhD, MD, principal investigator) **Phone:** 0032475471353 **Role:** CONTACT #### Locations **Location 1:** **City:** Mons **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Eliot Rudy Mbolo Ebubu (PhD candidate, MD, study investigator) - **Phone:** 0032485114738 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Alexandre Legrand (PhD, MD, principal investigator) - **Phone:** 0032475471353 - **Role:** CONTACT **Country:** Belgium **Facility:** University of Mons **State:** Hainaut **Status:** RECRUITING **Zip:** 7000 #### Overall Officials **Official 1:** **Affiliation:** University of Mons **Name:** Alexandre Legrand (PhD, MD, principal investigator) **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020966 - Term: Muscular Disorders, Atrophic - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12093 - Name: Muscular Dystrophies - Relevance: HIGH - As Found: Muscular Dystrophy - ID: M22188 - Name: Muscular Dystrophy, Facioscapulohumeral - Relevance: HIGH - As Found: Facioscapulohumeral Muscular Dystrophy - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M22697 - Name: Muscular Disorders, Atrophic - 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: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T3963 - Name: Muscular Dystrophy - Relevance: HIGH - As Found: Muscular Dystrophy - ID: T2182 - Name: Facioscapulohumeral Muscular Dystrophy - Relevance: HIGH - As Found: Facioscapulohumeral Muscular Dystrophy ### Condition Browse Module - Meshes - ID: D000009136 - Term: Muscular Dystrophies - ID: D000020391 - Term: Muscular Dystrophy, Facioscapulohumeral ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425432 **Brief Title:** Higher Order Aberration and Relationship With Soft Contact Lens Modulus **Official Title:** Higher Order Aberration and Relationship With Soft Contact Lens Modulus #### Organization Study ID Info **ID:** 6733 #### Organization **Class:** OTHER **Full Name:** Southern College of Optometry ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Southern College of Optometry #### Responsible Party **Investigator Affiliation:** Southern College of Optometry **Investigator Full Name:** Yueren Wang, OD **Investigator Title:** Assistant Professor **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:** Higher order aberrations are imperfects in the eye that affect the quality of image projected onto the retina. Soft contact lenses are made of different materials with different stiffness. This study looks to see if the soft contact lens material affects the amount of higher order aberrations in an eye. ### Conditions Module **Conditions:** - Corneal Wavefront Aberration **Keywords:** - Contact Lens - Higher order aberration - Modulus ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subject will present wearing habitual contact lenses for the aberrometry measurement. They will then remove their contact lenses and measurement repeated uncorrected. **Intervention Names:** - Device: OVITZ xwave aberrometer **Label:** CL first #### Arm Group 2 **Description:** Subjects will refrain from contact lens wear on day of the visit. Initial aberrometry measurement will be performed uncorrected. They will be then asked to insert their contact lenses and aberrometry measurements repeated. **Intervention Names:** - Device: OVITZ xwave aberrometer **Label:** Glasses first ### Interventions #### Intervention 1 **Arm Group Labels:** - CL first - Glasses first **Description:** wavefront aberrometer **Name:** OVITZ xwave aberrometer **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Measure HOA with contact lenses. And then measure HOA without contact lenses. **Measure:** Mean change in HOA with and without contact lenses **Time Frame:** Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal. #### Secondary Outcomes **Description:** Evaluate correlation between the lens modulus and changes in HOA **Measure:** Correlation between contact lens modulus and changes in HOA with and without contact lenses **Time Frame:** Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Willing and able to provide informed consent * Adults \> 18 years old regardless of gender, race, or ethnicity * Habitual single vision soft CL wearer for at least 1 week in any modality. Exclusion Criteria: * Multifocal soft CL wear * GP or ortho K wear in the last 3 months. * Active eye infections and inflammations. * Current use of ocular medication. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adults (\>18 years old) who are wearing single-vision soft contact lenses will be recruited. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yueren Wang, OD **Phone:** 901-252-3691 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Upon request **Description:** all IPD that underlie results in a publication **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** 6 months - 3 years after publication ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-13 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 197197 - Type Abbrev: Prot - Upload Date: 2024-05-20T13:06 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003316 - Term: Corneal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000012030 - Term: Refractive Errors ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M28721 - Name: Corneal Wavefront Aberration - Relevance: HIGH - As Found: Corneal Wavefront Aberration - ID: M6539 - Name: Corneal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M14872 - Name: Refractive Errors - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000057108 - Term: Corneal Wavefront Aberration ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425419 **Brief Title:** The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy **Official Title:** The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy #### Organization Study ID Info **ID:** 2023P002259 #### Organization **Class:** OTHER **Full Name:** Massachusetts Eye and Ear Infirmary ### Status Module #### Completion Date **Date:** 2026-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-01-09 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts Eye and Ear Infirmary #### Responsible Party **Investigator Affiliation:** Massachusetts Eye and Ear Infirmary **Investigator Full Name:** Leo Am Kim, M.D. **Investigator Title:** Associate Professor of Ophthalmology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the safety and efficacy of intravitreal topotecan for the treatment of patients with rhegmatogenous retinal detachment due to proliferative vitreoretinopathy (PVR) or resulting from an open globe injury, and compare the outcomes to those who do no receive intravitreal topotecan. The main objectives it aims to achieve are: * to study the safety profile of intravitreal topotecan in the treatment of PVR * to evaluate the efficacy of intravitreal topotecan in treating PVR. Post-consent, participants will: * undergo vitrectomy (with or without scleral buckle) as part of standard treatment for retinal detachment. * receive intravitreal topotecan at the time of surgery, post-operative day 7 and post-operative day 28 (if randomized to receive the medication) * come in at post-operative day 1, 7, 28, 56, 84, 126 and 168 to undergo a complete ophthalmic exam along with a fundus photography and optical coherence tomography of the macula, have their intraocular pressure and visual acuity measured and their adverse events monitored, if any. Researchers will compare participants who receive intravitreal topotecan for PVR to those who do not to see if there is a significant variability in recurrence of retinal detachment, rate of retinal reattachment and PVR grade 6 months after surgery. **Detailed Description:** Rhegmatogenous retinal detachment (RRD) is an acute, sight-threatening condition that occurs after separation of the neurosensory retina from the underlying retinal pigment epithelium (RPE) due to the presence of a retinal break. Proliferative vitreoretinopathy (PVR) represents growth of ectopic fibrocellular growth on the surface of, within and underneath the retina. PVR is hypothesized to occur secondary to the migration of RPE cells to the peri-retina, leading to a mesenchymal transition into contractile myofibroblasts. PVR affects 5-10% of RRDs and is the most common cause of surgical failure in RRD. Given that PVR involves a pro-inflammatory and pro-fibrotic cellular response, adjuvants such as corticosteroids and antimetabolites such as 5-fluorouracil have been attempted in the treatment of this condition. Overall, the efficacy results of these treatments have been mixed, and no standard of care adjuvant therapy has emerged. Topotecan is a chemotherapeutic agent that acts as a topoisomerase inhibitor. It is most commonly administered intravitreally for patients with refractory or recurrent vitreous seeds from retinoblastoma, and shows high efficacy in this setting. At the same time, intravitreal topotecan administered at doses of 5-30µg has been associated with no ocular or systemic complications or adverse electroretinogram changes. To the best of available knowledge, topotecan has not been administered for the treatment of proliferative vitreoretinopathy. Topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that is hypothesized to exhibit high efficacy for the treatment of PVR. In this study, the efficacy and safety of intravitreal topotecan for the treatment of PVR will be investigated. ### Conditions Module **Conditions:** - Proliferative Vitreoretinopathy - Proliferative Vitreo-Retinopathy - Rhegmatogenous Retinal Detachment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Half of the patients will receive intravitreal topotecan at the time of surgery. Randomization will be done based on a computer-generated list that would randomly allocate each of the 50 participants to being either in the treatment arm or in the control arm, in a particular order. Results will be printed on a card put in sealed envelopes that would be given to each research subject based on the allocation order given by that computer-generated list. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** These are the patients who will be receiving intravitreally 20 micrograms of topotecan in a 1cc syringe during surgery, at the post-operative day 7 and at the post-operative day 28. **Intervention Names:** - Drug: Topotecan **Label:** Participants who received intravitreal topotecan **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** These patients will not be receiving any intervention. **Label:** Participants who did not received intravitreal topotecan **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants who received intravitreal topotecan **Description:** 20 micrograms of intravitreal topotecan given in a 1 cc tuberculin syringe at a concentration of 20 mcg/20mcL. **Name:** Topotecan **Other Names:** - Hycamtin **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** an OCT of the macula will be taken to evaluate for any retinal changes throughout the study **Measure:** Optical coherence tomography (OCT) of the macula **Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168 #### Primary Outcomes **Description:** Investigators will be evaluating whether participant develop a recurrent retinal detachment throughout their follow up after their initial surgery. **Measure:** Recurrence of rhegmatogenous retinal detachment secondary to PVR **Time Frame:** 6 months after initial surgery, or last follow-up visit available #### Secondary Outcomes **Description:** Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up **Measure:** Best corrected visual acuity (BCVA) **Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168 **Description:** Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the grade of the PVR changes over time. PVR grade goes from grade A to grade C-Anterior to equator/ C-Posterior to equator (grade C being worse than grade A) **Measure:** Variation of PVR grade **Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168 **Description:** Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the retinal reattaches (whether completely or partially) after surgery **Measure:** Retinal reattachment rate at month 6 or last follow up **Time Frame:** at post-operative day 168 (or last follow-up visit available if the participant did not show up at post-operative day 168) **Description:** Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up **Measure:** Recurrence of rhegmatogenous retinal detachment due to any cause **Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168 **Description:** Any adverse event will be noted during surgery, and at each follow up visit for each participant if applicable. **Measure:** Number of participants and type of intraoperative or postoperative complications **Time Frame:** at time of surgery, and each follow up visit (post-operative day1, 7, 28, 56, 84, 126, 168) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients \> 18 years old * Patients presenting with retinal detachment due with PVR (grade C or higher) or retinal detachment associated with open globe trauma * Patients undergoing vitrectomy or vitrectomy with scleral buckle as part of standard care. Exclusion Criteria: * Patient unable to give consent * Patient unable to follow-up * Females of childbearing age who are pregnant at the time of recruitment. A pregnancy test will be done to all women of ages 18-55 prior to surgery to ensure they are not pregnant at the time of recruitment. * Patients with a history of tractional or exudative retinal detachment. * Patients with other planned ocular surgery following PPV * Active or chronic or recurrent uncontrolled ocular or systemic disease * Active or history of chronic or recurrent inflammatory eye disease * Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in the operative eye * Signs of ocular infection at presentation in either eye * Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively * No Light Perception vision in the operative eye * Failure to achieve intraoperative reattachment * Patient with silicone oil instilled in the operative eye at time of presentation **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Leo Kim, MD, PhD **Phone:** 617-391-5896 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Massachusetts Eye and Ear **Name:** Leo Kim, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ohman T, Gawriyski L, Miettinen S, Varjosalo M, Loukovaara S. Molecular pathogenesis of rhegmatogenous retinal detachment. Sci Rep. 2021 Jan 13;11(1):966. doi: 10.1038/s41598-020-80005-w. **PMID:** 33441730 **Citation:** Mysore Y, Del Amo EM, Loukovaara S, Hagstrom M, Urtti A, Kauppinen A. Statins for the prevention of proliferative vitreoretinopathy: cellular responses in cultured cells and clinical statin concentrations in the vitreous. Sci Rep. 2021 Jan 13;11(1):980. doi: 10.1038/s41598-020-80127-1. Erratum In: Sci Rep. 2021 Jul 22;11(1):15327. **PMID:** 33441813 **Citation:** Claes C, Lafeta AP. Proliferative vitreoretinopathy. Dev Ophthalmol. 2014;54:188-95. doi: 10.1159/000360466. Epub 2014 Aug 26. **PMID:** 25196769 **Citation:** Pastor JC, de la Rua ER, Martin F. Proliferative vitreoretinopathy: risk factors and pathobiology. Prog Retin Eye Res. 2002 Jan;21(1):127-44. doi: 10.1016/s1350-9462(01)00023-4. **PMID:** 11906814 **Citation:** Sadaka A, Giuliari GP. Proliferative vitreoretinopathy: current and emerging treatments. Clin Ophthalmol. 2012;6:1325-33. doi: 10.2147/OPTH.S27896. Epub 2012 Aug 14. **PMID:** 22942638 **Citation:** Rao R, Honavar SG, Sharma V, Reddy VAP. Intravitreal topotecan in the management of refractory and recurrent vitreous seeds in retinoblastoma. Br J Ophthalmol. 2018 Apr;102(4):490-495. doi: 10.1136/bjophthalmol-2017-310641. Epub 2017 Aug 26. **PMID:** 28844050 **Citation:** Bogan CM, Kaczmarek JV, Pierce JM, Chen SC, Boyd KL, Calcutt MW, Bridges TM, Lindsley CW, Nadelmann JB, Liao A, Hsieh T, Abramson DH, Francis JH, Friedman DL, Richmond A, Daniels AB. Evaluation of intravitreal topotecan dose levels, toxicity and efficacy for retinoblastoma vitreous seeds: a preclinical and clinical study. Br J Ophthalmol. 2022 Feb;106(2):288-296. doi: 10.1136/bjophthalmol-2020-318529. Epub 2021 May 10. **PMID:** 33972235 **Citation:** Nadelmann J, Francis JH, Brodie SE, Muca E, Abramson DH. Is intravitreal topotecan toxic to retinal function? Br J Ophthalmol. 2021 Jul;105(7):1016-1018. doi: 10.1136/bjophthalmol-2020-316588. Epub 2020 Jul 14. **PMID:** 32665221 **Citation:** Ghassemi F, Shields CL, Ghadimi H, Khodabandeh A, Roohipoor R. Combined intravitreal melphalan and topotecan for refractory or recurrent vitreous seeding from retinoblastoma. JAMA Ophthalmol. 2014 Aug;132(8):936-41. doi: 10.1001/jamaophthalmol.2014.414. **PMID:** 24789622 **Citation:** Cepeda MS, Boston R, Farrar JT, Strom BL. Comparison of logistic regression versus propensity score when the number of events is low and there are multiple confounders. Am J Epidemiol. 2003 Aug 1;158(3):280-7. doi: 10.1093/aje/kwg115. **PMID:** 12882951 **Citation:** Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14. **PMID:** 24605197 **Citation:** Machemer R, Aaberg TM, Freeman HM, Irvine AR, Lean JS, Michels RM. An updated classification of retinal detachment with proliferative vitreoretinopathy. Am J Ophthalmol. 1991 Aug 15;112(2):159-65. doi: 10.1016/s0002-9394(14)76695-4. **PMID:** 1867299 ## 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14998 - Name: Retinal Detachment - Relevance: HIGH - As Found: Retinal Detachment - ID: M20719 - Name: Vitreoretinopathy, Proliferative - Relevance: HIGH - As Found: Proliferative Vitreoretinopathy - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T5871 - Name: Vitreoretinal Degeneration - Relevance: HIGH - As Found: Vitreoretinopathy ### Condition Browse Module - Meshes - ID: D000012163 - Term: Retinal Detachment - ID: D000018630 - Term: Vitreoretinopathy, Proliferative ### Intervention Browse Module - Ancestors - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21674 - Name: Topotecan - Relevance: HIGH - As Found: Atrial Fibrillation - 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: D000019772 - Term: Topotecan ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425406 **Brief Title:** Application of HFNC for Children **Official Title:** Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** HFNC #### Organization **Class:** OTHER **Full Name:** Henan Provincial People's Hospital ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-12-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Henan Provincial People's Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Compared with adults, children have higher metabolic needs, and the airway is more likely to collapse. Before tracheal intubation after anesthesia induction, the patient 's spontaneous breathing completely disappears. At this critical stage, the residual oxygen of the lung is consumed, resulting in hypoxemia and atelectasis. Therefore, it is necessary to explore the best oxygenation strategy during intubation. In addition, ultrasound has become a common equipment in the operating room. It has the advantages of portability, repeatability, and no radiation, and can provide strong support for the diagnosis of gastric distension. **Detailed Description:** At present, hypoxia is still the main cause of complications and death during perioperative period. Compared with adults, children have lower functional residual volume and lower tolerance to hypoxia caused by apnea due to their special physiological and functional characteristics. During anesthesia induction and tracheal intubation, spontaneous breathing completely disappears. At this critical stage, hypoxemia is prone to occur, which in turn causes various serious complications. Mask ventilation may occur mask ventilation difficulties and flatulence ; since the introduction of nasal high-flow oxygen therapy ( HFNC ) into the operating room in 2015, its oxygenation method has been shown to be able to significantly improve blood oxygen when used alone in pre-oxygenation. When tracheal intubation is performed, HFNC can still maintain ventilation in the patient 's nose, so HFNC can combine the advantages of both masks to perform pre-oxygenation. There are few studies on the effect of HFNC on apnea oxygenation in children in the operating room. ### Conditions Module **Conditions:** - High-flow Nasal Cannula - Children - Pre-oxygenation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the HFNC group, the mask ventilation was performed after the patient lost spontaneous breathing until the end-tidal oxygen concentration reached 90 %. The mask was removed and HFNC ( AIRVO2, Fisher Parker Medical Company, Auckland, New Zealand ) was used to record the patient 's safe apnea time. After the end of positive pressure ventilation, intubation or laryngeal mask placement was performed after the end-tidal oxygen concentration reached 90 % or more. During the intubation or placement of the laryngeal mask, the HFNC nasal catheter was kept in the patient 's nose for apnea oxygenation. **Intervention Names:** - Device: high-flow nasal cannula **Label:** Group HFNC **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** No intervention **Label:** Group control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Group HFNC **Description:** In group H, mask ventilation was performed after the patient lost spontaneous breathing until the end-expiratory oxygen concentration reached 90 %. The lower mask was taken and HFNC was used to record the patient 's safe apnea time. **Name:** high-flow nasal cannula **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Investigators will record the time of oxygen saturation drop to 95 % during intubation. **Measure:** Apnoea time **Time Frame:** 2-10min ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 2-10 years old; * American Society of Anesthesiologists (ASA) Level I or II; * Children with healthy lungs and hearts; * Clear headed and able to cooperate with anesthesiologists for treatment. Exclusion Criteria: * Contraindications for HFNC: (1) Complete obstruction of the upper respiratory tract; (2) Skull base fracture or nasal bone fracture; (3) Patients who refuse to use HFNC; * The American Society of Anesthesiologists (ASA) rating is greater than Level II; * Children with upper respiratory tract infections within 2 weeks; * Pulmonary dysfunction, congenital heart disease in children; **Healthy Volunteers:** True **Maximum Age:** 10 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** KuangYu Zhao **Phone:** +8613251535857 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jun Zhou, PHD **Phone:** +8613592582222 **Role:** CONTACT #### Locations **Location 1:** **City:** Zhengzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zhou Jun - **Phone:** +8613592582222 - **Role:** CONTACT **Country:** China **Facility:** Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital **State:** Henan **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Henan Provincial People's Hospital **Name:** Jun Zhou, PHD **Role:** STUDY_CHAIR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425393 **Brief Title:** Intrafamilial Helicobacter Pylori Infection in Hong Kong **Official Title:** Prevalence and Risk Factors of Intrafamilial Helicobacter Pylori Infection in Hong Kong: a Prospective Cohort Study #### Organization Study ID Info **ID:** 2024.143 #### Organization **Class:** OTHER **Full Name:** Chinese University of Hong Kong ### Status Module #### Completion Date **Date:** 2026-12-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-11 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-20 ### 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:** Lily Wan Ying LAI **Investigator Title:** Resident doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** It is a single-centre, prospective cohort study, which will be conducted in a tertiary academic hospital. The study aims to investigate intrafamilial H. pylori infection status and to identify risk factors for H. pylori infection among household members. The rate of intrafamilial H. pylori spread in Hong Kong is currently unknown. It is also not clear whether the same risk factors for intrafamilial spread of H. pylori infection also apply in Hong Kong. In contrast to mainland China and Taiwan , recent consensus guideline on H. pylori management in Hong Kong in 2023 recommends against routine testing of asymptomatic household members or family members of H. pylori-infected adults. There is a knowledge gap on whether the family-based H. pylori screening is cost effective in our locality. Thus, the investigator aim to investigate infection status of household members of H. pylori infected individuals and risk factors for household infection in Hong Kong. The result from this study will shed light on the role of family-based screening and can inform future healthcare policy making on the strategy of H. pylori management and treatment in Hong Kong, ameliorating H. pylori infection-related disease and gastric cancer burden for society. **Detailed Description:** Helicobacter pylori infects around half of the population in the world, and it is believed to affect more than half of population in Hong Kong. H. pylori infection is a well-known cause of chronic gastritis, peptic ulcer diseases and gastric cancer. Early detection and eradication of H. pylori infection is of utmost importance. H. pylori infection is mainly transmitted by oral-oral, faecal-oral routes and water sources . Emerging studies demonstrated that intrafamilial spread is common. Recent national, family-based epidemiological study on H. pylori infection in mainland China showed a high familial infection rate ranging from 50.27% to 85.06%. In another study in central China, it was found that all family members were infected with H. pylori in 27.8% of the H. pylori infected households. Therefore, detection and eradication of H. pylori infection in family are very important to prevent development of H. pylori related diseases. Instead of the traditional strategies for individual-based management of H. pylori infection like 'test and treat' and 'screen and treat' strategies, a new strategy 'family- based H. pylori infection control and management' has been introduced. In 2021, China published a consensus report on the Family-based H. pylori infection control and management with an aim to reduce intrafamilial H. pylori spread in the Chinese population. In Taiwan, where the incidence of GC is high, a preventive strategy with 13C-urea breath test screening using the index case method and outreach the family members of the positive index cases. Eradication therapies for those who test positive and to follow up 2 years later to test the reinfection rate has been implemented to reduce the incidence of gastric cancers and reduce the cancer health inequality in indigenous communities. Previous studies have identified several risk factors for intrafamilial transmission of H. pylori infection. Large family size of 3 or more in a household and living in highly infected areas in Northwest China were risk factors for household H. pylori infection while family members with higher income and education level , using serving spoons or chopsticks , drinking boiled water from tap source were associated with lower risk of household infection. There is concern on the re-infection rate of H. pylori after eradication therapy. A systemic review revealed that global annual recurrence, reinfection and recrudescence rates of H. pylori were 4.3% (95%CI: 4-5), 3.1% (95%CI: 2-5) and 2.2% (95%CI: 1-3), respectively. An observational study in Turkey found that for H. pylori infected patients with whole family testing and eradication, the recurrence rate was 7.1% 9 months after treatment. On the other hand, when only the infected patient was eradicated but the whole family infection was not treated, the recurrence rate was 38.6% 9 months after treatment. These results suggest that treatment of the whole infected family is of great value in controlling H. pylori re-infection and preventing recurrence. ### Conditions Module **Conditions:** - H.Pylori Infection **Keywords:** - H.pylori infection ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients who are diagnosed to have H. pylori infection by either histology, rapid urease test or urea breath test will be recruited. At least 1 household member of each H. pylori infected subject will also be recruited. ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The H. pylori infected subject is responsible for providing details of the number of household members, family structure, family history of gastric diseases, family economy, living conditions, family hygiene and living habits. Patients also need to provide personal information including HKID, ethnicity. **Label:** H. pylori positive subjects **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** The household members of the index subjects will be invited to complete a questionnaire which includes the baseline demographics, past medical history, personal hygiene and living habits. Also, they will be received urea beath test (UBT). Referral will be given to those positive result household members. **Intervention Names:** - Diagnostic Test: Urea beath test (UBT) **Label:** H. pylori positive subjects' household members **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - H. pylori positive subjects' household members **Description:** H. pylori infection will be tested using a 13C-urea breath test Kit for all enrolled family members, following the manufacturer's instructions. The sensitivity and specificity of the assay are both over 95%, according to the manufacturer's introduction. **Name:** Urea beath test (UBT) **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The rate of H. pylori infection in household members of H. pylori infected subjects from the given UBT **Measure:** Rate of H. pylori infection in household members **Time Frame:** during the study period, 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults age\>=18 years of age * For H. pylori infected patients only: Diagnosed to have H. pylori infection by either histology, rapid urease test or urea breath test * Written informed consent obtained Exclusion Criteria: * Unable to perform urea breath test * Contraindications for urea breath test * Used antibiotics within the past month/proton pump inhibitors within two weeks **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Felix Sia **Phone:** 26370428 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** There will be no plan to share individual participant data. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - 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: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1804 - Name: Carbamide Peroxide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425380 **Brief Title:** Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy **Official Title:** Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy #### Organization Study ID Info **ID:** HUM00251803 #### Organization **Class:** OTHER **Full Name:** University of Michigan ### Status Module #### Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Michigan #### Responsible Party **Investigator Affiliation:** University of Michigan **Investigator Full Name:** Patricia Bloom **Investigator Title:** Assistant Professor of Internal Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy. The researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. Along with taking the study product participants health-related information and stool will be collected for this research study. ### Conditions Module **Conditions:** - Hepatic Encephalopathy - Cirrhosis **Keywords:** - Resistant Potato Starch ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This will be taken for four weeks by enrolled participants. **Intervention Names:** - Other: Resistant Potato Starch **Label:** Resistant potato starch **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Resistant potato starch **Description:** Participants will receive 4 weeks of resistant potato starch 20 grams (g) twice daily. Bob's Red Mill® potato starch will be used. Every patient will receive the same dose and there are no dose titrations. **Name:** Resistant Potato Starch **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The study team will compare the total concentrations of the 3 most abundant SCFAs in humans (acetate, propionate, and butyrate) at baseline and week 4. Stool will undergo SCFA quantification by the University of Michigan Metabolomics core. **Measure:** Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4 **Time Frame:** Baseline, Week 4 #### Secondary Outcomes **Description:** In this test patients name as many animals as they can in 60 seconds. The ANT score is the number of unique animals named. **Measure:** Change in animal naming test (ANT) from baseline to week 4 **Time Frame:** Baseline, Week 4 **Description:** The severity or grade of an adverse event may be measured using the following definitions: Mild: Noticeable to the subject, but does not interfere with subject's expected daily activities, usually does not require additional therapy or intervention, dose reduction, or discontinuation of the study. Moderate: Interferes with the subject's expected daily activities, may require some additional therapy or intervention but does not require discontinuation of the study. Severe: Extremely limits to the subject's daily activities and may require discontinuation of study therapy, and/or additional treatment or intervention to resolve and may be life-threatening or fatal. **Measure:** Number and type of adverse events from baseline to week 8 **Time Frame:** baseline to week 8 **Description:** Gastrointestinal questionnaire has six questions with a total score ranging from 1-30 with the lower score indicating a healthier status. **Measure:** Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4 **Time Frame:** Baseline, Week 4 **Description:** The Gas and Bloating scale has13 questions (scale 2-60; with higher scores corresponding to more severe gas/bloating). **Measure:** Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4 **Time Frame:** Baseline, Week 4 **Measure:** Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team **Time Frame:** start of screening, end of enrollment (approximately 20 months) **Description:** Proportion of study activities completed **Measure:** Feasibility of completing study activities **Time Frame:** baseline, week 8 **Description:** Proportion of study samples collected (number collected from all patients / number requested from patients). **Measure:** Feasibility based on the number of specimens collected **Time Frame:** baseline, week 4 **Description:** Proportion of drop outs **Measure:** Retention to end of study **Time Frame:** start of screening, end of enrollment (approximately 20 months) **Description:** Proportion of doses consumed **Measure:** Intervention adherence **Time Frame:** baseline, week 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to provide consent, with signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation. * History of at least one episode of overt Hepatic Encephalopathy (HE) in the last year. * Defined by West Haven Criteria Grades II to IV * Can be precipitated Hepatic Encephalopathy (HE) episode. * Sexually active women of childbearing potential enrolled in the study must agree to use a highly-effective method of contraception (defined in the protocol) for the duration of the study. Exclusion Criteria: * Hospitalization in the last 4 weeks * Current refractory ascites (requiring large volume paracentesis to manage ascites) * Gut-absorbable or intravenous antibiotic therapy in the last 4 weeks (rifaximin is permitted) * Anticipated antibiotics in the coming 4 weeks * Use of lactulose in the last 4 weeks * Alcohol or illicit drug intake in the last 4 weeks * By history * Alcohol use will be characterized as \>1 alcoholic drink / week * History of inflammatory bowel disease * History of primary sclerosing cholangitis * Total bilirubin in the last 3 months \> 4 mg/dL * Prior diagnosis of dementia or other primary neurocognitive disorder * Pregnancy or breast feeding * Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed \>3 months before enrollment) * Allergy to resistant potato starch **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Max Macgregor **Phone:** 734-764-0843 **Role:** CONTACT #### Locations **Location 1:** **City:** Ann Arbor **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Max Macgregor - **Phone:** 734-764-0843 - **Role:** CONTACT ***Contact 2:*** - **Name:** Patricia Bloom, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Michigan **State:** Michigan **Zip:** 48109 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan **Name:** Patricia Bloom, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000017093 - Term: Liver Failure - ID: D000048550 - Term: Hepatic Insufficiency - ID: D000001928 - Term: Brain Diseases, Metabolic - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11103 - Name: Liver Cirrhosis - Relevance: HIGH - As Found: Cirrhosis - ID: M9587 - Name: Hepatic Encephalopathy - Relevance: HIGH - As Found: Hepatic Encephalopathy - ID: M5204 - Name: Brain Diseases - Relevance: HIGH - As Found: Encephalopathy - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Cirrhosis - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M19415 - Name: Liver Failure - Relevance: LOW - As Found: Unknown - ID: M25970 - Name: Hepatic Insufficiency - Relevance: LOW - As Found: Unknown - ID: M5205 - Name: Brain Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T2722 - Name: Hepatic Encephalopathy - Relevance: HIGH - As Found: Hepatic Encephalopathy ### Condition Browse Module - Meshes - ID: D000008103 - Term: Liver Cirrhosis - ID: D000006501 - Term: Hepatic Encephalopathy - ID: D000001927 - Term: Brain Diseases - ID: D000005355 - Term: Fibrosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425367 **Acronym:** MHR-Blood **Brief Title:** Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients With Enterobacterales Bacteremia **Official Title:** Impact of Performing a Rapid Antibiotic Susceptibility Test (MHR-SIR) on Antibiotic Therapy Adaptation in Adult Patients With Enterobacterales Bacteremia, Controlled, Randomized Cluster and Cross-over Study #### Organization Study ID Info **ID:** 650-MHR Blood #### Organization **Class:** OTHER **Full Name:** Fondation Hôpital Saint-Joseph ### Status Module #### Completion Date **Date:** 2025-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondation Hôpital Saint-Joseph #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Bacteremia is defined as the presence of bacteria in the blood. They can potentially lead to life-threatening septic shock. Effective probabilistic antibiotic therapy must therefore be initiated immediately after blood cultures have been taken. To diagnose bacteremia, blood culture bottles must first be incubated, which allows bacterial growth and early detection. Then, as soon as the sample is positive, an antibiogram of the incriminated bacterium is carried out by inoculation on MH (Mueller Hinton) medium. This diffusion antibiogram is the reference method and is obtained 24 hours after the vial is positive, i.e. around 48 hours after blood cultures are taken. American recommendations agree that it is crucial to use rapid diagnostic tests to obtain the antibiogram. Antibiotic susceptibility test data can be used to broaden the spectrum of antibiotics in the event of ineffective therapy. They can also be used to reduce the spectrum of broad-spectrum antibiotics. This is part of the proper use of antibiotics and the reduction of multi-resistant bacteria (MRB) or highly resistant bacteria (HRB). Finally, it is also possible to carry out an early oral relay, thus avoiding intravenous infusions and their complications, and potentially reducing hospitalization times. The investigators have evaluated a rapid antibiogram by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. The investigators were able to obtain antibiogram results 7 hours after blood culture positivity, with excellent correlation compared with the standard method after 24 hours incubation on MH (Mueller-Hinton). The antibiotics tested were the same as with the standard method. Secondly, The investigators were able to evaluate prospectively the impact of diffusion antibiotic susceptibility testing on MHR-SIR medium on early modification of antibiotic therapy in bacteremia, on 167 patients Antibiotic susceptibility test data on MHR-SIR enabled us to adapt antibiotic therapy 8 hours after blood culture positivity for 74 patients (44%). Antibiotic therapy was ineffective for 30 patients (18%) and was therefore extended. It also enabled us to reduce the spectrum of antibiotic therapy, in particular through early oral relay, for 44 patients (26%). The aim of this multicenter trial is to validate on a large scale this strategy for obtaining rapid antibiotic susceptibility test results, with significant consequences in terms of optimizing antibiotic therapy. ### Conditions Module **Conditions:** - Bacteremia **Keywords:** - antibiogram - bacteremia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** cluster cross-over randomized trial ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 960 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** rapid antibiotic susceptibility testing by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. Antibiotic susceptibility test results are obtained 7 hours after blood culture positivity **Intervention Names:** - Diagnostic Test: Antibiotic susceptibility testing **Label:** MHR SIR **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard antibiotic susceptibility testing by diffusion on MH (Mueller-Hinton ) medium from the blood culture bottle Antibiotic susceptibility test results are obtained 24 hours after blood culture positivity **Intervention Names:** - Diagnostic Test: Antibiotic susceptibility testing **Label:** MH **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - MH - MHR SIR **Description:** antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization **Name:** Antibiotic susceptibility testing **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** percentage of patients with Enterobacterales bacteremia for whom antibiotic therapy was effective against the incriminating bacterium within 12 hours of a positive blood culture, according to the results of the antibiogram. **Measure:** Effective Antiobiotherapy **Time Frame:** 12 hours #### Secondary Outcomes **Description:** Time between blood sampling and antibiogram results **Measure:** Time Frame **Time Frame:** 3days **Description:** After obtaining the antibiogram result, was the antibiotherapy modified (Yes or No) and if yes, was it for narrowing the antibiotic spectra (yes or no) **Measure:** type of Antibiotherapy spectra modification **Time Frame:** 2 days **Description:** in hours **Measure:** Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results **Time Frame:** 2 days **Description:** in days **Measure:** time between the start of intravenous antibiotic therapy and oral antibiotics. **Time Frame:** 1month **Description:** In days, **Measure:** length of hospital stay **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * age \>= 18 * Patient hospitalized in a clinical department of each participating center * Patient managed in the context of bacteremia (microbiological criterion = positive blood culture) * Patient with positive blood culture for Enterobacterales * Patient affiliated to a health insurance scheme * Patient/relative having given free, informed and express oral consent Exclusion Criteria: * Patients with non-enterobacterial bacteremia * Patient under guardianship * Patient deprived of liberty * Patient under court protection * Pregnant or breast-feeding patient **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Helene BEAUSSIER **Phone:** +33144127038 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Juliette COURTIADE MAHLER **Phone:** +33144127963 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fondation Hôpital Saint-Joseph **Name:** Jean Claude NGUYEN VAN, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000018805 - Term: Sepsis - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M18877 - Name: Bacteremia - Relevance: HIGH - As Found: Bacteremia - ID: M7380 - Name: Disease Susceptibility - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - 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: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016470 - Term: Bacteremia ### Intervention Browse Module - Ancestors - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: HIGH - As Found: Physician - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000900 - Term: Anti-Bacterial Agents ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425354 **Brief Title:** Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study **Official Title:** Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study #### Organization Study ID Info **ID:** RIA24.1 #### Organization **Class:** OTHER **Full Name:** University of Roma La Sapienza ### Status Module #### Completion Date **Date:** 2027-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-04-15 **Type:** ESTIMATED #### Start Date **Date:** 2023-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Roma La Sapienza #### Responsible Party **Investigator Affiliation:** University of Roma La Sapienza **Investigator Full Name:** Francesco Alessandri **Investigator Title:** Prof **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 report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage. The main questions it aims to answer are: 1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation? 2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power \>17 J/min compared to \<17 J/min? Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP \<17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays. ### Conditions Module **Conditions:** - Mechanical Power ### Design Module #### Bio Spec **Description:** plasma serum and BAL **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Mechanical ventilatiom **Name:** Mechanical ventilation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP **Measure:** Patients who exceed 17 J/min of MP **Time Frame:** 4 years #### Secondary Outcomes **Description:** Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage. **Measure:** Inflammatory cytokines **Time Frame:** 4 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with AHRF (P/F \<300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms * Invasive mechanical ventilation for less than 6 hours * Evidence of newly developed lung consolidation on chest imaging (X-ray, CT) * Age ≥18 years Exclusion Criteria: * Prior invasive mechanical ventilation during the same hospitalization * Tracheostomy * Severe anemia (Hb\<7g/dL) * Severe neutropenia * Renal insufficiency or RRT (Renal Replacement Therapy) * Noradrenaline \>0.5 mcg/kg/min * Pregnancy * Extracorporeal circulation (ECCO2R, ECMO) * Life expectancy \<24 hours as clinically judged * Lack of consent **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with AHRF undergoing mechanical ventilation ### Contacts Locations Module #### Locations **Location 1:** **City:** Roma **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Francesco Alessandri - **Phone:** 0039 0649978924 - **Role:** CONTACT ***Contact 2:*** - **Name:** Giovanni Giordano - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** Sapienza University of Rome **Status:** RECRUITING **Zip:** 00161 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Acute Hypoxemic Respiratory Failure - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425341 **Brief Title:** A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B **Official Title:** A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B #### Organization Study ID Info **ID:** HRS-5635-201 #### Organization **Class:** INDUSTRY **Full Name:** Fujian Shengdi Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-09-19 **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:** 2026-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Fujian Shengdi Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B. ### Conditions Module **Conditions:** - Chronic Hepatitis B ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Multi-center, random, open, parallel design ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 165 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: HRS-5635 Injection **Label:** HRS-5635 Injection dose 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: HRS-5635 Injection **Label:** HRS-5635 Injection dose 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: HRS-5635 Injection **Label:** HRS-5635 Injection dose 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: HRS-5635 Injection **Label:** HRS-5635 Injection dose 4 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - HRS-5635 Injection dose 1 **Description:** HRS-5635 Injection low dose administered by subcutaneous injection **Name:** HRS-5635 Injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - HRS-5635 Injection dose 2 **Description:** HRS-5635 Injection medium dose administered by subcutaneous injection **Name:** HRS-5635 Injection **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - HRS-5635 Injection dose 3 **Description:** HRS-5635 Injection high dose administered by subcutaneous injection **Name:** HRS-5635 Injection **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - HRS-5635 Injection dose 4 **Description:** HRS-5635 Injection lowest dose administered by subcutaneous injection **Name:** HRS-5635 Injection **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12 **Time Frame:** Week 12 **Measure:** PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48 **Time Frame:** Week 48 #### Secondary Outcomes **Measure:** Changes from baseline in mean log10 serum hepatitis B surface antigen levels **Time Frame:** Pre-specified time points up to 72 weeks **Measure:** Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen **Time Frame:** Pre-specified time points up to 72 weeks **Measure:** Proportion of subjects with serum hepatitis B surface antigen loss **Time Frame:** Pre-specified time points up to 72 weeks **Measure:** Proportion of subjects with serum hepatitis B surface antigen seroconversion **Time Frame:** Pre-specified time points up to 72 weeks **Measure:** Proportion of subjects with hepatitis B e-antigen loss **Time Frame:** Pre-specified time points up to 72 weeks **Measure:** Proportion of subjects with serum hepatitis B e-antigen seroconversion **Time Frame:** Pre-specified time points up to 72 weeks **Measure:** Proportion of subjects with virologic breakthrough **Time Frame:** Pre-specified time points up to 72 weeks **Measure:** Proportion of subjects with drug resistance **Time Frame:** Pre-specified time points up to 72 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2; 2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening; 3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation; 4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization; 5. Need to take effective contraceptive measures； 6. Volunteer to sign an informed consent. Exclusion Criteria: 1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study; 2. With autoimmune disease; 3. History of solid organ transplantation or hematopoietic stem cell transplantation; 4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases; 5. Malignant tumors were diagnosed within 5 years prior to randomization； 6. Infection requiring intervention within 2 weeks prior to randomization; 7. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results; 8. Laboratory tests during the screening period were obviously abnormal; 9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period; 10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization; 11. Participated in clinical study of other drugs (received experimental drugs); 12. Pregnant or nursing women; 13. Allergic to a drug ingredient or component; 14. Other reasons for ineligibility as judged by the investigators. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaopeng Wang **Phone:** 0518-82342973 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jinlin Hou - **Phone:** 020-62787432 - **Role:** CONTACT **Country:** China **Facility:** Nanfang Hospital **State:** Guangdong **Zip:** 510515 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000007239 - Term: Infections - ID: D000004769 - Term: Enterovirus Infections - ID: D000010850 - Term: Picornaviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC06 - Name: Digestive 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: M9592 - Name: Hepatitis A - Relevance: HIGH - As Found: Hepatitis - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M21609 - Name: Hepatitis B, Chronic - Relevance: HIGH - As Found: Chronic Hepatitis B - ID: M9607 - Name: Hepatitis, Chronic - Relevance: HIGH - As Found: Chronic Hepatitis - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus 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: M7930 - Name: Enterovirus Infections - Relevance: LOW - As Found: Unknown - ID: M13745 - Name: Picornaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - 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: D000006506 - Term: Hepatitis A - ID: D000006509 - Term: Hepatitis B - ID: D000019694 - Term: Hepatitis B, Chronic - ID: D000006505 - Term: Hepatitis - ID: D000006521 - Term: Hepatitis, Chronic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425328 **Brief Title:** Effect of Nutritional Habits on Oral Microbiota in Adolescents **Official Title:** Effect of Nutritional Habits on Oral Microbiota in Adolescents #### Organization Study ID Info **ID:** ErciyesU-BVD-BAG-01 #### Organization **Class:** OTHER **Full Name:** TC Erciyes University ### Status Module #### Completion Date **Date:** 2023-11-17 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-17 **Type:** ACTUAL #### Start Date **Date:** 2023-06-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** TC Erciyes University #### Responsible Party **Investigator Affiliation:** TC Erciyes University **Investigator Full Name:** Betül Cicek **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 aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. **Detailed Description:** Oral microbiota; While it is associated with systemic diseases such as obesity, diabetes and cancer, it is also associated with oral diseases such as oral cancers, tooth decay and gum diseases. Nutrition is seen as an important factor in maintaining oral health. In particular, the amount and frequency of sugar consumption, the type and consistency of food, the frequency of eating, the consumption of cariogenic foods with other foods and the duration of carbohydrates remaining on the teeth are among the factors that affect oral health. The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. The study is planned to be carried out in 4 stages. First stage; A survey form will be filled out that questions general information about children, oral health practices, nutritional habits and frequency of food consumption. In the second stage; Children's anthropometric measurements (body weight (kg), height (cm), waist circumference (cm) will be taken and bioelectrical impedance analysis (BIA) results will be recorded. In the third stage, oral examinations of the children will be performed. In the final stage, saliva samples of the children will be collected. Bacteria Logarithmic values will be used when comparing the concentrations between groups. The suitability of the parameters to normal distribution will be evaluated with q-q graphs and Shapiro-Wilk test. Student t test will be used for variables that comply with normal distribution and Mann Whitney U test will be used for changes that do not comply with normal distribution. The relationship will be evaluated with the Spearman or Pearson correlation test according to the normality distribution. IBM SPSS (Statistical Package for Social Sciences) 22.0 package program will be used when evaluating the data obtained as a result of the study. While examining the hypothesis tests, α = 0.05 and accordingly the confidence interval will be determined as 95%. It will be evaluated at p\<0.05 level. In order to enable healthy adolescents to reach a good standard of living, there is a need for a more accurate understanding of the relationship between oral microbiota, nutrition and sleep. As a result of this study, it is aimed to reveal the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. ### Conditions Module **Conditions:** - Nutrition, Healthy - Adolescent Behavior - Microbial Colonization **Keywords:** - adolescent - Nutritional Sciences - Oral Health ### Design Module #### Bio Spec **Description:** Saliva samples were taken from all participants. **Retention:** NONE_RETAINED #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score below -1 SD are defined as underweight. **Label:** Underweight #### Arm Group 2 **Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, BMI z scores between -1 SD +1 SD are defined as normal weight. **Label:** Normal weight #### Arm Group 3 **Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score between +1 SD +2 SD are defined as overweight **Label:** Overweight #### Arm Group 4 **Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score above +2 SD are defined as obese. **Label:** Obese ### Outcomes Module #### Primary Outcomes **Description:** For oral microbiota analysis, saliva samples were taken from children who had brushed their teeth in the morning and had not consumed any food until 2 hours before, and microbiological procedures were performed. Saliva samples taken from all patients participating in the study were stored at -80°C until analysis. Saliva samples collected during the research process were transported to the center where the analyzes were carried out by preserving the cold chain, and DNA isolation and sequence analysis were carried out together with molecular biologists. DNA purification from saliva samples was carried out using standard commercial methods. In the polymerase chain reaction-based amplification of bacterial 16S rRNA sequences, primers belonging to the V3-V4 region, which were previously defined and stated to be suitable for the detection of bacterial diversity, were used. **Measure:** Oral microbiome characteristics **Time Frame:** 1 month #### Secondary Outcomes **Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. **Measure:** Anthropometric Measurements **Time Frame:** 1 month **Description:** On the first day of the food consumption record, a 24-hour retrospective was taken by the researcher, and on the other days, it was recorded in detail by telephone. **Measure:** 3 day food consumption record **Time Frame:** 1 month **Description:** Intraoral examination of all children in the study group was performed by sitting on a chair by the window and using a mirror-probe in daylight. Intraoral examination of all children was performed by a single pediatric dentist (E.D.) and recorded in the patient information form. The total number of decayed, missing and filled teeth (Decayed, Missing, And Filled Teeth: DMFT) and tooth surfaces (Decayed, Missing, And Filled Surfaces: DMFS) were calculated. **Measure:** Oral Examination **Time Frame:** 1 month **Description:** It is a 19-question survey that evaluates sleep quality and disorders by scoring them over a one-month period. The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality). **Measure:** Pittsburg sleep quality index **Time Frame:** 1 month **Description:** It is a 15-question survey developed to be used to determine hedonic hunger in school-age children. Items are rated on a 5-point Likert scale and summed to create a total score. Higher scores reflect greater responsiveness to the food environment. **Measure:** Children's Power of Food Scale **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 14-16 years old * Not receiving special medical nutrition therapy * No chronic systemic disease, nutritional disorder and/or endocrine disease that may affect growth and development * Adolescents without congenital developmental disorders Exclusion Criteria: * Those who had any severe oral disease or periodontal treatment including supragingival curettage and root planning before the study * Those who used any antibiotic, anti-inflammatory or sedative medication until 3 months before the study * Those with bleeding gums on the working day or within the previous 4 weeks * Those who smoke **Healthy Volunteers:** True **Maximum Age:** 16 Years **Minimum Age:** 14 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** The study included 40 adolescents aged 14-16, who were thin, healthy, slightly overweight and obese, who applied to İsmet Yılmaz Akansu Family Health Center and met the inclusion criteria. ### Contacts Locations Module #### Locations **Location 1:** **City:** Kayseri **Country:** Turkey **Facility:** Erciyes University ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - 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: HIGH - As Found: Microbial Colonization - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Microbial Colonization - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425315 **Brief Title:** Management of Malnutrition in Oncogeriatrics **Official Title:** Does Targeted Management of Undernutrition in Oncogeriatric Patients Aged 70 and Over, Undergoing Cancer Treatment and Hospitalized From January 2022 to December 2023, Improve Their Nutritional and Functional Status? #### Organization Study ID Info **ID:** 69HCL23_5390 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2024-08-24 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In France, undernutrition affects almost three million people, a third of whom are over 70 (Diagnosing undernutrition earlier in the elderly aged 70 and over, n.d.). In fact, 30 to 70% of hospitalized elderly patients suffer from protein-energy undernutrition (denutrition_personne_agee_2007_-_recommandations.pdf, n.d.). The Nutricancer 2 study published in 2014, demonstrated that undernutrition is common among cancer patients. Indeed, 39% of patients suffer from undernutrition and its prevalence depends on the type of cancer, with a predominance of esophagus, stomach and pancreas (60% to 66%), colon/rectum, ovary/uterus and lung (39% to 45%), hematological malignancies (34%), as well as prostate and breast (13% to 20%) (Hébuterne et al., 2014). Moreover, over the past 30 years, undernutrition has been observed in 30% to 50% of the population at the time of diagnosis and before the start of cancer treatment (Boranian et al., n. d.). Undernutrition is often associated with several terms such as malnutrition, anorexia, sarcopenia or cachexia, which refer to geriatric or metabolic syndromes of multifactorial origin that sometimes overlap, and are often observed in cancer patients. Cancer cachexia is a metabolic syndrome associated with undernutrition of multifactorial origin (Boranian et al., n.d.). Its prevalence is around 50% to 80% in cancer patients and is an independent indicator of morbidity and mortality in this population (Nicolini et al., 2013). Undernutrition is a major health issue in elderly cancer patients. It is therefore crucial to diagnose it early, given its high prevalence in this population and the serious complications it can lead to. In 2021, the HAS updated its recommendations on the diagnosis of undernutrition in the elderly. The diagnosis of severe undernutrition is based on several criteria, including serum albumin levels. This is a commonly used marker of nutritional status, especially in patients with involuntary weight loss. However, it is important to note that hypoalbuminemia can be observed in many pathological conditions, including inflammatory syndromes common in cancer. Therefore, interpretation of albuminemia results must take into account the patient's inflammatory status, assessed by C-reactive protein. This analysis makes it possible to distinguish undernutrition due to insufficient food intake from that associated with an inflammatory syndrome and hypercatabolism (Patry \& Raynaud-Simon, 2010). ### Conditions Module **Conditions:** - Undernutrition - Cancer **Keywords:** - Malnutrition - Geriartric oncology - Aged - Antineoplastic agents - Muscle strenght ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Our study population consists of oncogeriatric patients aged 70 and over, hospitalized in the oncogeriatric follow-up and referral unit (USSROG), with a diagnosis of moderate or severe undernutrition and undergoing cancer treatment. Patients will be recruited between January 1, 2022 and December 31, 2023. We anticipate a sample size of between 100 and 120 patients over this period. **Label:** Oncogeriatric patients with undernutrition ### Outcomes Module #### Primary Outcomes **Description:** the variation in albumin values associated with CRP values will be collected on admission and after the first month, at 2 months and then at 3 months of hospitalization. These values will then be analyzed using statistical analysis software, to determine whether the results obtained are relevant and favor an improvement in albumin levels, and consequently in the patient's nutritional status. **Measure:** The criterion chosen to demonstrate this is: absolute albumin values in g/l in patients with moderate undernutrition and in those with severe undernutrition after the first month of hospitalization, at 2 months and then at 3 months. **Time Frame:** It will be measured at the start of hospitalization and after the first month, at 2 months and then at 3 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 70 and over with a diagnosis of moderate or severe undernutrition * All patients with diagnosed cancer and ongoing cancer treatment. Exclusion Criteria: * Patients under 70 years of age * Hospitalized patients no longer undergoing anticancer treatment * All patients undergoing pre-habilitation for surgery **Minimum Age:** 70 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** The population of this study will be made up of oncogeriatric patients aged 70 and over, hospitalized in the USSROG unit with a diagnosis of undernutrition and undergoing anticancer treatment. ### Contacts Locations Module #### Locations **Location 1:** **City:** Lyon **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** KOUADJO Blé Evelyne - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** PIOT-BOISSIER Claude, Dr - **Role:** CONTACT **Country:** France **Facility:** Hopital Pierre Garraud **Zip:** 69005 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009748 - Term: Nutrition Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25306 - Name: Malnutrition - Relevance: HIGH - As Found: Undernutrition - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000044342 - Term: Malnutrition ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425302 **Acronym:** GOLSEEK-2 **Brief Title:** A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma **Official Title:** A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma #### Organization Study ID Info **ID:** CA073-1022 #### Organization **Class:** INDUSTRY **Full Name:** Celgene #### Secondary ID Infos **Domain:** WHO **ID:** U1111-1303-4594 **Type:** OTHER **Domain:** EU CTR **ID:** 2024-511304-16 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-11-27 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-11-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Celgene #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL). ### Conditions Module **Conditions:** - Lymphoma, Follicular **Keywords:** - Follicular lymphoma - Grade 1-3a Follicular lymphoma - BMS-986369 - CC-99282 - Lymphoma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine **Intervention Names:** - Drug: Rituximab - Drug: Cyclophosphamide - Drug: Doxorubicin - Drug: Vincristine - Drug: Prednisone - Drug: Bendamustine **Label:** Rituximab + Chemotherapy **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Golcadomide - Drug: Rituximab **Label:** Golcadomide Dose 1 + Rituximab **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: Golcadomide - Drug: Rituximab **Label:** Golcadomide Dose 2 + Rituximab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Golcadomide Dose 1 + Rituximab - Golcadomide Dose 2 + Rituximab **Description:** Specified dose on specified days **Name:** Golcadomide **Other Names:** - CC-99282 - BMS-986369 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Golcadomide Dose 1 + Rituximab - Golcadomide Dose 2 + Rituximab - Rituximab + Chemotherapy **Description:** Specified dose on specified days **Name:** Rituximab **Other Names:** - Mabthera **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Rituximab + Chemotherapy **Description:** Specified dose on specified days **Name:** Cyclophosphamide **Other Names:** - Endoxan **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Rituximab + Chemotherapy **Description:** Specified dose on specified days **Name:** Doxorubicin **Other Names:** - Caelyx - pegylated liposomal doxorubicin - PLD **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Rituximab + Chemotherapy **Description:** Specified dose on specified days **Name:** Vincristine **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Rituximab + Chemotherapy **Description:** Specified dose on specified days **Name:** Prednisone **Type:** DRUG #### Intervention 7 **Arm Group Labels:** - Rituximab + Chemotherapy **Description:** Specified dose on specified days **Name:** Bendamustine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Golcadomide + Rituximab arms only **Measure:** Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014 **Time Frame:** Up to approximately 12 months from participant randomization #### Secondary Outcomes **Measure:** Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0 **Time Frame:** Up to 28 days after last dose **Measure:** Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0 **Time Frame:** Up to 28 days after last dose **Description:** Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014 **Measure:** Best Overall Response (OR) **Time Frame:** Up to approximately 12 months from participant randomization **Description:** Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death **Measure:** Duration of Response (DoR) **Time Frame:** Up to approximately 3 years after randomization of the last participant **Description:** Defined as achieving CR based on Lugano criteria at 30 months from randomization **Measure:** Complete Response at 30 months (CR30) **Time Frame:** At approximately 30 months from randomization **Description:** Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization **Measure:** Complete Metabolic Response at 6 months from the randomization (CMR6) **Time Frame:** At approximately 6 months from randomization **Description:** Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization **Measure:** Complete Metabolic Response at 12 months from the randomization (CMR12) **Time Frame:** At approximately 12 months from randomization **Description:** Defined as time from date of randomization to first occurrence of disease progression or death from any cause **Measure:** Progression Free Survival (PFS) **Time Frame:** Up to approximately 3 years from randomization of last participant **Description:** Defined as time from date of randomization to death from any cause **Measure:** Overall Survival (OS) **Time Frame:** Up to approximately 3 years from randomization of last participant **Description:** Rituximab + Chemotherapy arm only **Measure:** Number of participants who achieve CMR as assessed by Lugano criteria 2014 **Time Frame:** Up to approximately 6 months from randomization ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis. * Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable. * Stage II to IV disease. * Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:. i) Bulky disease defined as:. A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm). ii) Presence of at least one of the following B symptoms:. A. Fever (\>38°C) of unclear etiology. B. Night sweats. C. Weight loss greater than 10% within the prior 6 months. iii) Splenomegaly with inferior margin below the umbilical line. iv) Any one of the following cytopenia due to lymphoma:. A. Platelets \<100,000 cells/mm3 (100 x 109/L). B. Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L). C. Hemoglobin \< 10g/dL (6.25 mmol/L). v) Pleural or peritoneal serous effusion (irrespective of cell content) vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal) Exclusion Criteria: * Clinical evidence of transformed lymphoma by investigator assessment. * Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification. * Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study. * Other protocol-defined Inclusion/Exclusion criteria apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **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:** Birmingham **Contacts:** ***Contact 1:*** - **Name:** Site 0152 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0152 **State:** Alabama **Zip:** 35294-3300 **Location 2:** **City:** Anchorage **Contacts:** ***Contact 1:*** - **Name:** Site 0055 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0055 **State:** Alaska **Zip:** 99508 **Location 3:** **City:** Phoenix **Contacts:** ***Contact 1:*** - **Name:** Site 0180 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0180 **State:** Arizona **Zip:** 85054 **Location 4:** **City:** Tucson **Contacts:** ***Contact 1:*** - **Name:** Site 0190 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0190 **State:** Arizona **Zip:** 85711 **Location 5:** **City:** San Francisco **Contacts:** ***Contact 1:*** - **Name:** Site 0035 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0035 **State:** California **Zip:** 94143 **Location 6:** **City:** Washington **Contacts:** ***Contact 1:*** - **Name:** Site 0022 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0022 **State:** District of Columbia **Zip:** 20007 **Location 7:** **City:** Jacksonville **Contacts:** ***Contact 1:*** - **Name:** Site 0005 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0005 **State:** Florida **Zip:** 32224 **Location 8:** **City:** Tampa **Contacts:** ***Contact 1:*** - **Name:** Site 0026 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0026 **State:** Florida **Zip:** 33606 **Location 9:** **City:** Peoria **Country:** United States **Facility:** Local Institution - 0013 **State:** Illinois **Zip:** 61615 **Location 10:** **City:** Fairway **Contacts:** ***Contact 1:*** - **Name:** Site 0019 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0019 **State:** Kansas **Zip:** 66205 **Location 11:** **City:** Jefferson **Contacts:** ***Contact 1:*** - **Name:** Site 0173 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0173 **State:** Louisiana **Zip:** 70121 **Location 12:** **City:** Baltimore **Contacts:** ***Contact 1:*** - **Name:** Site 0033 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0033 **State:** Maryland **Zip:** 21287 **Location 13:** **City:** Boston **Country:** United States **Facility:** Local Institution - 0001 **State:** Massachusetts **Zip:** 02114 **Location 14:** **City:** Boston **Contacts:** ***Contact 1:*** - **Name:** Site 0004 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0004 **State:** Massachusetts **Zip:** 02114 **Location 15:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Name:** Site 0031 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0031 **State:** Minnesota **Zip:** 55905 **Location 16:** **City:** Henderson **Contacts:** ***Contact 1:*** - **Name:** Site 0111 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0111 **State:** Nevada **Zip:** 89074 **Location 17:** **City:** Hackensack **Contacts:** ***Contact 1:*** - **Name:** Site 0183 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0183 **State:** New Jersey **Zip:** 07601 **Location 18:** **City:** New Brunswick **Country:** United States **Facility:** Local Institution - 0020 **State:** New Jersey **Zip:** 08903 **Location 19:** **City:** New York **Contacts:** ***Contact 1:*** - **Name:** Site 0036 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0036 **State:** New York **Zip:** 10029 **Location 20:** **City:** Salt Lake City **Contacts:** ***Contact 1:*** - **Name:** Site 0052 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0052 **State:** Utah **Zip:** 84106 **Location 21:** **City:** Norfolk **Country:** United States **Facility:** Local Institution - 0200 **State:** Virginia **Zip:** 23502 **Location 22:** **City:** Norfolk **Contacts:** ***Contact 1:*** - **Name:** Site 0201 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0201 **State:** Virginia **Zip:** 23502 **Location 23:** **City:** Seattle **Contacts:** ***Contact 1:*** - **Name:** Site 0166 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0166 **State:** Washington **Zip:** 98104 **Location 24:** **City:** Seattle **Contacts:** ***Contact 1:*** - **Name:** Site 0202 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0202 **State:** Washington **Zip:** 98109 **Location 25:** **City:** Liverpool **Contacts:** ***Contact 1:*** - **Name:** Site 0046 - **Role:** CONTACT **Country:** Australia **Facility:** Local Institution - 0046 **State:** New South Wales **Zip:** 2170 **Location 26:** **City:** Brisbane **Contacts:** ***Contact 1:*** - **Name:** Site 0070 - **Role:** CONTACT **Country:** Australia **Facility:** Local Institution - 0070 **State:** Queensland **Zip:** 4101 **Location 27:** **City:** Traralgon **Contacts:** ***Contact 1:*** - **Name:** Site 0181 - **Role:** CONTACT **Country:** Australia **Facility:** Local Institution - 0181 **State:** Victoria **Zip:** 3844 **Location 28:** **City:** Porto Alegre **Contacts:** ***Contact 1:*** - **Name:** Site 0061 - **Role:** CONTACT **Country:** Brazil **Facility:** Local Institution - 0061 **State:** Rio Grande Do Sul **Zip:** 90035-903 **Location 29:** **City:** Sao Paulo **Contacts:** ***Contact 1:*** - **Name:** Site 0058 - **Role:** CONTACT **Country:** Brazil **Facility:** Local Institution - 0058 **State:** São Paulo **Zip:** 04543-000 **Location 30:** **City:** Rio de Janeiro **Contacts:** ***Contact 1:*** - **Name:** Site 0060 - **Role:** CONTACT **Country:** Brazil **Facility:** Local Institution - 0060 **Zip:** 22250-905 **Location 31:** **City:** São Paulo **Contacts:** ***Contact 1:*** - **Name:** Site 0056 - **Role:** CONTACT **Country:** Brazil **Facility:** Local Institution - 0056 **Zip:** 05652-900 **Location 32:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Name:** Site 0064 - **Role:** CONTACT **Country:** Canada **Facility:** Local Institution - 0064 **State:** Ontario **Zip:** M5G 2M9 **Location 33:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Name:** Site 0049 - **Role:** CONTACT **Country:** Chile **Facility:** Local Institution - 0049 **State:** Región Metropolitana De Santiago **Zip:** 7500921 **Location 34:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Name:** Site 0050 - **Role:** CONTACT **Country:** Chile **Facility:** Local Institution - 0050 **State:** Región Metropolitana De Santiago **Zip:** 7580206 **Location 35:** **City:** Saint-Cloud **Contacts:** ***Contact 1:*** - **Name:** Site 0101 - **Role:** CONTACT **Country:** France **Facility:** Local Institution - 0101 **State:** Hauts-de-Seine **Zip:** 92210 **Location 36:** **City:** Lille **Contacts:** ***Contact 1:*** - **Name:** Site 0103 - **Role:** CONTACT **Country:** France **Facility:** Local Institution - 0103 **State:** Nord **Zip:** 59000 **Location 37:** **City:** Poitiers **Contacts:** ***Contact 1:*** - **Name:** Site 0121 - **Role:** CONTACT **Country:** France **Facility:** Local Institution - 0121 **State:** Vienne **Zip:** 86021 **Location 38:** **City:** Paris **Contacts:** ***Contact 1:*** - **Name:** Site 0118 - **Role:** CONTACT **Country:** France **Facility:** Local Institution - 0118 **Zip:** 75010 **Location 39:** **City:** Regensburg **Contacts:** ***Contact 1:*** - **Name:** Site 0197 - **Role:** CONTACT **Country:** Germany **Facility:** Local Institution - 0197 **State:** Bayern **Zip:** 93049 **Location 40:** **City:** Chemnitz **Contacts:** ***Contact 1:*** - **Name:** Site 0188 - **Role:** CONTACT **Country:** Germany **Facility:** Local Institution - 0188 **State:** Sachsen **Zip:** 09116 **Location 41:** **City:** Dresden **Contacts:** ***Contact 1:*** - **Name:** Site 0189 - **Role:** CONTACT **Country:** Germany **Facility:** Local Institution - 0189 **Zip:** 01307 **Location 42:** **City:** Rome **Contacts:** ***Contact 1:*** - **Name:** Site 0198 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0198 **State:** Lazio **Zip:** 00133 **Location 43:** **City:** Rozzano **Contacts:** ***Contact 1:*** - **Name:** Site 0179 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0179 **State:** Milano **Zip:** 20089 **Location 44:** **City:** Bari **Country:** Italy **Facility:** Local Institution - 0096 **State:** Puglia **Zip:** 70124 **Location 45:** **City:** Bari **Country:** Italy **Facility:** Local Institution - 0098 **State:** Puglia **Zip:** 70124 **Location 46:** **City:** Bari **Country:** Italy **Facility:** Local Institution - 0097 **Zip:** 70124 **Location 47:** **City:** Bologna **Contacts:** ***Contact 1:*** - **Name:** Site 0076 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0076 **Zip:** 40138 **Location 48:** **City:** Napoli **Contacts:** ***Contact 1:*** - **Name:** Site 0075 - **Role:** CONTACT **Country:** Italy **Facility:** Local Institution - 0075 **Zip:** 80131 **Location 49:** **City:** Hwasun Gun **Contacts:** ***Contact 1:*** - **Name:** Site 0104 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Local Institution - 0104 **State:** Jeonranamdo **Zip:** 58128 **Location 50:** **City:** Busan **Contacts:** ***Contact 1:*** - **Name:** Site 0100 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Local Institution - 0100 **State:** Pusan-Kwangyǒkshi **Zip:** 49241 **Location 51:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Name:** Site 0085 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Local Institution - 0085 **State:** Seoul-teukbyeolsi [Seoul] **Zip:** 03080 **Location 52:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Name:** Site 0086 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Local Institution - 0086 **State:** Seoul-teukbyeolsi [Seoul] **Zip:** 06351 **Location 53:** **City:** Bydgoszcz **Contacts:** ***Contact 1:*** - **Name:** Site 0186 - **Role:** CONTACT **Country:** Poland **Facility:** Local Institution - 0186 **State:** Kujawsko-pomorskie **Zip:** 85-168 **Location 54:** **City:** Warszawa **Contacts:** ***Contact 1:*** - **Name:** Site 0185 - **Role:** CONTACT **Country:** Poland **Facility:** Local Institution - 0185 **State:** Mazowieckie **Zip:** 01-748 **Location 55:** **City:** Skorzewo **Contacts:** ***Contact 1:*** - **Name:** Site 0187 - **Role:** CONTACT **Country:** Poland **Facility:** Local Institution - 0187 **State:** Wielkopolskie **Zip:** 60-185 **Location 56:** **City:** Palma **Contacts:** ***Contact 1:*** - **Name:** Site 0196 - **Role:** CONTACT **Country:** Spain **Facility:** Local Institution - 0196 **State:** Balears [Baleares] **Zip:** 07120 **Location 57:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Name:** Site 0192 - **Role:** CONTACT **Country:** Spain **Facility:** Local Institution - 0192 **State:** Valenciana, Comunitat **Zip:** 46017 **Location 58:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** Site 0191 - **Role:** CONTACT **Country:** Spain **Facility:** Local Institution - 0191 **Zip:** 28040 **Location 59:** **City:** Kaohsiung **Contacts:** ***Contact 1:*** - **Name:** Site 0094 - **Role:** CONTACT **Country:** Taiwan **Facility:** Local Institution - 0094 **Zip:** 807 **Location 60:** **City:** Kaohsiung **Contacts:** ***Contact 1:*** - **Name:** Site 0092 - **Role:** CONTACT **Country:** Taiwan **Facility:** Local Institution - 0092 **Zip:** 83301 **Location 61:** **City:** Taipei **Contacts:** ***Contact 1:*** - **Name:** Site 0123 - **Role:** CONTACT **Country:** Taiwan **Facility:** Local Institution - 0123 **Zip:** 10002 **Location 62:** **City:** Southampton **Contacts:** ***Contact 1:*** - **Name:** Site 0175 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Local Institution - 0175 **State:** Hampshire **Zip:** SO16 0YD **Location 63:** **City:** Canterbury **Contacts:** ***Contact 1:*** - **Name:** Site 0112 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Local Institution - 0112 **State:** Kent **Zip:** CT1 3NG **Location 64:** **City:** Edinburgh **Contacts:** ***Contact 1:*** - **Name:** Site 0115 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Local Institution - 0115 **State:** Midlothian **Zip:** EH4 2XU **Location 65:** **City:** Nottingham **Contacts:** ***Contact 1:*** - **Name:** Site 0105 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Local Institution - 0105 **Zip:** NG5 1PB #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** See plan description **Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** See plan description **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html ### 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 ### 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: M11221 - Name: Lymphoma, Follicular - Relevance: HIGH - As Found: Lymphoma, Follicular - 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: T2361 - Name: Follicular Lymphoma - Relevance: HIGH - As Found: Follicular lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000008224 - Term: Lymphoma, Follicular ### 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: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000059005 - Term: Topoisomerase II Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000000893 - Term: Anti-Inflammatory 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: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: HIGH - As Found: Cycle - ID: M14121 - Name: Prednisone - Relevance: HIGH - As Found: Outcomes - ID: M373 - Name: Rituximab - Relevance: HIGH - As Found: Healthy - ID: M7492 - Name: Doxorubicin - Relevance: HIGH - As Found: Cognitive - ID: M227339 - Name: Liposomal doxorubicin - Relevance: HIGH - As Found: Cognitive - ID: M430 - Name: Bendamustine Hydrochloride - Relevance: HIGH - As Found: Ratio - ID: M17495 - Name: Vincristine - Relevance: HIGH - As Found: Volume - 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: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - 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: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011241 - Term: Prednisone - ID: D000003520 - Term: Cyclophosphamide - ID: D000069461 - Term: Bendamustine Hydrochloride - ID: D000069283 - Term: Rituximab - ID: D000004317 - Term: Doxorubicin - ID: C000506643 - Term: Liposomal doxorubicin - ID: D000014750 - Term: Vincristine ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425289 **Brief Title:** Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy **Official Title:** Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial #### Organization Study ID Info **ID:** 69HCL23_5388 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2026-02-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial. ### Conditions Module **Conditions:** - Fluid Removal - Critically Ill - Continuous Renal Replacement Therapy - Fluid Overload **Keywords:** - Fluid removal - Hemodynamic - Net ultrafiltration - Continuous renal replacement therapy ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Procedure: Fluid balance negativation During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion . When the patient's baseline body weight is reached the UF net will be settled to maintain it. In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min and without tissue hypoperfusion. **Intervention Names:** - Other: Macrohemodynamic parameters **Label:** Experimental: Corrective strategy #### Arm Group 2 **Description:** Procedure: Body weight Stabilization During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance. In case of weight stabilisation failure (variation \>5%), the UF net can be increased to 1,5 ml/kg/h. In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min. **Intervention Names:** - Other: Macrohemodynamic parameters **Label:** Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: Corrective strategy - Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled **Description:** Macrohemodynamic parameters will be estimated with transpulmonary thermodilution every 6 hours during the intervention period (5 days). * Cardiac index * Extravascular lung water index * Pulmonary vascular permeability index * Cardiac function index * Global end-diastolic volume index * Central venous pressure * Fluid responsivness status (passive leg rising test) **Name:** Macrohemodynamic parameters **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Area under the curve of a cardiac index \< 2.4 L/min/m2 (L/min/m2.hr), determined by transpulmonary thermodilution every 6 hours, with three boli of cold saline in the superior vena cava territory. **Measure:** Area under the curve of a low cardiac index **Time Frame:** Every 6 hours between day 0 to day 5 (intervention period) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days, * At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or vasopressors administration\>12 hours), * Cumulative UF net less than 1000ml before inclusion, * Norepinephrine \< 0,5 µg/kg/min, * Absence of hypoperfusion signs, * Fluid overload defined as follows: fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (AKIKI edema scale \> 2). Exclusion Criteria: * Chronic renal failure hemodialyzed before admission to the ICU, * Mechanical circulatory support (ECMO, LVAD), * Pregnant, child -bearing age or lactating women, * Stroke less than 30 days, * Intestinal ischemia less than 7 days documented non-operated, * Interventional study participation or exclusion period on going, * Guardianship, curatorship or safeguard of justice, * Absence of signature of free and informed consent by the patient and/or relative, * Patients not affiliated to a social security scheme or beneficiaries of a similar scheme * Absence of transpulmonary thermodilution monitoring **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Critically ill patients with fluid overload and renal replacement therapy for fluid overload, included in EarlyDry trial (NCT05817539) and monitored with transpulmonary thermodilution. ### Contacts Locations Module #### Locations **Location 1:** **City:** Bron **Contacts:** ***Contact 1:*** - **Name:** RUSTE MARTIN, Dr - **Role:** CONTACT **Country:** France **Facility:** Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon **Zip:** 69500 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - 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: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critically Ill - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425276 **Brief Title:** Evaluate Safety and Efficacy of High-dose Melphalan HCL for Injection in MM Patients With Auto-HSC Transplantation **Official Title:** A Multicenter, Open-Label, Safety and Efficacy Study of High Dose Melphalan Hydrochloride for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation #### Organization Study ID Info **ID:** EVOM-CL-001 #### Organization **Class:** INDUSTRY **Full Name:** CASI Pharmaceuticals (China) Co., Ltd. ### Status Module #### Completion Date **Date:** 2021-09-18 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-07-08 **Type:** ACTUAL #### Start Date **Date:** 2020-07-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** CASI Pharmaceuticals (China) Co., Ltd. #### 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 learn if high-dose Melphalan HCl for Injection works to treat multiple myeloma. It will also learn about the safety of high dose Melphalan HCl for Injection. The main questions it aims to answer are: Does high-dose Melphalan HCl for Injection deplete bone marrow activity which results in a better outcome of patients'own stem cell (blood-forming cell) transplantation? What medical problems do participants have when taking high-dose Melphalan HCl for Injection? How fast is the high-dose Melphalan HCl for Injection cleared out from blood? Participants will: * Take high-dose Melphalan HCl for Injection for 2 days * Have stem cell transplantation one day after treatment * Stay in the hospital for at least 10days and visit the clinic once every week for the first month after transplantation and every month after for checkups and tests. **Detailed Description:** Autologous stem cell transplantation (ASCT) is a standard of care in transplant-eligible MM patients which has been demonstrated with a better complete remission rate (CR) and with longer survival. High-dose melphalan (200 mg/m2) has been the most commonly used conditioning regimen for ASCT in MM. EVOMELA (melphalan HCl for Injection) stabilized with Captisol, a specially modified cyclodextrin, has been believed to have better solubility and stability upon reconstitution which result in decreased toxicity, increased convenience and flexibility of administration without comprising efficacious data. Melphalan HCl for Injection has been approved by NMPA as a standard conditioning drug for ASCT in MM patients. The current study evaluated the efficacy, safety, and PK profile for high-dose Melphalan HCl for Injection as a myeloablative conditioning regimen in Chinese symptomatic transplant-eligible MM patients. ### Conditions Module **Conditions:** - Multiple Myeloma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 67 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive Melphalan HCl for Injection dosed at 100 mg/m2 on Day -3 and Day -2. Following 1 day of rest after the myeloablative conditioning (Day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (Day 0). **Intervention Names:** - Drug: Melphalan Hydrochloride for Injection **Label:** High-dose Melphalan HCl for Injection treatment arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - High-dose Melphalan HCl for Injection treatment arm **Description:** During the Study Period, patients will receive Melphalan HCl for Injection dosed at 100 mg/m2 on Day -3 and Day -2. **Name:** Melphalan Hydrochloride for Injection **Other Names:** - Evomela **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To record the percentage of patients who achieve myeloablation which is defined as absolute neutrophil count \[ANC\] \<0.5 × 109/L, absolute lymphocyte count \[ALC\] \<0.1 × 109/L, or platelet count \<20,000/mm3 in 2 consecutive daily assessments. **Measure:** Rate of patients achieveing myeloablation **Time Frame:** 95±5 days after ASCT **Description:** To record the time, in days, from the date of first dose of High-dose Melphalan HCL for Injection to the date of myoloablation which is defined as absolute neutrophil count \[ANC\] \<0.5 × 109/L, absolute lymphocyte count \[ALC\] \<0.1 × 109/L, or platelet count \<20,000/mm3 in 2 consecutive daily assessments. **Measure:** Time to achieveing myeloablation **Time Frame:** 95±5 days after ASCT **Description:** To record the time, in days, from the date of Auto-HSCT to the date when absolute neutrophil count (ANC) \>0.5 × 109/L in 3 consecutive daily assessments. **Measure:** Time to achieveing neutrophil engraftment **Time Frame:** 95±5 days after ASCT **Description:** To record the time, in days, from the date of Auto-HSCT to the date when untransfused platelet measurement \>20,000/mm3 in 3 consecutive daily assessments. **Measure:** Time to achieving platelet engraftment **Time Frame:** 95±5 days after ASCT **Description:** To characterize the safety, tolerability of High-dose Melphalan HCL for Myeloablation in MM Patients With Auto-HSC Transplantation by recording the incidence of death without relapse or progression of the disease. **Measure:** Incidence of Treatment-related Motality (TRM) **Time Frame:** 95±5 days after ASCT **Description:** To characterize the safety, tolerability of High-dose Melphalan HCL for Injection for Myeloablation in MM Patients With Auto-HSC Transplantation. **Measure:** Incidence and severity of AEs and SAEs, including changes in laboratory values **Time Frame:** 95±5 days after ASCT #### Secondary Outcomes **Description:** Response assessment per International Myeloma Working Group (IMWG) criteria **Measure:** Overall Response (ORR) **Time Frame:** 95±5 days after ASCT **Description:** Tmax of Melphalan HCL for Injection derived from plasma concentrations of each administration **Measure:** Tmax of Melphalan HCL for Injection derived from plasma concentrations **Time Frame:** 24 Hours **Description:** T1/2 of Melphalan HCL for Injection derived from plasma concentrations of each administration **Measure:** T1/2 of Melphalan HCL for Injection derived from plasma concentrations **Time Frame:** 24 Hours **Description:** Cmax of Melphalan HCL for Injection derived from plasma concentrations of each administration **Measure:** Cmax of Melphalan HCL for Injection derived from plasma concentrations **Time Frame:** 24 Hours **Description:** AUC of Melphalan HCL for Injection derived from plasma concentrations of each administration **Measure:** AUC of Melphalan HCL for Injection derived from plasma concentrations **Time Frame:** 24 Hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnosed as symptomatic multiple myeloma, according to the International Myeloma Working Group's IMWG Guidelines for the Diagnosis and Treatment of Multiple Myeloma, treatment is necessary and suitable for autologous hematopoietic stem cell transplantation; 2. When signing the informed consent form, males and females aged ≥ 18 years and ≤ 65 years old; 3. Adequate autologous hematopoietic stem cells were collected, defined as peripheral blood stem cells containing at least 2 x 106 CD34+cells/kg that have not been manipulated or refrigerated; 4. Important organ functions meet the following conditions: i. Echocardiography indicates left ventricular ejection fraction (LVEF) ≥ 40%; ii. Serum total bilirubin\<2 times the upper limit of normal value, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\<3 times the upper limit of normal value; Iii. creatinine clearance rate\>60 mL/min ; Iv. Blood oxygen saturation\>92% in non oxygenated state, without significant ventilation or ventilation dysfunction; 5. The Eastern Oncology Collaborative Group (ECOG) physical fitness status of the subjects is 0, 1, or 2; 6. The subject or their legal guardian voluntarily signs an informed consent form approved by the ethics committee before participating in the study, and agrees to complete the entire study treatment according to the clinical trial protocol. Exclusion Criteria: 1. Multiple myeloma subjects without treatment indications; 2. Suffering from plasma cell leukemia; 3. Suffering from systemic amyloidosis; 4. Subjects with extramedullary plasma cell tumors did not reach PR after induction therapy; 5. Suffering from POEMS syndrome (multiple peripheral neuropathy, organ enlargement, endocrine disorders, M-proteinemia, skin changes); 6. Suffering from Fahrenheit macroglobulinemia; 7. Subjects with non secretory multiple myeloma; 8. Subjects with active bacterial, viral, or fungal infections who require oral or intravenous antibiotic treatment according to the researcher's judgment; 9. The expected survival period of the subjects is less than 6 months; 10. Previously suffering from other malignant tumors, except for cured basal cell carcinoma or cervical carcinoma in situ. Malignant tumors that have undergone curative treatment and achieved complete remission (CR) for more than 5 years can be enrolled. If malignant tumors receive curative treatment but have achieved complete remission (CR) for ≤ 5 years, they cannot be enrolled unless approved by the sponsor; 11. Pregnant or lactating women; 12. Subjects who have fertility and are unwilling to take appropriate contraceptive measures within 3 months after signing the informed consent form until the end of treatment in this study; 13. Positive for human immunodeficiency virus (HIV) antibodies; 14. Subjects with positive hepatitis B virus DNA; 15. The subject receives other concurrent anti-tumor treatments (including chemotherapy, radiation therapy, hormone therapy, or immunotherapy) within 30 days prior to autologous hematopoietic stem cell transplantation, or plans to receive any such treatments before the last study visit on day 95 ± 5; 16. The side effects of chemotherapy drugs received before administration have not yet recovered, defined as not regressing to level 0/1 of the National Cancer Institute's Common Terminology Standard for Adverse Events (NCI-CTCAE v5.0), or at the level specified in the inclusion/exclusion criteria, except for adverse events such as hair loss that the researcher assessed and deemed not to affect the safety of the subject's participation in this study; 17. Allergy or intolerance to any component of the investigational drug formulation; 18. Participants participate in other clinical trials within one month before signing the informed consent form; 19. According to the researcher's judgment, subjects who are not suitable for enrollment, may affect treatment evaluation, or are at inappropriate risk. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Peking University People's Hospital #### Overall Officials **Official 1:** **Affiliation:** Peking University People's Hospital **Name:** Kaiyan Liu **Role:** PRINCIPAL_INVESTIGATOR ### 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: 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: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11541 - Name: Melphalan - Relevance: HIGH - As Found: Triangular - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008558 - Term: Melphalan ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425263 **Brief Title:** Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis **Official Title:** Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis #### Organization Study ID Info **ID:** OMFS 335 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mutaz Alkhair Hamad Elsayed **Investigator Title:** principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint. **Detailed Description:** Rationale for conducting the research: The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect. The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) in patients with TMJ internal derangement and osteoarthritis. Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic. Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function. For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with standard arthrocentesis with HA injection. ### Conditions Module **Conditions:** - Temporomandibular Joint Osteoarthritis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** comparison between injection of hyaluronic acids and adipose tissue in temporomandibular joint ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 28 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After standard arthrocentesis of the temporomandibular joint * Direct access to the buccal fat pad, is found at distobuccal depth of the maxillary tuberosity. * It may be dissected during the resection an upper mucosal incision posterior to the second molar * After a single scissor stab through the periosteum the (BFP)extrude into the operative site. * Closure of the flap by suitable suture. * Collection of lipids then manually manipulated with two syringes connecting together and pushing the lipids against each other to receive the injectable amount of micro fragmented adipose tissue . **Intervention Names:** - Biological: adipose tissue fragmented **Label:** injection with adipose tissue **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Arthrocentesis of the superior joint compartment was performed in all patients under local anesthesia using the technique described by Nitzan et al. Another 19-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL saline solution, allowing a free flow through the first needle. On termination of procedure, 2 mL commercially available hyaluronic injected into the superior compartment. **Intervention Names:** - Biological: adipose tissue fragmented **Label:** injection with hyaluronic acids **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - injection with adipose tissue - injection with hyaluronic acids **Description:** harvested from the case form buccal pad of fat **Name:** adipose tissue fragmented **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** by Vas measurement scale OF PAIN **Measure:** VAS **Time Frame:** 3 months #### Secondary Outcomes **Description:** degree of opening on each visit **Measure:** mouth opening **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \* TMJ osteoarthritis assessed by clinical examination and MRI imaging * Presence of TMJ-related symptoms including at least limited mouth opening and joint pain * Previously failed conservative treatment * Age superior to 14 years * No previous TMJ surgical procedures * Acquisition of informed consent; * Complete availability of the data acquired preoperatively and during each follow-up * Patients free from any systemic disease that may affect the procedure. Exclusion Criteria: * \* Previously diagnosed hematological and neurological conditions; * Previous malignant head and neck neoplasms; * Contraindication to fat harvesting. * Uncooperative patients. **Gender Based:** True **Gender Description:** age superior to 14 years of age **Minimum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **Description:** Dose Lipogems injection affect TMJ derangement more than hyaluronic acid in treatment of the temporomandibular joint osteoarthritis and internal derangement? Statement of the problem: Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint. **Info Types:** - CSR **IPD Sharing:** YES **Time Frame:** WITH IN THIS YEAR ## 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: 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 ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425250 **Acronym:** Campylo-BJI **Brief Title:** Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study **Official Title:** Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study #### Organization Study ID Info **ID:** 69HCL23_5284 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospices Civils de Lyon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature. ### Conditions Module **Conditions:** - Campylobacter Infections **Keywords:** - Management - Risk factors - Campylobacter spp. ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022 **Intervention Names:** - Other: Management, progression and risk factors for failure of BJI caused by Campylobacter spp. - Other: Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp. **Label:** Management, progression and risk factors for failure of BJI caused by Campylobacter spp. ### Interventions #### Intervention 1 **Arm Group Labels:** - Management, progression and risk factors for failure of BJI caused by Campylobacter spp. **Description:** Description of demographic data (sex, age), comorbidities (ASA and Charlson scores), orthopedic and septic history, and surgical and medical management (antibiotic therapy) **Name:** Management, progression and risk factors for failure of BJI caused by Campylobacter spp. **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Management, progression and risk factors for failure of BJI caused by Campylobacter spp. **Description:** Failure of treatment: defined according to a composite criterion bringing together * persistence of the infection under treatment, and/or * recurrence of the infection after stopping antibiotic therapy, and/or * need for surgical revision for septic reasons more than 5 days after initial treatment, and/or * superinfection, and/or * definitive explantation of the material, and/or * decision for suppressive antibiotic therapy, and/or * amputation, and/or * death linked to infection **Name:** Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp. **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Treatment failure will be defined as: i) infection persistence under appropriate antimicrobial therapy; ii) infection relapse; iii) need for unplaned surgery; iv) superinfection and/or v) infection-related death **Measure:** Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure. **Time Frame:** Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis . ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * \> 18 years * Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022: * Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter * Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter * Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter * Infection on joint prosthesis or osteosynthesis equipment: documented Campylobacter infection and meeting the definition of probable or confirmed JIBS infections * Patient who was informed and did not object to participating in the study Exclusion Criteria: - **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022 ### Contacts Locations Module #### Locations **Location 1:** **City:** Lyon **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Florent VALOUR, Dr - **Phone:** 04 72 07 11 07 - **Phone Ext:** +33 - **Role:** CONTACT **Country:** France **Facility:** Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse **Status:** RECRUITING **Zip:** 69317 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M5429 - Name: Campylobacter Infections - Relevance: HIGH - As Found: Campylobacter Infections - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000002169 - Term: Campylobacter Infections ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M16759 - Name: Tin Fluorides - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425237 **Acronym:** HERMES **Brief Title:** Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography **Official Title:** Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography #### Organization Study ID Info **ID:** 2020 0428 HP #### Organization **Class:** OTHER **Full Name:** University Hospital, Rouen ### Status Module #### Completion Date **Date:** 2027-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-09 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Rouen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Cerebral arteriography is a reference examination in medical imaging. This examination is performed to allow the diagnosis and therapeutic management of patients with vascular pathologies. It is most often accompanied by a situation of stress, anxiety and apprehension related to the course of the examination or the announcement of the results. These situations generate physiological reactions in patients, making the performance of cerebral arteriography more complex. In order to improve the quality of care for patients undergoing this invasive examination, it is proposed to use two non-medicinal techniques known for their soothing and relaxing properties: aromatherapy and music therapy alone or in combination. These two techniques will help to establish a common thread from the preparation of the patient before the examination to his return to the post-interventional surveillance room. ### Conditions Module **Conditions:** - Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 224 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** standard care **Type:** NO_INTERVENTION #### Arm Group 2 **Intervention Names:** - Other: music therapy **Label:** standard care and music therapy **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Other: aromatherapy **Label:** standard care and aromatherapy **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Other: music therapy - Other: aromatherapy **Label:** standard care ansd music therapy and aromatherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - standard care and music therapy - standard care ansd music therapy and aromatherapy **Description:** standard patient care in interventional radiology associated with a well-being atmosphere with the implementation of music therapy (soothing sound environment) in the preparation box and in the examination room. **Name:** music therapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - standard care and aromatherapy - standard care ansd music therapy and aromatherapy **Description:** standard patient care in interventional radiology associated with a well being atmosphere with the implementation of aromatherapy (essential oil of Ylang Ylang) in the preparation box and in the examination room. **Name:** aromatherapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** blood pressure **Measure:** influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography. **Time Frame:** day 1 #### Secondary Outcomes **Description:** scale :0 : no stress to 10 : a lot of stress **Measure:** stress **Time Frame:** day 1 **Description:** scale : 0 : no pain to 10 : unbearable pain **Measure:** level of pain **Time Frame:** day 1 **Description:** scale : 0 to 7: no anxiety no depressed and 7 to 10 : probably anxiety ans drepressed more than and 10 : symptomatology of anxiety and depressed **Measure:** hospital anxiety and depression scale **Time Frame:** day 1 **Measure:** Cumulative X-ray dose (mGy/cm2) received by the patient **Time Frame:** day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult (≥ 18 years old) * Patient who is scheduled for a cerebral arteriography with local anaesthesia * Patient who capable to read and understand the patient information and consent. * Patient capable to read and sign the consent form * Patient with social insurance * Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy) * Negative urine pregnancy test Exclusion Criteria: * Patients who have had a previous cerebral arteriogram * Patient with allergy to iodinated contrast medium * Patient with severe renal insufficiency * Patient requiring sedation and artificial ventilation * Patient who is deaf and/or hard of hearing * Patient with a known allergy to essential oils * Patient with anosmia * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship, * Pregnant or breastfeeding woman **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Magali DUVAL, radiology technician **Phone:** +33 2 32 88 83 83 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Déborah LEBEDIEFF **Phone:** +33 2 32 88 89 90 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** CHU Rouen **Name:** Magali DUVAL, radiology technician **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425224 **Acronym:** TENSPE2 **Brief Title:** Effectiveness and Safety of TENS Therapy for Premature Ejaculation **Official Title:** Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial #### Organization Study ID Info **ID:** BMGC-M1 #### Organization **Class:** INDUSTRY **Full Name:** Boston Medical Group ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2022-06-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Boston Medical Group #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is: Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine? Patients will: Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included. Be assigned by randomization to one of three treatment groups: * Group 1: Tens therapy + dapoxetine placebo on demand. * Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. * Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). ### Conditions Module **Conditions:** - Premature Ejaculation - Sex Disorder - TEN ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 129 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode is attached to the calcaneus. Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. **Intervention Names:** - Device: Tens therapy - Drug: Dapoxetine placebo **Label:** Group 1: Tens therapy + dapoxetine placebo on demand. **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session. **Intervention Names:** - Drug: Standard treatment (dapoxetine 30 mg as needed) - Device: Placebo therapy **Label:** Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Tens therapy + standard treatment (dapoxetine 30 mg as needed). Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. **Intervention Names:** - Device: Tens therapy - Drug: Standard treatment (dapoxetine 30 mg as needed) **Label:** Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1: Tens therapy + dapoxetine placebo on demand. - Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). **Description:** There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode (anode - black) is attached to the calcaneus. The equipment must previously be programmed under the following parameters: Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. **Name:** Tens therapy **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Group 1: Tens therapy + dapoxetine placebo on demand. **Description:** Patients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. **Name:** Dapoxetine placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. - Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). **Description:** Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study **Name:** Standard treatment (dapoxetine 30 mg as needed) **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. **Description:** In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session. **Name:** Placebo therapy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Average change in intravaginal latency time, measured with a stopwatch by the couple. **Measure:** Change in intravaginal latency time **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Average change in intravaginal latency time, measured with a stopwatch by the couple. **Measure:** Change in intravaginal latency time **Time Frame:** 24 weeks **Description:** Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time. **Measure:** Clinical improvement in premature ejaculation **Time Frame:** At weeks 12 (end of therapy) and 24 (three months of follow-up). **Description:** Proportion of patients with a change in the diagnosis of premature ejaculation according to the PEDT (Premature Ejaculation Diagnostic Tool) questionnaire score in the intervention groups **Measure:** Change in the diagnosis of premature ejaculation **Time Frame:** At weeks 12 and 24 (greater than 12 to less than 12). **Description:** Global Impression of Change Scale score **Measure:** Global Impression of Change Scale **Time Frame:** Weeks 12 and 24. **Description:** Change in the PEP (Premature Ejaculation Profile) questionnaire score **Measure:** PEP (Premature Ejaculation Profile) questionnaire score **Time Frame:** At weeks 12 and 24 **Description:** Type, frequency and severity of adverse events during therapy. **Measure:** Adverse events **Time Frame:** 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy. * Age between 18 and 62 years. * PEDT score greater than 11. * Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study. * Sexual activity at least once a week. * Minimum chronicity of PD of 6 months. * Voluntary participation in the study. * Signing of the informed consent prior to participation in the study. Exclusion Criteria: * IIEF-EF score less than 26. * Glaucoma * Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological. * History of retroperitoneal surgery, radiotherapy or multiple sclerosis. * History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions. * Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers. * Treatment for PE in the last 3 months. * Treatment for epileptic syndromes or Parkinson's disease. * Use of pacemaker or cardiac defibrillator. * Skin lesions in the area where the electrodes are placed. * Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs. * Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months. **Maximum Age:** 62 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Carolina Sandoval, Master **Phone:** +573133920816 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Héctor Corredor, MD **Phone:** +573174317162 **Role:** CONTACT #### Locations **Location 1:** **City:** Ciudad de México **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Carolina Sandoval, MSc - **Phone:** +573133920816 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Héctor Corredor, Md - **Phone:** +573174317162 - **Role:** CONTACT **Country:** Mexico **Facility:** Boston Medical Group **Status:** RECRUITING **Zip:** 01000 #### Overall Officials **Official 1:** **Affiliation:** Boston Medical Group **Name:** Jorge Barba, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000097910 - Term: Ejaculatory Dysfunction - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000020018 - Term: Sexual Dysfunctions, Psychological - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature - ID: M29853 - Name: Premature Ejaculation - Relevance: HIGH - As Found: Premature Ejaculation - ID: M15546 - Name: Sexual Dysfunction, Physiological - Relevance: HIGH - As Found: Sex Disorder - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M3452 - Name: Ejaculatory Dysfunction - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - 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: D000047928 - Term: Premature Birth - ID: D000061686 - Term: Premature Ejaculation - ID: D000012735 - Term: Sexual Dysfunction, Physiological ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425211 **Brief Title:** Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation. **Official Title:** Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation. #### Organization Study ID Info **ID:** BMGC-6 #### Organization **Class:** INDUSTRY **Full Name:** Boston Medical Group ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2021-10-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Boston Medical Group #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is: What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation? Patients will: * Have an initial consultation of pelvic floor rehabilitation before therapy. * Be given pelvic floor therapy. * Have a secondary consultation of pelvic floor rehabilitation after therapy. Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation. **Detailed Description:** The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. Methodology: Pre-post study. Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy, in three groups of patients, independently: * Group 1: Patients with premature ejaculation * Group 2: Patients with erectile dysfunction * Group 3: Patients with erectile dysfunction and premature ejaculation 66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks. Outcomes will be evaluated at the end of therapy (12 weeks), 3 and 6 months follow-up. ### Conditions Module **Conditions:** - Erectile Dysfunction - Premature (Early) Ejaculation - Premature Ejaculation - Pelvic Floor; Weak ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity. For muscular hypoactivity: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24 For muscular hyperactivity they will be given: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation **Intervention Names:** - Behavioral: Therapeutic exercises - Device: Perineal electromyographic biofeedback - Device: Electrical stimulation **Label:** Erectile Dysfunction **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation **Intervention Names:** - Behavioral: Therapeutic exercises - Device: Perineal electromyographic biofeedback - Device: Electrical stimulation **Label:** Premature Ejaculation **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation **Intervention Names:** - Behavioral: Therapeutic exercises - Device: Perineal electromyographic biofeedback - Device: Electrical stimulation **Label:** Premature Ejaculation + Erectile Dysfunction **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Erectile Dysfunction - Premature Ejaculation - Premature Ejaculation + Erectile Dysfunction **Description:** Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques. **Name:** Therapeutic exercises **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Erectile Dysfunction - Premature Ejaculation - Premature Ejaculation + Erectile Dysfunction **Description:** Free muscle work and gross motor coordination: **Name:** Perineal electromyographic biofeedback **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Erectile Dysfunction - Premature Ejaculation - Premature Ejaculation + Erectile Dysfunction **Description:** Muscular proprioceptive work: 50 Hz 300 µs **Name:** Electrical stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3) **Measure:** Change in baseline intravaginal latency time (IVLT) **Time Frame:** 12 weeks **Description:** International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3) **Measure:** Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3) **Measure:** Change in baseline intravaginal latency time (IVLT) at follow-up **Time Frame:** 3 and 6 months of follow-up. **Description:** Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3) **Measure:** Change Premature Ejaculation Perfil (PEP) score **Time Frame:** 12 weeks, 3 and 6 months follow-up. **Description:** Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3) **Measure:** Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score **Time Frame:** 12 weeks, 3 and 6 months follow-up. **Description:** Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up. **Measure:** Change Intracavity Assessment **Time Frame:** 12 weeks, 3 and 6 months follow-up. **Description:** Incidente of side effects related to therapy. **Measure:** Side Effects **Time Frame:** 12 weeks, 3 and 6 months follow-up. **Description:** International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the 3 and 6 months of follow-up. (Groups 2,3) **Measure:** Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up **Time Frame:** 3 and 6 months of follow-up. **Description:** Increase of 1 point in the baseline EHS at the end of therapy, 3 and 6 months of follow-up. (Groups 2,3) **Measure:** Change in Erection Hardness Score (EHS) **Time Frame:** 12 weeks, 3 and 6 months of follow-up. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Overall: * Men over 18 years of age * Erectile dysfunction or premature ejaculation for at least 6 months * Sexual activity with a heterosexual partner at least once a week * Signing of informed consent before the start of the study For the premature ejaculation group: * Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria * Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11 For the erectile dysfunction group: * Clinical diagnosis of primary erectile dysfunction * International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26 Exclusion Criteria: * Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months * Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction * History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction * History of pelvic radiotherapy * Pacemaker or cardiac arrhythmia, epilepsy * History of spinal cord trauma or spinal surgeries. * Inability to attend therapies or controls * Illiteracy or cognitive disability that prevents you from completing the questionnaires * Psychiatric, psychological disorders, or cognitive deficiencies * Injuries in the area of application of the therapy * Active pelvic organ cancer **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Carolina Sandoval, Master **Phone:** +573133920816 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Héctor Corredor, MD **Phone:** +573174317162 **Role:** CONTACT #### Locations **Location 1:** **City:** Bogotá **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Carolina Sandoval, Master - **Phone:** 57 3208899777 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Héctor Corredor, MD - **Phone:** +57 3174317162 - **Role:** CONTACT **Country:** Colombia **Facility:** Boston Medical Group Colombia **State:** Cundinamarca **Status:** RECRUITING **Zip:** 11022 #### Overall Officials **Official 1:** **Affiliation:** Boston Medical Group **Name:** Cristina Amaya **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000012735 - Term: Sexual Dysfunction, Physiological - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000020018 - Term: Sexual Dysfunctions, Psychological - ID: D000001523 - Term: Mental Disorders - ID: D000097910 - Term: Ejaculatory Dysfunction ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature - ID: M10217 - Name: Erectile Dysfunction - Relevance: HIGH - As Found: Erectile Dysfunction - ID: M29853 - Name: Premature Ejaculation - Relevance: HIGH - As Found: Premature Ejaculation - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - 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 - ID: M3452 - Name: Ejaculatory Dysfunction - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth - ID: D000007172 - Term: Erectile Dysfunction - ID: D000061686 - Term: Premature Ejaculation ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425198 **Brief Title:** Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment **Official Title:** A Phase 1, Multi-center, Open-label Study to Assess the Pharmacokinetics and Safety of BMS-986278 in Healthy Participants and Those With Mild, Moderate and Severe Hepatic Impairment #### Organization Study ID Info **ID:** IM027-1009 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2024-12-23 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function. ### Conditions Module **Conditions:** - Hepatic Impairment - Healthy Participants **Keywords:** - Healthy Volunteers - Pharmacokinetics - Liver Diseases - Mild, Moderate and Severe Hepatic Impairment - BMS-986278 ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BMS-986278 **Label:** Group A: Mild Hepatic Impairment BMS-986278 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: BMS-986278 **Label:** Group B: Moderate Hepatic Impairment BMS-986278 **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Drug: BMS-986278 **Label:** Group C: Severe Hepatic Impairment BMS-986278 **Type:** EXPERIMENTAL #### Arm Group 4 **Intervention Names:** - Drug: BMS-986278 **Label:** Group D: Normal Hepatic Function BMS-986278 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A: Mild Hepatic Impairment BMS-986278 - Group B: Moderate Hepatic Impairment BMS-986278 - Group C: Severe Hepatic Impairment BMS-986278 - Group D: Normal Hepatic Function BMS-986278 **Description:** Specified dose on specified days **Name:** BMS-986278 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Maximum observed concentration (Cmax) **Time Frame:** Up to day 9 **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 9 **Measure:** Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] **Time Frame:** Up to day 9 #### Secondary Outcomes **Measure:** Incidence of adverse events (AEs) **Time Frame:** Up to 62 days **Measure:** Incidence of serious adverse events (SAEs) **Time Frame:** Up to 62 days **Measure:** Number of participants with physical examination abnormalities **Time Frame:** Up to 62 days **Measure:** Number of participants with vital sign abnormalities **Time Frame:** Up to 62 days **Measure:** Number of participants with electrocardiogram (ECG) abnormalities **Time Frame:** Up to 62 days **Measure:** Number of participants with clinical laboratory abnormalities **Time Frame:** Up to 62 days **Measure:** Time of maximum observed concentration (Tmax) **Time Frame:** Up to day 9 **Measure:** Terminal elimination half-life (T-HALF) **Time Frame:** Up to day 9 **Measure:** Apparent body clearance (CLT/F) **Time Frame:** Up to day 9 **Measure:** Maximum observed plasma concentration of unbound drug (Cmax_u) **Time Frame:** Up to day 9 **Measure:** Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u] **Time Frame:** Up to day 9 **Measure:** Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u] **Time Frame:** Up to day 9 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: All Participants: * Must have a body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg. Mild, Moderate, or Severe Hepatic Impairment Participants: * Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use. * Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score. Matched Healthy Participants: * Free of any clinically significant disease that would interfere with the study evaluations. * Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants). Exclusion Criteria: All Participants: * History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). Mild, Moderate, or Severe Hepatic Impairment Participants: * Acute liver disease (eg, caused by an acute infection or drug toxicity). * History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant. Matched Healthy Participants: * Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study. * Other protocol-defined inclusion/exclusion criteria apply. **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com **Phone:** 855-907-3286 **Role:** CONTACT **Contact 2:** **Name:** First line of the email MUST contain NCT # and Site #. **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html **IPD Sharing:** NO ### References Module #### See Also Links **Label:** BMS Clinical Trial Information **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html **Label:** BMS Clinical Trial Patient Recruiting **URL:** https://www.bmsstudyconnect.com/s/US/English/USenHome ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11107 - Name: Liver Diseases - Relevance: HIGH - As Found: Hepatic Impairment - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008107 - Term: Liver Diseases ### 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425185 **Brief Title:** Differences and Changes in Lower Limb Muscle Activation and Ankle Stability in Different Blackboard Configurations **Official Title:** Differences in Electromyographic Activity of Ankle Stabilizer Muscles in the Different Configurations of a Specific Instability Device: an Observational Study #### Organization Study ID Info **ID:** 1271077 #### Organization **Class:** OTHER **Full Name:** University of Valencia ### Status Module #### Completion Date **Date:** 2024-05-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-31 **Type:** ACTUAL #### Start Date **Date:** 2024-04-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Valencia #### Responsible Party **Investigator Affiliation:** University of Valencia **Investigator Full Name:** Rodrigo Martín-San-Agustin **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 observational study is to analyze the differences in muscle activation of six muscles of the lower leg (soleus, gastrocnemius medialis, gastrocnemius lateralis, tibialis anterior, peroneus longus, peroneus brevis) in seven possible configurations of a specific instability device, the Blackboard (BB), as well as on the floor, among healthy active subjects. The main questions it aims to answer are: 1. Which configuration of the BB produces the highest activation for each studied muscle? 2. Which muscle is the most activated in each configuration of the BB? 3. What is the muscle activation pattern obtained in each configuration of the BB? A single group of participants will be analyzed. Both the studied leg and the order of configurations of the instability device and ground condition will be randomly assigned. Participants will first undergo a 2-minute continuous walking warm-up, followed by a performance of a maximum voluntary isometric contraction (MVIC) for each muscle, during which the maximum activation produced will be recorded. Each participant will be allowed a 30-second familiarization period on the most unstable configuration of the BB. Three repetitions of 20 seconds will be recorded on both the ground and each configuration, with a 30-second rest between repetitions. The central 10 seconds of each trial will be used for subsequent analysis. The mean of the three repetitions for each muscle will be calculated and subsequently processed and normalized by the maximum activation value during the MIVC. Finally, a statistical analysis of the differences in muscle activation in each configuration will be conducted with the intention of addressing the mentioned questions. **Detailed Description:** The use of different instability devices is common in the clinical setting, both for preventive and therapeutic purposes. Numerous studies have demonstrated their effectiveness in improving stability and proprioception, although in most cases in a generalized manner. The need to selectively target specific structures and joints has led to the development of specific instability systems, such as the Blackboard (BB). The BB is an instability device composed of two rectangular wooden boards, joined together, with Velcro on its base where rounded slats can be freely placed to generate the desired instability according to the patient's or subject's requirements. It is known for its portability, small size, and adaptability, and, as demonstrated in a previous study, similar to traditional devices (BOSU or Wobble board) in activating the Peroneus longus muscle, essential for single-leg stability. However, its detailed functioning is still not fully understood, as the muscle activation it produces during single-leg stance in its different configurations has not been analyzed yet. This study is a single-group cross-sectional observational study and it will include a sample of 30 participants who will be analyzed in a single session, during single-leg stance on the floor and on the different configurations of the BB. Electrode placement will follow SENIAM guidelines. The session will begin with a 2-minute continuous walking warm-up, followed by the recording of muscle activation in a maximum voluntary isometric contraction (MVIC). Subsequently, the participant will be allowed a 30-second familiarization period on the most unstable configuration of the BB (Total - see description below). Muscle activation of six leg muscles (soleus, medial gastrocnemius, lateral gastrocnemius, tibialis anterior, peroneus longus, and peroneus brevis) will be measured during single-leg stance on the different configurations of the BB and on the ground, randomly. The analyzed variable will be muscle activation, and the MuscleLab 4020e surface electromyography device from Ergotest Technology AS will be used. The maximum value obtained during the central 10 seconds of the measurement (which will last a total of 20 seconds) will be recorded, in three attempts with 30 seconds of rest between them. The hypothesis of this study is that by selecting a BB configuration that reinforces the expected muscle function based on ankle biomechanics, its activation will increase. Thus, configurations that require movements such as eversion, to increase activation of the peroneus longus and brevis, or supination, aiming to increase activation of the tibialis anterior, among others, will be analyzed. The description of the different configurations is detailed below, for the right foot: * Floor: single-leg stance on a firm surface, in this case, the floor * Rear: single-leg stance on the BB, with the front table fixed and the rear table with the slat placed centrally * Inver: single-leg stance on the BB, with the front table fixed and the rear table with the slat placed laterally (demanding an inversion movement of the heel) * Ever: single-leg stance on the BB, with the front table fixed and the rear table with the slat placed medially (demanding an eversion movement of the heel) * Sup: single-leg stance on the BB, with the rear table fixed and the front table with the slat placed laterally (demanding a supination movement of the forefoot) * Pro: single-leg stance on the BB, with the rear table fixed and the front table with the slat placed medially (demanding a pronation movement of the forefoot) * Fore: single-leg stance on the BB, with the rear table fixed and the front table with the slat placed centrally * Total: single-leg stance on the BB, with both the front and rear tables with the slats placed centrally In all cases, the subject's objective is to ensure that the edges of the BB are not in contact with the floor. Thus, the aim of this study is to analyze the differences in electromyographic activity of the six studied muscles across the eight different conditions. This includes identifying the most activated muscles in each condition and determining which condition produces the highest activation of each muscle. Additionally, a secondary aim is to establish patterns of muscular activation for each condition, that is, for each requested movement of the foot and ankle. ### Conditions Module **Conditions:** - Electromyography **Keywords:** - Ankle stability - Muscle activation - Instability device - Healthy ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study group consists of 30 subjects who are free from any specific medical condition or injury affecting the lower extremities. These subjects are physically active individuals without any known musculoskeletal disorders or impairments. They all will be assessed in the same way. Data collection will take place during single-leg stance on the BB in its different configurations and on the floor. Three attempts of 20 seconds each will be recorded for each condition. The subjects will perform these exercises under the guidance of a trained physiotherapist. **Intervention Names:** - Other: Single-leg stance under different instability conditions **Label:** Cross-sectional study group ### Interventions #### Intervention 1 **Arm Group Labels:** - Cross-sectional study group **Description:** Participants will perform three attempts of 20 seconds of single-leg stance on the floor and on the 7 selected configurations of the BB. The order of measurement will be randomized. The description of the chosen configurations can be found in the Detailed Description section. In all cases, the participant's objective is to ensure that the edges of the BB are not in contact with the floor. The position of the participant on the BB will be a single-leg stance on the randomly chosen foot, with the contralateral knee slightly flexed and hands placed on the hips. Participants will look at a fixed point placed 3 meters in front of them. A rest period of 30 seconds will be allowed between trials. The physiotherapist responsible for supervising the measurements will be the one to adjust the BB configurations when needed. **Name:** Single-leg stance under different instability conditions **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The electrode placement area will be shaved and cleaned with alcohol. Muscles analyzed will include soleus, gastrocnemius medialis, gastrocnemius lateralis, tibialis anterior, peroneus longus and peroneus brevis. The MuscleLab 4020e, Ergotest Technology AS surface electromyography device will be used, and adhesive electrode placement will follow SENIAM guidelines. Muscle activity will be recorded during 3 periods of 20" with 30" of rest in between. The single-leg stance will be done on the Floor condition and on the 7 instability configurations of the BB. The central 10" of the measurement will be used for subsequent analysis. The electromyography signal will be processed and cleaned, and the maximum value registered will be subsequently normalized by the muscle activation obtained during a maximal voluntary isometric contraction, yielding the normalized electromyography (nEMG) for each muscle. The average of the three attempts will be the value used for statistical analysis. **Measure:** nEMG level of six leg muscles during single-leg stance across eight different conditions **Time Frame:** Immediately after the MIVC test, during the single evaluation session, with an approximate duration of 30 minutes (20 minutes of measurement duration, plus time for familiarization and subject preparation) #### Secondary Outcomes **Description:** The maximum value of muscle activation during a maximal voluntary isometric contraction (MVIC) of the six muscles previously mentioned will be used to normalize the signal collected during the assessment. For the peroneus longus, peroneus brevis, and tibialis anterior muscles, this value will be recorded with the participant in supine position, with the examiner resisting eversion and dorsiflexion movements in each case. For the soleus, medial gastrocnemius, and lateral gastrocnemius, the participant will be asked to perform a maximal plantar flexion on one leg, first with the knee slightly flexed and then with the knee extended. After a practice trial, each muscle will be tested 3 times, each trial lasting 5", with a 2-minute interval between trials. Verbal encouragement will be provided during testing. Finally, the average of the 3 peak values will be used as the maximum reference value for normalization. **Measure:** Maximum value of muscle activation of six leg muscles during a maximal voluntary isometric contraction **Time Frame:** Immediately after the warm-up, during the single evaluation session, with an approximate duration of 40 minutes (36 minutes of measurement duration, plus time for familiarization and subject preparation) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Not to have experienced lower limb injury or pain within the last year prior to the study * Self-report as physically active, such that they perform at least 90 minutes of weekly physical activity Exclusion Criteria: * Previous participation in any lower limb balance or proprioception exercise program * The presence of known balance impairments such as vertigo, vestibular or central alterations **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** The participants are being sourced from the Faculty of Physiotherapy of the University of Valencia. They are undergraduate or master's students who have responded to an email invitation sent by one of the professors from the department involved in the study. ### Contacts Locations Module #### Locations **Location 1:** **City:** Valencia **Country:** Spain **Facility:** Rodrigo Martin-San Agustin #### Overall Officials **Official 1:** **Affiliation:** University of Valencia **Name:** Rodrigo Martín-San Agustín, Doctor **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425172 **Brief Title:** Monitoring System for Cranial Orthoses **Official Title:** A Monitoring System for Cranial Remolding Orthoses #### Organization Study ID Info **ID:** STU-2022-0556 #### Organization **Class:** OTHER **Full Name:** University of Texas Southwestern Medical Center ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** National Institute on Disability, Independent Living, and Rehabilitation Research #### Lead Sponsor **Class:** OTHER **Name:** University of Texas Southwestern Medical Center #### Responsible Party **Investigator Affiliation:** University of Texas Southwestern Medical Center **Investigator Full Name:** Tiffany Graham **Investigator Title:** Associate Professor **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:** This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow). **Detailed Description:** This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow). Although cranial remolding treatment has been used successfully for over 20 years, there is no clinical standard for objective monitoring of the fit and wear time. In total, participation will consist of 7 visits over 11 weeks: (1) measurements and clinical evaluation \[approximately 60 minutes\], (2) fitting of standard helmet and pre-fitting and/or fitting of the research helmet \[approximately 60 minutes\], (3) fitting of research helmet (if not done at Visit #2) and in-office testing \[approximately 2 hours\], (4)/(5)/(6) follow up visits for research helmet \[approximately 30-60 minutes each\], and (7) final follow up visit and in-office testing for the research helmet \[approximately 2 hours\]. During the 8 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day, and caregivers will keep a log of helmet wear time and any side effects (such as skin irritations), if they occur. The child will be seen clinically every 2 weeks (or more often, if caregivers request additional checkups). At the end of the trial, participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet. ### Conditions Module **Conditions:** - Plagiocephaly - Brachycephaly - Deformational Plagiocephaly - Deformational Posterior Plagiocephaly ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly. **Intervention Names:** - Device: Cranial Remolding Orthosis **Label:** Infants with with deformational head shapes ### Interventions #### Intervention 1 **Arm Group Labels:** - Infants with with deformational head shapes **Description:** A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research. **Name:** Cranial Remolding Orthosis **Other Names:** - Custom Helmet **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The temperature readings from the custom temperature sensor within the research helmet will be compared to the collected temperature readings from the iButtons. Using established software compatible with the iButton, wear time will be calculated based on previously reported temperature thresholds which indicate the helmet is being worn. Using similar temperature thresholds, wear time data from the custom sensors will be compared to the wear time reported by the iButton software. **Measure:** Wear time monitoring and validation **Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year. **Description:** We will examine pressure in the void space of the helmet throughout the 8 weeks of wear time. In theory, the pressure in this area should never increase as the cranium should not come in contact with this sensor no matter what position the infant is in (i.e. laying down, sitting, etc). **Measure:** Fit monitoring **Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year. #### Secondary Outcomes **Description:** Parents will take a survey regarding their experience with the research helmet **Measure:** Survey Participation **Time Frame:** Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year. **Description:** The wear time based on iButton and custom temperature readings will be compared to the caregiver-reported wear time log and any differences in log times reviewed. **Measure:** Wear time comparison between objective and subjective reporting **Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly) Exclusion Criteria: * non-English speaking caregivers * infants with craniosynostosis or those not indicated for cranial remolding * infants with developmental comorbidities which affect cranial growth **Maximum Age:** 18 Months **Minimum Age:** 3 Months **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Infants who are clinically indicated for cranial remolding orthoses. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tiffany Graham, MS **Phone:** 2146458250 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Texas Southwestern Medical Center **Name:** Tiffany Graham, MS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Individual participant data will be protected and only shared within the research team and treating practitioners. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019465 - Term: Craniofacial Abnormalities - ID: D000009139 - Term: Musculoskeletal Abnormalities - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000000013 - Term: Congenital Abnormalities - ID: D000013580 - Term: Synostosis - ID: D000004413 - Term: Dysostoses - ID: D000001848 - Term: Bone Diseases, Developmental - ID: D000001847 - Term: Bone Diseases ### 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M29382 - Name: Plagiocephaly - Relevance: HIGH - As Found: Plagiocephaly - ID: M26018 - Name: Plagiocephaly, Nonsynostotic - Relevance: HIGH - As Found: Deformational Plagiocephaly - ID: M6613 - Name: Craniosynostoses - Relevance: HIGH - As Found: Brachycephaly - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M21420 - Name: Craniofacial Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12096 - Name: Musculoskeletal Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M16357 - Name: Synostosis - Relevance: LOW - As Found: Unknown - ID: M7587 - Name: Dysostoses - 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: T4584 - Name: Plagiocephaly - Relevance: HIGH - As Found: Plagiocephaly - ID: T1638 - Name: Craniosynostosis - Relevance: LOW - As Found: Unknown - ID: T5091 - Name: Saethre-Chotzen Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000059041 - Term: Plagiocephaly - ID: D000049068 - Term: Plagiocephaly, Nonsynostotic - ID: D000003398 - Term: Craniosynostoses ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425159 **Acronym:** SHINE **Brief Title:** A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures **Official Title:** A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension #### Organization Study ID Info **ID:** BHV7000-304 #### Organization **Class:** INDUSTRY **Full Name:** Biohaven Pharmaceuticals, Inc. #### Secondary ID Infos **Domain:** EU CTR **ID:** 2023-508812-45-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Biohaven Therapeutics 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:** The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase. ### Conditions Module **Conditions:** - Generalized Epilepsy **Keywords:** - Idiopathic Generalized Epilepsy - Generalized - Epilepsy - tonic-clonic - generalized tonic-clonic - tonic - clonic - seizure - refractory epilepsy - generalized tonic-clonic alone - juvenile myoclonic epilepsy - juvenile absence epilepsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 242 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BHV-7000 **Label:** BHV-7000 75 mg **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BHV-7000 75 mg **Description:** BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily **Name:** BHV-7000 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Matching placebo taken once daily **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase **Measure:** Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period **Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period #### Secondary Outcomes **Description:** To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods. **Measure:** Percentage of Participants with freedom of GTC seizures during DBT Phase **Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period **Description:** To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs **Measure:** Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs **Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period **Description:** To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities. **Measure:** Number of Participants With Clinically Significant Laboratory Abnormalities **Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male and Female participants 18 to 75 years of age at time of consent. * Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. 1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks 2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed). * Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. * Ability of subject or caregiver to keep accurate seizure diaries * Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.). * Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks. Exclusion Criteria: * History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired conscious for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure. * History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having an unknown GTC seizure count during the screening phase. * Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chief Medical Officer **Phone:** 203-404-0410 **Role:** CONTACT #### Locations **Location 1:** **City:** Jacksonville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yasmeen Shabbir - **Phone:** 904-244-9856 - **Role:** CONTACT **Country:** United States **Facility:** University of Florida (Jacksonville) **State:** Florida **Zip:** 32209 **Location 2:** **City:** Orlando **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Michelle Clevenger - **Phone:** 407-652-6011 - **Role:** CONTACT **Country:** United States **Facility:** Research Institute of Orlando **State:** Florida **Zip:** 32806 **Location 3:** **City:** Weston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Antonio Barreiro - **Phone:** 954-777-8827 - **Role:** CONTACT **Country:** United States **Facility:** Encore Medical Research of Weston LLC. **State:** Florida **Zip:** 33331 **Location 4:** **City:** Elgin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ayesha Fatima - **Phone:** 847-497-0421 - **Role:** CONTACT **Country:** United States **Facility:** Revive Research Institute, Inc. **State:** Illinois **Zip:** 60123 **Location 5:** **City:** Lexington **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Morgan Medley - **Phone:** 859-313-4989 - **Role:** CONTACT **Country:** United States **Facility:** Bluegrass Epilepsy Research **State:** Kentucky **Zip:** 40504 **Location 6:** **City:** Baton Rouge **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** JoAnne Hollingsworth - **Phone:** 225-765-7659 - **Role:** CONTACT **Country:** United States **Facility:** OLOLRMC **State:** Louisiana **Zip:** 70808 **Location 7:** **City:** Livingston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Munazza Malik - **Phone:** 973-322-7425 - **Role:** CONTACT **Country:** United States **Facility:** Inst of Neurology **State:** New Jersey **Zip:** 07039 **Location 8:** **City:** Amherst **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hailley Pearson - **Phone:** 716-250-7002 - **Role:** CONTACT **Country:** United States **Facility:** Dent Neurosciences Research Center **State:** New York **Zip:** 14226 **Location 9:** **City:** Chattanooga **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Arlann Erskine - **Phone:** 423-698-4584 - **Role:** CONTACT **Country:** United States **Facility:** WR-ClinSearch **State:** Tennessee **Zip:** 37421 **Location 10:** **City:** Nashville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Melissa Osborn - **Phone:** 615-322-8817 - **Role:** CONTACT **Country:** United States **Facility:** Vanderbilt University Medical Center **State:** Tennessee **Zip:** 37232 **Location 11:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** J. Christina Howell - **Phone:** 214-750-9977 - **Phone Ext:** 293 - **Role:** CONTACT **Country:** United States **Facility:** Neurology Consultants of Dallas, PA **State:** Texas **Zip:** 75243 **Location 12:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Saad Ahmad - **Phone:** 713-500-7894 - **Role:** CONTACT **Country:** United States **Facility:** UTHealth Houston **State:** Texas **Zip:** 77030 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous 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: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M15452 - Name: Seizures - Relevance: HIGH - As Found: Generalized Tonic-Clonic Seizures - ID: M369 - Name: Drug Resistant Epilepsy - Relevance: LOW - As Found: Unknown - ID: M7985 - Name: Epilepsy, Generalized - Relevance: HIGH - As Found: Generalized Epilepsy - ID: M7987 - Name: Epilepsies, Myoclonic - Relevance: LOW - As Found: Unknown - ID: M7988 - Name: Epilepsy, Absence - Relevance: LOW - As Found: Unknown - ID: M22018 - Name: Myoclonic Epilepsy, Juvenile - 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: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T2109 - Name: Epilepsy Juvenile Absence - Relevance: LOW - As Found: Unknown - ID: T4008 - Name: Myoclonus Epilepsy - Relevance: LOW - As Found: Unknown - ID: T3175 - Name: Juvenile Myoclonic Epilepsy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy - ID: D000012640 - Term: Seizures - ID: D000004829 - Term: Epilepsy, Generalized ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425146 **Acronym:** TACO **Brief Title:** Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO) **Official Title:** Clinical-biological, Prospective, Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma (OSCC) #### Organization Study ID Info **ID:** ET23-384 TACO #### Organization **Class:** OTHER **Full Name:** Centre Leon Berard ### Status Module #### Completion Date **Date:** 2025-09-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Leon Berard #### 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 project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC). **Detailed Description:** Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality. Despite recent advances in diagnosis, treatment and monitoring, the overall 5-year survival rate of patients with epidermoid carcinomas of upper aerodigestive tract has not improved significantly and remains around 40-50 % for all combined locations. These pejorative survival rates, as well as the increase in the incidence of these cancers, have not changed much over the past 30 years. This situation can be attributed in part to a diagnosis too late. Indeed, only 1/3 of patients with high-risk squamous cell carcinoma of the head and neck are diagnosed at an early stage. This issue of early diagnosis is mainly due to the lack of suitable screening and diagnostic biomarkers. Beyond diagnosis, the identification of biomarkers is also a prognostic and predictive interest since they could predict the course of the disease as well as the response to treatment. "Drivers" mutations, with oncogenic potential, can be present from the very early stages of epidermoid carcinomas of upper aerodigestive tract and therefore constitute potential biomarkers. However, recent studies have demonstrated the presence of driver mutations in different types of oral cavity's healthy tissue, some being even associated with a protective effect against tumor initiation. In order to improve prevention and early diagnosis of OSCC, it is important to better understand the evolutionary dynamics of somatic mutations in the oral mucosa, which is still poorly characterized. ### Conditions Module **Conditions:** - Oral Squamous Cell Carcinomas **Keywords:** - Somatic mutations - Healthy oral mucosa - oral cancer - OSCC ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** A clinical-biological cohort of patients with epidermoid carcinomas of the oral cavity. Blood sample and cytobrush sample at inclusion and before anti-cancer treatment. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A clinical-biological cohort of 30 patients with epidermoid carcinomas of the oral cavity. Blood sample and cytobrush sample at inclusion and before anti-cancer treatment. **Intervention Names:** - Procedure: Cytobrush sample - Procedure: Blood sampling **Label:** Clinical-biological cohort **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Clinical-biological cohort **Description:** Healthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients **Name:** Cytobrush sample **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Clinical-biological cohort **Description:** Blood sampling (6 mL), taken from a routine biological exam **Name:** Blood sampling **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Selective advantage of the 62 driver genes already identified **Measure:** Selective advantage of OSCC driver mutations in normal-looking mucosa **Time Frame:** 1 year **Description:** Selective advantage of non-driver OSCC genes **Measure:** Non-drivers OSCC genes under positive selection in normal looking mucosa **Time Frame:** 1 year #### Primary Outcomes **Description:** Identified mutations described by type and number **Measure:** Identify somatic mutations of the driver genes from healthy oral mucosa from patients with epidermoid carcinomas of the upper aerodigestive tract **Time Frame:** 1 year #### Secondary Outcomes **Description:** Correlation between tobacco consumption and total number of somatic mutations detected **Measure:** Correlation between tobacco consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC **Time Frame:** 1 year **Description:** Correlation between alcohol consumption and total number of somatic mutations **Measure:** Correlation between alcohol consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * I1. Male or female aged 18 years or older at the date of signature of the informed consent to participate. * I2. Patient with histological diagnosis of epidermoid carcinomas of the oral cavity NB: All grades are eligible. * I3. Patient naive of any systemic anti-cancer treatment (radio- or chemotherapy). * I4. Patient able to understand, sign and date informed consent before the start of any study protocol procedure. * I5. Patient affiliated or covered by a medical insurance Exclusion Criteria: * E1. Patients at high risk of bleeding, such as those on anticoagulant or antiplatelet aggregant treatment, with clotting disorders or a history of severe bleeding in the two weeks prior to inclusion. * E2. Patient with lesions of all types on the mucosa of the cheek located on the opposite side of the area affected by an epidermoid carcinoma of the oral cavity which prevents painless removal of the healthy mucosa. * E3. Patient who had surgery for their epidermoid carcinoma of the oral cavity more than 6 months ago. * E4. Patient who uses cannabis. * E5. Patient with another active tumor or HPV-positive tumors. * E6. Patient under guardianship or curatorship or placed under the protection of justice. * E7. Pregnant and/or nursing patient. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Philippe Zrounba, M.D. **Phone:** (0)4 69 85 60 82 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Pierre Martinez, Ph.D. **Phone:** (0)4 69 85 60 82 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Lyon **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Philippe Zrounba, M.D. - **Role:** CONTACT **Country:** France **Facility:** Centre Léon Bérard **Zip:** 69008 #### Overall Officials **Official 1:** **Affiliation:** [email protected] **Name:** Philippe Zrounba, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M12022 - Name: Mouth Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1689 - Name: Squamous Cell Carcinoma of Head and Neck - Relevance: HIGH - As Found: Oral Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: T4267 - Name: Oral Squamous Cell Carcinoma - Relevance: HIGH - As Found: Oral Squamous Cell Carcinoma - ID: T4265 - Name: Oral Cancer - Relevance: LOW - As Found: Unknown - ID: T3466 - Name: Lip and Oral Cavity Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077195 - Term: Squamous Cell Carcinoma of Head and Neck ### 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: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425133 **Acronym:** CARE **Brief Title:** Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers **Official Title:** Impact of Regorafenib in Combination With Multimodal Metronomic Chemotherapy on Progression-free Survival Compared With Standard Regorafenib for the Treatment of Chemo-resistant Metastatic Colorectal Cancers #### Organization Study ID Info **ID:** 2023/805 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Besancon ### Status Module #### Completion Date **Date:** 2028-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Groupement Interrégional de Recherche Clinique et d'Innovation #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Besancon #### 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 is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer by assessing progression-free survival. ### Conditions Module **Conditions:** - Metastatic Colorectal Cancer **Keywords:** - Regorafenib - metronomic chemotherapy - colon cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 174 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** • Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity. For the first cycle: Regorafenib will be administered according to the "REDOS" schedule week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : no regorafenib For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle. **Intervention Names:** - Procedure: Blood sample - Other: Quality of life questionnaires - Procedure: Biopsy - Drug: Regorafenib **Label:** Regorafenib **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** • Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity. For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg daily week 2: 120 mg daily week 3: 160 mg daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle. * Metronomic chemotherapy will be administrated as following:Cyclophosphamide: 50 mg per os, daily, for 6 months,Capecitabine: 625mg/m²/orally twice daily, for 6 months. * Low-dose Aspirin: 75 mg orally, daily, until progression. **Intervention Names:** - Procedure: Blood sample - Other: Quality of life questionnaires - Procedure: Biopsy - Combination Product: Regorafenib + metronomic chemotherapy **Label:** Regorafenib+ metronomic chemotherapy + aspirin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Regorafenib - Regorafenib+ metronomic chemotherapy + aspirin **Description:** Blood sample for plasma collection, Blood sample for ctDNA (circulating tumoral DNA) collection **Name:** Blood sample **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Regorafenib - Regorafenib+ metronomic chemotherapy + aspirin **Description:** EORTC QLQ-C30 questionnaire (Quality of life questionnaire Cancer 30) CR29 questionnaire (Colo-rectal cancer 29) EQ-5D5L questionnaire (EuroQol-5 Dimensions, 5 levels): repeated measures at baseline, M2, M4, M6, M8, M10, M12 and during the end of treatment visit and during the follow-up **Name:** Quality of life questionnaires **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Regorafenib - Regorafenib+ metronomic chemotherapy + aspirin **Description:** Fresh tumor biopsy at baseline and week 8 **Name:** Biopsy **Type:** PROCEDURE #### Intervention 4 **Arm Group Labels:** - Regorafenib **Description:** For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle. **Name:** Regorafenib **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Regorafenib+ metronomic chemotherapy + aspirin **Description:** • Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity. For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle. * Metronomic chemotherapy will be administrated as following:Cyclophosphamide: 50 mg per os, daily, for 6 months,Capecitabine: 625mg/m²/orally twice daily, for 6 months. * Low-dose Aspirin: 75 mg orally, daily, until progression. **Name:** Regorafenib + metronomic chemotherapy **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Progression-free survival (PFS): defined as the time from the randomization to objective disease progression as per RECIST v1.1 or death from any cause, whichever occurs first. The time of the progression or recurrence event is determined using the first date when there is documented evidence that the criteria have been met, even in situations where progression is observed after one or more missed visits, treatment discontinuation, or new anti-cancer treatment. Patients with no defined events observed during the follow up period will be censored at the date of last news **Measure:** To evaluate the impact of a Regorafenib combined with metronomic chemotherapy and low-dose aspirin compared to standard Regorafenib treatment by assessing progression-free survival **Time Frame:** 5 months average ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with histologically proven metastatic colorectal cancer in progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF (vascular endothelial growth factor), trifluridine/tipiracil, anti-EGFR (epidermal growth factor receptor) therapy if KRAS (Kirsten rat sarcoma) and NRAS WT (wild type), anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 (Programmed Death-1) if MSI-H (microsatellite instability) /dMMR (deficient MisMatch Repair) tumor, or not considered as candidate for these treatments. 2. Life expectancy of at least 3 months 3. Female or male with age \>18 years old 4. Performance status = 0 or 1 (Annex 1) 5. Measurable disease defined according to RECIST v1.1 guidelines (scanner or MRI) 6. Adequate bone marrow, liver and renal functions. 1. Haemoglobin ≥ 9 g/dL; absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L 2. Total serum bilirubin ≤ 1.5 times upper normal value (ULN), serum alkaline phosphatase \< 5 times ULN, aminotransferases (AST/ALT) ≤ 3 × ULN in absence of hepatic metastasis or ≤ 5 if presence of hepatic lesions 3. Cockcroft glomerular filtration rate \> 50 ml/min 4. Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour 7. No contraindication to Iodine contrast media injection during CT 8. For female patients of childbearing potential, negative pregnancy test within 14 days before starting the study drug. Men and women are required to use adequate birth control during the study (when applicable), 9. Signed and dated informed consent, 10. Ability to comply with the study protocol, in the Investigator's judgment. 11. Registration in a national health care system (CMU included). Exclusion Criteria: 1. Diagnosis of additional malignancy within 2 years prior to the inclusion (exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical and/or bladder cancer), 2. Current participation in a study of an investigational agent or in the period of exclusion 3. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial ; 4. Patient under judicial protection (curators, autorship) and/or deprived of freedom, 5. Previous exposition to regorafenib or anti-angiogenic treatment other than bevacizumab and aflibercept 6. Treatment with any other investigational medicinal product within 28 days prior to study entry, EXCEPT for ASPIRIN, 7. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 3 weeks, 8. Chronic treatment with drug potentially interacting with regorafenib i.e. CYP3A4, CYP2C9 or UGT1A9 (UDP-glucuronosyltransferase 1-9) inductor/inhibitor; Epileptic disorder requiring medication; Recent or concomitant treatment with brivudine, 9. Complete deficit in dihydropyrimidine dehydrogenase (DPD), 10. Known hypersensitivity to any of the study drugs, study drug classes or excipient in the formulation: * History of severe and unexpected reactions to fluoropyrimidine therapy, * History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, * Mastocytosis, for whom the use of acetylsalicylic acid can cause severe hypersensitivity reactions, 11. Unresolved toxicity higher than CTCAE (v5) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neuropathy ≤ Grade 2, 12. Subject unable to swallow oral medications or any malabsorption condition, 13. Inadequate organ functions: * known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition * Congestive Heart Failure ≥ New York Heart Association (NYHA) class 2, * Myocardial infarction less than 6 months before start of study drug, unstable angina (anginal symptoms at rest), new-onset angina (begun within the last 3 months), Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted), * Uncontrolled hypertension (defined by systolic blood pressure ≥ 150 mmHg and/or diastolic pressure ≥ 100 mmHg despite optimal medical management), or history of hypertensive crisis, or hypertensive encephalopathy * Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE grade 2 dyspnea), * Interstitial lung disease with ongoing signs or symptoms, * Ongoing infection \>grade 2 CTCAE V5, * Dehydration CTCAE v5 grade ≥1, * Urinary tract obstruction 14. Constitutional or acquired hemorrhagic disease: * Any haemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication, * History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to inclusion, * Serious, Non-healing wound, active peptic ulcer or untreated bone fracture, * Major surgical procedure, open biopsy or significant traumatic injury within 28 days before start of study medication, 15. Planned surgical procedure within the first month of treatment or any procedure that might change the timing of regorafenib administration during the first month of treatment, 16. Known History of human immunodeficiency virus (HIV) infection; Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy, 17. Receipt of yellow fever vaccine within 28 days prior to study, 18. History of organ allograft, 19. Pregnant or breast-feeding subjects **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Angélique VIENOT, Dr **Phone:** +33 370632278 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Christophe BORG, Pr **Role:** CONTACT #### Locations **Location 1:** **City:** Auxerre **Contacts:** ***Contact 1:*** - **Name:** Anne VILLING, Dr - **Role:** CONTACT **Country:** France **Facility:** CHU d'Auxerre **Location 2:** **City:** Besançon **Contacts:** ***Contact 1:*** - **Name:** Angélique VIENOT, Dr - **Role:** CONTACT **Country:** France **Facility:** Centre Hospitalier Universitaire de Besançon **Zip:** 25000 **Location 3:** **City:** Colmar **Contacts:** ***Contact 1:*** - **Name:** Marion BOLLIET, Dr - **Role:** CONTACT **Country:** France **Facility:** CH de Colmar **Location 4:** **City:** Dijon **Contacts:** ***Contact 1:*** - **Name:** François GHIRINGHELLI, Pr - **Role:** CONTACT **Country:** France **Facility:** Centre Georges-François Leclerc (CGFL) **Location 5:** **City:** Metz **Contacts:** ***Contact 1:*** - **Name:** Theo LEGRAND, Dr - **Role:** CONTACT **Country:** France **Facility:** Hôpital Robert Schuman **Location 6:** **City:** Montbéliard **Contacts:** ***Contact 1:*** - **Name:** Christophe BORG, Pr - **Role:** CONTACT **Country:** France **Facility:** Hôpital Nord Franche-Comté **Location 7:** **City:** Montpellier **Contacts:** ***Contact 1:*** - **Name:** Eric ASSENAT, Dr - **Role:** CONTACT **Country:** France **Facility:** CHU de Montpellier **Location 8:** **City:** Reims **Contacts:** ***Contact 1:*** - **Name:** Olivier BOUCHE, Dr - **Role:** CONTACT **Country:** France **Facility:** CHU de Reims - Hôpital Robert Debré **Location 9:** **City:** Strasbourg **Country:** France **Facility:** Clinique Privée de Strasbourg **Location 10:** **City:** Strasbourg **Contacts:** ***Contact 1:*** - **Name:** Meher BEN ABDELGHANI, Dr - **Role:** CONTACT **Country:** France **Facility:** ICANS ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - 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: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Antipy - Name: Antipyretics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: LOW - As Found: Unknown - ID: M377 - Name: Capecitabine - Relevance: LOW - As Found: Unknown - ID: M4548 - Name: Aspirin - Relevance: LOW - As Found: Unknown - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425120 **Brief Title:** Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease **Official Title:** Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial #### Organization Study ID Info **ID:** 2023-ZX074 #### Organization **Class:** OTHER_GOV **Full Name:** China National Center for Cardiovascular Diseases ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** China National Center for Cardiovascular Diseases #### Responsible Party **Investigator Affiliation:** China National Center for Cardiovascular Diseases **Investigator Full Name:** Jing Li **Investigator Title:** JingLi, MD, PhD, professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This trials aims to assess, in 240 eligible patients with coronary heart disease, the effects on level of high-sensitivity C-reactive protein (hsCRP) changes from baseline to 12 weeks of Xuesaitong Soft Capsules. **Detailed Description:** In this multicenter, randomized, double-blind, placebo-controlled trial in patients with coronary heart disease,240 eligible patients aged ≥18 years will be randomized to receive placebo or Xuesaitong Soft Capsules(1.32g/d) and be followed up for 3 months. The primary endpoint of this study is hsCRP change from baseline to 3 months. The secondary endpoint is the changes of following indicators or scores from baseline to 3 months:(Ⅰ)other inflammation indicators except for hsCRP. (Ⅱ) inhibition of platelet aggregation; (Ⅲ)endothelial function indicators; (Ⅳ)blood lipid levels; (Ⅴ) seattle angina questionnaire score; (Ⅵ)36-item short form health survey score. The safety of using Xuesaitong soft capsules in patients with coronary heart disease will also be evaluated. The generalized linear mixed effects model will be used to evaluate the efficacy endpoint for the "full analysis set". For the safety analysis set, Chi-square test will be used to evaluate the safety endpoint. ### Conditions Module **Conditions:** - Coronary Heart Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each participant in the Xuesaitong Soft Capsule treatment group will take a daily dose of 1.32g. **Intervention Names:** - Drug: Xuesaitong Soft Capsule **Label:** Xuesaitong Soft Capsule **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Each participant in the placebo group will take matching placebo. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Xuesaitong Soft Capsule **Description:** Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g. **Name:** Xuesaitong Soft Capsule **Other Names:** - LixuwangⓇ **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Each participant in the placebo group will take matching placebo. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks **Measure:** hsCRP **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Changes in levels of interleukin-6, interleukin-10, interleukin-1β, tumor necrosis factor-α from baseline at 12 weeks **Measure:** Other inflammation indicators **Time Frame:** 12 weeks **Description:** Changes in level of inhibition of platelet aggregation from baseline at 12 weeks **Measure:** IPA **Time Frame:** 12 weeks **Description:** Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks **Measure:** Vascular endothelial function **Time Frame:** 12 weeks **Description:** Changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, small low-density lipoprotein cholesterol, and triglyceride levels from baseline at 12 weeks **Measure:** Blood lipid profiles **Time Frame:** 12 weeks **Description:** Changes in Seattle angina scores from baseline at 12 weeks **Measure:** Seattle Angina Questionnaire **Time Frame:** 12 weeks **Description:** Changes in Health Survey Scale (SF-36 Scale) scores from baseline at 12 weeks **Measure:** SF-36 **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years old 2. Chronic coronary artery disease: meet any of the following conditions, and the condition is stable for at least 6 months: 1. History of myocardial infarction 2. Have received coronary interventional therapy 3. There are symptoms of myocardial ischemia (such as chest pain) and objective evidence (stress electrocardiogram or stress myocardial perfusion imaging indicated myocardial ischemia or coronary artery stenosis ≥50% ) 3. High-sensitivity C-reactive protein ≥2mg/L 4. Currently taking moderate or above intensity statins lipid-lowering drugs 5. Currently taking antiplatelet drugs 6. Sign informed consent Exclusion Criteria: * Patients fulfilling any of the following criteria are not eligible for inclusion in this trial: 1. Acute coronary syndrome occurred or received percutaneous coronary intervention therapy within the past 6 months 2. Previously received coronary artery bypass grafting 3. Stroke occurred within the previous 6 months 4. Symptomatic heart failure (HF) in the past, or documented left ventricular ejection fraction \< 35% 5. Revascularization or surgical procedures are planned within the next 3 months 6. Progressive neuromuscular disease, or creatine kinase (CK) levels \> 3 times the normal upper limit (ULN) 7. Lupus, inflammatory bowel disease, severe arthritis and other inflammatory diseases 8. Immunosuppressants such as cyclosporine, tacrolimus, azathioprine, or systemic steroids are currently being taken or planned during the study 9. History of hereditary dyslipidemia such as familial hypercholesterolemia 10. There has been a change in lipid regulation treatment within the past 1 month, or there is a current adjustment plan 11. History of symptomatic non-traumatic cerebral hemorrhage at any time in the past 12. History of gastrointestinal bleeding or major surgery within the past 6 months 13. Use of Xuesaitong soft capsules or preparations containing the main ingredients of Xuesaitong in the past 1 month 14. There were clear adverse reactions to the main components of Xuesaitong in the past 15. Active liver disease, or alanine aminotransferase (ALT) levels \> 3 times the upper limit of normal (ULN) 16. Chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<60ml/ (min×1.73m2) 17. Pregnancy or planned pregnancy, or breastfeeding 18. Malignant tumors, or other serious diseases with an estimated survival of less than 1 year 19. Mental disorders or communication disorders, cognitive impairment, or other serious medical conditions that may affect study participation 20. Have participated in or are participating in other clinical trials within the last 1 month 21. Poor adherence to follow-up or medication is known **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jing Li, MD, PhD **Phone:** +86 (010) 6086 6077 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yan Li, MD **Phone:** +86 (010) 6086 6795 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ying Sun, BA - **Phone:** 18310888612 - **Role:** CONTACT **Country:** China **Facility:** Fuwai Hospital, Chinese Academy of Medical Sciences **State:** Beijing **Zip:** 100087 #### Overall Officials **Official 1:** **Affiliation:** National Center for Cardiovascular Diseases **Name:** Jing Li, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** National Center for Cardiovascular Diseases **Name:** Jiamin Liu, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Heart Disease - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Heart Disease - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Heart Disease - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular 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 ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases - ID: D000003327 - Term: Coronary Disease - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425107 **Acronym:** Bacon-Pocus **Brief Title:** Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection **Official Title:** Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection #### Organization Study ID Info **ID:** CET 23-2024 #### Organization **Class:** OTHER **Full Name:** Vittore Buzzi Children's Hospital ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Vittore Buzzi Children's Hospital #### Responsible Party **Investigator Affiliation:** Vittore Buzzi Children's Hospital **Investigator Full Name:** Anna Camporesi **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:** Prospective, observational multicentric study which aims at identifying lung POCUS (Point of Care UltraSound) findings associated with failure of noninvasive ICU-LRS (Intensive Care Unit Level Respiratory Support) (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI (Low Respiratory Tract Infection) and at identifying lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later. **Detailed Description:** Lower respiratory tract infections, primarily viral bronchiolitis, are a common cause of PICU admission for infants. While overall hospitalization rates for bronchiolitis are declining, ICU admission rates are actually increasing. The trend in respiratory management of critically ill infants with LRTIs has shifted from frequent invasive mechanical ventilation to more common use of non-invasive modalities, including CPAP, BiPap, and HFNC. Currently, the overwhelming majority of infants requiring ICU-level respiratory support (ICU-LRS) for bronchiolitis receive only noninvasive support. During the past decade, point-of-care lung ultrasound (POCUS) is increasingly being used in both adults and children to enhance diagnostic and prognostic ability in respiratory failure. Lung POCUS is appealing due to the lack of radiation exposure compared to x-rays, the added sensitivity and specificity that it can add compared to traditional imaging to help differentiate consolidation from atelectasis from edema (may all have similar appearance on x-rays), the dynamic nature of the study to evaluate the lung parenchyma, pleura, and diaphragm, and the fact that it can be easily applied and repeated at the bedside to guide adjustments to therapies and evaluate their response. Lung POCUS differs from traditional radiology-based lung ultrasound in that it is focused and goal-directed, is frequently performed serially by the clinician managing the patient at the bedside, and is frequently used to immediately direct care decisions in real-time. While lung POCUS is quickly becoming a standard of care for adults with respiratory failure, pediatric data, particularly in critically ill infants with bronchiolitis and other lower respiratory tract infections (LRTI) is largely lacking. Investigators from some sites within the BACON research group have begun to evaluate the role of lung POCUS in infants with bronchiolitis. These studies have primarily focused on the emergency department, but they have identified POCUS findings that are associated with clinical deterioration and have developed a pediatric lung ultrasound score that can predict infants who will require ICU-LRS. There are only two pediatric ICU bronchiolitis studies-one looking at the lung/pleura but in invasively ventilated patients only, and the other focused on the diaphragm in patients requiring noninvasive support. Unfortunately, there are minimal data on infants in the ICU with bronchiolitis, and all of these prior studies are limited by low sample size. Thus, there is a significant knowledge gap about the ability of lung POCUS and these previously identified findings and scoring systems to accurately predict failure of noninvasive ICU-LRS for infants in the ICU with bronchiolitis and other LRTIs. Furthermore, there are no data evaluating the role of lung POCUS in identifying patients who will have a favorable response to adjustments in ICU-LRS settings. Endpoints of the study are: 1, To identify lung POCUS findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI. 2. To identify lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later. There are no specific safety endpoints for this observational study. Families could end participation by their infant at any time, and the treating physician or investigator could withdraw the patient from the study but there are no pre-specified safety endpoints. ### Conditions Module **Conditions:** - Bronchiolitis - Noninvasive Ventilation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Ultrasound findings will be graded according to the scale proposed by the Italian Academy of thoracic Ultrasound: 0: normal A lines 1. short vertical artifacts and isolated B lines 2. multiple B lines (B lines with a distance of less than half centimeter to the confluence, remaining identifiable from each other) 3. white lung (subpleural field with various shades of grey/white without distinguishing B lines) and subpleural consolidations smaller than 1 cm 4. subpleural consolidations bigger than 1 cm **Measure:** Lung Ultrasound findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI. **Time Frame:** First 24 hours after ICU admission ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age \<1 year at the time of hospital admission 2. Admission to PICU for suspected/confirmed LRTI 3. Treatment (within the 1st 12 hours of ICU stay) with noninvasive ICU-LRS for respiratory failure (HFNC \>1L/kg/min, negative pressure, or noninvasive PPV via any interface (CPAP, BiPap, NIMV, etc.) Exclusion Criteria: 1. Invasive ventilation as initial support or within the 1st 12 hours of ICU stay, either via endotracheal tube or tracheostomy 2. Upper respiratory symptoms only (stridor, stertor) 3. Corrected gestational age \<37 weeks at time of ICU admission 4. ICU-LRS for only nonrespiratory reasons (e.g. shock) or for pulmonary edema felt to be solely due to noninfectious causes (cardiogenic, airway obstruction, drowning). Patients presenting with apnea can be included if they have a diagnosis of bronchiolitis or other LRTI 5. Prior inclusion in the study **Maximum Age:** 12 Months **Minimum Age:** 0 Months **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Infants \<1 year old admitted to the ICU for bronchiolitis and other lower respiratory tract infection who require noninvasive respiratory support ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Anna Camporesi, MD **Phone:** +393355793744 **Role:** CONTACT #### Locations **Location 1:** **City:** Milano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Anna Camporesi, MD - **Phone:** +393355793744 - **Role:** CONTACT **Country:** Italy **Facility:** Vittore Buzzi Children's Hospital **Status:** RECRUITING **Zip:** 20154 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Caiulo VA, Gargani L, Caiulo S, Fisicaro A, Moramarco F, Latini G, Picano E. Lung ultrasound in bronchiolitis: comparison with chest X-ray. Eur J Pediatr. 2011 Nov;170(11):1427-33. doi: 10.1007/s00431-011-1461-2. Epub 2011 Apr 6. **PMID:** 21468639 **Citation:** Gori L, Amendolea A, Buonsenso D, Salvadori S, Supino MC, Musolino AM, Adamoli P, Coco AD, Trobia GL, Biagi C, Lucherini M, Leonardi A, Limoli G, Giampietri M, Sciacca TV, Morello R, Tursi F, Soldati G, Ecobron Group. Prognostic Role of Lung Ultrasound in Children with Bronchiolitis: Multicentric Prospective Study. J Clin Med. 2022 Jul 21;11(14):4233. doi: 10.3390/jcm11144233. **PMID:** 35887997 **Citation:** Musolino AM, Toma P, De Rose C, Pitaro E, Boccuzzi E, De Santis R, Morello R, Supino MC, Villani A, Valentini P, Buonsenso D. Ten Years of Pediatric Lung Ultrasound: A Narrative Review. Front Physiol. 2022 Jan 6;12:721951. doi: 10.3389/fphys.2021.721951. eCollection 2021. **PMID:** 35069230 **Citation:** Amendolea A, Gori L, Adamoli P, Limoli G, Supino MC, Coco AD, Trobia GL, Tursi F, Soldati G, Buonsenso D; Gruppo di studio Pediatrico AdET. Pleuropulmonary Ultrasound in Pediatrics: Proposal of a Reporting Model From the Academy of Thoracic Ultrasound. J Ultrasound Med. 2022 Oct;41(10):2637-2641. doi: 10.1002/jum.15924. Epub 2021 Dec 29. **PMID:** 34964991 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000001991 - Term: Bronchitis - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5264 - Name: Bronchiolitis - Relevance: HIGH - As Found: Bronchiolitis - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: HIGH - As Found: Respiratory Tract Infections - ID: M5267 - Name: Bronchitis - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001988 - Term: Bronchiolitis - ID: D000012141 - Term: Respiratory Tract Infections ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425094 **Acronym:** Tetrasol **Brief Title:** Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function **Official Title:** Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function #### Organization Study ID Info **ID:** 5162 #### Organization **Class:** OTHER **Full Name:** Colorado State University ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Colorado State University #### Responsible Party **Investigator Affiliation:** Colorado State University **Investigator Full Name:** Tiffany Weir **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will be conducted to determine the effect of daily Tetradesmus Dimorphus by Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS) as primary outcome measures. The investigators also intend to explore fecal and blood biomarkers of intestinal permeability/function, determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers, establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance, explore the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition as secondary outcomes. **Detailed Description:** 1. Total number of subjects who will be approached (including screen fails, controls, and subject withdrawals) to reach enrollment numbers for the lifetime of the study for this investigator's site: 100-125 2. Total number of subjects to be enrolled at this site: The investigators plan to enroll 60 participants for a target completion of 50 participants (25/arm). Enrolling 60 individuals allows for a conservative 20% attrition rate. This is the first human study of the commercial product Tetrasol, which looks at intestinal health outcomes. Therefore, this will be considered a pilot study, and the data will allow us to determine the appropriate sample size for a statistically powered study to identify differences in gastrointestinal health between Tetrasol consumers and placebo. 3. Brief Description/justification for the proposed sample size in lay terms: The investigators have no human data related to our primary outcome measures for this product. Therefore, investigators propose a pilot study of 25 individuals in each study group. 4. Before the start of enrollment, 60 subjects will be randomly assigned using a random number generator. Upon enrollment, each subject will be assigned either intervention A or B, according to the randomization chart. 5. The study will be a double-blind, placebo-controlled study. Neither the investigators nor the participants will have knowledge of the contents of the capsules. The capsules will be labeled by Microphyt personnel who are not directly involved in the study, and they will maintain the code. Unlike the intervention capsules, the placebo does not contain rapeseed oil and calcium, as the product manufacturer developed these formulations. They wished to keep the placebo formula the same as the formula previously used in their in vitro assays and other clinical work for more equitable comparisons across studies. CSU clinical personnel will administer the two intervention capsules to the subjects according to the randomization strategy and will not be provided with the code for intervention groups until after all data analysis has been completed. In a very unlikely case of a severe adverse event (which is an event that requires the subject's hospitalization), the medical personnel will be provided information about the content of the capsules taken by the participant directly by the Microphyt personnel. The code will not be broken to the investigators until after all data has been analyzed and submitted as a preliminary report. A. Recruitment: Recruitment advertisements will be placed in the Coloradoan and other newspapers/newsletters as relevant and will be sent out electronically through the CSU faculty and administrative professionals list on the CSU State Classified list. The investigators will reach out to graduate students and undergraduates by sending the recruitment email to the appropriate administrative personnel in each department (i.e., Grad coordinators and academic success coordinators) and have them forward the study information to their students. Flyers will be posted and distributed throughout the CSU campus and at targeted locations within the community, including UC Health doctor's offices. Flyers will be sent out as direct mailers to individuals in the community; their names and addresses will be purchased from a reputable company that provides names and addresses of individuals in this age range (Alesco Data, http://www.alescodata.com/). To increase participant diversity, investigators will also reach out to student groups on campus, including the Adult Learner and Veterans Services, Asian Pacific American Cultural Center, Black/African American Cultural Center, El Centro, Native American Cultural Center, Pride Resource Center, and Women and Gender Advocacy Center, and cultural groups off campus such as the BIPOC Alliance. Finally, investigators will also contact individuals in our clinical database who participated in previous studies and indicated a willingness to be contacted for future studies. B. Screening Procedures or Interview/questionnaire: After a preliminary telephone screening (questionnaire attached), volunteers will undergo an in-person screening (visit 1) and provide written informed consent. A questionnaire will assess medical and health history and demographic information, followed by an anthropometric assessment (height, weight, waist, and hip circumferences). C. Informed consent process and timing of obtaining consent. Potential participants determined to be eligible through telephone screening will be emailed a copy of the consent form and asked to read it before their screening visit. At the screening visit, the study coordinator or other study personnel will review the consent form and encourage the participants to ask any questions about participation in the study. Study personnel conducting the consenting process will assess the ability of the individual to provide informed consent. They will also ensure that all participants know that consent can be withdrawn anytime. On the first visit (Screening, visit 1), after the participant receives a verbal and written explanation of the project and after the participant provides informed consent, investigators will assess the participant's medical and health history and dietary intake. The investigators will measure the participant's height, weight, and waist and hip circumferences. If the participant qualifies for our study, the participant will be scheduled for the second visit (Baseline, Visit 2). The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the next study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection prior to the next study visit. During the second visit (Baseline Visit, visit 2), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist, and hip circumferences will be measured. The participant will participate in the cold pressor test, which involves immersing the participant's hand in ice water for 2 and a half minutes while the participant's blood pressure is assessed. The investigators will provide the participants with daily dosing/treatment records and diet records, and the participants will complete sleep, physical activity, gastrointestinal, and mental health questionnaires. The investigators will perform a blood draw and collect the participant's saliva. The participant will then be scheduled for the participant's next appointment and given a 2-week supply of the participant's randomly assigned treatment capsules. This is a double-blind study, meaning neither the participant nor the investigators will know which treatment the participant has been assigned to take. The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the next study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection before the next study visit. The participant will also be provided with monetary compensation. During the participant's third visit (Midpoint Visit, Visit/Week 2), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist and hip circumferences, supine blood pressure, and heart rate will be measured. The investigators will check the participant's daily dosing/treatment records and diet records and perform a physical activity questionnaire. The investigators will perform a blood draw and collect the participant's saliva. The investigators will review the participant's gastrointestinal and mental health questionnaires. The participant will then be scheduled for the participant's next appointment and given the participant's final allocation of the participant's assigned treatment capsules. The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the final study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection before the next study visit. The participant will also be provided with monetary compensation. During the participant's fourth visit (Final Visit, visit 4, Week 4), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist, and hip circumferences will be measured. The investigators will check the participant's daily dosing/treatment records and diet records and perform a physical activity questionnaire. The investigators will perform a blood draw and collect the participant's saliva. The participant will also be subjected to an acute stress test, during which the participant will alternate between placing the participant's hand in ice-cold water for 2 and a half minutes while the participant's blood pressure is assessed. This additional test is non-invasive, and the entire test (with an included instructional period) will last approximately 30 minutes. The investigators will review the participant's gastrointestinal and mental health questionnaires. The participant will be provided with monetary compensation and will have completed the study. ### Conditions Module **Conditions:** - Gastrointestinal Problem - Anxiety - Stress - Gastrointestinal Symptoms **Keywords:** - Tetradesmus Dimorphus - Gastrointestinal Symptoms - Anxiety - Stress - Gastrointestinal Problem - Bowel Habits ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, parallel arm, double-blind, placebo-controlled diet intervention ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tetradesum dimorphus by Tetrasol extract, maltodextrin, vegetable magnesium stearate, dicalcium phosphate, hydrogenated rapeseed oil, hydroxypropylmethylcellulose **Intervention Names:** - Dietary Supplement: Microalgae Extract Capsules **Label:** Microalgae extract capsules **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** maltodextrin, vegetable magnesium stearate **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Microalgae extract capsules **Description:** Tetradesum dimorphus by Tetrasol extract(50mg per capsule) **Name:** Microalgae Extract Capsules **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** maltodextrin \& vegetable magnesium stearate **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze. **Measure:** The effect of daily Tetradesmus Dimorphus by Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS) **Time Frame:** 4weeks **Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze. **Measure:** Exploration fecal and blood biomarkers of intestinal permeability/function **Time Frame:** 4 Weeks **Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze. **Measure:** Determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers **Time Frame:** 4 Weeks **Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze. **Measure:** Establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance **Time Frame:** 4 Weeks **Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze. **Measure:** Exploration of the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition **Time Frame:** 4 Weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy, normal to overweight (BMI of 18.0-29.9) adults between 18-55 years of age with mild to moderate gastrointestinal distress confirmed by one positive response to the Rome IV criteria (Appended). Exclusion Criteria: * BMI \>30.0 or \<18.0 * Smoking or other use of tobacco products * Diagnosed intestinal diseases such as Celiac, Crohn's Disease, Ulcerative Colitis, or Gastrointestinal Cancers * Pregnant or breastfeeding individuals * Regular use of NSAIDs or MAO inhibitors * Clinically diagnosed mental health disorders (clinical depression, bipolar disorder, etc.) **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tiffany L Weir, MSc,PhD **Phone:** (970) 491-4631 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sarah A Johnson, RDN,MS,PhD **Phone:** (970) 491-3807 **Role:** CONTACT #### Locations **Location 1:** **City:** Fort Collins **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tiffany L Weir, MSc,PhD - **Phone:** 970-491-4631 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sarah A Johnson, RDN,MS,PhD - **Phone:** (970) 491-3807 - **Role:** CONTACT **Country:** United States **Facility:** Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University **State:** Colorado **Status:** RECRUITING **Zip:** 80526 #### Overall Officials **Official 1:** **Affiliation:** Colorado State University **Name:** Tiffany L Weir, MSc,PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Merchant RE, Andre CA. A review of recent clinical trials of the nutritional supplement Chlorella pyrenoidosa in the treatment of fibromyalgia, hypertension, and ulcerative colitis. Altern Ther Health Med. 2001 May-Jun;7(3):79-91. **PMID:** 11347287 **Citation:** Avila-Roman J, Talero E, Alcaide A, Reyes Cde L, Zubia E, Garcia-Maurino S, Motilva V. Preventive effect of the microalga Chlamydomonas debaryana on the acute phase of experimental colitis in rats. Br J Nutr. 2014 Oct 14;112(7):1055-64. doi: 10.1017/S0007114514001895. Epub 2014 Sep 5. **PMID:** 25192306 **Citation:** Avila-Roman J, Talero E, Rodriguez-Luna A, Garcia-Maurino S, Motilva V. Anti-inflammatory effects of an oxylipin-containing lyophilised biomass from a microalga in a murine recurrent colitis model. Br J Nutr. 2016 Dec;116(12):2044-2052. doi: 10.1017/S0007114516004189. Epub 2016 Dec 27. **PMID:** 28025954 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425081 **Acronym:** VIAB2L **Brief Title:** Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health of Healthy Adult Women (The VIAB2L Project) **Official Title:** Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health (The VIAB2L Project) #### Organization Study ID Info **ID:** 2023-07-14-VIAB #### Organization **Class:** INDUSTRY **Full Name:** DSM Nutritional Products, Inc. ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Universiteit Antwerpen #### Lead Sponsor **Class:** INDUSTRY **Name:** DSM Nutritional Products, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut and vaginal microbiome and metabolomics. It will also learn about the safety of the investigational product. The main questions it aims to answer are: Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome? Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome? Researchers will compare the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination to a placebo (a look-alike substance that contains no drug) to see if they can change gut and vaginal microbiome. Intervention period is 28 days. **Detailed Description:** The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut and vaginal microbiome and metabolomics. It will also learn about the safety of the investigational product. Participants are healthy adult females of reproductive age and will take the investigational products for 28 days. There will be several non-invasive measurements, including but not limited to gut microbiome measured in faecal samples and vaginal microbiome measured in vaginal samples. They will fill some questionnaires about their general health. The investigational product is a probiotic strain (1 billion CFU), colon-delivered riboflavin,(10mg) and their combination. Participants will: Take the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination or a placebo every day for 28 days. Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their bowel habits and provide fecal and vaginal sample at visits. ### Conditions Module **Conditions:** - Microbial Colonization **Keywords:** - Probiotic - vitamin - Riboflavin - Vitamin B2 - lactobacillus - microbiome - gut microbiome - vaginal microbiome - women's health - gut health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Double-blinded, randomized and placebo-controlled clinical trial ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The study will double blinded **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Probiotic strain, 1B CFU per day for 28 days in capsule format **Intervention Names:** - Dietary Supplement: Limosilactobacillus reuteri AMBV339 **Label:** L. reuteri AMBV339 (1x109 CFU per capsule) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 73 mg colon delivered riboflavin containing 10 mg pure riboflavin **Intervention Names:** - Dietary Supplement: Humiome B2 **Label:** Humiome B2 **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Combination of Arm 1 and Arm 2 **Intervention Names:** - Dietary Supplement: L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2 **Label:** L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2 **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Microcrystalline cellulose **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - L. reuteri AMBV339 (1x109 CFU per capsule) **Description:** Limosilactobacillus reuteri AMBV339 is a probiotic strain **Name:** Limosilactobacillus reuteri AMBV339 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Humiome B2 **Description:** Colon-delivered Riboflavin **Name:** Humiome B2 **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2 **Description:** Combination of supplements used in arm 1 and 2 **Name:** L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2 **Type:** DIETARY_SUPPLEMENT #### Intervention 4 **Arm Group Labels:** - Placebo **Description:** Microcrystalline cellulose **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Other Outcomes **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the excreted levels of riboflavin (in urine). Comparisons will be made between the active groups and with placebo. **Measure:** Excreted levels of riboflavin (in urine) **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of 28 days of supplementation with either Humiome B2 or L. reuteri AMBV339 or their combination on key anti-inflammatory and cytokine markers in the vagina , assessed by ELISA (e.g., beta-defensin-1 and secretory IgA as well as a broad panel of protein biomarkers). Comparisons will be made between the active groups and with placebo. **Measure:** Immune markers **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on GIT health will be measured using the GSRS questionnaire. Comparisons will be made between the active groups and with placebo. **Measure:** General GIT health **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on general Vaginal health will measured using a Ph meter. Comparisons will be made between the active groups and with placebo. **Measure:** General Vaginal health **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Body temperature using a thermometer. Comparisons will be made between the active groups and with placebo. **Measure:** General host health: Body temperature **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Pulse rate using a pulse rate monitor. Comparisons will be made between the active groups and with placebo. **Measure:** General host health: Pulse rate **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Respiration rate by counting the number of chest rises per minute in rest mode. Comparisons will be made between the active groups and with placebo. **Measure:** General host health: Respiration rate **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Blood pressure sphygmomanometer. Comparisons will be made between the active groups and with placebo. **Measure:** General host health: Blood pressure **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on user satisfaction levels based on a simple questionnaire of 10 point scale of how they felt before and after intervention (0 being the lowest point and 10 being the highest point). Comparisons will be made between the active groups and with placebo. **Measure:** User satisfaction of investigational product **Time Frame:** day 0 - day 28 #### Primary Outcomes **Description:** 1. To investigate if daily supplementation (for 28 days) with either Humiome B2 or Limosilactobacillus reuteri AMBV339 or their combination modulate the microbiome composition (relative abundance of different taxa) in the gastrointestinal tract (GIT). Comparisons will be made between the active groups and with placebo. **Measure:** Microbiome change in GUT **Time Frame:** day 0 - day 28 #### Secondary Outcomes **Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome composition (relative abundance of different taxa) in the vagina. Comparisons will be made between the active groups and with placebo. **Measure:** Microbiome change in vagina **Time Frame:** day 0 - day 28 **Description:** 2. To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome diversity in the GIT. Comparisons will be made between the active groups and with placebo. **Measure:** Gut microbiome diversity **Time Frame:** day 0 - day 28 **Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome diversity in the vagina. Comparisons will be made between the active groups and with placebo. **Measure:** Vaginal microbiome diversity **Time Frame:** day 0 - day 28 **Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the relative abundance levels of keystone taxa in the GIT. Comparisons will be made between the active groups and with placebo. **Measure:** Keystone bacterial taxa in gut **Time Frame:** day 0 - day 28 **Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the relative abundance levels of keystone taxa in the vagina. Comparisons will be made between the active groups and with placebo. **Measure:** Keystone bacterial taxa in vagina **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either L. reuteri AMBV339 or its combination with Humiome B2 on the presence, persistence and/or engraftment of L. reuteri AMBV339 in the GIT during the intervention and 1 week after the end of supplementation. Comparisons will be made between the active groups and with placebo. **Measure:** Presence of L. reuteri AMBV339 in gut **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either L. reuteri AMBV339 or its combination with Humiome B2 on the presence, persistence and/or engraftment of L. reuteri AMBV339 in the vagina during the intervention and 1 week after the end of supplementation. Comparisons will be made between the active groups and with placebo. **Measure:** Presence of L. reuteri AMBV339 in vagina **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on co-occurrence patterns of different bacterial taxa in the GIT, with particular attention to the possible role of riboflavin as an extracellular electron transfer molecule. Comparisons will be made between the active groups and with placebo. **Measure:** co-occurrence patterns of different bacterial taxa in the Gut microbiome **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on co-occurrence patterns of different bacterial taxa in the vagina, with particular attention to the possible role of riboflavin as an extracellular electron transfer molecule. Comparisons will be made between the active groups and with placebo. **Measure:** co-occurrence patterns of different bacterial taxa in the vaginal microbiome **Time Frame:** day 0 - day 28 **Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the metabolomic profile in the GIT. Comparisons will be made between the active groups and with placebo. **Measure:** Gut metabolomic profile **Time Frame:** day 0 - day 28 **Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the metabolomic profile in the vagina. Comparisons will be made between the active groups and with placebo. **Measure:** Vaginal metabolomic profile **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the levels of riboflavin in the GIT. Comparisons will be made between the active groups and with placebo. **Measure:** levels of riboflavin in the gut **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination for 28 days on the levels of riboflavin in the vagina. Comparisons will be made between the active groups and with placebo. **Measure:** levels of riboflavin in vagina **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of 28 days of supplementation with either Humiome B2 or L. reuteri AMBV339 or their combination on the systemic levels of riboflavin (in blood). Comparisons will be made between the active groups and with placebo. **Measure:** systemic levels of riboflavin (in blood) **Time Frame:** day 0 - day 28 **Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the levels of short-chain fatty acids (SCFAs) and related metabolites in the GIT. Comparisons will be made between the active groups and with placebo. **Measure:** Short chain Fatty Acid (SCFA) levels in gut **Time Frame:** day 0 - day 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women of reproductive age (appr. 18-45 years old) * Women of self-reported good general health * Living in Flanders and speaking Dutch * Using a combination contraceptive pill (without stop week) during the study and at least three months before the study * Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements. Exclusion Criteria: * Current pregnancy or breastfeeding * Antibiotic/antimycotic use during the last three months before the study * Use of group B vitamin supplements or vitamin C during the study (record vitamin use via questionnaires) * Ketogenic diet during the study and during the last two weeks before the study * Oral and vaginal probiotic, prebiotic, and postbiotic and synbiotic supplementation during the study or recent use during the last two weeks before the study * Vaginal douching during the study * Presence of general infection * Having a reproductive disorder or current vaginal infection or vaginal symptoms (VVC, BV, AV, etc.) * Having a gastro-intestinal disorder or current GIT infections or gastrointestinal disorders (Crohn, IBS, IBD, etc.) * Having any other medical condition that gives rise to exclusion from the study according to the responsible clinician/principal investigator of the study * Participation in another clinical trial **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sarah Ahannach, Dr **Phone:** +32 3 265 32 17 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mehdi Sadaghian, Dr **Phone:** +41793074667 **Role:** CONTACT #### Locations **Location 1:** **City:** Antwerp **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sarah Lebeer, Dr - **Phone:** +32 3 265 32 85 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Veronique Verhoeven, Dr - **Phone:** +32 3 265 25 18 - **Role:** CONTACT **Country:** Belgium **Facility:** Lab of Applied Microbiology and Biotechnology, University of Antwerp **Status:** RECRUITING **Zip:** 2020 #### Overall Officials **Official 1:** **Affiliation:** University of Antwerp Department of Family Medicine and Population Health **Name:** Veronique Verhoeven, Dr **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Antwerp Department of Bioscience Engineering **Name:** Sarah Lebeer, Dr **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - 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: HIGH - As Found: Microbial Colonization - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Microbial Colonization - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: HB - Name: Herbal and Botanical - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M15085 - Name: Riboflavin - Relevance: LOW - As Found: Unknown - ID: T355 - Name: Acidophilus - Relevance: LOW - As Found: Unknown - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown - ID: T463 - Name: Riboflavin - Relevance: LOW - As Found: Unknown - ID: T470 - Name: Vitamin B2 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425068 **Acronym:** Prepicare **Brief Title:** Assessment of an Innovative Air Mattress On Critically Ill Infants **Official Title:** Assessment of an Innovative Air Mattress On Critically Ill Infants #### Organization Study ID Info **ID:** Empa PSP 5211.02071 #### Organization **Class:** OTHER **Full Name:** Empa, Swiss Federal Laboratories for Materials Science and Technology ### Status Module #### Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-04-11 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University Children's Hospital, Zurich #### Lead Sponsor **Class:** OTHER **Name:** Simon Annaheim #### Responsible Party **Investigator Affiliation:** Empa, Swiss Federal Laboratories for Materials Science and Technology **Investigator Full Name:** Simon Annaheim **Investigator Title:** Principle Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. The currently used state-of-the-art support systems consist of conventional foam mattresses. In this study, the investigators explore the effect of a newly developed air mattress with regard to contact are and reduction in the average interface pressure in infants assigned to the pediatric intensive care unit of the childrens hospital in Zurich. **Detailed Description:** The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). This results in a further prolongation of the hospital stay, additional suffering of the patient, scarring, increased mortality and morbidity, and increased healthcare costs. Infants are at particular risk since their skin hasn't matured yet and is mechanically weak, and for example neonates lack a robust stratum corneum entirely. Furthermore, the thickness of their skin is reduced by 60% when compared to skin of adults. Thus, pressure cannot be equally absorbed leading to higher tissue internal stress. PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. Contact pressure can hamper blood flow in subcutaneous areas, increasing susceptibility for pressure injuries. While sophisticated equipment to manage the interface pressure and reduce the risk of developing pressure injuries is abundant for adults, very little is designed explicitly for neonates and infants. The currently available air mattresses are not being used due to safety concerns and impracticability. Furthermore, they are designed for infants from half a year of age and, thus, not considering the low body weight of premature babies or neonates. This is why the currently used conventional foam mattresses remain first choice. However, foam mattresses are designed for optimal support of a specific weight and, therefore, making them unsuitable for the use as a one-fits-all solution in a highly heterogenic patient cohort. In addition, compressed foam gets stiffer at compressed areas, increasing the local pressure impact and, thus, PI risk. On the other hand, the structures of the hereby-developed air mattress can freely move and optimally adjust to the patient's body shape. This increases contact area, reduces the average interface pressure and blunts local pressure peaks at the areas with the most indentation, ensuring a more homogenous pressure distribution at a lower level. This ultimately is expected to result in a lower PI incidence. As a side effect, lying comfort for the patient will be increased. ### Conditions Module **Conditions:** - Skin Abnormalities - Skin; Injury, Superficial - Skin; Ulcer, Decubitus **Keywords:** - Air mattress - Skin interface pressure - Skin contact area - Lying comfort ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** The study population comprises 26 patients being exposed to the conventional foam mattress (active comparator) and the novel air mattress (experimental) for one hour each in a random order. Interface pressure and contact are will be measured by means of a pressure mattress applied on top of the support systems. The patient comfort will be assessed objectively based on vital sign readings and subjectively based on questionnaire filled by professional care personnel and parents. ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 26 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Exposure of the patient to the novel air mattress. Recording of interface pressure and contact area between the patient and the air mattress for one hour. Regular measurement of vital signs and comfort and assessment of risk to develop side effects, particularly skin pressure injuries. **Intervention Names:** - Device: Exposure of the patient to a novel air mattress. **Label:** Investigation of contact pressure distribution in a novel air mattress **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Exposure of the patient to the conventional foam mattress. Recording of interface pressure and contact area between the patient and the foam mattress for one hour. Regular measurement of vital signs and comfort and assessment of risk to develop side effects, particularly skin pressure injuries. **Intervention Names:** - Device: Exposure of the patient to a conventional foam mattress. **Label:** Investigation of contact pressure distribution in a conventional foam mattress **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Investigation of contact pressure distribution in a novel air mattress **Description:** see information provided in the "Arms" section (experimental) **Name:** Exposure of the patient to a novel air mattress. **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Investigation of contact pressure distribution in a conventional foam mattress **Description:** see information provided in the "Arms" section (active comparator) **Name:** Exposure of the patient to a conventional foam mattress. **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Quantification of interface pressure between the patient and the mattress surfaces with emphasis on data of highest pressures (median for top 25% of pressure data observed; 4th quartile of pressure data). **Measure:** Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada). **Time Frame:** baseline **Description:** Quantification of interface pressure between the patient and the mattress surfaces with emphasis on data of highest pressures (median for top 25% of pressure data observed; 4th quartile of pressure data). **Measure:** Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada). **Time Frame:** after 60 minutes of exposure to the mattress #### Secondary Outcomes **Description:** Quantification of contact are between the patient and the mattress surface. **Measure:** Contact area resulting from the exposure of patients to the supportive structures as detected by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada) **Time Frame:** baseline **Description:** Quantification of contact are between the patient and the mattress surfaces. **Measure:** Contact area resulting from the exposure of patients to the supportive structures as detected by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada) **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Measurement of heart rate obtained from clinical routine patient surveillance. **Measure:** Difference in stress assessment by means of heart rate **Time Frame:** baseline **Description:** Measurement of heart rate obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of heart rate **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Measurement of respiratory rate obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of respiratory rate **Time Frame:** baseline **Description:** Measurement of respiratory rate obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of respiratory rate **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Measurement of blood pressure obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of blood pressure (mean arterial pressure) **Time Frame:** baseline **Description:** Measurement of blood pressure obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of blood pressure (mean arterial pressure) **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Measurement of blood oxygen saturation obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of blood oxygen saturation **Time Frame:** baseline **Description:** Measurement of blood oxygen saturation obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of blood oxygen saturation **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Measurement of body temperature obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of body temperature **Time Frame:** baseline **Description:** Measurement of body temperature obtained from clinical routine patient surveillance. **Measure:** Stress assessment by means of body temperature **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Quantification of comfort level ranging from 0 \[very uncomfortable\] to 10 \[very comfortable\]. **Measure:** Comfort assessment by means of a visual analogue scale **Time Frame:** baseline **Description:** Quantification of comfort level ranging from 0 \[very uncomfortable\] to 10 \[very comfortable\]. **Measure:** Comfort assessment by means of a visual analogue scale **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Quantification of stress level ranging from 0 \[totally relaxed\] to 10 \[very stressed\]. **Measure:** Stress assessment by means of a visual analogue scale **Time Frame:** baseline **Description:** Quantification of stress level ranging from 0 \[totally relaxed\] to 10 \[very stressed\]. **Measure:** Stress assessment by means of a visual analogue scale **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Assessment of pain indicators (crying, facial expression, body tension, heart rate) ranging from 0 points (no pain indication) to 3 points (high pain indication). Total values \>5 points for premature babies and \>3 points for term babies is indicative for pain. **Measure:** Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)" **Time Frame:** baseline **Description:** Assessment of pain indicators (crying, facial expression, body tension, heart rate) ranging from 0 points (no pain indication) to 3 points (high pain indication). Total values \>5 points for premature babies and \>3 points for term babies is indicative for pain. **Measure:** Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)" **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Values range from -1 (sleepy) to 0 (attentive and calm) to +4 (belligerent). **Measure:** Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire **Time Frame:** baseline **Description:** Values range from -1 (sleepy) to 0 (attentive and calm) to +4 (belligerent). **Measure:** Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Assessment of the capillary refill time according to Jevon and Gallier (2020). **Measure:** Skin perfusion assessment by means of capillary refill time **Time Frame:** baseline **Description:** Assessment of the capillary refill time according to Jevon and Gallier (2020). **Measure:** Skin perfusion assessment by means of capillary refill time **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Identification and localisation (nose, mouth, occipital, face, ear, back, leg, foot, heel, others) of skin irregularities and evaluation of severity of irregularity (redness, partial injury of skin layers, all skin layers affected, complete tissue loss) according to clinical routine **Measure:** Skin assessment according to standard clinical procedure **Time Frame:** baseline **Description:** Identification and localisation (nose, mouth, occipital, face, ear, back, leg, foot, heel, others) of skin irregularities and evaluation of severity of irregularity (redness, partial injury of skin layers, all skin layers affected, complete tissue loss) according to clinical routine **Measure:** Skin assessment by means of questionnaire **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Assessment of delirium indicators (eye contact, purposeful actions, awareness of surroundings, communication of needs, restlessness, refusal to be comforted, hypoactivity, response time) ranging from 0 points (not indicative for delirium) to 4 points (highly indicative for delirium). A delirium state is considered from a total value of \>8 points. **Measure:** Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD) **Time Frame:** baseline **Description:** Assessment of delirium indicators (eye contact, purposeful actions, awareness of surroundings, communication of needs, restlessness, refusal to be comforted, hypoactivity, response time) ranging from 0 points (not indicative for delirium) to 4 points (highly indicative for delirium). A delirium state is considered from a total value of \>8 points. **Measure:** Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD) **Time Frame:** after 60 minutes of exposure to the mattress **Description:** Assessment of withdrawal indicators (autonomic dysfunction \[4 aspects\], overstimulation of the central nervous system \[9 aspects\], dysfunction of the gastrointestinal tract \[2 aspects\] ranging from 0 points (not detectable) to 1 point (detectable). A withdrawal state is considered from a total value of \>3 points. **Measure:** Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS) **Time Frame:** baseline **Description:** Assessment of withdrawal indicators (autonomic dysfunction \[4 aspects\], overstimulation of the central nervous system \[9 aspects\], dysfunction of the gastrointestinal tract \[2 aspects\] ranging from 0 points (not detectable) to 1 point (detectable). A withdrawal state is considered from a total value of \>3 points. **Measure:** Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS) **Time Frame:** after 60 minutes of exposure to the mattress ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Informed consent signed by the legal guardian * Admitted to the pediatric intensive care unit (PICU) * Age: late preterm (\>34 gestational age) up to 6 months * Admission at least 24 hours to PICU prior to intervention * Presence/availability of at least one parent/legal guardian Exclusion Criteria: * Life threatening condition * Patients who cannot be positioned in supine position * Skin injury at body area in contact with support surface * Patients with congenital skin disorders * Patients with omphalocele or gastroschisis * Newborns with peripartum asphyxia and hypothermia therapy * Language communication difficulties with the legal guardians * Surgical patients on the day of surgery * birth weight \<1250g **Maximum Age:** 6 Months **Minimum Age:** 10 Days **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Simon Annaheim, PhD **Phone:** +41 58 765 77 68 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Barbara Brotschi, Prof **Phone:** +41 44 266 71 71 **Role:** CONTACT #### Locations **Location 1:** **City:** Zurich **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Barbara Brotschi, Prof - **Phone:** +41 44 266 71 71 - **Role:** CONTACT **Country:** Switzerland **Facility:** University Children's Hospital Zurich **Status:** RECRUITING **Zip:** 8032 #### Overall Officials **Official 1:** **Affiliation:** Universitäts-Kinderspital Zürich, Zurich **Name:** Barbara Brotschi, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data will be made available upon request for scientific analysis of the data. Research objectives and data analysis plan needs to be provided. **Description:** It is intended to publish the study in an open-access journal by December 2024. With this, the raw data of the interface pressure and contact area measurements will be made available upon request and fulfilling the access criteria as indicated below. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Data as indicated in the plan description will be available upon publication of the data Data will be available for an unlimited period of time. ### References Module #### References **Citation:** Jevon P, Gallier H. How to measure capillary refill time in patients who are acutely ill. Nursing Times [online]. 2020; 116(8): 29-30. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000013 - Term: Congenital Abnormalities - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6870 - Name: Pressure Ulcer - Relevance: HIGH - As Found: Skin; Ulcer, Decubitus - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M19010 - Name: Critical Illness - Relevance: LOW - As Found: Unknown - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M15672 - Name: Skin Abnormalities - Relevance: HIGH - As Found: Skin Abnormalities - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012868 - Term: Skin Abnormalities - ID: D000003668 - Term: Pressure Ulcer ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06425055 **Acronym:** ALPESTRIA-1 **Brief Title:** Vonafexor ALPort Syndrome Efficacy & Safety TRIAl-1 (ALPESTRIA-1) **Official Title:** Vonafexor Fixed Dose-escalation Safety and Proof-of-concept Study in Patients With at Risk of Progression Alport Syndrome #### Organization Study ID Info **ID:** EYP001-208 #### Organization **Class:** INDUSTRY **Full Name:** Enyo Pharma ### Status Module #### Completion Date **Date:** 2025-10-13 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-04 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-06 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Enyo Pharma #### 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 study is a proof-of-concept trial of vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome. **Detailed Description:** This is a multicenter study and several clinical sites and countries will be involved. This single arm, fixed dose escalation, open-label, non-randomized study will evaluate three dose levels of vonafexor on safety, tolerability and their effect on kidney function and renal biomarkers in 20 patients with AS at risk of progression. The total duration of study for a participant will be up to 40 weeks and include a screening period, a treatment period of 24 weeks and a follow-up period of 12 weeks. ### Conditions Module **Conditions:** - Alport Syndrome ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single arm fixed dose escalation ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is a single arm fixed dose escalation with three dose levels of vonafexor, all QD. **Intervention Names:** - Drug: Vonafexor **Label:** Single arm fixed dose escalation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Single arm fixed dose escalation **Description:** * One tablet of a low dose of vonafexor QD from Day 1 to Week 4 * One tablet of a medium dose of vonafexor QD from Week 5 to Week 8 * One tablet of a high dose of vonafexor QD from Week 9 to Week 24 **Name:** Vonafexor **Other Names:** - EYP001a **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** To determine the effect of vonafexor on and off treatment on exploratory renal biomarkers **Measure:** Change in albuminuria **Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline **Description:** To determine the effect of vonafexor on and off treatment on exploratory renal biomarkers **Measure:** Change in proteinuria **Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline **Description:** To determine the effect of vonafexor on and off treatment on exploratory renal biomarkers **Measure:** Change in Neutrophil Gelatinase Associated Lipocalin (NGAL) **Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline #### Primary Outcomes **Description:** To assess the safety and tolerability of vonafexor **Measure:** Number of Treatment-Emergent Adverse Event (TEAE) **Time Frame:** From first dose of treatment until 2 weeks after last dose of treatment, i.e assessed up to 26 weeks #### Secondary Outcomes **Description:** To determine the on with the off-treatment effect of three dose levels of vonafexor on renal function **Measure:** Change in eGFR **Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline **Description:** To determine vonafexor plasma concentrations levels **Measure:** Vonafexor plasma concentrations **Time Frame:** During on-treatment period, assessed up to 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed informed consent (also for legal representatives, as applicable in the US for under eighteen patients). * Has confirmed diagnosis of Alport syndrome: clinical diagnosis (haematuria, family history, hearing loss, ocular change) OR a kidney biopsy showing glomerular basement membrane abnormalities consistent with AS, AND Genetic confirmation of AS. * Has eGFR between ≥ 30 and \< 90 ml/min/1.73m2. * Has increased albuminuria criteria i.e. UACR ≥ 300 mg/g. * If on an angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB), should be on a stable well tolerated treatment during at least the 60 days prior D1. * If on Sodium-Glucose Transport Protein 2 (SGLT2), should be on stable well tolerated treatment with SGLT2 during at least 60 days prior D1. * If patient has a history of arterial hypertension, should be on stable anti-hypertensive therapy for at least 60 days prior to D1 and deemed controlled by the investigator at screening and D1. * Sexually active female subjects of childbearing potential and sexually mature male subjects must use two acceptable effective methods of contraception for the entire duration of the study and for at least 6 weeks after last dose. * Has negative results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV). * Is able to understand all study procedures in the informed consent form (ICF) and willing to comply with all aspects of the protocol. Exclusion Criteria: * Is an employee of a site, clinical research organization, vendor, or sponsor involved with this study. * Is pregnant or breastfeeding. * Has participated in any investigational drug study within 60 days prior to D1. * Any clinically significant illness within 30 days before D1 or surgical or medical condition (other than Alport syndrome) that could interfere with the subject's study compliance; confound the study results; impact subject safety. * Any history of active malignancy within the last 1 year before D1. * Any other condition or circumstance that, in the opinion of the investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety and well-being. * Has a history of an allergic condition that required the prescription of an emergency epinephrine injection (such as the EpiPen® Auto-Injector). * Any prohibited co-medications within 30 days prior D1. * Has ALT or AST above near normal (\>1.5×ULN) at baseline. * Are at high risk for atherosclerotic cardiovascular disease (ASCVD) risk, with an LDL-C level \> 160 mg/dL (4.15 mmol/L) and subjects at intermediate risk for ASCVD risk, with a LDL-C level \> 190 mg/dL (4.91 mmol/L). * Has moderate or severe hepatic impairment (Child-Pugh score B or C). * Is taking CYP3A4/5 inhibitors or inducers. **Maximum Age:** 55 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Isabelle Martin **Phone:** +33 4 37 70 02 44 **Role:** CONTACT #### Locations **Location 1:** **City:** Birmingham **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr Eric Wallace - University of Alabama **State:** Alabama **Status:** NOT_YET_RECRUITING **Zip:** 35294 **Location 2:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr Anjay Rastogi - UCLA Health, David Geffen School of Medicine **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90095 **Location 3:** **City:** Boise **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr Arnold Silva - Boise Kidney & Hypertension **State:** Idaho **Status:** RECRUITING **Zip:** 83703 **Location 4:** **City:** Hinsdale **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr Suneel Udani - NANI Research **State:** Illinois **Status:** NOT_YET_RECRUITING **Zip:** 60521 **Location 5:** **City:** Saint Louis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr Tingting Li - Washington University **State:** Missouri **Status:** NOT_YET_RECRUITING **Zip:** 63110 **Location 6:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr Andrew Bomback - Columbia University Medical Center **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 60521 **Location 7:** **City:** Cleveland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr James Simon - Cleveland Clinic Foundation **State:** Ohio **Status:** NOT_YET_RECRUITING **Zip:** 44195 **Location 8:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** United States **Facility:** Dr Ankit Mehta - Renal Disease Research Institute **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 75126 **Location 9:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** France **Facility:** Pr Claire Rigothier - CHU De Bordeaux **Status:** NOT_YET_RECRUITING **Zip:** 33076 **Location 10:** **City:** Marseille **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** France **Facility:** Dr Thomas Robert - Hôpital de la Conception **Status:** NOT_YET_RECRUITING **Zip:** 13385 **Location 11:** **City:** Montpellier **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** France **Facility:** Dr Moglie Le Quintrec - Hopital Lapeyronie **Status:** NOT_YET_RECRUITING **Zip:** 34090 **Location 12:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** France **Facility:** Pr. Bertrand Knebelmann - Necker Enfants Malades **Status:** NOT_YET_RECRUITING **Zip:** 75015 **Location 13:** **City:** Berlin **Contacts:** ***Contact 1:*** - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** Germany **Facility:** Charite Universitatsmedizin Berlin **Status:** NOT_YET_RECRUITING **Zip:** 10117 **Location 14:** **City:** Göttingen **Contacts:** ***Contact 1:*** - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** Germany **Facility:** University Medicine Goettingen **Status:** NOT_YET_RECRUITING **Zip:** 37075 **Location 15:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** Spain **Facility:** Fundacio Puigvert **Status:** NOT_YET_RECRUITING **Zip:** 08025 **Location 16:** **City:** El Palmar **Contacts:** ***Contact 1:*** - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Virgen de la Arrixaca **Status:** NOT_YET_RECRUITING **Zip:** 30120 **Location 17:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** Spain **Facility:** Fundacion Jimenez Diaz **Status:** NOT_YET_RECRUITING **Zip:** 28040 **Location 18:** **City:** Sagunto **Contacts:** ***Contact 1:*** - **Name:** ENYO Pharma - **Role:** CONTACT **Country:** Spain **Facility:** Hospital De Sagunto **Status:** NOT_YET_RECRUITING **Zip:** 46520 ### IPD Sharing Statement Module **Description:** Individual participant data that underline published results might be shared upon request with researchers who provide a methodologically sound proposal and to achieve objectives as set in the approved proposal. IPD will be shared deidentified and from 3 months and ending 5 years following article publication. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** From 3 months and ending 5 years following article publication. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000014564 - Term: Urogenital Abnormalities - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000009393 - Term: Nephritis - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000000013 - Term: Congenital Abnormalities - ID: D000003095 - Term: Collagen Diseases - ID: D000003240 - Term: Connective Tissue Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M12338 - Name: Nephritis - Relevance: LOW - As Found: Unknown - ID: M12339 - Name: Nephritis, Hereditary - Relevance: HIGH - As Found: Alport Syndrome - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M17314 - Name: Urogenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney 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 - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: T303 - Name: Alport Syndrome - Relevance: HIGH - As Found: Alport Syndrome ### Condition Browse Module - Meshes - ID: D000009394 - Term: Nephritis, Hereditary - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False